The MSH/RPM Plus program has been working in Rwanda since 2003 with funding from USAID under PEPFAR and, since 2007, under PMI. In 2003, RPM Plus was invited by USAID to examine the capacity of the pharmaceutical and laboratory systems to support the ART national program. In April 2004, RPM Plus shared its assessment findings with the national and international institutions involved in scaling up ART in Rwanda, and as a result, an action plan was developed for strengthening the pharmaceutical sector and ensuring the availability of ARVs in the country. In June 2004, the RPM Plus country office was established in Kigali, and since then, RPM Plus has been working closely with the MOH at both national and peripheral levels of the pharmaceutical system to improve selection, procurement, distribution, and use of ARVs, antimalarials, and other essential medicines and health commodities.

The MSH - USAID cooperative agreement RPM Plus came to an end in September 2007. In Rwanda as in many other countries, MSH is receiving funds under the newly awarded USAID program Strengthening Pharmaceutical Systems (SPS) to enhance the results achieved under of RPM Plus. The work of SPS is focused in four areas: good governance, strengthening pharmaceutical management systems, expansion of access to essential medicines, and containment of antimicrobial resistance.

During FY 2008, PEPFAR supply chain activities were effectively transferred to Supply Chain Management System (SCMS), while SPS focused its technical assistance on medicine safety specifically in the areas of pharmacovigilance and rational medicines use, at national and peripheral levels, which are specific areas of expertise of the SPS Program.

Promoting Medicine Safety and Rational Medicine Use in Rwanda In many countries, national drug authority is responsible for ensuring the quality, safety, and efficacy of the medicines available in the country through activities such as medicine registration, quality control testing, and pharmacovigilance. Although Rwanda is in the process of establishing a national drug authority, it is not yet functional. Despite the fact that Rwanda does not have a national drug authority or experience in pharmacovigilance interventions, PEPFAR in FY 2008, in collaboration with other donors (PMI and Global Fund), funded the implementation of a pharmacovigilance system in Rwanda to be coordinated by the Pharmacy Task Force (PTF). SPS helped the PTF, the National Malaria Control Program (PNILP), and other in-country counterparts develop a national plan for pharmacovigilance beginning in FY 2007 with PMI funds in close collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and the MOH. During FY 2008 implementation period, Rwanda identified the establishment of an adverse drug reaction notification system as one of its highest priorities.

Pharmacovigilance ensures medicine safety and includes prevention, detection, and understanding of: • Adverse drug reactions and side effects • Drug interactions with food or with other drugs • Medical errors • Lack of efficacy and antimicrobial resistance • Quality problems and counterfeit products

Pharmacovigilance is important in PEPFAR because the experience of use of ARV is still limited; ARVs are used always in combination (Tri- therapy) which increases the risk of drug interactions; ARVs are used for life, which increases the risks of cumulative toxicity; AIDS patients often need to take other medicines for prophylaxis or treatment of other infections, which increases even more the risks of interactions and toxicities; ARV manufacturers and suppliers are constantly increasing and the market is becoming more competitive, which requires more vigilance to avoid quality related problems; scaling up ART requires putting in place mechanisms to protect the patients from unsafe drugs.

Rational Medicines Use (RMU) requires the development and implementation of policies and guidelines that define what the medicines are going to be used for in country and how these medicines will be used. Therefore, RMU activities imply an absolute need to work with the MOH, with the prescribers, with the dispensers, and with the community. An important component of RMU is the need to respect the standard treatment guidelines for specific health conditions, such as treatment of AIDS. RMU is important for a variety of reasons, but two of the most significant reasons are; it increases the quality of care of a

patient and contains costs of the health care system.

RDU is important for PEPFAR because adherence to ARVs is essential to ensure the benefits of the therapy, to reduce failure and need to change to second line treatments that are more expensive. Care of HIV patients imply other medicines besides ARVs, such as medicines for the prevention and care of opportunistic infections, dispensers can play an important role between clinicians and patients, although ARVs are not dispensed in the private sector, patients —including HIV-positive patients— seek advice and medicines in private pharmacies. Scaling up the number of patients accessing ART should not be done at the expense of the quality of treatment.

MSH SPS is working closely with the Ministry of Health, Pharmacy Task Force and TRAC Plus to help build their capacity to achieve the above results thereby strengthening the in-country capacity to continue these activities in the future.

Support the MOH/PTF, Association Rwandaise des Pharmaciens (ARPHA) and La Rwandaise d'Assurance Maladie (RAMA) to improve RMU, pharmaceutical care, and good dispensing practices in the public and private sectors

In FY 2009 SPS provided significant assistance to the PTF to improve the rational use of medicines and dispensing practices at decentralized levels. SPS developed a plan to improve dispensing practices at pharmacies in public sector health facilities. SPS also produced targeted training materials and job aids for the dispensers. Trainings were conducted using the job aids and included modules on monitoring and evaluation at hospitals. This activity also included capacity building for district hospital pharmacists in selected districts, transferring to them the skills required to conduct training and supervision on proper dispensing practices at lower-level health centers.

During FY 2009, SPS implemented the following activities:

• Assisted the MOH/PTF to promote RMU through public education and participation in national health campaigns. • In collaboration with MOH/PTF, supported the establishment of DTCs in four additional district hospitals with training on DTC, RMU, AMR, pharmaceutical care and good dispensing practices; implemented an action plan through effective supervision. • Assisted MOH/PTF to support 18 DTCs to carry out their work plans by implementing quarterly monitoring-training-planning meetings. • Assisted MOH/PTF and ARPHA to implement RMU and pharmaceutical care interventions in the private sector. • In collaboration with the MOH/PTF and DTCs, conducted a drug use study to identify problems and design interventions to effectively address RMU issues in Rwanda.

In FY 2010, SPS will continue to support the MOH/PTF with its goal of expanding and strengthening of the Drug and Therapeutics Committees (DTCs) by doing the following:

• Assist the MOH/PTF to develop a strategy for it to assume full technical responsibility for supporting existing DTCs; assist the MOH/PTF with the implementation of that new approach to consolidate and strengthen existing DTCs. • Carry out decentralized trainings led through the TOT approach. • Assist the MOH/PTF to develop a strategy in collaboration with the existing DTCs to allow functioning DTCs to effectively roll out and monitor DTC activity in select health facilities in their districts. • Continue to provide follow-up TA to enhance DTC efficiency and actions in the areas of RMU, AMR, and pharmacovigilance. • Consolidate facility-level infection control activities, and initiate simple infection prevention awareness campaigns through community health workers (CHWs) and expand to all district hospitals.

Support for establishment of the Rwanda Food and Drug Authority by doing the following:

• Assist the district pharmacist to define their roles within the district health team. • Present a plan to implement from national strategies on ADR, RMU, pharmaceutical care (PC) activities. • Mentor/support new and veteran district pharmacists through TA at the district level on provision of pharmaceutical care, consolidation of ADR and other reporting system with the national system, and collaboration with faith based health facilities through Rwandan Faith-based Medical Stores (BUFMAR). • Expand involvement with the private sector pharmacies by establishing a link with national health insurance schemes; develop a framework and an approach (including the necessary structures, roles and responsibilities) required for measuring and monitoring standards of quality for pharmaceutical services both in the public and private sector. • Develop an accreditation scheme and checklist based on a set of standards for licensing and inspection of pharmaceutical services. • Provide support for the implementation of the accreditation standards. Support the MOH to develop a medicine pricing list and all the activities required for implementation

Expand Community Case Management (CCM) intervention by doing the following:

• Support the Community Health desk to standardize inventory management practices for CHWs and monitor the use of the drugs at community level through quarterly indicators collected at hospitals and randomized field visits • Support pharmaceutical information reporting by CHWs • Incorporate RMU into health centers supervision • Support RMU in the private sector

• Assist the district pharmacist to define their roles within the district health team. • Present a plan to implement from national strategies on ADR, RMU, pharmaceutical care (PC) activities. • Mentor/support new and veteran district pharmacists through TA at the district level on provision of pharmaceutical care, consolidation of ADR and other reporting system with the national system, and collaboration with faith based health facilities through Rwandan Faith-based Medical Stores (BUFMAR). • Expand involvement with the private sector pharmacies by establishing a link with national health insurance schemes; develop a framework and an approach (including the necessary structures, roles and responsibilities) required for measuring and monitoring standards of quality for pharmaceutical services both in the public and private sector. • Develop an accreditation scheme and checklist based on a set of standards for licensing and inspection of pharmaceutical services.

• Provide support for the implementation of the accreditation standards. Support the MOH to develop a medicine pricing list and all the activities required for implementation

Expand Community Case Management (CCM) intervention by doing the following:

• Support the Community Health desk to standardize inventory management practices for CHWs and monitor the use of the drugs at community level through quarterly indicators collected at hospitals and randomized field visits • Support pharmaceutical information reporting by CHWs • Incorporate RMU into health centers supervision • Support RMU in the private sector

• Develop strategies, appropriate organizational structures, HR systems, roles and responsibilities, standards, guidelines, and SOPs. • Define infrastructure and equipment requirements. • Adapt and adopt relevant tools, such as electronic medicine registration. • Train and engage in local capacity building for medicine registration, inspection, and licensing.

Support the pharmaceutical accreditation initiative by doing the following:

• Support PTF to draft roles and responsibilities, SOPs, job aids to support the district pharmacists to define their roles and responsibilities in the decentralized health system in Rwanda.