Introduction to Procurement of Controlled Substances
Session 4: Introduction to Procurement of Controlled Substances
Total Session Time: 120 minutes
Prerequisites
None
Learning Tasks
By the end of this session students are expected to be able to:
Define controlled substances
Classify controlled substances
Explain the sections of the Tanzania Food and Cosmetics Act, 2003 regulating procurement of controlled drugs.
Mention the Requirements for storing controlled substance
Resources Needed:
Flip charts, marker pens, and masking tape
Black/white board and chalk/whiteboard markers
SESSION OVERVIEW
Step
Time
Activity/
Method
Content
1
05 minutes
Presentation
Introduction, Learning Tasks
2
10 minutes
Buzzing
Presentation
Definition of Controlled Substances
3
30 minutes
Presentation
Classification of Controlled Substances
4
50 minutes
Presentation
Sections of the Tanzania Food and Cosmetics Act, 2003 Regulating Procurement of Controlled Drugs.
5
15 minutes
Presentation
Requirements for Storing Controlled Substances
6
05 minutes
Presentation
Key Points
7
05 minutes
Presentation
Evaluation
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (05 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 Controlled Substances (10 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
What are the controlled 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
Controlled substances
The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or
“controlled drug or controlled medicine” means any narcotic drug, psychotropic substance or precursors as listed under Section 77 of the Act;
THE DRUGS AND PREVENTION OF ILLICIT TRAFFIC IN DRUGS ACT 1971
Every schedule requires finding and specifying the "potential for abuse" before a substance can be placed in that schedule. The specific classification of any given drug or other substance is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.
STEP 3: Classification of Controlled Substances (30 minutes)
The following is classification of controlled substances;
Schedule I controlled substances
Schedule II controlled substances
Schedule III controlled substances
Schedule IV controlled substances
Explanation of the above classification of controlled substances;
Schedule I controlled substances
Schedule I substances are those that have the following findings:
The drug or other substance has a high potential for abuse.
The drug or other substance has no currently accepted medical use in treatment
There is a lack of accepted safety for use of the drug or other substance under medical supervision foreexamples:
Marijuana (–)-trans-tetrahydrocannabinol – is the dried leaves, flowering parts, stems and seeds of the Indian hemp plant, Cannabis. The dried resin from the flowering part is called hashish. Marijuana is smoked in pipes and cigarettes, its effects last two to three hours producing a feeling of wellbeing, excitement, etc.
Heroin: (diacetylmorphine), which is used in some European countries as a potent pain reliever in terminal cancer patients, and as second option, after morphine it is about twice as potent, by weight, as morphine and, indeed, becomes morphine upon injection into the bloodstream.
Cathinone (an amphetamine-like stimulant found in the shrub Catha edulis (khat). Somali Tea, Miraa, Arabian Tea, miraa, muhulo and muirungi. Khat consumption induces mild euphoria and excitement, similar to that conferred by strong coffee. Individuals become very talkative under the influence of the plant. The effects of oral administration of cathinone occur more rapidly than the effects of amphetamine pills; roughly 15 minutes as compared to 30 minutes in amphetamine. Khat can induce manic behaviours and hyperactivity, similar in effects to those produced by amphetamine.
Schedule II controlled substances
Schedule II substances are those that have the following findings:
The drug or other substances have a high potential for abuse
The drug or other substances have currently accepted medical use in treatment, or currently accepted medical use with severe restrictions
Abuse of the drug or other substances may lead to severe psychological or physical dependence. For example;
Cocaine: used as a topical anaesthetic and to stop severe epistaxis
Amphetamine
Methamphetamine: Treatment of ADHD (rare), severe obesity (limited use)
Opium tincture (Laudanum): a potent antidiarrheal
Fentanyl and most other strong pure opioid agonists
Methadone: treatment of heroin addiction, extreme chronic pain
Oxycodone (semi-synthetic opioid; active ingredient)
Morphine
Schedule III controlled substances
Schedule III substances are those that have the following findings:
The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
The drug or other substance has a currently accepted medical use in treatment.
Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. Fore examples;
Anabolic steroids – testosterone
Buprenorphine
Dihydrocodeine
Ketamine etc
Schedule IV controlled substances
"Placement on schedules; findings required Schedule IV substances are those that have the following findings:
The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
The drug or other substance has a currently accepted medical use in treatment in the country.
Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. Drugs in this schedule include;
Benzodiazepines, such as clonazepam, diazepam (Valium), and Lorazepam
Chloral hydrate, a sedative-hypnotic
Long-acting barbiturates such as phenobarbital
Some partial agonist opioid analgesics, such as pentazocine.
Generally these controlled substances can be classified as follows:
Stimulants for example; Amphetamines, Nicotine and cocaine
Hallucinogens: for example; LSD (lysergic acid diethylamide), and Marijuana
Depressants: for example; opiates (Narcotics, viz Morphine, heroin, codeine), Barbiturates, Benzodiazepines and Alcohol.
STEP 4: Sections of the Tanzania Food and Cosmetics Act, 2003 Regulating Procurement of Controlled drugs. (50 minutes)
Section 51 (1) of the TFDA act, 2003 prescribes that a medicinal product shall be registered only if:
The availability of the medicine is in the public interest
The medicine is proved to be safe, efficacious and of acceptable quality
The premises and manufacturing operations comply with the current GMP requirements
The medicine complies with any other requirements as may be prescribed by the authority.
Restriction on dealing in products regulated under this Act
Section 22 (1) of the Act prohibits the sell, supply or importation of any drug unless it is registered in accordance with the provisions of the Act.
The person holds the appropriate license or permit required and issued by the Authority
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.
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
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.
73- (import and export of drugs, medical devices, herbal or poisons) (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 5: Requirements for Storing Controlled Substances (20 minutes)
The requirements of Premises, Facilities and storage areas in general for controlled substance are as follow;
Narcotic drugs procured from suppler shall be recorded and stored in a controlled drugs box/room inside the main Pharmacy of the hospital.
These drugs shall be kept under lock and key in which the key shall be kept by the pharmacist in charge
Damaged, empty or expired controlled drugs, shall be returned to the pharmacist in charge for authentication and recorded
Precautions must be taken to prevent unauthorized persons from entering storage areas.
Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of materials and products including controlled substances
Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits.
Storage areas should be clean, and free from accumulated waste and vermin. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas
Highly active and radioactive materials, narcotics and pharmaceutical products, as well as substances presenting special risks of abuse, should be stored in a dedicated area that is subject to appropriate additional safety and security measures.
Narcotic drugs should be stored in compliance with international conventions, and national laws and regulations on narcotics.
STEP 6: Key Points (5 minutes)
Controlled substances means any narcotic drug, psychotropic substance or precursors as listed under Section 77 of the drugs and prevention of illicit traffic in drugs act 1971
Controlled substances are classified into Schedule I, II, III, IV of controlled substances
STEP 7: Evaluation (5 minutes)
How do you classify controlled substances?
What are the requirements for storing 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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