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

Abstract

Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area.Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data.Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures.Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil (n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil (n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone (n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil (n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir (n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir (n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001).Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.

Attitudes and behaviors regarding online pharmacies in the aftermath of COVID-19 pandemic: At the tipping point towards the new normal

“…Patients may be attracted by bargains, uncontrolled access and anonymity when purchasing medicines from unapproved online medicine retailers. Although illegal internet pharmacy websites are considered the dominant source of substandard and falsified medications among developed countries ( Mackey and Nayyar, 2016 ), limited and controversial real-world data is available regarding the prevalence of such dubious products and their direct health consequences ( Pozsgai et al, 2022 ). In order to ensure adequate safety when purchasing medicinal products online, drug authorities including the European Medicines Agency and the US Food and Drug Administration provide guidelines referencing the most important principles which should be followed by patients when making such purchases to increase consumer awareness ( US Food and Drug Administration, 2018 ; European Medicines Agency, 2022 ).…”

Navigating duplication in pharmacovigilance databases: a scoping review

“…Duplicates arise from various causes including data entry errors,20 21 multiple reporters and reporting channels,22 23 pressure from mandatory reporting requirements for healthcare professionals and pharmaceutical companies,4 24 challenges in data integration and harmonisation in pharmacovigilance databases,19 multiple representation of the same data due to the merging of pharmacovigilance databases,6 lack of standardised data management practices,6 and incomplete case information of key data elements 12 25…”

Antibiotic Resistance Diagnosis in ESKAPE Pathogens—A Review on Proteomic Perspective

“…Other factors include the lack of microbiological testing to prevent inappropriate antibiotic use, inadequate guidelines, and the easy procurement of antibiotics [ 5 ]. The AMR burden increases primarily from the inadequate availability of second- and third-line antibiotics, the availability of fake or inferior antibiotic drugs [ 6 , 7 , 8 ], and the lack of sanitation and hygiene [ 9 , 10 , 11 ]. The AMR pattern varies globally, with the existence of pathogen variants and variations in pathogen–drug interactions.…”