The Strengthening Pharmaceutical Systems (SPS) Project is a Leader with Associates award, led by Management Sciences for Health, and includes a variety of partners, including the WHO Collaborating Center for Pharmaceutical Policy at Harvard University. SPS aims to build capacity within developing countries to effectively manage all aspects of pharmaceutical systems. A follow on from Rational Pharmaceutical Management Plus (RPM+), SPS focuses on four key components through a more systematized approach: 1) Improve governance of the pharmaceutical sector, including policies, regulatory issues, strategic planning, and pharmacovigilance monitoring of adverse events, with a special focus on licensing and accreditation, promoting accountability and combating corruption in the procurement of medicines, and involving civil society and interest groups in the governance process; 2) Pharmaceutical systems strengthening to support public health services, with special emphasis on human resource capacity building through pre-service curriculum reform; 3) Containing the emergence and spread of anti-microbial resistance through institutional interventions, including infection control, Drug Therapeutic Committees (DTCs), and Drug Utilization Reviews (DURs), and implementation of WHO Anti-Microbial Resistance and Early Warning Indicator strategies, as well as through support for adherence and patient compliance, and support for quality control of medicines; 4) Expand access to essential medicines through the private sector using public private partnerships as well as providing support to the national drug regulatory authorities (NDRAs) to improve their prequalification and registration processes. SPS will also address financing and economic issues that create barriers to access to essential medicines.

SPS directly contributes to the goals and vision outlined in the Partnership Framework through its emphasis on strengthening health systems, human resource capacity building, and quality of care and adherence issues through pharmaceutical systems strengthening.

SPS will strengthen the capacity, leadership and governance of the MOH Department of Pharmacy, which is the drug regulatory authority for Mozambique and responsible for other aspects of the pharmaceutical sector not managed by Central Medical Stores (CMAM), including: defining drug policies, revising the

essential medicines list (EML), registration of pharmaceutical products, licensing, controlling quality of medicines, and managing a national pharmacovigilance program to identify and monitor adverse events, including for antiretrovirals (ARV). In 2010, the Pharmacy Department will become the official NDRA and will have national directorate status, ensuring independence of the MOH in pharmaceutical policy and decision-making.

USG is currently not providing any support to the Pharmacy Department for its activities. This has been identified as a gap in PEPFAR programming and is being introduced in FY 2010 planning. As a new partner, SPS will conduct an initial assessment to identify needs and priorities of the NDRA and the MOH, and gaps in existing external support, to determine follow-on activities. These activities could include support to the following areas: pharmacovigilance, accreditation, quality control and assurance; drug therapeutic committees (DTCs); systems for drug registration and licensing; rational use of medicines; and support to the Association of Pharmacists.

The geographical area will be national with an emphasis on developing or strengthening national policies and systems for the NDRA as well as strengthening the implementation of those policies and systems at provincial, district and site levels, depending on the results of the assessment and identification or priorities. The target audiences are the Pharmacy Department/NDRA, pharmacists and other health professionals, DPSs, Association of Pharmacists, pre-service institutions, and PEPFAR implementing partners.

It is envisioned that SPS will contribute to human resource capacity building through training of pharmacy staff within the pharmaceutical department and in the provinces. The training will focus on issues identified by the pharmacy department as a priority, including: quality control of medicines, and site-level identification of poor quality medicines and reporting; importation, registration and licensing of medicines; rational use of medicines, patient compliance, and anti-microbial resistance; setting up Drug Therapeutic Committees; and pharmacovigilance. Because this partner will be supporting very specific activities and needs as defined by the Pharmacy Department to transfer skills within the pharmaceutical sector, and will complement the work of supply chain management systems (SCMS), USG does not envision significant growth of this partner. Rather, based on the identified priorities, the TA approach will be through the placement of a technical advisor within the NDRA and/or periodic short to medium term technical assistance and mentoring visits and trainings. In addition, any support to adherence or patient compliance of medicines, including ARVs, will be closely coordinated with existing partners on the ground for economies of scale.

Based on the need assessment and follow-up activities, SPS will develop a monitoring and evaluation plan in conjunction with the NDRA with clear benchmarks and deliverables.

In November 2008, MOH held a 3-day national workshop to strengthen the pharmaceutical sector, culminating in a report and action plan outlining priority activities for the sector, including strengthening the pharmacy department and its role as the National Drug Regulatory Authority (NDRA), improving control of medicine quality, establishing a pharmacovigilance center, and combating corruption. A critical systems strengthening activity, SPS will prioritize assistance to the Pharmaceutical Department in line with priorities of the MOH and in coordination with other USG programs, PEPFAR implementing partners and donors.

As this is a new activity for USG in FY 2010, Strengthening Pharmaceutical Systems (SPS) will conduct a needs assessment to identify challenges and opportunities across the four key areas of SPS's work, and will engage the pharmaceutical department and other departments within the MOH, and other donors to identify the main priorities, which are not currently supported through other mechanisms. The needs assessment will also include field visits to districts and sites to understand issues around the rational use and product selection, antimicrobial resistance, medicine quality and quality reporting, and adverse event reporting systems in place at facility level for the pharmacovigilance program. Based on the findings from the assessment and the priorities outlined in the report from the national pharmaceutical conference, SPS will develop an action plan in conjunction with the NDRA and the MOH.

SPS will strengthen capacity to the Pharmaceutical Department on their role as NDRA, leadership and governance which will have impact on the health service delivery. Possible areas of follow-on support could include: support to the pharmacy department for drug registration, including strengthening and streamlining systems for registration, strengthening the pharmacovigilance program, supporting development of policies where needed and identified by the MOH, support to the department of laboratory for the quality control of medicines, support to the Association of Pharmacists, and to assess the interest of the MOH in developing an accreditation system for pharmacies.