Collaborative Health and Enforcement Operations on the Quality of Antimalarials and Antibiotics in Southeast Asia

Abstract

Counterfeit (or falsified) and substandard medicines pose a major public health risk. We describe the findings of Operation Storm I and II conducted in 2008–2009 to combat counterfeit medicines through partnership between national customs, Drug Regulatory Agencies (DRAs), and police in Cambodia, Indonesia, Laos, Myanmar, Singapore, Thailand, and Vietnam. Samples were obtained from seizures and market surveillance by national DRAs. Laboratory analysis using spectroscopic and chromatographic techniques and examination of packaging were performed. Ninety-three suspect antibiotics and 95 antimalarial samples were collected. Of the 93 antibiotics, 29 (31%) had % active pharmaceutical ingredient content (%API) < 85% or > 115% (including one counterfeit). Of the 95 antimalarials, 30 (32%) had %API < 85 > 115% API (including one counterfeit). A significant minority of samples, antimalarials (13%) and antibiotics (15%), were collected in plastic bags with minimal or no labeling. Of 20 ampicillin samples, 13 (65%) contained < 85% API (with one counterfeit containing additional amoxicillin). Of 34 oral artesunate samples, 7 (21%) contained %API out of the 85–115% range. Coordinated and synergistic partnership adopted by the participating countries, International Criminal Police Organization (INTERPOL), World Health Organization (WHO), and laboratories facilitated a platform for discussions and intelligence sharing, helping to improve each participating country's capacity to combat poor-quality medicines.

Combating poor-quality anti-malarial medicines: a call to action

“…Several recently published large surveys [ 23 – 25 ] and reports on drug seizures in Africa and Southeast Asia [ 16 , 26 ] warrant continued concern with regard to the prevalence of substandard medicines that fail tests of API content (Table 1 ). Some surveys conducted between February 2010 and February 2013 have also found artesunate monotherapy tablets in circulation in sub-Saharan Africa [ 23 , 27 , 28 ] and Southeast Asia [ 26 ]. This may be partly due to the difference in expense, as the total cost of ACT is approximately double that of monotherapy.…”

“…Operation Storm I and II, conducted in 2008 and 2009 in Cambodia, Indonesia, Laos, Myanmar, Singapore, Thailand, and Vietnam, offered an example of this sort of multisector collaboration. Coordinated by WHO and INTERPOL, these operations involved a synergistic partnership between customs authorities, police, NMRAs, and laboratories in participating countries [ 26 ]. Encouraging data from Cambodia suggest that measures to strengthen drug regulation and enforcement capacity and improve education and communication have reduced the circulation of falsified anti-malarial products, although substandard medicines remain common and are a specific threat for resistance [ 30 ].…”

The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives

“…Collectively, across the seven quality survey studies in the supplement, ~16,800 samples of antimalarials, antituberculosis medicines, antibiotics, and antileishmaniasis medicines were tested for quality and an estimated 9–41% of specimens failed quality specifications. 22 – 28 These studies used unique sampling and data collection strategies, including samples drawn from nationally representative surveys, government and Interpol seizures, “mystery shoppers” (unknown to the vendor), convenience samples, and overt and repeat randomized surveys. For instance, Yeung and others conducted sampling using mystery shoppers and overt surveys in the epicenter of antimalarial drug resistance in Cambodia.…”

“…This study offers a model example of how multiple national and international enforcement and regulatory agencies have come together to respond to poor-quality medicines. 28 …”

Triboelectric nanogenerator (TENG) mass spectrometry of falsified antimalarials

“…They not only constitute an impediment for patients to receive the expected treatment, but may also be a key but neglected driver of antimicrobial resistance . Lack of effective treatment, decreased public confidence, significant financial damage, and adverse reactions are only some of the known effects of the worldwide prevalence of PQM …”