EMA objavila smjernice za prevenciju i ublažavanje nestašica lijekova

EMA je objavila preporuke za prevenciju i smanjenje utjecaja nestašica lijekova: Good practices for industry for the prevention of human medicinal product shortages.

Sve češće i sve raširenije nestašice lijekova donose nove izazove za sve sudionike farmaceutske industrije i lanca opskrbe lijekovima, a sve to naravno ima i značajan utjecaj na korisnike lijekova. Nove smjernice kroz deset praktičnih i konkretnih preporuka obuhvaćaju nositelje odobrenja za stavljanje lijeka u promet (MAH), proizvođače i veleprodaje, a sve kako bi se reducirala pojava nestašica lijekova te učinak takvih nestašica smanjio na najmanju moguću mjeru.

U nastavku donosimo dva zanimljiva i skraćena izvatka iz smjernica:

Recommendation 4 - MAHs, manufacturers and wholesalers, should each have a shortage prevention plan specific to their role

Manufacturing issues are the most common cause of shortages.

Shortage prevention plans for manufacturers will focus on their manufacturing capabilities, sourcing raw materials, market trends, marketing activities and the supply of medicines manufactured by them.

Wholesale distributor prevention plans will identify and mitigate identified vulnerabilities from receipt of the medicine, its storage and through to delivery.

Recommendation 6 -  Optimise pharmaceutical quality systems to strengthen the reliability and resilience of supply chains throughout the lifecycle of a medicine

It is apparent from the data gathered that failures associated with pharmaceutical quality systems (i.e. regulatory issues) contribute to many shortages. While the current Good Manufacturing and Distribution Practices (GxPs) set out practically a minimum standard for quality, there is a need to shift the paradigm and focus of the industry to achieve an effective quality system that reduces the burden of shortages.

Chapter 1 of the GMPs describes the use of product quality reviews (PQRs) which is a mechanism to ensure that data captured by the quality system is reviewed for trends and can, in turn, support an environment of continuous improvement. For example, PQRs are designed to identify and implement recommendations for required continuous improvements. MAHs and manufacturers should adapt the PQRs to include assessing the robustness of the supply chain arrangements and any controls that are in place to prevent a lack of availability of the product for patients.

ICH guideline Q10 on Pharmaceutical Quality System is intended to provide a framework to move beyond just adherence to the GxPs. It describes the use of knowledge management and quality risk management as enablers, outlining potential opportunities where companies more actively demonstrate the effectiveness of their quality systems and regulators can take a more risk-based approach to regulatory oversight.