Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies

• Published in: Health policy and planning 2016-12, Vol.31 (10), p.1448-1466
• Main Authors: Hamilton, William L., Doyle, Cormac, Halliwell-Ewen, Mycroft, Lambert, Gabriel
• Format: Article
• Language: English
• Subjects: Certification; Clinical trials; Consumers; Coordination; Counterfeit Drugs; Crime; Criminal justice; Criteria; Developing Countries; Drug screening; Drugs; Falsification; Global Health - legislation & jurisprudence; Global Health - standards; Government Regulation; Health administration; Health care; Health care industry; Health education; Health Policy - legislation & jurisprudence; Health promotion; Health services; Humans; Internet; Intervention; Judicial system; Law enforcement; Leadership; Legislation; Legislation, Drug - standards; Medical personnel; Medicine; Mobile phones; Morbidity; Patient communication; Pharmaceuticals; Pharmacology; Pharmacovigilance; Pharmacy; Policies; Policy implementation; Public health; Public Health - legislation & jurisprudence; Qualitative analysis; Quality assessment; Quality Control; Registration; REVIEWS; Supply; Supply chains; Systematic review; Test equipment; Trade agreements; Training; Verification; Websites
• ISSN: 0268-1080; 1460-2237
• DOI: 10.1093/heapol/czw062

Abstract Background: Falsified medicines are deliberately fraudulent drugs that pose a direct risk to patient health and undermine healthcare systems, causing global morbidity and mortality. Objective: To produce an overview of anti-falsifying public health interventions deployed at international, national and local scales in low and middle income countries (LMIC). Data sources: We conducted a systematic search of the PubMed, Web of Science, Embase and Cochrane Central Register of Controlled Trials databases for healthcare or pharmaceutical policies relevant to reducing the burden of falsified medicines in LMIC. Results: Our initial search identified 660 unique studies, of which 203 met title/abstract inclusion criteria and were categorised according to their primary focus: international; national; local pharmacy; internet pharmacy; drug analysis tools. Eighty-four were included in the qualitative synthesis, along with 108 articles and website links retrieved through secondary searches. Discussion: On the international stage, we discuss the need for accessible pharmacovigilance (PV) global reporting systems, international leadership and funding incorporating multiple stakeholders (healthcare, pharmaceutical, law enforcement) and multilateral trade agreements that emphasise public health. On the national level, we explore the importance of establishing adequate medicine regulatory authorities and PV capacity, with drug screening along the supply chain. This requires interdepartmental coordination, drug certification and criminal justice legislation and enforcement that recognise the severity of medicine falsification. Local healthcare professionals can receive training on medicine quality assessments, drug registration and pharmacological testing equipment. Finally, we discuss novel technologies for drug analysis which allow rapid identification of fake medicines in low-resource settings. Innovative point-of-purchase systems like mobile phone verification allow consumers to check the authenticity of their medicines. Conclusions: Combining anti-falsifying strategies targeting different levels of the pharmaceutical supply chain provides multiple barriers of protection from falsified medicines. This requires the political will to drive policy implementation; otherwise, people around the world remain at risk.