- Todos > Medicine Access and Rational Use > Supply Management
- Todos > Quality and Safety: Medicines > Quality Assurance
- Palabras clave > antimalarial medicines (AMLs)
- Palabras clave > antimalarials – supply and distribution
- Palabras clave > artemisinin resistance
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmaceutical supply chain
- Palabras clave > post marketing surveillance
- Palabras clave > President's Malaria Initiative (PMI)
- Palabras clave > quality assurance - medicines
- Palabras clave > regulatory assessment
- Palabras clave > supply chain management
(2018; 39 pages)
Accelerated malaria elimination in the Greater Mekong Subregion (GMS) countries requires the availability and full implementation of updated national treatment guidelines (NTGs) based on the latest therapeutic efficacy studies (TES). The rapid decline of malaria cases following concerted efforts at elimination of multidrug-resistant forms of falciparum has presented new challenges. Among these challenges, the following two are the most important: the continued evolution of resistance requiring the regular updating of first- and second-line antimalarial medicines for foci of resistance; and the sourcing of increasingly small quantities of these drugs within a short time frame to ensure full implementation of revised guidelines in these foci.
Recent experience has demonstrated that NTGs can be updated rapidly by ministries of health for the management of resistant foci; however, their implementation is delayed due to regulatory challenges faced when importing new artemisinin-based combination therapies (ACTs) and problems in procuring small quantities of new ACTs for use in such foci. Full implementation of WHO recommendations on the use of primaquine to arrest the spread of falciparum malaria and the problem of relapses in vivax malaria due to poor compliance with primaquine regimens also remain challenging. As recommended by the World Health Organization (WHO), a virtual limited stockpile of ACTs has been initiated by the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to expedite country access to antimalarial medicines. Now, countries are encouraged to utilize the rapid supply mechanism (RSM) and ensure no delays occur in sourcing new ACTs for management of malaria in resistant foci. In the August 2017 meeting on WHO malaria treatment guidelines in the Western Pacific, problems associated with updating NTGs to address effective management of malaria in resistant foci, addressing regulatory constraints and procuring small quantities of new ACTs to use in resistant foci were identified as challenges requiring urgent solutions.
The Malaria, other Vectorborne and Parasitic Diseases (MVP) unit of the WHO Regional Office for the Western Pacific coordinated this meeting, bringing together representatives from ministries of health, staff from national malaria programmes, procurement divisions and national regulatory authorities (NRAs) to: identify appropriate first line treatments for management of malaria in resistant foci and possible alternatives based on current TES data; agree on a mechanism for the accessing the RSM of antimalarial medicines: discuss regulatory constraints to fully implementing updated malaria treatment policies; and address the continuing challenge of availability of substandard ACTs and artemisinin monotherapies in Western Pacific Region countries of the GMS.