Drug Recalls in Spain: A 14-year Retrospective Regulatory Analysis in Spain

Abstract

Purpose Drug (or medicine) recalls represent a public health risk and may contribute to shortages, potentially affecting sup ply continuity and, consequently, patient care. This study analyzed drug recalls issued by the Spanish Agency of Medicines and Medical Devices (AEMPS) and conducted an additional descriptive recall-related shortage assessment to estimate their potential impact on supply continuity in Spain. Methods A descriptive retrospective regulatory analysis was conducted on drug recalls in Spain over a 14-year period (2010–2023). Data from the AEMPS website were analyzed, and drug recalls recorded during the last 4 years of the study period (2020–2023) were cross‑referenced with national shortage records to assess their supply impact. Results A total of 1,120 drug recalls were identified, 87.86% (n = 984) involved prescriptions and 57.32% (n = 642) were classified as Class 2, recalls with a moderate risk of temporary or medically reversible adverse health consequences. The presence of nitrosamines (22.50%, n = 252) was the leading cause of recalls, driven by a phase-specific crisis (2018–2019), with the highest number of issued recalls (19.19%, n = 215) observed in 2018. Five manufacturers of active substances and finished products accounted for 27.32% (n = 306) of all recalls. Drug recalls issued between 2020 and 2023 (n = 195) resulted in a total of 55 drug shortages. Of these shortages, 10.91% (n = 6) were considered to have a high clinical impact on supply continuity. Conclusion Nitrosamines emerged as the leading cause of recalls in Spain during the study period. A subset of recalls was linked to shortages affecting supply continuity, posing a potential risk to patients’ health. These findings underscore the importance of monitoring recalls and addressing supply chain vulnerabilities to mitigate negative effects on patients’ health and access to essential medications