PHARMACY ACT 1 Pharmacy Education and Regulations Lecture – 2 29-02-2012 DR. SHAHNAZ USMAN Associate Professor Dept. of Pharmaceutics RAKMHSU.

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PHARMACY ACTPharmacy Education and Regulations

Lecture – 229-02-2012

DR. SHAHNAZ USMAN Associate ProfessorDept. of PharmaceuticsRAKMHSU

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Contents

1.Pharmacy Education and Regulations.

2.Drugs Control Department, UAE.

3.Objectives of Department.

4.Definitions.

5.Articles.

6.References.

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Pharmacy Education and Regulations

• Pharmacy is a highly-regulated profession, and the details of that regulation have been changing significantly in recent years to accommodate additional practice settings, increased scope of practice for pharmacists and other health care personnel, and dramatic changes in technology.

• Every pharmacist must stay abreast of changes in the regulatory environment to ensure safe and legal practice.

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• The pharmacist is an expert in medicines.

• A pharmacist can be involved in any aspect of the preparation and use of medicines, from the discovery of their active ingredients to their use by patients.

• Pharmacists also monitor the effects of medicines, both for patient care and for research purposes.

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• Laws regulate the labeling, recordkeeping, and drugs handled by pharmacies.

• Pharmacy boards exist to regulate the licensing and practices of pharmacists.

• To practice pharmacy, a pharmacist must become a Registered Pharmacist (RPh), also known as a Licensed Pharmacist.

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The Registration and Drug Control Department in Ministry of Health (UAE)

Aims and Objectives :

• Is to safeguard public health by ensuring that all medicines on the UAE market meet appropriate standards of safety, quality and efficacy.

• Safety aspects cover potential or actual harmful effects; quality relates to development and manufacture; and efficacy is a measure of the beneficial effect of the medicine on patients.

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• The department is also responsible for the licensing of pharmaceutical establishments (pharmacies, distributor’s stores and factories) and pharmacists and pharmacy assistants (technicians).

• This is to ensure that establishments comply with ministry, municipal and professional requirements.

• Licenses to practice as Pharmacists or pharmacy assistants are only given to people who satisfy the requirements described in the Pharmacy Law and these must be renewed every

year.

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The Department achieves its Objective through

• A system of licensing and pricing of medicinal products before they are allowed on to the market.

• Inspection of all medicines entering the country via airports, sea-ports and the postal service.

• Checking standards of pharmacy practice, pharmaceutical distribution and manufacture through it’s Federal Inspection team.

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• Enforcement of requirements according to the law.

• Liaison with the United Nations Drug Control Programmed for the International control of Narcotics, Psychotropics and Precursor substances.

• Monitoring of medicines and acting on safety concerns after they have been placed on the UAE and International market.

• Representing UAE pharmaceutical regulatory interests within the UAE through liaison with the Ministries of Agriculture and Fisheries, Interior, Trade and Industry and the General Municipal Authorities.

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• Representing UAE pharmaceutical regulatory interests internationally through the Gulf Cooperation Council.

• Responsibility for medicines control policy.

• Publishing guidelines and standards for pharmaceutical product registration and pharmacy practice.

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• In the application of the provisions of this law, the following words and phrases shall have the meanings stated herein:

The Country: The United Arab Emirates The Minister: The Minister of Health The Ministry: The Ministry of Health

• Pharmaceutical profession: Preparation, composition, separation, manufacturing, bottling or packing, selling or distribution of any medicine for protection or treatment of human beings or animals.

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

• Licensing Committee: The Committee stated in the article 6 of this law, which comprises of core members of all health professionals.

• Licensed Pharmacist: Any person licensed to pharmaceutical profession according to the provisions of this law.

• The Pharmaceutical Institution: Public or private, pharmacy, medicine factories and stores and scientific offices.

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• Medicine: Any medicine that contains one or more element for treatment or protection of human beings and animals.

• Chemical Elements: Basic elements composing the medicine

• Medical Appliances: Equipment other than medicine and which are used for medical purposes.

• Medical Store: Any institution inside the country for import, storage and distribution

of medicine (wholesale).

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• Medical Factory: The production unit inside the country and which manufactures medicine.

• Scientific Offices: The scientific centers that notify and give information about medicine and chemical elements produced by factories, which the scientific offices affiliate.

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ARTICLE 2 :

• No person is permitted to practice pharmaceutical profession without obtaining a license according to the provisions of this law.

• Persons who apply to obtain the license should:

1.Hold a pharmacy certificate from a recognized high institute, college or university.

2.Practiced pharmaceutical profession for a period not less than two years (for foreigners)

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3.Have a clear police record.

4.Fluent Arabic and foreign language.

5. Pass the examination to be organized by the Ministry in this regard and according to the rules to be issued by the Minster in consultation with the licensing committee.

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ARTICLE 3:

• No person should practice the profession of assistant pharmacist without obtaining the license according to the provisions of this law.

• To obtain the said license the applicant should be:

1. Holder of a recognized assistant pharmacist certificate

2. Practiced the profession for at least two years in one of the pharmaceutical institution under the supervision of a licensed pharmacist.

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3.Have a clear police record.

4.Fluent in Arabic and one of the foreign languages.

5.Pass the examination to be conducted by the Ministry for this purpose and according to the rules to be issued by the Minster after consultation with licensing committee.

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ARTICLE 4 :

• The documents to be attached to the application for obtaining the license stated in article 2 and 3 shall be determined by the decision to issue by the minister.

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ARTICLE 5 :

• The licensed pharmacist may appoint as an assistant pharmacist who fulfilled the conditions stated in the article 3 of this law.

• He may also appoint with him in the pharmaceutical institution students from Pharmacy College or assistant pharmacists who did not completed the training period after obtaining the Ministry’s approval and shall be responsible for the mistakes they may commit.

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ARTICLE 11 :

• The licensed pharmacist should not give any medicine or medicinal preparation without a medical prescription in a clear hand-writing carrying the name of the licensed doctor who issued it, its stamp and date issue.

• If the prescription included one of the drugs stated in one of the tables appended to this law

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• The licensed pharmacist should make sure of the following before giving the drug:

1- That the medical prescription is numbered and stamped by the Ministry’s stamp and issued in the form prepared for this purpose.

2- Written in an ineffaceable material

3- The prescription should include the amount of medicine in letters and figures, directions and name and address the patient.

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4- Should not be issued for a period exceeding two days.

5- The prescribed dose should not be more than what has been stated in the pharmacopoeia and the period of usage not to exceed three days.

• The provisions of the paragraph 1 of this article shall not apply on what is sold by a pharmacy to another or to a medical institution.

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ARTICLE 12 :

• Licensed pharmacist is not permitted to grant, dispense or sell poisons on amounts in excess of the doses laid down in the pharmacopoeia.

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ARTICLE 13:

• Licensed pharmacist is not allowed to make any changes in the medical prescription before consulting the doctor who issued the prescription.

• He is also not permitted before obtaining the approval of the doctor, to repeat the supply of tranquillizers or medicine including abortifacients or, a medicine, which may lead to addiction.

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ARTICLE 14 :

• If the licensed pharmacist discovered a mistake or omission in the medical prescription or become doubtful about part of it, he should discreetly contact the doctor who issued the prescription and he may return the prescription to the doctor if he rejected the clarification made by the doctor.

• In this case, the doctor should underline the issue in dispute and sign it.

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ARTICLE 16 :

• The licensed pharmacist should carry out his duties in conformity with regulations of the profession and in particular:

1- Shall not conduct any practices against the honor of the profession.

2- Shall keep confidential the disease, which he may come to know through the medical prescription presented to him or through any means related to practicing of his work.

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3- Shall abide by the laws and regulations followed in this profession.

4- Shall notify the communicable diseases he may discover during practicing his duties.

5- Should not under take himself any work other than his work in the pharmacy.

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ARTICLE 17 :

• The licensed pharmacist should not commit any work in violation of the duties of the profession in particular:

1- Encouragement of patients to buy medicine from his pharmacy through secret deals with others.

2- Monopoly, hiding or selling of medicine for prices higher than the fixed prices

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3- Change of medicine as regards quantity or quality in contradiction with the provision stated in the law

4- Selling of free medical samples

5- Practicing medical or nursing works except for those relating to first aid and in necessary cases

6- Dispensing of medical prescription through a code or a signal not agreed upon scientifically.

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7- Agreement with a doctor to write prescription in a special way or code between them.

8- Criticizing or abusing the doctor whom issued the prescription before others.

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ARTICLE 18 :

• No person is permitted to open a pharmacy before obtaining a license according to the provisions of this law.

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REFERENCE

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

2.Pharmacy Practice and The Law, 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 ????

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Students must demonstrate

1: What is the concept about pharmacy education?

2: What are the objectives of Pharmacy Regulations?

3: What are the aim and objective of the Registration and Drug Control Department in Ministry of Health (UAE)

4: How these departments obtains theirs objective?

5: Concept about the different term that used in pharmacy law such as Registered Pharmacist, pharmaceutical profession etc?

6: Concept about different articles used in Pharmacy Act.