PST05102 Law and Policies in Pharmacy Practice

NTA Level 5 • Semester 1 • PST05102 Drugs and Prevention of Illicit Drugs Traffic Act, 1997 on controlled substances Law and Policies in Pharmacy Practice • Source Session/Topic 11 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 11: Drugs and Prevention of Illicit Drugs Traffic Act, 1997 on controlled substances Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Give overview of this Act, 1997 Describe a Trafficking of controlled substances Mention section which prohibit possession and trafficking of narcotic drugs and psychotropic substances and cultivation of certain plants Explain the sections which prohibit possession and trafficking of narcotic drugs and psychotropic substances and cultivation of certain plants 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 Overview of this Act, 1997 3 10 minutes Buzzing Presentation Trafficking of Controlled Substances 4 30 minutes Presentation Section which Prohibit Possession and Trafficking of Narcotic Drugs and Psychotropic Substances and Cultivation of Certain Plants 5 50 minutes Presentation Explanations of the Sections which Prohibit Possession and Trafficking of Narcotic Drugs and Psychotropic Substances and Cultivation of Certain Plants 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: Overview of this Act, 1997 (15 minutes) An Act to consolidate the law relating to narcotic drugs; to make provision for the control and regulation of operations relating to narcotic drugs and psychotropic substances; 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: Trafficking of Controlled Substances (10 minutes) Activity: Buzzing (20 minutes) ASK students to pair up and buzz on the following question for 2 minutes What is trafficking? 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 "Trafficking" means the importation, exportation, manufacture, buying, sale, giving, supplying, storing, administering, conveyance, delivery or distribution, by any person of narcotic drug or psychotropic substance any substance represented or held out by that person to be a narcotic drug or psychotropic substance or making of any offer but does not include- the importation or exportation of any narcotic drugs or psychotropic substance or the making of any offer by or on behalf of any person who holds a licence under this act in accordance with the licence; the manufacture, buying, sale, giving, supplying, administering, conveying, delivery or distribution of any narcotic drug or psychotropic substance or the making of any offer by or on behalf of any person who has a licence under this Act; the selling or supplying or administering for medical purposes, and in accordance with the provisions of this Act, or the making of any offer by a medical practitioner or veterinary surgeon or dentist or by any other person qualified to do so on the instructions of the medical practitioner, veterinary surgeon or dentist; the selling or supplying in accordance with the provisions of this Act of any narcotic drugs or psychotropic substance by a registered pharmacist; "Use" in relation to narcotic drugs and psychotropic substances, means any substance specified in the Schedule or anything which contains any substance specified in that Schedule. STEP 4: Sections which Prohibit Possession and Trafficking of Narcotic Drugs and Psychotropic Substances and Cultivation of Certain Plants. (30 minutes) The following are the section which prohibition of possession and trafficking of narcotic drugs and psychotropic substances and cultivation of certain plants. Section 12 – Prohibition of cultivation of certain plants and substances. Section 13 – Power of the Commission to permit, control and regulate the cultivation, production or sale, etc., of opium, coca leaves, etc. Section 14 – Narcotic drugs and psychotropic substances not to be subject to distress or attachment. Section 15 – Restrictions on dealings in narcotic drugs and psychotropic substances. Section 16 – Penalty for possession, purchase, manufacture, etc., of narcotic drugs, etc. Section 17 – Penalty in respect of possession, use of small quantity of narcotic drugs and psychotropic substances. Section 18 – Penalty in contravention of section 17. Section 29 – Release of certain addicts for the purpose of undergoing treatment. Section 44 – Presumption as to document in certain cases Section 56 – Power of the Government to establish centres for identification treatment, etc., of addicts and for supply of narcotic drugs. Section 62 – Application of the Pharmaceutical and Poisons Act barred STEP 5: Explanations of the Sections which Prohibit Possession and Trafficking of Narcotic Drugs and Psychotropic Substances and Cultivation of Certain Plants. (50 minutes) Section 12 – Prohibition of cultivation of certain plants and substances. Any person who- cultivates any cannabis, coca plant or gathers any portion of coca plant; cultivates papaver somniferous (opium poppy) or papaver setigerum; being the owner, occupier or concerned in the management of any premises, permits the premises to be used for cultivation, gathering or production of any drugs referred to in paragraphs (a) and (b); produces, possesses, transports, imports into the United Republic sells, purchases, uses or does any act or omits to do anything in respect of poppy straw, cocaplants, coca leaves, prepared opium, opium poppy, cannabis, manufactured drug or any preparation containing any manufactured drug, psychotropic substance, narcotic drug, such act or omission amounting to contravention of the provisions of this Act

NTA Level 5 • Semester 1 • PST05102 Tanzania Food and Cosmetics Act, 2003 Regulating Distribution and Use of Medicines and Medical Supplies Law and Policies in Pharmacy Practice • Source Session/Topic 20 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 20: Tanzania Food and Cosmetics Act, 2003 Regulating Distribution and Use of Medicines and Medical Supplies Total Session Time: 60 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define Distribution of medicine and medical supplies Medicine administer Explain sections in TFDC Act, 2003 which regulates distribution, use 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 15 minutes Buzzing Presentation Definition of Distribution and Administration of Medicines and Medical Supplier 3 30 minutes Presentation Explanation of Sections in TFDC Act, 2003 which Regulate Distribution, Use of Medicines and Medical Supplies. 4 5 minutes Presentation Key Points 5 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. (15 minutes) Activity: Buzzing (20 minutes) ASK students to pair up and buzz on the following question for 2 minutes What does distribution of medicines mean? What is administration of medicines and medical supplies? 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 Distribution – means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicine, medical devices, food, cosmetics and veterinary medicines.(Pharmacy Act,2011) Administer – means administering of substance or article to a human being or an animal whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not and any reference in this Act to administering a substance or article shall be construed as a reference to administering it either in its existing state or after it has been dissolved or dispersed in, sprayed, or diluted or mixed with, some other substance used as a vehicle for such administration.(TFDC Act,2003) STEP 3: Sections in TFDC Act, 2003 which Regulate Distribution, Use of Medicines and Medical Supplies. (45 minutes) Section 24- supplying and dispensing drugs Subsection (1) A medical practitioner, dentist or veterinary surgeon, or a member of the staff of a hospital, dispensary or similar institution who has been authorized to do so by the general or special order of the Minister, on the advice of the Authority may supply or dispense a prescription drug for the purpose of medical, dental or veterinary treatment, as the case may be, subject to the following conditions – The drug shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed; The following particulars shall, within twenty four hours after the drug has been supplied or dispensed, be entered in a book used Regularly for the purpose, and which shall be called the Prescription Book the date on which the drug was supplied or dispensed; the name, strength and the quantity supplied; the name and address of the person to whom the drug was supplied; The name and address of the person by whom the prescription was given. Subsection (2) where an authorized seller of drugs supplies a prescription drugs, shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section. Subsection (3) Any person to whom subsection (1) applies and who supplies or dispenses any prescription drug in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not less than one hundred thousand shillings or to imprisonment for a term not exceeding one month, or to both such fine and imprisonment. Section 26.Licence to sell, supply or dispense. Subsection (1) Notwithstanding any of the provisions of this Act, relating to sell, supply or dispensing of drugs and if it is in the public interest so to do, the Minister may, on advise of the Authority and by order published in the Gazette, allow any person or group of persons to be licensed by the Authority to sell, supply or dispense such drugs as may be specified and under such conditions as may be prescribed in the regulations. Subsection (2) The Minister may in addition to any other conditions, require such a person to possess specified qualifications or training as the case may be. Section 27.Authority to issue dispensing certificate specified drugs. Subsection (l) The Authority may, when it is in the public interest and upon an application being made in a prescribed manner and subject to such conditions as may be prescribed in the regulations made under this Act, issue a dispensing certificate to a practicing medical practitioner, dentist or veterinary surgeon to dispense drugs, which he is entitled to prescribe. Subsection (2) upon application being made to the Authority pursuant to subsection (1), the Authority may issue a dispensing certificate subject to such conditions as it may deem necessary and for such duration of time as it may prescribe. Subsection (3) The Authority may, where it is satisfied that the applicant did not or is not fulfilling the conditions issued by it may suspend, revoke or withdraw the dispensing certificate issued under subsection (1) of this section Subsection (4) in this section ''public interest'' means and includes facilitation of accessibility of the public to drugs within a specified area. Section 86. No cosmetics shall be sold, given, manufactured, imported, stored or

NTA Level 5 • Semester 1 • PST05102 Procedures for Issuing Prescription Only Medicines in Emergency Situations Law and Policies in Pharmacy Practice • Source Session/Topic 19 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 19: Procedures for Issuing Prescription Only Medicines in Emergency Situations Total Session Time: 60 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Mention procedures for issuing prescription only medicines in emergency situations Understand exemptions in cases of forged prescriptions for prescription only medicines. 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 35 minutes Presentation Buzzing Procedure for Issuing Prescription Only Medicines in Emergency Situations 3 10 minutes Presentation Exemptions in Cases of Forged Prescriptions for Prescription only Medicines 5 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: Procedure for Issuing Prescription Only Medicines in Emergency Situations (30 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question for 2 minutes What are the procedures for issuing prescription only medicines in emergency situation? 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 following are procedure for issuing prescription only medicines in emergency situations according to the pharmacy Act 2011: section 41; Section 41- Exception when supplying / distribution and dispensing medicine. Subsection (1) Exception when supplying and dispensing medicines issuing prescription only medicines in emergency situations. A situation of emergency can arise where the prescription only medicines are required, this section therefore allows a medical practitioner, dentist, or veterinary or member of hospital staff and in the order from the minister and advice from the council supply medicines for the purpose of medical, dental or veterinary treatment subject to the following conditions; The medicine shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed; The following particulars shall, within twenty four hours after the medicine has been supplied or dispensed, be entered in a book used regularly for the purpose, and which shall be called the Prescription Book- The date on which the medicine was supplied or dispensed; The name, strength and the quantity supplied; The name and address of the person to whom the medicine was supplied; The name and address of the person by whom the prescription was made; and Name and address of a prescriber or prescribing health facility. Subsection (2) where an authorized seller of medicines supplies a prescription medicine shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section. Subsection (3) any person to whom subsection (1) applies and who supplies or dispenses any prescription medicine in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not more than one million shillings or to imprisonment, for term not exceeding six months or to both. In addition when a pharmaceutical personnel issuing prescription only medicines in emergency situations and if there is a possibilities must interview the patient, preferably face to face and if the pharmacist must be satisfied that there is an immediate need for the prescription-only medicine (POM) and that it is not practical for the patient to obtain a prescription without undue delay and then continuous with procedure stated in pharmacy Act, 2011, section 41, subsection (1) and (2). STEP 3: Exemptions in Cases of Forged Prescriptions. (20 minutes) The restrictions on sale and supply shall not apply to the sale and supply of a prescription only medicine by a pharmaceutical personnel in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine. STEP 6: Key Points (5 minutes) Right procedures have to be followed when issuing prescription only medicines in emergency situations Exemptions in cases of forged prescriptions for prescription only medicines. STEP 7: Evaluation (5 minutes) What are the procedures for issuing prescription only medicines in emergency situations? 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-salaamCooper and Gunns, Eds (1987). Dispensing for Pharmaceutical Students, (12th Ed). CBS Publishers and Distributors; Delhi. ← Previous TopicNext Topic →View all Law and Policies in Pharmacy Practice topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

NTA Level 5 • Semester 1 • PST05102 Pharmacy Act, 2011 Regulating the Use and Sale of Prescription Only Medicines Law and Policies in Pharmacy Practice • Source Session/Topic 18 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 18: Pharmacy Act, 2011 Regulating the Use and Sale of Prescription Only Medicines Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define prescription only medicines Explain sections of the Acts, which regulate use and sale of prescription only medicines. Mention requirements of valid prescription only medicines. 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 Definition of Prescription Only Medicines 3 45 minutes Presentation Sections of the Acts, which Regulate Use and Sale of Prescription Only Medicines. 4 45 minutes Presentation Requirements of Valid Prescription Only Medicines. 5 5 minutes Presentation Key Points 6 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 Prescription Only Medicines (15 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question for 2 minutes What are the prescription only medicines? 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 “Prescription only Medicines” means any drug product required to be dispensed only upon a prescription given by a veterinarian, medical practitioner, dentist or any other person approved by the Minister; STEP 3: Sections of the Acts, which Regulate Use and Sale of Prescription Only Medicines.(45 minutes) Section 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. Pharmacy Act 2011: 41(1) Exception when supplying and dispensing medicines. A medical practitioner, dentist or veterinary surgeon or member of the staff of hospital, health centre, dispensary or similar institution who has been authorized to do so by the general or special order of the minister , on the advice of the council, may supply or dispense a prescription medicine for the purpose of medical, dental or veterinary treatment subject to the following conditions; The medicine shall be distinctly labeled with the name and address of the person by whom it is supplied or dispensed; The following particulars shall, within twenty four hours after the medicine has been supplied or dispensed, be entered in a book used regularly for the purpose, and which shall be called the Prescription Book- The date on which the medicine was supplied or dispensed; The name, strength and the quantity supplied; The name and address of the person to whom the medicine was supplied; The name and address of the person by whom the prescription was made; and Name and address of a prescriber or prescribing health facility. Subsection (2) – Where an authorized seller of medicines supplies prescription medicines shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section. Subsection (3) – Any person to whom subsection (1) applies and who supplies or dispenses any prescription medicine in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not more than one million shillings or to imprisonment, for term not exceeding six months or to both. Section 5 – (2) National Drug Control Council: There should be national Drug Control council which includes the following: Minister responsible for legal affairs Minister responsible for home affairs Minister responsible for health Minister responsible for foreign affairs Minister responsible for finance Minister responsible for youth development Minister responsible for education Minister responsible for agriculture Minister responsible for transport Minister responsible for Community Development Section 11- Prohibition of Cultivation of Certain Plants and Substances. Subsection (1) Any person who- Cultivates any prohibited plant Possess or supplies seeds for production of drugs being the owner, occupier or concerned in the management of any premises, permits the premises to be used for cultivation of any prohibited plant produces, possesses, sells, purchase, transports, imports into the Mainland Tanzania exports, uses or does any act or omits to do anything in respect to prohibited plants, which act or omission amounting to contravention of this Act Commits an offence and upon conviction shall be liable to a imprisonment for a term not less than thirty years The Tanzania Food, Drugs And Cosmetics Act,2003 (Scheduling Of Medicines) Regulations, 2015 Section 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. 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 Section 73– import and export of drugs, medical devices, herbal or poisons Subsection (1) No person, other than a person issued with a license or permit

NTA Level 5 • Semester 1 • PST05102 Introduction to Prescription Only Medicines Law and Policies in Pharmacy Practice • Source Session/Topic 17 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 17: Introduction to Prescription Only Medicines Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define prescription only medicine Mention appropriate practitioners for writing prescription only medicine Outline the conditions regulating handling of prescription only 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 10 minutes Presentation Buzzing Definition of Prescription Only Medicine 3 15 minutes Presentation Appropriate Practitioners for Writing Prescription Only Medicine 4 40 minutes Presentation Medicinal Products on Prescription Only Medicines 5 40 minutes Presentation Conditions Regulating Handling of Prescription Only Medicine 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 of A Prescription Only Medicine (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes What is prescription only medicine?? 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 treatment that must be prescribed by a doctor and is not licensed for sale to the general public. A prescription medication is a licensed medicine that is regulated by law to necessitate a medical prescription before it can be obtained. The term is used to differentiate it from over-the-counter drugs which can be accessed without a prescription. Different jurisdictions have different interpretations of what constitutes a prescription drug. STEP 3: Appropriate Practitioners for Writing Prescription Only Medicine.(15 minutes) For the purposes of section ( ) of the Act ( )medicinal products on prescription only, doctors, dentists and veterinary surgeons shall be appropriate practitioners in relation to all prescription only medicines. STEP 4: Medicinal Products on Prescription Only Medicines. (40 minutes) 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. "prohibited plant" means cannabis, coca plant, papaver somniferum (opium poppy) and papaver setigerum; "drugs" means the narcotic drugs and psychotropic substances specified in the Schedule; "chemical precursors" means a substance frequently used in the illicit manufacture of narcotic drugs or psychotropic substances as defined in Article 12 of the UN Convention Against Illicit Drugs and Psychotropic Substances mentioned in Table I and Table II as provided for in the Second Schedule to this Act; TABLE I – contain the following products; Ephedrine Ergometrine Ergotamine Lysergic acid Ethyl ether 1-phenyl-2-propanone Pseudoephedrine Piperidine TABLE II – contain the following products; Acetic anhydride Acetone Anthranilic acid Phertylacetic acid STEP 5: Conditions Regulating Handling of Prescription Only Medicines. (40 minutes) A prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by a practitioner unless the conditions are specified. These conditions are The prescription shall be in writing and signed by the practitioner giving it with his usual signature and dated by him; The prescription shall contain the following particulars: The address of the practitioner giving it; Where the practitioner giving it is a doctor or dentist, the name and address of the person for whose treatment is given; Where the practitioner giving it is a veterinary surgeon, the name and address of the person to whom the prescription only medicine is to be delivered; Where the practitioner giving it is a dentist or a veterinary surgeon, a declaration by the practitioner that the prescription is “For dental treatment only” or “For animal treatment only”, as the case may be; and Indicate the total amount of the prescription only medicine to be supplied and the dose to be taken; In the case where the prescription does not specify whether it is a repeatable prescription or not, the prescription shall not be dispensed more than once; In the case of a repeatable prescription that does not specify the number of times it may be dispensed, it shall not be dispensed more than 3 times; In the case of a repeatable prescription that does not specify the time period between which the next dispensing may take place, it shall not be dispensed more than once in 3 days; At the time of dispensing, the person dispensing the prescription shall note on the face of the prescription, above the signature of the practitioner, the name and address of the person dispensing it and the date on which the prescription is dispensed; and In the case of a repeated prescription, if the prescription is being dispensed for the last time, it shall be retained after dispensation by the person dispensing it. The restrictions imposed by (restrictions on sale and supply) shall not apply to a sale and supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified is not fulfilled, where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is fulfilled in relation to that sale or supply. STEP 6: Key Points (5 minutes) A prescription only medication is a licensed medicine that is regulated by law to necessitate a medical prescription before it can be obtained Doctors, dentists and veterinary surgeons shall be appropriate practitioners in relation to all prescription only medicines. STEP 7: Evaluation (5

NTA Level 5 • Semester 1 • PST05102 Procurement Procedure for Vertical Program Medicines Law and Policies in Pharmacy Practice • Source Session/Topic 16 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 16: Procurement Procedure for Vertical Program Medicines Total Session Time: 120 minutes + X hours of Field trip/Assignment/ Tutorial Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Mention ways of procuring health services. List Sources of fund for procurement of vertical Programs. List of health products obtained from vertical programs. State Procurement principles for Vertical Program Medicines 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 25 minutes Presentation Buzzing Ways of procurement health services. 3 30 minutes Presentation Source of fund for Procurement of Vertical Program. 4 20 minutes Presentation Health Products Obtained from Vertical Program. 5 30 minutes Presentation Procurement Principles for Vertical Program Medicines Presentation 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: Ways of Procurement of Health Services. (25 minutes) Health services (curative and preventive) can be provided using two modes of delivery: horizontal and vertical. By horizontal delivery; all services that are delivered through public financed health systems and are commonly referred as comprehensive primary care (WHO 1978). Vertical delivery of health services implies a selective targeting of specific interventions not fully integrated in health systems (Banerji 1984; Rifkin and Walt 1986). STEP 3: Source of Fund for Procurement of Vertical Program in Tanzania. (30 minutes) Vertical program in Tanzania receive fund from government and support from various development partners. It’s MSD role to ensure the availability of Vertical Program medicines and medical supplies in all health facilities across the country. The Procurement, Storage and Distribution of the commodities strengthened resulted into increase the availability of ARV medicines, Reproductive supplies, TB /leprosy drugs and other drugs to treat emerging infections. On the other hand MSD receives Health commodities under the support from various development partners such as :- Global Fund, UNICEF, WHO and USAID. All partners either bring in specific health commodities to supplement GOT commodities or direct support in terms of fund for procurement of goods to be delivered to facilities. The recipient may, except when otherwise required by the Global Fund, use its own procurement and supply management systems, rules, processes and procedures or, at its own discretion, a contracted local, regional or international procurement and/or supply management agent, selected in a competitive manner to conduct health products procurement and/or supply management. OR The Global Fund`s Pooled Procurement Mechanism: one of the main tools to implement the Market Shaping Strategy and associated health product sourcing strategies. The mechanism serves 150 grant recipients in 60 countries. STEP 4: Health Products Obtained From Vertical Program.(20 minutes) Implementers can order the following core health products through the Pooled Procurement Mechanism As used in this context, the term “health products” includes; Pharmaceutical products Durable and non-durable in-vitro diagnostic products, microscopes and imaging equipment. Long-lasting insecticidal nets; and Consumable/single-use health products (including condoms, insecticides, therapeutic nutritional support, general laboratory items and injection syringes), which are financed out of the grant funds. Antiretrovirals (ARVs) Artemisinin-based combination therapies (ACTs) Long-lasting insecticidal nets Rapid diagnostic tests (for HIV and malaria) Viral Load and Early Infant Diagnostics The Pooled Procurement Mechanism is managed by the Global Fund. The Global Fund play a significant role in global markets for health products for these three diseases as a key financier and support countries get the most value for their investment. When using Global Fund grants to purchase medicines and other health products, implementers must follow the Global Fund’s procurement policy, which outlines the type of stringent regulations all products must meet. Eg: Attain cost efficiencies in procurement and supply management activities; Ensure the reliability and security of distribution systems; Encourage appropriate use of health products; Enable the monitoring of all procurement and supply management activities and, Support the timely procurement of quality-assured health products in adequate quantities. STEP 5: Procurement Principles for Vertical Program Medicines (30 minutes) The procurement of goods and services with grant funds shall be conducted in a manner that is based on the principles set out below: Value for money: Procurement shall be conducted with the aim of obtaining value for money. Competition: Procurement shall be carried out on a competitive basis to the maximum practical extent. Efficient and Effective Procurement: Procurement shall be conducted in a manner that maximizes the efficient use of Global Fund resources and ensures that the goods and/or services procured effectively meet the requirements of the users. Impartiality, Transparency and Accountability: Procurement shall be conducted in an impartial, transparent and accountable manner. Procurement ethics: Procurement should not be in violation of the Global Fund’s Policy on Ethics and Conflict of Interest for Global Fund Institutions, Code of Conduct for Suppliers, and Code of Conduct of the Global Fund to Fight AIDS, Tuberculosis and Malaria. In addition to the Global Fund’s existing polices for procurement practices, Principal Recipients must ensure that all pharmaceutical products are procured in accordance with the principles set out in the interagency guidelines. In using pharmaceuticals, Principal Recipients are also expected to maintain pharmacovigilance. Procurement plans are developed by the program with MSD based on the following: Current inventory levels, Issues data which is used as a proxy for consumption data, Lead times from the suppliers and donors, and established stock levels. The nationally established inventory control levels should have two months of stock and one month buffer stock at the health facilities; the district and regional levels should have 3 months

NTA Level 5 • Semester 1 • PST05102 Vertical Programs Total Session Time: 120 minutes Law and Policies in Pharmacy Practice • Source Session/Topic 15 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 15: Vertical Programs Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Explain Vertical Programs List Tasks of vertical Programs List of vertical Programs existing in Tanzania Mention Procurement Procedures for Vertical Program Medicines 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 20 minutes Presentation Buzzing Introduction to Vertical Programs 3 15 minutes Presentation Tasks of vertical Programs 4 20 minutes Presentation Vertical Programs existing in Tanzania 5 50 minutes Presentation Procurement Procedures for Vertical Program Medicines 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 Vertical Programs (20 minutes) Activity: Buzzing (10 minutes) ASK students to pair up and buzz on the following question for 2 minutes What are the vertical programs? 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 Vertical programs (also known as stand-alone, categorical or free-standing programs or the vertical approach) refer to instances where “the solution of a given health problem [is addressed] through the application of specific measures through single-purpose machinery” OR Are “so called because they are directed, supervised, and executed, either wholly or to a great extent, by a specialized service using dedicated health workers” In contrast, integrated programrs (also known as horizontal programs, integrated health services or horizontal approaches) seek to “tackle the overall health problems on a wide front and on a long-term basis through the creation of a system of permanent institutions commonly known as ‘general health services. In many countries, a number of vertical programrs are bundled to address “a circumscribed number of diseases … selected for prevention in a clearly defined population” and delivered together as a cluster in primary care. Examples include service packages such as the WHO Integrated Management of Childhood Illness (IMCI) strategy or harm reduction programrs for HIV. Vertical Programs [VP] are initiatives, which focus on a particular disease or group of diseases. In early 1980's to 1990's different programs such as Reproductive Health Program, National Aids Control Program, National Immunization Program, National TB / Leprosy Program were under the Ministry of Health but each was operating individually in term of logistics. The research findings in Health sector revealed that, running each programs individually in terms of its logistics functions was expensive and hence duplication of resources. The integration strengthened Vertical Programs services likewise lowered the operations costs of programs. This resulted into increase the availability of Vertical Programs Medicines, Medical Supplies and Laboratory Reagents to the health facilities. STEP 3: Tasks of Vertical Programs (25 minutes) Greater service specialization and concentration The most important rationale for vertical programrs is driven by the assumption that concentrating on a few well-focused interventions is an effective way of maximizing the impact and time response of the available resources. Waiting for changes in the health system to occur so as to deliver better services would simply be unacceptable for some. Increased profile for a high-priority disease or service The support galvanized by the United Nations Children’s Fund (UNICEF) and other partners around universal childhood immunization in the 1980s and 1990s has been replicated more recently for HIV, tuberculosis and malaria –leading to the establishment of the Global Fund as well as disease-specific initiatives such as Roll Back Malaria – and for neglected diseases such as schistosomiasis. Better accountability By making clear who is responsible for delivering what and what budget is avalable, vertical programs promote a more transparent environnent for accountability. More transparent governance arrangements and clearer lines of accountability suit bilateral and international agencies, which are publicly accountable More rapid results in weak health systems Vertical programs are likely to lead to more rapid results than strategies that attempt to strengthen broader systems as a platform for service delivery, especially in weak health systems. Better chance of success in weak states In weak states or states in conflict where health systems are already disintegrated, vertical programs might be the only means of ensuring the delivery of at least selected priority services. Demand factors For some programs, the target client group may not be readily accessible to the health system providers. This may be due to several reasons: they are not frequent users of general health services; they face access barriers due to sociocultural factors (such as stigma) that lead to avoidance behaviour or geographical barriers (in difficult-to-reach areas with limited transport); there is a fear of legal action (such as among injecting drug users or sex workers); or inability to pay for services (as is the case for many poor people in low- and middle-income countries). Services for which health systems do not function Vertical approaches are likely to be more appropriate if a service is urgently needed but systems are simply too weak and routinely used resources too limited to be able to provide it through the regular channels STEP 4: Vertical Programs Existing in Tanzania (10 minutes) There are 9 major vertical programs which operate in Tanzania. These programs are under MoHCDGEC and Health development partners who support health initiatives in this country. These programs are:- Reproductive Health Program National Aids Control Program National immunization Program National TB/Leprosy Program Neglected Tropical Disease Program National malaria Program Tanzania Food and Nutrition Program Dental Program and

NTA Level 5 • Semester 1 • PST05102 The Standard Treatment Guidelines Law and Policies in Pharmacy Practice • Source Session/Topic 14 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 14: The Standard Treatment Guidelines Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Describe the Standard Treatment Guidelines List Steps which involved during establishment of Standard Treatment Guidelines Outline Uses of Standard Treatment Guidelines Mention Advantages of Standard Treatment Guidelines Mention Disadvantages of Standard Treatment Guidelines 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 Standard Treatment Guidelines 3 15 minutes Presentation Steps which Involved During Establishment of Standard Treatment Guidelines. 4 15 minutes Presentation Uses of Standard Treatment Guidelines. 5 30 minutes Buzzing Presentation Advantages of Standard Treatment Guidelines. 6 30 minutes Brainstorming Presentation Disadvantages of Standard Treatment Guidelines. 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 Standard Treatment Guidelines (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes What is standard treatment guideline? 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 Definition of STG: A systematically developed statement designed to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances STGs—also known as standard treatment schedules, standard treatment protocols, therapeutic guidelines, list the preferred pharmaceutical and non-pharmaceutical treatments for common health problems experienced by people in a specific health system. STGs have existed for as long as the art of healing has existed. Traditional healers developed their standard sets of cures and passed them from generation to generation In modern medicine, however, the concept arose that more than one treatment modality may available for many medical conditions. This concept leads to confusion and, in many cases, incorrect treatment Doctors, nurses, pharmacists, community health workers, and other health care providers learn about all of the treatments that could be used, instead of focusing on the best treatment that should be used. Casual observation, as well as more systematic study of prescribing practices, frequently reveals a pattern of tremendous diversity among prescribers in the treatment of even the most common conditions Polypharmacy is one problem; for example, three, four, five, six, and sometimes more medicines may be prescribed for acute viral gastroenteritis, for which only oral rehydration therapy is effective in reducing morbidity and mortality. Other common problems are making incorrect medicine choices, overdosing, under dosing, and choosing a more expensive medicine when less expensive ones would be equally or more effective. STEP 3: Steps which Involved During Establishment of Standard Treatment Guidelines. (15 minutes) STGs establishment involves the following Eight steps: Establish a committee to address the development of the guidelines Develop an overall plan for guidelines. Identify the diseases that the STGs will cover. Determine appropriate treatment options Determine what information should be included in the STG; For example the following elements are suggestions for comprehensive STGs. Clinical condition Diagnostic criteria and exclusions Treatment Tasks (e.g., elimination of plasmodium parasites from a blood smear) Non-pharmaceutical treatment Medicines of choice (and alternatives) for the medical condition Important prescribing information— dose, duration, contra indications, side effects, warnings, medicine interactions Referral criteria Patient education information What to do when clinical response is poor Draft the STGs for comments and pilot testing Publish and disseminate Revise and update STEP 4: Uses of Standard Treatment Guidelines. (15 minutes) Standard treatments are used at different points of the therapeutic process they may be used to; Diagnose, Decide on treatment and pharmaceutical supply, and Assist with adherence to the prescribed treatment. This use will more likely lead to the desired clinical outcome. STEP 5: Advantages of Standard Treatment Guidelines. (30 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes What are the advantages of standard treatment guideline? 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 use of STGs can benefit health care providers, health care officials, supply management personnel, and patients in the following ways. Health care providers Provides standardized guidance to practitioners Encourages high quality care by directing practitioners to the most appropriate medicines for specific conditions Encourages the best quality of care since patients are receiving optimal therapy. Utilizes only formulary or essential medicines, so the health care system needs to provide only the medicines in the STGs Provides valuable assistance to all practitioners, especially to those with lower level skills Enables providers to concentrate on making the correct diagnosis because treatment options will be provided for them. Health care officials Provides a basis for evaluating quality of care provided by the health care professionals Provides the most effective therapy in terms of quality Provides a system for controlling cost by using funds more efficiently Provides information for practitioners to give to patients concerning the institution’s standards of care Can be a vehicle for integrating special programs (e.g., diarrhea disease control, acute respiratory infection (ARI), tuberculosis control, malaria) at the primary health care facilities using a single set of guidelines Supply management Utilizes only formulary or essential medicines, therefore the health care system needs to provide only medicines in the STGs Provides information for forecasting and ordering (because medicines and quantities

NTA Level 5 • Semester 1 • PST05102 Introduction to National Medicines Policy in Relation to Pharmaceutical Services Law and Policies in Pharmacy Practice • Source Session/Topic 13 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 13: Introduction to National Medicines Policy in Relation to Pharmaceutical Services Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define the terms Policy National medicine/drug Policy List Steps in formulating National medicine policy. List Elements of National Medicine Policy. Mention Common Components of National Medicine Policy. Explain Tasks of National Medicine Policy. Strategies to implement National Medicine Policy. Explain challenges to implementation of National Medicine 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 10 minutes Presentation Buzzing Definition of the Terms Policy and National Medicine/Drug Policy. 3 10 minutes Presentation Elements of National Medicine Policy. 4 15 minutes Presentation Common Components of National Medicine Policy. 5 15 minutes Presentation Tasks of National Medicine Policy. 6 30 minutes Presentation Strategies to Implement National Medicine Policy. 7 25 minutes Presentation Challenges to Implementation of National Medicine Policy. 8 5 minutes Presentation Key Points 9 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 the Terms Policy and National medicine/drug Policy. (10 minutes) Activity: Buzzing (5 minutes) PROVIDE students with the Pharmacy Act 2011 and Pharmacy Practice Regulations 2012 ASK students to pair up and buzz on the following question for 5 minutes Define the following terms; Policy National medicine policy ALLOW few pairs to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMERIZE by using the content bellow Policy: Defined as a system of laws, regulatory measures, courses of action, and funding priorities concerning a given topic promulgated by a governmental entity or its representatives. National medicine/drug Policy: Is the policy, usually of a government, regarding the control and regulation (access, quality and rational use) of drugs considered dangerous, particularly those which are addictive. STEP 3: Elements of National Medicine Policy. (5 minutes) The following are steps in formulating National medicine policy Organizing the process. Identifying and analysing problems. Setting goals and Tasks. Drafting the policy. Seeking wide agreement on the policy. Obtaining formal endorsement of the policy. Launching the policy. STEP 4: Common Components of National Medicine Policy. (10 minutes) Those five elements has the common components of national medicine policy which are; Legislative and regulatory framework e.g. Drug regulatory authority. Selection of essential medicine. Supply. Rational use of medicine. Affordability. Financial strategies for medicines. Human resources development. Monitoring and evaluation. Research. STEP 5: Common Components of National Medicine Policy. (15 minutes) A national drug policy is a comprehensive framework in which each component plays an important role in achieving one or more of the general Tasks of the policy (access, quality, and rational use). The following are explanation of key components of a National Medicine Policy; Selection of essential medicines: Drug selection, preferably linked to national clinical guidelines, is a crucial step in ensuring access to essential drugs and in promoting rational drug use. Affordability: Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors. Eg government commitment to ensuring access through increased affordability Drug financing: Drug financing is another essential component of policies to improve access to essential drugs, eg increased government funding for priority diseases, and the poor and disadvantaged, guidelines for drug donations, and commitment to measures to improve efficiency and reduce waste. Supply systems: The fourth essential component of strategies to increase access to essential drugs is a reliable supply system, through: public–private mix in drug supply and distribution systems, inventory control, prevention of theft and waste, disposal of unwanted or expired drugs, publication of price information on raw materials and finished products, drug supply systems in acute emergencies and commitment to good pharmaceutical procurement practices in the public sector. Rational use: The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community, this can be done through; Promotion of the concepts of essential drugs, rational drug use and generic Prescribing in basic and in-service training of health professionals; The need and potential for training informal drug sellers; Continuing education of health care providers and independent, unbiased drug information; Consumer education, and ways to deliver it; Financial incentives to promote rational drug use Research: Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy, so is an important tool that apart from other issues it assesses the drug policy’s impact on national health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the sociocultural aspects of drug use. Human resource development: Human resources development includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy, eg definition of minimum education and training requirements for each category of staff. Monitoring and evaluation: Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy. Key policy issues are: Explicit government commitment to the principles of monitoring and evaluation. Monitoring of the pharmaceutical sector through regular indicator-based surveys. Independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy. STEP 6: Tasks of National

NTA Level 5 • Semester 1 • PST05102 International Conventions Ratified on Controlled Drugs and Psychotropic Substances Law and Policies in Pharmacy Practice • Source Session/Topic 12 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 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;