Chronic underfunding of the health sector coupled with long-term civil unrest in the Democratic Republic of the Congo (DRC) has contributed to insufficient regulatory capacity to effectively manage the registration and approval of new medicines in the country. In partnership with the USAID-funded SIAPS Program, the country’s Ministry of Health supported a number of broad interventions to strengthen DRC’s pharmaceutical regulatory system. SIAPS provides technical assistance to the three national control programs—malaria, HIV/AIDS, and tuberculosis—to improving access to quality medicines and other commodities and increase the potential for achieving desired health outcomes.
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Technical Highlight: Strengthening Regulatory Systems in Democratic Republic of the Congo to Improve Access to Safe, Effective, and Quality Medicines
Swaziland is one of three remaining countries in the Southern Africa Development Community Region that do not have adequate regulatory and legislative frameworks to control the use, importation, manufacturing, and exportation of medicines. This is in the face of increased incidence of counterfeit medicines in the region; up to 25% of marketed medicines are substandard, and this is up to 64% for antimalarial medicines, according to a study conducted in 2011. Use of counterfeit and substandard medicines increases the burden of disease because of therapeutic failure, exacerbation of disease, and resistance to medicines. Swaziland’s weakness in medicines regulation and limited regulatory enforcement is also exploited by those smuggling prohibited and counterfeit medicines into neighboring countries.
By Wonder Goredema, Senior Technical Advisor and SIAPS Technical Support Lead/ Acting Country Project Director – Angola On September 27, 2016, Dra. Katiza Mangueira, the Head of the Angola Ministry of Health’s Directorate of Medicines and Equipment (Direcção Nacional de Medicamentos e Equipamentos [DNME]) accepted three desktop computers and power surge adaptors from the Angola […]
Systems thinking is now a widely accepted concept in global health. Governments, donors, and other actors in global health recognize that guaranteeing the availability of medicines is a necessary, but insufficient component to improving health outcomes. Rather, medicines availability must be bolstered by other components, such as ensuring that quality medicines are available and prescribed and dispensed appropriately by health care workers; patients must also use medicines properly. In order to achieve improvements in health for their populations and address health inequities, governments and donors must invest in strengthening health systems. A health system depends on its subcomponent, a pharmaceutical system, for the continuous availability of safe, effective, and affordable essential medicines and other health technologies of assured quality to deliver effective health interventions that improve health outcomes. This is in alignment with USAID’s Vision for Health Systems Strengthening (2015-2019). To this end, the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program focuses on achieving positive health outcomes by assuring the availability of quality pharmaceutical products and effective pharmaceutical services.
On October 1, the Pharmacy Department within Mozambique’s Ministry of Health successfully launched Pharmadex—a major achievement, and a significant step toward making the country’s medicines registration system more effective and transparent. Pharmadex, a SIAPS-supported web-based tool, supports a more efficient medicines registration process by organizing and housing all relevant information needed for an application to […]
Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia
SIAPS conducted a review of regulatory and quality assurance efforts in the GMS with the following objectives—
- To inform PMI of past and current initiatives to improve the capacity of the region to combat counterfeit, substandard, and banned antimalarial medicines
- To understand the current barriers to effective medicine quality control for malaria
- To recommend specific areas of focus or interventions to further improve regional and country capacity to combat counterfeit, substandard, and banned or illegal antimalarial medicines
The direct involvement of pharmacists in patient care (clinical pharmacy services) is a key intervention to optimize the outcomes of medicine therapy, thereby improving the quality of patient care. The Pharmaceuticals Fund and Supply Agency (PFSA) has been collaborating in efforts to implement clinical pharmacy services in the Ethiopian health care system. As part of the efforts, the preparation of a guiding document to standardize clinical pharmacy services provided by health facilities was determined to be necessary.
This is the first edition of the Standard Operating Procedures Manual for the Provision of Clinical Pharmacy Services in Ethiopia. This manual will contribute greatly to the standardization of the provision of clinical pharmacy services in the country.
In 2012, the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program conducted a comprehensive assessment of regulatory systems in Mozambique and addressed the challenges of the current information system being used by the Mozambique Ministry of Health Pharmacy Department (PD) for medicine registration and other regulatory functions. Recommendations for changes include introducing an online computerized information management system to handle the registration process that can significantly improve the efficiency of registration and reduce the backlog by tracking the process, enhancing communications, and improving document management.
To address this gap, SIAPS was asked to do a follow-on assessment to evaluate the PD’s information system and related technical assistance needs for product registration as well as other regulatory functions. SIAPS then collaborated with the department to analyze system requirements to define data elements and identify an appropriate tool that is compatible with local technology and capacity.
The Ministry of Health (Ministério da Saúde; MINSA)’s National Directorate of Medicines and Equipment (Direccao Nacional de Medicamentos e Equipamentos; DNME) is responsible for regulating medicines and other pharmaceutical products in Angola in collaboration with the Inspectorate General of Health (Inspecção-Geral da Saúde; IGS). Preliminary reports indicated that the regulatory system was not fully functional or operating effectively and thus needed assistance.
As a first step toward providing technical support and identifying additional sources of assistance to strengthen the regulatory system, the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, which has been providing support to the DNME since 2005 in pharmaceutical management, particularly supply chain management, conducted an assessment of the system and DNME’s capacity to implement it.
SIAPS Hosts Delegates from the National Drug Regulatory Authorities from Five South and Central Asian Countries
Staff from the USAID-funded Systems for Improved Access to Pharmaceutical Services (SIAPS) Program welcomed the opportunity to meet with visiting senior government delegates from Bangladesh, Bhutan, Kazakhstan, Kyrgyzstan, and Nepal at the MSH Arlington, VA office. The delegates were participating in a U.S. Department of State-sponsored professional exchange program to combat counterfeit and substandard medication.[i] […]