International Conventions Ratified on Controlled Drugs and Psychotropic Substances
Session 12: International Conventions Ratified on Controlled Drugs and Psychotropic Substances
Total Session Time: 120 minutes
Prerequisites
None
Learning Tasks
By the end of this session students are expected to be able to:
Understand the International conventions ratified on controlled drugs and psychotropic substances.
The requirements under the international treaties
The drug procurement/distribution system
Mention regulation of domestic manufacture and distribution of controlled substances
Mention the Regulatory system for importation/exportation of controlled substances
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
Introduction to the International Conventions Ratified on Controlled Drugs and Psychotropic Substances.
3
15 minutes
Presentation
The Requirements Under the International Treaties.
4
15 minutes
Presentation
The Drug Procurement/Distribution System.
5
30 minutes
Presentation
Regulation of Domestic Manufacture and Distribution of Controlled Substances
6
30 minutes
Presentation
Regulatory System for Importation/Exportation of Controlled Substances
7
5 minutes
Presentation
Key Points
8
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: Introduction to the International Conventions Ratified on Controlled Drugs and Psychotropic Substances. (15 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 5 minutes
Which convention regulates availability of opioids?
ALLOW few pairs to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMERIZE by using the content bellow
The 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol
(6, 8), is the principal international treaty regulating availability of opioids.
Methadone is regulated under the Single Convention. Buprenorphine is controlled under another international treaty.
The Convention on Psychotropic Substances, 1971; some of the controls to be applied to buprenorphine are therefore less strict than those applicable to narcotic drugs such as methadone. For example, imports and exports of buprenorphine need not to be reported to International Narcotics Control
Board (INCB) on a quarterly basis but only on annual basis (also see Section 2.2.3).
For practical purposes, however, it is not crucial to differentiate between the controls measures for methadone and buprenorphine, since, under the national legislation of many countries; buprenorphine tends to be controlled as a narcotic drug.
STEP 3: Requirements under the International Treaties (15 minutes)
This was the salient requirements under the international treaties,
The international treaties require that all individuals and enterprises in the procurement, manufacture and distribution system should be licensed or otherwise appropriately authorized, and that transfers of controlled substances take place only between properly registered parties. Patients may use controlled substances only according to a physician’s prescription. Records must be kept, and reports on consumption must be filed with the competent national authority.
These, along with security arrangements and inspections, are designed to prevent diversion from the legitimate system of drug distribution.
STEP 4: The Drug Procurement/Distribution System (15 minutes)
The drug procurement/distribution system
National estimates of medical need for controlled substances
Every year, competent national authorities prepare an estimate of the amount of controlled substances that will be needed in the country during the following calendar year. The estimate must be submitted to the International Narcotics
Control Board (INCB) by 30th June, that is, six months in advance of the year to which it applies. INCB notifies confirmed estimates by December of the same year.
The treaty requires the INCB to confirm the national estimate before the national government may permit the export of controlled substances to a country.
Under the Single Convention, the quantity of controlled substances manufactured in or imported into a country must not exceed the government’s official estimate of the amount needed.
When approved, the INCB publishes the list of the confirmed estimates for each country.
If an annual estimate proves to be inadequate, the competent national authority can submit supplementary estimates to INCB during the course of the year. In such circumstances the competent national authority has to provide an explanation of the circumstances necessitating the additional requirements. The updated totals of estimates of annual requirements for all countries are published on a monthly basis on the internet (at www.incb.org) and on a quarterly basis as hardcopies.
STEP 5: Mention Regulation of Domestic Manufacture and Distribution of Controlled Substances (30 minutes)
Some or all of the controlled substances needed may be manufactured by enterprises in the country itself; such enterprises need to be licensed by the government.
Regulation of manufacture of controlled substances includes the following;
Licensing; requirements for record-keeping and reporting; and quality control
Manufacturers need to provide resources for record-keeping, to provide secure facilities and maintain security procedures from the stage of acquisition of raw materials until the distribution of the finished products, in order to prevent diversion.
Regulation of distribution
A manufacturer may distribute the finished products directly to licensed pharmacies or hospitals, or they may be distributed by a wholesaler. Wholesalers must also be licensed by the competent national authority, and must obey rules concerning security and record-keeping.
The treaties do not require that health-care providers (when handling substances in their profession) or patients be licensed.
STEP 6: Mention the Regulatory System for Importation/exportation of Controlled Substances (30 minutes)
In this section the steps in the regulatory process applicable to the importation/exportation of controlled substances are outlined and illustrated with a figure. Section 3 combines these steps with the managerial processes involved. For a comprehensive understanding of the procurement process these two sections should be read in conjunction.
Specific practices/requirements may vary from country to country.
The regulatory system are;
Based on the requirement for a particular controlled substance communicated by the national program manager, the authorized importing agency applies to its competent national authority for an import certificate.
In certain countries where the competent national authority is an agency other than the pharmaceuticals regulatory authority, the importer is generally required to obtain approval from the pharmaceuticals regulatory authority before submitting an application for import certificate to the competent national authority.
In India, for instance, where the competent national authority is the Central Bureau of Narcotics (which is a part of the Department of Revenue, Ministry of Finance), the importer has to first obtain approval for import from the Drug Controller General (India) in the Ministry of Health.
The competent national authority considers whether the importing agency is properly licensed and whether the drug and amount are within the national estimate; if these are in order, the competent national authority issues an original import certificate/license along with a copy. If the confirmed estimate is inadequate, the competent national authority submits supplementary estimates to INCB.
The importer sends a copy of the import certificate to the agency proposing to export the substance.
The exporter applies to its competent national authority for an export certificate.
The competent national authority in the exporting country verifies that an import certificate has been issued and that the exporter is properly licensed; if the application is approved, the competent national authority issues an export certificate.
The competent national authority in the exporting country sends a copy of the export certificate to its counterpart competent national authority in the importing country.
The exporter ships the drugs to the importer, along with a copy of the export certificate.
The shipment must pass a customs inspection.
The importer sends a report to its competent national authority giving details of the products imported, as required by the competent national authority. It should be noted that many countries also have a certification procedure to prevent marketing of pharmaceutical products that are falsely labelled, counterfeit or substandard.
Reporting to INCB. Competent national authorities must report all imports and exports of controlled substances to the INCB every quarter. They are also required to make an annual inventory and report the total amount of controlled substances manufactured, consumed and in stock. The annual inventory does not include drugs stored in pharmacies, which for official purposes are considered to have been consumed. The INCB, in turn, uses these data to prepare reports and monitor global production and consumption of controlled substances
STEP 7: Key Points (5 minutes)
The international treaties require that all individuals and enterprises in the procurement, manufacture and distribution system of controlled substances should be licensed Patients may use controlled substances only according to a physician’s prescription
Records must be kept, and reports on consumption must be filed with the competent national authority
STEP 8: Evaluation (5 minutes)
Which convention regulates availability of opioids?
Which regulatory system regulates importation and exportation of controlled substances?
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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