Seminar LM4: Falsified medicines directive – did they forget the hospital pharmacy?

Linked to EAHP statements:
Section 2: Selection, Procurement and Distribution
Section 5: Patient safety and Quality Assurance

ACPE UAN: 0475-0000-17-010-L04-P. A knowledge based activity.

Abstract 

Trade of fake and substandard medications are not only an economic threat for the pharmaceutical industry but also a growing safety issue for patients. Reports show a varying proportion of falsified medicines ranging from less than 1 % in developed countries up to 60 % in developing countries. A difference is also noted between drugs delivered by a pharmacist and medications offered on the internet. But also the length and type of supply chain has its impact as the risk does nearly not exist when directly bought from the manufacturer or a trusted wholesaler versus a non-trusted party.

The European Commission responds to this problem with awareness campaigns for patients and healthcare professionals but also with pharmacovigilance programs and the publication of the Falsified Medicines Directive. This latter has to be implemented in national legislation of the European member states within 3 years and allows the dispensing pharmacist to check the medication package in a central repository.

A commendable initiative but does it cover all the risks and is the burden worth the benefit or are there alternatives available? Let’s cast a critical eye.

Learning objectives

After the seminar, the participant should be able to:
• describe the background, goal and flow of the required tracking system;
• explain the content of the barcode and the (inter)national repositories;
• estimate the impact for the hospital pharmacist when this system is implemented;
• evaluate cost/benefit of the system.

Keywords: falsified medicines directive, drug procurement, drug logistics, hospital pharmacy

* No conflict of interest has been declared.