Aug 02, 2012 News
Maryland, USA (PRNewswire) – USNewswire – Two articles recently published in Malaria Journal shed new light on the quality of antimalarial medicines circulating in countries in the Amazon Basin in South America.
Researchers from the Promoting the Quality of Medicines (PQM) program, a cooperative agreement between the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP), in conjunction with country partners, coordinated these studies in the context of the Amazon Malaria Initiative (AMI).
The first study, Quality of Antimalarials Collected in the Private and Informal Sectors in Guyana and Suriname, assessed the quality of circulating antimalarial medicines in the private (licensed pharmacies, wholesalers and distributors) and informal (unlicensed shops and convenience stores) sectors.
No information was previously available about the quality of these medicines. Though antimalarials are usually distributed through public health facilities at no cost in these countries, the private and informal sectors thrive in Guyana and Suriname—particularly in the remote interior regions where the presence of public facilities is limited or nonexistent, and large populations of workers in the gold mining and logging industries live.
Buying from these facilities poses increased risk of access to and use of non-recommended treatments and/or poor-quality products, which can have serious repercussions on patients’ health.
In Guyana, 45 of 77 (58 percent) of antimalarial medicines were found to be of poor quality. Visual and physical inspection unveiled 30 failures and analytical tests revealed 18; a medicine failing more than one test was considered a single failed medicine. Visual and physical inspections provide valuable information about the physical appearance and labeling of medicines, and in many cases these inspections can detect counterfeit medicines.
Quality control tests assess critical quality attributes of a medicine, such as identity, content, impurities and dissolution, among others. Of particular concern was the proportion of monotherapy (single drug) treatments failing quality control tests in Guyana (43 percent).
This included a high failure rate for artesunate monotherapy, a treatment not recommended by the World Health Organization (WHO) for Plasmodium Falciparum malaria, the most common type of malaria in the interior of Guyana. WHO recommends artesunate combination therapy for Plasmodium Falciparum.
In Suriname, 86 percent of the samples collected were Artecom, and only this antimalarial was analyzed. All Artecom samples lacked a label claim for the content of one of the components—primaquine—which resulted in an automatic failure of visual and physical inspection.
Inadequate labeling is problematic because it renders it impossible for patients to know the dosage of the medicine they are taking, which could lead to ineffective treatment. Additionally, undeclared strength of primaquine poses a safety concern to individuals who are glucose-6-phosphate dehydrogenase deficient. This antimalarial medicine was also found in Guyana; it is not registered in the countries nor is it part of their national treatment guidelines. All samples in Guyana and Suriname were collected between June and August 2009.
“These findings point to significant problems in the quality of antimalarials available in private and informal sector facilities in Guyana and Suriname,” said Lawrence Evans, Ph.D., the study’s lead author. “Besides the presence of medicines not included in the World Health Organization malaria treatment guidelines, the ease with which medications were procured without accurate diagnosis poses another major risk to patients’ safety. In addition, this could have serious implications for the development of drug-resistant strains of Plasmodium parasites, particularly Falciparum, as novel treatments are not foreseeable in the near future.”
AUBREY NORTON FRIGHTEN RENEGOTIATION AND RING-FENCING
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