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UNITED REPUBLIC OF TANZANIA

MINISTRY OF HEALTH
SIR. EDWARD COLLEGE OF HEALTH AND ALLIED SCIENCES

BASIC CERTIFICATE IN PHARMACEUTICAL SCIENCES

(NTA LEVEL4)
SEMESTER II
CONTINUOUS ASSESSMENT TEST TWO
MODULE CODE: PST04208
MODULENAME:LAWS AND ETHICS IN PHARMACY PRACTISE
ANSWER GUIDE

TIME: 2HOURS …….. JUNE

2024

GENERAL INSTRUCTIOS:
1. Read all Instructions carefully.
2. Write your examination number on each page of the answer sheet you
use.
3. Attempt all questions.
4. Cellular phones are NOT allowed in the examination room.
5. Each essay question to be answered on not more than 3
handwritten papers.
6. This paper consists of five (5) Sections.
7. The table below is for
OFFICIAL USE ONLY
SECTIO TYPEOFQUESTIONS MARKS SCORE INITI INITI
N ALLOCATIO D AL AL
N MARKS SIGNATURE SIGNATURE
OF OF
EXAMINATI EXAMINATI
ON MARKER ON
A MULTIPLE CHOICE 10
B MULTIPLE 10
TRUE/FALSE
C MATCHING ITEMS 10
D SHORT ANSWER 40
E GUIDED ESSAY 30
TOTAL 100

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SECTION A: MULTIPLE CHOICE QUESTIONS (10 MARKS)

INSTRUCTIONS:
 This section consists ten (10) items
 One(1) mark will be awarded for each correct answer
1. Answer item one(i) to ten(x) by choosing the letter of the most correct answer and write it in the
box provided using CAPITAL letters
i. Optimum conditions for sorting unfit medicines and cosmetic products include the
following EXCEEPT;
A. Sorting should be done in an open building
B. Sorting should be done as close as possible to the stockpile
C. Staff supplied with protective equipment should work under the direct supervision of a
Drug inspector.
D. Once sorted, the pharmaceuticals should be carefully packed into steel drums
E. The materials should be kept in a dry secure and preferably separate room to
avoid being confused with expired pharmaceuticals
ii. Which of the following concentration of Lignocaine is provided at a dispensary level?
A. Lignocaine –injection (hydrochloride) 1% in 10mls vials
B. Lignocaine jelly (hydrochloride) 5% in 30mg tube
C. Lignocaine – injection ( hydrochloride) 2% in 2mls vials
D. Lignocaine in dextrose –injection (hydrochloride) 5% in 2mls
E. Lignocaine –injection (hydrochloride) 2% with adrenaline:100,000 in 2ml ampoule for
dental use

iii. Which one of the following antibiotics is chiefly supplied at the highest level of health care
services in Tanzania?
A. Clindamycin capsule 150mg
B. Cloxacillin powder for injection (as Sodium salt) 250mg vial
C. Co-trimoxazole tablets 480 mg
D. Ciprofloxacin tablets 250mg, 500mg
E. Ceftriaxone injection 250mg, 500mg, 1g in vial

iv. What is the name of disposal method where untreated waste medicine and cosmetic are
placed into an uncontrolled, non-engineered open dump?
A. Engineered landfill
B. Highly engineered landfill
C. Inertization
D. Encapsulation
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E. Landfill for untreated waste

v. Which of the following analgesics is supplied at dispensary level?

A. Diclofenac tablets 100mg (slow release)
B. Tramadol tablets 50, 100mg
C. Piroxicam capsules 10mg
D. Allopurinol tablets 300 mg
E. Ibuprofen tablets 200mg

vi. The following are roles of pharmaceutical dispenser in ensuring rational use of drugs
EXCEPT
A. Appropriate distribution of drug
B. Appropriate interpretations of medicine prescription
C. Appropriate procurement of drug
D. Drug production
E. Information giving to patients

vii. Antineoplastics are best disposed off by

A. Flushing into water sources
B. High temperature incineration
C. Open space dump
D. Recycle
E. Burning in open air

viii. It is acceptable to discharge liquid pharmaceuticals, diluted or not ,into:

A. Slow moving or water fall
B. Slow moving or fast moving water
C. Slow moving or warier surface water
D. Slow moving or drinking water source
E. Slow moving or stagnant water
ix. Substandard medicines means
A. A medicine that do not meet the quality specifications
B. A medicine that contains a wrong active ingredient
C. A medicine that contains no active ingredient
D. A medicine that is contaminated
x. Which one of the following is a role of a pharmaceutical dispenser?
A. Participate in therapeutic committee
B. Promotion of medicines and medical supplies
C. Formulation of any medicines
D. Promotion of public health
E. Supervision of pharmaceutical assistant

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E. An expired medicine

SECTION B: MULTIPLE TRUE/FALSE QUESTIONS (20 MARKS)

 This section consist of eight ( 8 ) questions with five(5) options each
 Write the word TRUE for correct statement and the word FALSE for incorrect statement in the
space provided after each option.
 All responses should be in CAPITAL letters
 Half (0.5) mark will be awarded for each correct response
 Responses with letters T and F will not be awarded any mark
 Answer all the questions

2. Important information in the disposal form of unfit medicines

A. FALSE Reference number
B. TRUE Method of destruction used
C. FALSE Name and signature of Director General
D. TRUE Name and signature of the owner
E. FALSE Name of the products(Generic name and trade name)

3. Health care delivery system may have different medicines depending on the capacity of health
facility
A. TRUE In special hospitals, Clindamycin is used as antibacterial agents
B. FALSE Morphine narcotic are used at dispensary level
C. FALSE Albendazole tablets are restricted to specialized hospital level
D. FALSE Ergotamine tartrate is a drug of choice at health centers
E. TRUE Artementher-Lumefantrine is supplied at dispensary level

A. TRUE The permit should be given only to the premises in respect of which the
application relates shall be stored, meets the prescribed standards

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4. Important information in the Register book of unfit medicines and cosmetic products
A. FALSE Trade name only of the product
B. TRUE Pack size
C. FALSE Reference number
D. FALSE Date of issue
E. TRUE Total weight in Kilogram

5. The sorting process of unfit medicines and cosmetic products includes:

A. TRUE Identifying each item;

B. TRUE Making a decision on whether it is unusable;
C. TRUE If usable, leaving packaging intact;
D. FALSE leaving packages and boxes un intact until reaching their location,
E. TRUE Transport to an institution for use

SECTION C: MATCHING ITEMS: (10 MARKS)

INSTRUCTIONS:
 This section consists of two questions of matching with five (5) options each
 Match the items from column B with those in column A by writing a letter of the correct response
in the table provided after each question
 Each correct response will be awarded one (1) Mark.

6. (A) Match the categories of pharmaceutical products from COLUMN B with their corresponding
disposal methods from COLUMN A by writing the letter of the correct responses in the table
below

COLUMN A COLUMN B
(Disposal methods) (Categories of pharmaceutical products)
i. High temperature A. Disinfectants
incineration B. Solids, semi-solids and powders
C. Aerosols and inhalers
ii. Landfill without waste
D. PVC plastics and glass
inertization
E. Antibiotics
iii. Sewer or fast flowing water F. Antineoplastic and controlled substances
course G. Paper and cardboard

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iv. Landfill and recycling

v. Landfill and waste
immobilization

ANSWERS:

COLUMN A i. ii. iii. iv. v.

COLUMN B F C A D B

(B) Match the different level of health care system from COLUMN B with their appropriate
medicines from COLUMN A by writing the letter of the correct responses in the table below

COLUMN A COLUMN B
(Medicines) (Levels of Health Care System)
i. Mefenamic acid: tablet A. Medicines used at Council Hospital level and Regional
500mg Levels
B. Medicines used at Dispensaries level
ii. Ergotamine tartarate:
C. Medicines used at Zonal Referral, National and Special
tablet 2mg
Hospitals
iii. Diclofenac gel D. Medicines used at Health Centers level and National
hospital
iv. Colchicum: tablet 0.5mg E. Medicines used at Council Hospital level
v. Lignocaine injection 2% in F. Medicines used at Health Centres level
2ml vial G. Medicines used at Regional Referral Hospitals and
Referral Hospital, at Regional Levels

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ANSWERS:

COLUMN A i. ii. iii. iv. v.

COLUMN B E G B C F

SECTION D: SHORT ANSWER QUESTIONS (40 MARKS)

INSTRUCTIONS:
 This section consists of five (5) questions.
 Answer all questions on the space provided

7. Mention six (6) features of medicines and cosmetics products which are considered as unfit
(6marks)
 Expired
 Improperly sealed
 Damaged, unexpired and improperly stored
 Improperly labeled
 Counterfeit, substandard and adulterated
 Prohibited
 Unauthorized

8. Prepare a format of the register book of unfit medicine and cosmetic products (5marks)

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S/N Name of a Strength Dosage Pack quantity Batch Value

product where form size number (TZs)
Trade Generic applicable
name name

9. Define the following terms (3marks)

i) Storage of medicines and medical supplies
 Storage means putting and safe keeping of medicines and medical supplies up to the
point of use
ii) Good storage practices
 Means part of quality assurance that ensures that the quality of pharmaceutical products
is maintained by means of adequate control throughout the storage thereof
iii) Distribution of medicines and medical supplies
 Business of dealing in human medicines or medical devices in bulk or wholesale but
does not include importers of human medicines, medical devices, food, cosmetics and
veterinary medicines

10. Mention four (4) personnel who are involved in destruction process of unfit medicines and
cosmetic products (4marks)
 Health Officer
 Environmental Officer
 Policeman
 Drug Inspector
 Owner/witness/superintended (pharmacist in-charge) of the business.

11. With one example for each, enumerate three sorting categories of unfit medicines and cosmetic
products (3marks)
 Sorted by expired or unwanted pharmaceuticals eg. All expired pharmaceuticals, All
unsealed syrups or eye drops (expired or unexpired)
 Sorted by active ingredient eg. Controlled substances; e.g. narcotics, psychotropic
substances, Anti-infective drugs
 Sorted by dosage form eg. Solids, semi-solids and powders, liquids, Aerosol canisters

12. List eight (8) important information in the application form for disposal of unfit products (8marks)
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 Form number
 Postal address of TFDA
 Postal address of the applicant
 Specification of type of business of the applicant
 Type of products to be disposed
 License number
 Date of issue
 Location of business
 Name of in-charge and registration number
 Reason for disposal
 Weight of the total products in Kg
 Value of the total products in Tshs
 Declaration by the applicant
 Name of the receiving officer, signature and official stamp.

13. Outline five (5) hazards associated with improper disposal of unfit medicines and cosmetic
products (5marks)
 Contamination of drinking water.
 Non-biodegradable antibiotics, antineoplastics and disinfectants may kill bacteria necessary
for the treatment of sewage.
 Burning medicines and cosmetics at low temperatures or in open containers results in
release of toxic pollutants into the air
 Inefficient and insecure sorting and disposal may allow medicines and cosmetics beyond
their expiry dates to be diverted for resale to the general public.
 In the absence of suitable disposal sites, if stored in their original packing there is a risk of
diversion

14. Enumerate six(6) procedures of sorting process of unfit medicines and cosmetic products (6marks)
 Identifying each item
 Making a decision on whether it is usable
 If usable, leaving packaging intact
 If not usable, making a judgement on the optimal method of disposal and sorting
accordingly
 Leaving packages and boxes intact until reaching their location, prior to definitive disposal
or
 Transport to an institution for use

SECTION E: ESSAY QUESTIONS: (30 Marks)

Instructions:
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 This section consist of TWO (2) questions

 Answer all questions.

15. Describe in detail eight (8) requirements for proper management of unfit medicine and cosmetics
products at facility level.
Definition (unfit medicines and cosmetic products) – 2 marks
Main body ([email protected])
 Maintain a register book (Annex I) for unfit medicines and cosmetic products
 Keep them into different categories by dosage form such as:- Solids, semi-solids and
powders: capsules, powders for injection, tablets and Liquids: Solutions, suspension,
syrups, mixtures, lotions, aerosol, inhalers
 Keep separately medicines which fall under controlled drugs, antineoplastics, antibiotics
and any other hazardous medicines or cosmetic products.
 Keep in containers according to their dosage forms to facilitate verification exercise,
sorting and selection of disposal method
 Demarcate an area for keeping containers of unfit medicines and cosmetic products which
shall be labeled conspicuously with words: Expired medicines, Not for Sale, Unfit
medicines – Not for sale in red ink
 Maintain safe custody of unfit pharmaceutical products in registered premises until they are
disposed off to avoid pilferage
 The decision of when to initiate disposal of unfit medicines and cosmetic products shall be
made by regional, district or hospital pharmacist, owners, in-charge of facility, dispensers,
and inspectors to avoid accumulation of products.
 Application for disposal of unfit medicines from Government institutions shall be
accompanied by an approval from Accountant General declaring that the product have been
written off

Conclusion (1 marks)
16. Describe the Procedures for Application to Dispose off Unfit Medicines and Cosmetic
products (15 marks)
 Any person who intends to dispose off unfit medicines or cosmetic products shall
adhere to the following procedures:
 Request in writing to the Director General of TMDA by using application for (Annex
II) which is available at TMDA headquarter offices, TMDA zone offices, Regional
and District Medical officer‘s offices and TMDA website: www.tfda.ac.tz.
 A request shall be accompanied with a list of products to be disposed of and should
state clearly trade name, generic name and strength (where applicable), dosage form,
pack size, quantity, manufacturer, batch number and market value of product.
 Once the request has been received by TMDA, the Authority shall acknowledge and
inform the applicant through a letter to contact Directorate of Medicines and
Cosmetics to arrange or TMDA zone offices for verification of the product. In case of
regions where there are no TMDA zone offices, applicant shall be informed to contact
the Regional or District Medical officer‘s offices for the same.
 TMDA-HQ or TMDA zone office/Regional/District Medical officer‘s offices shall
send inspectors to the premises to verify and authenticate the information submitted.
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WISHING ALL THE BEST

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