Background
Within the Greater Mekong Subregion (GMS), 78% of malaria cases and 75% of malaria deaths occur in Myanmar, and the country’s border areas also have a weak public health care infrastructure[1]. Artemisinin-resistant malaria parasites caused by an extensive migrant population and widespread use of oral artemisinin-based monotherapies have been reported. Heavy dependence on the inadequately regulated private sector for health care services has also contributed to the widespread inappropriate use of antimalarials and subsequent resistance. Artemisinin-based combination therapy (ACT) was adapted as the principal treatment in 2002, but high reliance on the private sector with high prevalence of artemisinin monotherapies has reduced the possibility of decreasing mortality and morbidity due to malaria.
In 2015, the US President’s Malaria Initiative, with funding from the USAID Regional Development Mission for Asia and the USAID Missions in Burma (Myanmar) and Cambodia, funded SIAPS to assess interventions or efforts to reduce the availability of substandard and counterfeit antimalarials in the GMS.
Methodology
The study team reviewed more than 350 peer-reviewed journal articles, unpublished official documents, and other reports posted online. Most were in either English or local languages.
Results
- The legislative framework consists of the 1992 National Drug Law, which allows only registered drugs to be imported and sold.
- In 2013, the Myanmar Food and Drug Administration (FDAD) was upgraded to an autonomous department.
- Three authorities are involved in drug regulation: the Myanmar Food and Drug Board Authority; the FDAD; and Food and Drug Supervisory Committees at the central, state/division, district, and township levels.
- Myanmar has seven local pharmaceutical manufacturers, all of which are owned by the government or a semi-public entity.
- The FDAD issues drug marketing authorizations, conducts inspections at pharmaceutical manufacturing facilities and importers, and tests the quality of drugs using minilabs and a high-performance liquid chromatography and dissolution tester.
- Despite a ban on monotherapy treatment, artesunate monotherapy was found in 20% of pharmacies. In 2012, nearly 1,800 medicines (premarket and post-market drug samples) were tested at the drug quality control laboratory.
Interventions that Decrease the Prevalence of Counterfeit Medicines on the Market
- The World Health Organization (WHO) provided minilabs to the FDAD at the central and regional levels and collaborated with the Department of Vector Borne Disease Control (VBDC) to develop a national M&E plan to effectively monitor malaria cases.
- To decrease the use of artemisinin monotherapies and contain the spread of resistant malaria parasites, a five-year Myanmar Artemisinin Resistance Containment framework strategic plan initiative was launched with support from the Three Disease Fund. The complexity of banning monotherapy products was further complicated by the military’s continued use of monotherapies.
- With support from DFID and the Bill and Melinda Gates Foundation, Population Services International implemented an artemisinin monotherapy replacement intervention in the private sector.
- To strengthen post-marketing surveillance, the USAID-funded USP/PQM program has provided hands-on training in collaboration with the VBDC, FDAD, and WHO to establish a medicines quality monitoring program and compendia analysis of selected antimalarial medicines for FDAD labs.
- To test the quality of available antimalarial drugs in the private sector, the National Strategic Plan for Malaria Prevention and Control 2010–2015, a five-year, country-level strategic plan for malaria prevention and control, was implemented.
Gaps in Access to Quality Antimalarial Medicines
- The FDAD has limited technical staff to manage the registration functions required for pharmaceuticals, and the national drug testing laboratory is stretched beyond capacity.
- Pharmacovigilance is not actively conducted, and fewer than five adverse drug reactions were reported in 2010.
- There is limited law enforcement to control counterfeit and substandard medicines.
- Although public health centers provide ACT free of charge, people prefer to use private clinics because of long distances and costly transportation to the nearest public health center.
- Due to a lack of public awareness, patients prefer to buy lower-price products and do not complete treatment.
The Way Forward
- To improve access to quality medicines, GMP compliance of pharmaceutical manufacturing facilities, including unregistered, private, small pharmaceutical producers, needs to be institutionalized and implemented.
- Close monitoring of the presence of artemisinin resistance is needed through cross-border collaboration in the GMS.
- Systematic control and management of approved medicines through regular monitoring and surveillance by the national drug quality testing laboratory is needed.
- The roles of the FDAD and VBDC in taking administrative action to detect fake and substandard medicines and the legal response to such crimes need to be strengthened and enforced.
Resources
- Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia
- Other Documents
