Pharmaceutical Sciences Notes

NTA Level 5 • Semester 1 • PST05102 Sections of the Public Procurement Act, 2011 Regulating Procurement of Medicines and Medical Supplies Law and Policies in Pharmacy Practice • Source Session/Topic 1 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 1: Sections of the Public Procurement Act, 2011 Regulating Procurement of Medicines and Medical Supplies Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define the term procurement. Mention sections of the Public Procurement Act, 2011 regulating procurement of medicines and medical supplies. Give explanation of sections of the Public Procurement Act, 2011 regulating procurement of medicines and medical supplies. State the functions of the Public Procurement Policy. 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 Buzzing Presentation Definition of the Term Procurement. 3 60 minutes Presentation Explanation of Sections of the Public Procurement Act, 2011 Regulating Procurement of Medicines and Medical Supplies. 4 20 minutes Brainstorming Presentation Functions of the Public Procurement Policy. 5 10 minutes Presentation Key Points 6 10 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 the Term Procurement. (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes What is procurement? 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 Procurement means buying, purchasing, renting, leasing or otherwise acquiring any goods, works or services by a procuring entity and includes all functions that pertain to the obtaining of any goods, works or services, including description of requirements, selection and invitation of tenderers, preparation and award of contracts. STEP 3: Sections of the Public Procurement Act, 2011 Regulating Procurement of Medicines and Medical supplies. (20 minutes) Following are sections of the public procurement Act, 2011 which regulate procurement of medicines and medical supplies Section 43 – Third party procurement Section 51 – Qualification of tenderers Section 57 – Language Section 59 – Rejection of tenders Section 63 – Application of the basic principles of procurement and disposal Section 65 – Emergency procurement Section 43 – Third party procurement Where there is lack of technical capacity and, subject to the procedures laid down in the regulations, a procuring entity may engage the Agency or third party procurement services. The accounting officer of a procuring entity shall, in deciding to invite third party procurement services- Ensure that funds are available to pay in full and on time for those services; Follow the procedures laid down in the regulations. Section 51 – Qualification of tenderers Tenderers shall, in order to participate in procurement proceedings, have to qualify by meeting appropriate criteria set out in accordance with this Act and Regulations made under it. Local tenderers wishing to participate in any procurement proceeding shall satisfy all relevant requirements for registration with appropriate statutory bodies in Tanzania. Foreign tenderers wishing to participate in the proceedings are exempted from the requirement of subsection (2), but where as a result of the procurement proceedings, any foreign tenderers is selected as having submitted the lowest evaluated responsive tender or the best ranked proposal, such a tenderer shall register with the appropriate professional statutory body and shall be required to submit evidence of registration as an approved supplier, contractor or consultant in Tanzania. Section 57 – language Pre-qualification documents and tender documents shall be written in English and tenders shall be invited in that language except as provided for in subsection (2). Where a procuring entity has limited participation to national competitive tendering or to Tanzania nationals only, tender documents may be written in either Kiswahili language or English language and tenders may be requested for in either of the languages Section 59 – Rejection of tenders Tender documents and request for proposals may provide that procuring entities reject all tenders or all proposals. The rejection of all tenders or all proposals under this section shall be justified where- There is lack of effective competition; Tenders or proposals are not substantially responsive to the tender documents or to the request for proposals; The economic or technical data of the project have been altered; Tenders or proposals involve costs substantially higher than the original budget or estimates Exceptional circumstances render normal performance of the contract impossible; Tenders received contain serious irregularities resulting in interference with the normal play of market forces; or Funds voted or earmarked for the procurement have not been withheld, suspended or have otherwise not been made available. Section 63 – Application of the basic principles of procurement and disposal All public procurement and disposal by tender shall be conducted in accordance with the basic principles set out in this Act. Subject to this Act all procurement and disposal shall be conducted in a manner that maximizes competition and achieve economy, efficiency, transparency and value for money. 65 – Emergency procurement (1) Emergency procurement may be made where the accounting officer determines that it is in the public interest that goods, works or services be procured as a matter of urgency. (2) For the purpose of subsection (1), emergency procurement shall meet one of the following criteria: (a) compelling urgency that creates threat to life, health, welfare or safety of the public by reason of major natural disaster, epidemic, riot, war, fire or such other reasons of similar nature; (b) situation whereby, without the urgent procurement, the continued functioning of the Government or organization would suffer irreparable loss, the preservation or protection of

NTA Level 5 • Semester 1 • PST05102 Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies Law and Policies in Pharmacy Practice • Source Session/Topic 2 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 2: Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Give the general overview of Tanzania Food, Drugs and Cosmetics Authority (''TFDCA''). Define the term Food, Drug and Cosmetics. Mention sections of the Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies. Give explanation of sections of the Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies. 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 5 minutes Presentation Introduction to TFDCA. 3 20 minutes Buzzing Presentation Definition of the Terms Food, Drug, Medical Devices and Cosmetics 4 30 minutes Presentation Functions of the Tanzania Food, Drugs and Cosmetics Authority (TFDC) 5 50 minutes Presentation Explanation of Sections of the Tanzania Food, Drugs and Cosmetics Authority Act, 2003 Regulating Procurement of Medicines and Medical supplies. 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: Introduction to TFDCA (5 minutes) There is hereby established the Tanzania Food, Drugs and cosmetics Authority or by the acronym ''TFDCA''. Consign, convey or deliver for sale or authorise, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange supply or dispose of to any person whether for a consideration or otherwise. The Authority shall be an Executive Agency and shall operate in accordance with the Executive Agencies Act, 1997. The Authority shall have a common seal and the seal of the Authority shall be authenticated /valid by the signature of the Director General or m his absence any person acting on his behalf authorised by him in writing. STEP 3: Definition of the Terms Food, Drug, Medical Devices and Cosmetics (20 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question for 2 minutes Define the following terms; Food Drug Medical device Cosmetics 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 ''Food'' – means any article other than drugs, cosmetics and tobacco used as food or drink for human consumption and includes any substance used in manufacture or treatment of food. 'Drug'' ''Medicine'' or ''Pharmaceutical product'' – means any substance or mixture of substances manufactured, sold or presented for use in:- The diagnosis, treatment, mitigation or prevention of a disease, disorder, abdominal physical or mental state, or the symptoms thereof, in man or animal; Restoring, correcting or beneficial modification of organic or mental functions in man or animal; or Disinfection in premises in which food and drugs are manufactured, prepared or kept, hospitals, equipment and farm houses; Articles intended for use as a component of any articles specified in clause (a), (b) or (c); but does not include medical devices or their components, parts or accessories. ''Medical device'' or ''Devices'' – means, an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is – Recognized in the Official National Formulary, or Pharmacopoeia or any supplement to them; Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals or; Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principle intended purposes. Cosmetics are substances or products used to enhance or alter the appearance of the face or fragrance and texture of the body STEP 4: Functions of the Tanzania Food, Drugs and Cosmetics Authority (TFDC). (30 minutes) In according to section five of this Act, the Authority shall be the regulatory body for the products regulated under this Act, and shall in particular to:- Regulate all matters relating to quality, and safety of food, drugs, herbal drugs, medical devices, poisons and cosmetics; Regulate in accordance with this Act, the importation, manufacture, labelling, marking or identification, storages promotion, sell and distribution of food, drugs, cosmetics, herbal drugs and medical devices or any materials or substances used in the manufacture of products regulated under this Act; Ensure that evidence of existing and new adverse events, interactions and information about pharmacovigilance of products being monitored globally, are analyzed and acted upon; Ensure that, clinical trials on drugs, medical devices and herbal drugs are being conducted in accordance with prescribed standards; Foster co-operation between the Authority and other institutions or organizations and other stakeholders; Approve and register products regulated under this Act, manufactured within or imported into, and intended for use in the United Republic; Examine, grant, issue, suspend, cancel and revoke certificates and licenses or permits issued under this Act; Appoint inspectors and order inspection of any premises; Promote rational use of drugs, medical devices and herbal drug; Establish and maintain the Tanzania National Formulary and Tanzania Pharmacopoeia; Provide the public with unbiased information on products regulated under this Act; Prescribe standards of quality

NTA Level 5 • Semester 1 • PST05102 Medical Stores Department Act, 1993 Regulating Procurement of Medicines and Medical Supplies Law and Policies in Pharmacy Practice • Source Session/Topic 3 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 3: Medical Stores Department Act, 1993 Regulating Procurement of Medicines and Medical Supplies. Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Give explanation about MSD Give an overview on MSD Tender Board List advantages of zones and facility level at MSD Mention MSD Tendering methods List Source of procurement at MSD Mention Criteria Considered when awarding contracts List Functions of MSD Mention Sources of funds for procuring medicines at MSD Explain Quality assurance process at MSD Explain the Procurement challenges Explain on how Vertical Programs are run in MSD 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 MSD 3 10 minutes Presentation Advantages of Zones and Facility Level at MSD 4 50 minutes Presentation Source of Procurement at MSD 5 5 minutes Presentation Criteria Considered when Awarding Contracts 6 10 minutes Presentation Buzzing Functions of MSD 7 5 minutes Presentation Quality Assurance in MSD 8 10 minutes Presentation Vertical Programs in MSD 9 5 minutes Presentation Key Points 10 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 MSD (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes Why was MSD established? 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 Medical Stores Department (MSD) was established by the Act of Parliament No.13 of 1993 as an autonomous department under the Ministry of Health, Social Development, Gender, Elderly and Children responsible for developing, maintaining and managing an efficient and cost effective system of procurement, storage and distribution of approved medicines and medical supplies required for use by all public health facilities The Board of Trustees is the highest decision-making body that governs and sets the direction of MSD on behalf of the Ministry of Health, Social Development, Gender, Elderly and Children. The Board is comprised of nine (9) members appointed after every three years. The President of the United Republic of Tanzania appoints the Chairman while the Minister responsible for health appoints the rest (8) members. The Director General serves as the Secretary to the Board but has no right to vote Medical Store Department (MSD) mission is to make available at all times medicines, medical supplies and Laboratory reagents of acceptable quality at affordable price to all Tanzanians. We have served the nation for more than 20 years and continue to innovate by sharing ideas with all our stakeholders to ensure that their concerns are consistently understood and addressed with the objective of making our mission tangible, visible and felt among the Tanzanians who access our services. STEP 3: Advantages of Zones and Facility Level at MSD (10 minutes) The area managers are responsible for procurement at the zonal levels, while At the health facility level, different people procure medicines; this could be the supplies officer, Nursing Officer, Head of Facility, Pharmacist or RCH coordinator depending on the facility in question. Strategically MSD zones ware intended; To distribute medicines, medical supplies and laboratory reagents to Health facilities. Communicate with customers and provide information on the products availability. Attend customer complaints. Carry out market survey and advice on the rationality of MSD price catalogue for medicines and medical supplies. Promote sales of dormant and obsolete items and communicate new arrivals to customers. Provide Logistics and Support Services to customers. Sourcing special orders and follow up after sales services. Enhance compliance to delivery schedule and order fulfilment. Improve lead-time and reduce order-processing time. Ensure timely completion of transaction in the system to improve stock integrity. To be accessible seller and distributor of Medicines and Medical Supplies of right quality, price, quantity and at right time offering superior services to the customers. To improve services to our customers through shortens lead-time, increase stock availability, quality health commodities and stabilized working ERP System. To expand market, retain existing customers, revive dormant customers and enhance customers /stakeholders STEP 4: Source of Procurement at MSD (50 Minutes) Source of procurement at MSD International supplier e.g. procuring essential medicines, Antimalarial, Vaccines, and Contraceptives uses this source. International manufacturer e.g. HIV/AIDS medicines, condoms, and Contraceptives uses this source to procure medicines. Local Distributor e.g. essential medicines, HIV/AIDS medicines, Medicines for opportunistic infections and Medical supplies. Local Manufacturer e.g. essential medicines and medical supplies. MSD Procures Medicines, Medical Supplies and Laboratory Reagents on behalf of Public Health Facilities, Vertical Programs as well as Private Health Facilities approved by the Ministry of Health, Community Development, Gender, Elderly and Children. As core business fundamental, Procurement procedures as laid under the Public Procurement Act no.21 of 2004. MSD is the largest importer of which 80% of medicines, 90% of medical supplies and 100% laboratory supplies are imported from different countries across the world. From 2017, MSD procures its medicines and medical supplies direct from manufacturers instead of suppliers to ensure the improvement of medicines availability as well as lowering the medicine prices by half and quarter to some medicines of which most prices were before. MSD continues to collaborate with private sector to open local manufacturing industries as provided in Public Private Partnership Act, 2010. MSD envisages that this will enable the country at large to source

NTA Level 5 • Semester 1 • PST05102 Introduction to Procurement of Controlled Substances Law and Policies in Pharmacy Practice • Source Session/Topic 4 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 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

NTA Level 5 • Semester 1 • PST05102 Guidelines Governing Procurement of Controlled Substances Law and Policies in Pharmacy Practice • Source Session/Topic 5 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 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

NTA Level 5 • Semester 1 • PST05102 Requirements for Storing Controlled Substances Law and Policies in Pharmacy Practice • Source Session/Topic 6 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 6: Requirements for Storing 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 store for controlled substances Mention an authorized personnel and responsibilities for storing controlled substances List the storage requirements for controlled substance Mention the equipment for storing controlled substances List storage restriction for storing 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 5 minutes Presentation Definition store for Controlled Substances 3 30 minutes Presentation An Authorized Personnel and Responsibilities for Storing Controlled Substances 4 30 minutes Brainstorming Presentation The Storage Requirements and Equipments for Controlled Substance 5 30 minutes Presentation Buzzing Storage Restriction for Storing Controlled substances 6 10 minutes Presentation Key Points 7 10 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 Store for Controlled Substances (5 minutes) A store is a room where medicines are kept under lock and key for the security and safety of controlled substance. It is an area set aside into which all the items and materials required for production, sale/distribution are received, where they are housed for safekeeping, and from which they will be issued as required. Also refers to a service department headed by a store-keeper who is responsible for a proper storage, protection and issuing of controlled substance. Controlled substances must be stored securely. Controlled substances should be separated from other drugs or other hazardous chemicals. This practice will help to prevent loss by limiting access to only those who are assigned to work specifically with controlled substances. It is recommended that access be limited to a minimum number of approved personnel as possible. When in use, controlled substances should never be left unattended. STEP 3: Authorized Personnel and Responsibilities for Storing Controlled Substances (30 minutes) Authorized Personnel are individuals designated by the specific institution to access and work with controlled substances under a specific condition of Controlled Substance requirement. The authorized personnel responsibilities are as follows; Use controlled substance exclusively for the purpose stated in guidelines Maintain a secure storage location for controlled substance at all the time. Return controlled substance to the secure storage location when not in use. Record dispensation of any controlled substance in the log sheet. Do not share keys for room of controlled substance with non-authorized personnel. Report controlled substance inventory discrepancies, suspected misuse, or theft to the responsible in charge immediately. STEP 4: Storage Requirements and Equipments for Controlled Substances (30 minutes) Activity: Brainstorming (5 minutes) ASK students to brainstorm on the following question: What requirements and equipments are needed for storing controlled substances? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMERIZE by using the content bellow Storage and security of controlled substance require a coordinated approach that includes facility controls (e.g., camera surveillance), physical access controls (e.g., locks or biometric access technology), and frequent inventory checks and surveillance to allow discrepancies to be discovered in a timely manner. Key elements of controlled substance storage and security include the following; Controlled substance are stored in a locked and secured location (e.g. Automated dispensing devices, safe, locked cabinet/drawer) at all times unless in the direct physical control of an authorized individual. When implementing or assessing facility and physical access controls, the security and safety of controlled substance are taken into consideration. Storing controlled substance in transportable lock boxes or “fanny packs” is avoided. If used, such lock boxes follow the same requirements for storage, security, and chain-of custody controls as other inventory. Transportable lock boxes are not considered secure and are stored in a locked area accessible only to authorized personnel when not in use or otherwise unattended. Lock-out times for electronic locks on carts (e.g., medication or anesthesia carts) containing controlled substance are limited to the narrowest window of time that is appropriate for the particular setting. There is a defined process to ensure that only authorized individuals have access to controlled substances. Access to controlled substances. Storage areas is minimized and limited to authorized personnel. There is a complete assessment of all personnel with access privileges to ensure that only those permitted to access have access (i.e., currently employed, temporary employees, or licensed independent practitioners with privileges), and removal of access privileges occurs immediately upon separation. There are policies and procedures regarding controlled substances. Access, including restrictions through assignment, key controls, and the use of passwords. For automated dispensing devices, biometric identification with a user ID is preferred over passwords. Controlled substances cabinets and carts that are not automated dispensing devices are secured with an electronic lock that requires a user-specific biometric identification, code, or badge swipe. Access is recorded and retrievable for surveillance. Where traditional key lock security and manual inventory systems are used, there is a procedure to track keys, secure keys after hours, replace lost keys, and change locks. Any personnel authorized to have access to or prescribe controlled substances will be able to provide appropriate photo identification upon request. The physical plant should provide for monitoring of secure locations (e.g., video surveillance and recording), particularly in high-volume storage areas at risk for theft and diversion, such as the main pharmacy vault, inventory storage location, and packaging areas. Camera surveillance should be considered In locations where there is high risk for diversion, In locations where electronic or biometric access is not available, In remote locations, and To

NTA Level 5 • Semester 1 • PST05102 Strategies of Preventing Misuse of Controlled Substances Law and Policies in Pharmacy Practice • Source Session/Topic 7 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 7: Strategies of Preventing Misuse 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 the following terms used in preventing misuse of controlled substance. Drugs, Prevent, Drug prevention, Diversion and Drug diversion. Mention the aim of preventing misuse of controlled substances Explain the common risk areas and methods of misuse or diversion of controlled substances. Explain ways used to prevent misuse of controlled substances. Explain the effective prevention principles of misuse of 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 5 minutes Presentation Introduction, Learning Tasks 2 10 minutes Buzzing Presentation Definition of the Following terms Drugs Prevent Drug prevention Diversion and Drug diversion 3 10 minutes Presentation Aim of Preventing Misuse of Controlled Substances 4 20 minutes Buzzing Presentation The Common Risk Areas and Methods of Misuse or Diversion of Controlled Substances. 5 40 minutes Presentation Ways Used to Prevent Misuse of Controlled Substances. 6 30 minutes Presentation The Effective Prevention Principles of misuse of controlled substance. 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: Definition of Terms Used in this Session (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes What do the following terms mean? Drug Drug prevention Drug diversion 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 A drug is defined as a substance that changes the body in some ways. This includes controlled drugs, over-the-counter and prescribed medication, volatile substances, alcohol and tobacco. By definition, to “prevent” something means to stop something from happening. “Drug prevention” traditionally has referred to a range of activities, from regulation to education, with the aim of controlling the supply of drugs and reducing of the demand for them. Diversion The term includes any unaccountable loss, theft, and use for unintended purposes, or tampering of a drug. For purposes of this session, drug diversion is a medical and legal concept involving the transfer of any legally prescribed drug from the individual for whom it was prescribed to another person for any illicit use, including any deviation that removes a prescription drug from its intended path from the manufacturer to the intended patient. STEP 3: Aim of Preventing Misuse of Controlled Substances (10 minutes) The aim of preventing misuse of controlled substances are; To prevent misuse of initial use of controlled substances, To delay ill-use beginning of use of controlled substances, To providing wider support and reducing the repertoire of risk and problematic behaviours of misuse of controlled substance. To promote cessation of misuse controlled substances and To reduce harms resulting from misuse of controlled substances. STEP 4: The Common Risk areas and Methods of Misuse or Diversion of Controlled Substances. (20 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes Which are the common risk areas of misuse or diversion of 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 Examples of common risk points and methods of misuse or diversion of Controlled Substances are divided in five ways shown below; Procurement. Purchase order and packing slip removed from records, Unauthorized individual orders for Controlled Substances on stolen Drug, Enforcement Administration Form 222 and Product container is compromised. Preparation and Dispensing. Controlled Substances are replaced by product of similar appearance when pre-packaging, Removing volume from pre-mixed infusion, Multi-dose vial overfill diverted and Prepared syringe contents are replaced with saline solution. Prescribing. Prescription pads are diverted and forged to obtain Controlled Substances, Prescriber self-prescribes Controlled Substances, Verbal orders for Controlled Substances created but not verified by prescriber and Written prescriptions altered by patients. Administration. Controlled Substances are withdrawn from an Automated Distribution Device (ADD) on discharged or transferred patient, Medication documented as given, but not administered to patient, Waste is not adequately witnessed and subsequently diverted and Substitute drug is removed and administered while Controlled Substances is diverted. Waste and Removal. Controlled Substances waste is removed from unsecure waste container, Controlled Substances waste in syringe is replaced with saline and Expired Controlled Substances are diverted from holding area. STEP 5: Explanations of Ways Used to Prevent Misuse of Controlled Substances in Pharmacy. (40 minutes) We can prevent misuse of controlled substance in our pharmacy by controlling the following; Procurement Controls All controlled substance are procured from the pharmacy. If other departments or individuals are authorized to procure controlled substance, there are checks and balances established to ensure the same policies and procedures are consistently followed throughout the organization. The number of people authorized to order controlled substance is limited to individuals authorized and defined by policy. Electronic controlled substance ordering system (CSOS) is used and controlled substance ordering system (CSOS) order files are backed up to an organization based system to ensure that archived files are readily retrievable by designated personnel. Separation of duties exists between the ordering and receipt of controlled substance. Two authorized individuals count and sign (two signatures) for controlled substance upon receipt (packing slip) and confirm that what is received matches what was ordered and invoiced

NTA Level 5 • Semester 1 • PST05102 Drugs and Prevention of Illicit Drugs Traffic Act, s Governing Distribution and Use of Controlled Substances Law and Policies in Pharmacy Practice • Source Session/Topic 8 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 8: Drugs and Prevention of Illicit Drugs Traffic Act, s Governing Distribution and Use 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: Explain a term Illicit Drugs Traffic Mention the Act, which explain Prevention of Illicit Drugs Traffic governing distribution and use of controlled substances. List international conventions on drugs control List the United Nations bodies for drugs control 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 Illicit Drugs Traffic 3 30 minutes Presentation The Act, Which Explain Prevention of Illicit Drugs Traffic Governing 4 30 minutes Presentation International Conventions on Drugs Control 5 20 minutes Presentation The United Nations Bodies for Drugs Control 6 15 minutes Presentation Buzzing 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: Explanation of a Term Illicit Drugs Traffic (15 minutes) Illicit trafficking in narcotic drugs and psychotropic substances is an international term that includes many offences involving narcotic drugs and psychotropic substances such as the production, cultivation, import, smuggling and promotion. The term extends to include crimes related to the tools and means of transportation used in the commission of the offences and the diversion of precursors and chemicals used in the illicit manufacture of narcotic drugs and psychotropic substances as well as crimes related to proceeds used in or resulting from illicit trafficking according to Article (3) of the United Nations Convention Against Illicit trafficking in Narcotic Drugs and Psychotropic Substances (1988) (Vienna Convention) and Article (2) of the Arab Convention Against Illicit Trafficking in Narcotic Drugs and Psychotropic Substances (1994). The narcotic drugs and psychotropic substances problem has become one of the world's major issues. In the past, the problem of drugs trafficking was of concern only to a limited number of countries that suffered there from, but nowadays it is threatening all people and the entire global community; the countries that do not have a drug problem are only an exception. The international nature of illicit trafficking in narcotic drugs and psychotropic substances is evident in the cultivation and production of drugs in many countries as well as smuggling them across another country to be consumed in a third one. It is clear that the large funds generated from illicit trafficking in narcotic drugs and psychotropic substances and the trend of criminal groups in laundering these proceeds and giving them licit source, result in damaging national economies of countries. The laundered funds cause destabilization of the economy as they move quickly from one country to another to be spent as legitimate funds. Furthermore, the proceeds of illicit trafficking in drugs and psychotropic substances lead to social and economic disruption at the same time, where some people become wealthy without working or making an effort. This exacerbates unequal income distribution. STEP 3: Explanations of the Act which Prevent of Illicit Drugs Traffic Governing Distribution and Use of Controlled Substances. (30 minutes) The United Nations Convention against Illicit trafficking in Narcotic Drugs and Psychotropic Substances, 1988 included international legal provisions and countries' obligations with respect to illicit trafficking. Article 3 of the Convention required each Party to adopt such measures, as may be necessary, to establish the following acts, as criminal offences under its domestic law, when committed intentionally: (1)The production, manufacture, extraction, preparation, offering, offering for sale, distribution, sale, delivery on any terms whatsoever, brokerage, dispatch, dispatch in transit, transport, import or export of any narcotic drugs or any psychotropic substance contrary to the provisions of the 1961 Convention, the 1961 Convention as amended or the 1971 Convention. The cultivation of opium poppy, coca bush or cannabis plant for the purpose of the production of narcotic drugs contrary to the provisions of the 1961 Convention and the 1961 Convention as amended. The possession or purchase of any narcotic drug or psychotropic substance for the purpose of any of the activities enumerated in (1) above. The manufacture, transport or distribution of equipment, materials or of substances listed in Schedule I and Schedule II, knowing that they are to be used in or for the illicit cultivation, production or manufacture of narcotic drugs or psychotropic substances. The organization, management or financing of any of the offences enumerated in (1), (2), (3) or (4) above (1) The conversion or transfer of property, knowing that such property is derived from any offence or offences established in accordance with subparagraph (a) of this paragraph, or from an act of participation in such offence or offences, for the purpose of concealing or disguising the illicit origin of the property or of assisting any person who is involved in the commission of such an offence or offences to evade the legal consequences of his actions. The concealment or disguise of the true nature, source, location, disposition, movement, rights with respect to, or ownership of property, knowing that such property is derived from an offence or offences established in accordance with subparagraph (a) of this paragraph or from an act of participation in such an offence or offences. Subject to its constitutional principles and the basic concepts of its legal system: The acquisition, possession or use of funds, knowing at the time of receipt, that such funds were derived from an offence or offences established in accordance with subparagraph (a) of

NTA Level 5 • Semester 1 • PST05102 Drugs and Prevention of Illicit Traffic in Drugs Act, 1995 that Explains the Handling of Controlled Medicines Law and Policies in Pharmacy Practice • Source Session/Topic 9 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 9: Drugs and Prevention of Illicit Traffic in Drugs Act, 1995 that Explains the Handling of Controlled Medicines Total Session Time: 120 minutes Prerequisites None Students Learning Tasks By the end of this session students are expected to be able to: Give Introduction on the drugs and prevention of illicit traffic in drugs Act Mention the sections of the Act, 1995 that explain the handling of controlled medicines. Mention source of the fund for control of drug and prevention of illicit traffic. Mention sections which Prevention on holding illicitly control of drug/medicine. 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 on the Drugs and Prevention of Illicit Traffic in Drugs Act. 3 30 minutes Presentation The Section of the Act, 1995 that explain the handling of controlled medicines. 4 20 minutes Presentation Source of the Fund for Control of Drug and Prevention of Illicit Traffic. 5 30 minutes Presentation Sections which Prevention on Holding Illicitly Control of Drug/Medicine 6 15 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. Mention the section of the Act, 1995 that explain the handling of controlled medicines. STEP 2: Introduction to the Drugs and Prevention of Illicit Traffic in Drugs Act.(15 minutes) Activity: Buzzing (20 minutes) ASK students to pair up and buzz on the following question for 2 minutes What do you know about Drugs and Prevention of illicit drugs Act? 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 The drugs and prevention of illicit traffic, is an Act to consolidate the law relating to controlled drugs; To make provision for the control and regulation of operations relating to controlled drugs and psychotropic substances; And also to provide for the forfeiture of property derived from or used in illicit traffic in narcotic drugs and psychotropic substances; To provide for the prevention of illicit traffic in narcotic drugs and psychotropic substances and to implement the provisions of the International Convention on Narcotic Drugs and Psychotropic Substances. STEP 3: Section of the Act, 1995 that Explains the Handling of Controlled Medicines. (30 minutes) Section 78. Application of the Drugs and Prevention of Illicit Traffic in Drug Act. Subsection (I) Without derogating the provisions of the Drugs and Prevention Of Illicit Traffic in Drugs Act, 1995, no person shall manufacture, pose unless he complies with the provisions of this Act Subsection (2) The provisions of the Drugs and Prevention of Illicit Traffic in Drugs Act, 1995 in relation to offences and penalties shall apply mutatis mutandis to offences committed under this Act. Subsection (3) The provisions of this Act, shall be in addition to and not in derogation of the Drugs and Prevention of Illicit Traffic in Drugs Act, 1995, or any other written laws having functions similar to those specified under this Act. Subsection (4) Notwithstanding the provision of subsection (6), any person who contravenes or fails to comply with any provisions or regulation under this Act relating to the keeping of books or the issuing, or dispensing of Prescriptions containing controlled drugs to which this Act applies, commits an offence and shall upon conviction be liable to a fine of not less than fifty thousand shillings, or to imprisonment for a period not exceeding six months or to both such fine and imprisonment. STEP 4: Source of the Fund for Control of Drug/Medicine(30 minutes) Section 11. – The fund for control of drug abuse Sub (1) The Commission shall, by notice published in the Gazette, constitute a Fund to be known as the Fund for Control of Drug Abuse and there shall be credited thereto- A sum of money allocated to the Fund by the Parliament; The sale proceeds of any property forfeited under Part VI; Any grants that may be made by any person or institution; Any income from investment of the amounts credited to the Fund under the provisions of this Act Sub (2) The Fund shall be applied by the Commission to meet the expenditure incurred in connection with the measures taken for combating illicit traffic in or controlling abuse of narcotic drugs and psychotropic substances. Sub (3) The Anti-Drug Commissioner shall advise the Commission in regard to the application of the Fund. STEP 5: Sections which Prevention on Holding Illicitly Control of Drug/Medicine (30 minutes) Section 47. Prohibition on holding illegally acquired property Sub (1) No person shall hold any illegally acquired property either by himself or through any other person on his behalf. Sub (2) where any person holds any illegally acquired property in contravention of the provisions of subsection (1), such property shall be forfeited to the Commission in accordance with Part IV of the Proceeds of Crime Act. Sub (3) No property shall be forfeited under this Part if such property was acquired by a person to whom this Act applied before a period of three years from the date on which he was charged for an offence relating to illicit traffic. Section 48. Commissioner to authorise investigation or survey Sub (1) The Commission may authorise any officer to inquire, investigate or survey any person or group of persons as it may by order or direct and such officer shall on receipt