Project dates: 2012-2018
In Mozambique, SIAPS has been working with the Ministry of Health’s (MOH) pharmaceutical department (PD), which functions as the country’s regulatory authority, to strengthen its capacity at the national level. The PD’s main function is to ensure access to safe, effective, and quality pharmaceuticals through the public and private sectors that contribute to the best possible health outcomes. One of the PD’s priorities has been to develop a monitoring and evaluation (M&E) system to assess department performance; improve transparency and ensure accountability; help guide the planning, coordination, and implementation of regulatory activities; and foster a culture of evidence-based decision making.
Inefficient and irrational use of medicines is a well-documented problem in both developed and developing countries. It leads to cost increases and adverse clinical effects for patients. The inappropriate use of medicine can be reduced if health care professionals involved in the different aspects of medicine use promote good practices for medicine management and use. An appropriate forum for the development and implementation of medicine policies is the Drug and Therapeutics Committee (DTC).
In Mozambique, the establishment of hospital DTCs was officially requested by the Ministério da Saúde (MISAU) (Ministry of Health) in the document The Departamento de Farmacia Hospitalar (DFH) (Department of Hospital Pharmacy) in the Direcção Nacional de Assistência Médica (National Directorate of Medical Assistance) of MISAU also took on the establishment of hospital DTCs as a priority intervention to improve the appropriate use of medicines at the hospital level. SIAPS has provided technical assistance to assist hospitals in establishing DTCs to improve medicine use, and in the collection and analysis of medicine use information for decision making as part of its support to counterparts in the pharmaceutical sector.
In 2012, the Government of Mozambique began a national accelerated response to HIV and AIDS. As a result, better awareness, funding, and deployment of proven interventions have significantly improved HIV prevention, treatment, and care support. This includes the rapid scaling up of antiretroviral therapy. With significant support from the US President’s Emergency Plan for AIDS Relief, coverage of eligible adults rose from 47% in 2012 to 72% by the end of 2013 (PEPFAR Mozambique Country Operational Plan, FY14).
However, there is a shortage of quality essential medicines in the country, exacerbated by the time it takes for medicine importers and distributors to get authorization for importing and selling medicines. The longest wait times are for antiretroviral, antimalarial, and new molecule medicines that require more complex documentation, such as World Health Organization (WHO) prequalification. To help close these gaps, Mozambique engaged SIAPS to strengthen the pharmaceutical sector’s institutional and individual capacity.
Technical Brief: Strengthening Drug and Therapeutics Committees to Promote Rational Medicine Use in Mozambique
Mozambique is one of the poorest countries in the world, with approximately 70% of the population living below the poverty line. Many women and children are unable to access essential health services and medicine due to inadequate geographic coverage, financing, and available health professionals. Neonatal mortality is 30 deaths per 1,000, and under-five mortality is 90/1,000. Malaria accounts for approximately 26% of hospital deaths. Dual infections of tuberculosis (TB) and HIV and the threat of increasing multidrug-resistant TB complicate the national TB program response. To support priority programs such as HIV prevention and treatment and maternal and child health, Mozambique’s Ministry of Health and SIAPS are establishing Drug and Therapeutics Committees (DTCs) and training committee members to improve medicine management and use, thereby helping to achieve good health outcomes.
The Systems for Improving Access to Pharmaceuticals and Services (SIAPS) Program Mozambique has been working with DFH and partners in the pharmaceutical sector and in priority health programs to assist pharmaceutical services in improving the availability of pharmaceutical products and appropriate use at the service delivery points with the aim of achieving desired health outcomes. SIAPS technically assists hospitals to create DTCs to improve medicine use, as well as the collection and analysis of medicine use information for decision-making as part of its support to its counterparts in the pharmaceutical sector.
In August 2013, SIAPS supported the DFH to conduct a two-day DTC orientation workshop. This orientation covered the DTC’s main functions, roles, and responsibilities, as well as how to monitor and identify medicine use problems, and to implement interventions and strategies, including use of standard treatment guidelines (STGs) and essential medicine list, to improve medicine use. During the workshop, the participants presented the status of their hospital DTC, and reviewed Mozambique’s current official DTC’s terms of reference (TOR) and made recommendations for additions and modifications. In addition, with SIAPS technical guidance, the participants conducted a brief study on prescribing indicators in a clinic in Maputo. The study found that more than 60% of patient encounters received an antibiotic. This orientation was attended by 49 health professionals, including physicians, pharmacists, dentists, laboratory technicians, and hospital administrators from the 11 hospital DTCs, the Ministry of Health (MOH), and nongovernmental organizations that support clinical services and supply chain operation.
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.
SIAPS was asked in 2013 to review the information system and related technical assistance needs of the Mozambican PD for product registration, licensing and inspection, pharmacovigilance, and quality assurance. In addition, a system analysis was performed to define data elements and identify an appropriate tool that is compatible with local technology and capacity. Based on the needs of the Mozambican PD, Pharmadex was chosen as the most appropriate electronic tool for the management of Mozambique’s regulatory systems information.
The goal of the training was to implement Pharmadex in the PD with the aim of ensuring that the department had the necessary skills, knowledge, and technical support to effectively use and sustain it. Implementation involved adapting the tool to agreed-upon data elements, procuring the required hardware and/or software, identifying in-country IT support and maintenance, installing the program(s), finalizing the software, training users, and preparing for launch of the system.
The irrational use of medicines is a pervasive problem that threatens healthcare systems and quality of patient care in countries worldwide. The World Health Organization (WHO) estimates that 50% of patients receive unnecessary medicines and half of patients take their medicines incorrectly.
Irrational use behaviors include polypharmacy (the use of too many medicines per patient); the use of incorrect medicine(s) for a particular indication; the use of medicines with uncertain or unproven efficacy; inappropriate self-medication, particularly with prescription-only medicines; and taking medicines in incorrect dosages or for an improper duration.
To counter the problems of irrational use, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program and Ministério da Saúde (MISAU) (Ministry of Health) are working together in Mozambique to improve medicine management and use. SIAPS is seeking to create sustainable Drug and Therapeutics Committees (DTCs) to monitor and identify medicine use problems and to implement interventions to improve medicine use at the local health-facility level. SIAPS will also support the revision of the National Essential Medicines List (NEML) and development of new standard treatment guidelines (STGs) to complement those that are currently available.
This technical report provides information on the DTC workshop conducted on August 4-5, 2014, and on field visits to two hospitals in the Maputo area: Maputo Central Hospital and Matola Provincial Hospital. These field visits were designed to meet with hospital officials and DTCs, as well as to develop specific DTC activities to address medicine use problems.
The focus of SIAPS’ support to DF will be improving the effectiveness, efficiency, transparency, and overall functioning of the regulatory system—including product registration, pharmacovigilance (PV), and inspection—to ensure the safety, efficacy, and quality of pharmaceutical products in circulation in the country. SIAPS will focus on improving pharmaceutical services at public hospitals, including the management of commodities, rational use of medicines, and patient safety.
- The Use of Pharmaceutical Information for Decision Making in Namibia's National ART Program: Assessment Report
Download The focus of SIAPS’ support to DF will be improving the effectiveness, efficiency, transparency, and overall functioning of the […]
Project dates: 2012-2018
- Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program Inventory of Key Technical Resources
Project dates: 2012-2018