The Over The Counter drugs with azo excipients: guide for the prevention of unsafe use in pharmaceutical dispensing and indication

Abstract

Introduction: The OTC (Over The Counter) drugs are free use drugs and can be dispensed without a prescription.

Azo dyes are known for their potential toxicity in patients allergic to ASA. Therefore, the exposure to them should be accompanied by precautions, warnings and contraindications to the use.

Objective: To design a dispensing guide to prevent insecurity due to cross-reaction with azo excipients in patients allergic to ASA.

Methods: The list of OTC marketed in Spain was obtained from the BOT plus and the AEMPS technical sheets. The BOT plus sheets were reviewed to detect discrepancies between files and to search for safe alternatives (also OTC) for those with azoic agents.

Results: Of the 1194 OTC evaluated, 110 (9%) contained some azo, ASA or salicylamide. 

Among the 784 for oral administration: 18 contain ASA, 4 include salicylamide and 78 azo. For all 78 oral OTC with azo dyes, except for 2, an alternative OTC from the same therapeutic group was found. The alternative OTC respected the same route of administration but not the same pharmaceutical form in 28.9% of the cases.

Eleven discrepancies were detected between the AEMPS and BOT plus technical sheets. They were corrected after having been communicated to the General Council of Official Associations of Pharmacists (CGCOF).

Conclusions: This guide will be very useful for Pharmaceutical Care (PC) in the dispensing and indication of OTC with azo excipients in patients allergic to ASA. In addition to preventing situations of insecurity, it enriches the PC protocols available for healthcare practice in the Pharmacy Office.