Guidelines Governing Procurement of Controlled Substances

Session 5: Guidelines Governing Procurement of Controlled Substances

Total Session Time: 60 minutes

Prerequisites

None

Learning Tasks

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

Define the terms used in guidelines.

Dealer in controlled drugs

Narcotic drugs

Psychotropic substances

Mention general requirements for dealing with procurement of controlled drugs

Mention requirements of application for Procurement of controlled / narcotic drugs

Mention the suppliers of Psychotropic substances and pharmaceutical precursors

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

10 minutes

Buzzing

Presentation

Definition of the Terms Used in Guidelines.

3

10 minutes

Presentation

General Requirements for Dealing with Procurement of Controlled Drugs

4

15 minutes

Presentation

Requirements of Application for Procurement of Controlled / Narcotic Drugs

5

10 minutes

Buzzing

Presentation

Suppliers of Psychotropic Substances and Pharmaceutical Precursors

6

5 minutes

Presentation

Key Points

7

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 the Terms Used in Guidelines. (10 minutes)

Activity: Buzzing (5 minutes)

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

Define the following terms;

Narcotic drugs

Psychotropic substances

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

Dealer in controlled drugs: Means a person who carries on directly or otherwise the business of buying, selling, supplying, manufacturing and distributing controlled drugs.

Narcotic drugs: means any of the substance natural or synthetic on schedule I and II of the single convention on narcotic drug, 1961 and that convention as amending the single convention on narcotic drugs or and as annexed in the Tanzania Food, Drugs and Cosmetics Act, 2003.

Psychotropic substances: means any substance, natural or synthetic or any natural material in schedule I, II III and IV of the convention on psychotropic substances, 1971 and as annexed in the Tanzania Food, Drugs and Cosmetics Act, 2003.

STEP 3: General Requirement for Dealing with Procurement of Controlled Drugs (10 minutes)

General requirement for dealing with controlled drugs are

The Ministry of Health has appointed the Medical Stores Department (MSD) to be a sole importer and distributor of narcotic drugs to hospitals i.e. public, private, mission, veterinary clinics, and research institutions and registered Non-Government Organization (NGOs). However, psychotropic substances and pharmaceutical precursors can be imported by pharmaceutical manufacturer, wholesaler and retailer as listed below:

Government Department such as Medical Stores Department (MSD)

Holder of importation license (wholesalers)

Pharmaceutical manufacturers

Holder of an ethical clearance certificate to conduct clinical trials in the country using the named drug

Any other institution granted permission by the authority to import controlled drugs using the named drug.

STEP 4: Requirements of Application for Procurement of Controlled Narcotic Drugs (15 minutes)

Applicant shall apply in the prescribed form (Annex I) to the TFDA

The application form shall be accompanies with two passport size photographs of a registered pharmacist in charge/authorized persons of narcotic drugs; together with a certified copy of pharmacist registration certificate (if in charge is a pharmacist). This shall only apply for first time applicants and in case of change of pharmacist in charge/authorized persons.

The application form should state the type of drug, strength and estimated quantity to be consumed for a period of twelve months.

Before issuance of a permit (Annex II), inspection of the respective premises shall be conducted (checklist is annexed as III) to check compliance with regards to storage of controlled drugs and records such as DDA box, strong room, existence of ledger books etc.

After meeting all the requirements the authority shall issue a permit to procure a stated quantity of narcotic drugs.

The permit shall be renewable annually and the authority may suspend/revoke the permit in case of violation of requirements.

STEP 5: The Suppliers of Psychotropic Substances and Pharmaceutical Precursors (10 minutes)

Activity: Buzzing (5 minutes)

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

Who can procure psychotropic substances and pharmaceutical precursors?

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

Any authorized dealer may procure psychotropic substances and pharmaceutical precursors from any authorized importer, distributor or wholesaler.

Patients shall procure the drugs from retail pharmacies by producing a valid prescription.

STEP 6: Key Points (5 minutes)

Medical Stores Department (MSD) is a sole importer and distributor of narcotic drugs to hospitals

In order to procure narcotic drugs a permit from authority should be obtained

The permit shall be renewable annually and the authority may suspend/revoke the permit in case of violation of requirements.

STEP 7: Evaluation (5 minutes)

Who is an authorized importer of controlled substances?

Which procedures should be followed during application for procurement of controlled/narcotic drugs?

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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