Interventions To Overcome the Challenges for Identifying Substandard, Spurious, Falsely Labeled, Falsified and Counterfeit Drugs (SSFFC).A Systematic Review.
Author(s)
Shailee Dewan, PhD;
Manipal College of Pharmaceutical Sciences, Pharmaceutical Regulatory Affairs and Management, Manipal, India
Manipal College of Pharmaceutical Sciences, Pharmaceutical Regulatory Affairs and Management, Manipal, India
Presentation Documents
OBJECTIVES: The objective of this review is to systematically assess the evidence on the effectiveness of interventions to overcome the challenges for the identification of SSFFC drugs.
METHODS: A systematic search was executed across multiple databases, including PubMed/Medline, EMBASE, Google Scholar and Web of Science and grey literature from 2004 to July 2024.Observational and Analytical studies were included. Systematic reviews, meta-analyses and narrative reviews were excluded that do not present original data.We assessed the risk of bias through The JBI tool (Joanna Briggs Institute tool).Two reviewers independently completed in duplicate, the study selection, data abstractions and risk of bias assessment.We registered the protocol in PROSPERO, an international prospective register of systematic reviews (CRD42024598 808).
RESULTS: Out of 10,444 citations,26 studies met the inclusion criteria. The majority (84.62%) of them focused on analytical techniques, followed by pharmacosurveillance (7.69%) and product development (7.69%). It includes 22 studies on analytical technology conducted across both developed and developing countries, 2 studies focus on supply chain management in the United States and Bangladesh, while another 2 studies explore 2D technology and QR codes in Europe and China.The analytical studies examined outcomes like efficiency,reliability, cost-effectiveness, and the ability to detect poor-quality drugs.Analytical studies faced challenges with methods suitable only for crystalline substances, confirmatory test failures due to overlapping spectra and limited applicability to certain drug samples. Pharmacosurveillance struggled to track falsified drugs outside official channels, while product development dealt with issues like complex sample preparation and pending of regulatory approvals.
CONCLUSIONS: Several factors are critical for developing the interventions to combat the challenges of SSFFC drugs. Sparse evidence exists on their efficiency, reliability, and ability to detect SSFFC drugs. Policymakers and stakeholders need to strengthen the regulatory framework, adopt supply chain technology to enhance post-market surveillance where more research is needed to reduce the prevalence of SSFFC drugs.
METHODS: A systematic search was executed across multiple databases, including PubMed/Medline, EMBASE, Google Scholar and Web of Science and grey literature from 2004 to July 2024.Observational and Analytical studies were included. Systematic reviews, meta-analyses and narrative reviews were excluded that do not present original data.We assessed the risk of bias through The JBI tool (Joanna Briggs Institute tool).Two reviewers independently completed in duplicate, the study selection, data abstractions and risk of bias assessment.We registered the protocol in PROSPERO, an international prospective register of systematic reviews (CRD42024598 808).
RESULTS: Out of 10,444 citations,26 studies met the inclusion criteria. The majority (84.62%) of them focused on analytical techniques, followed by pharmacosurveillance (7.69%) and product development (7.69%). It includes 22 studies on analytical technology conducted across both developed and developing countries, 2 studies focus on supply chain management in the United States and Bangladesh, while another 2 studies explore 2D technology and QR codes in Europe and China.The analytical studies examined outcomes like efficiency,reliability, cost-effectiveness, and the ability to detect poor-quality drugs.Analytical studies faced challenges with methods suitable only for crystalline substances, confirmatory test failures due to overlapping spectra and limited applicability to certain drug samples. Pharmacosurveillance struggled to track falsified drugs outside official channels, while product development dealt with issues like complex sample preparation and pending of regulatory approvals.
CONCLUSIONS: Several factors are critical for developing the interventions to combat the challenges of SSFFC drugs. Sparse evidence exists on their efficiency, reliability, and ability to detect SSFFC drugs. Policymakers and stakeholders need to strengthen the regulatory framework, adopt supply chain technology to enhance post-market surveillance where more research is needed to reduce the prevalence of SSFFC drugs.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR28
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas