The significance of dosage forms for pharmacovigilance in the case of topical corticosteroids

Abstract

Introduction: In addition to the active pharmaceutical ingredient (API), excipients and the pharmaceutical dosage form can also affect the overall effect of pharmacotherapy. Knowledge about these effects is not important only from the aspect of drug efficacy, but also from the aspect of pharmacovigilance. Materials and Methods: This paper presents secondary academic study results. Data on the dosage form and content of excipients were taken from SmPC documents on the official website of Medicines and Medical Devices Agency of Serbia. The presence of excipients with known effect (EKE) and their labeling was considered in accordance with the national and European regulations regarding this area. Results: We analyzed a total of 50 medicines for topical administration that are registered in Serbia. These all contained corticosteroids as API. Thirty-five (70 %) of them had one or more EKE. Creams had the highest number of different EKE per drug (3.25). Five out of seven identified EKE have the preservative function in formulations, which could be avoided by extemporaneous drug production. The labeling of these compounds was in accordance with the regulations in most drugs. Conclusions: The cause of an adverse drug reaction should be considered in a wider context and all the drug ingredients should be taken into account. In case of topical corticosteroids, over two third of drugs have the potential to cause adverse drug reactions that are non-API-related.

Keywords

• excipient with known effect
• adverse drug reactions
• local use of corticosteroids