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.

Sources

http://www.ihe.net/
https://www.ihe-europe.net/ 
http://www.ihe.net/Pharmacy/
http://ihe.net/uploadedFiles/Documents/Pharmacy/IHE%20Pharmacy%20FMD%20Guide_Rev1.0_2017-02-08.pdf

Sunday, July 10, 2016

eHealth Forum: Catalyst for Reform – Enabler for Growth


The eHealth Forum will be held in Athens, Greece on the 25th and 26th of October, 2016 at the Megaron Athens International Conference Centre.

The eHealth Forum becomes the annual meeting point for Greece, the South East Mediterranean and the Middle East, to reach and network with key stakeholders. The eHealth Forum invites policy makers, industry leaders, medical professionals, health care providers, tech innovators, researchers, investors, pharma, telecommunications companies, patient advocacy groups and major health IT players to connect and pursue the role of ehealth as a catalyst of reform and enabler of economic growth.

The rapidly growing eHealth sector estimated to dominate all areas of industry by 2020 presents a unique opportunity for collaboration, financial and scientific growth and social reform. Within this expanding market further developing information technologies and applications in digital health is essential to promote the reform of the healthcare system and therefore act as a catalyst for these imperative changes. The process of reforming healthcare is, in and of itself, an enabler for economic growth in various sectors: research, industry, information and telecommunications technologies. The eHealth Forum presents “hot” topics high on the “digital agenda” in Europe and the surrounding region, while providing the channel to present and disseminate information on scientific and technological advancements in healthcare.

Themes 
1. eHealth Framework
2. eHealth in practice today
3. Clinical management of chronic illness
4. Patient at the centre: Health Applications
5. Data-aware medical devices
6. Big Data
7. Cyber-security
8. Behavioural Change


Source

http://www.ehealthforum.org/

Saturday, July 09, 2016

IHE Pharmacy Educational Webinar 2016

IHE (Integrating the Healthcare Enterprise) annually presents a series of free educational webinars from June through September.
The series will help your organization learn about IHE; engage in IHE development and testing activities; and, leverage IHE solutions to develop and implement interoperable health IT systems.

Pharmacy webinar Learning Objectives:
  • Understand PHARM vision, mission and strategic goals.
  • Understand PHARM domain’s liaison and collaboration with HL7 and ISO.
  • Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan
  • Overview of other PHARM domain activities, including Supply Chain and FHIR
  • Understand how PHARM work benefits the pharmacists.
  • How to get involved in PHARM committee work.
Download:

Tuesday, March 08, 2016

IHE (Integrating the Healthcare Enterprise) World Summit 2016


The IHE World Summit will be held in parallel to eHealth Week on 7 and 8 June 2016 in Amsterdam, The Netherlands
IHE brings together healthcare IT system users and developers to address interoperability issues that impact clinical care. The work involves identifying real-world scenarios/use cases, writing and reviewing specifications, implementing in products, monitoring vendor testing, etc. We invite you to become involved in one or more of these activities.

IHE (Integrating the Healthcare Enterprise) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. 
IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care. 
Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.

Source

IHE World Summit 2016

Thursday, February 11, 2016

European Commission publishes the final text for the Falsified Medicines Directive Delegated Regulation


The European Commission has published the long-awaited Delegated Regulation, setting out the requirements for the future system of medicines verification that must operate in all EU countries.

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

COMMISSION DELEGATED REGULATION (EU) 2016/161 
of 2 October 2015 
supplementing Directive 2001/83/EC 
of the European Parliament and of the Council 
by laying down detailed rules for the safety features appearing on thpackaging of medicinal products for human use. 

This Regulation lays down: 
 (a) the characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified;
(b) the modalities for the verification of the safety features;
(c) the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;
(d) the list of medicinal products and product categories subject to prescription which shall not bear the safety features;
(e) the list of medicinal products and product categories not subject to prescription which shall bear the safety features;
(f) the procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification in accordance with the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC;
(g) the procedures for a rapid evaluation of and decision on the notifications referred to in point (f) of this Article. L 32/6 EN Official Journal of the European Union 9.2.2016


Tuesday, February 09, 2016

The European Medicines Verification Organisation (EMVO) signs framework agreements with service providers to establish blueprint systems


The European Medicines Verification Organisation (EMVO) is a Luxembourgish non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines
Its founding members are EFPIA, the European Federation of Pharmaceutical Industries and Associations, the EGA, the European Generic and Biosimilar medicines Association, PGEU, the Pharmaceutical Group of the European Union, GIRP, the European Association of Pharmaceutical Full-line Wholesalers and EAEPC, the European Association of Euro-Pharmaceutical Companies.
The stakeholder organisation EMVO last Friday finalised its contract negotiations with 3 partners that will be the preferred providers to implement the repositories system in compliance with the Falsified Medicines Directive. The 3 partners are: Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.
The repositories system will allow the verification for authentication of medicines in Europe. For this purpose 5 European stakeholder associations (EAEPC, EFPIA, EGA, GIRP and PGEU) have established in February of this year a non-profit organisation EMVO that is taking the lead in the creation of this system.