The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines

Abstract

BackgroundFalsely labelled, falsified (counterfeit) medicines (FFCm’s) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm’s is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.MethodsThe tool consists of a questionnaire referring to a watch-list of FFCm’s identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under “real-life conditions” in 371 patients in 5 ambulatory and in-patient care sites (“sub-studies”). The physicians participating in the study scored the patients and classified their risk of harm as “unlikely” or “probable” (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool’s value.ResultsIn 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm’s. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels:a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm’s): LR + 4.9/LR-0, post-test probability: 35%;b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm’s) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%.In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm’s.The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.ConclusionsThis “decision aid” is a systematic tool which helps find in medical practice patients harmed by FFCm’s. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups.The establishment of systematic communication between authorities and the medical community concerning FFCm’s, current patterns of use and case reports may sustain positive public health impacts.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-017-2235-y) contains supplementary material, which is available to authorized users.

Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study

“…Although we have listed several limitations, this research is the first to present data related to definite counterfeit and falsified medicine-related ADR cases and to describe their characteristics and affected active pharmaceutical ingredients. With these results, we can add further data to support the identification of patient harm, such as the tool from Anđelković et al (2017) . Further potential usage of our initial research can be the basis of other retrospective and prospective data collection strategies for drug–drug interactions as well as to increase real-world evidence and knowledge.…”

“…The authors think that the modified version of the tool to identify patients harmed by substandard and falsified medicines developed by Anđelković et al (2017) can be a good choice for prospective real-world data collection. This method can be applied in an ambulatory care setting on clients with potential risk factors, as it contains five domains, such as health complaints; medical history; use of medicines; use of health care products; lifestyles relevant for exposure to SF medicines.…”

“…The SF medicine watchlist was developed based on Medicrime drug seizures and national Official Medicines Control Laboratories (OMCL) working actively in the market surveillance programs. Medicines such as antibiotics, anti-obesity medicines, lifestyle products, anabolics, products against erectile dysfunction, and psychoanaleptics were included in the questionnaire ( Anđelković et al, 2017 ; Venhuis et al, 2018 ).…”

“…In their work, they highlight that the quality of these reports only provided inadequate or conflicting data. Although Anđelković et al (2017) published their prospective data collection tool to identify patients harmed by substandard and falsified medicines, their method has not been widely used yet. In many countries, the complete investigation of these cases is rare and related to forensic departments and laboratories.…”

Falsified Drugs in the Opinion of Patients Diagnosed with Cardiovascular Diseases—Nationwide and Cross-Sectional Study on the Example of EU-Member Country

“…Apart from legal matters, these terms can be used interchangeably. Recently, a new term has been coined, which is to be understood as a compromise “falsified (counterfeit) medicines (FFCms)” [ 30 ].…”