Promoting the Rational Medicine Use of ARVs, Anti-TB, and OtherMedicines and Preventing the Development of AntimicrobialResistance in Namibia: Workshop and Stakeholders ForumDavid MabiriziDan KibuuleMathias AdorkaTim RennieEvans SagwaVictor SumbiKennedy KambyambyaHarriet R. KagoyaFrancis KalemeeraAugust 2013Republic of NamibiaMinistry of Health andSocial ServicesUniversity of Namibia

Promoting RMU of ARVs, Anti-TB, and Other Medicines and Preventing Development of AMR in NamibiaThis report is made possible by the generous support of the American people through the US Agency forInternational Development (USAID), under the terms of cooperative agreement number AID-OAA-A-1100021. The contents are the responsibility of Management Sciences for Health and do not necessarilyreflect the views of USAID or the United States Government.About the University of Namibia (UNAM)The University of Namibia (UNAM) is a leading public higher education institution with a studentpopulation of close to 13,000 students each year. Academic programs at UNAM emanate from eightfaculties and two schools: the Faculty of Agriculture and Natural Resources; Faculty of Economics andManagement Science; Faculty of Education; Faculty of Engineering and Information Technology; Facultyof Humanities and Social Sciences; Faculty of Law; Faculty of Health Sciences, consisting of the Schoolof Nursing and Public Health and the School of Medicine; and the Faculty of Science.In 2006, UNAM was rated as the best higher education institution in Namibia by the ProfessionalManagement Review of South Africa and won a Golden Arrow Award. The previous year, the Genevabased Foundation for Excellence in Business Practice nominated UNAM to receive its Gold Medal forExcellence in Business Practice. UNAM has graduated over 17,000 students who are serving the countryin various sectors of the economy, with most occupying prominent positions in government and the privatesector.About SIAPSThe goal of the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is toassure the availability of quality pharmaceutical products and effective pharmaceutical services to achievedesired health outcomes. Toward this end, the SIAPS result areas include improving governance, buildingcapacity for pharmaceutical management and services, addressing information needed for decision-makingin the pharmaceutical sector, strengthening financing strategies and mechanisms to improve access tomedicines, and increasing quality pharmaceutical services.Recommended CitationMabirizi, D, Kibuule D, Adorka M, et al. Promoting the Rational Medicine Use of ARVs, Anti-TB, andOther Medicines and Preventing the Development of Antimicrobial Resistance in Namibia: Workshop andStakeholders Forum. Developed in collaboration with the University of Namibia-School of Pharmacy andMinistry of Health and Social Services, Division of Pharmaceutical Services. Submitted to USAID by theSIAPS Program. Arlington, VA: Management Sciences for Health, 2013.Key WordsAntimicrobial resistance, antiretroviral, drug resistance, HIV/AIDS, Namibia, tuberculosis, rationalmedicine useUniversity of NamibiaSchool of PharmacyPrivate Bag 13301, 340 Mandume Ndemufayo Ave, Pionierspark,Windhoek, NAMIBIA http://www.unam.naSystems for Improved Access to Pharmaceuticals and ServicesCenter for Pharmaceutical ManagementManagement Sciences for Health4301 North Fairfax Drive, Suite 400Arlington, VA 22203 USATelephone: 703.524.6575Fax: 703.524.7898E-mail: [email protected]: www.siapsprogram.orgii

CONTENTSAcronyms and Abbreviations . ivAcknowledgments. vExecutive Summary . viBackground . 1Purpose of this Activity . 2Expected Results of this Activity. 2Scope of Work for the Workshop and Forum . 4SIAPS/Namibia FY13 Work Plan Activity . 4Specific Tasks . 4Deliverables or Products to be Developed . 5Goals, Objectives, and Summary of the Workshop and Forum . 6Goal . 6Specific Objectives . 6Workshop and Forum Proceedings Summary . 6Summary of Sessions . 7Key Stakeholders and Roles in RMU and AMR Prevention and Containment . 10Namibia AMR/RMU Action Plan . 12Stakeholders’ Meeting, July 24, 2013. 15Opening Remarks. 15Panel Discussion . 15Discussion . 16Final Comments from Panelists . 17The Call to Action . 18AMR Intervention Model for Namibia . 20Workshop Evaluation, Key Comments, and Recommendations . 21Comments from Attendees . 22Achievements . 23Next Steps . 23Annex A. Attendance List. 24Annex B. Selected Photographs from the Workshop and Forum . 26Annex C. Workshop Program . 30Annex D. AMR/RMU Stakeholders Forum Program . 32Annex E. Workshop Evaluation Form . 33Annex F. Presentations . 35List of TablesTable 1. Session Summaries . 8Table 2. Stakeholders and Their Roles in Containing AMR in Namibia . 10Table 3. The AMR/RMU Activities Action Plan . 12Table 4. Participants’ Evaluation of the Workshop . 21List of FiguresFigure 1. Proposed approach for advocacy and containment of AMRin Namibia – July 2013 . 20iii

ACRONYMS AND ABBREVIATIONSAIDSAMRARTARVCDCCMSDRDSPDiv. USAIDWCHWHOacquired immunodeficiency syndromeantimicrobial resistanceantiretroviral therapyantiretroviralUS Centers for Disease Control and PreventionCentral Medical Storesdrug resistanceDirectorate of Special ProgrammesDivision of Pharmaceutical ServicesElectronic Dispensing ToolEssential Medicines Listearly warning indicatorhealth care workerhuman immunodeficiency virusHead of DepartmentHealth Professions Council of Namibiamultidrug resistanceMinistry of Health and Social ServicesManagement Sciences for Healthmedicine use evaluationNamibians Against Antimicrobial Resistancenongovernmental organisationNational Health Training CentreNamibia Institute of PathologyNamibia Medicines Regulatory Councilpharmacist’s assistantpeople living with HIVPharmaceutical Society of Namibiarational medicine useSystems for Improved Access to Pharmaceuticals and ServicesSchool of Pharmacystandard treatment guidelineTreatment Advisory CommitteetuberculosisTherapeutics Committee(s)United Nations Programme on HIV/AIDSUniversity of NamibiaUS Agency for International DevelopmentWindhoek Central HospitalWorld Health Organizationiv

ACKNOWLEDGMENTSThe workshop organizers and the authors of this report thank the US Agency for InternationalDevelopment (USAID)-funded Systems for Improved Access to Pharmaceuticals andServices (SIAPS) Program for supporting the workshop and stakeholders’ forum oncontaining antimicrobial resistance and promoting rational medicine use in Namibia. Theteam is equally grateful to the University of Namibia, School of Pharmacy and the Ministryof Health and Social Services Division of Pharmaceutical Services (Div. PhS) for the effortsput into preparations that ensured success of the workshop and forum. Thanks also to theUNAM and SIAPS administrative staff for their contribution to the success of the workshop.We also acknowledge all participants for the enthusiasm and active participation in theworkshop.v

EXECUTIVE SUMMARYRational medicine use (RMU) and prevention of antimicrobial resistance (AMR) are vitalcomponents of ensuring efficient, safe, and cost-effective health service delivery. In Namibia,the role of the university and academia in general in ensuring availability of medicine-relatedresearch is pivotal in supporting the Ministry of Health and Social Services (MoHSS) toimplement interventions based on evidence.This activity included a workshop and a stakeholders’ forum to raise awareness of RMU,develop action plans to combat the emergence of resistance against antimicrobials, andmobilize consensus through a call to action. The specific objectives were to: Enhance awarenessMobilize stakeholders for a common goalIncrease availability of evidenceAgree on a call-to-action on RMU and prevention of AMR in NamibiaThe University of Namibia (UNAM) School of Pharmacy (SOP) did an excellent job ofcoordinating the training. The key achievements of this activity included training and raisingthe awareness of more than 60 students, health workers, and allied health professionals andmobilizing key stakeholders. As a result of these efforts, the course was accredited by theHealth Professionals Council of Namibia. Therefore, academicians and health workers fromUMAN, MoHSS, and the private sector have been engaged in improving RMU andpreventing AMR in Namibia.The call to action and action plan developed and agreed upon by stakeholders will serve askey documents in the implementation of activities to improve RMU in Namibia. Throughthese achievements, UNAM is in a good position to continue coordinating RMU and AMRactivities and to develop activities that will enhance operational research on antibiotics andantivirals in health facilities in Namibia.UNAM and other stakeholders have agreed upon their roles and responsibilities, and withcontinued support from UNAM and MoHSS, the call to action will be disseminated andactivities implemented as proposed in the action

BACKGROUNDNamibia has adopted the public health approach to scaling up antiretroviral therapy (ART) thatinvolves the use of standardized and simplified treatment regimens. Drug resistance (DR) toantiretroviral (ARVs) medications is inevitable in populations on life-long ART. Namibia is oneof the three countries in Africa (in addition to Botswana and Rwanda) that has reached 80 percentcoverage for ART1 (Joint United Nations Programme on HIV/AIDS - UNAIDS, 2011). By June2013, 100,0002 public sector patients were on ART in Namibia and this number continues togrow. MoHSS continues to increase access to ART by decentralization and adoption of the 2013WHO guidelines on the management and treatment of people living with HIV (PLWHIV).Namibians continue to have access to medicines for managing a variety of conditions includingtuberculosis (TB) and other communicable and non-communicable diseases. In ensuringavailability and access to these safe, efficacious, and cost-effective antibiotics and antivirals for alarge population of patients, it is important to improve rational use medicines to prevent andminimize the risk of AMR.To minimize the development of HIV DR, the focus should be on early detection factorsassociated with increasing the risk of DR (e.g., associated with prescription patterns, adherenceto ARVs) and implementation effective interventions to minimize the impact of these factors.The challenges of HIV and AIDS management are not unique to Namibia, but are similar to themanagement of other health issues and medicines including— Insufficient capacity to coordinate and support RMU activities, particularly the lack ofcapacity to generate evidence (through operational research) on the burden and risk ofAMR Limited local evidence on evaluation of practices and interventions that increaseawareness or advocate for prevention of AMR Limited advocacy for and coalitions on RMU and AMR, thereby limiting opportunitiesfor discussions and for enhancing awareness and training High prevalence of multidrug resistant (MDR) and extensively resistant TB in NamibiaIn recognition of the challenges, MoHSS and its partners have put in place a number ofinterventions including— Development and implementation of the HIV/AIDS early warning system to detect andprevent HIV DR Formation and use of a multidisciplinary coalition of professionals to strengthenadvocacy (Namibians Against Antimicrobial Resistance [NAAR]) Optimisation of the partnership with UNAM, which provides a great opportunity toenhance operational research and availability of evidence for decision making1Joint United Nations Programme on HIV/AIDS - UNAIDS. (2011). World AIDS Day Report. Geneva: UNAIDS.Mugala-Mukungu, F. (2012). Antiretroviral Therapy in Namibia. SA HIV/AIDS Conference. 25-28 November201221

Promoting RMU of ARVs, Anti-TB, and Other Medicines and Preventing Development of AMR in Namibia Strengthening the analysis and use of antimicrobial sensitivity data for decision making Establishment of the Therapeutics Information and Pharmacovigilance Centre (TIPC) toenhance awareness and facilitate the generation and use of medicine-related evidencePurpose of this ActivityContaining AMR is a key focus of the Systems for Improved Access to Pharmaceuticals andServices (SIAPS) Program in Namibia. SIAPS proposes to work with UNAM SOP, MoHSS, andother stakeholders to strengthen local initiatives and networks to help prevent the developmentand spread of resistance to ARV, anti-TB, and other antimicrobial agents.In view of the challenges and measures put in place by MoHSS and partners to minimize DR inNamibia, SIAPS has supported UNAM SOP in two key activities to: Organize and conduct a national workshop on promoting rational use of ARVs and othermedicines Establish an International Network for Rational Use of Drugs Namibia chapter at UNAMSOP and engage key stakeholders in developing and implementing an effective strategyto reduce the risk of AMR in NamibiaThe overall objectives are to build institutional capacity for UNAM to deliver this training andother pharmaceutical trainings and for UNAM SOP to become a pivotal resource for conducting,analyzing, disseminating, and coordinating operational research activities on RMU and AMR.This activity and subsequent interventions all lead to RMU and AMR-related operationalresearch activities by UNAM SOP and other stakeholders.Key opportunities— Develop a platform for advocacy and technical assistance to establish a coalition ofinterested stakeholders that are committed to discussing and implementing an array ofinterventions to reduce the negative impact of irrational use of medicines in Namibia Develop and adapt SIAPS in-service AMR curriculum and related training materials for apre-service training module in the UNAM SOPExpected Results of this Activity Increase in the number of health care workers (HCWs) who successfully complete an inservice training on strategic information (monitoring and evaluation, surveys, surveillance,evaluations, health information systems) Holding of the stakeholders forum RMU and AMR training accredited by the Health Professionals Council2

Background Incorporation of RMU and AMR training in the pre-service curriculum of the bachelor ofpharmacy programTo prepare and facilitate the workshop, the following activities were carried out— Training materials for a workshop and stakeholders’ forum were revised and adapted. The UNAM SOP team was oriented and guided on the purpose and opportunities oftraining and the stakeholders’ forum. The SOP team was also supported on how best toaccomplish their role as the lead in conducting the workshop and stakeholders’ forum.Key RMU and AMR stakeholders in Namibia were identified and mobilized toeffectively participate in the discussions. Provide structured follow-up of the action plan activities.3

SCOPE OF WORK FOR THE WORKSHOP AND FORUMSIAPS/Namibia FY13 Work Plan ActivityThis activity is in SIAPS Namibia’s approved work plan and focuses on providing technicalassistance to increase UNAM’s and the National Health Training Centre’s (NHTC) capacity toconduct pharmaceutical-related operational research. (NHTC is a MOHSS pharmacists’assistants’ training institute network.) This research will enhance availability of locally generatedevidence that will guide decision making on the rational use of ARVs and other medicines andthe use of metrics to monitor the performance of the pharmaceutical sector in the delivery ofservices in Namibia.This activity is to build capacity of UNAM SOP to coordinate and support RMU activities inNamibia. The activities include generating evidence through operational research on the burdenand risk of AMR, evaluating the results of AMR interventions, assessing clinician compliance totreatment guidelines, advocacy, coalition building and providing training in RMU/AMR, and theeffective management of therapeutics committees. Additionally, UNAM’s increased capacitywill support MoHSS in routine indicator monitoring of the quality of pharmaceutical services,such as— How many patients report being satisfied with the information they received about theirmedications How many patients know correct information about their medications How many treatment sites implement good standards for dispensing medicines How many prescriptions are in compliance with current standard treatment guidelines(STGs) How many patient encounters result in an antibiotic being prescribedSpecific TasksThis training focused on promoting the rational use of ARVs and adherence to ARVs/anti-TBmedicines. The overall goal is to establish research capacity at UNAM to provide ongoingperformance monitoring of the pharmaceutical service delivery. SIAPS facilitated this workshopusing the principles of developing a national forum and agenda for addressing RMU issues andinvestigating medicine use problems. These principles include identification and mobilization ofstakeholders, identification of a national champion to facilitate this process, development andagreement on a call to action and drafting of an action plan. The specific tasks included— Supporting UNAM SOP to organize and conduct a national workshop on promotingRMU that covered—o Appropriate antimicrobial (including ARVs) use and prevention of AMRo Proper techniques on investigating problems related with the use of ARVs and othermedicines4

Scope of Work for the Workshop and Forumo HIV DR early warning indicators (EWIs)o Strategies for remedying the identified medicine use problemso Strengthening therapeutic committees in control of the use of antimicrobials,strengthening patient adherence to prescribed ARVs and other medications, andpromoting clinicians’ compliance with treatment guidelines Providing a platform for advocacy and technical assistance in establishing theInternational Network for Rational Use of Drugs Namibia chapter at UNAM SOP,including engaging with key stakeholders such as relevant MoHSS divisions, thepharmaceutical and medical professional bodies, Namibia Institute of Pathology, andNAAR Developing and adapting SIAPS in-service AMR curriculum and related trainingmaterials for a pre-service training module at UNAM SOP, School of Medicine, Schoolof Nursing, and NHTCDeliverables or Products to be Developed Technical report and an action plan to combat AMR in NamibiaDraft module for pre-service training on RMU/AMR5

GOALS, OBJECTIVES, AND SUMMARY OF THE WORKSHOP AND FORUMWorkshop Theme: Advocacy and Containment of AMR in NamibiaGoalThis workshop was to raise awareness of RMU, develop action plans to combat the emergence ofresistance against antimicrobials, and mobilize consensus through a call to action.Specific Objectives Enhance awareness of rational use and AMR to antibiotics and ARVs Mobilize stakeholders for a common goal of reducing the risk of AMR in Namibia Increase availability of evidence on AMR and rational use and enhance use of this evidencein decision making Agree on a call to action and developing an action plan or agenda for preventing and buildingmomentum for AMR activities in NamibiaWorkshop and Forum Proceedings SummarySeveral collaborative preparatory meetings were held for the workshop and stakeholders’ forum.Key stakeholders involved included UNAM SOP, MoHSS Div. PhS, and NAAR. The workshopand forum were held at UNAM SOP. A total of 66 individuals attended, including academicians(lecturers) from UNAM, administrators from MoHSS, and HCWs from public and privatefacilities. The workshop participants were physicians, pharmacists, nurses, and other alliedprofessionals critical in the prevention of AMR (for agenda and content of the workshop, refer toannex C).6

SUMMARY OF SESSIONSThe workshop was officially opened by Prof. Peter Nyarang’o, Dean, Faculty of HealthSciences, and Founding Dean, School of Medicine, University of Namibia. In his remarksentitled “Guilty as Charged,” he emphasized the fact that as much as health workers save lives,they are guilty of misusing medicines, which results in AMR and increases the risk of morbidity.Health workers should therefore take the responsibility to put in place measures to minimize therisk of AMR and enhance the achievement of health outcomes of reduced morbidity andmortality. He called on participants to change individual practices and improve health caredelivery, saying that, “We need multiple approaches— technical, professional behavior, andpolitical action.”7

Promoting RMU of ARVs, Anti-TB, and Other Medicines and Preventing Development of AMR in NamibiaTable 1. Session SummariesSession titleDay 1GlobalChallenge ofIrrational Useof MedicinesObjectivesSummary of the session The presentation showed that the problem of irrational use of medicines, particularlyantimicrobials—including but not limited to anti-TB and ARV medicines—is a challenge in anumber of countries. It was shown that AMR is one of the major effects of irrational use ofantimicrobials. The presenter also showed that irrational use of medicines emanates fromproblems with medicine supply, poor quality of medicines, and health system problems, suchas failure to implement STGs. UnderstandingMedicine UseProblems Provide an overview of the extent andnature of inappropriate use ofmedicinesDiscuss irrationalities pertaining to theuse of antimicrobials, including thoseused in the treatment of HIV/AIDS andTBUnderstand the adverse impact ofinappropriate use of medicinesIdentify factors underlying theirrational use of medicinesDescribe the process of identifyingand changing medicine use problemsIdentify and evaluation sources ofquantitative and qualitative dataUnderstand the importance ofstudying provider and patientmotivationsIntroduce qualitative researchmethodsWhat the audience learned from this presentation: Irrational use of ART and TB medicines is not expected as their management involves onlya limited number of medicines, but it has been observed. Namibia has data that can be analyzed to generate recommendations for policy makersand prescribers, but it is not being analyzed. The consequences of irrational drug use are far reaching, for example, in the area ofincreased cost of medicines for management of drug-resistant TB. EWIs are essential for the monitoring of outcomes of ART programs.The presenter explained the components of the drug use system, understanding thesecomponents exposes the areas where medicine use interventions can be targeted. Hepresented the systematic implementation of medicine use evaluations (MUEs) with detaileddiscussion in the following areas: measurement of existing practices, identifying the specificproblems and causes, designing and implementing intervention; and assessing change inoutcomes. Furthermore, he explained quantitative and qualitative methods in MUEs. Hestressed that qualitative methods are crucial as they answer the question “why.”In response to questions: On MUEs for antibiotics: it was advised that 30 prescriptions of antibiotics provide asample that can be analyzed, as long as the selection of prescriptions is not biased.On which source to depend for selection of antibiotics: he shared that MoHSS hasproduced STGs, which have medicines that are in tandem with the Essential MedicinesList (EML). But he also emphasized that laboratory results on sensitivity of organismsaffecting the patient should be a guiding factor.On the life-span for the EML: the discussion highlighted the need for evidence that willbe used to design the EML and the lifespan of the EML varies from two to five yearsdepending on the number of changes in the global and local guidelines.8

Summary of SessionsSession titleInterventionsto ChangeMedicine UseProblemsDay 2EvaluatingChanges inMedicine UsePractice andMedicine UseRelatedOutcomesOverview ofAMR andInterventionsRecommendedto ContainAMRObjectives Provide an overview of the strategiesand interventions that can be utilizedto address medicine use problems Discuss education, managerial andregulatory methods to improve use ofmedicines Discuss strategies to encourage RMUin the treatment of HIV/AIDS and TBSummary of the sessionThe presenter highlighted the need for a multipronged approach as a means for realizingstrategies to combat AMR. Particularly, he emphasized each of the four strategies that weredesigned by Management Sciences for Health (MSH) and WHO, including education,managerial, economic, and regulatory. He suggested that for TB and HIV the followinginterventions are necessary: update ART guidelines, advocate for newer and better ARVs andformulations; use of fixed-dose combinations, rationalization of regimens, minimization ofvariability on medicines due to supplier differences in the medicines provided, and promotionof treatment literacy. The presenter emphasized that the key to successful initiation of an MUE is to have buy-infrom management and to have the MUE sanctioned by the TC. The presenter also pointed outthat MUEs are audits of medicine use practices, and because they are a kind of audit, if theyare not carefully planned and implemented, they have potential to cause unnecessary anxiety.It was emphasized that the MUE is not a fault finding activity, but rather a quality improvementprocess. Thus the interventions target a system. On the other hand, it was noted that theinterventions may target an individual. UsingIndicators toMonitor HIVDR Provide detailed information on theconcepts and process of conducting amedicine use evaluationDescribe MUE as a mechanism thatcontributes to quality assurance andcontinuous quality improvementProvide an overview of AMR,including its causes and impact,around the world and in Africa,Give an overview of the problem ofdrug resistance in HIV and TBProvide the key interventionsrecommended for containment ofAMR in the 2011 World Health DayAMR Policy PackageProvide a brief overview ofinterventions recommended tocontain HIV and TB DRSharing successful implementation ofthe early warning indicators of HIV DRin NamibiaThe bottom line of the presentation was to emphasize that the MUEs should be implementedin a stepwise approach, should be consultative and should avoid unnecessary anxiety.The presenter talked about how resistance to antimicrobials develops. He pointed out that themajor cause for AMR is human practice, especially in countries where medicine regulation isabsent or poorly impleme

Promoting RMU of ARVs, Anti-TB, and Other Medicines and Preventing Development of AMR in Namibia . of Nursing and Public Health and the School of Medicine; and the Faculty of Science. . Program is to assure the availability of quality pharmaceutical products and effective pharmaceutica