P26: Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety
Project Safety Physician, Pharmacovigilance
To investigate the degree of difference between labels for generic and originator products, the possible consequences of this discrepancy for patients, and its implications for risk minimization.
Consistencies and discrepancies between summaries of product characteristics (SmPCs) for originator and generic products were analyzed. The percentile distribution of discrepancy classifications was calculated. A scoring system was applied for the potential impact on patients.
Among the 50 drugs selected initially, 31 were eligible for the study and were analyzed further. Of those 31 drugs, 13 (41.9%) presented critical label differences between originator and generic products, 6 (19.4%) showed major label differences, 7 (22.6%) exhibited minor label differences, and 5 (16.1%) showed very minor label differences. Over 60% of the selected drugs (19, 61.3%) presented important (critical, major) label differences between originator and generic products. None of the selected drugs had fully aligned labels of originator and generic products. Label misalignments that could potentially have a fatal or life-threatening impact on the patient were observed for 4 (12.9%) of the selected drugs.
Label misalignments that could have a severe patient outcome were noted for 11 (35.5%) of the selected drugs, and label misalignments that could have a medium impact on the patient were seen for 6 (19.35%) of the selected drugs. The label misalignments observed for 10 (32.25%) of the selected drugs would potentially lead to only a minor or no effect on the patient. Almost half (15, 48.4%) of the selected drugs presented label misalignments that could have a critical (fatal, life-threatening, severe) influence on the patient.
In this sample, SmPC alignment between generic and originator medicinal products was found to be insufficient for generic drugs and could lead to the diffusion of discrepant messages to healthcare professionals and patients. In order to address this SmPC alignment problem, health authorities such as the EMA and the FDA should conduct retrospective analyses of all drugs on the market as a first step towards realigning labels. These analyses could be performed during the evaluation of aggregate reports.