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The World Health Organization and its member states have agreed to the ambitious goal of reducing the risk of premature mortality from noncommunicable diseases, including heart disease and stroke, by 25% by 2025. This voluntary goal includes a national health system response target of “80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major noncommunicable diseases in both public and private facilities.”1 A 2012 United Nations report2 estimated that essential medicines were available in 52% and 68% of public and private pharmacies, respectively, between 2007 and 2011, which demonstrates this availability gap. While this health system response target assumes that the available medicines will contain the active pharmaceutical ingredient at the stated level, data from some studies, such as those focused on malaria,3 suggest that these drugs fail chemical analysis in up to one-third of samples and thus may not achieve disease prevention and control.
In this issue of JAMA Cardiology, Antignac et al4 take an important initial step toward evaluating the medicine quality of common drugs used for cardiovascular disease prevention and control in 10 sub-Saharan African countries using standardized methods from 2012 to 2014. The authors use high-quality reversed-phase liquid chromatography with tandem mass spectrometry, which is a sophisticated, relatively expensive, and reliable method. Cheaper, field-based, real-time methods to evaluate drug quality, such as the Global Pharma Health Fund Minilab or other similar platforms, will likely be even more useful for larger-scale efforts in the future. The authors use strict thresholds to define poor drug quality that some may debate, but their overall findings emphasize the scope and importance of drug safety not only in sub-Saharan Africa but all around the world, particularly in an era of globalized drug manufacturing and distribution in the absence of any global law or treaty against medicine crime. Drugs on national and global essential medicines lists, including the medicines evaluated by Antignac et al, represent priority medicines for surveillance.
To improve drug quality, the World Health Organization has created a Global Surveillance and Monitoring System for substandard, spurious, falsely labeled, falsified, and counterfeit medical products, which was launched in western Africa in 2013 following the development of the African Medicines Regulatory Harmonization Initiative in 2009. The World Health Organization provides technical support, including training, to member states for addressing suspected medical products while facilitating international collaboration among national focal points. This network seeks national-level reporting on regulatory capacity, international collaboration, and identification of major needs and challenges and will report its findings to the World Health Assembly in 2017. Improving and maintaining the safety of the global medicine supply is a shared priority for many stakeholders, including patients, physicians, governments, and payers as well as legitimate pharmaceutical manufacturers, who all benefit from a safe and effective medicine supply chain. To my knowledge, most reports have focused on drugs for communicable diseases to date. Data from Antignac et al highlight the growing importance of access to safe, essential medicines for preventing and controlling the leading causes of global deaths, namely heart disease and stroke, to achieve the “25×25” goal.
Conflict of Interest Disclosures: The author completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Huffman receives grant support from the World Health Federation to serve as the senior program advisor for its Emerging Leaders program, which is supported by Boehringer Ingelheim, Bupa, and AstraZeneca.
Huffman MD. Evaluating and Improving the Cardiovascular Drug Supply for Better Global Health. JAMA Cardiol. 2017;2(2):225. doi:10.1001/jamacardio.2016.3880
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