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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