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NTA Level 5 • Semester 1 • PST05105 Role of Pharmaceutical Personnel in Promoting Rational Use of Medicines 109 Rational Use of Medicines • 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: Role of Pharmaceutical Personnel in Promoting Rational Use of Medicines 109 Background There is currently an ever increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs)worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training, particularly of lower cadre pharmaceutical personnel. The Pharmacy Council formed a Steering committee that conducted a stakeholders workshop from18th to 22ndAugust 2014 in Morogoro to initiate the implementation of the project. Key activities in the implementation of this project included carrying out situational analysis, curriculum review and harmonization, development of training manual/facilitators guide, development of assessment plan, training of trainers and supportive supervision. After the curricula were reviewed and harmonized, the process of developing standardized training materials was started in August 2015 through Writer’s Workshop (WW) approach. The approach included two workshops (of two weeks each) for developing draft documents and a one-week workshop for reviewing, editing and formatting the sessions of the modules. The goals of Writers Workshops were to build capacity of tutors in the development of training materials and to develop high-quality, standardized teaching materials. The training package for pharmacy cadres includes a Facilitator Guide, Assessment plan and Practicum. There are 12 modules for NTA level 4 making 12 Facilitator guides and one Practicum guide. Acknowledgment The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their tireless efforts to mobilize funds from development partners. Special thanks to Multi Actors Partnership (MAP) for the financial and technical support. Particular thanks are due to those who led this important process to its completion, Centre for Education Development in Health Arusha (CEDHA), Ms. Diana Gamuya, Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating the process. Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings and workshops, and their input in the development of this training manual/facilitators guide have been invaluable. These participants are listed with our gratitude below: Ms. Elizabeth Shekalaghe Registrar, Pharmacy Council of Tanzania Dr. Catherine Jincen Principal, CEDHA Dr. Saitore Laizer Deputy Principal, CEDHA Dr. Sungwa N. Kabissi Project Manager – MAP, CSSC Ms. Diana Gamuya CEDHA Ms. Emily Mwakibolwa Pharmacy Council Ms. Tumaini H. Lyombe MUHAS Ms. Dilisi J. Makawia KSP Director of Human Resources Development Ministry of Health, Community Development, Gender, Elderly and Children Introduction Module Overview This module content is a guide for tutors of Pharmaceutical schools for training of students. The session contents are based on sub-enabling outcomes and their related tasks of the curriculum for Basic Technician Course in Pharmaceutical Sciences. The module sub-enabling outcomes and their related tasks are as indicated in the in the Basic Technician Certificate in Pharmaceutical Sciences (NTA Level 5) Curriculum Target Audience This module is intended for use primarily by tutors of pharmaceutical schools. The module’s sessions give guidance on the time, activities and provide information on how to teach the session. The sessions include different activities which focus on increasing students’ knowledge, skills and attitudes. Organization of the Module The module consists of fifteen (15) sessions; each session is divided into several parts as indicated below: • Session Title: The name of the session • Total Session Time: The estimated time for teaching the session, indicated in minutes • Pre-requisites: A module or session which needs to be covered before teaching the session. • Learning Tasks: Statements which indicate what the student is expected to learn by the end of the session • Resources Needed: All resources needed for the session are listed including handouts and worksheets • Session Overview: The session overview box lists the steps, time for each step, the activity or method used in each step and the step title • Session Content: All the session contents are divided into steps. Each step has a heading and an estimated time to teach that step as shown in the overview box. Also, this section includes instructions for the tutor and activities with their instructions to be done during teaching of the contents • Key Points: Key messages for concluding the session contents at the end of a session This step summarizes the main points and ideas from the session, based on the learning tasks of the session • Evaluation: The last section of the session consists of short questions based on the learning tasks to check the understanding of students. • Handouts: Additional information which can be used in the classroom while teaching or later for students’ further learning. Handouts are used to provide extra information related to the session topic that cannot fit into the session time. Handouts can be used by the students to study material on their own and to refer to them after the session. Sometimes, a handout will have questions or an exercise for the participants including the answers to the questions. Instructions

NTA Level 5 • Semester 1 • PST05105 Ethical Issues in Medicines Marketing and Promotion Rational Use of Medicines • 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: Ethical Issues in Medicines Marketing and Promotion Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Give introduction of ethical issues in medicines marketing and promotion • List objectives of ethical issues in medicines marketing and promotion • Identify ethical issues in medicines marketing and promotion • Identify ethical issues in medicines marketing and advertisement Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |25 Minutes |Presentation |Introduction to Ethical Issues in | | | | |Medicines Marketing And Promotion | |3 |25 Minutes |Presentation |Objective of Ethical Criteria in | | | | |Medicines Marketing and Promotion | |4 |30 Minutes |Presentation |Ethical Issues in Medicines | | | |Buzzing |Marketing and Promotion | |5 |25 Minutes |Presentation |Ethical Issues in Medicines | | | | |Marketing and advertisement | |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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Introduction to Ethical Criteria in Medicines Marketing and Promotion (25 minutes) • Ethical issues for drug promotion should lay the foundation for proper behaviour concerning the promotion of medicinal drugs, consistent with the search for truthfulness and righteousness. • The criteria should thus assist in judging if promotional practices related to medicinal drugs are in keeping with acceptable ethical standards. • WHO ethical criteria for medicinal drug promotion of 1988 require promotion of prescription and over-the-counter drugs to contain reliable claims without misleading or unverifiable statements. • The ethical promotion of medicine is vital to the pharmaceutical industry’s mission of helping patients for better healthcare. • The pharmaceutical industry has an obligation and responsibility to provide accurate information about its products to healthcare professionals in order to establish a clear understanding of the appropriate use of medicines. • The criteria could be used by people in all walks of life; by governments; the pharmaceutical industry (manufacturers and distributors); the promotion industry (advertising agencies, market research organizations and the like)health personnel involved in the prescription, dispensing, supply and distribution of drugs; universities and other teaching institutions; professional associations; patients' and consumer groups. • There is evidence that drug utilization problems are increasing encountered in many developing countries due to unethical practices of medicine promotion. STEP 3: Objective of Ethical Criteria in Medicines marketing and Promotion (25 Minutes) The following are the objectives of ethical criteria for medicines marketing and promotion: • To support and encourage the improvement of health care through the rational use of medicinal drugs and discourage unethical practices. • To lay the foundation for proper behavior concerning the promotion of medicinal drugs, consistent with the search for truthfulness and righteousness. • To assist in judging if promotional practices related to medicinal drugs are in keeping with acceptable ethical standards. • To ensure that healthcare professionals have access to information they need and that medicines are prescribed and used in a manner that provides the maximum healthcare benefit to patients. STEP 4: Ethical Issues in Medicines Marketing and Promotion (30 minutes) |Activity: Buzzing (10 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are the ethical criteria in medicines marketing and promotion? | |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 the ethical criteria in medicines marketing and promotion • Healthcare professionals should not be influenced to prescribe, recommend, purchase, supply or administer a product because of any benefits offered (financial or otherwise). • Promotion should encourage the appropriate use of pharmaceutical products by presenting them objectively and without exaggeration. • Ethical criteria for Medicines marketing and Promotion call for promotion of prescription drugs, non-prescription drugs (over-the-counter drugs), traditional medicines and any other product promoted as a medicine to contain reliable claims without misleading statements. • The criteria also state that promotion should not contain omissions that could lead to health risks • The criteria state that promotion should not contain unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. • They emphasize that promotion should not be disguised as educational or scientific activities. • Active promotion within a country should take place only with respect to drugs legally available in the country. • Promotion should be in keeping with national health policies and in compliance with national regulations. • All promotion making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, and capable of substantiation and in good taste. • The word "safe" should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. • Promotional material should not be designed so as to disguise its real nature. • Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. • Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs. • Scientific and educational activities should not be deliberately used for promotional purposes STEP 5: Ethical Issues

NTA Level 5 • Semester 1 • PST05105 Significances of Uncontrolled Medicines Marketing and Promotion Rational Use of Medicines • 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: Significances of Uncontrolled Medicines Marketing and Promotion Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Define the terms used in uncontrolled medicines marketing and Promotion • Identify Significances of uncontrolled Medicines marketing and promotion • Explain the effects of medicines marketing and promotion on prescribing and dispensing behaviour • Identify guiding principles to fight for significance of uncontrolled medicines marketing and promotion Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes|Presentation |Introduction, Learning Objectives | |2 |20 |Presentation |Definition of Terms Used in Uncontrolled | | |Minutes | |Medicines Marketing and Promotion | |3 |35 |Presentation |Significances of Uncontrolled Medicines | | |Minutes |Brainstorming |Marketing and Promotion | |4 |30 |Presentation |Effectsof Medicines Marketing and | | |Minutes |Group |Promotion on Prescribing and Dispensing | | | |Discussion |Behavior | |5 |20 |Presentation |Guiding Principles to Fight For | | |Minutes | |Significance of Uncontrolled Medicinal | | | | |Marketing and Promotion | |6 |05 |Presentation |Key Points | | |Minutes | | | | 7 |05 |Presentation |Evaluation | | |Minutes | | | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (05 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Definition of Terms used in Uncontrolled Medicines Marketing and Promotion (20 Minutes) Medicines: • Medicines have an integral part in the health care system all over the world. When the appropriate use of medicine is done, they can cure the different ailments and promote the health of the patients and results in the wellbeing of the patients. However, the irrational use of medicines is the major issue in this regard and it is practiced all over the world. Pharmaceutical marketing: • These are activities focused on making physicians as well as the general public aware of new and existing pharmaceutical brands, • It can include giveaway samples, detailed product literature, disease management programs, and support material for patients, internet initiatives, and events/meetings for physicians. • Also can be defined as a management process that serves to identify and meet patients’ needs in a profitable way. Uncontrolled Medicinal Marketing and Promotion: o This is when the medicines which are promoted and marketed are not regulated and authorized by regulatory body such as: TFDA STEP 3: Significances of Uncontrolled Medicines Marketing and Promotion (35 Minutes) |Activity: Brainstorming (15 Minutes) | |Ask students to brainstorm on the following question: | |What are the Significances of uncontrolled Medicines marketing and | |promotion? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | The following are significances of uncontrolled marketing and promotion: • May encourage inappropriate use of expensive drugs that are incorrectly perceived to be more efficacious than existing cheaper alternatives • Creates an opportunity cost for the health service • Reduces the available resources for the provision of other essential services. • Encourages further expenditure on drug promotion, reducing the proportion of the total company budget available for research and development as a result of increased revenue generated by altered prescribing practices in response to drug promotion as interpreted by pharmaceutical companies • Reliance on drug promotion for revenue generation by pharmaceutical companies has a negative impact on the size of the pipeline of new drugs to deal with pressing medical problems. • Reduces the choice for prescribers and patients in which drug promotion is required at greater levels to increase market penetration of existing drugs to the detriment of the development of new ones. • In the absence of effective regulation of drug promotion, community interventions to promote rational drug use will have insufficient impact hence, leading to irrational use of medicines. • For the case of antibiotic uncontrolled medicines can lead to drug resistance due to improper use of medicines. • Encourage community to use medicines without proper diagnosis which results to chronic disease. STEPS 4: Effects of Medicines Marketing and Promotion on Prescribing and Dispensing Behavior(30Minutes |Activity: Small Group Discussion ( 15 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the effect of medicines marketing and promotion on prescribing| |and dispensing behaviour? | | | |ALLOW students to discuss for 10 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using the contents below | Pharmaceutical marketing and promotions Influence prescriber behaviors. • Medical practitioners’ attitudes to the pharmaceutical industry, their knowledge about pharmaceutical products, and prescribing behavior are influenced by industry promotion and gift-giving. • Most of pharmaceutical personnel who work at community pharmacies encourage patients to buy medicines from certain pharmaceutical manufacturers for their personnel interest • Spending on prescription drugs by different countries is increasing continuously by significant margin every year and one of the identified and most prominent cause of this increase is continuing switch to new drugs which is an outcome of increasing promotional influence. • Pharmaceutical marketing is a unique as decision-making of buying of medicine lies in the hand of intermediate customer (prescriber) rather than final customer (patient), therefore pharmaceutical companies influence the customer (prescriber) rather than the final customer (patient). • Prescriber are the most important players in pharmaceutical marketing system, Prescriber write the prescriptions that determined which drugs (brands) will be used

NTA Level 5 • Semester 1 • PST05105 Legal limitations on Medicines Marketing and Promotion Rational Use of Medicines • 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: Legal limitations on Medicines Marketing and Promotion Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Define the terms used in legal limitations on medicines marketing and promotion. • Give general understanding of legal limitations on medicines marketing and promotion. • Identify responsibilities of TFDA on medicines marketing and promotion • Describe pharmaceuticals promotion control • Identify importance of promotion and marketing in pharmacy • Describe pharmaceuticals advertisement control Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |10 Minutes |Presentation |Definition of Terms used in Legal | | | | |Limitations on Medicines Marketing | | | | |and Promotion. | |3 |15 Minutes |Presentation |Introduction to Legal Limitations on| | | | |Medicines Marketing and Promotion. | |4 |30 Minutes |Presentation |Responsibilities of TFDA on | | | |Brainstorming |Medicines Marketing and Promotion | |5 |10 Minutes |Presentation |Pharmaceuticals Promotion Control | |6 |20 Minutes |Presentation |Important of Promotion and Marketing| | | |Buzzing |in Pharmacy | |7 |10 Minutes |Presentation |Pharmaceuticals Advertisement | | | | |Control | |8 |05 Minutes |Presentation |Key Points | | 9 |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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Definition of Terms inLegal limitations on Medicines Marketing and Promotion. (20 Minutes) • Pharmaceuticals Promotion: refers to all informational and convincing activities by manufacturers and distributors, the effect of which is to encourage the prescription, supply, purchase and/or use of medicinal drugs. • The important of Promotion is to create an image, to modify attitudes to support sales increases and to create awareness • Marketing: creating customer value and satisfaction. It is a process by which individuals or groups obtain what they need and want through creating and exchanging products and value with others. i.e. It is simply the delivery of customer satisfaction at a profit • Advertising: Any form of communication using any form of mass media or a controlled message in purchased time or space. It is non-personal and paid. The forms of advertising include journals, direct mail & e-mail, bill boards, newspapers and TV. It includes every form of advertising, whether in a publication, or by the display of any notice or by means of any catalogue, price list, letter, whether circular or addressed to a particular person, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting, or television or any other means of communication. STEP 3: Introduction to Legal Limitations on Medicines Marketing and Promotion. (15 Minutes) • Medicines have the potential for benefit to individuals who use them and to the public health. But all effective medicines may be associated with adverse effects. • The law recognizes that medicines should not be treated as an ordinary general commodity by placing specific restrictions on them. • Activities conducted as part of pharmaceutical marketing and promotions are an important component of educating and informing consumers and health care professionals about new treatments. • Direct-to-consumer (DTC) advertisements aim to inform patients of important treatment options, while pharmaceutical sales representatives work to get accurate, up-to-date information on medicines to health care professionals. STEP 4: Responsibilities of TFDA on Medicines Marketing and Promotion (30minutes) |Activity: Brainstorming (15 Minutes) | |Ask students to brainstorm on the following question: | |What are the responsibilities of TFDA on medicines marketing and | |promotion? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | TFDA is the effective medicines regulatory body which promotes and protects public health by ensuring that: • Medicines are of the required quality, safety and efficacy, medicines are appropriately manufactured, stored, distributed and dispensed, illegal manufacturing and trade are detected and adequately sanctioned, health professionals and patients have the necessary information to enable them to use medicines rationally. • Ensure that promotion and advertising is fair, balanced and aimed at rational drug use, access to medicines is not hindered by unjustified regulatory work. STEP 5: Pharmaceuticals Promotion Control (10 Minutes) • Product promotion means any activity undertaken by a company or individual to promote and encourage the prescription, supply, sale, administration or purchase of food, drugs, herbal drugs, cosmetics, and medical devices. (in relation to products regulated by TFDA such as medicines) • Such promotion can be presented in various forms like: o Brochures, posters, leaflets, TV, radio, newspaper, magazine, and internet advertisement, Journal or direct mail advertising, supply of free samples, sponsorship of promotional meeting and sponsorship of scientific meeting • Product promotion Control section of the TFDA routinely scrutinizes promotional materials before approval is granted. • Promotion of food, drugs, herbal drugs, cosmetics, and medical devices is controlled under the Tanzania Food, Drugs and Cosmetics Act, 2003 sections 95 to 98 and 122(1) (r) regulations, 2010. • No promotional activity should be conducted in Tanzania mainland unless it is approved by the TFDA. • In order to get approval, two copies of the promotional materials should be submitted to the Director General, TFDA. Upon approval, one copy will remain with the TFDA. STEP 6: Importance of Promotion and Marketing in Pharmacy (20 Minutes) |Activity: Buzzing (10 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are

NTA Level 5 • Semester 1 • PST05105 Importance of (STG) and (EML) in Reducing Irrational Use of Medicines Rational Use of Medicines • 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: Importance of (STG) and (EML) in Reducing Irrational Use of 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 overview of Tanzania STGs and EML • Outline Importance of STGs • Describe the Relation between STGs and EML • Identify Advantages of Using Generic Names or INN in Medicine Use. • List potential benefits of standard treatment guidelines Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Figure 10.1: Relationship between treatment guidelines and essential medicine list SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 Minutes |Presentation |Introduction, Learning Tasks | |2 |20 Minutes |Presentation |Introduction to Tanzania STGs and | | | | |EML | |3 |20 Minutes |Buzzing |Importance of STGs | | | |Presentation | | |4 |25 Minutes |Presentation | Relationship Between STGs and EML | |5 |20 Minutes |Presentation |Advantages of Using Generic Names or| | | |Group Discussion|INN in Medicine Use. | |6 |20 Minutes |Presentation |Potential Benefits of Standard | | | | |Treatment Guidelines | |7 |05 Minutes |Presentation |Key Points | | |05 Minutes |Presentation |Evaluation | |8 | | | | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing STEP 2: Introduction to Tanzania STGs and EML (20 Minutes) • The Standard Treatment Guidelines (STG) and the National Essential Medicine List for Tanzania (NEMLIT) was first published in 1991, the second edition was published in 1997. • The third edition, published in 2013 incorporates the essential current medical knowledge and new developments in medicines. • It has incorporated major changes in the care and treatment of disease conditions such as Tuberculosis and Leprosy, Malaria and HIV/AIDS due to new scientific updates. • Treatment guidelines (Standard treatment guidelines (STGs), treatment protocols, clinical guidelines) are systematically developed statements that assist prescribers in deciding on appropriate treatments for specific clinical problems. • These guidelines usually reflect the consensus on the optimal treatment options within a health facility or health system. • The information is disease centered, emphasizing the common diseases and complaints and the various treatment alternatives. • Information on medicines is usually limited to strength, dosage, and duration. Most guidelines indicate a treatment of first choice. Some include diagnostic criteria for starting the treatment or for choosing among treatment alternatives. • Standard clinical guidelines are an effective tool for assisting health professionals to choose the most appropriate medicine for a given condition. These should be developed and updated on a regular basis. It is not sufficient to develop standard clinical guidelines without an education and training program to encourage their use. STEP 3: Importance of STG’s (20 Minutes) |Activity: Buzzing (10 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are the Importance of Standard Treatment Guidelines (STG’s) | |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 the important of standard treatment guidelines (STG’s) in the health management: • Providing guidance to health professionals on the diagnosis and treatment of specific clinical conditions • Orienting new staff about accepted norms in treatment. • Providing prescribers with justification for prescribing decisions made in accordance with STGs • Providing a reference point by which to judge the quality of prescribing and dispensing • Aiding efficient estimation of drug needs and setting priorities for procuring and stocking drugs. STEP 4: Relationship Between Treatment Guidelines and Essential Medicine List (25 Minutes) The subsequent are the relationship between Treatment guidelines and Essential medicine list: • The NEMLIT attached to the STG retains its purpose of identifying medicines that are considered to be essential for the treatment of common disease conditions in Tanzania. • Treatment Guideline follows the principles and concepts of essential medicines so as to simplify the management of medicines supply and support a streamlined logistics system. • Medicines in Treatment Guidelines are selected using the WHO Essential medicines List (EM) as a model. Choice of medicines in STG’s and EMLIT is based on: • National health policy o Free health care o Subsidized health care o Managed health care • National medicine policy o Free medicine policy o Subsidized cost of medicines or cost recovery o Cost sharing • Patterns and prevalence of diseases Quality and type of care provided at o Primary health care institution o Secondary health care institution o Tertiary health care institution • Available human resources o Medical care (general MD and specialist care) o Nursing care (nursing, midwifery, psychiatry) o Pharmaceutical care (pharmacists, pharmacy technicians, Pharmaceutical assistants) • Financial resources. • International Nonproprietary Names (INNs), also known as generic names, are normally used in identifying selected medicines. • INNs are intended for use in pharmacopoeias, labeling, production information, advertising and other promotional material, pharmaceutical regulation, and as a basis for generic product names • The choice of medicines by generic names requires the existence of an effective Drug Regulatory Authority (i.e. TFDA) to ensure the availability of good-quality, safe, effective and affordable drugs Figure 10.1: Relationship between treatment guidelines and essential medicine list [pic] STEP 5: Advantages of Using Generic Names or INN in Medicines (20Minutes) |Activity: Small Group Discussion ( 15minutes) | |DIVIDE students into small manageable groups | |ASK students to discuss on the following

NTA Level 5 • Semester 1 • PST05105 Factors Hindering Promotion of Rational Use of Medicine Rational Use of Medicines • 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: Factors Hindering Promotion of Rational Use of Medicine Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Give overview of factors hindering promotion of rational use of medicine • List factors hindering promotion of rational use of medicine • Explain Factors hindering promotion of rational use of medicine Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |15 Minutes |Presentation |Introduction to Factors Hindering | | | | |Promotion of Rational Use of | | | | |Medicine | |3 |30 Minutes |Presentation |Types of Factors Hindering Promotion| | | |Buzzing |of Rational Use of Medicine | |4 |60 Minutes |Presentation |Factors Hindering Promotion of | | | | |Rational Use of Medicine | |5 |05 Minutes |Presentation |Key Points | | 6 |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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Introduction to Factors Hindering Promotion of Rational Use of Medicine (15 Minutes) • Promoting the correct and appropriate use of medicinal products is the main goal of pharmaceutical personnel activities. • The pharmaceutical personnel activities can be summarized as following: consulting, selection of drugs, drug information, formulation and preparation, drug use studies and research, pharmacokinetics/ therapeutic drug monitoring, clinical trials, pharmacoeconomy, dispensing & administration, teaching & training. • The aims of these activities are to maximize rational use of medicines, clinical effect of medicines, to minimize the risk of treatment-induced adverse events and to minimize the expenditures for pharmacological treatments for the national health systems and for the patients STEP 3: Types of Factors Hindering Promotion of Rational Use of Medicine (30 Minutes) |Activity: Buzzing (10 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are the factors hindering promotion of rational use of 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 | The following are the factors hindering promotion of rational use of Medicine • Poor communication between professionals and patients/clients • Lack of objective information • Inadequate public education • Cost of medicines • Proliferation of brands • Prescribing errors • Defective drug supply system and ineffective drug regulation • Promotional activities of pharmaceutical industries STEP 4: Explanation of Factors Hindering Promotion of Rational Use of Medicine (60 Minutes) The subsequent are the explanations of factors hindering promotion of rational use of medicine Poor communication between professionals and consumers • Communication between professionals and patients is fundamental to the improvement of rational use of medicines by patients. • The following information should be provided to patients: the name of the medicine, the purpose for which the medicine is being taken, dose, frequency of use, and duration of use. • The adverse effects due to medicines for chronic disease like cancer and HIV/AIDS should be explained clearly to patient to avoid confusion and irrational use of medicines. • The shortage of qualified health personnel in public health facilities has resulted in inadequate labelling of medications by prescribers and dispensers, and in insufficient time spent by them to inform the patients on how to take the medicine. Lack of objective information • The pharmaceutical market has been saturated by medical representatives whose aim is to achieve higher sales for the companies they represent. • These sales professionals have become the principal source of information for many Prescribers and dispensers despite the fact that the information they provide is geared towards promoting the sales of pharmaceutical companies. • The essential medicines list, standard treatment guidelines, national drug policies are often good sources of literature on medicines use, but these reference materials are not widely disseminated. • Media can play a key role in raising awareness on problems with drugs and publicizing serious health hazards related to drugs; however the media has at times been used by pharmaceutical companies to covertly promote their medicines. • The existence of counterfeits has sometimes been used to discredit generic products by some media houses as a result consumers end up with mixed reactions on the use of generics and irrational use of medicines. Inadequate public education • Developing countries have ineffective public education programmes. The most important sources of information for consumers about medicines are Doctors; followed by the pharmaceutical personnel, then nurses and other healthcare personnel. • Medical professionals must not only know the correct information to convey, but the skill and the time to do it well, However, skill and time are scarce resources. • Patients may not be aware of the kind of information they need or what questions they should ask, so there is a significant, general educational challenge. • The emergence of HIV/AIDS and other chronic diseases has exacerbated the problem since there are higher patient numbers but fewer of them are able to access the medicines they require. • In the event that the prescribed medicines are dispensed, the HIV/AIDS patients go back home but most of them do not get regular outpatient support to encourage them to take the medicines. • A successful patient follow up mechanism has been put in place in many countries to encourage the rational use of TB medicines; unfortunately no similar mechanisms have

NTA Level 5 • Semester 1 • PST05105 Types of Interventions in Promoting Rational Medicines Use Rational Use of Medicines • 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: Types of Interventions in Promoting Rational Medicines Use 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 national interventions in promoting rational medicines use • Identify types of national interventions in promoting rational medicines use • Explain national interventions in promoting rational medicines use Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 Minutes |Presentation |Introduction, Learning Tasks | |2 |15 Minutes |Presentation |Introduction to National | | | | |Interventions in Promoting Rational | | | | |Medicines Use | |3 |30 Minutes |Buzzing |Types of National Interventions in | | | |Presentation |Promoting Rational Medicines Use | |4 |60 Minutes |Presentation |National Interventions in Promoting | | | |Group |Rational Medicines Use | | | |Discussion | | |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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Introduction to National interventions in promoting rational medicines use (15 Minutes) • Subsequent are some of the major and supreme roles and strategies in order to eliminate the irrational use of the medicines, the contribution of WHO, Pharmaceutical personnel, prescribers and government is important in this regard. • Based on this evidence, WHO has developed recommendations for twelve core national policies and structures that are needed to promote rational use of medicines. STEP 2: Types of National interventions in promoting rational medicines use (30 minutes) |Activity: Buzzing (15 minutes) | |ASK students to pair up and buzz on the following question for 2 | |minutes | |What are the types of national interventions in promoting rational | |medicines use? | | | |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 twelve core national interventions to promote rational use of medicines • A mandated multi-disciplinary national body to coordinate medicine use policies • Clinical guidelines • Essential medicines list based on treatments of choice • Drugs and therapeutics committees in districts and hospitals • Problem-based pharmacotherapy training in undergraduate curricula • Continuing in-service medical education as a licensure requirement • Supervision, audit and feedback • Independent information on medicines • Public education about medicines • Avoidance of perverse financial incentives • Appropriate and enforced regulation • Sufficient government expenditure to ensure availability of medicines and staff STEP 3: Explanation of the Types of National Interventions in Promoting Rational Medicines Use (60 minutes) The following are the explanation for twelve National core interventions in promoting rational medicines use A mandated multi-disciplinary national body to coordinate medicine use policies • Many societal and health system factors, as well as professionals and many others, contribute to how medicines are used. • Therefore, a multi-disciplinary approach is needed to develop, implement and evaluate interventions to promote more rational use of medicines. • A national regulatory authority (RA) is the agency that develops and implements most of the legislation and regulation on pharmaceuticals. • Ensuring rational use will require many additional activities which will need coordination with many stakeholders. • Thus a national body is needed to coordinate policy and strategies at national level, in both the public and private sectors. • The form this body takes may vary with the country, but in all cases it should involve government (ministry of health), the health professions, academia, the RA, pharmaceutical industry, consumer groups and non- governmental organizations involved in health care. • The impact on medicine use is better if many interventions are implemented together in a coordinated way, single interventions often having little impact. Clinical guidelines: • Clinical guidelines i.e. standard treatment guidelines or prescribing policies consist of systematically developed statements to help prescribers make decisions about appropriate treatments for specific clinical conditions. • They provide a benchmark of satisfactory diagnosis and treatment against which comparison of actual treatments can be made. • They are a proven way to promote more rational use of medicines provided they are: o developed in a participatory way involving end-users; o easy to read; o introduced with an official launch, training and wide dissemination; o Reinforced by prescription audit and feedback. • Guidelines should be developed for each level of care ranging from paramedical staff in primary health care clinics to specialist doctors in tertiary referral hospitals, based on prevalent clinical conditions and the skills of available prescribers. • Evidence-based treatment recommendations and regular updating help to ensure credibility and acceptance of the guidelines by practitioners. • Sufficient resources are needed to reimburse all those who contribute to the guidelines, and to cover the costs of printing, dissemination and training. Essential medicines list based on treatment of choice: • Essential medicines are those that satisfy the priority health care needs of the population. • Using an essential medicines list (EML) makes medicine management easier in all respects; procurement, storage and distribution are easier with fewer items and prescribing and dispensing are easier for professionals if they have to know about fewer items. • A national EML should be based upon national clinical guidelines. • Medicine selection should be done by a central committee with an agreed membership and using explicit, previously agreed criteria, based on efficacy, safety, quality, cost and cost-effectiveness. • EMLs should be regularly updated and

NTA Level 5 • Semester 1 • PST05105 Essential Medicines Concept in Promotion of Rational Medicines Rational Use of Medicines • 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: Essential Medicines Concept in Promotion of Rational Medicines Use Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Identify key factors for developing essential medicine list • Identify important of essential medicine list • Describe essential medicine list in promoting rational use of medicines • List criteria for selection of essential medicines Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |30 minutes |Presentation |Key Factors for Developing Essential| | | |Buzzing |Medicine list | |3 |25 minutes |Presentation |Important of Essential Medicine List| | | |brainstorming | | |4 |25 minutes |Presentation |Essential Medicine List in | | | | |Promoting Rational Use of Medicines | |5 |25 minutes |Presentation |Criteria for Selection of Essential | | | | |Medicines | |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 objectives and clarify ASK students if they have any questions before continuing STEP 2: Key Factors for Developing an Essential Medicines List (30 Minutes) |Activity: Brainstorming (10 Minutes) | |Ask students to brainstorm on the following question: | |What are the key factors for developing an essential drug list? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | The following are factors for developing of an essential medicines list |Establishing a transparent process for creating and updating the list | |of essential medicines, provide a voice for key stakeholders, but | |ensure a scientific, evidence-based process | |Linkage with standard clinical guidelines and involvement of both | |specialists and primary care providers | |Garner support from senior clinicians, academic institutions, public | |health professionals, professional organizations, non-governmental | |organizations and community members | |Making the list available (essential medicines, formulary manuals and | |clinical guidelines) in all health care facilities/health care | |providers in both printed and electronic format | |Consider launching of new or revised lists with the involvement of | |concerned government officials with adequate publicity | |Making clear the specific legal or administrative authority of the | |essential medicines list for training, procurement, reimbursement and | |public information | |Establishing an administrative or budgetary “safety valve” for the | |limited supply and use of non-listed medicines | |Regular Updating of the list so that it reflects therapeutic advances | |and changes in cost, resistance patterns and public health relevance. | STEP 3: Important of Essential Medicine List (25 Minutes) |Activity: Brainstorming (10 Minutes) | |Ask students to brainstorm on the following question: | |What are important of essential medicine list? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | A list of essential medicines is an immensely useful tool for: • Policy making. • Selection, procurement, distribution and quality assurance. • For financing. • For training health professionals: o A selected list of essential medicines can form the basis for training health professionals in the proper use of medicines. • For providing information and imparting education relating to medicines: o Patient education and efforts to promote proper use of medicines by patients are enhanced when centred on specific medicines. STEP 4: Essential Medicine List in Promoting Rational Use of Medicines (25 Minutes) Essential medicine list can promoting rational use of medicines for the reason that: • When a limited list of essential medicines represents the physician's consensus on the treatment of first choice, the quality of care improves. • Irrational treatments are avoided. • Physicians and dispensers become familiar with a smaller number of medicines – thus promoting rational drug use STEP 5: Criteria for Selection Essential Medicines (25 Minutes) Essential medicines should be selected on the basis of: • Relevance to the pattern of prevalent diseases; Having medicines available for the treatment of most prevalent diseases, ailments, sicknesses and so forth at the levels of care provided. • Proven efficacy and safety • Adequate scientific data and evidence of performance in a variety of settings • Adequate good quality • Affordable and cost-effectiveness so as to optimize the use of financial resources. (Favorable cost-benefit ratio ) • Desirable pharmacokinetic properties STEP 6: Key Points (05 Minutes) The essential medicines concept embraces the following guiding principles such as: • The vast majority of health problems for most members of the population can be treated with a small, carefully selected number of medicines. • In practice, most doctors and other health professionals routinely use a small fraction of medicines produced. • Training and clinical experience should focus on the proper use of these few medicines. • Procurement, distribution and other supply activities can be carried out most economically and most efficiently for a limited list of pharmaceutical products. STEP 7: Evaluation (05 minutes) • List the importance of essential medicine list • What are Key factors for developing of an essential medicines list? • What are criteria for selection of essential medicines References Kar SS1,Pradhan HS2,Mohanta GP3, (2010). Concept of essential medicines and rational usein public health.Indian Journal of Community Medicine. Tripathi KD. (2010), Aspects of Pharmacotherapy; Clinical pharmacology and DrugDevelopement In: Essentials of medical pharmacology. Jay pee brothers medical publishers (p) ltd, New Delhi 6th ed. Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.).

NTA Level 5 • Semester 1 • PST05105 Concept of National Essential Medicines Rational Use of Medicines • 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: Concept of National Essential Medicines Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Define essential medicine list • Give overview of model list of essential medicines list • Describe national concept of essential medicines list • Outline advantages of a limited list of essential medicines • Identify problems of national essential medicines list Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |5 minutes |Presentation |Introduction, Learning Tasks | |2 |10 Minutes |Presentation |Define Essential Medicine List | |3 |25 Minutes |Presentation |Introduction of Model List of | | | | |Essential medicines | |4 |30 Minutes |Presentation |National Concept of Essential | | | | |medicines List | |5 |20 Minutes |Brainstorming |Advantages of a Limited List of | | | |Presentation |Essential Medicines | |6 |20 Minutes |Buzzing |Problems of National Essential | | | |Presentation |Medicine list | |7 |05 Minutes |Presentation |Key Points | | 8 |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 objectives and clarify ASK students if they have any questions before continuing. STEP 2: Definition of Essential Medicines list (10 minutes) • Essential medicines are those that satisfy the priority health care needs of the population, they are selected with due regard to disease prevalence and public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness. STEP 3: Introduction of Model List of Essential Medicines (25 Minutes) • The concept of essential medicines has been worldwide accepted as a powerful tool to promote health equity and its impact is remarkable as the essential medicines are proved to be one of the most cost- effective elements in health care. • World Health Organization (WHO) introduced the concept of essential medicines in 1977 and develops the first essential medicines list in 1977 and since then the list has been revised every 2 years. • Lists of essential medicines are also used by UNICEF, the United Nations high commissioner for refugees, and many non-governmental organizations. • The WHO Model List of Essential Medicines is a useful reference, derived from the consensus of recognized international experts and updated. • The model list of WHO serves as a guide for the development of national and institutional essential medicine list. Both its content and the process by which it is updated are intended as a model for developing countries. STEP 4: National Concept of Essential medicines list (30 minutes) • Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. • The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; • Medicines which are regarded as essential remains a national responsibility. • Experience has shown that careful selection of a limited range of essential medicines results in a higher quality of care, better management of medicines (including improved quality of prescribed medicines), and a more cost-effective use of available health resources. • Medicines are integral parts of the health care and the modern health care is unthinkable without the availability of necessary medicines. • They not only save lives and promote health, but prevent epidemics and diseases too. • The medicines are undoubtedly one of the weapons of mankind to fight disease and illness. Accessibility to medicines is too the fundamental right of every person. STEP 3: Advantages of a Limited List of Essential Medicines(20 minutes) |Activity: Brainstorming (10 Minutes) | |Ask students to brainstorm on the following question: | |What are the advantages of a limited list of essential medicines? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | The following are the advantages of having limited list of essential medicines in different aspect: Supply Medicines and medical suppliers benefit by: • Easier procurement, storage, and distribution • Lower stocks • Better quality assurance • Easier dispensing Prescribing and Dispensing Pharmaceutical personnel and prescribers benefit it because: • Training more focused and therefore simpler • More experience with fewer medicines • Non availability of irrational treatment alternatives • Reduction of antimicrobial resistance • Focused drug information • Better recognition of adverse drug reactions Cost • Lower prices, more competition Patient use Patients and other consumers of medicines and medical suppliers benefit it because they: • Focused education efforts • Reduced confusion and increased adherence to treatment STEP 4: Problems of National Essential Medicine List (20 Minutes) |Activity: Buzzing (10 Minutes) | |Ask students to brainstorm on the following question: | |What are the problems of national essential medicine list? | |ALLOW few students to respond | |WRITE their responses on the flip chart/ board | |CLARIFY and SUMMARISE by using the content below | The following are problems of national essential medicine list • Range of diseases covered by the Model List is not clear • Discrepancies between Model List and treatment guidelines • Selection is more consensus-based than evidence-based • Use of data on cost and cost-effectiveness unclear • Reasons for selection is insufficiently recorded • Drugs included without pharmacopoeia standard or supplier • Official report comes out too late, and in English only STEP 6: Key Points (05 Minutes) • Establishing and using a limited list of