FORENSIC EXAM REVIEW REVISIONS:

4th SEPTEMBER 2013

1 What is the condition for the registration of the drug med devices

or herbal drugs as stipulated in the TFDA act

„ The availability of the drug in the interest of the public

„ Safety and efficacy and of acceptable quality

o Drugs for human in relation to the effect on human health

o For animals in relation to its effect on animal health, consumers of

animal products the environment and users.

o For medical devices its safety and efficacy

„ The premises and the manufacturing should meet the current GMP

requirements as stated in the act.

2．What are the three omissions that can lead to the registered

person to be removed from the register.

z Who no longer complies with the requirements and conditions to be

registered as a pharmacist

z Who fails to pay the annual fees or

z Who is deceased

3. What are the two principles that should be applied for a

pharmacist for the stock rotation?

1. FEFO first expiring first out

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 It is common knowledge that issuing out drugs with the shortest

remaining shelf life is the best way to reduce waste and increase

profitability in pharmaceutical products management in all

pharmaceutical.

2. FIFO first in first out

• Control inventory level.

• For fast moving items.

• To minimize price fluctuation.

4. What do u understand by the following words in a package insert?

Indication; is a valid reason to use a certain test, medication, procedure,

or surgery

Indications for medications are strictly regulated by the Food and Drug

Administration (FDA), which includes them in the package insert under

the phrase "Indications and Usage". Most countries and jurisdictions have

a licensing body whose duty is to determine whether to approve a drug

for a specific indication, based on the relative safety of the drug and its

efficacy for the particular usage being investigated e.g.TFDA in Tanzania

Contra indication; is a condition or factor that serves as a reason to

withhold a certain medical treatment.

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Some contraindications are absolute, meaning that there are no

reasonable circumstances for undertaking a course of action. For

example, children and teenagers with viral infections should not be given

aspirin because of the risk of Reye's syndrome, and a person with an

anaphylactic food or medication allergy should never eat the food or

medication to which they are allergic.

Side effects; Side effect is an effect that is secondary to the one intended.

Side effect may also refer to Therapeutic effect, an unintended but

desirable consequence of medical treatment.

Adverse effect, an unintended and undesirable consequence of medical

treatment.

An adverse drug reaction (abbreviated ADR) is an expression that

describes harm associated with the use of given medications at a normal

dosage during normal use. ADRs may occur following a single dose or

prolonged (cumulative) administration of a drug or result from the

combination of two or more drugs. The meaning of this expression differs

from the meaning of "side effect", as this last expression might also imply

that the effects can be beneficial.

An adverse drug event (ADE) refers to any injury caused by the drug

(at normal dosage and/or due to overdose) and any harm associated with

the use of drug (e.g. discontinuation of drug therapy). ADRs are a special

type of ADEs

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 5．Comment on the following cases.

a) You are asked by a nurse to inform her staff about the

recommendation for the drug therapy on HIV PEP for low risk and

high risk.

In most cases for the PEP therapy it should include a double therapy for a

low risk and triple therapy for a high risk.

The ARV regimen according to level of risk.

Risk ARV regimen Drug regimen

category
ZDV+3TC (COMBIVIR) or TDF+FTC (TRUVADA)
Low risk Dual

therapy

High risk Triple ZDV+ 3TC + EFV or ZDV+ 3TC + Lopinavir/(r)

therapy

b) A terminal ill patient is prescribed morphine for pain management :

• Given as a palliative care to relieve the pain for the terminal ill patient

• It helps the family members and other care takers on the management of

the patient

• It gives a social, psychological and physical relief to the patient to ensure

the quality of life to the patient though at terminal stage of illness.

• The patient should be give morphine at a dosage of 5- 10ml for every 4

hrs orally.
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• The patient may encounter shortness in breath, vomiting, constipation;

therefore morphine at these conditions should be dispensed concomitantly

with laxatives and antiemetic.

6. a) briefly discuss the title pharmaceutical assistant, pharmaceutical

technician and pharmacist under section 19 of pharmacy act 2002.

• Pharmaceutical assistant means a person enlisted under section 28 of

this act

• Pharmaceutical technician means a person enrolled under section 24 of

this act.

• Pharmacist means a person registered under section 16 of this act

b) What is the:

• Certificate of enlisting is a certificate issued to the pharmaceutical

assistant under section 29 of this Act.

• Certificate of Registration is a certificate issued to the pharmacist

under section 20 of this Act

• Certificate of Enrollment is a certificate issued to the pharmaceutical

technician under section 25 of this Act

7. section 3 of the pharmacy act of 2011, states that there is hereby

establish a Council to be known as the pharmacy council which shall

be a sole authority for Registering, Enrolling and listing of

pharmacists, pharmaceutical technicians and pharmaceutical

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 assistants respectively.

a) With reference to the above quoted section answer the following

questions

i.Describe the composition the pharmacy council

ii.What are the committees of the pharmacy council?

The pharmacy committee

There shall be a committee to be known as the pharmacy committee

whose function shall be to prescribe and evaluate the qualification for

the enlisting, ``enrollment and registration and evaluation application

for premise registration under this act and making recommendations to

the councils.

The pharmacy committee shall consist of the chairman to be appointed

from amongst the members of the council and for other four members

to be appointed by the council

The disciplinary committee

There shall be a committee to be known as the disciplinary committee

whose function shall be to conduct preliminary investigation into any

case where it has alleged that a registered, enrolled or enlisted person has

misbehaved to his capacity as a pharmacist, pharmaceutical technician or

pharmaceutical assistant or should be for any reason be a subject for a

proceeding before the council.

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 The disciplinary committee shall consist of the chairman to be

appointed from amongst the members of the council and for other

four members to be appointed by the council

Other committees

iii.List down at least five functions of the councils

• Enlisting, registering and enrolling the PA,PST and PT

• Enquire any issue arising from the community regarding pharmacy

profession for interest of the public.

• Upholds and safe guard the acceptable pharmaceutical conduct in the

public and private systems.

• Prescribe the scope of practice of the persons registered, enrolled and

enlisted under this act.

iv.Mention the tenure of the office for the council members

• A member shall unless his appointment is terminated by the minister or

he ceases in any other way to be a member, hold office for a period of

three years and shall be eligible for reappointment

• Members appointed by the virtues of their offices shall cease to be

members upon ceasing to hold the office entitling to the appointment to

the council.

• Member of the council shall cease to be a member if

z The minister in the public interest terminates his membership after giving

a written notice to the member to show why his membership should be

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 terminated.

z Ceases to hold the position entitled his appointments

z He fails without good cause to attend three consecutive meetings of the

council.

z He is convicted of a criminal offence and sentenced to save jail for a term

of beyond six months.

z He becomes mentally ill.

z He is disqualified to practice under this act.

z deceased

v.Describe the quorum of the council

The quorum at any meeting of the council shall be half of the members

b) Basing on its function differentiate between the pharmacy council

and the TFDA.

TFDA PHARMACY COUNCIL

Is a National regulatory Authority Is a sole National professional body

registering products (i.e. drugs, registering, enrolling and enlisting

herbal drugs, medical devices, of the pharmaceutical personnel’s.

poisons, foods and cosmetics) used

in provision of medical and health

care services.

Keeps and maintains the registers Keeps and maintains the registers

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for: for:

All products registered (drugs, Registered pharmacists

herbal drugs, medical devices, Enrolled pharmaceutical

poisons, foods and cosmetics) Technicians.

under TFDC Act 2003. And list for enlisted

Whole salers, distributors pharmaceutical assistants.

purporting for exports and

importers products licenses,

certificates and permits.

Holder of ethical clearance

certificates granted permits for

conducting clinical trials.

Ensure that clinical trials are To prescribe the scope of practice

performed under the prescribed of the registered, enlisted and

standards in this act enrolled pharmaceutical personnel’s

under this act.

Appoint inspectors and order Regulate standards and practices of

inspection of premises pharmacy profession.

Ensures unbiased information about Advice the minister on matters

products regulated under this act. relating to the pharmacy profession.

Be responsible for its human Determine fees payable under this

resource development and act.

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managements.

Foster cooperation with other Ensure proper collection of fees

bodies payable under this act.

Registration of products Pay any member, staff, committee

or any person entrusted by any task

under this act such allowances as

may determined.

Promote rational use of drugs, Promote rational use of drugs.

medical devices and herbal drugs.

Attend to and where possible and Enquire into any queries related to

takes the legal actions on pharmacy practice raised by the

complaints made by the consumers, public.

manufacturers of the products

regulated under this Act.

Approve and register products Ensures that the pharmaceutical

regulated under the TFDC Act education is provided up to the

2003, to be manufactured within or prescribed standards.

imported into and intended to be

used in the united Republic of

Tanzania.

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Establish and maintain the Tanzania Promote interest in the

national formulary and advancement of the pharmacy

pharmacopoeia profession.

Regulate all matters relating to Regulate activities of the

quality and safety of foods, drugs, pharmacists, pharm tech and pharm

herbal drugs, medical devices, assistants.

poisons and cosmetics.

Examine, grant, issue, suspend,

cancel and revoke certificates and Uphold and safe guard the

licenses for permits and products acceptable standards of the

issued under the Act. pharmaceutical profession to the

private and public sectors.

Ensure that evidence existing and

new ADRs and information about Collaborate with TCU and NACTE

pharmacovigillance of products to evaluate the academic and

monitored globally are analyzed practical qualifications for

and acted upon. pharmacists, pharm tech and pharm

assistant for the purpose of

registering, enrolling and enlisting.

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8 what information or documents are required by the pharmacy

council when the person applies to be registered enrolled or enlisted

as a full pharmacist, pharmaceutical technician, and pharmaceutical

assistant in Tanzania?

Pharmacist Pharmaceutical Pharmaceutical

technitician assistant

Fill and submit form Fill and submit form Fill and submit form

PCF 1 to the registrar PCF 3 to the registrar PCF 5 to the registrar

as set out in the first as set out in the first as set out in the first

schedule to these schedule to these schedule to these

regulations. regulations. regulations.

A certified copy of his A certified copy of his A certified copy of his

pharmaceutical degree pharmaceutical pharmaceutical

or qualification diploma or certificate certificate.

equivalent to a degree as the case may be

offered in Tanzania.

A full transcript of the A full transcript of the A full transcript of the

academic record academic record academic record

certified by the head of certified by the head of certified by the head of

institution or the institution or the institution or the

academic body where academic body where academic body where

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he graduated as a he graduated as a he graduated as a

pharmacist。 pharmaceutical pharmaceutical

technician assistant

A letter of completion Certificate of good Certificate of good

of internship from a standing from standing from

supervisor of in case of apprenticeship apprenticeship

those sponsored by the supervisor supervisor

ministry of health a

letter from the chief

pharmacist thereby

that he has completed

internship.

Two recent passport Two recent passport Two recent passport

size photographs size photographs size photographs

endorsed at the back endorsed at the back endorsed at the back

by a public notary as by a public notary as by a public notary as

true likeness of the true likeness of the true likeness of the

applicant applicant applicant

A letter of passing the A copy of current cv A copy of current cv

forensic examination

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9. What does the abbreviation ALU stand for?

ALU-Artemether Lumefantrine

How would u advice an adult patient on how the ALU dose?

Dosage:

Day 1st day 2nd day 3rd day

Dose 1st 2nd 3rd 4th 5th 6th

Hours 0 8 24 36 48 60

Tabs 4 4 4 4 4 4

Effect of food and interactions

Food enhances the absorption of both artemether and lumefantrine，

patients are advised to take medication with fat food, this is because

lumefantrine is well absorbed with fat food.

Artemether has a potential to prolong the QT interval, so combinations

with other drugs having that property can cause irregular heartbeat,

potentially leading to lethal ventricular fibrillation.

The combination with halofantrine, another antimalarial drug, can

cause a life-threatening QT prolongation.

Drugs and other substances influencing the activity of the liver enzyme

CYP3A4, including, can either increase or lower blood levels of

artemether/lumefantrine, grapefruit juice depending on the sort of

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 substance. This can either lead to more severe side effects or to

reduced efficiency.

10. Why are code of ethics and professional conduct important for

pharmaceutical Personnel’s?

• Express broad ideas of pharmaceutical practices.

• It spells out what values are required at particular circumstances.

• Set standards of professional conduct of all pharmaceutical personnel’s.

• Form a base of complains for misconduct.

• Put emphasis on the societal duty of the pharmaceutical personnel as

stipulated in the oath of the pharmaceutical personnel “Concern for

Human Welfare’’ and “Relief of human sufferings’’.

11. a). What do you understand by the term rational use

of medicine

This is the term expresses the medicine has been dispensed to the right

patients, at right dose/ regimen, right time and route of administration at

low treatment cost/ economic treatment cost and as well with right

documentations.

Rational use of medicine leads to patient appropriate medication for

their clinical needs in a dose that does meet their own individual needs

for an adequate period of time at lower cost for them and their

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 community.

a) List down types of irrational use of medicine

Prescribing

The factors that cause irrational use of medications are:

• Prescriber; Failure to initiate the right diagnoses due to lack of skills and

drug information.

• Patient: Failure to express correctly to medical practitioners to what is

suffering from.

• Dispensing; Failure to read and interpret correctly the prescription

regarding to prescribed medications, which leads to wrong counting or

filling of the prescribed medicines, or a patient not able to provide basic

information regarding to the use of the dispensed medicines and

precautions to be observed in the storage of the medicines at home during

treatments.

Under prescribing: It occurs when the indicated medications are not

prescribed due to lack of prescriber important skills and information or

the patient didn’t provide all information to the prescriber during history

taking, which may lead to the dosage prescribed not enough for

treatments.

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Over prescription: Occurs if a drug prescribed is not needed or dose is

too large or administration time length is too long. Also over prescribing

may occur if done empirically without requesting labs results to be sure

of the patient diagnosis in order to prescribe the indicated medicines.

Incorrect prescribing: Occurs when a drug is given for an incorrect

diagnosis, wrong drug selection for the diagnosed indication. Also it may

occur if the prescriber lacks important drug information and skills to

handle the case, from diagnosis up to prescribing.

The use of too many medicines per patient (polypharmacy):

Is a situation where a patient is prescribed with multiple medications

which are not coordinated in the management or treatment of the patient

clinical indications. Also polypharmacy occurs if the patient is prescribed

medications from different prescribers visited for seeking treatments, as

the result patient became dispensed with multiple medicines for the

clinical condition to be treated.

Inappropriate use of antibiotics: Always occurs if medicines are used

without establishment of right diagnoses and patient indication as the

result the patient take not indicated antibiotic medications in a wrong

regimen not sufficient for treatments, or sometimes taking antibiotics for

non-bacterial infections also inappropriate use of antibiotics.

Over-use of injections: It occurs when injectables are used in the

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 treatment while an alternative for oral formulations would be more

appropriate to manage the patient clinical conditions.

Inappropriate self-medication: Often occurs if medications are taken

for wrong indication, e.g. antibiotics taken for flue indications or other

unindicated clinical conditions. Also the use of prescription-only

medicines without diagnosis establishment from a licensed medical

practitioner is a major cause of inappropriate self-medication.

Dispensing: It occurs when the dispenser do:

• Incorrect interpretation of the prescription.

• Incorrect counting, weighing, volume filling, apparatus calibration and

compounding.

• Inadequate labeling.

• Don’t adhere to dispensing protocols (Good Dispensing Techniques) and

professional ethics which leads to patient not following to directions

given by the dispenser due to lost hope of being cured from the

medications given.

b) What is the role of the pharmacist promotion rational use of

medicine?

• Proper cancelling when dispensing medications to the patient and advice

on storage conditions, drug interaction, side effects of the drug and any

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 other important information on the safety use of medication.

• Tidiness: Ensure sanitary procedures laid down in the dispensing outlet

and compounding area.

• Communication skills: Ensure good communication with patients,

doctors, nurses and other hospital staffs or facility staffs, and clear any

doubt between prescriber and dispenser when arise to the patient

prescribed regimen.

• Promotion and provision of general drug information education to the

public on proper of medicines.

12. The proliferation of the counterfeit drugs in Tanzania is

increasing at an alarming rate, as the result to cause a great impact

on public healthcare.

a) What do you understand by counterfeit in relation to medicinal

products?

A counterfeit drug or a counterfeit medicine is a medication which is

produced and sold with the intent to deceptively represent its origin or

effectiveness to that already present superior drug in the market.

Counterfeit medicines are drug copy imitated from the patented and

registered medicine manufactured from the originator drug manufacturing

company.

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 A counterfeit drug may be one which does not contain active

ingredients, contains an insufficient quantity of active ingredients, or

contains entirely incorrect active ingredients (which may or may not

be harmful), and which is typically sold with inaccurate, incorrect, or

fake packaging.

Fake medicines and generic drugs which are deliberately mislabeled in

order to deceive consumers are therefore counterfeited.

b). List down three characteristics that could help to

recognize the counterfeit medicine in your practice.

• Packaging: The container and packaging of the drug will show

difference in dimensions appearance to that of the original drug container.

• Font colour: The colour of text and font can be different to that of the

original drug labeling.

• Label appearance: It will also show differences to that of the original

drug label due to differ in label length and width dimensions and water

mark sign imbedded from the original label.

c). What do you think are the best measures to be taken to

combat this alarming situation in the country?

• Raising Awareness: Government typically view and thus manage the

counterfeit drug issue as a public health and criminal enforcement

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 challenge, yet indisputable and growing links between this industry and

organized crime and terrorist organizations indicate that the national

security community must play a larger role in preventing counterfeit

drugs. Government must encourage a more widespread recognition of the

multidimensional nature of this growing threat and institute appropriate

collaborative mechanisms. Legitimate private industry must also

recognize their role in prevention and work more transparently with the

government.

• Mandate action by the national security community: The growth of

trafficking networks around the globe has helped bring about a

convergence of threats: counterfeit pharmaceuticals, narcotics, human

trafficking, dual-use nuclear black markets, small arms and conflict

resources including diamonds and timber. Together, these challenges

have become so widespread that they threaten to overwhelm the

capabilities of even well-intentioned government to mitigate their

destructive effects. The national security community must be given an

explicit mandate to address these challenges in order to ensure the

adequate and coordinated resources necessary to ameliorate the threat. In

short, like the prevention of drug and human trafficking, counterfeit

pharmaceuticals must become a mandate of government security

apparatuses.

• Enhanced security over international purchasing and distribution: At

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 present, the lion’s share of concern over the counterfeit pharmaceutical

threat remains the developing world. As a large percentage of

pharmaceutical products are distributed by international relief agencies

and through government assistance programs, it is incumbent upon these

actors to ensure that the products they are distributing are safe. At times,

these agencies’ pursuit of low-cost drugs has led them to deal with

unapproved suppliers. This irresponsible practice should stop as it

provides a direct conduit for organized crime and terrorist organizations

to capitalize upon well-meaning development assistance for nefarious

purposes.

• Development of a transparent and verifiable chain of custody from

point of production to point of sale: Efforts to establish a so-called “e-

pedigree” system to track and trace pharmaceuticals have lagged because

of the costly and complex infrastructure necessary to institute such a

system, lack of agreed-upon industry standards, and questions regarding

patient privacy raised by some civil liberties organizations pressure

should be brought to bear by the national security community to ensure

that the public and private sectors collaborate in the design and

implementation of a nationwide drug serialization system with a track-

and-trace capacity. Governments should work collaboratively with

industry to identify common e-pedigree standards and, where necessary,

incent compliance with those criteria.

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• Legal gap analysis: the government should be encouraged to ensure that

they have relevant, up-to-date laws, as well as rigorous penalties

consistent with the trafficking in illicit narcotics to ensure that traffickers

can be prosecuted and/or sufficiently deterred.

• Enhanced early “authentication” procedures: Governments should be

more proactive in exercising early validation of manufactured products

circulating in the market obtained from reputable registered potential

suppliers.

• Identification Manufacturing sites: Through scheduled visit and

inspection and formal registration/validation of all importers both from a

public health perspective, as well as from a national security standpoint.

This should include not only more rigorous enforcement of importers and

at national borders, but also with domestic manufacturers whose

standards and custody practices may not be consistent with either public

health standards or national security interests.

• Enhanced enforcement: Although public health agencies—even in the

developed world—recognize the challenges presented by counterfeits,

their ability to enforce compliance with existing laws is ineffectual due to

limited resources. Recognizing that the challenges these products pose are

not only a threat to public health but also a direct threat to international

security, additional resources should be directed toward enforcement

agencies at all levels, in all countries, to inhibit the growth of this

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 scurrilous industry.

• Quality insurance systems.

• Regular inspection.

• Post marketing inspection.

• Control of import and export on free trade zones.

• Cooperation with other bodies.

• Education on counterfeit identification.

13．With reference to the Tanzania Food, Drug and

Cosmetics Act of 2003.

a) What are the conditions for a body of corporate to become

authorized seller of drugs and poisons?

• Anybody of corporate carrying out the business involving the sell of

drugs shall be an authorized seller of drugs within the meaning of this Act

if:

i). With regard to the keeping, selling, dispensing and

compounding the business is under the management of a

superintendent who;

• Is a pharmacist.

• Has signed and sent to the director general a statement in writing on

behalf of the body of corporate stating his name and specifying whether

or not he is a member of the body of corporate and,

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• Is not at the same time acting at the similar capacity for any other

body.

• In each set of premises for the sell of drugs the business is carried out

either under the personal supervision of the superintendent or

subject to his direction under the personal control of another

pharmacist.

ii). The name and the certificate of registration of the

Superintendant or of another pharmacist having control of

the business are conspicuously exhibited in the

premises.

b) Give a short explanation on the procedures followed when one wants

to destroy the expired drugs in Tanzania?

a) Request in writings to the TFDA general director by using the

application form (Refer to annex II) available at the TFDA head offices,

TFDA zonal offices, regional and district medical officer’s offices and

TFDA web sites.

b) A request shall be a companied with a list of products to be disposed

and should state clearly the trade name, the generic name, strength

where applicable, dosage form, pack size , quantity, manufacturer,

batch number and market value of the product.

c) Once the request has been received by TFDA the authority shall

acknowledge and inform the applicant through a letter to contact the

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 directorate of medicine and cosmetics or TFDA zonal offices to

arrange a day for the unfit product verification process, in case there is

no TFDA zonal offices the applicant shall be informed to contact the

regional or district medical officer’s offices for the same issue.

d) The TFDA HQ or TFDA zonal offices or regional or district medical

officer’s offices shall send inspectors to the premises to verify and

authenticate the information submitted.

14. You are a drug inspector, visiting a certain pharmacy in town.

The premises deal with the compounding and dispensing of

medicines. On fascia of the pharmacy there is an advertisement that

reads:

• Best quality medicament.

• Most qualified professional advice.

• All drugs are available including antibiotics, injections and capsules for

human and veterinary use.

• Affordable prices.

What does the law say about this discuss?

• A person shall not advertise and promote any medicine, medical devices

or herbal medicine in a manner that is false misleading, deceptive or that

is likely to create incorrect impression regarding to its values, safety,

quantity composition or efficacy as the case may be.

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• A person shall not advertise or sale by retail any medicine or medical

devices or herbal medicine in connection with any offer or bonus or

discount.

• A person shall not carry out any promotion to the any medical devices or

herbal medicine in relation to pharmacy practices without any written

approval of the council.

15. (a) compare the effectiveness between amoxicillin and ampicillin.

Amoxicillin and ampicillin are similar in chemical structure except

Amoxicillin has an OH group on the benzene ring.

• Amoxicillin have better oral absorption than ampicillin.

• Amoxicillin cause fewer diarrheas due to its better oral absorption.

• Amoxicillin is less interfered with food.

• Amoxicillin has smaller super infections occurrences than ampicillin.

• Amoxicillin is less effective against shigella and Hemophilus influenza.

• Amoxicillin antimicrobial effectiveness is enhanced when formulated

with Clavulanic acid, and while ampicilline is formulated with

Salbactam.

b) The label on the bottle of dry powder mix for reconstitution states

that when 128ml of water are added, 150ml of an oral suspension,

containing 250mg of amoxicillin in each of 5ml each. How many mls

of water should be added to the dry powder mix if the strength of

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 150mg of amoxicillin per 5ml is desired?

Soln:

• Let; C1=250mg/5ml and V1=150ml

and C2=150mg/5ml and V2=? (To be determined).

By using the relation C1V1=C2V2

Then on making V2 the subject;

V2=C1V1/C2

• On substituting the data; V2=[(250mg/5ml)X150ml]/(150mg/5ml)

=250ml.

The 250ml is the volume of suspension resulted after reconstitution of

powder.

• On taking the proportions of water and final suspension volume formed,

the unknown volume can be found.

128ml/150ml = X/250ml

Then X = (128ml X 250ml)/150ml

=213.33ml

ANSWER: 213.33ml of water will be added in a dry powder mix for

reconstitution to give 250ml suspension of concentration 150mg/5ml.

16. Define the following terms

a) Spirits:

Is an alcoholic or hydroalcoholic soln of volatile substance with alcohol

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 content ranging from 62-85%.

b) Plasters:

Is a small dressing used for injuries not serious enough to require a full-

size bandage.

"Bandage" is the common American English term, while "plaster" is the

term in British English usage.

The adhesive bandage protects the cut, e.g. from friction, bacteria,

damage, or dirt. Thus, the healing process of the body is less disturbed.

Sometimes they have antiseptic properties. An additional function is to

hold the two cut ends of the skin together to make the healing process

faster.

c) Aerosol:

Tiny solid particles or liquid suspended in a gas, used in a cane or

bottle that contains a liquid under high pressure.

The word aerosol derives from the fact that matter "floating" in air is a

suspension (a mixture in which solid or liquid or combined solid–liquid

particles are suspended in a fluid).

d) Tinctures:

Is an alcoholic extract or solution of a non-volatile substance e.g. of

iodine. To qualify as a tincture, the alcoholic extract is to have an ethanol

percentage of at least 40-60% (sometimes a 90% pure liquid is even

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 achieved).

e) Emulsion:

A dosage form consisting of two phase systems comprised of two

immiscible liquids, one of which is dispersed as droplets within the other

liquid in a continuous phase.

Emulsion can be oil in water (O/W) means oil is dispersed phase and

water is the continuous phase or water in oil (W/O) which means water is

dispersed phase and oil is the continuous phase.

f) Shelf life:

• Is the length of time assigned to foods, beverages, pharmaceutical

drugs, chemicals, and many other perishable items to be used before

they are considered unsuitable for sale, use or consumption. In some

regions, a best before, use by or freshness date is required on packaged

perishable foods.

• Shelf life is also is the recommendation of time that products can be

stored, during which the defined quality of a specified proportion of the

goods remains acceptable under expected (or specified) conditions of

distribution, storage and display.

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g) Immune reconstitution inflammatory syndrome:

It also known as "Immune recovery syndrome" It is a condition seen in

some cases of AIDS patients co-orinfected with tuberculosis or having

strong immunosuppression, when the patient treated with ant

tuberculosis and antiretrovirals in which when the immune system begins

to recover, but the patient condition responds to a previously acquired

opportunistic infection with an overwhelming inflammatory response

that paradoxically makes the symptoms of infection worse.

h) Generic name, drug:

• The chemical name of a drug.

• A term referring to the chemical makeup of a drug rather than to the

advertised brand name under which the drug is sold.

• A term referring to any drug marketed under its chemical name without

advertising.

i) prescription, extemporaneous,

1. (Magisterial prescription) is a prescription for a non-official drug.

2. A prescription that directs the pharmacist to compound the specified

medication, as contrasted with a prescription that specifies medication

available in precompounded form.

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3. Extemporaneous prescription is also a fresh prepared medicine upon the

request prescription written by registered prescriber, to be taken by the

patient at once or in continuation whose shelf life (expire date) is fourteen

days effectively from the date of preparation.

j) Polypharmacy is the use of multiple medications by a patient, especially

when too many forms of medication are used by a patient, when more

drugs are prescribed than is clinically warranted, or even when all

prescribed medications are clinically indicated but there are too many

pills to be taken (pill burden). Furthermore, a portion of the treatments

may not be evidence-based. The most common results of polypharmacy

are increased adverse drug reactions, drug-drug interactions and higher

costs. Polypharmacy is most common in the elderly but is also

widespread in the general population.

Polypharmacy is most common in people with multiple medical

conditions. Combination therapy is the use of multiple drugs specifically

to treat a single medical condition; monotherapy is the use of a single

drug.

7. The pharmacy council may upon recommendation by pharmacy

committee grant a temporary registration to an applicant if he satisfy

some conditions. Please mention them.

• He is not a resident of TANZANIA.

• He is intends to work in Tanzania in the capacity which he is applying for

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 the express purpose of carrying out specific assignment for research or

teaching.

• He is or immediately before entering in Tanzania was acting as a

pharmacist and he is eligible for registration as a pharmacist under

section 15 of the Pharmacy Act 2011.

• His professional and personal conducts render him fit to be registered

pharmacist.

18. Briefly explain the factors which guide the ARV initiation.

• For adults and adolescents, initiation of therapy is dependent on

WHO clinical staging and CD4 count.

• Tanzania’s national guidelines endorse the WHO recommendations for

initiating HAART:

– WHO stage IV disease irrespective of CD4 count.

– WHO Stage III disease with CD4 count <350/mm3

– WHO Stages I-II disease with CD4 count <200/mm

• For infants aged 1.5 yrs and above

• Stage III and IV irrespective of the CD4 count.

• Stage I and II with CD4 count less than 15 %.

• Starting HAART is rarely an emergency. However, treatment of

opportunistic infections may be an emergency.

19. a). Discuss the difference between the clinical trial

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 certificate and an ethical clearance certificate.

A clinical certificate is certificate offered to an individual or group of

individuals authorised by the authority to carry out a clinical trial after

certifying the necessary conditions before starting a clinical trial.

An ethical clearance certificate is certificate issued by any approved

institution for medical research and bearing relevant information for

conducting the clinical trial as provided under the guidelines for the

registration of a drug for the clinical trial.

b). A researcher has been authorised to carry out a clinical trial on a

certain drug what are the condition that should be fulfilled before

carrying out a clinical trial?

• Inform all person taking part in the trial or person whose animals’ will

take in the trial about.

• The aims and objectives of the clinical trial and the way it will be

conducted.

• The possible risks or discomforts and other adverse effects that may

result there from.

• Ensure in such conditions as may be prescribed from time to time by the

authority and animals or persons taking part in the clinical trial against

any injury or risk of that may be sustained during the trial.

20. Define IPT (intermittent preventive treatment), aim, gestational time

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 of administration and alternative drug for IPT.

• IPT is the administration of drug therapy at full therapeutic doses at

predetermined intervals during pregnancy even if an individual has no

signs of malaria.

AIM

• It should not be considered for chemoprophylaxis; the aim is to prevent

the worst effect of malaria infection in pregnancy rather than to cure

the potential illness.

Gestation time of administration:

• Between 20-24 weeks for the first dose and between the 28-32 weeks for

the second dose.

The alternative drug.

• Sp (sulfadoxine pyrimethamine) remain the only drug of choice though

not regarded first drug of choice for malarial treatment since it is known

to be safe in pregnancy.

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 21. Explain the management and treatment of severe malaria.

Severe malaria is an emergency medical emergency, commonly

presented with anemia and cerebral symptoms of malaria.

At home At dispensary At Health centre At Hospital level
General Pre referral General
management management management
Carry out early
Carry out early diagnosis including Carry out early
Control fever
diagnosis including blood testing of diagnosis including
with ant pyretic Administration of
blood testing of malaria which blood testing of
and fanning intra muscular
malaria which should not delay malaria which should
quinine
should not delay treatment not delay treatment
treatment Provide intravenous Provide intravenous
quinine quinine
Where meningitis
and septicemia are Treatment of
Provide pre-referral suspected hypoglycemia a
Administration of
treatment with intra antibiotics e.g. major problem to
oral ALU
muscular quinine chloramphenicol children and
should be pregnant women General management
administered health care and nursing
Correction of
Continue feeding hypoglycemia Treatment of
Immediate referral Immediate referral
and fluid intake using oral sugar complications eg.blood
with a referral with a referral
water transfusion
summary to the summary to the
Treatment of
nearest health care Control fever with nearest hospital
hypoglycemia a major
Immediate where the facilities ant pyretic and when clinical need
problem to children
referral to the for the management fanning dictates e.g. blood
and pregnant women
nearest health of severe malaria transfusion or
care facility are available Control convulsion intensive care
Lab investigation on
with diazepam
other complications

At dispensary, health care centre and hospital levels the following

assessments and resuscitation should be performed.

• Maintain airway open

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 • Pull the patient at semi prone position

• Ensure proper breathing

• Measure PR and BP

• Blood glucose estimation

• Hb estimation

• Blood slide for MPS

21. Explain the treatment of uncomplicated malaria in pregnant

women.

Malaria is a common infection among pregnant women especially the

primigravidae.

Uncomplicated malaria management.

• During the history taking and physical examination it important to elicit

signs and symptoms of severe malaria.

• Whenever malaria is suspected laboratory investigation should be

performed if possible, if laboratory facilities are not available treatment

should be started basing on the clinical presentation.

• If the laboratory results shows a negative results should not rule out

malaria.

• Quinine is safe during pregnancy in all gestational ages.

• It is the drug of choice during the first trimester for the uncomplicated

malaria treatment, during the second and third semesters ALU should be

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 used.

• Under therapeutically dosage quinine does not induce labor.

• ALU is not recommended for the treatment of malaria in pregnancy

during the first trimester of pregnancy.

22. What are the powers of the council?

• Appoint any officer or inspector to perform any duty or act on behalf

of the council as the council may determine.

• Prescribe and determine the powers and the duties of the officers and

inspector appointed to pursue the above role.

• Remove any name from the register, roll or list subject to such

conditions as the council may impose.

• Consider any matter affecting the pharmacy profession and take such

action in connection there with as the council as may consider necessary.

• Delegate any of its power to any officer, inspector or organization.

23. What do you understand about the secretariat of the council?

• From section 13 of the Pharmacy Act 2003, it is stated “there shall be the

secretariat of the council which shall consist of The Registrar, Deputy

Registrar and such other officers or staffs as the council may

determine’’

• The officers or the staffs of the council shall be the government

employees.

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• The officer of the council shall be paid allowances or remuneration as the

council may determine subject as the minister may approve.

24. Who is the registrar and what are his responsibilities?

• From section 12 of the Pharmacy Act 2003 “the minister shall appoint a

registered senior pharmacist in the public services to be the registrar for

the council.

• Shall be secretary of the council.

• Subject to this act he shall be responsible for the management and

administration of the affairs of the council.

• There shall the deputy registrar appointed by the minister who shall

assist the registrar on the day to day of activities and such other

activities as the council may determine.

25. What are the types of the registration and their conditions?
Permanent registration
Given to a pharmacist
Holder of a
pharmaceutical degree or
any other relevant
qualification being
equivalent to a
pharmaceutical degree.
A letter of passing forensic
pharmacy examination
A full academic transcript
certified by the head of an
institution or an academic
Temporary registration Provisional registration
Given Foreigners Given Intern pharmacist
Intends to be employed Holder of a pharmaceutical
in Tanzania for express degree or any other relevant
purposes qualification being
equivalent to a
pharmaceutical degree.
Practicing as a Dully completed application
pharmacist before form
entering in Tanzania and
is eligible for
registration.
Professional and general A full academic transcript
conduct and professional certified by the head of an
conduct render him fit institution or an academic
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body where he graduated
as a pharmacist
Three passport size photos
endorsed at the back by a
public notary as a true
likeness of an applicant
A cv
for registration. body where he graduated as
a pharmacist
Three passport size photos
endorsed at the back by a
public notary as a true
likeness of an applicant
A cv

A letter of completion of Completed filled and

internship from the signed contract as approved
supervisor or from the by the council for taking of
chief pharmacist. internship
Additional requirements Evidence of approve by the
or documents as the council of where the
council may determine. internship shall taken.
A fully filled PCF 1 Evidence of approval by the
council of the pharmacy or
provider where the
internship shall be
undertaken.
A subscribed fee A subscribed fee A subscribed fee

26. The council for the purpose of pharmacy practice shall prescribe

(section 38)

1. The scope of practice of a registered, enrolled, or enlisted under this act

be deemed to act pertaining to the pharmacy profession and conditions

under which services must be provided.

2. The services to be provided in various pharmacies and the conditions

under which the services shall be provided

3. Rules relating to:

Codes of conduct of pharmacist, pharmaceutical technician and

pharmaceutical assistants
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4.Good pharmacy practice

-The services under which the pharmacist may levy fees. The titles or

trading names under which a pharmacy may be conducted.

-Matters relating to investigation and inspection of pharmacy practice and

the conduct of the business of a pharmacist.

27. What are the types of permits issued by the council shall consist

of ;( section 37)

Retail

Distribution

Institutional

Any other business the council; may deem fit for the purpose of this act.

28. You are a pharmacist in a community pharmacy. How

many books of records you will need? Give the details of

each book?

The retail pharmacy superintendent shall cause records in each particulars

of the pharmacy documentation and record books:

-Ledger book or an appropriate inventory control system.

-Sales book it also referred to Prescription book (in Pharmacy Act

2011, used in retail pharmacy only) or poison book (in Poison Act

1978, used in retail pharmacy only).

-Inspection reports file complaints handling book

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 -Expired drugs register.

-Controlled drugs register (Pharmacy Act 2011) or Dangerous

drugs book (poison Act 1978) either of the books are used in

whole sale and retail pharmacy).

In addition to the above, a retail pharmacy shall maintain a dispensing

book for enabling traceability of any drug dispensed.

The whole sale pharmacy shall in addition maintain the following

records:

-Final invoices with corresponding certificates of importation.

-Recall book.

-Copies of delivery notes.

29. What are the procedures of dispensing controlled drugs such as

morphine and pethidine?

1.Check whether the prescription is signed by a licensed medical

practitioner/veterinary surgeon. And also, then check following on the

prescription:

-Dated, have patient name, age, sex and address.

-Have drug name, quantity, strength and dosage form of the drug.

-Date of dispensing.

-It should bear the official seal of the institution from which it has

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 been prescribed.

-Should contain only one drug only the controlled drug only

-The signature of the prescriber.

2.The prescription containing the controlled drug shall not be dispensed

on the 21 days lapse from the date it was issued.

3.The person dispensing the prescription has taken reasonably sufficient

steps to satisfy himself that it is a genuine prescription.

4.The dispenser has to be familiar with the signature of the prescriber

5.The drug shall not be supplied for more than once one the same

prescription provided that if the prescription so direct, the drug can be

supplied for more than once but not more than three times at interval

specified on the prescription

6.The person dispensing shall mark there on the date on which it is

dispensed and shall keep it in the premises where it is dispensed so that

it shall be available for inspection

7.Every person who supply the narcotics shall enter into a special register

drug purchasing or received or supplied on the same day following the

transaction.

8.He shall cancel or alter any entry. Any mistake shall be corrected at the

marginal note or foot note giving correct particular and date.

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30. What are the side effects of aspirin.

• Lack, bloody, or tarry stools;

• Coughing up blood or vomit that looks like coffee grounds;

• Severe nausea, vomiting, or stomach pain;

• Fever lasting longer than 3 days;

• Swelling, or pain lasting longer than 10 days; or

• Hearing problems, ringing in your ears.

Less serious side effects may include:

• upset stomach, heartburn;

• drowsiness; or

• Headache.

31. Explain the aims of the Narcotic & Psychotropic convention of

January 23rd 1972

The convention enlisted the psychotropic substances which were not

included in the previous International conventions which were highly

abused in the society which would lead to deterioration of social health

and welfare.

32．Why many antibiotic may cause diarrhea

Normal floras in the colon are interfered making room for the growth of

dangerous bacteria. Furthermore depletion of vitamin B complex causing

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the morphological deformation.

33. What is the composition of the inter-ministerial commission?

The inter-ministerial commission is composed of the followings:

-The Prime Minister who will be the Chairman of the commission.

-The Ant-drug commissioner, appointed by the United Republic of

Tanzania, will be the secretary of the commission.

-The minister for Legal affairs.

-The minister for Home affairs.

-The Minister for Health & Social Welfare.

-The Minister for Community development.

-The Minister for Foreign affairs.

-The Minister for Finance.

-The Minister for Youth developments.

-The Minister of state (Office of the Chief Minister Zanzibar).

-The Minister for Tourism (Zanzibar).

-The Minister of State and Planning (Zanzibar).

-And other members active in the drug abuse control.

-In additional: Other Ministers may be called upon to serve on the

commission in accordance with the items on the agenda.

The commission may also invite any other person to attend, if it is

deemed necessary to invite such person.

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34. Define the following terms:

a) Superintendent, b) Business, c) Pharmacy, d) Retail Pharmacy, e)

Controlled drugs, f) Drug, Medicine or Pharmaceutical products.

a). Superintendent: Means is any person who is a manager and controls

the business of a pharmacist.

b). Business: Means is a professional practice and any other activities

carried on by the person or persons in relation to products regulated

under TFDC Act 2003.

c). Pharmacy: Means registered pharmacy department in a hospital,

clinic or health centre or community pharmacy.

d). Retail Pharmacy: Means a business which consists of or includes

the retail sale of drugs products but does not include professional

practice carried by medical practitioner, dentist or veterinary surgeon.

e). Controlled drugs: Means any narcotic drug, psychotropic substance

or precursor chemicals as provided under section 77 of the TFDC Act

2003.

f). Drug, medicine or pharmaceutical product: Means any substance or

mixture of substances manufactured, sold or presented for use in:

i). The diagnosis, treatments, mitigation or prevention of diseases

disorder, abnormal physical or mental state, or the symptoms

thereof, in man or animal or,

ii). Restoring, correcting or beneficial modifications of organic or

46
 mental functions in man or animal or

iii). Disinfection in premises in which drugs are manufactured,

prepared or kept in hospitals equipment and farm houses.

iv). Article intended for use as a component of any article

specified in clause (a), (b), or (c) but does not include medical

devices or their components, parts of accessories.

Prepared& compiled By Samson Jeremiah

Intern pharmacist 2012/2013
MHN
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