OBJECTIVE TYPE QUESTIONS (02 Marks)

1. Classify hospital on clinical basis.

This type of the classification based on the diagnosis and treatment of disease; it further classified;
1. Medicine : Medicine for general Communicable disease and special medicine for psychatric disorders, TB,
orthopedic etc.
2. Surgery : It is done for the gynecologic, orthopedic patients.
3. Maternity : It deal with delivery case.
4. Pediatric : They treat disease of children.

2. What are allergic drug reactions?

Allergic drug reaction ranges from very mild reaction to anaphylaxis and death may occur after exposure to wide variety
of drugs.
1. The reaction do not resemble to the expected pharmacological effect of drug.
2. Their is delay between first exposure to drug and development of allergic reaction.
3. Allergic reaction re-occurs on repeated exposure of drugs.
eg.
Allergic responce Allergic drug
reactions
1. Anaphylaxis 1. Penicillin
2. Skin rashes 2. Barbiturates
3. Hepatitis 3. Methyldopa
4. Haemolytic anaemia 4. Penicillin,
Guanidine

3. Give two examples of Drug drug interaction.

Drug - drug interaction means when a drug can interact with another drug. They both drug act in body and cause side
effect.
Eg :
1. Aspirin + Warfarin Synergism (excess bleeding)
2. PPI + H2 blocker → Alterations ( increase pH of stomach)

4. What are the different types of Adverse drug reaction?

Adverse Drug Reaction : ADR is defined as any undesirable or unintended effect of drug treatment.
Types-
1) Excessive therapeutic effect
2) Secondary pharmacological effect.
3) Idiosyncracy.
4) Allergic reaction.
5) Genetic make up of patient.
6) Sudden withdrawal of drug.
7) Drug interaction.

5. Enumerate different professional staff in hospital pharmacy

i. Committee of Head of Department
ii. Chief Hospital pharmacist
iii. Pharmacy & therapeutic Committee
iv. Assistant chief Pharmacist
v. Secretory
vi. Staff pharmacist, Pharmacy helpers
vii. Pharmacy Student
viii. Clerk
6. Enlist the functions of hospital pharmacist.
1. He should dispense drug and medicine as per the prescription order for in and out patient.
2. He should participate in the teaching programmes for pharmacy and nursing student.
3. He should counselling to patients about the proper use of their medication.
4. He should maintain the proper records of distribution of drug.
5. He should maintain liasion between medical staff, nursing staff and patient themselves.

7. Explain legal requirement for establishment of drug store in India .

There are two type of licence are issued i)General license and ii) Restricted license
i) General license : They are granted to the person who have permission for business and who engage the service of
qualified person to supervise sale of drug store.
 License for detail sale of drug other than the Specified in schedule C, C1, X are issued in form 20 for drug specified
in C, C1 excluding those specified in schedule X in form of 21 and for schedule X drug in form 20 F.
ii) Restricted license : The license for restricted sale of drug other than specified in schedule C, C1 and those specified
in schedule C, C1 but no in schedule X are issued in form of 20A and 21A respectively.

8. Enlist objectives of hospital pharmacy.

1. To teach hospital pharmacist about ethics of the Hospital pharmacy
2. To establishment of drug information service in hospital
3. To ensure availability of right medication in reasonable cost.
4. To co-ordinate and co-operate with other department of hospital.

9. Explain functions of hospital.

1. Patient Care : Primary function refers to any type of the care given to patient by health of team members.
Eg. - Physicians, Nurses.
2. Health Educaton : Secondary function refer to the education of professionals and technical personal who provide
health service. Eg. – Physicians, Therapist.
3. Health Promotion : Hospitals are major community health center can sponsor program of environmental and
occupational health, home care service etc.
4. Health Related Research : Research that focuses on the improvement of health prevention of disease.

10. Draw organizational structure of hospital.

11. Add a note on facilities services available in hospital .
i) Nursing service : They are responsible for carrying out the treatment plan developed by physician.
ii) Pathology Service : The pathology department is one of largest department and has responsibility for making test
and studies on blood, sputum, fetes, body fluids, tissue.
iii) House keeping Service : Cleaning of floor and walls with help of the detergents, cleansing agent, change curtain of
door and window.
iv) Medical record keeping service : If provide data for research and education if help treatment of patient in future.

12. Enlist methods to detect ADR.

i) Cohart study
ii) Spontanious Case Studies
iii) Record linkage studies.
iv) Case Control studies
v) Computer based study.
vi) Complication oriented system.
13. Enlist Equipments required in hospital pharmacy.

Administrative material and equipment Professional material and equipment

1. Book Cases Work table
2. Desk Weighing machine
3. Work Table Water distillation
4. Notice board Balances
5. Clock Mixing tank
6. Calculator Homogenizers
7. Computer Tablet mfg. equipment
8. Cash register Capsule mfg. equipment
9. Stationaries Sterilization Equipment

14. What is hospital formulary?

• It is a list/manual of pharmaceutical preparations including important information which reflects the current clinical
investigation for the medical staff.
• In every hospital, Hospital and Therapeutic Committee (HTC) prepares a list of drugs to be used in hospital. This list
of drugs is called as Hospital Pharmacy.
• Hospital formulary is a method whereby the medical staff of a hospital evaluates and selects agent from among
numerous available medicinal agents and dosage forms that are useful in the patient care in the particular hospital.
• It assists in procuring, prescribing, dispensing and administrating drug.

15. What is drug basket method.

Drug Basket Method: • This method is adapted where nurses verify the availability of medicines in all rooms as well
as in the refrigerator and accordingly prepare a master list for the pharmacy.
• Nurses fill demand form for delivery of drug at the floor.
• When there is empty container, the nurses take it in the drug basket.
• Ones the procedure is completed, the drug basket containing empty container and demand form for floor stock supplies
sent to pharmacy.
• Immediately in the morning, the pharmacy staff initiates to fill each container and dispense the requested ampoules
and vials as ordered and demand.
• Once the basket is completed it is delivered to floor via messenger services.

16. Classify staff required in community pharmacy.

i) Minimum standard of qualification.
ii) Over hiring means superior people should not be hired for interior job.
iii) Promotion within pharmacy stuff may be appropriate.
iv) All the employment policies & procedures must be consist with applicable laws.

17. Enlist sources of finance used in community pharmacy .

The organization and management of community pharmacy differ type to type and mainly dependent on ownership and
control of community pharmacy. In the organization, one should consider mainly three types of resources viz.
infrastructure, human and financial.
• Infrastructure resources include; location, space, furniture, storage facility including refrigerator and any expansion
activities.
• The human resource include; pharmacist (proprietor/owners), sales person (pharmacy technicians) and helpers.
• Finance: Required for establishing infrastructure, salaries of human resource and purchase of drugs and other
healthcare products and miscellaneous expenses.
18. List the parameters considered while carrying out location analysis of community pharmacy.
i) Population of the community.
ii) Income distribution among the population.
iii) Types of Pharmacy
iv) Flow of traffic
v) Competition
vi) Special services
vii) Customer type
viii) Business locality.

19. List the content of hospital formulary.

i) Prescription writing
ii) Format
iii) Size
iv) Type of format
a) Loose leaf / bound.
b) Printed / mimeographed.
v) Indexing and Assigning categorise.
vi) Formulary drug listing service.
vii) Formulary drug listing service preparation.
viii) Categorise and indexing.
ix) Pharmacological index.

20. Why there is need for Therapeutic drug monitoring.

i) To assist the optimization of drug therapy, minimizing risk of drug toxicity.
ii) To identify a drug or substance which may be Contributing to presentation of medical emergency.
iii) TDM commonly performed for drug with a narrow therapeutic index, where small changes in dose may result in
dose of efficacy, toxicity.
iv) TDM may be useful in patient with bipolar disorder receiving lithium who continuous to have the symptoms of
Mania.

21. Name the drug and disease condition in which Therapeutic drug monitoring is required
Digoxin : Increase force of contraction in heart.
Theophylline : Bronchodilation and Antinflammatory action.
Lithium : Prophylaxis of mania.
Phenytoin : Anticonvulsant effect.

22. Differentiate between medication adherence and patient counseling.

Medication adherence Patient counseling

Medication adherence is the extent to which a patient
follows the instructions for taking their medication.
This includes taking the medication as prescribed, in the
correct dosage, and at the correct times.
Medication adherence is important because it ensures that
patients receive the full benefits of their medications.
When patients are not adherent to their medications, they
are more likely to experience adverse events, have their
condition worsen, or even die.
Focuses on ensuring that patients receive the full benefits
of their medications.
Patient counseling is the process of providing information
and support to patients about their medications.
This can include discussing the purpose of the medication,
how to take it, potential side effects, and what to do if they
miss a dose.
Patient counseling can help to improve medication
adherence by providing patients with the information and
support they need to take their medications correctly.
Counseling can also help to identify and address any
barriers to adherence, such as financial constraints,
transportation problems, or lack of understanding.
Focuses on helping patients take their medications
correctly.
23. In which clinical situations medication adherence is important.
1. The involuntary causes such as forgetfullness.
2. The voluntary reason such as fear of adverse event.
3. High cost of medicine.
4. Complex regimen
5. Lack of education.
6. Poor quality life.
7. Busy schedule of patient.
8. Poor patient - physician relationship.
9. Perception about disease severity and drug effectiveness.
10. Substance abuse.

24. How the patient should be priorities for taking medication history interview.
1. The patient's age and health status.
2. The patient's cognitive status.
3. The patient's recent changes in medication use.
4. The patient's overall risk for medication related problems.

25. Summarize steps involved in medication history interview.

1. Information Source
• Patient name, age, sex.
• Medication list.
• Community pharmacy.
2. Question to Ask
• Any allergy to medication?
• The name of medication?
• The dosage form?
• How are you taking?
3. Medication history taking tips.
• Ask what, how, why, when questions.
• Avoid lead question
• Avoid Comments
4. Other Question
• Have you recently started any medication?
• Did you changed dose or stopped taking medication?
5. Additional question
• Any medication cause side effect?
• Whenever you feel better, do you stop taking medicine?
6. Clinical Education
• Educate client to bring medication as per prescription.
• Encourage one pharmacy.

26. Enlist factors to be considered in during therapeutic drug monitoring

i. Pharmacokinetics.
ii. Pharmacodynamics.
iii. Dose.
iv. Sampling time and type.
v. Testing Methodology.
vi. Genetic polymorphism.
vii. Smoking.
viii. Drug formulation.
27. Name the primary secondary and tertiary resources used for answering drug information query?
i. Primary source : Information is presented by authors without any evaluation by a second party provide must current
information about drugs.
ii. Secondary Source : The original source has been evaluated by second party other than publisher.
iii. Tertiary Source : Information obtained from primary and secondary source and arranged in manner to represent.

28. What is the output of effective patient counseling.

i) Satisfaction of having fulfilled his / her professional duty.
ii) Serving patient and their well - being.
iii) Improve patient compliance
iv) Pharmacy seen as professional or caring pharmacy.
v) Formation of trusting relationship with patients.

29. Enlist the counseling aids used in patient counseling.

i. Introduction of session.
ii. Content of session.
iii. Process to be followed.
iv. Conclusion of session.
OR
i. Establish care relation with patient
ii. Identity to what you are speaking
iii. Ask health problem.
iv. Importance of counseling.
v. Dose regimen.

30. Which type of patients should always be counseled.

i. Patient with HIV and AIDS.
ii. Patient with mental illness.
iii. Homeless patient.
iv. Adolescent patient.
v. Patient having physical disabilities.

31. Give the composition of Pharmacy and Therapeutic committee.

i. At least 3 physicians from medical staff (one is chairman).
ii. A chief Pharmacist (secretory).
iii. A representative from nursing staff. (joint secretory).
iv. A hospital administrator, who should be on the ex-officio member of committee.

32. Enlist the functions of Pharmacy and Therapeutic committee.

i) To advice the medical staff and hospital administration and matter relating use of drug.
ii) To serve an evaluate educational and advisory capacity to medical staff and organizational administration in all
matter related to drug use.
iii) To develop formulary of drug accepted for use in organization.
iv) To study problem related to distribution and administration of used in hospital.
v) To participate in Quality Assurance Activities.
33. What medicine related point should be covered in patient counseling
Counseling about Medications Prescribed:
1. First check the correctness of prescription and medications therein.
2. Tell the patient the name and its action of the drug.
3. Inform him how to take the medication, when to take and how long (duration) to take the drugs prescribed.
4. Special instructions such as; shaking the bottle before use, before meal, after meal, exact dose, etc. should be
explained to the patient.
5. If needed then in addition to verbal instructions, written information be provided.
6. About storage of drugs, the information must be provided to patient.
7. Ensure the patient has followed the instructions so that, he will adhere to the instructions.
8. Upon counseling about medication use, ask the patient whether he predicts any difficulty taking these medications.
9. In addition, tell him as to when the drugs shall start showing their effects.
10. Finally how long he shall to continue taking these medications.

34. Enlist the barriers in Patient Counseling

i. Environmental barrier.
ii. Semantics
iii. Perception
iv. Negative attitude.
v. Personal barrier
vi. Administrative barrier.
vii. Time barrier.

35. What is medication error?

Medication Errors:
1. Medication error broadly defined as the, any error in prescribing, dispensing or administration of drug.
2. Such error lead to the adverse reaction that cause patient harm.
3. The drug distribution and administration systems followed in hospitals may contribute to medication errors.
4. It has been shown that unit dose drug distribution system has significantly reduced the occurrence of medication
errors, but this area still demands the attention of pharmacy and nursing personnel.

36. What is rational use of drugs

Rational use of drug is appropriate, efficacious, cost effective and safe drug for right indication, right dose, right
formulation, at right intervals, for right duration of time.
Any medication, prescription or non-prescription (OTC) have the potential of showing ADR's, side effects, allergies
even interactions with other drugs, food material consumed, etc. Hence, precautions need to be taken while
recommending and dispensing OTC medications to the patients. For ensuring rational use of such medications
pharmacist must counsel the patient adequately atleast in the following two things:
1. Pharmacist should never forget to tell the patient to contact physician if the condition is not improved or if symptoms
worsen or if new symptoms are developed.
2. Specific instructions for appropriate use and necessary precautions while using OTC medications supplied to the
patient.

37. Define pharmaceutical care

Pharmaceutical Care: • Pharmaceutical care is responsible provision of the drug therapy for purpose of achieving
definite outcome that improve patient quality of life.
• It is a modern of pharmacy practice.
• It is patient centered, outcome oriented pharmacy practice, wherein pharmacist work in concert with patient and
patient's other healthcare provides to promote health, to prevent disease and to assess, monitor, initiate and modify
medication use to assure that drug therapy regimen are safe and effective.
• The goal is to optimize patients health related quality of life and to achieve positive clinical outcomes within realistic
economic expenditure.
38. What is internal and external training program in a hospital
• Internal Training Programme : It is considered to be those which involves the training of student, nurses,
conducting seminars for graduate nurses, house staff, medical staff, helping in training. UG student in hospital pharmacy
conducted patient teaching programme and trained clinical pharmacist in hospital.
• External Teaching Programme : In this process an external trainer from the training company, trainer is the invited
to conduct 1/2 day workshop for employees, pharmacist, nurses. This is external training.

39. Write a note on drug information bulletin

 Physicians is generally not involved in the prescribing the OTC medication.
 A proper guidance about the use of OTC medication must be given by pharmacist.
 IP, BP, Merck Index are those material containing sufficient information to guide a patient.
 Internet facility can used as the best source to gain information.

40. State reasons behind irrational use of drugs.

Rational Use of (OTC) Drugs: • As OTC drugs are available without physician's prescription, sometimes there are
chances of drug addiction.
• Self-medication is another major issue with OTC drugs.
• Many studies have been conducted on OTC drugs and self-medication.
• Every drug has adverse effects, if consumed for long time.
• Drug addicts are controlled by their habit.
• Everything they do is geared towards satisfying their need.
• Addicts will persist in taking drugs even though they fully aware of consequences.
• Some of the addiction forming OTC drugs are analgesics, pain killers and cough preparations.

41. What do you mean by patient medication history?

A patient medication history is detailed, accurate, and complete account of all prescribed and the non - prescribed
medication that patient had taken or currently taking prior to newly initiated institutionalized or ambulatory care.

42. What are the objective of drug therapy review .

i) Evaluating effectiveness of medication therapy.
ii) Enhancing responsibility or accountability in medicine use process.
iii) Controlling medicine cost.
iv) Preventing medication related problem. Eg. ADR.
v) Creating guidelines for drug utilization.

43. Explain computerized services, storage and retrieval of drug information.

1. Collection and Storage of Information:
(a) Books and monographs
(b) Current biochemical literature (files)
(c) Mannuals and journals, medical journal advertising
(d) Electronic data processing, Tapes, floppies, etc.
These sources would not replace the pharmacist as the drug information specialist, but rather would function as tools in
this service.
2. Retrieval of Stored Information: Commercially available systems produce journals covering pharmacy practice, the
pharmaceutical sciences and the clinical and economical aspects of drug.
• All these commercially available systems for retrieval have a significant lag time-the time between original publication
of article and inclusion of the article in the retrieval systems.

44. In which conditions vitamin preparations are used irrationally.

1. When there is no evidence of a vitamin deficiency.
2. Most healthy adults get enough vitamins from their diet.
3. Taking vitamin supplements when you don't need them is not only unnecessary, but it can also be harmful.
4. When taken in excessive amounts.
5. Taking too much of a vitamin can lead to toxicity, which can cause a variety of health problems.
45. What do you mean by medical ward rounds.
A ward round is the visit made by medical practitioner along with team of health care professionals in hospital to check
patients at their besides to review and followed progress in their health at least one ward round conducted at daily.

46. Give the advantages and disadvantages of OTC drugs.

Advantages Disadvantages
i. Self Diagnose. Poorer compliance.
ii. Self Treat. More difficult to study drug effect.
iii. Health practitioner are not more difficult to study drug Reduced opportunities to receive counseling about
effect. possible life style therapies.
iv. Drug addicts are controlled by their habit. Every drug has adverse effects.

47. What is Scope of clinical Pharmacy in India ?

i) Preparation of patent medication history : Any hypersensitivity or allergy to specific drugs observed in the past
any particular drug or food habit or intoxication with the chemicals due to occupational hazards, all they are interfere
with therapy.
ii) Rational prescriptions : The clinical pharmacist can suggest physician and help in selecting right drug. Some
examples of irrational combination identified by pharmacist are : Haloperidol + Diazepam + Amitriptiline
Reserpine + Sintamil.
iii) Bioequivalence and generic equivalence of pharmaceutical formula.
iv) Patient monitoring
v) ADR
vi) IV admixtures
vii) Drug Information Specialist.
viii) Retail Pharmacy store.
ix) Discharge counseling.
x) Compliance.

48. Define Pharmacist intervention and its importance in patient safety.

Pharmacist intervention is the process of identifying and resolving drug-related problems (DRPs) to improve patient
safety and outcomes. DRPs can be caused by a variety of factors, including medication errors, drug interactions, and
patient-specific factors. Pharmacists can intervene at any point in the medication use process, from prescribing to
dispensing to administration.
Importance in patient safety :
1. For Medication reconciliation
2. For Drug-drug interaction checking
3. For Dose optimization
4. For Patient education

49. Name the primary and secondary Pharmacokinetic parameters.

A. Primary Pharmacokinetic Parameters
1. Clearance (CL) : The volume of blood or plasma that is cleared of a drug per unit time.
2. Volume of distribution (Vd) : The apparent volume in which a drug is distributed in the body.
B. Secondary Pharmacokinetic Parameters
1. Half-life (t1/2) : The time it takes for the concentration of a drug in the body to decrease by half.
2. Bioavailability (F) : The fraction of an administered dose of a drug that reaches the systemic circulation.
3. Mean residence time (MRT) : The average time that a drug molecule spends in the body.
4. Area under the curve (AUC) : The total area under the concentration-time curve for a drug.
50. Give clinical Significance of half life.
The half-life of a drug is the time it takes for the concentration of the drug in the body to decrease by half. It is a
measure of how long a drug stays in the body. The half-life of a drug is important for several clinical reasons, including:
1. Determining the dosing regimen : The half-life of a drug can be used to determine how often a drug should be
dosed. For example, a drug with a short half-life (such as 2 hours) will need to be dosed more frequently than a drug
with a long half-life (such as 24 hours).
2. Predicting the drug's effects : The half-life of a drug can be used to predict how long the drug's effects will last. For
example, a drug with a short half-life will have a shorter duration of action than a drug with a long half-life.
3. Monitoring the drug's levels in the body : The half-life of a drug can be used to monitor the drug's levels in the
body. This is important for drugs that have a narrow therapeutic index, meaning that there is a small difference between
the dose that is effective and the dose that is toxic.
4. Managing drug toxicity : The half-life of a drug can be used to manage drug toxicity. For example, if a patient
overdosed on a drug with a short half-life, the drug can be cleared from the body more quickly by increasing the
frequency of dosing.

51. What are the reasons for which drug has recalled from market.
There are many reasons why a drug may be recalled from the market. Some of the most common reasons include:
1. Safety : If a drug is found to be unsafe, it may be recalled. This could be due to side effects that were not known
before the drug was marketed, or due to new information that has come to light about the drug's safety.
2. Effectiveness : If a drug is found to be ineffective, it may be recalled. This could be due to the drug not working as
well as expected, or due to the drug not being effective for the condition it was intended to treat.
3. Manufacturing problems : If there are problems with the manufacturing process of a drug, it may be recalled. This
could be due to contamination, incorrect dosage, or other problems that could make the drug unsafe or ineffective.
4. Labeling errors : If there are errors on the label of a drug, it may be recalled. This could be due to incorrect dosage
instructions, missing information, or other errors that could make the drug unsafe or ineffective.
5. Marketing violations : If a drug company violates the law in marketing a drug, the drug may be recalled. This could
include making false or misleading claims about the drug, or failing to report safety problems.

52. Define purchasing and inventory control.

Purchasing : Purchasing may be defined as the function concerned with search, selection then purchase receive storing
and final use of commodity in accordance with the catering policy of establishment. OR
Purchasing is the activity directed toward securing materials, supplies, equipment & service requirement in operation of
an enterprise.
Inventory control : Inventory control is a process by which inventory is measured and regulated according to the
predetermined norms such as economic lot size for order or production, safety, stock, minimum level, max level and
order level etc.

53. What are storage conditions with temperature and humidity in pharmacy store.
Pharmacy stores are used to store all kind of material like capsule, tablet, liquid dosage form and injections.
i) Cold storage : 2 - 8°C
ii) Cool temp : 8 - 25°c
iii) Room temp : Working area
iv) Warm temp : 30 - 40°c
v) Excessive heat : Above 40°c

54. Give the objectives of inventory control.

i. It helpful in formulating proper purchase policies.
ii. A detailed and more reliable check obtained.
iii. Continuous stock verification will make stock keeper move vigilant and efficient.
iv. Capital investment in materials will be under control.
v. Error and shortage of stock are readily discovered and effort are made a void the shortage in future.
55. Give formula for economic order quantity in inventory control.
2𝑎𝑏
EOQ =√ 𝑐𝑠
Where, a = annual consumption
b = buying cost
c = cost of one unit
s = inventory carrying cost

56. List the Biochemical tests used to assess kidney function.

Biochemical tests used to assess kidney function:
1. Creatinine : Creatinine is a waste product that is produced by muscles. It is normally filtered out of the blood by the
kidneys and excreted in the urine. A high level of creatinine in the blood can indicate kidney damage.
2. Blood urea nitrogen (BUN) : BUN is a waste product that is produced by the liver. It is also normally filtered out of
the blood by the kidneys and excreted in the urine. A high level of BUN in the blood can indicate kidney damage.
3. Urine protein : Protein in the urine is a sign of kidney damage. The amount of protein in the urine is measured by a
test called a urinalysis.
4. Urine albumin : Albumin is a protein that is normally found in the blood. However, it can leak into the urine if the
kidneys are damaged. A high level of albumin in the urine is a sign of kidney damage.
5. Estimated glomerular filtration rate (eGFR) : eGFR is a measure of how well the kidneys are working. It is
calculated from a blood test that measures creatinine. A low eGFR can indicate kidney damage.

57. What do you mean by Investigational drugs?

• These are not the general-purpose use and these are not yet to release or certified by FDA for general use or for sale in
commercial interest.
• Investigational drug should be used only in hospital setup, which is the primary center for the clinical investigations.
• It is responsibilities of hospital and medical staff to check and establish the proper procedure for the use of
investigational drugs for their patient's benefits.
• The investigational drugs should be used under strict medical supervision, mainly under the supervision of principal
investigator who is supposed to be a member of medical staff and having responsibilities of obtaining of necessary
consent.

58. Give Significance of presence of protein and glucose in urine

• Proteinuria is high levels of protein in the urine. It shows that the kidneys are not filtering blood as they should. Causes
of proteinuria can be temporary, such as dehydration, or chronic, such as an autoimmune disease. People with diabetes
or high blood pressure have the highest risk of proteinuria.
• Normally, urine contains very little or no glucose. But if you have too much glucose in your blood, your kidneys will
get rid of some of the extra glucose through your urine. So, a high level of urine glucose may mean that your blood
glucose is high, too, and that could be a sign of diabetes.

59. Define and Explain types of anemia.

Anemia is a condition in which the body does not have enough healthy red blood cells. Red blood cells carry oxygen to
the body's tissues, so when there are not enough red blood cells, the tissues do not get enough oxygen. This can cause a
variety of symptoms, including fatigue, shortness of breath, and pale skin.
Types of Anemia
1. Iron deficiency anemia : This is the most common type of anemia. It is caused by a lack of iron, which is needed to
make hemoglobin, the protein that gives red blood cells their oxygen-carrying ability. Iron deficiency can be caused by
blood loss, poor diet, or malabsorption.
2. Vitamin B12 deficiency anemia : This type of anemia is caused by a lack of vitamin B12, which is needed to make
red blood cells. Vitamin B12 deficiency can be caused by a poor diet, pernicious anemia, or malabsorption.
3. Folate deficiency anemia : This type of anemia is caused by a lack of folate, which is another vitamin needed to
make red blood cells. Folate deficiency can be caused by a poor diet, pregnancy, or malabsorption.
4. Hemolytic anemia : This type of anemia is caused by the destruction of red blood cells. Hemolytic anemia can be
caused by inherited disorders, infections, or autoimmune diseases.
5. Aplastic anemia : This type of anemia is caused by a decreased production of red blood cells in the bone marrow.
Aplastic anemia can be caused by infections, medications, or autoimmune diseases.
60. What are the causes of hyponatremia.
Some of the most common causes of hyponatremia include:
1. Water intoxication : This occurs when a person drinks too much water too quickly. This can happen during
endurance events, such as marathons or triathlons, or if a person takes too many diuretics.
2. Syndrome of inappropriate antidiuretic hormone (SIADH) : This is a condition in which the body produces too
much of the hormone ADH. ADH causes the kidneys to retain water, which can lead to a low sodium level.
3. Dehydration : This occurs when the body loses too much water. This can happen due to sweating, vomiting,
diarrhea, or burns.
4. Kidney disease : Kidney disease can cause the kidneys to lose sodium, which can lead to a low sodium level.
5. Liver disease : Liver disease can cause the liver to produce too much ADH, which can lead to a low sodium level.
6. Heart failure : Heart failure can cause the kidneys to retain water, which can lead to a low sodium level.
7. Medications : Some medications, such as lithium and certain antidepressants, can cause hyponatremia.

61. Enlist various methods of purchasing.

1. Spot purchasing
2. Contract purchasing
3. Request For Quotation (RFQ)
4. Tender
5. Co-operative purchasing
6. Just-in-time (JIT) purchasing

62. Enlist factors affecting inventory control.

1. Demand
2. Lead time
3. Cost of carrying inventory
4. Cost of stockouts
5. Nature of the product
6. Seasonality
7. Technology

63. What is VED analysis?

VED Analysis: It attempts to classify the items used into three broad categories namely; Vital, Essential and Desirable.
The analysis classifies items on the basis of their criticality for the industry or company.
Vital: Vital category items are those items without which the production activities or any other activity of the company,
would come to a halt, or at least be drastically affected.
Essential: Essential items are those items whose stock-out cost is very high for the company.
Desirable: Desirable items are those items whose stock-out or shortage causes only a minor disruption for a short
duration in the production schedule.

64. What is ABC analysis?

• ABC analysis: The ABC analysis is widely used for unfinished good, manufactured products, spare parts, components,
finished items and assembly items. ABC analysis is a technique for prioritizing the management of inventory.
Inventories are categorized into three classes; A, B, and C. Most management efforts and oversights are expended on
managing A items. C items get the least attention and B items are in-between.
• Item A: In the ABC model of inventory control, items categorized under A are goods that register the highest value in
terms of annual consumption. The top 70 to 80 per cent of the yearly consumption value of the company comes from
only about 10 to 20 per cent of the total inventory items. Hence, it is crucial to prioritize these items.
• Item B: These are items that have a medium consumption value. There amount to about 30 percent of the total
inventory in a company which accounts for about 15 to 20 per cent of annual consumption value.
• Item C: The items placed in this category have the lowest consumption value and account for less than 5 percent of the
annual consumption value that comes from about 50 per cent of the total inventory items.
65. State the normal values of different haematological parameters.
Normal values of different haematological parameters:
A. Haemoglobin (Hb) :
1) Adults: 13.5-17.5 g/dL (females)
2) Adults: 14.5-18.5 g/dL (males)
3) Children: 11.5-14.5 g/dL
B. Hematocrit (Hct) :
1) Adults: 40-54% (females)
2) Adults: 41-54% (males)
3) Children: 33-43%
C. Red blood cell (RBC) count :
1) Adults: 4.5-5.5 million/µL (females)
2) Adults: 5.4-6.2 million/µL (males)
3) Children: 3.8-5.2 million/µL
D. Mean corpuscular volume (MCV) :
1) Adults: 80-100 fL
2) Children: 70-90 fL
E. Mean corpuscular hemoglobin (MCH)
1) Adults: 27-32 pg
2) Children: 25-30 pg
F. Mean corpuscular hemoglobin concentration (MCHC)
1) Adults: 32-36 g/dL
2) Children: 30-34 g/dL
G. Platelet count
1) Adults: 150,000-450,000/µL
2) Children: 150,000-350,000/µL
H. White blood cell (WBC) count
1) Adults: 4,500-11,000/µL
2) Children: 5,000-10,000/µL

SHORT ANSWER QUESTIONS (05 Marks)

1. Explain the Pharmacodynamic aspects of drug interaction.

Pharmacodynamics aspects of Drug Interactions:
• Pharmacodynamic interactions are alteration in the pharmacological response of a drug which may be caused by direct
competition at certain sites of action or by indirectly involving altered physiological mechanisms but do not always
modify a drug's concentration in tissue fluids.
• Different terminology is used to describe outcomes depending on whether two drugs are active or inactive
• If the response from the combination is greater than predicted, then the outcome is termed synergism (both drugs
active), potentiation (one drug active), or coalism (neither drug active).
• If the response is equal to that predicted, then the outcome is termed additivity/independence (both drugs active) or
inertism (one or both drugs inactive)
• Antagonism refers to a less-than predicted response if one or both drugs are active
• Idiosyncratic interactions produce effects that are not expected based on the known effects of either agent when given
alone
• Pharmacodynamic interactions can be beneficial in that an improved therapeutic response may occur or be detrimental
in that toxicity may be heightened. Also, therapeutic activity and toxic effects may occur simultaneously in opposite
directions, resulting in a balance between positive and negative responses.
• Beneficial pharmacodynamic drug interactions abound in infectious disease therapy because of the many of drug
combinations used to treat infections.
• An example of such an interaction is the effective synergistic combination of ampicillin and gentamicin or
streptomycin in the treatment of enterococcal endocarditis.
• Combinations of drugs often are used as therapeutic advantages because of their
beneficial effects are additive or synergistic.
• According to their effects i.e. beneficiary or adverse interactions they are classified as follows -
(A) Drug having Similar/related Pharmacological Effects:
• Drug acting at the same site or influencing the same physiological system cause synergistic effect.
• The excessive pharmacological actions are seen due to use of drug which having similar pharmacological action.
(B) Drug having Opposite Pharmacological Effects:
• The interaction occurs due to use of two drugs which having opposite pharmacological effect. These effects observe
due to secondary effects of certain drugs.
(C) Interactions at Receptor Site:
• The drug effects seen as a result of binding to specialized areas on the receptor site. When drugs are concurrently
administered, they may interact at the same receptors or different receptors but physiologically related site.
• Administration of both the drugs Morphine and Nalorphine act at the same receptors site but the effect of Morphine
such as respiratory depression is antagonized by Nalorphine.
(D) Alteration of Electrolyte Level:
• When the drugs alter the electrolyte level then it is importantly monitoring the effect when they are included in
therapeutic regimen.
• Example: Thiazide diuretics can cause loss of potassium at extreme level. If digoxin is administered without
correcting the level of potassium in thiazide used patient, heart become more sensitive to the response of digoxin and
arrhythmia may occur.
Other drugs which alter the electrolyte level are: Lithium/ NSAIDS/Sodium intake, ACEIS, A2-antagonists/K, K-
sparing, Diuretics, K supplement, NSAIDS/antihypertensive agents.
2. Describe normal value of serum electrolytes and disorders related to them.
3. Give the objectives and functions of hospital pharmacy.
Hospital Pharmacy : It is defined as the actual practice of pharmacy in a hospital. This department in the hospital,
under the supervision of professionally competent and legally qualified pharmacists and from where:
(a) All medications are supplied to the nursing units.
(b) Special prescriptions are filled for in-patients and out-patients.
(c) Pharmaceuticals are manufactured in bulk.
(d) Narcotics, biological and prescribed drugs are dispensed.
(e) Injectable are prepared and sterilized.
(f) Professional supplies are often stocked and dispensed.
Objectives of Hospital Pharmacy =
The objectives of hospital pharmacy are to draw the plans in co-ordination and implement these plans for the
purposes:
1. To teach the hospital pharmacist about the philosophy and ethics of hospital pharmacy and guide them to take
responsibility for professional practice.
2. To strengthen the management skills of hospital pharmacist working as the head of the department.
3. To strengthen the scientific and professional aspects of practice of hospital pharmacy such as consulting role of
hospital pharmacist, his teaching role and research activities.
4. To utilize as maximum as possible the resources of hospital pharmacy for the development of the profession.
5. To attract greater number of well-trained pharmacists to work in the hospital pharmacy.
6. To promote the payment of good salaries to hospital pharmacist in order to retain the services of these professionals.
Functions of Hospital Pharmacy
The following are the functions of hospital pharmacy:
1. Dispensing of out-patient and discharge prescriptions.
2. Supply and distribution of in-patient medications and maintenance of ward medication stocks.
3. Clinical pharmacy review services to in-patient areas.
4. Drug information and adverse drug reaction reporting.
5. Preparation of specialized sterile pharmaceuticals.
6. Preparation and sterilization of injectable drugs when manufactured in the hospital.
7. Dispensing of drugs including narcotics, chemicals and pharmaceutical preparations.
8. Dispensing and sterilization of parenteral preparations manufactured in the hospital.
9. Planning, organizing and directing pharmacy policies and procedures in accordance with established policies of the
hospital
10. Management and purchase for the requirements of the stores.
11. Maintenance of specifications of quality and source for purchase of all drugs, chemicals, antibiotics, biological and
other pharmaceutical preparations used in the hospital.
12. Proper storage of drugs with specifications and maintenance of records.
13. Discarding the expired drugs and containers with damaged labels.
14. Maintenance of approved stock of antidotes and other emergency drugs.
15. Implementation of decisions of Pharmacy and Therapeutic Committee (PTC).
16. Co-operation in teaching students in nursing and medical training programme.
17. Collection and circulation of information regarding the drugs to physicians, interns and nurses.
18. Preparation of periodic reports for submission to the administrator of the hospital.
19. Support for clinical medication trials.
20. Establishment and maintenance of "Drug Information Centre" which will provide information regarding medications
to the physicians, nurses or any other competent person who deals in drugs.
21. Providing drug monitoring services by studying various effects of drugs administered to the patients especially the
indoor patients from 'Patients charts' maintained in the wards.

4. Define hospital pharmacy explain its organization structure of hospital pharmacy.

Hospital Pharmacy is defined as the actual practice of pharmacy in a hospital. This department in the hospital, under
the supervision of professionally competent and legally qualified pharmacists and from where:
(a) All medications are supplied to the nursing units.
(b) Special prescriptions are filled for in-patients and out-patients.
(c) Pharmaceuticals are manufactured in bulk.
(d) Narcotics, biologicals and prescribed drugs are dispensed.
 (e) Injectables are prepared and sterilised.
(f) Professional supplies are often stocked and dispensed.
Functions of Hospital Pharmacy : The hospital pharmacy is one of the many departments of the hospital and it has in
general following basic functions:
1. To provide and evaluate service in support of medical care for achieving the objectives and policies of hospital.
2. To implement the philosophy, objectives, policies and standards of the hospital.
3. To participate in the functioning of all other department and services of the hospital.
4. To estimate the requirements of the department and to recommend and implement policies and procedures to maintain
an adequate and competent staff.
5. To develop and maintain an effective system of clinical and/or administrative records sup and reports.
6. To estimate the requirements for facilities, supplies and equipment.
7. To co-ordinate with the financial plan of operation for the hospital.
8. To initiate and participate in studies or research project designed for the improvement of healthcare of patients and
other hospital services.
9. To provide and implement continuing education in pharmacy programme for all health professionals in the hospital.
10. To initiate and participate in the safety programme of the hospital.
Objectives of Hospital Pharmacy : The objectives of hospital pharmacy are to draw the plans in co-ordination and
implement these plans for the purposes:
1. To teach the hospital pharmacist about the philosophy and ethics of hospital pharmacy and guide them to take
responsibility for professional practice.
2. To strengthen the management skills of hospital pharmacist working as the head of the department.
3. To strengthen the scientific and professional aspects of practice of hospital pharmacy such as consulting role of
hospital pharmacist, his teaching role and research activities.
4. To utilise as maximum as possible the resources of hospital pharmacy for the development of the profession.
5. To attract greater number of well trained pharmacists to work in the hospital pharmacy.
6. To promote the payment of good salaries to hospital pharmacist in order to retain the services of these professionals.
7. Ensure the availability of right medication.
8. Co-ordinate with other department of hospital.
Location And Lay-Out Of Hospital Pharmacy : The location of a hospital pharmacy should be such that, it is
convenient for providing service to all departments of hospital and personnel who make daily use of such service.
In a general hospital of less than 200 beds, the pharmacy should be located on the first floor in the centre and near
to the out-patient department (if present in hospital). This will increase the efficiency and reduce the man-hours of work.
In majority of hospitals, pharmacy serving in-patient and out-patient facility is constructed.
5. Which factors are to be considered while selecting a site for drug store.
Selecting Site For Drug Store : The success of any manufacturing activity is largely dependent on the procurement of
raw materials of right quality, in the right quantities, from right source, at the right time and at right price popularly
known as ten 'Rs' of the art of efficient purchasing. They are described as the basic principles of purchasing. There are
other well-known parameters such as; right contractual terms, right material, right place, right mode of transportation
and right attitude are also considered for purchasing.
Factors :
i. Right price Negotiation Learning curves
ii. Right quantity ECQ and Inventory Models
iii. Right time Reorder point Lead time Analysis
iv. Right source Vendor rating Purchase
v. Right quality Rejections and Specifications
vi. Right attitude SWOT analysis
vii. Right contracts Legal aspects Models
viii. Right material Value analysis Standardization
ix. Right transportation Cost analysis Cost analysis & logistics
x. Right place of delivery Price communication:
(i) Right Price: It is the principal factor for any manufacturing organization to get an item at the right price. Right price
does not mean the lowest price always. The 'tender system' of buying is normally used in public sector organizations but
the objective should be to identify the lowest 'responsible' bidder and not the lowest bidder. Proper planning and not by
rush buying can keep the price low. Moreover, price negotiation is also another factor which can also help to determine
the right prices.
(ii) Right Quality: Right quality means that quality is available, measurable and understandable. Prior sampling, it is
good to determine the quality of a product. The right quality is determined by the cost of materials and the technical
characteristics as suited to the specific requirements.
(iii) Right Time: For determining the right time, the purchase manager should have lead time information for all
products and analyze its components for reducing the same. Factors like floods, strikes should be considered while
determining the purchases, the buyer has to consider emergency situations, etc. He should have 'contingency plans'
when force major clauses become operative, for instance, the material not available due to strike, lock-out, floods, and
earthquakes.
(iv) Right Source: The selection of right source is very important for the purchase department. The source should be
dependable and capable of supplying items of uniform quality.
(v) Right Quantity: The right quantity is the most important parameter in purchasing. Factors such as; economical
quantity of order, economical purchase quantity, duration and fixed quantity systems, are some of the factors which
must be considered before placing the purchase order.
(vi) Right Attitude: The purchase manager should be innovative and his long-term objective should be to minimize the
cost of the ultimate product. He will be able to achieve this if he aims himself with techniques, such as; value analysis,
materials intelligence, purchases research, SWOT analysis, purchase budget lead time analysis, etc.
(vii) Right Contracts: The buyer has to adopt separate policies and procedures for capital and consumer items. He
should be able to distinguish between indigenous and international purchasing procedures. He should be aware of the
legal and contractual aspects in international practices.
(viii) Right Material: Right type of material required for the production is an important parameter in purchasing.
Techniques, such as, value analysis will enable the buyer to locate the right material.
(ix) Right Transportation: Right mode of transportation has to be identified as this forms a critical segment in the cost
profile of an item. It is an established fact that the cost of the shipping of ore, gravel, sand, etc. is normally more than
the cost of the item itself.
(x) Right Place of Delivery: Specifying the right place of delivery like; head office or works, would often minimize
the handling and transportation cost.
6. Explain staff and finance management in community pharmacy.
Community Pharmacy : A community pharmacy is a healthcare facility which provides pharmacy services to people
in a local area or community. Community pharmacy provides quality, safe and effective dispensing and health-related
services to both patients and consumers in general.
• The main responsibilities of a community pharmacy include; compounding, counselling and dispensing of drugs to the
patients with care, accuracy and legality along with the proper procurement, storage, dispensing and documentation of
medicines.
Staff Management : • The right type of organization is selected, then it becomes necessary to fill in the various job
positions with right kind of people, who can effectively perform their assigned activities
• The process of hiring and developing the required personnel to fill in various positions the organization.
• It involves the scientific and systemic procurement, allocation, utilization conversation and development of human
resources.
• The main objective of the staffing is to ensure the optimum utilization of human resources as well as to provide
personal and social satisfaction to the employees.
Features of Staffing : • Staffing is a function of management
• It is a continuous and pervasive function.
• It is an integral part of the management process.
• It is a difficult function because it deals with human beings who have their own needs, emotions and aspiration.
• It is concerned with the human resources of an organization.
Importance of Staffing : • Staffing helps to build up a healthy organization in which the job performance and
satisfaction of every employee can be high.
• Staffing injects life into the organization by providing right person for every job. The
effectiveness of directing and control functions also depends upon staffing.
• Employees in the organization are the most valuable asset of an organization. The quality of human assets largely
determines the success and growth of the organization.
Finance Management : Financial management is defined as dealing with and analying money and investment for a
business to help make business decisions.
Financial management is a process of planning, organising, controlling and monitoring resources to achieve
organizational goals and objectives.
What is Finance? Finance represents money management and the process of acquiring needed funds. It also
encompasses the oversight, creation, study of money, banking credit, investment and liabilities that make up financial
systems. For an entrepreneur (community pharmacist) to achieve success in entrepreneurship (running a community
pharmacy) apart from professional knowledge and skills, the financial literacy is of utmost importance.
Here are some of the important tips to be understood and followed:
• Choose the right finance when starting business.
• Check the finance options available.
• Types of bank finance for business.
• Types of non-bank finance.
• Plan and forecast your sales.
• Understand cashflow forecast.
• Set up a profit and loss account statement.
• Understand balance sheet.
• Understand how to manage cashflow.
• Setup a record-keeping system.
Importance of Financial Management : (1) Financial management helps to take appropriate financial decisions.
(2) It helps to establish guidelines that enable the entrepreneur to earn more profit with minimum costs.
(3) A good financial management helps to control financial aspects of business.
(4) It provides correct and reliable information about business activities through financial reporting.
(5) An effective financial management is vital for business survival and growth.
Objectives of Financial Management : (1) The basic objective of any business is to acquire profit and objective of
financial management is to maximise profit with appropriate spendings.
(2) Financial management goal is the proper mobilization of finance.
(3) Survival and growth of the business organization.
(4) Financial management needs to establish co-ordination between financial decision areas and other supportive
disciplines such as; accounting, marketing, production, etc.
(5) The operational objective of financial management is ensuring safety of investments.
(6) Searching new and better sources of finance.
Financial Management Functions: Following are the important management functions:
(1) Financial planning and forecasting.
(2) Determination of capital composition.
(3) Fund investment.
(4) Maintain proper liquidity.
(5) Disposal of surplus.
(6) Financial controls.
Financial Decisions : There are four main financial decisions:
1. Investment Decision : • It is concerned with investment of firm's available funds in assets. Investment in capital
assets is long-term investment which is not much relevant in community pharmacy management, while short-term
investment Le. working capital investment is much important decision.
2. Financial Decision : • It is concerned with the raising of finance from various long term sources of funds. The cash
flow position of the business is an important factor in financial decision.
3. Dividend Decisions: • It is concerned with the distribution of profits earned by the organization. It is not much
concerned with community pharmacy.
4. Working Capital Decision: • The goal of working capital management is to ensure that the firm is able to continue
its operations and that it has sufficient cash flow to meet upcoming operational expenses. This decision is most
important in community pharmacy management.

7. Enlist different records required to maintain in retail and wholesale drug store with its significance.
Community Pharmacy : A community pharmacy is a healthcare facility that is able to provide pharmacy services to
people in local area or community.
• Community pharmacy includes all the establishments that are privately owned and whose function is to serve the
society's need for drug products and pharmaceutical services.
• It includes corporate pharmacy chain to pharmacy department in supermarket and independently owned
pharmaceutical shop.
• It is a hybrid of professionalism and business.
Types of drug stores :
1. Traditional Drug Stores: These types of drug stores are designed in such a manner that, the entire area of drug store
is exposed to customers.
2. Personal Service Drug Stores: In this type of design, the whole of the area is not exposed to the customer but the
customer is required to interact with the drug store personnel at the service counter.
3. Prescription Oriented Drug Store: These types of drug stores provide a comfortable waiting area where the
customers are expected to wait while his prescription is proceeding.
4. Pharmaceutical Centre: These types of centres sell medicines, convenience orthopedic and surgical appliances.
5. Super Drug store: Such types of drug stores have a huge floor area ranging from 5,000 to 10000 ft with a square
design.
Types of different records required to maintain in retail and wholesale drug store with its significance.
1. Legal Records
2. Patient Records
3. Financial Record
1. Legal Records : • These should be maintained according to federal and state law.
• Adequate and up to date records should be maintained according to Drugs and cosmetics act 1940, Rules 1945 and
Poison Act 1919.
• Adequate record related to acquisition and disposition of certain drugs should be maintained.
• Records of distribution of poisonous and hazardous substances should be maintained.
2. Patient Records : • Patients drug history should be maintained.
• Information on all kinds and number of drugs taken by average patients should be recorded and maintained.
• Source of information on insurance claims and income tax deduction of patients should also be recorded and
maintained.
3. Financial Records : • For making sound decision regarding future needs, inventory requirements, etc. financial
documents should be maintained.
• These records should be registered and maintained in order to evaluate past operations, plan present activities, forecast
needs and control the activities.
• Maintaining financial records also help in analyzing revenues and expenses.
8. Enlist staff requirements with their role in hospital.
Hospital consists of various departments that depend upon specialize services and how large the hospital. All the major
departments within hospital occupy specialists as per their needs. All the departments are leaded by experts and they are
in turn headed by a higher authority/director. Hospital consists of various departments like, outpatient department
(OPD), inpatient department (IPD), manufacturing of sterile products, therapeutics committee, etc. Every department
dealing with drugs and there play a role by hospital pharmacist. Following should explain briefly the roles of hospital
pharmacists:
Hospital and Therapeutic Committee: Pharmacist is an important member of hospital and therapeutic committee. A
pharmacist usually comes second in command, after a physician in the committee. Pharmacist work toward to maximize
and maintain rational drug use.
Dispensing to IPD / OPD : Before dispensing of drug, pharmacist must make sure about the correct prescription of
drug and its validity with regards to diagnosis and treatment. Pharmacist should also check for any modification with
respect to dose regimen. Pharmacist is responsible for distribution of drugs within the ward and he is coordinating with
nurses. Pharmacist also supervises steady supply of drugs as per their needs. IPD/OPD pharmacist works together with
inventory, drug distribution in-charge and physicians.
Drug Distribution: Pharmacist has major role in supervises regarding proper distribution of drugs across inventory,
pharmacy, floor pharmacy, ward pharmacy, IPD, OPD, etc. to avoid ambiguities or any other failures. A pharmacist also
supervises the purchase orders, manages logs of material transfer across departments and maintains smooth functioning
of drug distribution across hospital.
Purchasing, Inventory Control and Budget: Hospital pharmacist plays an important role in purchasing drug account.
There are varieties of products with similar characteristics in such cases pharmacist has to choose the best few from a
variety of products. Pharmacist has to take balancing and rational decision considering economy, health and end user
service. Pharmacist has to play a role in budgeting pharmacy. The role also includes paper work and clerical jobs.
Pharmacists are officially a part of budgeting committee and they must skillfully plan an economic budget to
deliver services at cheaper possible rates. To plan out a budget that strikes balance between all the aspects a vigorous
experience and skills are required. To balance quality and economy of drugs best brands/generics are generally chosen.
Controlled Substances, Procurement and Distribution: Hospitals procure controlled substance in large volume thus
supervising this unit by pharmacist has crucial. For the procurement of control substances there require complete legal
paper work and pharmacist is an authorized by law for procurement. Without consent of pharmacist hospital cannot
procure the same. Pharmacist has also responsibility to regulate the use of such substances in hospital premises because
such substances are very likely to misuse.
Manufacturing Bulk and Sterile Product: Large hospitals manufacture their own bulk drugs to save the cost and
allow steady supply of commonly used drug, for example: Paracetamol, Ranitidine, Saline solution, Dextrose solution,
etc. In such hospital, the manufacturing plant or unit is segregated into several departments like manufacturing,
packaging, labeling, QA, etc. Pharmacist has to supervise the activities of manufacturing as well as responsibility to
control over them.
Hospital Formulary: Hospital Formulary is a brief and compilation of all information related to drug and guidelines for
regulation in hospital. It is similar to pharmacopoeia but intended towards incorporating better and cheaper, condition
specific drugs in the hospital pharmacy. It generally contains the drug information which particularly prefer by hospital
pharmacist for the patient. A pharmacist plays an actively involved in preparation, updating, reviewing and following a
hospital formulary.
Investigational Drug Use: Based on the technical expertise hospital pharmacist are work in phase 1 and phase 2
clinical trials. Drugs used in clinical trials are generally reviewed by hospital pharmacist and HTC before use.
Educational and Training Programs: Majority of hospitals provide the training programs for healthcare practitioners.
Such training programme runs under diverse faculty of physicians, administrators, nurses, pharmacists etc. In such
programme pharmacist has play a role in training to fresh or junior pharmacist. They provide the theoretical and
practical training to trainers.
9. Enlist causality assessment scale in ADR and explain any one
ADR : WHO defines an ADR as; A response to a drug which is noxious and unintended and which occurs at doses
normally used in person for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic
function". Adverse Drug Reactions (ADRs) are unwanted or undesirable effects of a medication caused by normal
therapeutic doses that occurs during usual clinical use. Adverse drug reactions occur almost daily in healthcare sector
and can adversely affect a patient's quality of life, often causing considerable morbidity and mortality.
Classification of ADR’s
Type A reactions, are predictable and are caused by an excess of the drug's primary pharmacological effect. (e.g.,
bleeding from warfarin) or a low therapeutic index (e.g., nausea from digoxin).
• Type A reactions constitute approximately 80% of adverse drug reactions.
• Dose-related adverse drug reactions occur most often with drugs that have a steep dose- response curve and/or small
difference between therapeutic and toxic doses (ie., a low therapeutic index = toxic dose/therapeutic dose).
• These reactions are dose-related and usually mild, although they may be serious or even fatal (e.g., intracranial
bleeding from warfarin).
• Commonly used drugs with a low therapeutic index include; anticoagulants, hypoglycemic drugs, digoxin,
antiarrhythmics, aminoglycosides, xanthines, cytotoxic and immunosuppressive drugs.
• Such reactions are usually due to inappropriate dosage, especially when drug elimination is impaired.
• The term side effects is often applied to minor type A reactions.
Type B ('idiosyncratic) also called as non-dose related reactions are not predictable from the drug's main
pharmacological action, are not dose-related and are severe, with a considerable mortality.
• The underlying pathophysiology of type B reactions is poorly if at all understood and often has a genetic or
immunological basis.
• Type B ADR are rare and occur infrequently (1:1000-1:10000 treated subjects being typical).
Type C: This type of ADR is usually due to the long-term use of drugs (e.g., neuroleptic- related tardive dyskinesia or
analgesic nephropathy).
Type D: This type of ADR is considered as delayed reactions due to the usage of the drug (e.g. alkylating agents
leading to carcinogenesis, or retinoid-associated teratogenesis).
Type E: This type of ADR takes place after stopping the use of the drug such as; adrenocortical insufficiency follows
withdrawal of glucocorticosteroids, or withdrawal syndromes following discontinuation of treatment with
benzodiazepines or ẞ-adrenoceptor antagonists.
Adverse Drug Reporting And Management
Adverse Event Reporting Types:
1.Spontaneous Reporting: The healthcare professionals spontaneously report any adverse events to their national
pharmacovigilance center, health authority or to the drug manufacturer itself.
• In most parts of the world, adverse event reports are submitted electronically using a defined format.
• Spontaneous reports are a crucial element in the worldwide pharmacovigilance system and form the core of the WHO
Database.
2. Aggregate Reporting: Aggregate or periodic reporting plays a key role in the safety assessment of drugs.
• Cases that do not involve a serious, unlabelled adverse event is subjected to non-expedited or periodic reporting.
• Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time.
• The advantage of aggregate reporting is to provide a broader view of the safety profile of a drug.
• Worldwide, the most important aggregate report is the PSUR.
3. Expedited Reporting: Reporting of Individual Case Study Reports involves serious and unlabelled event related to
use of a drug is termed as expedited reporting.
• In most countries, the timeframe for reporting expedited cases by the drug company after receiving notification of such
a case is 15 calendar days.
• Within clinical trials the Suspected Unexpected Serious Adverse Reaction is an event that involves a life- threatening
or fatal event is subject to be reported within 7 days.
4. Clinical Trial Reporting: Safety information from clinical studies is used to establish safety profile of drug in
humans.
• Serious Adverse Event (SAE) occurring to any study patients (subjects) during conduction of clinical trials is the key
component for the drug regulatory authorities in the decision-making to grant or deny market authorization for a drug.
• SAE information is forwarded to the sponsoring pharmaceutical company that is responsible for the reporting to the
drug regulatory authorities.
5. Reporting Backdrops: The major weakness of the spontaneous reporting system by clinician is under-reporting,
though the figures vary greatly between countries and in relation to minor and serious ADRS.
• ADR reporting behaviour varies greatly between countries and in relation to the seriousness of the events, but in
general probably less than 5-10% of all adverse events that occur are actually reported.
• Another problem is that overworked medical personnel do not always see reporting as a priority, especially if the
symptoms are not serious.
• Even if the symptoms are serious, they may not be recognized as the possible side effect of a particular drug.
• Though spontaneous reports are submitted voluntarily although under certain circumstances these reports may be
encouraged or stimulated, by media reports or articles published in medical or scientific publications or by product
lawsuits.
Management of Adverse Drug Reactions:
• Rapid action is sometimes important because of the serious nature of a suspected adverse drug reaction, for example,
anaphylactic shock.
• Otherwise, using clinical benefit-risk judgment, together with help from investigations, one decides which medicine or
medicines should be withdrawn as a trial.
• The patient should be observed during withdrawal.
• The waiting period will vary, depending on the rate of elimination of the drug from the body and the type of
pathology. For example, urticaria usually disappears quickly when the drug is eliminated, whereas fixed psoriatic skin
reactions can take weeks to resolve. If the patient is clearly getting better, if the patient cannot manage without a
medicine that has caused an adverse reaction, provide symptomatic relief while continuing the essential treatment.
10. Explain how Therapeutic drug monitoring helps in better patient care.
Basic Principles of Therapeutic Drug Monitoring
To confirm an optimum therapeutic drug monitoring following are some important criteria need to be considered:
• At appropriate time interval of drug administration, there is a need to estimate the patient's plasma drug concentration.
• Adequate information should be known on the pharmacological and pharmacokinetic profiles of the administered
drugs.
• There should be adequate and relevant information on the patient's profile such as demographic data, laboratory,
clinical status and other clinical evidence.
• There is needed to interpret the plasma drug concentration for the individualization of drug regimen according to need
of patients.
Need of Therapeutic Drug Monitoring
1. There is indication of TDM if the consequences of overdosing and underdosing are serious.
2. TDM is indicated if there is a small difference between a therapeutic and toxic dose range.
3. TDM is indicated if there is a certain change in the physiologic state of patient that may unpredictably influence the
circulating drug concentrations.
4. TDM is indicated because of drug interaction in such cases where the patient is more than two drugs.
5. There is need of TDM to establish therapeutic regimen in several physiological conditions like; pregnancy, neonate,
children, elderly; and pathological conditions such as renal disease, hepatic disease, etc..
6. There is need of TDM when there is unexpected lack of efficacy or toxicity.
7. TDM helps in monitoring patient compliance.
Limitations of Therapeutic Drug Monitoring:
1. TDM is unnecessary performed for wide therapeutic range drug.
2. TDM is also unnecessarily or no need to perform for those drugs whose pharmacological effects can be clinically
quantified.
3. It is not applicable for those drugs who follows linear kinetic.
4. Clinical outcome cannot be correlated to either dose or plasma concentration for certain drugs.
Drugs those are not suitable for TDM:
 TDM is not suitable for those drugs which have wide therapeutic index.
 In concerned with toxicity which is not a realistic concern such as for Penicillin.
 TDM is not suitable for those drugs whose effects can be estimated by functional laboratory tests like
anticoagulants.
 It is not suitable when the plasma concentration of drug cannot not predict with relation to its effects. For
example- Anticoagulants.
 It is not suitable when the relationship of response of drugs is undefined. Example- Antidepressants.
Objectives And Significance / Indications Of Therapeutic Drug Monitoring
1. Therapeutic drug monitoring is important for the drugs that have narrow therapeutic range. (Drugs which are below
range are not effective and the drugs which have above range are toxic). Thus, small changes in concentration of such
drugs, lead to no effects or toxic effect. Thus, for the prevention of ineffectiveness and toxic effects, it is important to
monitor the drug that has narrow therapeutic range.
2. Therapeutic drug monitoring is important for optimization of dosage according to therapeutic response seen in
particular patients.
3. There is importance of therapeutic drug monitoring for the drugs such as; theophylline which shows abrupt dose
response curve.
4. TDM is indicated to use for drug such as; digitalis for which there is struggle in estimating or interpreting the
therapeutic response or toxic effects. Digitalis produces nausea and vomiting in digitalis toxicity as well as in congestive
heart failure when used at therapeutic dose level.
5. Therapeutic drug monitoring is also important to detect the changes in pharmacokinetic parameters of drugs in certain
patients due to disease or any influence condition.
6. TDM is very helpful for drugs which shows saturable metabolism like with Phenytoin. 7. TDM used for those drugs
who has poorly defined the end point or difficult to predict the clinical effect. For example: immunosuppressant drugs.
8. Therapeutic drug monitoring is an important tool to monitor the patient compliance but the major limitation is that it
is costly and generally used in clinical trials only.
9. Therapeutic drug monitoring is useful for those drugs whose therapeutic effects cannot be readily assessed by clinical
observation. There is variation in plasma concentration of similar drugs in different variables in such cases TDM is an
important tool to analyze drug concentration.
10. Therapeutic drug monitoring indicating to established relationship between concentration of drugs in plasma and its
therapeutic or toxic effects.
11. Therapeutic drug monitoring is important for those drugs which follow non-linear kinetics.
12. Therapeutic drug monitoring is important to investigate unexpected lack of efficacy.
13. TDM is indicated in renal disease: There is alteration in plasma concentration of drug as alter in the dose of drug.
This relationship is affected by the renal disease. In which high plasma concentration is associated with renal
impairment which leads to toxicity even in small increased in the dose of drug. It is mostly seen with the drug which has
narrow therapeutic index such as; in case of digoxin, lithium and aminoglycoside antibiotics.
14. Drug interactions: There is need to monitor the therapeutic concentration/response of drug when there is concurrent
administration of more than two drugs. It is essential because concurrent administration of drugs may alter the
relationship between dose and plasma concentration. For example, administration of thiazide increases the plasma
concentration of lithium.
15. Therapeutic drug monitoring is useful for the diagnosis of suspected toxicity and makes a decision for the case of
drug abuse.
16. TDM is also used in guiding purpose for withdrawal of drug therapy.
11. Explain in detail preparation and revision of hospital formulary.
Hospital Formulary : A hospital formulary is a compendium of prescriptible medicines and other information, which
reflects the clinical judgment of the hospital's medical staff.
• The formulary is continually updated keeping in view the inference-based opinions of physicians, surgeons,
diagnosticians, pharmacists and other experts concerned with the treatment of disease.
Preparation of Formulary : • The preparation of the hospital formulary is the prime responsibility of the Pharmacy
and Therapeutic Committee.
• The committee is free to make the necessary decisions related to the materials to be included in the formulary and the
pharmacists undertake the production aspects of the preparation.
• The initial step in the compilation of a formulary for any hospital respective of size, speciality or control is the
selection of a competent of Pharmacy and Therapeutic Committee.
• The physical appearance and structure of the formulary plays an important influence on its use but elaborate and
expensive artwork is of no use, as it is meant for professional use so it should be virtually pleasing easily readable with
proper grammar, correct spelling and with neat designing.
A typical formulary will have the composition in the following manner:
1. Title page
2. Names and titles of the members of pharmacy and therapeutic committee
3. Contents
4. Information on hospital policies and procedure conceming drugs :
(a) The Pharmacy and Therapeutic Committee of hospital
(b) Objective and operation of formulary systems.
(c) Hospital regulations and procedure for prescribing and dispensing drugs
(d) Hospital pharmacy services and procedures.
(e) How to use the formulary
5. Product accepted for use in hospital : (a) Generic, brand name, cross-reference list
(b) Pharmacologic/therapeutic index with relative cost codes
(c) Descriptions of formulary drug products by pharmacologic therapeutic class
6. Appendix : (a) Central service equipment and supply list
(b) Guidelines for calculating paediatric dosage.
(c) Schedule of standard drug administration.
Revision of Formulary :
• Hospital formulary requires regular review and revision every year because the additio deletion, changes in the
product, removal of drugs from the market changes in the hosp policies and procedures necessitates periodic revision.
• Entry of a new drug in the formulary a complex procedure and the members are not competent enough to evaluate e
therapeutic agent, thus PTC has framed certain guidelines for inclusion and deletion of drug in the formulary.
• There should be definite system for revision of the formulary
• One method is to attach formulary supplements sheets to the back covers of formul books and second method is by
using different colours for the cover of each edition of t formulary, which will help reduce any confusion between
current and past edition.
• During preparation and revision of formulary system, cost effectiveness and cost benefit analysis methods are often
used.
Distribution of the Formulary : • Each patient care unit like: clinics and out-patient care departments such as
emergency rooms should receive a copy of the formulary.
• Heads of the departments who are providing direct patient care. hospital administration and medical staff should get
formulary free of cost.
• The pharmacy divisions like: in-patient and out-patient dispensing, drug information service too should get cost-free
formulary.
• Administration should ensure that paramedic staffs are familiar with the formulary and its usage
Limitation of Hospital Formulary :
1. The system may deprive the physician's right to prescribe and obtain the brand of his choice
2. The system in many instances permits the pharmacists to purchase and dispense drugs of their own choice
3. The system may allow purchase of inferior quality medicine where there is no staff pharmacist
4. The systems do not minimize the cost of medicine to the patient by passing the discount or any scheme received at the
time of purchase in bulk quantity by the hospital.
Legal Importance of the Formulary System : • A written and signed prescription constitutes the only legal permit to
fill a prescription. It is only the prescriber's prerogative to prescribe the brand or generic name.
• The pharmacist is only supposed to abide by the doctor's prescription. However, a pharmacist may dispense liable.
• It is desirable for every hospital to adopt a formulary system, as it is a health practice the drug, which in his
professional judgment meets the therapeutic need without being and a good inventory control measure that provides a
wide choice for the physicians to fulfill the needs of the patient.
• In such a system, a doctor prescribes and the pharmacist fills the prescription.
• If for any reason, the physician is not aware of the formulary, the pharmacist should inform him about the use of the
drug from the formulary.
12. Explain in detail precaution to be taken while dispensing of controlled drugs.
Dispensing of Controlled Drugs : The term controlled drug is defined as; "Substances, products or preparations
including certain medicines, that are either known to be or have the potential to be dangerous or harmful to human
health, including being liable to misuse or cause social harm. The examples of such substances of natural origin are
morphine and allied alkaloids of opium. Coca leaves, cocaine and resins of cannabis indica and synthetic or semi-
synthetic derivatives of morphine like; heroin and pethidine. These substances mainly cause CNS depressant effects
(Narcotics) and also have the potential to cause euphoria and hence addiction.
Prescribing of medicinal products that are liable to abuse requires special attention and hence, subjected to
specific statutory provisions. The practitioners may need to be authorised to prescribe controlled drugs. In such cases, it
might be necessary to indicate the details of the authority on the prescription. In view to have control on the use of such
substances in India Dangerous Drugs Act 1930 was enacted. The act regulated and controlled the cultivation,
possession, transport, dispensing, distribution and administration of opium, Indian hemp, coca by farmers, traders,
doctors, pharmacists and nurses. Later on the synthetic and semi-synthetic products such as; pethidine, LSD were
developed. However, the law did not cover these synthetic substances.
The retail sale and possession of such substances is covered by Schedule H, C and X of drugs and Cosmetics
Rules, 1945. Drugs like; opium, coca, help which produce drug addiction are included in Schedule X of Drugs and
Cosmetics Rules, 1945. For the control of operations relating to the narcotic drugs and psychotropic substances the act
viz. Narcotic Drugs and Psychotropic Substances Act, 1985 has been passed, wherein stringent provisions have been
made. The records regarding purchasing and distribution are required to be kept in prescribed formats and maintained at
different levels of operations. In hospitals a requisition form along with empty containers are sent from wards to the
central pharmacy. Before issue of quantities of controlled substances, the account of previous supply in the form of
summary of daily controlled drugs administered need to be checked by pharmacy. Account of every dose of controlled
substance supplied to ward is kept.
For patients admitted in the hospital, prescriber must write the medication order of controlled drugs in patients
controlled drug order sheet of patients chart. The following information is mandetary in such drug order sheet.
1. Date
2. Patients full name
3. Patients hospital admission number
4. Name of the drug ordered with strength
5. Total number of doses
6. Doctor's name and signature
7. Signature of nurse administering the drug.
For prescribing and dispensing controlled drugs to ambulatory patients, the provisions specified in Rule 65 (9) and Rule
(21) of Drugs and Cosmetics Rules 1945 concerned with drugs specified in Schedule X (Narcotic Drugs and
Psychotropic Substances) be complied. These are as follows:
1. Rule 65 (9):
(a) Substances specified in Schedule H and Schedule H1 or Schedule X shall not be sold by retain except and on in
accordance with the prescription of a registered medical practitioner and in the case of substances specified in Schedule
X, the prescription shall be in duplicate one copy of which shall be retained by the licensee for a period of two years.
(b) The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to registered medical practitioners,
hospitals, dispensaries and nursing homes shall be made only against the signed order in writing which shall be
preserved by the licensee for the period of two years.
2. Rule 65 (21):
(a) The supply of drugs specified in Schedule X shall be recorded at the time of supply in register specially maintained
for the purpose and separate pages shall be allotted for each drug. (b) The following particulars shall be entered in the
said register namely:
(i) Date of transaction
(ii) Quantity received if any, the name and address of the supplier and the number of relevant licence held by the
supplier.
(iii) Name of the drug.
(iv) Quantity supplied.
(v) Manufacturers name. (vi) Batch or Lot number.
(vii) Name and address of the patient/purchaser.
(viii) Reference number of the prescription against which supplies were made.
(ix) Bill number and date in respect of purchases and supplies made by him.
(x) Signature of the person under whose supervision the drugs have been supplied.
13. Discuss in detail drug distribution method for In patients system in hospital with merits and demerits
Dispensing Of Drugs To Inpatient
Inpatient: Inpatients are those who get hospitalized for the purpose of treatment of disease, surgery and rehabitation.
Drug distribution to inpatients falls within four categories are as follows:
1. Individual prescription order system.
2. Complete floor stock system (Charging Policy).
3. Combination of above 1 and 2.
4. Unit dose dispensing method.
1.Individual Prescription Order System : This system is generally used by the small and/or private hospitals because
of the less manpower requirement and the appeal for individualized service.
Advantages :
 All medication orders are directly reviewed by the pharmacist.
 Easily interaction of pharmacist, doctor, nurse and patient in the medication matters.
 Medication errors could avoid.
Disadvantages
 Possible delay in obtaining the required medication and the increase in cost to the patient.
 This system cannot be used in big hospitals.
 Difficulty in dispensing of drug in absence of pharmacist.
2. Complete Floor Stock System (Charging Policy):
 Under this system, both pharmacy and nursing are responsible for drug distribution to patients.
 According to this system, the drugs are stored at the nursing station and administered by nurse according to
order of physician.
 Commonly used drugs in significant quantity are stocked on the floor stock or in ward.
Drugs which are dispensed in complete floor stock system are categorized as:
(a) Charge floor stock drugs
(b) Non-charge floor stock drugs
This system is generally used by governmental and other hospitals in which charges are not made to the patient or when
the all-inclusive rate is used for charging. It does not have applicability to the general hospital.
(a) Charge Floor Stock Drug:
 Charge floor stock drugs are those where patient is charged for every single dose administered to him.
 Selection of these drugs in various wards is decided by pharmacy and therapeutic
 Examples of drugs in this stock are antibiotics, antihypertensive drugs, anticoagulant, antiepileptic,
antidepressant, diphenhydramine.
Method of Dispensing Charge Floor Stock Drugs:
Envelop Method: In this system, pharmacist fills a prelabelled envelops with needed drugs and gives it to nursing
ward. The nurse after receiving the envelops, writes the name and room number of patients on the envelop and put it
into her out basket and sent to pharmacy for costing and forwarded to billing section of accounting office.
(b) Non-charge Floor Stock Drugs:
Drugs are dispensed to all patients on floor on non-charged basis.
Method of dispensing non-charge floor stock drugs:
Drug Basket Method: This method is adapted where nurses verify the availability of medicines in all rooms as well as
in the refrigerator and accordingly prepare a master list for the pharmacy. Nurses fill demand form for delivery of drug
at the floor. When there is empty container, the nurses take it in the drug basket. Ones the procedure is completed, drug
basket containing empty container and demand form for floor stock supplies sent to pharmacy.
Immediately in the morning, the pharmacy staff initiates to fill each container and dispense the requested ampoules
and vials as ordered and demand. Once the basket is completed it is delivered to floor via messenger services.
Mobile Dispensary Unit: It consists of specially constructed stainless-steel trolley which is mounted on bottom tiers.
According to requirement, patients get the medicine via this unit.
Advantages of Complete Floor Stock System:
(i) Ready availability of the required drugs.
(ii) Minimize the return of drug to pharmacy.
(iii) Reduction in the number of pharmacy personnel required.
Disadvantages of complete floor stock system
(i) Medication errors may increase.
 (ii) Increased drug inventory on the porches.
(iii) Increased hazards associated with drug deterioration.
(iv) Lack of proper storage facilities on the ward may require capital outlay to provide them.
3. Combination of Individual Prescription Order System and Complete Floor Stock System: It is used in those
hospitals, where patients have to pay for their hospitalization. In this system, their primary mean is to dispense the drugs
according to individual prescription order system. Today most of the hospital uses this system. Some hospital modifies
it to include the use of unit dose medications.
4. Unit Dose Dispensing : Unit dose medications are those which are ordered, packaged, and administered in single or
multiple units containing predetermined amount of drug and doses.
Advantages of Unit Dose System
1. Patients receive better health service and have to charge for those drug and doses which are administered to them.
2. Nurses get more time for patient care because all doses of medication are prepared by the pharmacist.
3. To reduce the medication errors pharmacist allow checking a copy of the physician's original order.
4. Elimination unwarranted repetition of orders and paper work at the nursing station and pharmacy.
5. Eliminates recognitions.
6. Encourages more proficient utilization of professional and non-professional personnel.
7. Reduces revenue losses.
8. Preserves space in nursing units by removing bulky floor stock.
9. Eliminates waste of drug and dosage.
10. System has control throughout the hospital from the time of writing of medication order by physician to time up to
patient receives the unit-dose.
11. Communication of medication orders and delivery systems are improved.
Dispensing Procedure in Unit Dose System : This system could be followed by two ways: Centralized Unit Dose
Distribution System [CUDDS] and De-centralized Unit Dose Distribution System [DCUDDS].
(a) Centralized Unit Dose System : In this system, all the drugs are stored in central area of pharmacy and the drugs
are dispensed to all inpatients in unit doses.
To operate the delivery system effectively, various medication carts are used to transport unit doses to the patients
and to forward a copy of the physician original medications order to the pharmacy for direct explanation and filling.
(b) Decentralized Unit Dose System : Unlike the centralized system, decentralized unit dose system function through
small satellite pharmacies which are located on each floor of the hospital.
In this system, the core pharmacy becomes a procurement, manufacturing, storage and packaging center which
provides all medicine to all the satellites pharmacies.
The delivery process of this system is accomplished by the use of medication carts. Such type of system can be
used for a hospital with separate buildings.
Following are the step by step outline procedure necessitated in a decentralized unit dose system.
1. During the admission of patient in hospital all the patients related data such as diagnosis profile, medication history,
any allergies and other applicable data are entered on to the patient profile card.
2. Afterward direct copies of medication orders are sent to the pharmacist. 3. Entry of all medications ordered made into
patient profile card.
4. Pharmacist verify the medication order for allergies, drug interactions, drug laboratory test effects, and rational of
drug therapy.
5. Dosage time table is organized with nursing station.
6. According to medication order pharmacy technician insert the drugs in baskets of transfer cart.
7. Medication cart is filled for particular dosage schedule delivery.
8. Prior to release the medication cart pharmacist check the cart.
9. At the time of drug administration by patient the nurse supervises the medication and makes appropriate entry on her
medication record.
10. Before sending the cart to pharmacy for refilling it get recheck by nurse.
Pharmacist is available for the consultation throughout the complete process. In addition, he is maintaining
supervision for discontinued medical orders.
14. Which aspects of medication use are considered in medication history interview
Medication History : "A medication history is a detailed, accurate and complete account of all prescribed and non-
prescribed medications that a patient had taken or is currently taking prior to a newly initiated institutionalized or
ambulatory care. It provides valuable insights into patients' allergic tendencies, adherence to pharmacological and non-
pharmacological treatments, social drug use and probable self-medication with complementary and alternative
medicines."
An accurate medication history provides a foundation for assessing the appropriateness of a patient's current
therapy and directing future treatment choices. It can prevent medication errors and during the process of obtaining a
history other pharmaceutical issues such as poor or non-adherence can be identified.
1. A good medication history comprises information related to all current and recently prescribed drugs, previously
reported adverse drug reactions including hypersensitivity reactions, any over-the counter medications, including herbal
or alternative medicines and adherence to therapy. Medication history is considered very significant in prevention of
prescription errors and consequent hazards to the patients. Moreover, precise medication history can also detect drug-
related pathology or deviations in clinical conditions due to drug therapy.
2. Medication history errors like omitting drugs mistakenly are very common and can result significant hazardous
effects in patients. Moreover, allergic or hypersensitivity reactions are often poorly documented, which may lead to
unnecessary avoidance of a drug. Accurate documentation of concomitant herbal or alternative therapies is rare, despite
the fact that these therapies may have serious complications resulting in adverse effects or drug-drug interactions.
There are several factors which should be considered before taking an accurate medication history:
 Knowledge of previous and currently taken drugs by the patient and responses to those drugs will help in
planning future treatment.
 Drugs can alter the results of investigations. For example, amiodarone alters thyroid function tests.
 Drug effects should always be on the list of differential diagnosis, since drugs can cause illness or disease, either
directly or as a result of an interaction.
 Drugs can mask clinical signs. For example, B-adrenoceptor antagonists can prevent tachycardia in a patient
with haemorrhage.
Errors are more common on admission to hospital for many reasons: Mostly patients are not able to report their drug
history accurately and may not get describe the drugs themselves or cannot even produce a recent list of medications.
A drug prescribed in error is not easy to find out until a pharmacist reviews the patient's prescription, which
sometimes may be for up to 72 hours after admission. Therefore, the medication history must be accurate at the time of
admission and should be checked at the earliest opportunity during a patient's hospital stay.
The details that should be elicited in a good medication history are described below:
History from the patient : When taking the history from the patient use the words 'medicines' or 'medications', rather
than 'drugs', which may be mistaken for drugs of abuse or recreational drugs. Elicit the following information:
1. Current prescribed drugs, formulations (e.g., modified-release tablets), doses, routes of administration (e.g., oral,
transdermal, by inhalation), frequencies, duration of treatment.
2. Other medications (e.g., over-the-counter drugs and herbal or natural remedies, such as; vitamins and glucosamine).
3. Drugs that have been taken in the recent past (important for drugs with long half- lives, such as amiodarone).
4. Previous drug hypersensitivity reactions, their nature and time course (e.g., a rash, anaphylaxis).
5. Previous adverse drug reactions, their nature and time course (e.g., nausea with erythromycin, peripheral oedema with
amlodipine).
6. Adherence to therapy (e.g., 'Are you taking your medication regularly?'), recognizing that the information may be
inaccurate.

15. Explain a layout of ideal retail drug store.

Ideal drug store should possess following plan to execute properly:
1. Supervision and controlling of material handling and transportation.
2. Proper designing of suitable work locations.
3. Allocation of suitable locations as a production centers and service centers.
4. Minimized the movement of worker at production centre and wherever it required.
5. Minimized the waiting time of the semi furnished product.
6. Improvement in the methodology of work so there can reduce the production cycle in terms of times.
7. Flexibility to change the design of product for their future expansions.
A good layout permits the supply of the materials through the plant at the desired speed with the lower cost.
Following are the types general layouts for the retail and wholesale pharmacy store for efficient functioning.
Types of Layout : There are mainly following types of layouts:
1. Process Layout: • It is also known as functional layout and is categorized by keeping similar machines/operational
tool at one location.
• The arrangement is like a separate department, in which, particular class of machine or operational tool doing
particular type of work or process e.g. cutting machines may be placed under cutting department.
Advantages : (i) Better utilization of resources.
(ii) Greater flexibility.
(iii) Better supervision which ultimately leads to better production.
(iv) While doing such arrangements, there may require a smaller number of machines or other resources thereby results
into reduced capital.
Disadvantages: • In pharmaceutical and chemical industries, the functional layout type may not be possible due to
sequential performance/operation of many of the unit/sector.
2. Product Layout : • This type of layout also called as straight-line layout and is required to standardize in beginning
according to manufacturing process of particular product.
• Using such product layout design, the product can be manufactured in large quantity by repetitive operation.
Advantages : (i) Less space requirements for the same volume of production.
(ii) Smooth and continuous work flow.
(iii) Processing of work is quick and smooth.
(iv) Floor space can be properly utilized.
(v) Less in-process inventory.
(vi) Cost of material handling can be reduced by using conveyors.
(vii) Manufacturing time is reduced and manufacturing cycle can be speeded up.
This type of layout is more suitable for the Pharmaceutical Industries.
3. Combination layout : • In this layout, they use a combination of both functional and product layout for more
advantages
• A combination of process and product layout combines the advantages of both types of layout.
• The layout should be well-organized by keeping handling of material at a minimum level. While there requires suitable
layout planning to keep the cost of product minimum.
16. Which parameters of communication are important for effective patient counseling?
Explain the various counseling aids used in patient counseling
Communication Skills in Pharmacy Practice: Regulation 2015 (PCI), reemphasized about knowledge-based
implementation of prescription by pharmacist for optimum efficacy and safety. Therefore, there is a communication
between:
 Pharmacist and Patient (for patient counselling)
 Pharmacist and Physician (for clarification on medication)
This communication process between health professionals and patients serves two primary
1. It establishes an ongoing relationship between the professionals and the patient.
2. It provides the exchange of information among doctor/pharmacist/patient, necessary to assess a patient's health
condition, implement treatment of medical problems, and evaluate the effects of treatment on a patient's quality of life.
Patient Counselling : Patient counselling is "knowledge-based implementation of prescription by pharmacist by
imparting information to the patients or their representative to provide proper directions of use, advice on side effects,
storage, diet and life style modifications for optimum efficacy and safety." Because padents may not be receptive to
counselling efforts by physician because they may be overwhelmed by a new diagnosis or simply aren't in a frame of
mind where they can process the information. Good number of such medicines is given by pharmacist with proper
counselling/explanation related to method of use/administration, ADRS, storage, maintenance and dos/don'ts.
Patient counselling should include information on the who, what, where, when and how:
Patient : Who is the patient?
Drug : What is the name of the medication? What is the strength and dosage form? What is the purpose of the
medication?
Direction : How should the medication be taken (including duration, frequency and route of administration)? What to
do in the event of missed doses? Where to store the medication?
Precautions : What are potential adverse drug effects? What are potential food/drug interactions and contraindications?
Monitoring : What are the expected outcomes? How to monitor if treatment is effective? What to do if there are
unwanted outcomes? When to seek medical attention? Whether there are refills?
Be sure to include any additional information specific to the patient or medication.
Patient
• Confirm identity
1.Drug
• Name
• Strength
• Indication
2.Directions
• Route
• Frequency
•Duration
• Missed doses
• Storage
3.Precautions
• Adverse effects
• Food & Drug interactions
• Contraindications
• Steps to take if any of the above are encountered
4.Monitoring
• How to monitor response to therapy
• Expected therapeutic outcomes
• When to seek medical attention
• Refill information
• Any other information specific to drug/patient
Objectives Of Patient Counselling
1. Patient should recognize the importance of medication for his wellbeing.
2. A working relationship and a foundation for continuous interaction and consultation should be established.
3. Patient understands of strategies to deal with medication side effects and drug interactions should be improved.
4. Should ensure better patient compliance.
5. Patient becomes an informed, efficient and active participant in disease treatment and self-care management.
6. The pharmacist should be perceived as a professional who offers pharmaceutical care.
7. Drug interactions and adverse drug reactions should be prevented.
8. Reducing medication errors.

17. Describe in detail methods to detect medication non adherence.

MONITORING OF PATIENTS MEDICATION ADHERENCE : There are several methods reported to measure
compliance. The method of measuring the compliance can be grouped into direct and indirect methods of measurement.
Each method has advantages as well as some limitations. But no one consider as a gold standard to measure patient
compliance. The simplest way of measuring adherence is from the patient's self-report.
• Adherence of drugs in children can be done by asking questions to care giver. The easy to use methods for assessment
of drug adherence are questioning the patients, checking patient diaries, and assessment of clinical response. Among
these questioning to patient regarding compliance indicates misinterpretation and results in overestimating the patient
adherence
Methods of assessing compliance include:
1. Direct Method : Measuring the concentration of the drug in body fluids (Direct method).
• Measuring the pharmacological effect (Direct Method).
2. Indirect Method:
• Tablet counting
• Patient self report
• Patient diaries
• Recording devices
• Refilling of Prescription
Measuring the patient compliance by using direct methods such as; direct observed therapy, measuring the
concentration of drug or its metabolites in biological fluid, etc. are very most accurate methods but they are very
expensive and generally used in research purpose and in clinical trial. While in such methods, variation in metabolism
can give false impression of compliance. Differences in bioavailability and renal clearance also influence quantitative
profile of drugs.
Indirect methods for assessing the compliance include patient questionnaires, pill counts, patient self reports,
electronic medication monitors, rates of prescription refills, as well as checking patient diaries.
From the reports it suggested that patient compliance cannot predict accurately than by chance, thus specific
method should be used for assessing the compliance. Sometime direct questioning can be asked to patient regarding
adherence to drug therapy.
If the doctor asks the questions tactfully, then patient is more willing to admit defaulting in andherance.
Counting of remaining pills in patient medications bottles or vials is very common method of assessing the
compliance. The pill count method is very simple but it has so many disadvantages such as; discarding the remaining
pills before visit in hospital. Thus, this is not the ideal method to assess the compliance. This method does not give the
information of dose timing and drug holidays.
Rates of refilling prescriptions are a truthful measure of on the whole adherence in a closed pharmacy system
since refills are measured at several points in that time.
Electronic monitor methods are also giving the information of compliance. In this method, there is recording
and stamping the time of opening bottles, dispensing drops or activating canister (metered dose inhaler for asthma). The
disadvantage of this method is that patient may open the bottle of medicine but not guarantee to take medicine. Patient
may take wrong amount of medicine or may take multiple doses.
Checking of patient self-report is a common and convenient method for assessing compliance. The report of
patient can be obtained from standard interview or simple questionnaires regarding use of drugs. This method is
relatively inexpensive. This method provides accurate information even of unobservable experience and behaviour of
patient. For example: patients explain reasons for their non-compliance due to some of adverse effects of drugs.
Another indirect method for assessment of compliance is checking of patient diaries involves daily recording
by patient on drug used. This method provides the assessment of compliance for all drugs and for entire period. While
the limitation is method required more time for the evaluation of diary as well as entry of large recorded events. The
major limitation of this method is in completion of diary. Completion of diary is impossible for those patients who has
problem with literacy, loss of vision or memory.
18. Write a note on Individual prescription order and floor stock system
1. Individual Prescription Order System: This system is generally used by the small and/or private hospitals because
of the less manpower requirement and the appeal for individualized service.
Advantages
• All medication orders are directly reviewed by the pharmacist.
• Easily interaction of pharmacist, doctor, nurse and patient in the medication matters.
• Medication errors could avoid.
Disadvantages
• Possible delay in obtaining the required medication and the increase in cost to the patient.
• This system cannot be used in big hospitals.
• Difficulty in dispensing of drug in absence of pharmacist.
2. Complete Floor Stock System (Charging Policy):
• Under this system, both pharmacy and nursing are responsible for drug distribution to patients.
• According to this system, the drugs are stored at the nursing station and administered by nurse according to order of
physician.
• Commonly used drugs in significant quantity are stocked on the floor stock or in ward.
Drugs which are dispensed in complete floor stock system are categorized as:
(a) Charge floor stock drugs
(b) Non-charge floor stock drugs
This system is generally used by governmental and other hospitals in which charges are not made to the
patient or when the all-inclusive rate is used for charging. It does not have applicability to the general hospital.
(a) Charge Floor Stock Drug:
• Charge floor stock drugs are those where patient is charged for every single dose administered to him.
• Selection of these drugs in various wards is decided by pharmacy and therapeutic committee.
• Examples of drugs in this stock are antibiotics, antihypertensive drugs, anticoagulant, antiepileptic, antidepressant,
diphenhydramine.
Method of Dispensing Charge Floor Stock Drugs:
• Envelop Method: In this system, pharmacist fills a prelabelled envelops with needed drugs and gives it to nursing
ward. The nurse after receiving the envelops, writes the name and room number of patients on the envelop and put it
into her out basket and sent to pharmacy for costing and forwarded to billing section of accounting office.
(b) Non-charge Floor Stock Drugs: Drugs are dispensed to all patients on floor on non-charged basis.
Method of dispensing non-charge floor stock drugs:
• Drug Basket Method: This method is adapted where nurses verify the availability of medicines in all rooms as well
as in the refrigerator and accordingly prepare a master list for the pharmacy. Nurses fill demand form for delivery of
drug at the floor. When there is empty container, the nurses take it in the drug basket. Ones the procedure is completed,
the drug basket containing empty container and demand form for floor stock supplies sent to pharmacy.
Immediately in the morning, the pharmacy staff initiates to fill each container and dispense the requested
ampoules and vials as ordered and demand. Once the basket is completed it is delivered to floor via messenger services.
• Mobile Dispensary Unit: It consists of specially constructed stainless-steel trolley which is mounted on bottom tiers.
According to requirement, patients get the medicine via this unit.
Advantages of Complete Floor Stock System:
(i) Ready availability of the required drugs.
(ii) Minimize the return of drug to pharmacy.
(iii) Reduction in the number of pharmacy personnel required.
Disadvantages of complete floor stock system
(i) Medication errors may increase.
(ii) Increased drug inventory on the porches.
(iii) Increased hazards associated with drug deterioration.
(iv) Lack proper storage facilities on the ward may require capital outlay to provide them.

19. Describe the steps involved in answering drug information query?

20. Justify the role of pharmacist in rational drug use.
Rational drug use : The concept of rational drug use during the past few years has been the theme of various national
and international gatherings. Various studies conducted in developed as well as in developing countries during past few
years regarding the safe and effective use of drugs. Irrational drug use is a global phenomenon and only few
prescriptions justify rational use of drugs. In simplest words, rational use means prescribing right drug, in adequate dose
for the sufficient duration and appropriate to the clinical needs of the patient at lowest cost.
Factors that lead to sudden realization for rational drug use are as follows:
1. Drug Explosion: Increase in the number of drugs and their multiple brands has incredibly completed the choice of
appropriate drug for particular indication.
2. Efforts to prevent the development of Resistance: Irrational use of drugs may lead to the premature demise of
highly efficacious and life saving new antimicrobial drug due to development of resistance in human population.
3. Growing Awareness: Today, the information about drug development, its uses and adverse effects travel from one
end of the planet to the other end with amazing speed through various media.
4. Cost Effective Treatment: Increases in cost of the drug increases economic burden on the public as well as on the
government. This can be reduced by rational drug use.
5. Consumer Protection Act (CPA): Extension of CPA in medical profession may restrict the irrational use drugs.
6. Pharmacovigilance Activitites have increased creating level of medical-awareness.

Role Of Pharmacist In Rational Drug Therapy

1. Counseling of the patients and physicians: • The counseling about the new drugs, variations in the drug policies,
availability of drug etc., should be provided timely to the patient and physician.
• Patient should be counseled against proper drug usage.
2. Stating adverse drugs: • Adverse drug reactions should be reported to proper monitoring centers like hospital
management, regional/country head office.
3. Drug procurement: • The section and the range of drug should be based on essential drug concept in accordance
with the needs of the situation.
• Procurement must have cost effective drugs in a right quality and there should be selection of right supplies of right
quality products.
4. List preparation: • Pharmacist as being a drug representative in a public state about the physio-social requirement of
the prevailing population and can be contribute to prepare the most cost-effective list.
5. Effective communication with prescriber: • Should get in touch with doctor with relevant details to clarify and
correct the prescription error.
6. Ethical dispensing of OTC: • Pharmacist should dispense only allowed OTC drugs that to
with sound knowledge of clinical aspects.
• OTC dispensing of schedule H, H-1, X has given rise to problems like side-effects, dr resistance, drug abuse and
economical burdens.
22. Give in detail the Interpretation of Prescribed Medication Order
INTERPRETATION OF MEDICATION ORDERS :
1) In institutional patient care, the traditional physician - pharmacist patient relationship is shifted to physician-
pharmacist-nurse-patient relationship.
2) The medication order is written in 'Physician Order Sheet' and nursing staff administer the medications those
available at nursing drug station and simultaneously transcribe the medication order for sending to pharmacy.
3) When multiple copies of physician order sheet are used then, one copy is sent to pharmacy.
4) However, when multiple copies are not used; then while transcribing the medication order errors might be
possible due to misinterpretation by nursing staff.
5) Hence, pharmacist must review the order sheet carefully to avoid such errors during transcription.
6) Frequently the prescribers while writing medication order use abbreviations.
7) The abbreviations cause confusion and may be misinterpreted, resulting into supplying and administering wrong
medications, even by wrong route of administration.
8) It is the responsibility of pharmacist to interprete the medication order correctly; by reviewing the physician
order sheet, as it provides much more information other than drugs.
9) This additional information such as; diagnostic findings, pathological tests suggested, non-pharmacelogic
measures suggested (diet, physiotherapy etc.) gives clues for suggested medication order and thus, help in
interpreting the mediation order.
10) Moreover, poor handwriting of prescribers may lead to confusion and wrong interpretation of medications
ordered.
11) Another possibility is that as the same order sheet is used multiple times for ordering medications, some
medications may be left unnoticed by nursing staff.
12) Every time checking the date of ordering and physicians signature, such missing of medication can be avoided.
13) Use of multiple order sheets, computerised physician order entry shall avoid errors introduced during
transcribing the written orders.
14) When physician order newly marketed drug and if the staff members (nurse, pharmacy technician) are not
aware of such new drug then there are chances of misinterpretation. Pharmacist while reviewing the order
should correct such error.
15) The clinical screening of medication order performed by the pharmacist with respect to need of drug, allergies,
other contraindications, proper dose and proper route of administration further help in interpretation of
medication orders.

23. Explain Role of Pharmacist in pharmacy and therapeutic committee.

Pharmacy and Therapeutics committee (PTC) : It is a group of medical staff and they perform advisory functions for
the safety of patient's health. The PTC has a power to take decision about entry of new drug into hospital formulary.
Mission of PTC : The mission of Pharmacy and Therapeutics Committee is to encourage the health care professionals
(physicians) for prescribing and recommend using of high quality and cost-effective medication for patient health care.
Goals and Objectives: • To promote the appropriate use of high duality and cost-effective medication.
• To ensure compliance with applicable standards and federal regulations.
Role of pharmacist in pharmacy and therapeutic committee : • The pharmacy and therapeutics committee is
responsible for to prepare and maintain up ated formulary.
• The committee follows three main basic principles in the preparation of formulary. These principles are based on
weightage of proven effectiveness of medication, safety of the patients, and most important is cost of medicine.
1. Proven effectiveness documented in the medical literature : • The primary concern in the preparation of formulary
is consideration of degree to which a medication produces desirable clinical effects.
• Before inclusion of new medicine/drug in the list of formulary, PTC should assess and discuss the favorable effect of
new medication based on its strength of scientific evidence in the reported literature, its pharmacoeconomic studies, case
reports, randomized clinical trial, outcome of the research and the medical opinion on the new drugs.
2. Maximizing safety and minimizing the potential for errors : • During preparation of formulary, PTC should
assess the risk and benefit ratio of the new product/medicine compared to existing drug product in the treatments.
• During preparation there is a need to minimize the errors that may cause by appearances of the products in formulary
such as: name of drug product, dosage form and packaging that carries fears to safety of patient or potential for errors in
the health care system.
3. Optimizing pharmacoeconomic : • It is responsibility of PTC to compare the overall cost of new medicinal product
with existing treatment cost as well as compare the risk and medical outcomes.
• Generally, PTC gives the preferences to those medicinal products whose safety and efficacy profile are much more
compared to existing treatment at affordable cost to the largest potential population.
4. Prominence of the medicinal products essential to health care.
5. Patient convenience, adherence, and satisfaction : • PTC has prime responsibilities to review the favorable
medicinal products to increase the patient convenient adherence and satisfaction.
• Such as inclusion of convenient dosing, various form of dosage form, storage requirements, ability to divide the
dosage by themselves.
6. To support the standard treatment algorithm while preparation to health care.
7. Long term stability of formulary decisions : • PTC should be able to look towards the stability of formulary for
long time.
• For the stability of members in the committee, agenda regarding changes in the formulary should be minimized.
8. The formulary will serve as a guideline for the vast majority of patients: • To promote the utilization of
formulary, the PTC should apply the management policy such as prior authorization, quality limits, step wise edition in
the formulary and the age limit of the formulary.
• Considering the patient health care, the formulary should be readily available and easy to use in timely manner so such
type of care should be taken by PTC.

24. Give objective and information of Drug and Poison information centres.
• Drug use process is complex and drug related problems exist at various levels. Availability of thousands of drug
formulations further add to this complexity. As successful therapy requires rational use of medications, the healthcare
professionals and public must be provided with accurate and unbiased information about drugs.
• Pharmacist being expert on drug related matters is the most suitable and competent professional who can provide drug
information services. Logically drug information has to be a part of pharmacy practice and pharmacist be a drug
information specialist/scientist. Information related with drugs is of varied in nature and needs to be provided to variety
of healthcare professionals and public (patients).
• Drug information means the information related with the drugs. However, many of the times the information
pertaining to dietary supplements, disease prevention and poison is requested. Hence, sometimes the drug information
centre is also named as drug and poison information centre.
Drug Information Centre : • Drug information provides either in writing or verbally in response to request from other
healthcare providing organisations, committees, patients and public community. The information is provided by
pharmacist.
• Drug information centre provides detailed accurate source of drug information to meet needs of practicing physicians,
pharmacists and other healthcare professionals.
• The drug information service includes; collection, reviewing, evaluation, indexing and distribution/communication of
requested information.
• The best place to establish Drug Information Centre is in a teaching hospital because here the clinical experience,
college library, research facilities and educational environment help to perform centre activities quite effectively and
efficiently.
• However, the centres may be established in pharmaceutical industry, pharmacy colleges and even in community. For
establishing DIC the requirements include physical resources and human resources.
• The physical resources include; the space, computer facilities, print and online sources of information and financial
support.
Objective of drug and poison information center : • Describe the evolution of drug information.
• Define drug information and related terms.
• Describe the importance of drug information to the practice of pharmacy.
• Explain the need for drug information skills as a healthcare practitioner.
• Describe the essential components needed to develop drug information.
• Explain how drug information has changed and how the practice must change to meet future of healthcare needs.
• To participate in undergraduate and graduate teaching programs.
• To develop and participate in research programs.
• To provide the toxicovigilance services
• To develop educational activities and programs on the appropriate use of the drugs for community patients.
• To prepare and distribute drug information bulletin to health care personnel.
• To assist in the prevention of poisoning
25. Explain the role of pharmacist in health education.
Role of Pharmacist in Health Education
The following are described the main roles of pharmacist towards health education:
1. Processing of Prescriptions :
• Pharmacist verifies the prescription order for its originality; correctness and drug safety.
• Pharmacist also check the patient medication record (if available in pharmacy department) before dispensing of
medication according to prescription.
• While dispensing the medication, pharmacist ensures the correct quantity and strength of medication dispensed.
Pharmacist ensures the medications are handed to right patients with necessary counselling.
• pharmacist is a unique position in hospital and pharmacist is fully aware of patients past and current drug history as
well as provide the necessary advice to other health care professionals.
2. Care of patients or clinical pharmacy: • The pharmacist tries to gather and integrate the patient information with
respect to drug history, explains the proposed dosage regimen and method of drug administration.
• Pharmacist also advices on various precautions on drug related.
• In some countries, pharmacist is also responsible for the monitoring the therapeutic response of drugs
3. Monitoring of drug utilization: • The pharmacist can contribute in monitoring of drug utilization such as monitoring
and analyzing of the adverse reactions associated with prescription drugs.
4. Small-scale manufacture of medicines : • Pharmacist play a great role in the manufacturing of the medicines as per
the guidelines of good manufacturing and distribution practice.
• Pharmacists have expertization in the preparation of medicine. So, they can do this service in anywhere in the
pharmacy and can adjust the drug formulation according to the need of the individual patient,
• Pharmacist may also use the new technology in the drug delivery system in the modification of medicine to fulfil the
need of the patient.
5. Traditional and alternative medicines : • Pharmacist is also involved in the dispensing of the traditional and
homeopathic medications as prescribed by the health care professionals.
6. Responding to symptoms of minor ailments: • The pharmacist received various kind of inquiry on the symptoms
from public and asking for advice on medications for the same, in such cases when indicated pharmacist refers such
inquiry to consultants or health care professionals.
• If the symptoms are related to minor ailments such as, body pain, acidity. general fever, seasonal cough and cold then
pharmacist can supply non-prescription medicine with advising to consult medical practitioner of the symptoms persist
for few days even after completing the course of non-prescriptional medicine.
• Otherwise, the pharmacist may give recommendation to consult medical practitioner without supplying of respective
medicines.
7. Informing health care professionals and the public: • The pharmacist can collect and maintain information of all
medicines especially for the medicines which are newly introduced.
• After compilation and as necessary a pharmacist provides this information with advice and explanation to other health
care professionals as well as to the patients for promoting the rational use of drugs.
8. Health promotion : • The pharmacist can participate in the various local and national health promotion campaigns;
wide range of health-related topics such as national program of leprosy, HIV/AIDS tuberculosis, etc. and drug related
topics such as; alcohol abuse, rational use of drugs, abuse of organic solvent, use of tobacco, warning of drug use during
pregnancy, poison prevention, etc.
• They may also participate in the various educational campaigns on health promotion and disease prevention programs
such as; immunization, polio free committee, malaria prevention, and blindness programs in local community group.
9. Domiciliary hospitalization or treatment : • Pharmacist is also involved in the delivering of the health care services
including; the supply of medicines to residential home for disabled, elderly and long-term patients.
• There are certain policies being developed by various countries under which the pharmacist visited certain categories
of patients and counsel them about medications as well as supply the medicines as per the prescription order.
10. Agricultural and veterinary practice : • Pharmacists also involved in the providing of animal medicine
(veterinarian medicines) and medicated animal feed.

26. Explain code of ethics for community pharmacy.

The Code of Ethics sets out the principles that must follow as a pharmacist or pharmacy technician
The code is founded on following principles which express the values central to identity of the pharmacy professions:
1. A pharmacist respects the covenantal relationship between the patient and pharmacist
2. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner
3. A pharmacist respects the autonomy and dignity of each patient
4. A pharmacist acts with honesty and integrity in professional relationships
5. A pharmacist maintains professional competence
6. A pharmacist respects the values the abilities of colleagues and other health professionals
7. A pharmacist serves individual, community and societal needs
8. A pharmacist seeks justice in the distribution of health resources
CODE OF ETHICS FOR COMMUNITY PHARMACY
• From every profession, the society expects certain values, obligations and ethical behaviour to be observed and served
by its practicing professionals.
• The professional code of conduct serves several purposes, to allow a profession to regulate itself, to state the agreed
upon values of profession, to make members aware of issues and to provide guidelines for ethical behaviour.
• Pharmacy Council of India, the apex body controlling pharmacy, profession, while adopting the code of
pharmaceutical ethics has stated the ideas set up by Charaka, the ancient philosopher.
• Physician and Pharmacist in his enunciation: "Even if your own life be in danger you should not betray or neglect the
interests of your patients".
1. Pharmacist in relation to his job : • When premises are registered under statutory requirements and opened as
pharmacy, a reasonably comprehensive pharmaceutical services be provided.
• It includes the supply of commonly required medicines and willingness to furnish emergency supplies at all times.
Conduct of the Pharmacy : • Facilities, design and arrangements in the pharmacy should be such that, risk of errors
and accidental contamination of preparations, dispensing and supply of medicines shall be avoided.
• Appearance of premises should reflect professional character of pharmacy. In every pharmacy, there should be a
pharmacist in personal control of the pharmacy.
Prescription Handling and Dispensing : 1. Pharmacists should hold the health and safety of each patient to be of
primary consideration.
2. Pharmacists supply medications and health related products that are safe, effective and of good quality.
3. Pharmacist should act with honesty, integrity and compassion and establish professional relationship with each
patient.
4. Pharmacist provide correct, accurate and reliable information to their patients and counsel them to take informed
decision about their healthcare.
5. Pharmacist should be very judicious in dealing with drugs and medicinal preparations known to be poisonous or to be
used for addiction or any other abusive purposes.
6. Pharmacist should see that apprentice pharmacists are given full facilities and training so that, they acquire adequate
techniques and skills.
2. Pharmacist in relation to his trade : 1. Pharmacist should stick to fair trade practices and no attempt should be
made to capture the business of a contemporary by cut-throat competition.
2. Drugs should always be purchased from genuine and reputable sources.
3. Hawking of drugs and medicinals should not be encouraged.
3. Pharmacist in relation to other Healthcare professionals : 1. No pharmacist should recommend particular medical
practitioner unless unspecifically asked to do so.
2. Pharmacist should respect values and abilities of colleagues and other healthcare professionals.
3. Pharmacist should maintain professional relationships with colleagues and ensure that patient's need are met.
4. Pharmacist in relation to his profession : 1. It is not only sufficient for a pharmacist to be law-abiding and to deter
from doing things detrogatory to society and his profession, but it is his duty to make others also fulfil the provisions of
the laws and regulations.
2. Pharmacist should join and advance the cause of professional organisations, the aims and objectives of which are
conductive to scientific moral cultural well-being of pharmacists.
3. Pharmacists should continuously improve their levels of professional knowledge and skills to upgrade the
professional competence to provide better patient care.
A pharmacist must, above all be a good citizen and must uphold and defend the laws of the state and the nation.
27. Add a note on communication skill required by pharmacist in interdepartmental communication in hospital or
clinical settings
Skills
(a) Patient counselling
(b) Drug information services
(c) Reporting, monitoring and prevention of ADR's
(d) Case note reviews, interactions and rug use reviews
(e) Interpretation of laboratory results
(f) Promotion of rational drug use and essential medicines concepts
Role of Pharmacist in the Interdepartmental Communication
1) Medical care encompasses preventive, curative and even rehabilitative measures.
2) Apart from diagnosis and treatment for ill patients, the modern hospitals take measures to prevent the
occurrences of diseases through immunization, community screening to identify people at risk, to tackle their
health problems.
3) In modern Pharmacy Practice, the concept of 'Pharmaceutical Care' has been accepted. Pharmaceutical care is a
patient focused, outcomes oriented pharmacy practice that requires the pharmacist to work in concert with the
patient and patient's other healthcare providers to promote health, to prevent disease thereby improving the
patient's quality of life.
4) Provision of medical care requires a group of people, educated and expert in medical and paramedical sciences.
5) This group of people is termed as 'healthcare team' which while providing medical care work in a tem and share
a common health good.
6) Pharmacist providing 'Pharmaceutical Care' as a part of medical care requires working in a healthcare team.
7) In a team work, communication with other members in a team is of paramount importance.
8) In 'institutional care', settings pharmacist is continuously communicating with other healthcare professionals and
patients.
9) In ambulatory patient care (community pharmacy) too; the pharmacist needs to communicate with and work in
collaboration with the other healthcare professionals.
10) This is required especially while performing the role of "educating the community".

28. What are OTC Drugs? Gives its types and common indications.
29. Discuss medication chart endorsement.
Medication Chart Review
• It is a fundamental responsibility of a pharmacist to ensure the appropriateness of medication orders.
• It serves as starting point for other clinical pharmacy activities (medication counseling, TDM, DI and ADR).
• Organizing information according to medical problems (e.g., disease) helps breakdown a complex situation into its
individual parts.
Goals : 1. To optimize the patient's drug therapy.
2. To prevent or minimize drug related problems/medication errors.
Procedure: • The patients medical record should be reviewed in conjugation with the medication administration record.
• Recent consultations, treatment plans and daily progress should be taken into account when determining the
appropriateness of current medication orders and planning each patient's care.
• All current and recent medication orders should be reviewed.
Components of Medication Order Review Include : 1. Checking that medication order is written in accordance with
legal and local requirements.
2. Ensuring that the medication order is comprehensible and unambiguous, that appropriate terminology is used and that
drug name are not abbreviated. Annotate the chart to provide clarification as required.
3. Detecting orders for medication to which the patient may be hypersensitive/intolerant.
4. Ensuring that medication order is appropriate with respect to: (a) The patient's previous medication order.
(b) Patient's specific considerations e.g.. disease state, pregnancy.
(c) Drug dose and dosage schedule, especially with respect to age, renal function and liver function.
(d) Route, dosage form and method of administration.
5. Checking complete drug profile for medication duplication, interactions or incompatibilities.
6. Ensuring that administration times are appropriate e.g.. with respect to food, other drugs and procedures.
7. Checking the medication administration record to ensure that all ordered medications have been administered.
8. Ensuring that the drug administration order clearly indicates the time at which drug administration is to commence.
9. Special considerations should be given especially in short course therapy as in antibiotics and analgesics.
10. Ensuring that the order is cancelled in all sections of medication administration record when the drug therapy is
intended to cease.
11. If appropriate follow up of any non-formulary drug orders, recommending a formulary equivalent if required.
12. Ensuring appropriate therapy monitoring is implemented.
13. Ensuring that all necessary medication is ordered. e.g., premedication, prophylaxis.
14. Reviewing medication for cost effectiveness.
15. Identification of drug related problems:
• Untreated indication.
• Inappropriate drug selection.
• Sub-therapeutic dose.
• Adverse drug reaction.
• Failure to receive drug.
• Drug interactions.
• Drug use without indication.
• Overdosage.
Medication Chart Endorsement : • Another important goal of treatment chart review is to minimize the risk of
medication errors that might occur at the level of prescribing and/or drug administration.
• A medication error is any preventable error that may lead to inappropriate medication use or patient harm.
• To prevent potential morbidity and mortality associated with these errors, pharmacists should systematically review
the medication chart and write annotations on the chart where the medication orders are unclear.

30. What is Label information controlled by the FDA for OTC drugs.

31. What are the objectives for clinical pharmacist on ward rounds.
Ward round is nothing but the routine rounds by the health care provider to meet/visit the patient for normal check up
on daily basis to check the progress of health of patients. Mostly physician is the leading person along with their team
who may be assistant, nurse and pharmacist in the ward round to observe the patient condition and routine checkup and
decide further therapeutic regimen for their patient.
Goals and Objectives of the Ward Round Participation:
1) Monitors the patient's condition and take immediate decision on medication to improve the patient condition
and avoid death.
2) To check the case history of patients and accordingly change the approaches of treatments.
3) To ensure the safe and cost-effective treatment plan for the patients.
Role of Pharmacist: Pharmacist should always associate as a team members of health care professional during ward
round participation. Pharmacist is an expert person in decision making process in matters of dosage regimens,
monitoring of adverse drug reactions, interaction with medications, and interpretation of prescription as well as
associated with drug and poison information services.
• Pharmacist has great role in the enrichment of treatment accuracy and uses several pharmaceutical services
considering the patient safety and efficacy of treatment
• Pharmacist is a qualified person in a hospital and should participate with team to promote healthcare practice in the
management of disease.
• Pharmacist should prevent negative perspective of therapeutic outcome due to the medication errors and incorporation
of incorrect dosage regimen.
Responsibilities of the Pharmacists:
• Pharmacist should participate with physician during the ward round as well as he should do visit alone to provide
information related with medication and its administration and necessity care to concerned patient.
• During ward round with physician, pharmacist should follow the treatment given by the physician as well as check the
prescribed dose by referring the formulary.
• Pharmacist may also thing on the prescribed medication and assess the possible risk to the patients while drug
administration and will report or alert to the health care team to prevent further causality.
• Pharmacist must target the patients prior to discharge while his ward round and advice regarding practice of drug
administration which are necessary to take after discharge of the patient. Pharmacist should also motivate the patient
while discharging regarding to take proper diet and exercise for disease management.
32. Add a note on ward round follow up.
33. Define and Classify the types of Budget.
Budget is a plan of activities to be carried out in future for specific period in financial term. Budget is used to project
future income and expenses. Budgets are a multi-purpose management tool supporting planning, control, co-ordination,
communication, performance evaluation and motivation. Budgets are an important mechanism in the allocation of
decision rights. Budgets are often used to measure performance. Budgets are also used as a mechanism for control.
Objectives of Budgeting : 1. Basically budget is used for planning and control of the activities of the organization. It
enables the organization to concentrate on cash flow, reducing costs, improving profits and increase return on
investment.
2. Budgeting facilitates co-ordinating operations of various departments.
3. Budgeting is useful for policy formulation and implementation.
4. Budgeting gives guidance regarding the direction in which the organization is supposed to be going.
5. It helps in predicting cashflows.
6. To decide upon allocation of resources such as; fixed assets, purchase, etc.
7. Useful in measuring the performance through use of variances from budget.
Classification of Budgets:
Based on time period, budgets can be classified into two types:
1. Long Term Budget : • It considers the planning of operations of the organization for period of 5 to 10 years.
• The happening of any unpredictable factors shall have adverse impact on the budget. Hence, it should be supplemented
with short-term budget.
2. Short Term Budget : • Usually prepared for one year and thus, are prepared in details.
• These budgets are quite useful for control point of view.
Types of Budgets:
There are four main types of budgeting methods:
1. Incremental: It is a simple method of preparing current years budget by taking last years actual figures and adding or
subtracting some percentage to it. The major disadvantages include; the perpetuation of inefficiencies and ignorance of
external factors thereby resulting into budgetary slack.
2. Activity Based: It is a top-down budgeting approach that determine the amount of inputs required to support the
target.
3. Value Preposition: The inclusion of item in the budget is based on creation of value to the customer, staff or
stakeholders. In other words, the justification of cost of item is required for its inclusion. The major advantage is that the
unnecessary expenditure
is avoided.
4. Zero Based: It stars with the assumption that all departments budgets are zero and thus, manager must be able to
justify every single expenditure.
Other types includes -
i)Sales budget: Estimation of sales forecast for specific period
ii)Production budget: Estimation of cost for manufacturing a product
iii)Labour budget: Wages and incentives of work force
iv) Fixed budget: Remains unchanged irrespective of level of activity
v) Flexible budget: Calculate depending upon changes in amount of actual revenue
vi)Master budget: Oveall picture of proposed activities
vii)Cash budget: Cash plan for specific period of time
viii)Personnel budget: Manpower requirement
ix)Administrative budget: Salaries of managerial personnel
x)Selling and distribution
expenses budget: Expenses for promotion and distribution of products.
Advantages of Planning a Budget/Benefits of Budget:
• All levels of management plan ahead.
• Definite objectives for evaluating performance.
• Early warning system for potential problems.
• Coordination of activities within the business.
• Management awareness of the entity's overall operations.
• Motivates personnel throughout organization to meet planned objectives.
Disadvantages of Budgeting:
• Budgets are prepared on the basis of estimates. If the estimates are wrong, the budgets will be misleading.
• Future is uncertainty and cannot be predicted accurately. A budget is prepared for future period.
• A budgetary program is rigid one. The deviations are find out by comparing actual performance with budgeted figures.
• If budgets are revised frequently, it may lead to more administrative expenses and even employee may lose their faith.
• Budgets demotivate employees because of lack of participation.
• Budgets can create competitors for resources and politics.

34. What is the relationship between volume of distribution, clearance and half life ?
35. Write a note on misuse and abuse of OTC drugs
Any medication, prescription or non-prescription (OTC) have the potential of showing ADR's, side effects, allergies
even interactions with other drugs, food material consumed, etc. Hence, precautions need to be taken while
recommending and dispensing OTC medications to the patients. For ensuring rational use of such medications
pharmacist must counsel the patient adequately atleast in the following two things:
1. Pharmacist should never forget to tell the patient to contact physician if the condition is not improved or if symptoms
worsen or if new symptoms are developed.
2. Specific instructions for appropriate use and necessary precautions while using OTC medications supplied to the
patient.
As OTC drugs are available without physician's prescription, sometimes there are chances of drug addiction. Self-
medication is another major issue with OTC drugs. Many studies have been conducted on OTC drugs and self-
medication. Every drug has adverse effects, if consumed for long time. Drug addicts are controlled by their habit.
Everything they do is geared towards satisfying their need. Addicts will persist in taking drugs even though they are
fully aware of consequences. Some of the addiction forming OTC drugs are analgesics, pain killers and cough
preparations.
Safety of OTC Products:
All OTC drug products must meet FDA standards in terms of quality, efficacy and safety. Though easier to purchase
and use than prescription medicinal products, it is important to understand that these are herbal products though not
without risk. You can think about advantages and the risks before using any drug to make the best choice for you.
Evaluate the products, and ask yourself.
• What is the persistence of this drug?
• Do I need to use that product?
• Is there any risk for interactions with other medications or foods?
• What are the side-effects?
• When will I stop taking the medication and contact physician?
• How much medicine will I be taking?
• How often and for how long, and how do I take medicine?
36. Explain Roles and responsibilities of clinical Pharmacist.
Role of Clinical Pharmacist
1. Supervision of all drug distribution activities for drug use control and patient safety.
2. Selection of effective prescription drug products having reasonable cost.
3. Record patient's medication history and adverse effects if any thereof.
4. Detection and reporting of adverse drug reactions and drug interactions.
5. Counseling the patient on proper use of drugs and instructions.
6. Assuring the patient compliance to medications and instructions.
7. Advice and recommend the patients, the appropriate OTC medications.
8. Assist physicians in selecting rational drug therapy for a patient.
9. Establishing most effective dosage regimens for patients.
10. Supervising the management of patients with acute and economic diseases.
11. Establishing comprehensive treatment plan considering psycho-socio-economic aspects of healthcare.
12. Detecting and preventing incompatibilities in drug mixtures.
13. Supervise the dispensing of prescriptions by dispensing assistants.
14. Provision of drug information to patients and other health professionals.
15. Performing drug utilisation reviews.
16. Providing health education to community.
17. Monitoring the patient therapy by utilizing patient medication profile and other resources.
Responsibilities Of Clinical Pharmacist
1. Drug Evaluation and selection : • Pharmacist has become a valuable resource person for section of drugs used for
the treatment of diseases where the pharmacist can provide exclusive service in evaluation of drugs because of
knowledge about pharmaceuticals.
• Pharmacists can achieve professional respect from the medical community by furnishing essential scientific
information on drug evaluation and selection.
2. Drug information : • The provision of drug information is the foundation of clinical parmacy practice.
• The pharmacist must realize the importance of recent literature and utilize the Information retrieval techniques to
provide the available updated information in a rapid and efficient manner.
• The drug information center can be an incredible resource which can serve as a bank of important information.
• The provision of information should not be limited to discussions with a person seeking information.
• Drug information should be provided via intrahospital newsletters, in-service education and community lectures.
3. Drug utilization: Professional obligation to monitor drug utilization. Pharmacist should be ever mindful of:
(1) Drug abuse (2) Abnormal prescribing patterns
(3) Drug-drug interactions (4) Drug-food interactions
(5) Drug-laboratory test interactions (6) Adverse drug reactions
(7) Intravenous admixture incompatibilities (8) Duplicated prescriptions
Patient drug profile is very useful document in monitoring blood utilization. A new role revolving for the
institutional practitioner is the supervision of drug administration.
4. Drug distribution systems: • The complete understanding and appreciation of the various drug distribution systems
are essential for communication with other health professional and the public regarding unit dose packaging, system of
distribution and control procedures.
• Clinical instructor, hospital pharmacist and community pharmacy can establish accurate and safe medication
distribution system in hospital.
5.Patient education : • Patient need to be educated on the mode of admin storage of drug, their possible action and side
effects, the importance of compliance, possible interaction with other prescription and non-prescription drugs and
reporting of adverse or unusual effect to the physician or to the clinical pharmacist.
• This type of information can make the patient aware of disease symptoms, course of therapy, side effects and food and
drinks which should be avoided with the prescribed medicines.
6. Patient care: • The clinical pharmacist is responsible for medication related inquiries and follows up of laboratory
investigation.
• Clinical pharmacist is required to monitor the available pharmacokinetic data.
• If necessary, consult the physician or other healthcare professional regarding the therapy. The clinical pharmacist may
be called upon for selected and chronic disease patients.
• The clinical pharmacist may audit the medication order and the prescription.
7. Participation in drug utilization studies: By virtue of his professional training, clinical pharmacist is an important
person to conduct patient care audit which could highlight the deficiency in the existing system and devise strategies for
the overall involvement in the quality of healthcare of the patient.
8. Formulation and management of drug policies : • The important function of clinical pharmacist is formulation of
drug related policies of the hospital.
• Being in a key position in assessing and monitoring drug therapy as well as knowledge about the various aspects of
drugs and adverse reactions, clinical pharmacist in collaboration and interaction with members of the healthcare team,
holds a key position in framing and implementation of drug policies.
9. Education of Medical and paramedical staff: By the virtue of being a source of knowledge on drugs, clinical
pharmacist has a role to play in educating the medical and paramedical staff on rational drug therapy.
10. Pharmacist in research and development: Pharmacist can be an important person in undertaking a research on
drug development, formulation and bioavailability studies.
11. Review of medication history of the patient: Clinical pharmacist can review the medication history of patient
including maintenance of past and current medical conditions, medication history for both prescription and non-
prescription drugs, drug allergy and sensitivity, side effects, incorrect drug administration and any specific problem
associated with the administration of a drug to the patient.

37. Explain in short Two Bin System.

38. What are barriers of Patient counseling.
Patient Counseling Barriers : All communication barriers must be overcome to be able to give pro-barriers to effective
communication include physical, psychological, administrative or time conflict. Such conflicts prevent effective
communication from being established.
Patient counseling barriers are of the following types.
1. Environment : • The environment should be conducive to proper interaction between patient and pharmacist. There
should be privacy and enough time for proper interaction.
• Environmental barriers such as a lack of privacy or furniture that creates
physical barriers between patients and doctors/pharmacists can prevent effecti communication.
• Environmental barriers are examples of physical barriers.
2. Patient Based Barriers: • Patient may not like to listen. He/she may have some disadvantage/may not know your
language/may feel shy or inhibited. These barners must be overcome with patience.
• However, if the patient is reluctant about accepting advice, it is better to leave him and not insist on giving advice.
3. System Based Barriers: • The owners of the establishment may not like patient counselling or there may not be
enough space where counselling may be done.
• Administrative barriers such as management may view the lack of money compensated for communication as a reason
not to communicate.
• More money is made by prescribing medication, not caring for patients.
• Time barriers are interlinked with administrative barriers because management is responsible for staffing levels.
4. Provider Based Barriers: • The pharmacist who is giving the counselling may have problem with language or
subject or some other problem may be there.
• Personal barriers include low self-confidence, shyness, dysfunctional internal monologue, lack of objectivity, cultural
differences, discomfort in sensitive situations, and conflicting values to healthcare practice.
5. Semantics: • Semantics relate to meanings of words and symbols used in interpersonal communication.
• Words only contain meaning in terms of people's reactions to them. Words can also have multiple meanings.
• Therefore, effective patient communication requires the use of words that are carefully chosen. • Jargon should be
clearly defined or avoided.
• Semantics is an example of a psychological barrier. • Perception is how a message is perceived by a patient. The
patient may view the doctor as only being interested in diseases, drugs and money, not people.
• If the patient views the doctor as being incompetent or uncaring, he/she is less likely to trust the doctor's advice.
Perception is an example of a psychological barrier.
- Time restraints are often excuses not to counsel, though it often does not take very long.
- Messages become helpful to the patient only when they are accurately received messages are distorted or incorrect;
they could be harmful to the patient and prevent a positive patient outcome.
- It is important to understand these potential communication barriers so a strategy could be developed to minimize or
remove them.
39. Define Purchasing, Give its types and functions
40. Explain the role of advisory committee in investigational use of drugs.
Advisory Committee
• In the view of drugs which are used in the investigational purpose in the hospital are subjected to review by advisory
committees which are nothing but the committee on the human use in research; and Pharmacy and Therapeutics
Committee (PTC).
• In which the principle investigator should provide all the information related to investigational drugs to the PTC and
should letter for intention to use of investigation drugs in patients.
• It is the responsibilities of hospital and members of PTC to develop procedures and policies for the handling of
investigational drugs in the hospital for the patient's benefits.
• The committee on the human use in the clinical research is the standing committee of hospital and is responsible for
the providing the guiding principles and policies issues in association with the use of human/patients for the clinical
research investigations.
Following are some important policies which are need to be implemented in hospital where enforcing the use of
investigational drugs for the safeguard the rights and welfare of human subjects.
• The use of investigational drug in patient must be approved from the human subject committee, pharmacy and
therapeutic committee and if applicable isotope committee before the use for the patients in the hospital.
• The principle investigator shall be informed in the written that, neither the hospital nor other hospital staff will be
responsible for any legal liabilities which may occur during the use of investigational drugs.
• Investigator should not proceed to use the investigational drug before obtaining of the consent form from the patient or
legally responsible person.
• The principle investigator is responsible for to register each investigational drug in pharmacy department and provide
all the related information to prepare investigational drug data sheet and drug formulary.
• In order to ensure the continuing observation of the research project by the committee of human use in research, each
principle investigator should prepare a continuing surveillance report on quarterly basis and forward it to the secretary
of the committee of the use of human in research investigations regularly.

41. Explain in detail the drug recall procedure.

42. Describe the role of pharmacist in drug procurement.
Procurement of Medications : Procurement of quality and cost effective medications is of utmost importance for
efficient functioning of community pharmacy. Basically, the procurement of medications should be based on balancing
two contradictory situations viz. fulfilling patient's need i.e. at no time there should be shortage of medications and there
should not be too much of stock causing trying up of money. The additional factors to be considered on priority order
include:
(1) Quality of medications
(2) Availability of budget provision
(3) Reliable supplier
(4) timely delivery of items
(5) Cost-effectiveness
(6) Compliance to regulatory provisions
Based on these factors, the community pharmacist should select reliable supplier/ wholesaler. In India, almost 90% of
purchases of medications by retailers is from wholesalers and stockists. For each wholesaler it may not be possible to
keep stock of thousands to procure their requirements. However, before selecting the supplier, a community pharmacist
needs to be very careful about following things:
1. What medications to be ordered?
2. From whom to order?
3. How much to order?
4. What quantity of medications to be ordered?
5. When to order?
6. Time required for delivery of supply
7. Cost considerations.
In general the answers of these questions are based on inventory control methods followed by the pharmacist. On the
basis of his knowledge, managerial skills and experience the pharmacist will be able to select most reliable supplier.
Such examination and observations of supplier's premises and transport facility is termed as 'vendor audit'.
1. Possession of valid licence for wholesaling.me
2. Activities carried out under supervision of pharmacist.
3. Staff handling medicines are trained.
4. Transport of medicines in proper vehicle.
5. Precautions are taken to prevent mixups of returned/damaged medicines.
6. All records are filled and maintained.
7. Storage area is with appropriate storage conditions and is clean.
8. Storage conditions such as; temperature, humidity are adequate.
9. Independent/separate storage areas for different items.
10. Storage, handling of controlled substances is as per legal provisions.
11. Prompt and timely delivery.
12. The complaints are handled efficiently.
13. Vendor have written SOP's and are carefully followed.
A procurement cycle needs to be established, wherein upon ongoing sales of medications, the information regarding
what medications and in what quantities are being sold is collected. Checking the shelves for availability and quantity of
medications shall help to gather the information on the basis of which pharmacist selects the medicines for next
purchase order.
43. What are hematological test and explain in detail any two.
Hematological test : Hematological testing is related with blood only. The test includes blood and its components such
as blood cells, haemoglobin, protein, bone marrow, platelets, etc. The conditions such as; hemophilia, thrombus
formation, bleeding disorders, leukemia, multiple myeloma etc. affects the process of blood formation and functions of
each components reflected by abnormal laboratory values. Following are describing various hematological parameters
used in laboratory investigation.
Hematological test : Hematological testing is related with blood only. The test includes blood and its components such
as blood cells, haemoglobin, protein, bone marrow, platelets, etc. The conditions such as; hemophilia, thrombus
formation, bleeding disorders, leukemia, multiple myeloma etc. affects the process of blood formation and functions of
each components reflected by abnormal laboratory values. Following are describing various hematological parameters
used in laboratory investigation.
Hematological test
1) White blood cell test
2) Hematocrit
3) Erythrocyte sedimentation rate (ESR)
4) Haemoglobin
5) Differential cell count
6) Haemoglobin electrophoresis
7) Red blood cell count
8) Red cell indices

1] Test: ESR (Erythrocyte Sedimentation Rate)

• The ESR measures the time required for erythrocytes from a whole blood sample to settle the bottom of a vertical tube.
• Factors influencing the ESR include red cell volume, surface to area, density, aggregation, and surface charge.
• The sample must be examined within 2 hours of collection and it must be handled gently, no clotting of sample must
take place.
Normal value: 0-20 mm/hr (gradually increase with age)
• The ESR is a sensitive, but non-specific test that is frequently the earliest indicator of disease.
• It often rises significantly in widespread inflammatory disorders due to infection or autoimmune mechanisms. • Such
elevations may be prolonged in localized inflammation and malignancies.
Increased ESR: • may indicate pregnancy, acute or chronic inflammation, tuberculosis, rheumatic fever,
paraproteinemias, rheumatoid arthritis, some malignancies, or anemia. Decreased ESR: • may indicate polycythemia,
sickle cell anemia, hyperviscosity, or low plasma protein.
2] Test: WBC Count (White Blood Cell Count/Leukocyte Count) Laboratory test that counts the actual number of
WBCs in the blood. Normal value: Total WBCS: 4,500 to 10,500.
Basic types of WBCs:
• Neutrophils (Granulocyte)
• Lymphocytes (Non-Granulocyte)
• Monocytes (Non-Granulocyte)
• Eosinophils (Granulocyte)
• Basophils (Granulocyte)
Clinical implications:
• As we all know, WBCs are our body's first line of defense against invading bacteria and most other harmful
organisms.
• This test (WBC), measures the total number of all types of WBCs.
• Further examination of the different types and numbers of cells present, could tell much about the state of the body's
defense system.
• WBC count will normally vary as much as 2,000 on any given day.
3] Test: Differential Cell Count also known as "diff" or "differential" : Laboratory test that counts actual numbers
of different types of WBCs:
Clinical implications:
• Interpretation of the results of the differential must always be done with the total number of WBCs in mind.
• The WBC differential evaluates the distribution and morphology of white blood cells.
• Therefore, it provides more specific information about a patient's immune system than the WBC count alone.
• In the differential test, the lab classifies 100 or more white cells in a stained film of peripheral blood according to two
major types of leukocytes. They are:
(i) Granulocytes (neutrophils, eosinophils, basophils)
(ii) Non-Granulocytes (lymphocytes, monocytes).
• The percentage of each type is then determined.
• The differential count is the relative number of each type of white cell in the blood. By multiplying the percentage
value of each type, by the total WBC count, the lab obtains the absolute number of each type of white cell.
• Although little is known about the function of eosinophils in the blood, abnormally high levels of them are associated
with various types of allergic disorders and reactions to parasites.
• In such cases, the eosinophil count is sometimes ordered as a follow-up to the white cell differential.
• This test is also appropriate if the differential WBC count shows a depressed eosinophil level.

44. Enlist parameters of urine analysis with its clinical significance

URINALYSIS : The urinalysis is another common test routinely taken in almost all acute hospitals as an admission lab
screening test. It can easily reveal renal and systemic pathologies. Even the routine urinalysis should be a midstream
specimen after cleansing the meatus. This does not require any special equipment or expense to the patient.
1. Test: Appearance :
Clinical implications: Turbidity and other terms are used to characterize the appearance of a urine specimen. Urine
may contain red or white blood cells, bacteria, fat, or chyle and may reflect renal or urinary tract infection.
2. Test: pH :
Clinical implications: Urine is normally slightly acid (4.5 - 7.2 normal range). If alkaline, it can be indicative of
infection. However, the urine pH does change during the day due to dietary influences and water intake. A 24 hours
specimen would reveal an optimum pH of about 6.0.
3. Test: Specific Gravity: Specific gravity is the weight of the urine as compared to water.
Normal value: 1.005 to 1.025
Clinical implications: Specific Gravity will increase with the amount of dissolved particles (concentrated) in it.
Specific gravity will decrease when the water content is high and the dissolved particles are low (less concentrated).
Low specific gravity (<1.005) is characteristic of diabetes insipidus, nephrogenic diabetes insipidus, acute tubular
necrosis, or pyelonephritis.
4. Test: Protein :
Clinical implications: Only a very small amount of protein should be excreted into the urine in a 24 hours period
(normal is 0-trace). Albumin is usually the first protein to be excreted in disease conditions.
5. Test: Glucose and ketones :
Clinical implications: The how and why glucose gets into the urine is dependent upon several factors. Without disease,
it is possible to "spill" glucose after eating a large meal. Once serum glucose reaches 180 mg/100 ml and above, it is
possible to spill small amounts of glucose into the urine.
Urinalysis: Microscopic Examination of the Urine : A microscopic examination of the urine may reveal many
different disease conditions. The following tests are the usual components of the examination:
1. Test: RBCs
Clinical implications: This will detect the presence of RBCs in the urine. Normal is 0-3 RBCs. Gross bleeding into the
urine is usually obvious. On lab exam of the urine, numerous, many, and gross are terms used to describe the amount of
blood in gross bleeding. However, all bleeding is not that obvious. In order to detect slower bleeding and inflammation
in the urinary tract, the microscopic exam is needed.
2. Test: WBCs
Clinical implications: WBCs are most often present in the urine due to direct infection/inflammation of the renal
system. An infection in the urinary tract or in the kidney itself is usually the most common reason for this inflammation.
3. Test: Casts
Clinical implications: Casts are solid, formed elements which appear in the urine, secondary to some other type
of cell destruction. They can also be formed from other waste material as well as from dead cells.
4. Test: Crystals and other Components : Some crystals normally appear in urine, but numerous calcium oxalate
crystals suggest hypercalcemia or ethylene glycol ingestion. Cystine crystals (cystinuria) reflect an inborn error of
metabolism.
45. Describe organization of drug store
Organization of Drug Store -
• Drug store management is one of the important aspects in pharmaceutical business.
• It is also called as retail pharmacy, which consists of final activity and is a place where drugs will be in the hands of
the patients/consumers or to provide services to the patients/consumers.
• The word retail is derived from the French word Retailer, meaning to cut a piece off or to break bulk. For successful of
any retail firm, some important factors are taken into consideration.
• As pharmacy is specialized field, some of factors are different compared to other retail outlets.
Sources of Finance:
• Finance represents money management and the process of acquiring needed funds.
• The importance of finance to business is like; blood to human body Without adequate finance, both the substainance
and growth of business is not possible.
• The finance for business is required mainly for the purposes viz.
(1) Erecting permanent assets
(2) Working capital.
1. Permanent Assets: The permanent assets of a community pharmacy include; land, building, equipment and furniture.
The expenditure on these items is termed as fixed capital.
2. Working Capital: It is required for purchase of raw materials (in case of community pharmacy the pharmaceutical
products, other healthcare products) and other expenses such as, salaries, wages, rent, taxes, interests, etc.).
• A business enterprise will have two sources for raising the funds required for establishing and running the business.
• These include; owned capital L.e. finance available with proprietor for investment in the business.
• It may be in the form of cash or fixed asset like; land, building, equipment, etc. However, for establishing business;
even when land and building are available, the working capital to the tune of few lakhs of rupees is required.
• This can be acquired through the other sources of finance viz. loan capital i.e. finance raised from financing
institutions in the form of loan.
• It is provided by the financing institutions against mortgage or pledge of the property of the borrower.
• The repayment of loan amount Le. interest and principal component shall be made as per the terms and conditions as
laid down and agreed upon by the borrower.
• Here, it is worth noting that in India till 1990's, the rate of interest on loans were high ranging from 12 to 20 percent
per annum, • Now-a-days, the Government policies and schemes are quite favourable to entrepreneurs and finance is
available from different financing institutions at reasonably low rates of interest.
The financing institutions can be broadly be classified into two categories viz.
(1) Government (central and state) schemes
(2) Banks.
(1) Government Financing Institutions: The Government institutions such as; Industrial Finance Corporation,
Industrial Credit and Investment Corporation of India (ICICI), National Industrial Development Corporation, State
Finance Corporation, State Industrial Development Corporation and Unit Trust of India, mainly provide finance to
industrial units.
• The recent Government scheme specially meant for community pharmacies worth mentioning here is "Pradhan Mantri
Bharatiya Janaushadhi Pariyojana" launched by departments of pharmaceuticals, Government of India to provide quality
medicines at affordable prices to the masses.
• Under the scheme, financial support of ₹ 2.5 lakhs shall be extended to individuals establishing PMB Janaushadhi. In
Government hospital premises, the space shall be provided free. The interested entrepreneurs are advised to refer
Janaushadi.gov.in" for details.
(2) Banks: • An institution that accepts deposits from depositors and provide finance in the form of loans to borrowers.
Variety of banks are functioning in India.
• Reserve Bank of India controls all commercial banks, co-operative banks. Industrial banks and exchange banks, etc.
Commercial Banks: Accept deposits and pay interest on it to the depositors provide finance for trade, industry and
commerce. They lend money by way of loans, cash credits and even overdrafts. State Bank of India, Bank of India,
ICICI bank, HDFC bank Axis bank are some of the examples.
Co-operative Banks: These institutions work on the principle of co-operation. These nclude: Credit Societies. District
Central Co-operative Banks and State Co-operative Banks. They provide finance to farmers, small scale industrial units
and trade.
Industrial Banks: Industrial banks accept customer deposits and provide loans for consumers and small businesses
IDBI Bank, ICICI Bank, Unit Trust of India. Industrial Reconstruction Bank of India, Industrial Investment Bank of
India are some of the examples
LONG ANSWER QUESTIONS(10 Marks)
1. Describe in detail location, layout and staff requirement in hospital pharmacy.
2. Define and describe Drug Interaction specially focusing on Pharmacokinetic interaction with Suitable examples.
Drug Interaction : Goodman and Gilman's in their book viz. pharmacological basis of therapeutics have defined drug
interaction as; "Drug interaction is a situation in which, the effects of one drug are altered by prior or concurrent
administration of another drug".
Drug interactions also include:
1. Drug-food interactions where food or certain dietary item influence the activity of the drug.
2. Drug-laboratory test interaction where, administered drug alters the laboratory test results.
3. Drug-disease interaction where drug causes undesired effects in patients with certain disease states.
4. Drug-environment interaction where, environmental chemicals or smoking influence the activity of the drug.
Pharmacokinetic Drug Interactions : In these, one drug affects the absorption, distribution, metabolism and excretion
(ADME) of another drug resulting in a change of concentration of other drug in plasma.
1. Interactions affecting Gastrointestinal Absorption : Different mechanisms affect gastrointestinal absorption of a
drug. The amount of drug absorbed may be reduced or delayed which decreases the drug plasma concentration level,
reducing the therapeutic effect. Sometimes, the slower absorption rate prolongs the effect of drug causing difficulty as in
case of hypnotics. Following are the factors which affects the Gl absorption.
(i) pH: The pH of the GI contents affects the absorption of drugs. The non-ionised form of drug (the more lipid soluble)
gets absorbed more readily than the ionised form of drug. The acidic drugs remain in the non-ionised form in the
stomach (low pH), hence, these will get readily absorbed. If antacid is administered with acidic drugs, it will raise the
pH of GI contents and inhibits the absorption of the drug.
The enteric coated bisocodyl (oral dosage form of laxative) should not be given with antacid or milk because
increase in pH of GI contents may cause disintegration of enteric coating, releasing the drug in stomach causing
irritation and vomitting.
(ii) Complexation: Drugs like; tetracycline form complexes with metal ions such as; calcium, magnesium, aluminium
and iron which are poorly absorbed. Hence, tetracycline should not be administered alongwith milk (containing
calcium) and drugs containing metal ions such as; iron containing preparations and antacids.
For example, fluoroquinolones like; ciprofloxacin and norfloxacin should not be administered with aluminium
and magnesium containing antacids since these metal ions complex the fluoroquinolones.
(iii) Adsorption: Antidiarrhoeal mixtures contain the adsorbents like; kaolin which adsorb the other medications if
administered simultaneously, this decreases the absorption of the medication administered.
(iv) Changes in GI motility: Drugs like; cathartics increase the GI motility, resulting in a decreased absorption of
drugs which are normally absorbed slowly and which require prolonged contact with absorbing surface.
Anticholinergic drugs decrease GI motility, resulting in increased absorption of drug. The effect may be
decreased absorption of drug due to slow dissolution of drug.
(v) Food: Presence of food in stomach influences the absorption of a number of drugs. Food also reduces the
absorption of drug by binding with it, or by changing the pH of GI contents and it reduces the dissolution rate of drug.
The absorption of antibiotics is reduced in presence of food. Hence, penicillin and tetracycline derivatives should
be given 1 hour before meal or 2 hours after meal to achieve optimum absorption.
Some drugs such as; diazepam achieve higher serum level following food whereas, drug like; cimetidine needs
slower absorption, hence it is advantageous to take it with meal.
(vi) Inhibition of GI enzymes: The absorption of certain drugs depends on their metabolism by the enzymes. If these
enzymes are inhibited then the absorption of drugs also decreases.
For example: Folic acid - Phenytoin interaction.
Phenytoin inhibits the intestinal enzyme conjugate which is responsible for conversion of poorly absorbed form of
folic acid i.e. polyglutamate to readily absorbed form of folic acid ie monoglutamate. This results in deficiency of folic
acid (Anaemia).
2. Interactions Affecting Distribution of Drugs : The drug gets distributed by binding to plasma proteins. Hence,
when two drugs capable of binding to proteins are administered concurrently, the interaction affects the distribution. The
drug with greater affinity for binding sites will displace the other from plasma or tissue proteins.
Examples:
(i) Phenyl butazone replaces tolbutamide from protein binding and enhances hypoglycemic effect.
(ii) Phenyl butazone displaces the warfarin from its binding sites resulting in the increased amount of free form of
warfarin causing haemorrhage.
3. Interactions Affecting Metabolism of Drugs: (a) Inhibition of metabolism:
 (1) Isoniazid inhibits the hydroxylation of diphenyl hydantoin and may cause toxicity of diphenyl hydantoin.
(ii) Cimetidine inhibits the metabolism of benzodiazepines (diazepam) and enhances the sedative effect of these.
(iii) Erythromycin inhibits the hepatic metabolism of carbamazepine increasing its toxicity.
(iv) The enzyme xanthine oxidase (responsible for metabolism of mercaptopurine) is inhibited by Allopurinol, reducing
the production of uric acid.
(b) Induction of metabolism: Barbiturates stimulate the microsomal enzyme system in liver and thus, increase
metabolic degradation of other drugs such as; alcohol, coumarin anticoagulants, phenytoin, etc.
4. Interactions Affecting Excretion : One drug may block the renal excretion of another by competing for the same
tubular transport system or may increase the excretion of the drug by increasing, its ionization.
(i) Inhibition of excretion: Probenecid competes with penicillin in renal secretion and this inhibits the excretion of
penicillin, thus increasing its activity.
Probenecid also decreases the renal excretion of methotrexate and clofibrate.
Quinidine and verapamil both cause increase in the serum digoxin level by inhibiting the renal tubular secretion and
renal excretion and non-renal clearance of digoxin.
(ii) Increase in renal excretion: Antacids like; sodium bicarbonate make the urine alkaline and thus enhance the
ionization of weak acidic drugs like; salicyclates, barbiturates and lead to their rapid excretion.
3. Give an exhaustive account of Education and Internal and external training programs in the hospital.
Role of Pharmacist in Education And Training : The following are the roles and functions of pharmacists that need
to be strengthened and supported:
• To instruct on all medicine including; pharmacokinetic properties, adverse drug reactions and drug interactions.
• To instruct and educate on the proper use of all medicines.
• To monitor products sold directly to the public, of prescription trends, and of the selection, management, and
procurement of drugs by government and local purchasing agents.
• Development and drafting of rules for controlling the manufacture, distribution and supply of drugs.
• Training, supervision and guidance community health workers with pharmacy tasks.
1. Internal Training Programs: Internal training programs are generally carried out in hospital and these are taught by
someone staff of hospital organization that has expertization in special type of work. Internal training methods
associated to use of hospital own resources and expertise to develop and deliver the specific type of training.
a. Induction: This type program is generally provided to the entire new recruited employee at the time of their joining
of hospital organization. In this type of program, session of introductions to the hospital's quality policy, Vision,
Mission, any other hospital policies and procedures, job description and responsibilities etc. are taught to employee.
b. On Job Training: The purpose of this type of training in hospital is to make the employees familiar with the normal
working condition such as handling of patient, cleaning of machinery, storage of material, sterilization, handling of
equipments, management of various risks accompanying with the care environment etc. Such type of training also helps
the employee to make comfort during execution of the jobs. Such type of activities generally learned during training
session given by supervisor/department head or the more experienced employee of the hospital while performing out a
specific task. During this task the learners should follow the directions of supervisor and perform out the task.
• In this type of training, hospital staff e.g. nursing staff, OT/ICU staff, housekeeping staff, pharmacist, laboratory
technician, imaging dept. staff etc., are get trained on various work duties such as infection control practices that include
needle stick injury, injection and infusion practices, patient handling, practice of hand washing and sanitization, use of
appropriate personal protective equipment's (PPEs), various practices of bio-medical waste management system etc.
c. Training during rotation of staff: There is need to give the training to those employees who are transfer or get rotate
to other departments of hospital in order to make him familiar to new things, understanding of new assignments and
responsibilities.
• The most observable benefit of internal training program is that it is the most cost effective, informal and helps in
improvement in the existing training methods as well as communication between employees. The internal training
programs are generally conducted by experts employee of own hospital organization and within hospital space so there
are no issues of travel expenses, additional space cost, payments for program conduct, expenses of educational materials
etc.
• While there may some issues like the training programs are not conducted by efficient staff or formally conducted or
not given sufficient time and not taken seriously by enrolled learner or trainer. All these create negative impact on
patient care services and may down the reputation of hospital.
2. External Training Programs: The external training programs are generally conducted by someone from the outside
of the hospitals. In this program the external courses are taught by professionals who has skilled and expertization at the
subject of the training. In such training program an outside perception is one of the main benefits. In this outsource
person may offer a new way of approach that have not previously considered.
• In the internal training program, the trainer form own hospital may be good at their job but the advanced care plan or
skill update may not available with him to train others. Professionals have the capabilities and experience in wide range
of services and they are able to give in depth knowledge in the specific subject area to the learner staff which can be
valuable for the hospital organization.
• External training program sometime also name as off-the-job training which is organized at a site, which is away from
the hospital work environment for a particular time period. In this program, to get the complete theoretical knowledge
the learning material is provided to the trainees. In this program, various case studies, conferences, audio-visuals,
seminars, simulations, role play and lectures are conducted by external expert. While the major limitation of such type
of training programs are expenses on place of training, arrangement of facilities, travelling expenses, study material
cost, course cost, hiring of experts to provide the training. Following are some additional examples of external training
program.
• Advancement/introduction/change in Technology / equipment: As per the need every concerned employee has to
provide training to upgrade them according to situations. For example, training for servicing of new instruments or
advanced care and treatment of patient.
• Mock Drills: Such type of training generally conducted twice in a year for different category of employee. In such
program, practical training for the handling of critical situations such as various emergency codes like fire, bomb
threats, mass casualties etc. are given to concerned employee. Thus to conduct such training program there require
regulatory measures as well as financing mechanisms in the hospital organization.

4. Define TDM. Which drugs required TDM? Explain the steps involved in performing TDM with suitable example
of drug.
Therapeutic Drug Monitoring (TDM) : It is defined as determining the concentration of drug in the body fluids of
patient and using it for designing the dosing regimen of the patient. Along with observed clinical effects; TDM enables
the physician to ascertain whether desired optimal concentration of drug is renched and maintained over the treatment
period or not. Thus, in 'special population' and in case of certain drugs whose actions can't be readily assessed clinically,
TDM is the only process that helps to decide individualized dosage regimen that improve the care.
Drug Candidates For TDM : Drugs that are currently subjected to TDM have at least following common
characteristics:
1. Drugs having narrow therapeutic index.
2. Drugs for which small change in the concentration of drug in plasma are likely to exhibit large changes in drug
response.
3. Drugs showing wide interindividual variations in the rate of metabolism.
4. Drug which exhibit saturation kinetics/thereby causing a steep relationship between dose and plasma levels within
therapeutic range.
5. Drugs whose signs of overdosage and underdosage are difficult to distinguish.
6. When drug is used chronically and thus is more likely to induce toxicity or changes in pharmacokinetics.
TDM Process : The goal of TDM is to optimise patients clinical outcome by managing their medication regimen with
the help of measured drug concentrations. This is done by adjusting for known pharmacokinetics variations and to
ensure that adequate concentration of drug continues to remain in the body.
• Before deciding whether TDM shall help improve the clinical situation of patient, it is essential to gather information
regarding patient and drugs prescribed to him/her. This care be done by visiting patient admitted in the ward and
consulting the attending physician.
• The following criteria are to be considered by the clinical pharmacist before taking action.
1. Compliance with medication regimen.
2. Toxicity suspected - toxic concentrations.
3. Inadequate therapeutic response - Subtherapeutic concentration.
4. Assess therapy following a change in dosage regimen.
5. Change in clinical state of patient - Various disease state.
6. Potential drug interactions.
7. Manifestations of toxicity and disease state are indifferent.
5. Define community pharmacy. Explain the role of community pharmacist.
Community Pharmacy : • It is a diverse, dynamic and constantly changing practice environment comprised of several
different practice settings and offering many opportunities for pharmacy practitioners.
• It is the major pharmacy practice area where, the medications and other healthcare needs of community (society) are
fulfilled. In India, these are privately owned practice settings popularly known as Drug Stores/Medical Stores/Chemist
and Druggist/Pharmacies, etc.
• As opposed to hospital pharmacy, these settings are flexible to adopt advances in technology, medicines and
accordingly modify to fulfill the expectations of community.
• People use community pharmacists as their sole source of healthcare information and look at him/her for information,
advice and counselling.
• However, transformation of their functioning from mere drug seller to healthcare provider in a more professional
manner is highly expected.
1. Receive and Review the Prescription: Prescription is a legal document and required to be authentic, complete and
accurate. Only upon conforming the legality of prescription, it can be processed further.
(a) Prescription should be written, dated and signed by the registered medical practitioner. RMP is a legally qualified
and registered with state medical council with a registration number. In addition, the address and phone number of the
prescriber may prove the authenticity but, mainly it will be useful for contacting the prescriber if certain clarification
about prescription is required.
(b) Date of prescription need to be checked. If prescription is not fresh then refill information is to be checked. Further,
if refill information is not available then depending on the nature of medications prescribed, the possibility of abuse,
misuse, etc. may be judged. In case of suspicion, pharmacist should politely refuse to dispense the prescription, asking
the patient to contact the doctor for fresh prescription.
(c) Checking of patient information such as; name, address, age and gender shall ensure that medications shall be given
to right patient. It will further be useful for assessing correctness of dose and even medications.
(d) Checking medication details is the most important task of the pharmacist. Here, any guesswork regarding name of
medication may spoil whole act of dispensing. Even if a slight doubt is there, the salesperson/pharmacy technician
should consult the pharmacist immediately or else confirmation from prescriber on telephone is best way of clarification
of doubt. Further, the strength of medicine need to be confirmed. Similarly, the dosage form (e.g. tablet, capsule, liquid,
etc.) of the drug prescribed should be confirmed. The dosing frequency and the total number of doses for a given drug
will give a clear idea about the dosage regimen. Checking of medication details is to be done quite sincerely and with
full attention. This information is also useful for counselling the patient.
(e) Signature of Prescriber: A prescription becomes legal document, when it is signed by the registered medical
practitioner (prescriber). The signature should be in full so that, it can be verified in case of any dispute.
(f) Other Information: The information regarding refilling of prescription when prescriber intends that a patient should
take another course of same treatment then a advice regarding refill of prescription is given. Pharmacist can refill only
those prescriptions on which prescriber has given refill information on the prescription.
Tips for Pharmacist for Efficient Review and Interpretation of Prescription:
(i) Read and interprete the prescription correctly. Don't make haste, rather take reasonable time doing this.
(ii) Comprehend the patients clinical situation and accordingly confirm the doses prescribed to the patient.
(iii) Make sure that there are no possibilities of potential drug-drug interactions.
(iv) Do check patient's previous medication history if available, or by questioning to patients, identify any allergies to
prescribed medications.
2. Assembling Medications: Once the legality, correctness, accuracy and completeness of prescription is assured, then
next steps is to check the availability of prescribed medications in the pharmacy. If some of the medication is not
available, the patient is to be informed about it. Once availability of all medications is confirmed then take out the
required quantities from the shelves. For one prescription, collect the medications in one plastic container. Once again
check the medications assembled in container and then proceed for preparing the bill.
3. Preparing the Bill: It is important to note that the prescribed medications before handing over to patient should be
checked and rechecked so as to avoid introduction of any error in the dispensing process. While preparing bill, the
person making the bill checks the medications against the prescription.
4. Counselling the Patient: The plastic container in which medicines have been assembled alongwith bill copies and a
prescription should be handed over to the counselling pharmacist, who preferably in a separate counselling area; will be
counselling the patient. Counselling will further reinforce the instructions given to the patient by the prescriber. It will
mainly focus on ensuring the compliance to medication by the patient.
5. Handing over the Medications to the Patient: Finally the bill shall be checked and signed to registered pharmacist.
The salesperson then pack the medicines in a final suitable package and alongwith the copy of bill shall handover the
medications to the patient. The second copy of the bill shall be retained in the pharmacy.

6. Explain in detail the strategies to improve medication adherence.

Strategies To Improve Medication Adherence : Physician plays a role in minimizing non-compliance but pharmacist
has a particularly valuable opportunity to encourage the compliance as his advice is given with actual dispensing of
medication and he is the last professional to see the patient before the medication is used.
• The pharmacist is a health professional to assume the major responsibility in minimising non-compliance.
• The phamacists can improve the compliance with drug therapy by the following manner.
(a) The simplest medication regimen should be developed for patients therapy which should be compatible with the
patients normal activities. The more complex medication regimen causes the greater risk of the non-compliance. But the
patient must not be deprived of needed medication. The use of any non-essential drugs should be avoided.
(b) To reduce inconvenience and forgetfulness of the patient, the medication regimen should be tailored such that doses
of medication are administered at times which corresponds to some regular activities in the patient's daily schedule.
(c) The patients should be educated regarding drug therapy and illness by verbal communication, written
communication or with the help of audio-visual materials. Verbal communication is the most important aspect of patient
education because it directly involves both the patient and the pharmacist in a two-way exchange and provides the
opportunity to patient for asking the questions. Written instructions can be retained by the patient and referred to
whenever the patient is in doubt at later date. Many pharmacists are now giving patients medication instrumentation
cards which are beneficial for compliance of drug therapy.
• The use of audio-visual aids may be particularly valuable in certain situations because the patient may be better able to
visualize the nature of his illness or how his medication acts or is to be administered (e.g. the administration of Insulin).
The pharmacists can make good of such aids by making them available in a patient waiting room area, while the
prescription is being prepared.
(d) The accurate and specific labelling on the container helps in better compliance. The additional information regarding
use, precautions and storage on labels also helps in attainment of compliance.
(e) The various forms such as; Medication Calenders and Drug Reminder Charts are developed and designed to help the
patient in self- administering drugs. These charts are proved to be beneficial in chronic illness treatments like;
hypertension, diabetes and cancers.
(f) The new dosage form such as; transdermal drug-delivery system is also useful for better compliance due to less
frequent administration of the drugs (e.g. nitroglycerin) given by this route.
(g) The patient should be educated for monitoring his drug therapy with the help of medication calenders and drug
reminder charts.
(h) The pharmacists role in minimizing non-compliance does not end when the prescription is dispensed. The
pharmacists should monitor the drug therapy of the patient and if he becomes aware that patient is not using the drug as
prescribed, then he should determine and resolve the problems that may exist.
• The pharmacist is in an excellent position to detect non-compliance pertaining to the use of drug used in the
management of chronic conditions such as; hypertension and diabetes by paying close attention to the frequency with
which a patient has refilled his prescription.
(i) Pharmacists should anticipate the dates on which the patients exhaust their supply of medication and should mail the
post-card refill reminders to the patients who have not refilled the prescriptions by the anticipated dates.
7. Describe the purpose and functions of PTC and how PTC ensures drug safety in hospital.
The Pharmacy And Therapeutics Committee : It is a committee in a hospital that decides, which drugs shall appear
in hospital formulary.
• The committee usually consists of hospital's staff involved in prescribing, dispensing and administering medications as
well as administrators who evaluate medication use.
• It is a policy recommending body to the medical staff and the administration of organisation on matters related to the
use of drugs in the hospital.
• It is constituted in such a way that, it represents different departments of healthcare providers.
Functions And Purpose of the Committee
1. To advise the medical staff and hospital administration in matters relating to the use of drugs.
2. To establish and develop suitable educational schemes to improve the hospital's professional staff on the matters
related to the use of drugs.
3. To develop and compile formulary of drugs and prescriptions accepted for use in hospital. It also minimises the
duplication of the same type of drugs or products.
4. To study problems related to the distribution and administration of drugs used in hospital.
5. To review adverse drug interactions occurring in hospital.
6. To initiate and promote the studies on drug use and review the results of such studies.
7. To recommend drugs which need to be stocked in the hospital patient care areas. 8. To advise the pharmacy in the
implementation of effective drug distribution and control procedures.
Committee Agenda: A typical agenda consists of the following:
1. Minutes of the previous meeting.
2. Review of the specified section of the formulary for updating and deletion of products.
3. Listing of new drugs which have become commercially available.
4. Investigational drugs currently in use in the hospital.
5. Review of adverse drug reactions reported in the hospital since the last meeting.
6. Drug safety in the hospital.
The Role of Pharmacy and Therapeutic Committee in Drug Safety
• The responsibility of hospital pharmacist increases proportionately with the vast increase of therapeutic agents.
• Along with increased responsibility, the capability of ensuring safety in the handling and administration of drugs must
increase.
• Hence, the function of drug safety in the hospital will be the responsibility of the committee.
The following are the guidelines for the committee in achieving Drug Safety in the hospital.
1. Hospital should employ a qualified registered pharmacist (atleast B. pharm.) as a chief pharmacist and others who are
Diploma holders.
2. Hospital should not permit personnel without a pharmacy degree to dispense drugs
3. Sufficient number of qualified personnel must be employed in the hospital.
4. Hospital should provide adequate and safe work space and storage facilities for the pharmacy.
5. Adequate number of equipment in good condition should be provided for safe practice of pharmacy.
6. Automatic stop order regulation should be there in the hospital.
7. A drug formulary should be there in hospital which is periodically revised and kept up to date.
8. The poisonous materials should be kept separately from non-poisonous materials in the pharmacy and nursing
stations.
9. The external use preparations should be separated from internal use preparations in the pharmacy and in the wards.
10. The hospital should allow the chief pharmacist to engage in teaching programme to familiarise the nursing and
residential staff with new drugs.
11. No one should be permitted other than registered pharmacist into the pharmacy "after hours."
12. All nursing drug stations should be periodically inspected for removing the deteriorated and outdated drugs.
13. Adequate reference library should be provided for the pharmacy and nursing staff.
8. What are steps involved in patient counseling? Explain in detail verbal and non verbal communication with
techniques used during Patient counseling.
Steps Involved In Counseling: Rational use of drugs requires that patients receive medications appropriate to their
clinical needs, in doses that meet their own individual requirements for an adequate period of time, at the lowest cost to
them and their community. Amongst the important measures to ensure rational use of drugs, the provision of appropriate
information to patients regarding his/her condition and medications is of utmost importance. Pharmacists have
tremendous opportunity to ensure rational use of drugs by way of educating and counseling the patients. The steps
involved in patient counseling are as under:
1. Introduction: The patient counseling should begin with the introduction; wherein pharmacist introduces himself to
the patient. This establishes relationship and helps in building trust amongst them. At the same time, pharmacist
(counsellor) shall confirm the identity of the patient (counsellee). Pharmacist must study thoroughly well in advance i.e.
before beginning the counseling, the patient, his disease state, the medications prescribed, etc.
2. Understanding the Patient: Pharmacist should ensure that, the patient is interested in listening, knowing about his
condition, etc. and thus, effective communication is possible with him. The purpose and importance the session should
be explained to patient Demonstrate that the exercise is going to benefit him.
3. Understanding Patients Medical Condition: Ask the patient about his health troubles; what doctor told him about
disorder and treatment strategy. Has he earlier suffered from similar disorder? and if yes; what treatment recovered him
from the disorder? Discuss about possible reasons for the current disorder. Whether patient's occupation or his habit if
any is contributing to present condition? See whether patient adhere to medication.
4. Counseling about Medications Prescribed: First check the correctness of prescription and medications therein. Tell
the patient the name and its action of the drug. Inform him how to take the medication, when to take and how long
(duration) to take the drugs prescribed. Special instructions such as; shaking the bottle before use, before meal, after
meal, exact dose, etc. should be explained to the patient. If needed then in addition to verbal instructions, written
information be provided. About storage of drugs, the information must be provided to patient. Ensure the patient has
followed the instructions so that, he will adhere to the instructions. Upon counseling about medication use, ask the
patient whether he predicts any difficulty taking these medications. In addition, tell him as to when the drugs shall start
showing their effects. Finally how long he shall have to continue taking these medications.
5. Counelling about Major Side Effects: Patient should be informed of those side effects which will allay his fears and
help him to avoid injury to himself e.g. change in colour of urine, drowsiness. What steps the patient can take to prevent,
alleviate or manage the side effects. What patient should do when side effects become serious or intolerable. Pharmacis
should emphasise the benefits of therapy in comparison to the side effects.
6. Counseling about Drug Interactions: Considering what other medications (OTC drugs) patient is taking, the
possibility of drug-drug interactions should be explained to patient. While patient is taking this therapy, he should avoid
eating some foods because of the possibility of drug-food interactions; accordingly instructions be given to the patient.
7. Precautions and Aucillary Instructions: Certain habits of patient (smoking, drinking alcohol, chewing tobacco)
may interfere in achieving expected therapeutic benefits. These things need to be discussed with patient. Ask patient to
check their medicines before leaving pharmacy.
8. Refill Information: Pharmacist should inform the patient, verbally whether the prescription is refillable or not. If it is
then for how many times it may be refilled and length of time during which it may be refilled. If it is non-refillable, he
should be instructed so that he may contact the physician for the same drug if needed.
9. Ensure about Understanding of Patient: In the process of counseling, counsellor continuously receives feedback
from counselee indicating whether counselee (patient) is listening, showing concern, and understanding the information
and instructions or not. In essence, it is understanding by the patient, decides the success of whole exercise. Hence, at
the end of counseling session, pharmacist should judge whether he could educate, convince the patient effectively or
not.
10. Ask Patient whether he has any Queries: Pharmacist should motivate the patient to ensure his involvement in
getting rid of the health problem. Pharmacist should take every effort to understand the concerns of the patient and
respond to it with empathy.
Ten Features of Effective Patient Counseling:
1. Establish trust.
2. Communicate verbally.
3. Communicate non-verbally (written, body language).
4. Listen carefully.
5. Ask questions.
6. Remain clinically objective.
7. Show empathy and encourage patient.
8. Provide privacy and confidentiality.
9. Tailor counseling to meet patient needs.
10. Motivate (inspire) patient.
Key Points to cover during Counseling:
1. Name, strength, dosage, route of administration, purpose, expected benefit of medications.
2. How and when to take medications.
3. Adverse effects associated with use of medicines.
4. Potential precautions, contraindications, drug-drug, drug-food interactions including; non-prescription medicines.
5. Proper storage of medications.
6. What to do if dose is missed.
7. Refill information and follow-up plan.
8. Ask patient if he has any questions.
9. Encourage to call pharmacist/physician if they have any questions/concerns.
9. Explain in detail Medication History Interviews and Patient Information Leaflet (PILs) as Communication
between Prescribers and Patients.
• A medication history is vital to the total patient information accumulation.
• Communication skills, both verbal and non-verbal communication, interview techniques, probing with open ended
questions, etc. should be used for success of interview.
• It is the pharmacist's responsibility to obtain and document the medication history and present it to the consulting
physician.
• The conduct of interview should be well planned and systematically arranged, and shall consist of beginning phase,
middle phase and termination (closing) phase.
• In the beginning phase, an introduction is made and the purpose of interview is explained to the patient.
• Once the patient understands the purpose, then interviewing leads to success.
Need For Patient Medication History Interview: • Bad prescribing lead to ineffective and unsafe treatment,
exacerbation or prolongation illness, distress and harm to the patient and higher cost.
• The guide to good prescribing Geneva, WHO 1994 provides steps involves in rational prescribing and thus, to promote
rational use of drugs.
• It is stated that drug treatment should be individualized to the needs of each patient.
• This is possible only upon understanding the patient and his/her experience of illness.
• The information collected in clinical interview is useful in rational prescribing.
• The very first step of defining patient's problem is based on many pieces of information.
• Amongst these pieces of information, the patient's medication history record is of paramount importance.
• Once patient's problem is identified and defined; specifying therapeutic objectives follow.
• Considering patient's clinical situation and causes behind it, the therapeutic objectives may be specified.
• For understanding the etiology, the patient's medication history record shall prove to be the best source of information.
• In each step for ensuring rational therapeutics the record generated in clinical interview shall prove as a useful tool.
The objectives of patient's medication history interview can be summarised as follows:
1. To prepare a list of patient's current and past medications.
2. To know about patient's self prescribing habits.
3. To know about what over the counter (OTC) drugs he/she prefers.
4. To know about patient's drug allergies and adverse drug reactions.
5. To learn patient's ability to follow prescribed medication regimen and the overall patient's adherence.
6. To know about patient's habits of taking alcohol, smoking, tea or beverages.
7. To know about patient's diatery habits.
Patient Information Leaflets (PILS) are produced by either manufacturer or pharmacists for the benefit of the patients
and are universally accepted as the most important tool to educate the patient about their medications and disease.
• PILS do affect patient health outcomes.
• A good Patient Information Leaflet is one that is clear and easy to understand.
• This means that the information is presented in a way that allows the reader to understand and act on it after a single
reading.
• Information in PIL should be authentic and unbiased, information given in the leaflet text should be optimum as per
patient's requirement and the language used should be so simple and easy to understand the content of the product.
Importance Of Patient Information Leaflet (PIL): Leaflets and other materials can therefore play an important part in
supplementing and reinforcing information provided by clinicians, but the information they contain must conform to the
highest standards of scientific accuracy and must be tested for comprehensibility and relevance.
• Patient Information leaflets are widely used by diverse health organizations and professionals as part of patient
education or health promotion efforts, in support of preventive, treatment and compliance objectives.
• Booklet helps patients in their self management decisions to provide information about self management and guidance
about when it was important to see the doctor.
• The use of pictorial aids enhances patients understanding of how they should take their medications, particularly when
pictures are used in combination with written or oral instructions.
• Quality client education requires use of either educational materials appropriate for the measured reading level of
clients or alternatives to written material.
• The aim of our patient education intervention was to encourage behavioral changes in patients, including increased
medication adherence, which could help bring about better blood pressure control.

10. Discuss the various aspects of Clinical pharmacy and explain the roles of a Clinical pharmacist.
• Clinical pharmacy is a patient oriented practice that promotes and assures safe and rational drug therapy.
• The essence of clinical pharmacy is the application of drug knowledge to patient care considering patients medical
status and need to understand his drug therapy.
• Clinical pharmacy is a novel discipline that carries a traditional hospital pharmacist from his product oriented approach
to a healthier patient oriented approach, so as to ensure the patient's maximum well being while on drug therapy.
Three basic aspects of clinical pharmacy practice are communication, counselling and consulting.
1. Communication: • The potential for service to patients and other health professionals by the pharmacist is not
realized simply because of lack of communication.
• The pharmacist must develop his communicative skills to become an effective clinical practitioner.
• In communicating with patients, the pharmacist must attempt to understand such factors as the psychological aspects
of various illness and the behavioural characteristics of individuals from differing socio-economic strata.
• The pharmacist must become familiar with medical terminology and their functions for effective communication with
physicians and other health professionals. The pharmacist must possess and convey a confidence in his abilities, a
willingness to listen, a concern for the patients well being and an enthusiasm for contributing to patient care.
2. Counselling: • Another primary component of the clinical practice of pharmacy is counselling.
• Counselling used in the context of pharmacy practice might be defined as the provision of advice on therapeutic
matters to patients or members of the healthcare team.
• An essential component for proper counselling is the maintenance of a patient drug profile that provides the
pharmacist with biographic information about the patient and summarises his complete drug therapy, including over the
counter medications.
• By properly utilizing this document in applying his knowledge of pharmacology and pathology, the pharmacist can
monitor the patient for possible drug-drug interactions, drug-food interactions, adverse drug reactions, etc. and can
counsel the patient and physician accordingly.
• Verbal instructions should concise and exact in counselling.
• The pharmacist should attempt to evaluate the patient's mental ability to comprehend and adjust the conversation
accordingly.
• The patients ability to understand should never be over estimated.
3. Consulting: • One of the most promising and potentially significant aspects of the clinical practice of pharmacy is
consulting.
• The demand for a source person for detailed drug information will increase as the "information explosion" continues,
medical care becomes more complex, health man power shortages become more acute and potential hazards of drug
therapy become more evident.
• The pharmacist can expand his role to function as a therapeutic consultant to the public and to the physician and other
health professionals.
Role of Clinical Pharmacist: The functions and responsibilities of clinical pharmacist are as follows:
1. Supervision of all drug distribution activities for drug use control and patient safety.
2. Selection of effective prescription drug products having reasonable cost.
3. Record patient's medication history and adverse effects if any thereof.
4. Detection and reporting of adverse drug reactions and drug interactions.
5. Counseling the patient on proper use of drugs and instructions.
6. Assuring the patient compliance to medications and instructions.
7. Advice and recommend the patients, the appropriate OTC medications.
8. Assist physicians in selecting rational drug therapy for a patient.
9. Establishing most effective dosage regimens for patients.
10. Supervising the management of patients with acute and economic diseases.
11. Establishing comprehensive treatment plan considering psycho-socio-economic aspects of healthcare.
12. Detecting and preventing incompatibilities in drug mixtures.
13. Supervise the dispensing of prescriptions by dispensing assistants.
14. Provision of drug information to patients and other health professionals.
15. Performing drug utilisation reviews.
16. Providing health education to community.
17. Monitoring the patient therapy by utilizing patient medication profile and other resources.
11. Explain in detail components of drug therapy review.
Drug Therapy Monitoring: • The pharmacists responsibilities in the drug use process have greatly expanded in the last
decade.
• He is also expected to monitor drug therapy.
• This new responsibility requires pharmacist to actively ensure that prescribed drug therapy is effective.
• Safe and economical patients response in terms of initially defined therapeutic endpoint must be frequently assessed,
to identify existing or potential drug problems resulting from drug therapy.
• The evidence of adverse response must be sought periodically.
• The health professionals including; physician, nurse and clinical pharmacist share this responsibility.
• It requires the pharmacist to assimilate patient data and continually assess whether, the drug therapy is producing
expected therapeutic benefit or not.
• If not then, what are the possible reasons for the same.
Components of Drug Therapy Review: Several steps are involved in the systematic process of drug therapy
monitoring. These steps are as follows:
1. Collection of Patient Data: To monitor therapy effectively, one must have an adequate data base of patient
information. The data base is central to the monitoring process and consist of the followings:
(a) Patient's Demographic Data: Patient factors such as; age, sex, weight, mental status and attitude towards disease
are important variables both in deciding drug therapy and monitoring patient response.
(b) Chief Complaints: The chief complaints and causative factors need to be integrated with reference to patients
medication history, pathological findings and other related data. This data is needed for both in deciding drug therapy
and in monitoring patients therapy.
(c) Past Medical and Drug Therapy: Patient's medication history is vital to the patient information accumulation. The
goals are to obtain complete and correct mediation history of the patient; to benefit the patient.
(d) History of present illness.
(e) Physical examination.
(f) Social history.
(g) Laboratory data: The most important source of information is the Patients Medication Chart (PMC). An individual
patient medication chart contain the information such as; name and phone number of attending physician, allergies,
idiosyneracies, chronic diseases, the prescribed drug therapy, patient's demographic information and instructions.
• Reviewing the nurses progress notes in the medical record (Basic body functions i.e. vital signs temperature, pulse,
respiration rate (TPR), blood pressure, fluid intake and output (1/0), etc. may provide a record of patients day to day
physiologic and psychologic changes that are particularly helpful in monitoring for side effects of drug therapy.
• Once patient information has been reviewed, data pertinent to drug therapy monitoring should be summarised and
organised into useful format.
• The information collected may be placed on monitoring sheets of various design or may be computerised by the
monitoring pharmacist.
2. Statement of Therapeutic Goal: • The pharmacist must familiarize himself with the therapeutic goals that have been
set for a patient in association with the physician.
• This knowledge shall be useful to assess the therapy and knowing the importance of clinical problems.
• Pharmacist should participate in therapeutic rounds (ward rounds) along with physicians when treatment plans are
being established.
• The therapeutic goal can also be derived by reviewing the physicians admitting notes in patients medication chart.
• The review of nursing care plan shall also be useful in understanding therapeutic goals. E.g. Therapeutic goal for
patient with pneumonia would be to cure infection, while for patient with Congestive Heart Failure (CHF) would not be
to cure but rather to restore function to normal limits.
3. Selection of Drug Therapy: • A pharmacist can make his knowledge of drugs available to the prescriber to ensure
that the patient receives the most appropriate drug or dosage form.
• This can be done either before a drug is selected or after a drug has been prescribed.
• The pharmacist should be available to the physician to discuss therapeutic alternatives before a drug is selected and
prescribed.
• The selection of a drug to achieve a therapeutic goal is a logical process in which, a patient's condition is matched to a
drug's characteristics.
• The characteristics of each drug should be considered regarding side effects, method of administration, cost and
potential drug interaction with concurrent therapy, disease states and diet.
4. Establishment of Monitoring Parameters: • Pharmacist should establish monitoring parameters to assess the
progress toward the therapeutic end point.
• A monitoring plan should outline parameters that will be useful in determining whether, the therapy is effective and
whether, the drug is producing any side effects.
• A monitoring plan usually consists of a combination of objective and subjective parameters.
(a) Objective Parameters: Include factors which are measurable by laboratory tests, vital signs, x-ray reports and blood
levels of drugs.
(b) Subjective Parameters: Include factors which are not measurable and require a value judgement such as; general
appearance or the patients own assessment of his progress.
An example of parameters useful in monitoring therapy of patient treated with digitalis glycoside is as follows:
• Objective Parameters: Such as; digoxin blood level, pulse rate, Heart size, ankle oedema.
• Subjective Parameters: Would be increased exercise tolerance and nausea.
• Pharmacist should monitor these parameters daily and also review the progress notes of the physician and nurses.
Pharmacist should maintain communication with physician, nurses and the patient to increase the effectiveness of the
monitoring process.
5. Identification and Confirmation of Problems: • A key function in the drug monitoring process is the pharmacist
identification of existing or potential problems resulting from drug therapy.
• Pharmacists should use all the information sources for identification and confirmation of problems.
• The pharmacist should screen and separate patient problems into those which could benefit from drug therapy and
those which may be induced by drugs.
• When a problem is thought to be related to drug then research must be conducted concerning the disease state,
laboratory data, drug dosage and other drugs to document the relationship.
6. Communication of Findings: • When a problem related to drug therapy has been identified, the phamacist must
communicate with the appropriate health professional to initiate action.
• For a problem involving drug administration, a nurse may be the professional who can best solve the problem.
• If problem involves patient intolerance to a drug, the pharmacist should consult with the physician to suggest an
alternate drug or dosage formulation.
• Pharmacist should communicate the finding in the “clinical communication form”.
• This form should be prepared in the duplicate in which one copy is sent to the appropriate health professional and the
duplicate is kept by the pharmacist to document his activities.
12. Explain the different types of ward rounds in India, add a note on pre ward round preparation?
13. Define Inventory Control, Give its objective and various methods to store the items based on their cost and utility.
Inventory Control: • Inventory control is a tool available to modern management to decide the level of inventory that
can be economically maintained.
• Inventory control is to find the optimum between the procurement and carrying cost to keep the total cost at the
minimum.
• Inventory control is basically a scientific term which indicates when to order and how much to order.
• The inventory control has been defined as the management tool, which is used to maintain an economic investment in
materials and products for the purpose of obtaining a maximum financial return.
• Inventory control is a technique, which ensures that the optimum amount of inventory is held by hospital so that, its
internal and external demand requirements are met economically.
Objectives of the Inventory Control :
1. To minimize the cost of ordering and holding inventory which is often the largest single investment of the hospital.
2. To maintain acceptable levels of patient care services by minimizing stock outs.
3. To reconcile the potential conflict between these objectives. Inventory control policies and techniques therefore to
aim to optimize stock levels viz-a-viz patient care requirements.
4. To reduce financial investment in the inventories: The capital required to carry inventories costs money and holding
unduly large amount of inventory leads to blockage of scarce capital.
5. To facilitate hospital operation: Hospital functioning depends on the supply of various items for day-to-day operation.
The disruption of supply will lead to disruption of schedule services leading to loss of productivity and decreased
utilization.
6. To avoid losses from inventory obsolescence.
7. To improve patient care services.
8. Smooth and uninterrupted supply of the item in a hospital will lead to efficient and better patient care.
Tools and Techniques of Inventory Control:
1. Inventory analysis
2. Inventory cost
3. Ordering system
1. Inventory Analysis: It is imperative to undertake a systematic analysis of all items in stores for achieving the
objectives of inventory control. A high degree of control on inventories of each item would neither be practical
considering the work items are not of equal importance. The three levels of analysis for effective control over
inventories are as follows:
(i) Overall analysis, (ii) Category analysis, (iii) Individual item analysis
(i) Overall Analysis: This analysis takes an overview of total inventory over a period of time to find out trends if any.
It is useful for the top management for keeping track of inventory behaviour in relation to consumption or requirement.
This inventory index should be calculated periodically and reported to the top management.
(ii) Category Analysis: This is the second level of analysis wherein stocks of each category (group of similar items) is
analyzed in order to achieve optimum stock levels and effective control. The management should fix targets for each
category of items according to various conditions lead time, nature of item, etc.
(iii) Individual Item Analysis: It is desirable to clarify group the items, and subject each class or group of items to
controls commensurate with its importance. The items can be classified according to their use, consumption, value, lead
time, etc. The selective control of the items deserving attention leads to better control. Some of the important individual
item analyses are:
(a) ABC analysis, (b) VED analysis, (c) SDE analysis, (d) HML analysis, (e) FSN analysis
(a) ABC analysis: The ABC analysis is widely used for unfinished good, manufactured products, spare parts,
components, finished items and assembly items. ABC analysis is a technique for prioritizing the management of
inventory. Inventories are categorized into three classes; A, B, and C. Most management efforts and oversights are
expended on managing A items. C items get the least attention and B items are in-between.
Item A: In the ABC model of inventory control, items categorized under A are goods that register the highest value in
terms of annual consumption. The top 70 to 80 per cent of the yearly consumption value of the company comes from
only about 10 to 20 per cent of the total inventory items. Hence, it is crucial to prioritize these items.
Item B: These are items that have a medium consumption value. There amount to about 30 percent of the total
inventory in a company which accounts for about 15 to 20 per cent of annual consumption value.
Item C: The items placed in this category have the lowest consumption value and account for less than 5 percent of the
annual consumption value that comes from about 50 percent of the total inventory items.
(b) VED Analysis: It attempts to classify the items used into three broad categories, namely; Vital, Essential and
Desirable. The analysis classifies items on the basis of their criticality for the industry or company.
Vital: Vital category items are those items without which the production activities or any Other activity of the company,
would come to a halt, or at least be drastically affected.
Essential: Essential items are those items whose stock-out cost is very high for the company.
Desirable: Desirable items are those items whose stock-out or shortage causes only a minor disruption for a short
duration in the production schedule.
(c) EOQ Analysis: Economic order quantity (EOQ) is the order quantity that minimizes the total holding costs and
ordering costs. It is one of the oldest classical production scheduling models.
EOQ applies only when demand for a product is constant over the year and each new order is delivered in full when
inventory reaches zero. The purpose of determining the EOQ is to minimize the Total Incremental Cost (TIC), beyond
the cost of purchasing, in consideration of two main total costs: Total Ordering Cost (TOC) and Total Handling Cost
(THC).
(d) SDE Analysis: This analysis is based upon the availability of an item specially where there are certain scarcities.
The items of the inventory are categorized into; scarce, difficult, and easily available items depending upon the
availability of the items. It focuses attention of managers on the scarce and difficult items, which helps in proper control
of inventory to prevent stock out situation.
(e) HML Analysis: This analysis is based on the per unit cost of the items of inventory. It is to be noted that this
analysis is based on the cost of each item as against the total annual cost of items in ABC analysis. The items of
inventory are classified into high, medium and low-cost items according to unit cost of the items. It helps in
management of concentrating on costly items.
(f) FSN Analysis: In this analysis, quantity and rate of consumption of items is analyzed to classify item as fast moving
(f), slow moving (s) and non-moving (n) items. This analysis helps in deciding the stocks, distribution and handling
methods.
2. Inventory Cost: Once the inventory analysis has been carried out the two basic problems of inventory control needs
to be considered:
(i) What quantity of an item should be ordered each time? (ii) When should an order be placed?
There are three cost factors, which require attention when solutions to the above problems are sought. These are:
(i) Cost of materials itself.
(ii) The cost associated with keeping the materials in stock (inventory carrying costs).
(iii) The cost associated with the placement of a purchase order (ordering costs).
Inventory Carrying Costs: This is the cost associated with keeping the materials in the stores. This comprises the
interest charges in the cost of the inventory. Storage and handling cost, cost of insurance and cost of deterioration and
obsolescence. This cost also includes:
Opportunity cost: Loss of interest money invested in stock of materials, which can be equal to the rate of interest paid
by the banks.
Insurance cost: It is the cost of insurance charges paid for the insurance of stores and buildings.
Wealth tax/property tax: Property taxes are levied on the assessed value of assets.
Storage cost: This includes; cost on account of salaries, operating supplies, building maintenance, repairs and
depreciation, etc.
Cost of obsolescence and deterioration: Obsolescence and deterioration of material and equipment while in inventory
and these costs are part of inventory carrying costs.
Inventory shrinkage cost: It represents the cost of pilferage and it is estimated to be 4 to 6% of the total inventory cost.
Staff salaries: The salaries of the staff are important constituents of cost analysis and a major portion of expenditure of
the hospital is used for the salaries of the staff.
3. Ordering System: Ordering medications is one of the most important inventory management tasks a pharmacy
technician is required to complete, because the pharmacy is continuously depleting its stock of medications and
supplies. Ensuring the pharmacy is adequately stocked with medications to serve its customers' needs must be balanced
with preventing overstock of medications that could expire before they are used.
Although a lot of the ordering process is now computerized and automated, ordering must be manually checked and
confirmed, and occasionally edited as needed. Ordering generally takes place on the computer through an online
ordering system. This system contains a list of all medications that can be ordered, including the drug's name, item
number, and package size. Some wholesalers offer the use of their online ordering system in the pharmacy. This allows
the pharmacy staff to see exactly what is in stock at the wholesaler's facility and the quantity available, as well as giving
pharmacies the ability to see a more detailed description of the product, including package size and even pictures of the
item.
14. What do you mean by investigational use of drug and explain the role and responsibility of pharmacist while
handing in clinical research?
Investigational drug : Investigational drug should be used only in hospital setup, which is the primary center for the
clinical investigations.
• As per the definition, these are not the general-purpose use and these are not yet to release or certified by FDA for
general use or for sale in commercial interest.
• It is responsibilities of hospital and medical staff to check and establish the proper procedure for the use of
investigational drugs for their patient's benefits.
Role of Hospital Pharmacist In Handling Of Investigational Drugs
1. Assisting in the Development of the Study Design: Pharmacists provide his support in the development of the new
protocol and control on the use of investigational drugs in the hospital. The investigational drugs are assigned to
pharmacist for dispensing purpose according to written order from principle investigator in predetermined pattern.
2. Acting as Independent Collaborator: Pharmacist act as an independent collaborator by maintaining all the records
and codes in the handling of investigational drugs in the hospital. This would give the investigators the advantages of
having code information available for 24 hours a day and 7 days a week and the ability to break the code for an
individual patient without exposing the rest of the study.
3. Collecting, Storing and Distributing Essential Information Concerning the Investigational Drug Being
Studied: As per the brochure provided by the manufacturer, the pharmacist should prepare data sheet on the
investigational drug which provide the all information about the investigational drugs.
• This drug data sheets gives information to the medical, pharmacy and nursing staff. This form should contain:
(a) Drug designation and common symptoms.
(b) Dosage form and strengths available.
(c) Dosage schedule and route of administration.
(d) Indicators.
(e) Expected therapeutic effects.
(f) Expected and potential untoward effects.
(g) Contraindications.
(h) Storage requirements.
(i) Instructions for dosage preparation and administration.
(j) Instructions for disposition of unused doses.
(k) Names and Telephone numbers of principal and authorized co-investigators.
• The data sheet on the investigational drug is reviewed by the principal investigator and then the copies are distributed
to the appropriate pharmacy staff and all the patient care units whenever the drug will be used.
4. Packaging and Labelling of Investigational Dugs for Multiple or Unit Dose Containers: Investigational drugs
must be properly packaged in accordance with all applicable regulatory standards for example: F. D. A, C.P. Packaging
act.
5. Preparing Dosage Forms: The pharmacist can provide a valuable service to the new drug researcher by formulating
new dosage form from the pure chemical.
6. Dispensing of Investigational Drugs to both Inpatients and Outpatients: Dispensing of investigational drugs
should be incorporated with the rest of the drug distribution system.
• The pharmacist should maintain the inventory record for the dispensing of investigational drug.
• This form should contain name of drug, dosage form, and strength, batch number and name of manufacturer along
with complete address.
• In this form there is need to maintain the record of other information which are essential for the drug order.
• It is essential to provide the sufficient information on proper dosage, route of administration, possible toxic reactions
and side effects, precautions and proper labelling is available to them.
15. Define and Classify ADR , Explain in detail Adverse drug reaction reporting and management
ADR : WHO defines an ADR as; A response to a drug which is noxious and unintended and which occurs at doses
normally used in person for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic
function". Adverse Drug Reactions (ADRs) are unwanted or undesirable effects of a medication caused by normal
therapeutic doses that occurs during usual clinical use. Adverse drug reactions occur almost daily in healthcare sector
and can adversely affect a patient's quality of life, often causing considerable morbidity and mortality.
Classification of ADR’s
Type A reactions, are predictable and are caused by an excess of the drug's primary pharmacological effect. (e.g.,
bleeding from warfarin) or a low therapeutic index (e.g., nausea from digoxin).
• Type A reactions constitute approximately 80% of adverse drug reactions.
• Dose-related adverse drug reactions occur most often with drugs that have a steep dose- response curve and/or small
difference between therapeutic and toxic doses (ie., a low therapeutic index = toxic dose/therapeutic dose).
• These reactions are dose-related and usually mild, although they may be serious or even fatal (e.g., intracranial
bleeding from warfarin).
• Commonly used drugs with a low therapeutic index include; anticoagulants, hypoglycemic drugs, digoxin,
antiarrhythmics, aminoglycosides, xanthines, cytotoxic and immunosuppressive drugs.
• Such reactions are usually due to inappropriate dosage, especially when drug elimination is impaired.
• The term side effects is often applied to minor type A reactions.
Type B ('idiosyncratic) also called as non-dose related reactions are not predictable from the drug's main
pharmacological action, are not dose-related and are severe, with a considerable mortality.
• The underlying pathophysiology of type B reactions is poorly if at all understood and often has a genetic or
immunological basis.
• Type B ADR are rare and occur infrequently (1:1000-1:10000 treated subjects being typical).
Type C: This type of ADR is usually due to the long-term use of drugs (e.g., neuroleptic- related tardive dyskinesia or
analgesic nephropathy).
Type D: This type of ADR is considered as delayed reactions due to the usage of the drug (e.g. alkylating agents
leading to carcinogenesis, or retinoid-associated teratogenesis).
Type E: This type of ADR takes place after stopping the use of the drug such as; adrenocortical insufficiency follows
withdrawal of glucocorticosteroids, or withdrawal syndromes following discontinuation of treatment with
benzodiazepines or ẞ-adrenoceptor antagonists.
Adverse Drug Reporting And Management
Adverse Event Reporting Types:
1.Spontaneous Reporting: The healthcare professionals spontaneously report any adverse events to their national
pharmacovigilance center, health authority or to the drug manufacturer itself.
• In most parts of the world, adverse event reports are submitted electronically using a defined format.
• Spontaneous reports are a crucial element in the worldwide pharmacovigilance system and form the core of the WHO
Database.
2. Aggregate Reporting: Aggregate or periodic reporting plays a key role in the safety assessment of drugs.
• Cases that do not involve a serious, unlabelled adverse event is subjected to non-expedited or periodic reporting.
• Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time.
• The advantage of aggregate reporting is to provide a broader view of the safety profile of a drug.
• Worldwide, the most important aggregate report is the PSUR.
3. Expedited Reporting: Reporting of Individual Case Study Reports involves serious and unlabelled event related to
use of a drug is termed as expedited reporting.
• In most countries, the timeframe for reporting expedited cases by the drug company after receiving notification of such
a case is 15 calendar days.
• Within clinical trials the Suspected Unexpected Serious Adverse Reaction is an event that involves a life- threatening
or fatal event is subject to be reported within 7 days.
4. Clinical Trial Reporting: Safety information from clinical studies is used to establish safety profile of drug in
humans.
• Serious Adverse Event (SAE) occurring to any study patients (subjects) during conduction of clinical trials is the key
component for the drug regulatory authorities in the decision-making to grant or deny market authorization for a drug.
• SAE information is forwarded to the sponsoring pharmaceutical company that is responsible for the reporting to the
drug regulatory authorities.
5. Reporting Backdrops: The major weakness of the spontaneous reporting system by clinician is under-reporting,
though the figures vary greatly between countries and in relation to minor and serious ADRS.
• ADR reporting behaviour varies greatly between countries and in relation to the seriousness of the events, but in
general probably less than 5-10% of all adverse events that occur are actually reported.
• Another problem is that overworked medical personnel do not always see reporting as a priority, especially if the
symptoms are not serious.
• Even if the symptoms are serious, they may not be recognized as the possible side effect of a particular drug.
• Though spontaneous reports are submitted voluntarily although under certain circumstances these reports may be
encouraged or stimulated, by media reports or articles published in medical or scientific publications or by product
lawsuits.
Management of Adverse Drug Reactions:
• Rapid action is sometimes important because of the serious nature of a suspected adverse drug reaction, for example,
anaphylactic shock.
• Otherwise, using clinical benefit-risk judgment, together with help from investigations, one decides which medicine or
medicines should be withdrawn as a trial.
• The patient should be observed during withdrawal.
• The waiting period will vary, depending on the rate of elimination of the drug from the body and the type of
pathology. For example, urticaria usually disappears quickly when the drug is eliminated, whereas fixed psoriatic skin
reactions can take weeks to resolve. If the patient is clearly getting better, if the patient cannot manage without a
medicine that has caused an adverse reaction, provide symptomatic relief while continuing the essential treatment.