PEPFAR's annual planning process is done either at the country (COP) or regional level (ROP).
PEPFAR's programs are implemented through implementing partners who apply for funding based on PEPFAR's published Requests for Applications.
Since 2010, PEPFAR COPs have grouped implementing partners according to an organizational type. We have retroactively applied these classifications to earlier years in the database as well.
Also called "Strategic Areas", these are general areas of HIV programming. Each program area has several corresponding budget codes.
Specific areas of HIV programming. Budget Codes are the lowest level of spending data available.
Expenditure Program Areas track general areas of PEPFAR expenditure.
Expenditure Sub-Program Areas track more specific PEPFAR expenditures.
Object classes provide highly specific ways that implementing partners are spending PEPFAR funds on programming.
Cross-cutting attributions are areas of PEPFAR programming that contribute across several program areas. They contain limited indicative information related to aspects such as human resources, health infrastructure, or key populations programming. However, they represent only a small proportion of the total funds that PEPFAR allocates through the COP process. Additionally, they have changed significantly over the years. As such, analysis and interpretation of these data should be approached carefully. Learn more
Beneficiary Expenditure data identify how PEPFAR programming is targeted at reaching different populations.
Sub-Beneficiary Expenditure data highlight more specific populations targeted for HIV prevention and treatment interventions.
PEPFAR sets targets using the Monitoring, Evaluation, and Reporting (MER) System - documentation for which can be found on PEPFAR's website at https://www.pepfar.gov/reports/guidance/. As with most data on this website, the targets here have been extracted from the COP documents. Targets are for the fiscal year following each COP year, such that selecting 2016 will access targets for FY2017. This feature is currently experimental and should be used for exploratory purposes only at present.
Years of mechanism: 2010 2011
The quality of medicines determines their effectiveness and safety and, hence, the health outcome of the patient. If the quality of medicines is compromised, investments in pharmaceutical commodities, health systems and pharmaceutical management systems are negated. Assuring medicine quality signifies that the medicine reaching the patient is efficacious, safe and of appropriate quality for a positive health outcome.
Developing countries are at particular risk of having counterfeit or substandard medicines circulate in their markets because of a lack of demand for good-quality medicine (undue focus on price over quality), lack of effective regulatory oversight of medicines in circulation, inadequate financing of health programs, and a paucity of skilled personnel in quality assurance and control systems. The reality of weak legislation, lack of political will, and limited commitment to law enforcement also play an integral role in the proliferation of poor-quality medicines.
In order to address these systemic challenges, under this award the United States Pharmacopeia (USP) will draw upon its expertise in pharmacopeia education and standards setting authority to provide technical assistance to the Drug Administration and Control Authority (DACA) of Ethiopia, to strengthen its regulatory functions, quality assurance and quality control capabilities. USP sets standards, recognized by the Congress of the United States which enable the detection of counterfeit and sub-standard medicines world wide. With International Standards Organization (ISO)-accredited quality control laboratories in India, China, Brazil and the United States, USP is aptly suited to conduct testing of various medicines and training of quality control (QC) lab staff in various countries. Under this award, the system of drug registration, post-market surveillance and quality control of medicines will be strengthened, thereby contributing to the strengthening of the entire health system. In addition, USP will work with DACA to develop policies, systems and procedures to promote good practices, increase accuracy, trust and performance.
Specific areas of the health system that will be strengthened include: (1) strengthened regulatory capacity and increased oversight to detect counterfeit and sub-standard medicines; (2) improved governance in licensing and inspection of facilities and established norms and standards in medicine registration; (3) improved knowledge base on quality, safety and effectiveness of medicines and data used to inform medicine selection and regulatory decisions; and (4) an established accredited laboratory institution for the quality control of pharmaceuticals, recognized by international and donor organizations and participating in testing of commodities for such organizations.
The USP intervention will be focused on the central quality assurance and quality control system at DACA in Addis Ababa with the goal of strengthening the regional systems in future interventions.
In order for the award to be cost-effective, USP will leverage the resources of other mechanisms conducting similar or related activities in the country. For example, DACA will be encouraged to include quality assurance and quality control systems strengthening in future Global Fund To Fight AIDS, Tuberculosis and Malaria (GFATM) proposals. Also collaboration will be established with World Bank health systems strengthening initiatives and activities will be aligned where appropriate. USP activities will be aligned with Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS), ensuring that they are complementary and not duplicative. USP will work closely with MSH/SPS to align pharmaceutical management activities with quality control of commodities. A joint work plan will be developed to ensure consistency and complementarity.
Under this award, USP activities will benefit both PEPFAR and the Presidential Malaria Initiative (PMI) because DACA will also be used to assure the quality of antimalarials. The quality of anti-TB medicines can also be assessed because similar lab techniques are needed to test these medicines. The benefits of the interventions will also be cross-cutting because they will contribute to human resource development in the areas of improved management skills of DACA staff and improvement in quality systems.
In the area of economic strengthening, laboratories will be equipped to provide testing services for the private sector which would then generate funds to sustain and maintain the equipment.
Monitoring and evaluation measures will be put in place to monitor program effectiveness and impact on DACA in particular and on Ethiopia health system as a whole. Program effectiveness will be monitored and evaluated by the following indicators: number of new medicines registered per year, time taken for dossier review and registration of new products, number of DACA staff trained on good drug registration practices, at least one full round of sampling and testing of ARVs completed by end of 2010, number of regulatory actions taken against unregistered products and sub-standard and counterfeit medicines circulating in the country, all key standard operating procedures (SOPs) drafted and implemented and the quality manual completed by DACA quality control laboratory, and progress made (modules completed) toward accreditation of the laboratory by ISO 17025 and/or World Health Organization (WHO) prequalification.
The main goal of United States Pharmacopeia (USP) support is to strengthen medicine quality assurance systems in Ethiopia. USP will address the quality assurance gaps by working closely with the Drug Administration and Control Authority (DACA) to strengthen three critical functions in quality control and quality assurance of antiretrovirals (ARVs) and other medicines: 1) Drug Registration; 2) Drug Quality Control laboratory tests, and 3) Post Marketing Surveillance. It received Presidential Malaria Initiative (PMI) funding and leverages this wrap-around resource with PEPFAR funds.
Drug Registration is a major function of DACA and it is critical in assuring quality of medicines. DACA does not have complete control over the medicines circulating in the market because many are not registered. Improving drug registration practices would give DACA better control and oversight of imported and locally produced medicines in the country. Good registration practices ensure that only medicines that meet the strict standards of efficacy, safety and quality are allowed on the market.
Drug Quality Control
DACA operates a drug quality control and toxicology laboratory. Based on recent assessments, major constraints were identified regarding competency of the lab staff, calibration of equipment and lack of proper quality systems in the lab. USP has developed an implementation plan for the DACA lab to become proficient in compendial testing and to be accredited for the International Standards Organization (ISO) 17025 and/or World Health Organization (WHO) prequalification.
Post Marketing Surveillance Program
In an effort to ensure that ARVs imported into the country are of good quality, a robust post-marketing surveillance of the quality of ARVs and other medicines is critically important. The quality of medicines can be compromised by storage and distribution practices and infiltration of counterfeits of legitimate products could compromise treatment programs.
Indicator targets will be established in order to measure the effectiveness of interventions including number of trainings in drug registration, number of samples tested in post-market surveillance, and standard operating procedures developed by the DACA.
