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Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain.
PLoS One. 2014; 9(5):e96810.Plos

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.

Authors+Show Affiliations

Papua New Guinea Institute of Medical Research, Goroka, EHP, Papua New Guinea; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.Curtin University, School of Pharmacy, Perth, WA, Australia.Central Public Health Laboratory, Boroko, NCD, Papua New Guinea.Papua New Guinea Institute of Medical Research, Goroka, EHP, Papua New Guinea; The University of Queensland, School of Population Health, Herston, QLD, Australia.Papua New Guinea Institute of Medical Research, Madang, MDG, Papua New Guinea.University of Western Australia, School of Medicine and Pharmacology, Fremantle, WA, Australia.Central Public Health Laboratory, Boroko, NCD, Papua New Guinea.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24828338

Citation

Hetzel, Manuel W., et al. "Quality of Antimalarial Drugs and Antibiotics in Papua New Guinea: a Survey of the Health Facility Supply Chain." PloS One, vol. 9, no. 5, 2014, pp. e96810.
Hetzel MW, Page-Sharp M, Bala N, et al. Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain. PLoS One. 2014;9(5):e96810.
Hetzel, M. W., Page-Sharp, M., Bala, N., Pulford, J., Betuela, I., Davis, T. M., & Lavu, E. 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. https://doi.org/10.1371/journal.pone.0096810
Hetzel MW, et al. Quality of Antimalarial Drugs and Antibiotics in Papua New Guinea: a Survey of the Health Facility Supply Chain. PLoS One. 2014;9(5):e96810. PubMed PMID: 24828338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of antimalarial drugs and antibiotics in Papua New Guinea: a survey of the health facility supply chain. AU - Hetzel,Manuel W, AU - Page-Sharp,Madhu, AU - Bala,Nancy, AU - Pulford,Justin, AU - Betuela,Inoni, AU - Davis,Timothy M E, AU - Lavu,Evelyn K, Y1 - 2014/05/14/ PY - 2014/01/10/received PY - 2014/04/11/accepted PY - 2014/5/16/entrez PY - 2014/5/16/pubmed PY - 2014/12/31/medline SP - e96810 EP - e96810 JF - PloS one JO - PLoS One VL - 9 IS - 5 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/24828338/Quality_of_antimalarial_drugs_and_antibiotics_in_Papua_New_Guinea:_a_survey_of_the_health_facility_supply_chain_ L2 - https://dx.plos.org/10.1371/journal.pone.0096810 DB - PRIME DP - Unbound Medicine ER -