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PHARMACYBOARDOFMALAYS~

· MINISTRY OF HEALTH MALAYSIA

QUALIFYING EXAMINATION TO PRACTISE PHARMACY

DATE 8TH JUNE 2016


TIME 9.00 A.M -12.30 P.M (THREE AND HALF HOURS)

This booklet contains;

100 Multiple Choice Questions

Instructions to candidates:

1. Candidates are required to answer all questions.


2. Candidates are allowed to refer to relevant acts/regulations, Code of Conduct
for Pharmacists and Bodies Corporate 2009, references regarding Malaysian
National Medicines Policy [Dasar Ubat Nasional (DUNas)], Good Governance
of Medicine (GGM)
3. Please use pencil and choose only one answer for each question.

DO NOT READ THE QUESTIONS UNTIL FURTHER ANNOUNCEMENT

l All rights reserved. No part of this examination paper may be reproduced,


stored in a retrieval system, or transmitted in any form or by any means,
electronic, mechanical, photocopying, recording or otherwise, without the
prior permission of Pharmacy Board Malaysia.

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1. According to the Registration of Pharmacists Act 1951 and its regulations, the
Minister need not seek the advice or consultation of the Pharmacy Board
regarding the

A registration of a provisionally registered pharmacist having a


qualification in pharmacy other than the qualifications specified under
Schedule 1.
B. imposition of restrictions and conditions on any person provisionally
registered under paragraph 6(1)(b).
C. postponement from commencing of the public service of a fully
registered pharmacist.
D. amendment of the Second Schedule by order published in the Gazette.

2. The following statement is TRUE of a body corporate:

I. A registered pharmacist shall be a superintendent of a body corporate


at any time.
II. The Minister shall issue a certificate of registration to the body
corporate.
Ill. It may appeal to the Minister if it is the aggrieved by any of the
punishments imposed by the Board
IV. If it fails to obtain an annual certificate for the coming year, its name will
be struck out from the register without any recourse to an appeal.

A. I and II only
B. I and Ill only
C. Ill and IV only
D. None of the above

3. Regarding the Poisons Act 1952, a Drug Enforcement Officer may

I. include any licenced pharmacist in the private sector.


II. be authorized through a verbal instruction by the Director General of
Health.
Ill. examine orally any person supposed to be acquainted with the facts of
the commission of any offence under the Act.
IV. enter a premise where an offence has been committed.

A I and II only
B. II and IV only
C. Ill and IV only
D. All of the above

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4. For the manufacture of any psychotropic substance:

A. A "Manufacturing Register For Psychotropic Substance~~ shall be kept


and maintained.
B. The register must be preserved for a period of 24 months from the date
of the last entry in such register.
C. Without a prior written notice, a prohibition may be issued via an order
by the Minister if a registered pharmacist responsible for manufacturing
is suspected to handle psychotropic substances in an irresponsible
manner.
D. The word "Poison" in Bahasa Malaysia, English, Chinese and Tamil
shall be printed in red to a container which is enclosed in an unbroken
case or package as received from any manufacturer of the
psychotropic substance outside Malaysia.

5. According to the Sale of Drugs Act 1952 and its regulations, medicinal
purpose includes·

I. diagnosis of a disease.
II. relieving pain.
Ill. anaesthetic.
IV. arbotifacient.

A. I, II and Ill only


B. I, II and IV only
C. II and Ill only
D. All of the above

6. According to the Sale of Drugs Act 1952 and its regulations regarding
cosmetics, an exemption may be applied for

I. selling a manufactured notified cosmetic which is slightly contaminated.


II. recall of a notified cosmetic having serious or high incidences of
adverse events.
Ill. manufacturing a cosmetic by a school of pharmacy for teaching and
research purposes.
IV. importing of a cosmetic for assessing the market acceptance.

A. I and II only
B. Ill only
C. Ill and IV only
D. All of the above

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7. According to the Medicines .(Advertisement And Sale) Act 1956 and its
regulations, an "authorized officer"

A. may conduct the prosecution in respect of offences committed under


this Act and its regulations.
B. is authorized in writing by the Director General of Health.
C. may by order in writing require the attendance before himself of any
person who lives within a 15 kilometer radius, and who appears to be
acquainted with the circumstances of the case.
D. may report to the Medicine Advertisements Board any person who
refuses the request for attendance before himself by an order in
writing.

8. The following statement is TRUE of members of the Medicine Advertisements


Board :

I. Seven are appointed by virtue of their positions.


II. A pharmacologist in the private sector may be appointed.
Ill. A physician in the public sector may be appointed.
IV. A temporary member may be appointed by the Chairman of the Board.

A. I and II only
B. II and Ill only
C. Ill and IV only
D. None of the above

9. According to the Dangerous Drugs Act 1952 and its regulations, manufacture
of a drug or drug preparation includes the act of

I. producing.
II. transforming.
Ill. compounding.
IV. refining.

A. I and II only
B. II and Ill only
C. Ill and IV only
D. All of the above

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10. The following statement is TRUE of the Register under the Dangerous Drugs
Act 1952 and its regulations:

I. The required entry must be made on the day in which the drug or
preparation is transacted without any delay allowed.
II. A registered dentist who enters details of the transaction in a day-book
and a reference in a separat~ book is exempted from keeping the
Register as set out in the Second Schedule.
Ill. A licenced retail seller of Part I Poisons may enter in the Register a
reference of the transaction as in the Prescription Book.
IV. The master of any ship may enter in the ship's official log book.

A. I, II and Ill only


B. I and IV only
C. II, Ill and IV only
D. Ill and IV only

11 . For Malaysia, the Good Governance for Medicine (GGM) initiative is most
closely related to the

A. National Integrity Plan.


B. National Unity Plan.
C. Government Transformation Programme.
D. Eleventh Malaysia Plan.

12. According to the Good Governance for Medicine (GGM) initiative, the
following statement is TRUE of weaknesses related to any drug selection
committee of hospital:

I. No written guidelines on conflict of interest regarding the selection of


rational drugs.
II. Membership is not time-limited.
I i! Ill. The committee membership only includes experts from medicine and
pharmacy field.
IV. The criteria do not require committee members to declare any conflict
of interest issues.

A. I and II only
B. II and Ill only
C. Ill and IV only
D. All of the above

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13. The following statement is TRUE of strategies to ensure fair access to
medicines according to the Malaysian National Medicines Policy:

I. A transparent medicines selection mechanism in accordance with the


country's health needs by emphasizing on clinical effectiveness and
cost-effectiveness of treatments.
II. An efficient and effective procurement mechanism and supply chain
network of quality medicines.
Ill. An efficient financing management mechanism for optimizing health
outcomes to ensure value for money
IV. Minimising the availability of orphan medicines due to their high cost.

A. I, II and Ill only


B. I, II and IV only
c. II, Ill and IV only
D. All of the above

14. The following statement is TRUE of Responsibility for Standards of


Professional Practice of a pharmacist:

I. Provide accurate and current information for which they are qualified in
their area of competence and within their scope of practice.
II. Aware of the limitations of their knowledge and skills and refer patients
to appropriate health care professionals when they are unable to meet
the needs of their patients.
Ill. Establish personal relationship with the patient as a moral obligation.
IV. Respect the autonomy of patients with diminished competence in
decisions regarding their health.

A. I, II and Ill only


B. I; II and IV only
C. II, Ill and IV only
D. All of the above

15. With reference to the Code of Conduct for Pharmacists and Bodies Corporate,
the following act is considered derogatory to the reputation of the profession:

A. Prioritising respect for human life


B. Personal misuse of alcohol
C. Declaring conflict of interest with clients
D. Maintaining decency when dealing with patients

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16. Any amendment to the Poisons List shall be made by the

A. Director General of Health after consultation with the Minister.


B. Poisons Board after consultation with the Director General of Health.
C. Poisons Board after consultation with the Minister.
D. Minister after consultation with the Poisons Board.

17. A licenced pharmacist shall maintain a Prescription Book when he sells

I. Diphenhydramine Syrup with a prescription.


II. Dihydrocodeine Tablets with a prescription.
Ill. Ampicillin Capsule with a prescription.
IV. Naproxen Tablets without prescription.

A. I and Ill only


B. I, Ill and IV only
C. II and m·only
D. All of the above

18. The following is an offence under Regulation 18A(1) Control of Drugs and
Cosmetics Regulations 1984:

I. Possession for the purpose of sale of a cosmetic that is not notified


II. Sale by retail of a notified cosmetic without a valid license
Ill. Sale by retail of a cosmetic that is not notified
IV. Manufacture of a cosmetic that is not notified

A. I, II and Ill only


B. I and Ill only
C. I, Ill and IV only
D. All of the above

19. Persons appointed under the Sale of Drugs Act 1952 include:

I. Officer
II. Inspector
Ill. Drug Enforcement Officer
IV. Analyst

A. I and II only
B. I, II and IV only
C. II and Ill only
D. All of the above

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20. An Authorized Officer under the Medicines (Advertisement And Sale) Act
1956 may;

I. search and examine any premise at all reasonable time.


II. remove any prohibited medical advertisement.
Ill. examine orally any person supposed to be acquainted with the facts
and circumstances of the case.
IV. arrest any person suspected of contravening the law.

A. I and II only
B. I, II and Ill only
C. Ill and IV only
D. All of the above

21. The following statement is TRUE regarding the Medicines (Advertisement and
Sale) Act 1956 and its regulations:

I. The control of advertisement on a traditional medicine to treat diabetes


is not under this Act.
II. An advertisement, which is approved by the Medicine Advertisements
Board, shall be given a serial number according to the medium of
advertisement and the year in which approval is issued.
Ill. No sanction is required to conduct prosecution for offences
· IV. The Minister may authorize in writing any pharmacist in public service
to exercise the power of an authorized officer.

A. I, II and Ill only


B. I, Ill and IV only
C. II and IV only
D. All of the above

22. The sale and supply of the following is under the control of the Dangerous
Drugs Act 1952 and its regulations:

I. Unregistered Dihydrocodeine tablets


II. Codeine Phosphate Powder
Ill. Registered Methadone syrup
IV. Unregistered Cocaine Guttae

A. I and II only
B. I, II and IV only
C. II and IV only
D. All of the above

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23. The following form or preparation of codeine sulphate is classified as a
dangerous drug:

I. Powdered form
II. Unregistered product
Ill. Flavoured syrup
IV. Registered product

A. I, II and Ill only


B. I, II and IV only
C. I, Ill and IV only
D. All of the above

24. With reference to the Registration of Pharmacists Act 1951 and its
regulations, the investigation on a complaint against a registered pharmacist
received by the Secretary of the Pharmacy Board is conducted by the

I. Pharmacy Board.
II. Committee of Inquiry appointed by the Pharmacy Board.
Ill. Inspector appointed under Section 21 of the Act.
IV. Disciplinary Committee of the Pharmaceutical Service Division.

A. I and II only
B. I, II and IV only
C. Ill and IV only
D. None .ofthe above

25. With reference to the Registration of Pharmacists Act 1951 and its
regulations, the following statement is TRUE regarding a Provisionally
Registered Pharmacist:

I. A Provisionally Registered Pharmacist is deemed to be a public


servant.
II. There is no fee for provisional registration.
Ill. The Minister may amend the Second Schedule by order published in
the gazette.
IV. The Board may extend the period of employment for not more than 2
years.

A. I and II only
B. I, II and Ill only
C. I and Ill only
II D. All of the above

I i

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26. The Poisons (Psychotropic Substances) Regulations 1989 control substances
as listed in the ·

I. Third Schedule of the Poisons Act 1952.


II. Third Schedule of the Dangerous Drugs Regulations 1952.
Ill. Part Ill of first Schedule of the Dangerous Drugs Act 1952.
IV. Second Schedule of the Poisons (Psychotropic Substances)
Regulations 1989.

A. I only
B. I, II and Ill only
C. I and IV only
D. II and Ill only

27. The import authorization is required under the Dangerous Drugs Act 1952 for
the following item

I. Codeine tablet
II. Pethidine injection
Ill. Tramadol tablet
IV. Diphenoxylate tablet

A. I and II only
B. I, II and IV only
C. Ill and IV only
D. All of the above

28. Alprazolam tablet may be sold or supplied

I. for purpose of medical treatment.


II. by a registered dentist Division II.
Ill. by a pharmacy assistant in a private hospital.
IV. by a licenced pharmacist upon a prescription.

A. I and II only
B. I, Ill and IV only
C. I and IV only
D. II and IV only

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29. Prevention of cancer advertisement is prohibited except by any

I. person authorized by the Minister.


II. governing body of a private hospital.
Ill. registered body corporate governed by any local council.
IV. a private medical practitioner.

A. I only
B. I and Ill only
C. II and IV only
D. All of the above.

30. The Drug Control Authority may issue the following licence:

I. Import licence
II. Clinical trial import licence
Ill. Manufacturer's licence
IV. Wholesaler's licence

A. I and II only
B. I, Ill and IV only
C. II only
D. None of the above

31 . T he following provision of the Control of Drugs and Cosmetics Regulations


1984 relates to the requirement of the importation of a registered product.

I. Regulation 7(1)(b)
II. Regulation 12(b)
IIIII Ill. Regulation 12(d)
IV. Regulation 21(1)

A. I and II only
B. I and Ill only
C. I, Ill and IV only
D. Ill and IV only

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32. The following person may investigate the contravention of section 3(1) of the
Medicines (Advertisement and Sale) Act 1956

I. An authorized officer
II. A Drug Enforcement Officer
Ill. A registered pharmacist in public services
IV. Any offi~r of the Ministry of Health

A. I only
B. I and Ill only
C. II and IV only
D. All of the above

33. A licenced pharmacist shall maintain a Prescription Book when he supplies

I. Acyclovir capsule as a dispensed medicine.


II. Salbutamol tablet to a private hospital.
Ill. Salmeterol powder to be used in animal feeds.
IV. Betamethasone Cream upon prescription.

A. I only
B. I, II and Ill only
C. I and IV only
D. None of the above

34. The following substances may be supplied as a dispensed medicine

I. Diazepam
II. Sulphinpyrazone
Ill. Oxyphenbutazone
IV. Nimetazepam

A. I and II only
B. I and IV only
C. II, Ill and IV only
D. All of the above

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35. The supply of the following poison shall be recorded in Poisons Wholesale
Sales Book

I. Methadone Syrup dispensed by a registered pharmacist


II. Prednisolone Tablet supplied by a licenced pharmacist to a private
medical practitioner
Ill. Atenolol tablet by a licenced pharmacist upon prescription
IV. Hydrochloric Acid more than 21 % w/w to a professional person or
tradesman for the purpose of such person or tradesman profession.

A. I, II and Ill only


B. II only
C. II and IV only
D. IVonly

36. A notification note issued by the Director of Pharmaceutical Services is


required for a notified cosmetic to be

I. imported.
II. exported.
Ill. manufactured.
IV. supplied by wholesale.

A. I and II only
B. I and Ill only
C. I, Ill and IV only
D. II and IV only

37. A written approval by Director Pharmaceutical Services authorises cosmetic


to .be

I. imported by a parcel post for one month's use.


II . imported as a part of a personal luggage.
Ill. imported for assessing market acceptance.
IV. supplied in the international carriage by aircrafts.

A. I and II only
B. I, II and Ill only
C. Ill and IV only
D. All of the above

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38. Manufacture, in relation to a dangerous drug includes:

I. The making, producing, compounding and assembling of the drug


II. The making, producing, compounding and assembling a preparation of
a drug
Ill. The refining or transformation of the drug into another dangerous drug
IV. Any process done in the course of the foregoing activities

A. I and Ill only


B. I, II and Ill only
C. II and IV only
D. All of the above

39. Any breach of the ·Code of Conduct for Pharmacists and Bodies Corporate
2009 shall be deemed in opinion of the Board as misconduct of a

I. Licenced pharmacist
II. Registered pharmacist
Ill. Superintendent
IV. Registered body corporate

A. I and II only
B. II only
C. Ill and IV only
D. IVonly

40. With reference to the Code of Conduct for Pharmacists and Bodies Corporate
2009, abuse of professional privileges and skill refer to

I. accountability.
II. compliance of policy.
Ill. abuse of confidence.
IV. undue influence.

A. I and II only
B. I, Ill and IV only
C. Ill only ·
D. All of the above

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41. The following statement is TRUE regarding dangerous drugs:

I. Importation requires an Import Authorization


II. Dangerous drugs may be possessed and supply by a pharmacy
assistant at government hospital
Ill. Any dangerous drug which is imported shall be recorded into Day Book
and Separate Book Dangerous Drug
IV. The supply of Methadone Syrup for medical treatment _shall comply to
the Poisons (Psychotropic Substances) Regulations 1989

A. I and II only
B. I and IV only
C. II, Ill and IV only
D. All of the above·

42. Where any poison is sold or supplied as a dispensed medicine, or as an


ingredient in a dispensed medicine, the container of such medicine shall be
labelled, in a conspicuous and distinct manner, with

I. the name and address of the supplier or seller.


II. the name of the medicine and adequate directions for the use of such
Medicine.
Ill. the date of manufacturing and expiration of such medicine.
IV. a reference to the serial number where such medicine is sold or
supplied and entered in a prescription book.

A. I and II only
B. I, II and IV only
C. II and Ill only
D. All of the above

43. The Public Prosecutor may authorize in writing such persons to conduct
prosecutions in respect of offences under the Poisons Act 1952:

I. Drug Enforcement Officer


II. Any registered pharmacist in the public service
Ill. Licenced pharmacist
IV. Any health officer

A. I and II only
B. I, II and Ill only
C. II, Ill and IV only
D. All of the above

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44. Every prescription for any psychotropic substance prescribed by a registered
medical practitioner, registered dentist Division I, or veterinary surgeon shall

I. be in writing, signed and dated by the prescriber.


II. state the full name, address and telephone number of the prescriber.
Ill. state the age, full name and address of the patient.
IV. indicate ~he total amount of psychotropic substance to be supplied and
the dose.

A. lonly
B. I, II and Ill only
C. II and Ill only
D. All of the above

45. Under the relevant pharmacy legislations, the following persons shall keep
and maintain a register to be called the "Register of Psychotropic Substance
Received, Delivered or Administered".

I. A registered medical practitioner


II . A person engaged in the delivery of any psychotropic substance
Ill. An officer of Customs when acting in the course of his duty
IV. A Drug Enforcement Officer

A. I and II only
B. I and Ill only
C. Ill and IV only
D. All of the above

46. The Minister may make regulations under the Sale of Drugs Act 1952 for the
following purpose to

I. prescribe the standard of strength, quality or quantity of any drug.


II. prohibit the addition of any specified thing to any drug.
Ill. prohibit any modes of preservation of any drug.
IV. dispensing of any drug.

A. I, II and Ill only


B. I and Ill only
C. II and IV only
D. All of the above

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47. The following person may investigate the commission of any offence under
the Sale of Drugs Act 1952 and its regulations:

I. Officers and Inspectors


II. Drug Enforcement Officer
Ill. Authorized Officer
IV. Senior Customs Officer

A. I only
B. I and II only
C. II only
D. II, Ill and IV only

48. Under the Control of Drugs and Cosmetics Regulations 1984, the Director of
Pharmaceutical Services may issue written such directives or guidelines to
any person or a group of persons which in particular relate to

I. product quality, safety and efficacy.


II. change of particulars of a product.
Ill. product cost and sales outlet.
IV. product retailing price.

A. I and II only
B. I, Ill and IV only
C. II and Ill only
D. All of the above

49. Under the Control of Drugs and Cosmetics Regulations 1984, a register of the
products registered, kept and maintained by the Secretary shall contain

I. batch number of the product.


II. the name and address of the manufacturer.
Ill. the standard packages and price of the product.
IV. the content and quantity of the active ingredients.

A. I and tl only
B. II and IV only
C. I, II and Ill only
D. All of the above

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50. The following statement is true regarding the restriction on use of certain titles
under the Registration of Pharmacists Act 1951 :

I. No person shall use the name or title of pharmacist unless he is


registered under this Act.
II. No person shall affix to his premises any title reasonably calculated to
suggest that he possesses any qualification with respect to the
compounding of drugs other than the qualifications which he in fact
possesses.
Ill. The use of the description "pharmacy" in any premises shall be
deemed to imply that the owner of the business in those premises is
registered under this Act.
IV. Any medical practitioner and veterinary surgeon registered under any
written law in Malaysia may use and affix the word "pharmacy" in their
business premises.

A. I and Ill only


B. I, II and Ill only
C. II and IV only
D. All of the above

51. The following persons shall be the members in the establishment and
constitution of the Pharmacy Board:

I. The Health Minister


II. The Director General of Health
Ill. The Director of Pharmaceutical Services.
IV. Two registered pharmacists not in the public service, appointed by the
Director General of Health

A. l .and II only
B. II and Ill only
C. II, Ill and IV only
D. All of the above

52. Under the Registration of Pharmacists Act 1951, the Board may make
regulations for and in respect of all or any of the following matters:

I. The pupillage, the conditions under which the practical training of


apprentices or students shall be conducted and any other matter
relating to the training and qualification of pharmacists.
II. The examination prescribed or set by the Board to be passed by any
person before he is eligible to apply to be admitted to the register under
this Act.
Ill. The establishment of a Committee of Inquiry to inquire into complaints
or information regarding any matters which the Board may inquire.
IV. The registration of bodies corporate.

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A. I and II only
B. I, II and Ill only
C. II , Ill and IV only
D. All of the above

53. The following statement is TRUE regarding power of investigation and


prosecutions of any offences under the Medicines (Advertisement and Sale)
Act 1956 and its regulation.

I. Drug Enforcement Officer may investigate the commission of any


offences and conduct prosecutions.
II. Authorized officer may investigate the commission of any offences.
Ill. Officers and inspectors may investigate and conduct prosecutions.
IV. Authorized officer may conduct prosecutions.

A. I only
B. II, Ill and IV only
C. II and IV only
D. All of the above

54. The following person may conduct prosecution in respect of any offences
under the Dangerous Drugs Act 1952 and its regulation.

I. Drug Enforcement Officer


II. Any police officer not below the rank of Sub-Inspector
Ill. Any senior officer of customs
IV. Any officer of customs authorized in writing by Minister

A. I and II only
B. II and Ill only
C. II, Ill and IV only
D. All of the above

55. Quality Use of Drugs shall be achieved by promoting rational prescribing and
II appropriate use of medicines by consumers through

I. training and education.


II. provision of independent, evidence-based drug information.
Ill. establishment of therapeutic committees, development of standard
treatment guidelines and standards of professional practice.
IV. ethical promotion of drugs and provision of relevant legislations.

A. I and II only
B. II and Ill only
C. Ill and IV only
D. All of the above

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56. The following statement are the Objectives Of The Good Governance For
Medicine Programme (GGM):

I. To inculcate and enhance integrity among pharmacist dealing in all


areas involved in pharmaceuticals industries
II. To promote transparency, accountability and ethical practices among
health professionals in pharmaceutical sector
Ill. To raise ·awareness of the potential for corruption in the pharmaceutical
Sector
IV. To promote and implementing good business competition and profit
making among the owners of the pharmacy outlet

A. I and II only
B. I, II and Ill only
C. II and Ill only
D. All of the above

57. The following statement is TRUE regarding the requirement for the
importation of cosmetic:

I. The importer shall be the person responsible for placing the notified
cosmetic in the market or a person authorized in accordance with the
notification note.
II. The cosmetic shall be notified with the Drug Control Authority.
Ill. The importer shall have an import licence issued under the Control of
Drugs and Cosmetics Regulations 1984.
IV. The importer shall have a licence issued under the Poisons Act 1952.

A. I only
B. I, II and IV.only
C. II and Ill only
D. All of the above

58. Under the Control of Drugs and Cosmetics Regulations 1984, the following
activity requires a written approval by the Director of Pharmaceutical Services:

I. To manufacture any cosmetic for the purpose of export only


II. To import any product to be assembled, enclosed, packed or labelled
for the sole purpose of re-exporting the product ·
Ill. To import any product for assessing the market acceptance
IV. To import, as part of his personal luggage, any product meant solely for
his use, in quantity not exceeding for one month's use

A. I and II only
B. I, Ill and IV only
C. Ill and IV only
D. All of the above

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59. The following person may be exempted from the requirement of an import
licence under the Control of Drugs and Cosmetics Regulations 1984:

I. A person who imports a product in order to obtain samples for purpose


of registration.
II. A person who imports a product solely for the purpose of treatment of a
person suffering from a life-threatening illness.
Ill. An· officer of the Government importing any product in the course of his
duty.
IV. A person who imports a product for market acceptance.

A. I and II only
B. I, II and Ill only
C. Ill and IV only
D. All of the above

60. Under the Control of Drugs and Cosmetics Regulations 1984, a licenced
manufacturer shall

I. establish a quality control department under the supervision of a


registered pharmacist.
II. conduct regular inspection of his manufacturing and quality control
activities.
Ill. ensure all measuring equipment are regularly calibrated.
IV. maintain a proper record for every batch of finished registered product.

A. I and II only
B. I, Ill and IV only
C. II , Ill and IV only
D. All of the above

61. The following is a requirement under the Dangerous Drugs Regulations 1952,
regarding a registered product containing Pholcodeine:

I. The related records shall be preserved for a period of two years from
the date on which the last entry is made therein.
II. The prescription issued shall be preserved for a period of three years
from the date on which it is issued .
Ill. Every drug used in manufacturing shall be entered in the Register.
IV. Supply by way of wholesale dealing shall be by a person duly
authorized by a "Licence To Keep And Sell Dangerous · Drugs By
Wholesale"

A. I and Ill only


B. I, Ill and IV only
C. II and IV only
D. All of the above

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62. Under the Dangerous Drugs (Hospital, etc) (General Exemption) Order 1952,
a public hospital shall comply with the following:

I. All orders for supplies of drug shall be signed by the registered


pharmacist attached to the hospital.
II. In the absence of the registered pharmacist, the order for supplies of
drug shall be signed by a registered medical practitioner or registered
dental practitioner attached to the hospital.
Ill. A drug shall be dispensed only for the use of an individual patient.
IV. The matron shall only administer the drugs in accordance with the
directions of the registered pharmacist or registered practitioners
attached to or attending the hospital.

A I and Ill only


B. I, Ill and IV only
C. IVonly
D. All of the above

63. The following poison may be supplied by a registered medical practitioner for
the medical treatment of his patient:

I. Carbadox
II. Clioquinol
Ill. Cetirizine
IV. Cetrorelix

A I and II only
B. I, II and IV only
C. Ill and IV only
D. All of the above

64. Under the Poisons Act 1952 and its regulations, the Drug Enforcement Officer
may

I. investigate the commission of an offence under the Act.


II. examine orally any person supposed to be acquainted with the facts of
the case.
Ill. enter, search and examine such premises where it is believed that an
offence under the Act has been committed.
IV. arrest any person, being in such premises, who is reasonably
suspected to have concealed such article therein.

A I and II only
B. I, II and Ill only
C. Ill and IV only
D. All of the above

Pharmacy Board of Malaysia 2016 Page22


65. The supply of the following poison by the following person shall be recorded in
the Prescription Book:

Poison Person supplied


I. Zopiclone A registered medical practitioner for medical
treatment of his patient
II. Mefenamic Acid A registered dentist in a private dental clinic for
dental treatment of his patient
Ill. Ibuprofen . A licenced pharmacist for medical treatment of a
particular individual
IV. Prednisolone A veterinary officer in a private veterinary clinic
to his client for animal treatment

A. II and Ill only


B. II, Ill and IV only
C. IVonly
D. All of the above

66. The following statement is TRUE regarding the meeting of the Medicine
Advertisements Board (MAB):

I. The Director General of Health shall be the Chairman of the MAB and
shall preside at all meetings which he attends.
II. In the absence of the Chairman from any meeting the members
present shall elect one of their members to preside.
Ill. The MAB may invite any person to attend any meeting of the MAB.
IV. · The quorum of the meeting is four including the Chairman.

A. I and Ill only


B. II and Ill only
C. I, II and Ill only
D. All of the above

67. The following statement is TRUE regarding Registrar under the Registration
of Pharmacists Act 1951:

I. He is appointed by the Minister.


II. He is a member of the Pharmacy Board.
Ill. He is responsible for the maintenance and custody of the register of
pharmacists
IV. All certificates shall be signed by him.

A I and II only
B. II, Ill and IV only
C. Ill and IV only
D. All of the above

Pharmacy Boord of Malaysia 20 16 Page 23


68. The following statement is TRUE regarding Inspectors under the Registration
of Pharmacists Act 1951 :

I. The Minister may appoint any person to be Inspectors.


II. The Chief Minister may appoint such number of person to be
Inspectors within the state.
Ill. Only a registered pharmacist may be appointed as an Inspector.
IV. The Inspector may remove and detain any document from such
premises to furnish evidence of commission of an offence.

A. I and Ill only


B. I and IV only
C. II and IV only
D. All of the above

69. The following statement is TRUE regarding the supply of poisons:

I. Does not include the direct administration of poisons by a registered


medical practitioner
II. Compounding or mixing of a poison is an act of supply
Ill. Part I Poisons shall be supplied by wholesale by licenced wholesaler
IV. Any poisons may be supplied to any person for the purpose of medical
treatment of such person

A. I and Ill only


B. I, Ill and IV only
C. II and IV only
D. None of the above

70. The following statement is TRUE regarding "immediate personal supervision"


relating to Part I Poisons:

I. Group A poisons may be sold under the immediate personal


supervision of the licenced pharmacist.
II. Every medicine containing poison may be prepared under the
immediate personal supervision of registered medical practitioner.
Ill. A person working under the immediate personal supervision of the
registered pharmacist shall dispense, compound or mix any poison
with any other substance.
IV. Immediate personal supervision shall be deemed to have been so done
when such person has himself checked such dispensing, compounding
or mixing.

A I and Ill only


B. II and Ill only
C. II, Ill and IV only
D. All of the above

Pharmacy Board of Malaysia 2016 Page 24


71. The Supply of Methadone Syrup in a government hospital for the medical
treatment shall be

I. done by a pharmacist or pharmacy assistant or in his absence by


medical assistant upon prescription.
II. recorded in Production Register for Psychotropic Substances.
Ill. labelled as dispensed medicine.
IV. recorded in Prescription Register for Psychotropic Substances.

A. I and II only
B. I and IV only
C. Ill and IV only
D. IVonly

72. The following statement is TRUE regarding psychotropic substance

I. Importation requires an Import Authorization


II. A stock of the raw material received to be recorded in Production
Register for Psychotropic Substances
Ill. Shall be stored in a room, cabinet, safe or receptacle in the premises to
which such psychotropic substances relates to dispensing
IV. Disposal shall be witnessed by Inspector

A. I and II only
B. I, II and Ill only
C. Ill and IV only
D. All of the above

73. The following statement is TRUE regarding the Medicines (Advertisement and
Sale) Act 1956:

I. A notice about a naturally occurring substance requires the approval of


the Medicine Advertisements Board
II. Advertisement may be published by Malaysian Pharmaceutical Society
with an approval of the Minister
Ill. A book on diseases need to be approved by the Medicine
Advertisements Board
IV. Advertisement may be circulated among medical . profession without
approval of Medicine Advertisements Board

A. I and II only
B. I and Ill only
C. II, Ill and IV only
D. II and IV only

Pharmacy Board of Malaysia 2016 Page25


74. The following statement is TRUE related to the officer and inspector under the
Sale of Drugs Act 1952:

I. May enter and inspect any place where there is any drug intended for
sale
II. May seize any drug which is unwholesome or deleterious to health
Ill. Any public servant may be appointed as officer and inspector
IV. Certificate of analysis issued by the officer and inspector is a prima
facie evidence

A. I and Ill only


B. I, II and IV only
C. II and Ill only
D. All of the above

75. The following statement is TRUE pertaining the proceedings for offences
under the Sale of Drugs Act 1952:

A. The summons to the accused is served less than 14 days before trial
B. To be carried only before Magistrate Court
C. May be instituted more than sixty days from the time of any article of
drug has been purchased or procured for the test purposes
D. Certificate of analysis by the analyst to be prima facie evidence

76. The following statement is TRUE regarding the Secretary of the Pharmacy
Board:

I. The period of the appointment is 3 years but shall be eligible for


reappointment.
II. The appointment is by the Minister and the Minister may at his
discretion, terminate the appointment.
Ill. The secretary shall not be a member of the Board.
IV. Only a pharmacist in the public service may be appointed as the
Secretary.

A. I and II only
B. II and IV only
C. Ill and IV only
D. JVonly

Pharmacy Boord of Malaysia 2016 Poge 26


77. The following statement is TRUE regarding dangerous drugs:

I. Importation requires an Import Authorization.


II. Import of the raw material to be recorded in Part I Register.
Ill. Supply for medical treatment to be labelled as dispensed medicine.
IV. Disposal shall be witnessed by Drug Enforcement Officer.

A. I, li and Ill only


B. I, II and IV only
C. Ill and IV only
D. All of the above

78. The following is a TRUE statement regarding members of the Poisons Board:

I. All members other than the Director General of Health are appointed
by the Minister.
II. The Director of Pharmaceutical Services is the ex-officio member.
Ill. The Minister may, after consultation with the Board, appoint a
Secretary who shall not be a member.
IV. The Board may appoint a person to be a temporary member who shall
be deemed to be a member of the Board.

A. I and II only
B. I and Ill only
C. I, Ill and IV only
D. All of the above

79. The following is a TRUE statement regarding the meeting of the Poisons
Board:

I. The Director General of Health shall be the Chairman and shall preside
at all meeting he attends.
II. The Director of Pharmaceutical Services is the alternate Chairman.
Ill. The Board may invite any one or more persons to attend any meeting
of the Board.
IV. At any meeting, four members including the Chairman shall form a
quorum.

A. I, II and Ill only


B. I, Ill and IV only
C. II and Ill only
D. All of the above

Pharmacy Boord of Malaysia 2016 Page 27


80. Mr. X is a senior Chemist of the Department of Chemistry in Petaling Jaya. llo
has 30 years working experience in that department. The following statement
is TRUE regarding Mr. X with reference to the Poisons Act 1952:

I. The Director General of Health may appoint him as a member of the


Poisons Board.
II. The Minister may appoint him as a temporary member of the Poisons
Board in ·the absence from Malaysia of any member of the Board.
Ill. The Board may invite him to attend any meeting of the Board.
IV. The Minister may after consultation with the Poisons Board, appoint
him as the Secretary.

A. I, II and Ill only


B. II and Ill only
C. Ill and IV only
D. All of the above

81 . MissY is a licenced pharmacist who operates a community pharmacy outlet


for many years. She is a member of the Malaysian Pharmaceutical
Association. Under the Poisons Act 1952, she may be nominated and be
appointed as the following:

I. A member of the Poisons Board


II. A temporary member of the Poisons Board during the incapacity
through illness of any member of the Board
Ill. As the Chairman of the Poisons Board
IV. As the Secretary of the Poisons Board

A. I, II and Ill only


B. I and IV only
C. II and Ill only
D. All of the above

82. The following person may compound or mix any poison with other substance,
for the purpose of it being used for medical treatment:

I. A registered pharmacist
II. A licenced pharmacist
Ill. A registered medical practitioner
IV. A registered dentist Division I
A. I, II and Ill only
B. I and Ill only
C. Ill and IV only
D. All of the above

Pharmacy Bo ord of Malaysia 2016 Page 28


83. The following is classified as Part II Poison as specified in the First Schedule
of the Poisons Act 1952:

I. Ampicillin when compounded with animal feeds


II. All preparations of Ammonia
Ill. All preparations of Caffeine
IV. All preparations of Hydrofluoric Acid

A. I, II and Ill only


B. I and IV only
C. II and Ill only
D. All of the above

84. Under the Poisons Act 1952, a Type B licence holder may sell as wholesale
Hydrochloric Acid 25% to

I. another licenced wholesaler.


II. a manufacturer to be used in his factory and not for resale.
Ill. a licenced pharmacist for resale.
IV. a tradesman for the purpose of his trade and for resale ..

A I, II and Ill only


B. I and Ill only
C. II and IV only
D. All of the above

85. Under the Poisons Act 1952, a licenced pharmacist may sell by retail the
following poison as a dispensed medicine in accordance with a prescription
prescribed by a registered medical practitioner:

I. Group A poison
II. Group B poison
Ill. Medicine containing psychotropic substances
IV. Group C poison

A. I and II only
B. II, Ill and IV only
C. Ill and IV only
D. All of the above

Pharmacy Boord of Malaysia 20 16 Page 29


86. The following is the duty of the Secretary of the Pharmacy Board:

I. Publish annually in the gazette a list of all registered pharmacists and


of all bodies corporate
II. Appoint the place and time of the Board meeting
Ill. Responsible for the payment of legal advisors
IV. Responsible for the maintenance of the register of pharmacists

A. I, II and Ill only


B. II and IV only
C. IVonly
D. None of the above

87. The following statement is TRUE regarding the appointment of the members
of the Pharmacy Board:

I. The period of appointment shall be three years for non ex-officio


members
II. The appointment is by the Minister
Ill. Permanent residents of Malaysia may be appointed as a member
IV. The appointment of all members shall be published in the Gazette

A. I and II only
B. I and IV only
C. Ill and IV only
D. None of the above

88. The following statement is TRUE regarding appointment of a Committee of


Inquiry members to investigate a complaint of misconduct of a registered body
corporate:

I. The appointment is by the Minister


II. The period of appointment is three years
Ill. The Minister is the Chairman
IV. The appointment is by the Pharmacy Board

A. I and II only
B. I and Ill only
C. Ill and IV only
D. IVonly

Pharmacy Board of Malaysia 20 16 Page 30


89. Professor Z is a permanent resident of Malaysia working as the Dean of the
Faculty of Pharmacy in a private institution in Petaling Jaya. He is also a
temporarily registered phannacist with the Pharmacy Board.

With reference to the Registration of Pharmacists Act 1951- & its regulations,
Professor Z may be appointed as

I. a member of the Pharmacy Board.


II. a member of a Committee of Inquiry.
Ill. the Secretary of the Pharmacy Board.
IV. a superintendent of a registered body corporate.

A. I, II and Ill only


B. I and Ill only
C. II and IV only
D. IVonly

90. The following statement is TRUE regarding the Sale of Drugs Act 1952:

I. The Act is applied ·throughout Malaysia in 1989


II. The Chief Minister may appoint any chemist from the Department of
Chemistry for the purposes of this Act as an inspector
Ill. An inspector may at all reasonable times enter and inspect any
premises and arrest the owner for the purpose of investigating the
offences under this Act
IV. Sanction is required to conduct prosecution under this Act

A. I and II only
B. I and Ill only
· C. II and IV only
D. Ill and IV only

91 . The following is an offence under the Control of Drugs and Cosmetics


Regulation 1984:

I. Possess for sale any product which is not registered


II. Manufacture a notified cosmetic without having manufacturing licence
Ill. A retailer selling a registered product without having any licence
IV. Import any cosmetic as part of personal luggage for personal use for
one month's use

Pharmac y Board of Malaysia 20 16 Page31


A. I only
B. I and II only
C. I, II and Ill only
D. All of the above

92. The following statement is TRUE regarding the superintendent of a registered


body corporate under the Registration of Pharmacists Act 1951 :

I. The business of such body corporate shall be under the control and
management of a superintendent who is a registered pharmacist.
II. Any body corporate that having more than one premise, each of the
premises shall be managed by a separate superintendent.
Ill. A copy of the registration certificate of the superintendent shall be
conspicuously exhibited in each premise if such body corporate is
having more than one premise.
IV. The superintendent shall be a citizen of Malaysia.

A. I and II only
B. I and Ill only
C. II and IV only
D. All of the above

93. The following statement is TRUE regarding licences under the Control of
Drugs and Cosmetics Regulation 1984:

I. The Director of Pharmaceutical Services may issue licences


II. The processing fee for a manufacturer's licence is RM 1000.00
Ill. All licences issued other than a clinical trial import licence shall be valid
for one year
IV. The Minister may if he thinks fit without assigning any reason, refuse
any application for a licence

A. I, II and Ill only


B. I and Ill only
C. II and IV only
D. IVonly

Pharma cy Boord of Malaysia 20 l6 Page 32


94. Bisoprolol is a poison classified as

I. Part I poison
II. Group B poison
Ill. Part II poison
IV. Group C poison

A. I and II only
B. I and IV only
C. II and Ill only
D. Ill and IV only

95. The following person may possess a liquid solution of nicotine

I. A vape vendor
II. Division II Dentist
Ill. A registered nurse
IV. A medical sales representative

A. I only
B. II and Ill only
C. I, II and Ill only
D. All of the above

96. Members of the Drug Control Authority include the

I. Director General of Health.


II. Director of Pharmaceutical Services.
Ill. Secretary of the Drug Control Authority.
IV. Director of the National Pharmaceutical Control Bureau.

A. I, II and Ill only


B. I, II and IV only
C. II, Ill and IV
D. All of the above

Pharmacy Board of Malaysia 2016 Page 33

I II
97. The following statement is FALSE regarding the implementation of Good
Governance for Medicine:

A. Maintaining secrecy over membership of the hospital drug selection


committee
B. Providing online services, including registration of medicines
C. Information made available on website, such as the list of essential
medicines and results of tenders
·D. Declaration of conflict of interest by members of committees involved in
the procurement of medicines

98. The Second Malaysian National Medicines Policy (MNMP) is an improvement


of the original MNMP in the following components EXCEPT:

A. The Human Resources Development, Research and Development and


Technical Cooperation components have been dropped.
B. The Quality, Safety and Efficacy, and Quality Use of Medicines
components are maintained.
C. The Medicines Availability and Medicines Affordability components are
combined into one component entitled Access to Medicines.
D. A new component of Governance in Medicines has been introduced.

99. The following statement is FALSE on clinical trial as stipulated under Control
of Drugs and Cosmetics Regulations 1984:

A. It is a scientific investigation to study the safety and efficacy of a


product.
B. The clinical trial import licence is as in Form 4 in the Schedule.
C. The licence issued shall be valid for one year.
D. May apply for exemption from the provisions of regulation 7(1 ).

Pharmacy Board of M alaysia 20 16 Page 34


100. According to the Medicines (Advertisement and Sale) Act 1956, the following
does not constitute an advertisement of a substance recommended as a
medicine:

I. A pen bearing the name of a medicinal product given free to members


of the public
II. A video to promote a medicinal product
Ill. A speech made by a university researcher on his latest discovery of a
plant extract with possible anti-cancer property ·
IV. Using a television personality to recommend the use of a product to
overcome infertility in a television talk show

A. I, II and IV only
B. I and Ill only
C. II, Ill and IV
D. All of the above

Phonnocy Boord of Malaysia 2016 Page35