Introduction to Pharmacy Act

Pharmacy Laws

Lecture – I22-02-2012

DR. SHAHNAZ USMAN Associate ProfessorDept. of PharmaceuticsRAKMHSU

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Contents

1. Introduction to Pharmacy Act.

2. Objectives.

3. Definitions.

4. UAE Federal Law.

5. Code of Ethics- Key Responsibilities and Principles

6. 23 Service Standards.

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The Purpose of Pharmacy Law

Protect the Public Health

– Medical Use of Drugs

– Drug Abuse How far should government go to protect

people who use medications from the

consequences of their own risky choices in

drug therapy? Market Failures: Reasons to Regulate

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The drugs are life-saving and also potent which require proper handling at the counters in retail-outlets and hospitals.

Their mishandling by non-qualified persons shall play havoc with national health care system

Before Pharmacy Act, there was practically no restriction on entry of persons into the profession of pharmacy.

Anybody who could read a prescription could become a pharmacist

Introduction

In 1860 the APhA (American Pharmacy Association) took steps for the public safety and maintenance of occupational security by introducing a model Pharmacy Act

Making the right medicaments available to the public is the primary obligation of pharmacy in order to safeguard the public health.

The Pharmacy Act was passed in 1983 by UAE Federal Law, with a broad objective of regulating the Practice of Pharmacy.

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The people of the UAE have access to a high standard of medical care and this has been applauded by the World Health Organization

The WHO, together with the International Pharmacy Federation (FIP) have published Good Pharmacy Practice guidelines and have called for all countries to develop minimum standards of Pharmacy Practice.

Objective of Pharmacy Law

1. To monitor the profession of pharmacy in the country.

2. To ensure that the medicines are handled, dispensed, sold only by qualified persons, namely registered pharmacist.

3. To regulate the profession and practice of pharmacy.

4. Provides the course, the nature, period of training, examinations to become a registered pharmacist.

5. To introduce a course of instruction for minimum qualification of registration as a pharmacist.

 

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Definitions

Registered Pharmacist: means a person

whose name is for the time being entered

in the register of the state in which he is for the time being residing or carrying on his profession or business of pharmacy.

Register: means a register of pharmacists prepared and maintained under the Act.

State Council: means a state council of pharmacy constituted under the Act and

includes a joint state council of pharmacy8

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The Pharmacist: any person holder of pharmacy certificate from a recognized high institute, college or university

Licensed Pharmacist: any person licensed to pharmaceutical profession according to the provisions of this law

UAE Federal Law, 1983

The Pharmaceutical Professions and Institutions

The 15-chapter Federal Law No. 4, was issued by late Sheikh Zayed Bin Sultan Al Nahyan to regulate licensing pharmacists and assistant pharmacists, and control medical prescriptions

�The law stipulates conditions for granting licenses to pharmacies, pharmaceutical factories and medical outlets.

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Registrations of drugs and pharmaceutical companies, as well as pricing of medicines are also governed by the law

The law contains warnings concerning poisons, controlled drugs, chemical precursors and dangerous medicines.

It clearly specifies penalties that would be imposed in the event of breach of pharmacy rules.

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Key Responsibilities

The Code of Ethics identifies the key responsibilities of a pharmacist in the following terms:

1- Pharmacists understand the nature and effect ofmedicines of medicinal ingredients, and how they may be used to prevent and treat illness, relieve symptoms or assist in the diagnoses of disease.

Pharmacists in professional practice use their knowledge for the well-being and safety of patients and the public.

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2- At all times pharmacists must act in interests of

patients and other members of the public, and seek to provide the best possible health care for the community in partnership with other health professions.

Pharmacists must treat all those who seek pharmaceutical services with courtesy, respect and

confidentiality.

Pharmacists must respect patients’ rights to participate in decisions about their care and

must provide information in a way in which it

can be understood.13

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3- Pharmacists must ensure that their knowledge, skills and performance are of a high quality, up to date, evidence based and relevant to their field of practice

4- Pharmacists must ensure that they behave with

integrity and probity, adhere to accepted standards of personal and professional conduct and do not engage in any behavior or activity likely to bring the profession into disrepute or undermine public confidence in the profession.

 

Principles

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There are a number of guiding principles which stand at the core of the Code of Ethics:

1- A pharmacist’s prime concern must be for the welfare of both patients and public.

2- A pharmacist must uphold the honor and dignity of

the profession and not engage in any activity which may bring the profession into disrepute

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3- A pharmacist must at all times have regard to the

laws and regulations applicable to pharmaceutical

practice and maintain a high standard of professional conduct.

A pharmacist must avoid any act or omission which would impair confidence in the pharmaceutical profession.

When a pharmaceutical service is provided, a

pharmacist must ensure that it is efficient

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4- A pharmacist must respect the confidentiality of information acquired in the course of professional

practice relating to patients and their families.

Such information must not be disclosed to anyone without the consent of the patient or appropriate guardian unless the interests of the public or the patient require such disclosure

5-A pharmacist must keep abreast of the progress of pharmaceutical knowledge in order to maintain a high

standard of professional competence relative to his sphere of activity.

 

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6- A pharmacist must neither agree to practice under any conditions of service which compromise his professional independence nor impose such conditions on other pharmacists.

7- Publicity for professional services is permitted provided that such publicity does not create and invidious distinction between pharmacists or pharmacies, is dignified and does not bring the profession into disrepute.

8- A pharmacist offering services directly to the public must do so in premises which reflect the professional character of pharmacy

 

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9-Pharmacist must at all times Endeavour(make an effort) to cooperate with professional colleagues and members of other health professions so that patients and the public may benefit.

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There are 23 areas covered by the service standards, as follows:

1.Standards for premises appearance, safety, condition and tidiness of premises, environment, size of dispensary, and hygiene.

2. Standards for dispensary design and equipment stability of dispensary, work surface and shelves, floor covering, water supply, waste disposal, and dispensing equipment.

3. Standards for procurement and sources for materials- responsibility for procurement,

sources of supply, safe systems of work,

and medical gases.

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4.Standards of manufacturing and quality assurance good manufacturing practice, quality assurance and control, batch numbers, manufacturing formulae, and documentation, equipment and sources of supply for manufacturing.

5.Standards for dispensing procedures, supervision of dispensing and sales, safety in dispensing procedures, forged prescriptions, dispensing containers, re-use of containers, re-use of medicines, labels, storage, recalls, and personal hygiene.

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6. Standard for professional indemnity

7. Standards for education, training and development – competency, self – assessment, legislative changes and new services

8. Standards for relationships with patients and the public

9. Standards for relationships with other health care professionals

10. Standards for administration and management

11. Standards for community pharmacists providing a repeat medication service

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12.Standards for the sale of non–prescribed medicines – request for medicine by name, pharmacist’s involvement, special purchases or users, medicines requiring special care

13.Standards for pharmacists providing services to nursing and residential homes

14.Standards for pharmacists providing installment dispensing services

15.Standards for the home delivery of medicines

16.Standards for pharmacists providing domiciliary oxygen services.

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17.Standards for pharmacists providing needle and syringe exchange schemes

18.Standards for the collection and disposal of pharmaceutical waste by community pharmacies

19.Standards for provision of on-line pharmacy services: security/confidentiality, request for supply of medicines, information and advice, record keeping.

20.Standards for pharmacists dispensing extemporaneously prepared products

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21.Standards for pharmacists serving drug users

22.Standards for pharmacists providing aseptic dispensing services from non-licensed units

23.Standards for pharmacists involved in writing and/or providing patient group directions

References

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1.Pharmacy Law and Practice by Jonathan Merrills and Jonathan Fisher, Fourth Edition 2006 (Elsevier)

2.Pharmacy Practice and The Law by Richard R. Abood, Fifth edition 2008 (Jones and Bartlett Publishers).

3.A textbook of Forensic Pharmacy by N.K.Jain, seventh edition, pg no. 20.

4.Text book o Forensic Pharmacy by CK Kokate, Pharma Book Syndicate, pg.no. 19.

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Any Question ????

Students must demonstrate

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1: When Pharmacy Act was implemented in UAE?

2: What are the objectives of Pharmacy Act?

3: What is the meaning of Registered Pharmacist?

4: What are the key responsibilities of a Pharmacist?

5: What are the Code of Ethic?

6: Which areas are covered by the service standards?