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Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness
BACKGROUND: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the interv...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5045490/ https://www.ncbi.nlm.nih.gov/pubmed/27752221 http://dx.doi.org/10.1007/s40290-016-0156-4 |
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author | Fadlallah, Racha El-Jardali, Fadi Annan, Farah Azzam, Hayat Akl, Elie A. |
author_facet | Fadlallah, Racha El-Jardali, Fadi Annan, Farah Azzam, Hayat Akl, Elie A. |
author_sort | Fadlallah, Racha |
collection | PubMed |
description | BACKGROUND: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. OBJECTIVE: The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. METHODS: We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. RESULTS: Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. CONCLUSION: Several factors are critical to the successful design and implementation of systems-level interventions to combat or prevent drug counterfeiting. Policymakers need to take these into consideration to ensure success of these interventions. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40290-016-0156-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5045490 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-50454902016-10-15 Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness Fadlallah, Racha El-Jardali, Fadi Annan, Farah Azzam, Hayat Akl, Elie A. Pharmaceut Med Systematic Review BACKGROUND: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. OBJECTIVE: The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. METHODS: We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. RESULTS: Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. CONCLUSION: Several factors are critical to the successful design and implementation of systems-level interventions to combat or prevent drug counterfeiting. Policymakers need to take these into consideration to ensure success of these interventions. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40290-016-0156-4) contains supplementary material, which is available to authorized users. Springer International Publishing 2016-08-19 2016 /pmc/articles/PMC5045490/ /pubmed/27752221 http://dx.doi.org/10.1007/s40290-016-0156-4 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Systematic Review Fadlallah, Racha El-Jardali, Fadi Annan, Farah Azzam, Hayat Akl, Elie A. Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title | Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title_full | Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title_fullStr | Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title_full_unstemmed | Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title_short | Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness |
title_sort | strategies and systems-level interventions to combat or prevent drug counterfeiting: a systematic review of evidence beyond effectiveness |
topic | Systematic Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5045490/ https://www.ncbi.nlm.nih.gov/pubmed/27752221 http://dx.doi.org/10.1007/s40290-016-0156-4 |
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