Pharmacotherapy I

By : Lolita
Component of Assessment
Mid term exam : 30%
Final term exam : 30%
Task : 35%
Other component / attendance : 5%
Main Theme by System
Before mid
Rational Pharmacotherapy (1x) : Mrs. Lolita
Pain and Inflammation (4x) : Mrs. Lolita
Gastrointestinal (2x) : Mrs Woro Supadmi
After mid
Gastrointestinal (4x) : Mrs. Woro Supadmi
Infection (3x) : bacterial, viral, parasite, protozoa :
Mrs Sudewi and Lolita

Specific Issues
Pain & Inflammation
1. Nociceptic & Neuropatic pain : central,
peripheral
2. Headache disorders/cephalgia (migraine,
vertigo, tension, cluster, sinus)
3. Joint pain : (osteoarthritis, rheumatoid
arthritis, gout, bursitis)
4. Post-operative pain & cancer pain



Learning Indicator
Patophysiology
Clinical Data Interpretation
Pharmacotherapy
Specification of Drug
References
Primary :
Dipiro, JT., Hamilton, CW.,
Schwinghammer, TL., and Wells,
BG, 2000, Pharmacotherapy
Handbook, McGraw Hill, New
York.
Greene, RJ and ND Harris, 2000,
Patology and Therapeutics for
Pharmacists : a basic for clinical
pharmacy practice
Secondary :
Lacy C. F., Armstrong L. L.,
Goldman M. P., Lance L. L., 2010,
Drug Information Handbook, Lexi-
Comp Inc., Ohio.


The Benefit Outcomes
Assist students in understanding the use of the
drug in specific disease
Students are able to choose the right medicine
Students are able to provide drug information (for
example about the side effects of drugs, drug
contraindications, drug interactions with other
drugs or drug interactions with food, and etc)
Students are able to interact with physicians and
other medical personnel
Students help patients perform self-medication

Rationale Pharmacotherapy
Pharmacotherapy
Greek : Pharmacon & Therapeia
Pharmacotherapy is the treatment of disease through
the administration of drugs.
Choose a drug based on the types and signs of disease.
Area of pharmacy practice that is responsible for
ensuring the safe, appropriate, and economical use of
drugs in patient care.


Therapy
Approach
Nonpharmacology
Pharmacology
Pharmacotherapy
Alternative therapy
Radiotherapy
Surgery
Genetherapy
Drug therapy
Imunotherapy
1600 chemical agents
40.000 formulations
100.000 OTC
Pharmacotherapy Process
Symtoms/Signs
Diagnose
Treatment Methods
DRUG THERAPY
Drug Selection
Dosage Adjustment
Prescription
Drug Administration
Drug Utilization
Effect
Bad Response
Good response
Rational Drug Therapy

Prescribing and choosing the drug in manner
that maximizes clinical effect (maximizing
efficacy and minimazing toxicity), functional
status, overall patient satisfaction, health
quality of life at the lowest possible total cost.


The 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, and at
the lowest cost to them and their community.

correct drug
appropriate indication
appropriate drug considering efficacy, safety, suitability
for the patient, and cost
appropriate dosage, administration, duration
no contraindications
correct dispensing, including appropriate information for
patients
patient adherence to treatment
WHO conference of experts Nairobi 1985
Clinical
features
of illness
Patient
expectations
Potential
consequences







Presenting
symptoms
2. Understanding

pathophysiology
1. Making Dx
3. Reviewing menu
of Rx options
4. Selecting
optimal drug/
dose for patient
5. Choosing
endpoints
to follow
6. Making alliance
with patient,
following
endpoints
Clinical
outcomes
efficacy
toxicity
morbidity
mortality
Patient
satisfaations
Costs
direct
indirect
Functional Outcome
relief of symptoms
Patient Presentation Process of Rational
Therapeutics
Result of
Intervention
Process of rational drug therapy
The Purpose of Prescribing
Maximise
effectiveness
Minimise risks
Minimise costs
Respect patients choice
The most effective
The most safest
The most affordable
The challenge of
prescription
Prescribing
Patient Compulsion
Economic
Pressure
Limited time
Individual
preference
Unknowledge
Pharmaceutical Companies Interference
Rational Drug Used
Right
Follow up Diagnosis
Indication
Types of drug
Information
Dosage, route and frequence
Patient condition
Why Rational Use ?


Drug explosion
Efforts to prevent the development of
resistance
Growing awareness
Increased cost of the treatment
Consumer Protection Act. (CPA)


% Primary Health Care patients treated
according to guidelines
0
10
20
30
40
50
60
70
1990/1 1992/3 1994/5 1996/7 1998/9 2000/1
Africa Asia
Source: WHO database on drug use 2003
WHO, Dept. Essential Drugs and Medicines Policy
% drugs that are prescribed unnecessarily
estimated by a comparison of expected versus actual prescription
Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000
0
10
20
30
40
50
60
70
80
Nepal Yemen Nigeria
% antibiotics % injections % drugs % cost
5-55% of PHC patients receive injections -
90% may be medically unnecessary
0% 10% 20% 30% 40% 50% 60%
East ern Caribean
Jamaica
El Salvador
Guat emala
Ecuador
L.AM ER. & CAR.
Nepal
Indonesia
Yemen
ASIA
Zimbabwe
Tanzania
Sudan
Nigeria
Cameroon
Ghana
AFRICA
% of primary care patients receiving injections
Source: Quick et al, 1997, Managing Drug Supply
15 billion injections per year globally
half are with unsterilized needle/syringe
2.3-4.7 million infections of hepatitis B/C
and up to 160,000 infections of HIV per
year associated with injections
30 to 60 % of PHC patients receive antibiotics -
perhaps twice what is clinically needed
0% 10% 20% 30% 40% 50% 60% 70%
Guatemala
Jamaica
El Salvador
Eastern Caribean
L.AMER. & CAR.
Bangladesh
Nepal
Indonesia
ASIA
Zimbabwe
Tanzania
Ghana
Cameroon
Swaziland
Sudan
AFRICA
% of PHC patients receiving antibiotics
Source: Quick et al, 1997, Managing Drug Supply
WHO, Dept. Essential Drugs and Medicines Policy
Prescribing by dispensing and non-dispensing doctors in Zimbabwe
Trap et al 2000
2.31
28.4
58
8.65
1.67
9.5
48
13
0 10 20 30 40 50 60 70
no.drug items/Px
% Px with injections
% Px with antibiotics
consultation time (mins)
dispensing doctors non-dispensing doctors
Problems with Irrational Pharmacotherapy :
1. Complex diseases or health problems:
Example: A patient has many symptoms, but is embarrassed to
talk about the main one, so the situation does not get addressed
2. Lack of appropriate training skills by prescribers to give
proper diagnosis:
Example: Prescriber does not do a physical exam and prescribes
drugs based solely on oral information provided by the patient
Diagnosis
3. Overworked prescribers:
Example: health facility has only one prescriber, and an average of 300 patients per day
to consult
4. Lack of basic diagnostic equipment and tests
Example 1: No microscope or reagents to examine blood & urine
Example 2: No x-ray machine to test a patient suspected of having
tuberculosis
Prescribing
1. Using expensive drugs when equivalent ones are available
Example 1: The antibiotic cefalexin is more expensive than co-trimoxazole in
treating simple infections
Example 2: Ampicillin injection is prescribed when the patient could
take ampicillin tablets, which are cheaper, easy to take, and
involve lower risk of side effects

2. Selecting the wrong drug for the patients illness
Example: An antidiarrhoeal drug is prescribed when the patient is
dehydrated with simple diarrhoea and only ORS is needed
3. Prescribing several drugs when fewer drugs would
provide the same effect
Example: Sulfadoxine/pyrimethamine and paracetamol are prescribed when
the patient has fever, but not malaria
4. Prescribing drugs when the disease is self limiting and
the patient would get better without taking any drugs
Example: Ampicillin is prescribed when the patient has a simple cold, without
sore throat, cough or fever

1. Wrong interpretation of the prescription:
Example: Ampicillin is prescribed, but amoxicillin is dispensed.

2. Wrong quantity dispensed
Example: Artemether/Lumefantrine is prescribed to be taken four
tablets two times daily for three days (should be a total of 24 tablets),
but the patient only receives 16 tablets, which is sufficient for only 2 days

3. Labelling incorrect or inadequate
Example: Sulphadoxine/pyrimethamine (white tablet) is dispensed, but
the name of the drug is not written on the container label,
meaning that the drug will be unidentifiable once the patient
leaves the pharmacy

Dispensing
4. Incorrect/insufficient dispensing information:
Example: paracetamol 250mg is prescribed for a
child, but only paracetamol 500mg is
available in the pharmacy. The higher
dosage pill is given to the childs mother
without telling her to divide the tablet
before giving it to the child

5. Unsanitary practices:
Example: 20 tablets of paracetamol 500mg were
being counted, when some tablets fell to the floor.
These were picked up and dispensed to be given to the
patient anyway

Packaging
1. Poor quality of packaging material
Example: packaging material must protect the drug against the
sun and humidity in order to ensure the integrity and
quality of the dosage form required by the patient

2. Inadequate container size when repackaging the product
Example: the size of the packaging material must conform to the
quantity of medication dispensed. In the case of oral
drugs, too large a container could cause break-up of
the items packed within

3. Inadequate labelling and identification of the drug
After the patient leaves the health centre and arrives home, it is
very easy to forget instructions given by the prescriber and
dispenser.

At the very minimum, the following information must be written
on the container label:
Name of patient
Date drug was dispensed
Name of the drug
Strength of the drug
Quantity dispensed
Instructions on how to take the drug during the day
(example: 1 tablet 4 times daily)
Instructions on how long to take the drug (example, for 5
days)
Comments, instructions or warnings specific to the drug
(example, take with milk, may cause drowsiness)


Poor Compliance

Compliance is the degree to which the patient
carries out the physicians instructions on
how to take the prescribed drug and
treatment.
Many studies about outpatient compliance carried
out in developing countries indicate that only about
50% of patients follow the instructions given by the
physician
Poor Compliance
Causes of poor compliance include:
1. Improper labelling
Neither the name of the patient, nor the name of the
drug is on the container labels when dispensed. If
two or more drugs are dispensed together, the
patent does not know which drug he/she is taking
2. Inadequate instructions:
The instructions on dosage frequency must be
written on the drug label, or the patient could
forget how to take it when he/she arrives home and
becomes involved in other activities

3. Treatment /instructions that do not consider the
socio-economic and cultural aspects of the
patient
Example: In cases where the patient does not know how
to read, proper instructions would include
graphic symbols of how to take the drug.

For a treatment of three days, for example, you could number
the days 1 to 3, and then below each day, make a mark for each
time the drug must be taken that day
Explanations Poor Compliance :
Lack of knowledge
Influenced by others
Negative attitudes
Own experience
Own perceptions
Difficult/complicated regimen
Extremes of age and need for assistance

Consequences in Irrational Therapy
Public Health and Economic Consequences
Adverse possibility lethal effects, e.g. due to antibiotic
misuse or inappropriate use of drugs in self
medications
Limited efficacy, e.g. in the case of under-therapeutic
dosage of antibiotic, tuberculosis or leprosy drugs
Antibiotic resistance, due to widespread overuse of
antibiotics as well as their use in under-therapeutic
dosage
Drug dependence, e.g. due to daily use of pain killers
and of tranquilizers
Risk of infection due to improper use of injections:
abscesses, polio, hepatitis and HIV/AIDS
WHO, Dept. Essential Drugs and Medicines Policy
Adverse drug events
Review by White et al, Pharmacoeconomics, 1999, 15(5):445-458
4-6th leading cause of death in the USA
Estimated costs from drug-related morbidity &
mortality 30 million-130 billion US$ in the USA
4-6% of hospitalisations in the USA & Australia
commonest, costliest events include bleeding,
cardiac arrhythmia, confusion, diarrhoea, fever,
hypotension, itching, vomiting, rash, renal failure
WHO, Dept. Essential Drugs and Medicines Policy
Overuse and misuse of antimicrobials contributes
to antimicrobial resistance
Malaria
choroquine resistance in 81/92 countries
Tuberculosis
2 - 40 % primary multi-drug resistance
Gonorrhoea
5 - 98 % penicillin resistance in N. gonorrhoeae
Pneumonia and bacterial meningitis
12 - 55 % penicillin resistance in S. pneumoniae
Diarrhoea: shigellosis
10-90+ % amp, 5-95% TMP/SMZ resistance
Source: DAP, EMC, GTB, CHD (1997)
Ecomomic consequences

Inappropriate drug use or irrational therapy
have also a impact on household and national
health budgets,
Example :
- the use of expensive brand-name product
while cheaper generic drug are available,
- combinations preparation,
- multi-drug prescribing

Improve Rational Therapy
Educational
Intervention
Type
Managerial
Financial
Regulatory
Prescribers
Consumers
Interventions targeted at prescribers
1. Educational materials
Standard treatment guidelines or clinical guidelines
Bulletins/newsletters
Flow charts/diagnostic cards
Simple forms of printed informations
2. Approaches to introduce educational materials
Face to face education
Seminar or workshop
Focus group discussion/participatory training approach
Peer review and feedback
In-service training/supervision
Involving the target group in developing of training
materials
Drug informations centers

3. Managerial Strategies
Essential drug list
Kit system distribution
Pre-printed order form
Stock control
Course-of-therapy packaging
Effective package labelling
4. Financial interventions
Drugs are sold at a slightly higher price to create a fund for
improving PHC services
Making people pay for drugs could reduce overconsumption
Improve drug supply and cost-sharing
5. Regulatory strategies
Banning unsafe drugs
Limiting the import of drugs on the market
Interventions targeted at consumers/patients
1. Educational materials
Patient education
Public education
2. Managerial stategies
Course of therapy packaging
Blister packs facilitated patient adherence to
leprosy treatment
The use of antimalarial drug packaging resulted
in a significant improvement in patient
compliance
3. Financial interventions
Community revolving drug funds
4. Regulatory strategies
Regulatory strategies are not targeted at
consumers
Six Key Steps When Practising
Approach Pharmacotherapeutics
1. Making an accurate diagnosis
2. Understanding the pathophysiology of disease
3. Reviewing the menu of pharmacotherapeutic options
4. Selecting patient-spesific drug and dose
5. Selection end point to follow
6. Maintaining a therapeutic alliance with the patient
Approach to rational therapeutics
1. Knowing the diagnosis with reasonable certainly

i. Problem that lead to empiric therapy
Febrile leukemic patient, now neutropenic
with chemotherapy, who is approptriately
started on broad-spectrum antibiotics.

ii. Inappropriate acceptance of empiric treatment
The rule for treatment of febrile
immunosuppressed patient often are
generalized and applied to other population
of patient who donot cancer, have not
recieved chemotherapy, are not
immunosuppressed and are not neutropenic.
2. Understanding the pathophysiology of the patients
disease
i. Confusion between syndrome and disease
Hyponatremia (psychogenic polydepsia,
bronchogenic carcinoma, servere lossed of
salt and water, adrenal insufficiency)
ii. Being misled by a name
Lupus erythematosus and lupus
anticoagulant
iii. Further advantages of understanding the disease
Proper understanding of disease not only
leads to appropriate therapeutic plan but also
appropriate preventive measures as well
3. Understanding the pharmacology of useful
drugs
i. Drugs that have no evidence of efficacy
ii. Prescribing drugs because it makes
sense
iii. Factors that perpetuate incorrect
information about drugs
4. Optimizing selection of drug and dose
The option of not using a drug.
New drug information not provided by the
manufacture
Increasing knowledge of drugs adverse effects
Impact of drug costs
Irrational beliefs
Detailing and counterdetailing
Conflicts of interest.
5. Selection of appropriate therapeutic end point
Appropriate end points of efficacy
End point reflecting toxicity
The prescription as an experiment
6. The physician-patient relationship
Patient-physician communication can affect the
choice of therapy and its outcome
Attention to rational therapeutics
Guiding Principles of Pharmacotherapy
1. There should be justified and documented indication for every
medication that is used
2. A medication should be used at the lowest dosage and for the
shorten duration that is likely to achieve the desired outcome.
3. When patient is adequated treated with a single dose,
monotherapy is preferred
4. Newly approach medication should be used only if there are clear
advantages over older medication.
5. Whenever possible, the selection of a medication regimen should
be based upon evidence obtained from controlled clinical trial.
6. The timing of drug administration should be considered as a
possible influence on drug efficacy, adverse effects, and
interactions with other drugs and food.
7. A medication regimen should be simplified as much as possible to
enhance patient adherence.
8. A patients prescription of illness or the risks and benefits of
therapy may affect adherence and treatment outcome.
9. Careful observation of a patients response to treatment is
necessary to confirm efficacy, prevent, detect, or manage adverse
effect, assess compliance, and determine the need for dosage
adjustment or discontinuation of drug therapy.
10. A medication should not be given by injection when giving
by mouth would be just as effective and safe.
11. Before medications are used, lifestyle modification should
be made, when indicated, to obviate the need for drug
therapy or to enhance pharmacotherapy outcome.
12. Initiation of drug regimen should be done with full
recognition that a medication may cause a disease, sign,
symptom, syndrome or abnormal laboratory test.
13. When a variety of drugs are equally efficacious and equally
safe, the drug that result in the lowest health care cost or is
most convenient for the patient should be chosen.
14. When making a decision about drug therapy for individual
patients, societal effects should be considered.
15. The possible reasons for failure of medication regimen
include inappropriate drug selection, poor adherence,
improper drug dose or interval, misdiagnosis, concurrent
illness, interaction with foods or drugs, environmental
factors, or genetic factors.
Guiding Principles of Pharmacotherapy (cont. .)