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Health policy
Research
Interventions to combat or prevent drug counterfeiting: a systematic review
  1. Fadi El-Jardali1,2,3,
  2. Elie A Akl1,3,4,5,
  3. Racha Fadlallah1,
  4. Sandy Oliver6,
  5. Nadine Saleh7,
  6. Lamya El-Bawab1,
  7. Rana Rizk8,
  8. Aida Farha9,
  9. Rasha Hamra10
  1. 1Center for Systematic Review in Health Policy and Systems Research (SPARK), American University of Beirut, Beirut, Lebanon
  2. 2Faculty of Health Sciences, Department of Health Management and Policy, American University of Beirut, Beirut, Lebanon
  3. 3Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  4. 4Department of Internal Medicine, American University of Beirut, Beirut, Lebanon
  5. 5Faculty of Health Sciences, Department of Epidemiology and Population Health, American University of Beirut, Beirut, Lebanon
  6. 6Evidence for Policy and Practice Information and Coordination Centre, Social Science Research Unit, Institute of Education, London, UK
  7. 7Faculty of Public Health, Laboratory of Epidemiological and Clinical Research, Lebanese University, Beirut, Lebanon
  8. 8Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands
  9. 9Saab Medical Library, American University of Beirut, Beirut, Lebanon
  10. 10Department of Health Education, Ministry of Public Health, Beirut, Lebanon
  1. Correspondence to Dr Fadi El-Jardali; fe08{at}aub.edu.lb

Abstract

Objective Drug counterfeiting has serious public health and safety implications. The objective of this study was to systematically review the evidence on the effectiveness of interventions to combat or prevent drug counterfeiting.

Data sources We searched multiple electronic databases and the grey literature up to March 2014. Two reviewers completed, in duplicate and independently, the study selection, data abstraction and risk of bias assessment.

Study eligibility criteria, participants and interventions We included randomised trials, non-randomised studies, and case studies examining any intervention at the health system-level to combat or prevent drug counterfeiting. Outcomes of interest included changes in failure rates of tested drugs and changes in prevalence of counterfeit medicines. We excluded studies that focused exclusively on substandard, degraded or expired drugs, or that focused on medication errors.

Appraisal and synthesis We assessed the risk of bias in each included study. We reported the results narratively and, where applicable, we conducted meta-analyses.

Results We included 21 studies representing 25 units of analysis. Overall, we found low quality evidence suggesting positive effects of drug registration (OR=0.23; 95% CI 0.08 to 0.67), and WHO-prequalification of drugs (OR=0.06; 95% CI 0.01 to 0.35) in reducing the prevalence of counterfeit and substandard drugs. Low quality evidence suggests that licensing of drug outlets is probably ineffective (OR=0.66; 95% CI 0.41 to 1.05). For multifaceted interventions (including a mix of regulations, training of inspectors, public-private collaborations and legal actions), low quality evidence suggest they may be effective. The single RCT provided moderate quality evidence of no effect of ‘two extra inspections’ in improving drug quality.

Conclusions Policymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions. Future effectiveness studies should address the methodological limitations of the available evidence.

Trial registration number PROSPERO CRD42014009269.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-006290

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