Sunday, September 17, 2017

Medicines Shortages - European Commission eCOST Research Network - Action CA15105

eCOST (European Cooperation in Science and Technology) is the longest-running European framework supporting trans-national cooperation among researchers, engineers and scholars across Europe.

European Medicines Shortages Research Network - addressing supply problems to patients (Medicines Shortages) 

The problems created by supply shortages of medicines have been widely reported by healthcare professionals and patients over recent years, and acknowledged at the European level by the European Medicines Agency and European Commission. The cited causes are multifaceted ranging from production disruptions, natural disasters, discontinuations as well as difficulties created by various legal, trade and pricing frameworks. Healthcare professionals require access to reliable and up-to-date information about the unavailability of a medicine in order that they can treat the patient in the best way possible. The significant patient impact because of the lack of medication, in terms of safety and management of their condition, will be researched. In addition the forced substitution to an alternative product or requirement to produce a medicine may increase the risk of error, stress and overall cost to the healthcare system. According to the largest pan-European survey of healthcare professionals yet conducted on the topic, the products mainly affected in the European hospital sector are antimicrobials and oncology products used for large populations. This Action will encourage systematic sharing of information and research about past, ongoing and future shortages of medicines and nutritional products. The Action aims to respond to clinical, financial and quality of life interests, to achieve analytical clarity on disruption causes, to simulate decision making in medicines production and trade, to highlight restrictive legal and economic frameworks, to disclose disincentives in the supply chain such as conflicts of interest or problematic cost-benefit ratios, and to reflect on best coping practices.

Wednesday, February 15, 2017

IHE Pharmacy (PHARM) Educational Article, Falsified Medicines Directive - Supply chain interoperability in support of safer medication usage

This document is an initiative of IHE Pharmacy to describe how interoperability can support the effort against falsified medicines, as laid out in the Falsified Medicines Directive - EU Regulation 2016/161.

IHE provides a standard interoperability architecture for the supply of healthcare products. This effort covers traceability, barcode scanning, message exchange, etc. All of these matters help monitor the supply chain and thus support the enforcement of the Falsified Medicines Directive.

This paper explains that the requirements of the Falsified Medicines Directive constitute in identifying the medicinal products along the supply chain, and reporting that to a central data hub. Using publicly available message structures helps software solution providers benefit of IHE’s testing opportunities and support a truly interoperable tracking mechanism.

Scanning the products poses an operational challenge for users: even for easy barcode scanning, for normal volumes it becomes burdensome. In a medium hospital, the effort of identifying all the received primary packages upon reception would exceed one dedicated professional. For this, it is essential to use standardized AIDC (Automatic Identification and Data Capture) technologies: standard media (e.g. Datamatrix barcodes) and standardized content.

Standardized interoperability mechanisms also play a role in this: By providing a standard electronic shipment list, the supplier can inform about the content and unique identification numbers included in each shipped carton so that the users may scan the outside package, and the contents of the package are automatically filled into the necessary systems.

This document explains how these mechanisms - reporting and shipment content - can enable proper tracing of medicinal products, and when standardized they enable the different actors to do so with reduced effort.