Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain

Hetzel, Manuel W., Page-Sharp, Madhu, Bala, Nancy, Pulford, Justin, Betuela, Inoni, Davis, Timothy M. E. and Lavu, Evelyn K. (2014) Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain. PLoS One, 9 5: e96810.1-e96810.10. doi:10.1371/journal.pone.0096810


Author Hetzel, Manuel W.
Page-Sharp, Madhu
Bala, Nancy
Pulford, Justin
Betuela, Inoni
Davis, Timothy M. E.
Lavu, Evelyn K.
Title Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain
Journal name PLoS One   Check publisher's open access policy
ISSN 1932-6203
Publication date 2014-05-14
Sub-type Article (original research)
DOI 10.1371/journal.pone.0096810
Open Access Status DOI
Volume 9
Issue 5
Start page e96810.1
End page e96810.10
Total pages 10
Place of publication San Francisco, CA, United States
Publisher Public Library of Science
Language eng
Formatted abstract
Background: Poor-quality life-saving medicines are a major public health threat, particularly in settings with a weak regulatory environment. Insufficient amounts of active pharmaceutical ingredients (API) endanger patient safety and may contribute to the development of drug resistance. In the case of malaria, concerns relate to implications for the efficacy of artemisinin-based combination therapies (ACT). In Papua New Guinea (PNG), Plasmodium falciparum and P. vivax are both endemic and health facilities are the main source of treatment. ACT has been introduced as first-line treatment but other drugs, such as primaquine for the treatment of P. vivax hypnozoites, are widely available. This study investigated the quality of antimalarial drugs and selected antibiotics at all levels of the health facility supply chain in PNG.

Methods and Findings: Medicines were obtained from randomly sampled health facilities and selected warehouses and hospitals across PNG and analysed for API content using validated high performance liquid chromatography (HPLC). Of 360 tablet/capsule samples from 60 providers, 9.7% (95% CI 6.9, 13.3) contained less, and 0.6% more, API than pharmacopoeial reference ranges, including 29/37 (78.4%) primaquine, 3/70 (4.3%) amodiaquine, and one sample each of quinine, artemether, sulphadoxine-pyrimethamine and amoxicillin. According to the package label, 86.5% of poor-quality samples originated from India. Poor-quality medicines were found in 48.3% of providers at all levels of the supply chain. Drug quality was unrelated to storage conditions.

Conclusions: This study documents the presence of poor-quality medicines, particularly primaquine, throughout PNG. Primaquine is the only available transmission-blocking antimalarial, likely to become important to prevent the spread of artemisinin-resistant P. falciparum and eliminating P. vivax hypnozoites. The availability of poor-quality medicines reflects the lack of adequate quality control and regulatory mechanisms. Measures to stop the availability of poor-quality medicines should include limiting procurement to WHO prequalified products and implementing routine quality testing.  
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Public Health Publications
 
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Created: Wed, 21 May 2014, 17:40:29 EST by Justin Pulford on behalf of School of Public Health