Shortages of Medicines Originating from Manufacturing

Abstract

The shortages of medicines in certain markets, and therefore the difficulty of patients to access to them, is a serious and recurrent issue that has its roots in several factors, including manufacturing, considered as the set of activities that begin from the procurement of the starting materials until the delivery of the finished product to the hospitals or the intermediate distributors or wholesalers. The main purpose of the content is to investigate what are the different factors, individual or combined, related to the production steps of the final dosage forms, which may be the source of shortages on the market. From the analysis of the risks’ factors, and their likelihood of occurrence and severity, born a series of considerations necessary to understand how the risk, associated with each element, can be reduced and made acceptable with mitigation measures. The risk reduction and the management of the emergency situations are the critical aspects that need to be controlled, especially for those medicines whose supply is critical for the patients. The author tries to propose a systematic approach to the management of the situations that generates shortages, independently from market drivers or dystonias, related to specific events connected to the manufacturing chain, whose occurrence can’t be neglected for the health impact that could result. The author, with a significant experience in the pharmaceutical field, intends to bring to the attention of the readers, his knowledge of the practical aspects governing the analysis and risk containment of the shortages originating from manufacturing in order to proactively react to their occurrence.