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.
Informal health care providers (IPs) comprise a significant component of health systems in developing nations. Yet little is known about the most basic characteristics of performance, cost, quality, utilization, and size of this sector. To address this gap we conducted a comprehensive literature review on the informal health care sector in developing countries. We searched for studies published since 2000 through electronic databases PubMed, Google Scholar, and relevant grey literature from The New York Academy of Medicine, The World Bank, The Center for Global Development, USAID, SHOPS (formerly PSP-One), The World Health Organization, DFID, Human Resources for Health Global Resource Center. In total, 334 articles were retrieved, and 122 met inclusion criteria and chosen for data abstraction. Results indicate that IPs make up a significant portion of the healthcare sector globally, with almost half of studies (48%) from Sub-Saharan Africa. Utilization estimates from 24 studies in the literature of IP for healthcare services ranged from 9% to 90% of all healthcare interactions, depending on the country, the disease in question, and methods of measurement. IPs operate in a variety of health areas, although baseline information on quality is notably incomplete and poor quality of care is generally assumed. There was a wide variation in how quality of care is measured. The review found that IPs reported inadequate drug provision, poor adherence to clinical national guidelines, and that there were gaps in knowledge and provider practice; however, studies also found that the formal sector also reported poor provider practices. Reasons for using IPs included convenience, affordability, and social and cultural effects. Recommendations from the literature amount to a call for more engagement with the IP sector. IPs are a large component of nearly all developing country health systems. Research and policies of engagement are needed.
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.
Systematic Review Question»Systematic review of interventions
