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10-Oct-17

Introduction to Pharmacy Profession (BPH1101)


Lecture 2

Role of Pharmacists in society Legislation and


FACULTY OF PHARMACY
Ethics of Pharmacy
INTRODUCTION TO PHARMACY PROFESSION
Course Code: BPH 1101 Topic Learning Outcome
Lecture 2: . Outline the role of the pharmacist in society
Role of Pharmacist in Society Legislation and Ethics of
Pharmacy
. Legislation governing the pharmacy profession
. What is ethical pharmacy practice.
Khairulanwar bin Husain
khairulanwar.husain@qiup.edu.my

Khairulanwar bin Husain


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What define a profession as


What define a profession as
professional?
professional?

1. Specific sphere of knowledge Specific sphere of knowledge


2. National body representing the profession 1. Training School, which have a specialized course
3. Ethics and code of conduct specifically for the in pharmacy or support of pharmacy profession
profession 2. Universities or school of higher learning
institution that provide pharmacy courses which
4. Uniformity in Practice has been validated
The student will be evaluated and assess accordingly
There is a specific body (MQA) which monitor and
evaluate the course
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What define a profession as What define a profession as


professional? professional?

National body representing the profession Ethics and code of conduct specifically for the
Is needed to represent the profession especially in
matters that concern the profession profession
MPS (Malaysian Pharmaceutical Society) Code of Conduct
Association at state level
Law and legislation
MAP (Malaysian Academy of Pharmacy)
MCPG (Malaysian Community Pharmacy Guild) Accountability
PhAMA (Pharmaceutical Association of Malaysia) Responsibility
MyPSA (Malaysian Pharmaceutical Student Autonomy
Association)
University level
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What define a profession as


Area Of Practice
professional?
Research
Uniformity in practice Safety
Full time occupation Distribution
Direct working relationship
Specific i.e. nuclear pharmacy
Capitalist morality
Patient, clients rather than customers
Dispensing
Military
Education

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Legislation and Law Act and Regulations


Law n. 1. The enforceable body of rules that govern
any society 2. One of the rules making up the body of
law, such as an act of Parliament.
Poisons Act 1952 (Revised 1989) & Its Regulations
Legislation n. 1. The whole or any part of the countrys Dangerous Drugs Act 1952 (Revised 1980) & Its Regulations
written law 2.The process of making written law. Medicines (Advertisement And Sale) Act 1956 (Revised
( oxford dictionary of law 8th ed. 2105) 1983) & Its Regulations
Main purpose of law for the pharmacy profession Sale Of Drugs Act 1952 (Revised 1989) & Its Regulations
To control
Registration Of Pharmacists Act 1951 & Its Regulations
Procurement of scheduled poison
Code Of Conduct
The storage of scheduled poison Code Of Conduct For Pharmacists And Bodies Corporate
The distribution of scheduled poison
2009 by Pharmacy Board Of Malaysia DUNas
To regulate the profession
Reference materials relevant to National Medicines Policy
(DUNas) and Good Governance of Medicine (GGM)
Accountability of the practitioner
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Poison Act 1952 Poison Act 1952


Give the right to establish the poison board
Give the Minister the power to amend the poison list*
An Act to regulate the importation, possesion, List the requirement that a person or registered body cooperate
needed to handle schedule poison.
manufacture, compounding, storage, Allowance and restriction in handling schedule poison in form or
transport, sale and use of poisons Poison License
Classification and list of schedule poison
(1) This Act may be cited as the Poisons Act List what is required when handling schedule poison i.e.
1952. (2) This Act shall apply throughout Storing
Malaysia.

Selling
Moving
Applied in Peninsular Malaysia in 1952, East Importing
Exporting
Malaysia 1978 COmpounding

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Allowance and restriction in handling


schedule poison in form of Poison
License
"dispensed medicine" means a medicine Licensing
Type A : issued to a pharmacist
supplied by a registered medical practitioner,
Type B : issued to any person license, to import, store and
registered dentist or veterinary surgeon under sell by wholesale such poisons (not being a Group A
and in accordance with section 19 or supplied, Poison) as may be specified in such license
Type C : Sell by retail Group F Poisons only
for the purpose of the medical, dental or
Type D : To store and sell by retail such Part II Poisons as
animal treatment, of a particular individual by may be specified therein
a licensed pharmacist on the premises Type E : Regulate the of uses Sodium Hydroxide especially
if it is used in such substantial quantity that the Licensing
specified in his license Officer deems it appropriate to issue to him a license to
import, store and use Sodium Hydroxide

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Classification Of Schedule Poison Classification Of Schedule Poison


Part I Part II : Scheduled item which not used
Group A Poison Sell By license pharmacist or a person
Group B Poison Sell by prescription the have the 5 pharmaceutical dosage form.
requirement to be recorded in the prescription book:
Name of prescriber with
Address of the prescriber Exemption : Scheduled item that contains in
Name and address of the patient
Name of the item to be supplied items exist naturally, the concentration is very
Amount to be supplied low, exempted because of method of usage or
Group C Poison By a license pharmacist to be recorded in from provision in other act
the poison book
Group D Poison By a license pharmacist, which also have to
be recorded in the poison book
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Poison (Psychotropic Substances) Act and Regulations


Special provision in the Poisons Regulation.
Item is listed in the 3rd schedule i.e. Registration of Pharmacy Act 1951 (Act 371)
midazolam, alprazolam, dihydrocodeine An Act to the establishment of a Pharmacy Board
and the registration of pharmacist.
Drug enforcement officers
Registration of Pharmacy Regulation 2004
Regulation Minister can make on
Regulation in which to exercise the powered
importation, manufacture, sales, dispensing,
conferred by section 22 of the Registration of
storage, licenses Pharmacist Act 1951, the Board with the approval
Special control and record of the Ministers

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Registration of Pharmacy Act 1951 (Act


Act and Regulations
371)
Detailed the formation of the Pharmacy Board
Detailed the scope of the pharmacy profession Sale of Drugs Act 1952 (ACT 368)
An Act relating to the sale of Drugs.
Detailed the Registration of a Pharmacist
Peninsular Malaysia 1st November 1952
the person who is responsible in registering the
Sabah, Sarawak, Federal Territory of Labuan 1st
pharmacist and to include them in the form he September 1989
deem suitable
Control of Drugs and Cosmetics Regulations
Type of registration i.e. provisional
1984
What to do if foreigner is hired as a pharmacist To exercise of the powers conferred by section 28
(1) of the Sale of Food and Drug Ordinance 1952
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Sale of Drug Act and Regulations


Power of the drug enforcement officer to
enter, mark, seal, destroy (section 4) take Medicines (Advertisement and Sale) Act 1956
(Act 290)
samples (section 5) An act to prohibit certain advertisements relating to
Selling of adulterated drugs (section 10) medical matters and to regulate the sale of substances
recommended as a medicine
Section 21. Analysts certificate to be prima West Malaysia 1st October 1956
facie evidence Sabah and Sarawak 1st January 1976
Medicine Advertisements Board Regulations
1976
In exercise of the powers conferred by section 7 of the
Medicines (Advertisement and Sale) Ordinance 1956.
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Act and Regulations


advertisement includes any notice, circular,
report, commentary, pamphlet, label, wrapper Dangerous Drugs Act 1952 (Act 234)
An act to make further and better provision for the
or other document, and any announcement regulating of the importation, exportation, manufacture,
sale, and use of opium and of certain other dangerous
made orally or by any means of producing or drugs and substances, to make special provision relating to
transmitting light or sound; the jurisdiction of courts in respect of offences thereunder
and their trial, and for purposes connected therewith.
Section 6, disclosure of composition of Peninsular Malaysia 1st November 1952
medicines Sabah and Sarawak 1st June 1978

Dangerous Drugs Regulations 1952


In exercise of the powers conferred by section 7, 16 and 47
of the Dangerous Drugs Ordinance 1952
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Code Of Conduct For Pharmacists And


Bodies Corporate 2009
Regulating of the importation, exportation
manufacture, sale and use of opium and of Code Of Conduct For Pharmacists And Bodies Corporate 2009 by
Pharmacy Board Of Malaysia
certain other dangerous drugs and It is the minimum standards of proper conduct and professionalism for
guidance of pharmacists.
substances. Standard that is used as a reference when the board considers cases of
misconduct in professional sense
Power of arrest and seizure It covers 2 main area
Code of conduct
Weight of dangerous drugs in presumptions Professional responsibility
Abuse of professional privileges and skills
section 37 Conduct derogatory to the reputation of the profession
Advertising, canvassing and related professional offences
Trafficking in dangerous drugs Disciplinary jurisdiction and procedure
Disciplinary jurisdiction of the board
Drug enforcement officer

Procedure of inquiry
Punishments
appeal
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National Medicines Policy (DUNas) and


Why do we need code of conduct
Good Governance of Medicine (GGM)
When the issue is not covered by the law
National Medicines Policy (DUNas) and Good
If it raises moral problems for you or a Governance of Medicine (GGM)
member of the profession To promote equitable access and rational use of safe,
When a correct and incorrect response is effective and affordable essential medicines of good
not clear quality to improve health outcomes of the people.
Governance in medicine
If you are forced to consider where your Quality, safety and efficacy of medicines
obligations and duties lie. Access to medicines
Quality use of medicine
Uniformity in practice
Partnership and collaboration for the healthcare industry
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Thank You

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