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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;

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 Procurement Controlled Drugs Law and Policies in Pharmacy Practice • Source Session/Topic 10 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 10: Tanzania Food and Cosmetics Act, 2003 Regulating Procurement Controlled Drugs Total Session Time: 120 minutes Prerequisites None Learning Tasks By the end of this session students are expected to be able to: Define cosmetics, procurement and controlled drugs. Give explanation of sections in TFDC Act, 2003 which regulate procurement of controlled drugs. Explain requirements Exception of controlled drugs State how to document and reporting for controlled drugs. 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 Cosmetics, Procurement and Controlled Drugs 3 35 minutes Presentation Sections in TFDC Act, 2003 which Regulate Procurement of Controlled Drugs 4 20 minutes Presentation Requirements for Exception of Controlled Drugs 5 30 minutes Presentation Documentation and Reporting for Controlled Drugs 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. STEP 2: Definition of Cosmetics, Procurement and Controlled Drugs (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 5 minutes Define the following terms Cosmetics Procurement Controlled drugs ALLOW few pairs to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMERIZE by using the content bellow Cosmetic – means any article intended to be used by means of rubbing, pouring, steaming, sprinkling, spraying on or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and includes any article intended for use as component of a cosmetic; such articles exclude articles intended besides the above purposes for use in the diagnosis, treatment or prevention of diseases and those intended to affect the structure or any function of the body. 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. Controlled substances – 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 STEP 4: Explanation of Sections in TFDC Act, 2003 which Regulate Procurement of Controlled Drugs (35 minutes) Section 73; Import and export of drugs, medical devices, herbal drugs or poisons. Subsection (1) No person, other than a person issued with a licence or permit under the provisions of this Act, may import or export into Mainland Tanzania any drugs, medical devices, herbal drugs or poisons Subsection (2) Subject to subsection (1), the Authority may if it is in the public interest so to do, authorize parallel importation of any drug. Subsection (3) Notwithstanding the provisions of this Act, any bona-fide tourist or visitor who enters into, or person normally resident, who re-enters the United Republic, may bring with him such quantity of any drug as may be required during a period of twenty-one days for the medical treatment of himself, or any member, or partner travelling with him. Subsection (4) No person shall import any drug with shelf life more than twenty four months whose remaining shelf life is less than 60% and a drug with shelf life of less or equal to twenty four months whose remaining shelf life is less than 80%. Subsection (5) if any person imports any drug, medical devices, herbal drugs or poison, contrary to the provisions of this Act, the Authority may order destruction or re-export of such drug, medical devices, herbal drugs or poisons at his own expenses. Subsection (6) any person who contravenes the provisions of this section commits an offence and upon conviction shall be liable to a fine of not less than one million or to imprisonment for a term of not less than six months or to both such fine and imprisonment. Subsection (7) in this section ''parallel importation'' means importing a drug into the country without authorization of the drug registration holder from another country where it is legitimately placed. Section 74; Sale and administration of drugs subject to prescription by appropriate practitioners Subsection (1) Subject to the Provisions of this section, no Person shall sell by retail, or supply in circumstances corresponding to retail sale or administer, other than to himself, a drug product of a description or a class specified by order made by the Minister and published in the Gazette except in accordance with a Prescription given by appropriate practitioner. Subsection (2) In this Part ''appropriate Practitioner'' means a medical practitioner, dentist, veterinary surgeon and any other person as the Minister may by Order published in the Gazette specify. Subsection (3) Any Person who contravenes the provisions of 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 three months or to both such fine and imprisonment. Section 75; Prohibition of adulterated or unfit drugs medical devices and herbal drugs Subsection (1) No Person shall – add any substance to, or subtract any substance from a drug so as to affect adversely the composition of the drug with intention of selling the drug in that changed state; or sell or supply,

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

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 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 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 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 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