PST Level 6 Semester 2

NTA Level 6 • Semester 2 • PST06211 Controlling Substandard and Counterfeit Monitoring and Evaluation of Medicine Use • Source Session/Topic 17 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 17: Controlling Substandard and Counterfeit Medicines Total Session Time: 60 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List and explain methods for controlling substandard and counterfeit medicines • Explain mechanisms for curbing spread of substandard and counterfeit medicines in Tanzania Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 25 minutes Presentation and Methods for Controlling Substandard and 2 Buzzing Counterfeit Medicines 20 minutes Curbing Spread of Substandard and Counterfeit Presentation and 3 Medicines in Tanzania Brainstorming 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 131 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: Methods for Controlling Substandard and Counterfeit Medicines (25 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What measures can be taken to control substandard and counterfeit medicines? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below Given the diverse and complex nature of the issues and challenges related to substandard and counterfeit medical products, a wide range of interventions are needed to effectively address them. • Member States should reaffirm their commitment to the fight against counterfeit medical products and engage in updating, developing, implementation and monitoring of national medicines policies. • Member States should establish NMRAs that have adequate legal mandate, independence and institutional capacity to ensure and strictly enforce compliance of medical products with standards of quality, safety and efficacy; and to effectively • Control the manufacture, export, import and distribution of substandard/spurious/falsely labeled/falsified/counterfeit medicines. • In order to address the problem of sufficient training and availability of qualified staff, Member States should develop and implement a sustainable human resource strategy for the pharmaceutical sector that ensures adequate human resource capacity including specialized training and retention of regulatory personnel • Continuing education and training programmes should be constituted into training curricula to enhance the knowledge and skills of health personnel to enable them to prevent, PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 132 recognize and appropriately deal with cases of substandard and counterfeit medical products. • Member States should put in place reliable supply systems and the requisite financial resources to ensure the availability of quality and affordable essential medical products in public health facilities. Comprehensive quality assurance systems for procurement and distribution should be strengthened for the public, private and other health care providers. • Necessary measures to ensure access to affordable medical products that meet quality and safety standards should be incorporated and given due emphasis in national health policies and strategic plans. Government authorities should monitor and regulate the prices of medical products to ensure their availability and affordability • Member States should establish effective systems to carry out specific studies and routine market surveillance to quantify the magnitude of the problem and to inform the development and implementation of appropriate policies and regulations • The strategy should involve all activities aimed at fighting illegal production, distribution and use of these medical products. • Based on the findings of the studies, Member States should develop information, education and communication strategies to increase awareness of policy makers, health workers and the general public about the dangers of using substandard/spurious/ falsely labeled/falsified/ counterfeit medical products • Member States should establish effective national, regional and interregional cooperation and collaboration mechanisms including reinforcing regulatory networks and exchange of information among public health, law enforcement, professional associations, NGOs and other relevant authorities to improve prevention, detection, investigation and prosecution of cases related to substandard/ spurious/falsely labeled/ falsified/counterfeit medical products. • WHO should o further develop tools and guidelines enabling Member States to adapt and implement policies and strategies; o Continue to assess and strengthen National Medicine Regulatory Aauthorities in order to ensure the quality, efficacy and safety of medical products o (Support Member States to mobilize more resources for developing human resource capacity for the pharmaceutical sector; o Continue to facilitate the exchange of objective and independent regulatory information among Member States o Intensify the promotion and implementation of good governance, accountability and transparency in Member States; o Strengthen the conduct and dissemination of operational research on substandard/spurious/falsely labeled/falsified/counterfeit medical products and encourage Member States to use evidence for policy actions; and o Strengthen monitoring and evaluation of programmes dedicated to combating the manufacture, distribution and use of substandard and counterfeit medicines. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 133 STEP 3: Curbing Spread of Substandard and Counterfeit Medicines in Tanzania (20 minutes) Activity:Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What measures can be taken to control spread of substandard and counterfeit medicines in Tanzania? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • The following are measures to be taken to control spread of substandard and counterfeitmedicines in Tanzania o At the national levels, the government must:  Improve the availability and affordability of medicines;  Enact deterrent legislation prohibiting the manufacture, importation, exportation, distribution and sale of substandard and counterfeit medicines; 

NTA Level 6 • Semester 2 • PST06211 Monitoring and Evaluation of Medicine Use – Complete Full Notes Complete educational source text in one page Completeness safeguard: this page keeps the complete educational module/source wording in one place so learning material is not lost when browsing topic by topic. Presenter/tutor metadata is intentionally excluded. UNITED REPUBLIC OF TANZANIA Ministry of Health, Community Development, Gender, Elderly and Children PST 06211 MONITORING AND EVALUATION OF MEDICINE USE NTA Level 6 Semester 2 Facilitator Guide March 2019 NTA Level 6 Semester 2 Facilitator Guide i Copyright © Ministry of Health, Community Development, Gender, Elderly and Children – 2019 PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide i Table of Contents Background …………………………………………………………………………………………………………………… iii Acknowledgment ……………………………………………………………………………………………………………. v Introduction ………………………………………………………………………………………………………………….. vii Abbreviations ………………………………………………………………………………………………………………… ix Session 1: Introduction to Monitoring and Evaluation …………………………………………………………. 1 Session 3: Assessing Monitoring and Evaluation of PharmaceuticalsServices ……………………… 19 Session 4: Performance Indicators for Monitoring and Evaluation ……………………………………… 31 Session 5: Factors Hindering Monitoring and Evaluation of Medicines Use …………………………. 42 Session 6: Indicators in Monitoring and Evaluation Medicines Use ……………………………………. 47 Session 7: Tools for Monitoring and Evaluation of Medicine Use ………………………………………. 54 Session 8: The Concept of Pharmacovigillance: ……………………………………………………………….. 62 Session 9: Pharmacovigillance Methods ………………………………………………………………………….. 69 Session 10: Documentation of Pharmacovigillance Data ……………………………………………………. 78 Session 11: Reporting Pharmacovigillance Data ………………………………………………………………. 84 Session 12: Introduction to Adverse Drug Reactions (ADRs) …………………………………………….. 91 Session 13: Documentation of ADRs ………………………………………………………………………………. 97 Session 14: Reporting of ADRs …………………………………………………………………………………….. 103 Session 15: Substandard and Counterfeit Medicines ………………………………………………………… 112 Session 16: Detection of Substandard and Counterfeit Medicines ……………………………………… 121 Session 17: Controlling Substandard and Counterfeit Medicines ………………………………………. 131 Session 18: Distribution of Substandard and Counterfeit Medicines ………………………………….. 139 PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide ii 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. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter- institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‘s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick-off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‘s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitator‘s guide and assessment plan was participatory approach which included a number of activities through various workshops such as PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide iii planning, and orientation of material development. After these preliminary workshops, experts developed materials individually and in-groups. Thereafter, developed draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‘s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 12 modules for NTA level 6 making 12 Facilitator guides and one Practicum guide. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide iv 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 (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuyafor her commitment in coordinating and facilitating the planning and

NTA Level 6 • Semester 2 • PST06211 Distribution of Substandard and Counterfeit Medicines ………………………………….. 139 Monitoring and Evaluation of Medicine Use • Source Session/Topic 18 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 18: Distribution of Substandard and Counterfeit Medicines ………………………………….. 139 PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide ii 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. CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and strengthen health care in Tanzania through improvement of pharmaceutical training and an inter- institutional coordination of actors. This will harmonize and improve access to quality pharmaceutical service in Tanzania. The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS, RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs on teaching and assessment methods in Tanzania and thus improved health delivery through increased qualified human resource. It was also observed that in the previous stakeholder‘s meetings there was a need for the development of training manuals and assessment plans for NTA Level 5 & 6, in order to support the establishment and implementation of the curriculum in PTIs. During MAP kick-off workshop done in February 2018, Stakeholders agreed that there was a need for development of the said manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this project aims at developing facilitator‘s guide and assessment plans for NTA Level 5 & 6. Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a qualified service provider with experience in material development to develop the mentioned training manuals and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6 and assessment plan. Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with the instructions to include experts who have developed teaching materials for NTA Level 4. These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors. The mode of operation used by CEDHA to develop facilitator‘s guide and assessment plan was participatory approach which included a number of activities through various workshops such as PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide iii planning, and orientation of material development. After these preliminary workshops, experts developed materials individually and in-groups. Thereafter, developed draft materials were reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs. Finally, CEDHA submitted the finalized Facilitator‘s guides and assessment plans for NTA level 5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities. There are 12 modules for NTA level 6 making 12 Facilitator guides and one Practicum guide. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide iv 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 (German Ministry of Industry and action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project, CSSC has been able to provide the financial and technical support needed during the development of this training material. Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts on health material development and training who coordinated the development of these module sessions particularly Ms. Diana H. Gamuyafor her commitment in coordinating and facilitating the planning and development to its completion. Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating and providing their expertise to the success of this work. It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive staff that made this process a success; accountant, secretary, drivers and printers 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.FadhiliLyimo Assistant Director Allied Health,MoHCDGEC Dr. Jacqueline Uriyo Acting Principal, CEDHA Dr.Sungwa N. Kabissi Project Manager – MAP, CSSC Ms. Diana H. Gamuya CEDHA Ms. Grace Mallange PC Mr.WensaaMuro KSP PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide v Ms. Emily Mwakibolwa Pharmacy Council Mr.Samwel M. Zakayo Pharmacy Council Mr.SamweliMdallingwa NACTE Dr.ByeraShwekerela CEDHA Dr.MwanduJiyenze CEDHA Mr.StephanoKiberiti CEDHA Mr.Amani Phillip HKMU Mr.OmaryMejjah CUHAS Mr.Rajabu I. Amiri MUHAS Ms.Tumaini H. Lyombe MUHAS Ms.Dilisi J. Makawia KSP Mr.NemesUisso RAS-KLM Mr.GoodluckMdugi RuCU Mr.EvalistShileki DECOHAS Mr.EliabuMshashi KIUT Dr.Loishooki S. Laizer Director of Human Resources Development Ministry of Health, Community Development, Gender, Elderly and