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


METHODS
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.


CONCLUSIONS
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.
University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK wlh26@cam.ac.uk.|Wellcome Trust Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridge, CB10 1SA, UK.
William L
WL
Hamilton
University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK.
Cormac
C
Doyle
University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK.
Mycroft
M
Halliwell-Ewen
University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK.
Gabriel
G
Lambert
D058110:Counterfeit Drugs; D003906:Developing Countries; D014943:Global Health / Q000331:legislation & jurisprudence / Q000592:standards; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D011634:Public Health / Q000331:legislation & jurisprudence*; D011786:Quality Control
D058110:Counterfeit Drugs
Falsified; antibiotic; antimalarial; counterfeit; drugs; medicine; medicine safety; pharmaceutical; pharmacovigilance; poor quality; substandard