Pharmacy Act, 2011 Regulating the Use and Sale of Prescription Only Medicines

Session 18: Pharmacy Act, 2011 Regulating the Use and Sale of Prescription Only Medicines

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

By the end of this session students are expected to be able to:

Define prescription only medicines

Explain sections of the Acts, which regulate use and sale of prescription only medicines.

Mention requirements of valid prescription only medicines.

Resources Needed:

Flip charts, marker pens, and masking tape

Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

Step

Time

Activity/

Method

Content

1

5 minutes

Presentation

Introduction, Learning Tasks

2

15 minutes

Presentation Buzzing

Definition of Prescription Only Medicines

3

45 minutes

Presentation

Sections of the Acts, which Regulate Use and Sale of Prescription Only Medicines.

4

45 minutes

Presentation

Requirements of Valid Prescription Only Medicines.

5

5 minutes

Presentation

Key Points

6

5 minutes

Presentation

Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning Tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Prescription Only Medicines (15 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

What are the prescription only medicines?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

“Prescription only Medicines” means any drug product required to be dispensed only upon a prescription given by a veterinarian, medical practitioner, dentist or any other person approved by the Minister;

STEP 3: Sections of the Acts, which Regulate Use and Sale of Prescription Only Medicines.(45 minutes)

Section 19 – (1) TFDCA 2003 scheduling of medicines 2015 (prescription only human medicines).

A person shall not sell by retail or supply in circumstances corresponding to retail sale a medicinal product of or forming part of this category except in accordance with prescription given by a medical practitioner, dentist or any other authorized prescriber.

Pharmacy Act 2011: 41(1) Exception when supplying and dispensing medicines.

A medical practitioner, dentist or veterinary surgeon or member of the staff of hospital, health centre, dispensary or similar institution who has been authorized to do so by the general or special order of the minister , on the advice of the council, may supply or dispense a prescription medicine for the purpose of medical, dental or veterinary treatment subject to the following conditions; The medicine shall be distinctly labeled with the name and address of the person by whom it is supplied or dispensed;

The following particulars shall, within twenty four hours after the medicine has been supplied or dispensed, be entered in a book used regularly for the purpose, and which shall be called the Prescription Book-

The date on which the medicine was supplied or dispensed;

The name, strength and the quantity supplied;

The name and address of the person to whom the medicine was supplied;

The name and address of the person by whom the prescription was made; and

Name and address of a prescriber or prescribing health facility.

Subsection (2) – Where an authorized seller of medicines supplies prescription medicines shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section.

Subsection (3) – Any person to whom subsection (1) applies and who supplies or dispenses any prescription medicine in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not more than one million shillings or to imprisonment, for term not exceeding six months or to both.

Section 5 – (2) National Drug Control Council:

There should be national Drug Control council which includes the following:

Minister responsible for legal affairs

Minister responsible for home affairs

Minister responsible for health

Minister responsible for foreign affairs

Minister responsible for finance

Minister responsible for youth development

Minister responsible for education

Minister responsible for agriculture

Minister responsible for transport

Minister responsible for Community Development

Section 11- Prohibition of Cultivation of Certain Plants and Substances.

Subsection (1) Any person who-

Cultivates any prohibited plant

Possess or supplies seeds for production of drugs

being the owner, occupier or concerned in the management of any premises, permits the premises to be used for cultivation of any prohibited plant

produces, possesses, sells, purchase, transports, imports into the Mainland Tanzania exports, uses or does any act or omits to do anything in respect to prohibited plants, which act or omission amounting to contravention of this Act

Commits an offence and upon conviction shall be liable to a imprisonment for a term not less than thirty years

The Tanzania Food, Drugs And Cosmetics Act,2003 (Scheduling Of Medicines) Regulations, 2015

Section 13. – (1) All manufacturers, wholesalers, importers, distributors, scientists, scientific institutions and hospitals, shall keep records of quantities of each human controlled drug manufactured and individual acquisition and disposal of drugs.

Section 13 – (4) The management, wholesaler, importers, distributor, scientist, scientific institutions and hospitals, shall ensure that all medicines are stored in a locked receptacle, in a cabinet or approved safe, which shall be opened by the person who is in lawful possession of the controlled medicines.

The preparations for narcotic drugs containing controlled substances in low strengths shall be exempted from the requirements of controlled drugs.

Pharmacists and other health professionals involved in storage, compounding, manufacture and dispensing of pharmaceuticals when executing their duties shall operate under acceptable safety conditions as prescribed by the national and internationally recognized regulations

Section 73– import and export of drugs, medical devices, herbal or poisons

Subsection (1) No person, other than a person issued with a license or permit under the provisions of this Act, may import or export into Mainland Tanzania any drugs, medical devices, herbal drugs or poisons.

Drugs and substances that are recognized as narcotic drugs shall be controlled medicines and shall include their isomers, derivatives, esters, ethers, salts and salts of isomers, esters, ethers and substances and intermediate opiate raw materials. (TFDCA 2003)

STEP 2: Requirement of use or to Sell Prescription Only Medicines. (45 minutes)

Section 74. TFDCA 2003. Sale and administration of drugs subject to prescription by appropriate practioners

Subsection (I) Subject to the Provisions of this section, no Person shall sell by retail, or supply in circumstances corresponding to retail sale or ad-minister, other than to himself, a drug product of a description or a class specified by order made by the Minister and published in the Gazette except in accordance with a Prescription given by appropriate practitioner.

Subsection (2) In this Part ''appropriate Practitioner'' means a medical practitioner, dentist, veterinary surgeon and any other person as the Minister may by Order published in the Gazette specify.

Subsection (3) Any Person who contravenes the provisions of this section commits an offence and upon conviction is liable to a fine of not less than one hundred thousand shillings or to imprisonment for a term not exceeding three months or to both such fine and imprisonment.

The sale and supply shall be —

subject to the presentation of an order signed by the purchaser stating —(i) the name and address of the institution for which the prescription only medicine is required(ii) the purpose for which the prescription only medicine is required; and(iii) the total quantity required; and(b) for the purposes of the education or research with which the institution is concerned.

The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in subparagraphs (a) to (f) in the first column stating the status of the person signing it and the amount of the prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.

STEP 6: Key Points (5 minutes)

Prescription only Medicines” means any drug product required to be dispensed only upon a prescription given by a veterinarian, medical practitioner, dentist or any other person approved by the Minister

Section 74. TFDCA 2003 explains the requirement of valid prescription only medicines.

STEP 7: Evaluation (5 minutes)

What are the prescription only medicines?

Which sections of TFDCA 2003 regulate use and sale of prescription only medicines?

What are the requirements of valid prescription only medicines?

References

MSH and WHO (2012). Managing Access to Medicines and Health Technology, (3rd Edition). Kumarian Press

MoHSW (2003). Tanzania, Food, Drugs and Cosmetics Act, Government Printers Dar es Salaam

MoHSW (2011). Pharmacy Act, Government Printers Dar es Salaam

United Republic of Tanzania (1971). the drugs and prevention of illicit traffic in drugs act, Government Printers Dar es Salaam

United Republic of Tanzania (2011). Public Procurement Act, Dar es Salaam

MoHSW (2003). The National Health Policy, Government Printers Dar es Salaam

MoHSW (1991). The National Drug Policy, Government Printers Dar es Salaam

United Republic of Tanzania (1993).Medical Stores Department Act, Government Printers Dar-es-salaam

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