CPD 18: Patient Medication Safety Continuing Professional Development
CPD 60 Second Summary In its annual report on EU Customs Enforcement of IPRs, released on 24 July 2012, the European Commission puts forth numbers and statistics clearly highlighting the increasing threat of counterfeit medicines entering the EU – with medicines appearing among the top categories of articles stopped by customs in 2011. To fight this growing threat to public health and enhance patient safety, EFPIA (European Federation of Pharmaceutical Industries & Associations), EAEPC (the European Licensed Parallel Distribution Industry), GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the respective European organisations of research-based manufacturers, parallel distributors, wholesalers and pharmacists at EU level, have joined forces to secure pharmaceutical distribution through 2D barcoding at the level of secondary medicinal packaging. At EU level, the FMD is an important step in better protecting patients from counterfeit medicines. Our objective, as ESM stakeholders, is to develop a system that provides a high level of security for patients while being cost effective and integrating into existing structures and practices in the distribution chain. The verification system proposed by EAEPC, EFPIA, GIRP and PGEU comprises a European hub connected to a series of national data repositories that serve as the verification platforms, which pharmacies and other registered parties can use to check a product’s authenticity. At EFPIA, and within the ESM partnership, we are convinced that patient safety must come first. Using counterfeit medicine represents a health risk and there is therefore an inherent need to focus on ensuring that the supply chain is as safe as possible and encourage patients to buy from reliable sources.
23
European Federation of Pharmaceutical Industries and Associations (EFPIA) EFPIA brings together 33 European national pharmaceutical industry associations as well as 40 leading companies undertaking research, development and the manufacture in Europe of medicinal products for human use. EFPIA include: research-based pharmaceutical companies, developing and manufacturing medicines in Europe for human use – called corporate members; and those organisations representing pharmaceutical manufacturers at national level
1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice. 2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.
3. PLAN - If I have identified a knowledge gap - will this article satisfy those needs - or will more reading be required? 4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs? 5. WHAT NEXT - At this time you may like to record your learning for
future use or assessment. Follow the 4 previous steps, log and record your findings. Published by HPN, sponsored by MSD. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. MSD has no editorial oversight of the CPD programmes included in these modules.
2D barcoding in the safe labelling of pharmaceuticals Efforts taken by Europe’s key pharmaceutical supply chain players to secure the legal supply chain and protect patient safety are outlined below European Federation of Pharmaceutical Industries and Associations (EFPIA), The threat of counterfeit medicines is substantive and growing. Counterfeit medicines have been documented in every therapeutic category and in every region of the world. Recent cases of, for example, counterfeit oncology treatments underline the urgent need for action and stringent measures to protect patients worldwide. In its annual report on EU Customs Enforcement of IPRs, released on 24 July 2012, the European Commission puts forth numbers and statistics clearly highlighting the increasing threat of counterfeit medicines entering the EU – with medicines appearing among the top categories of articles stopped by customs in 2011 (24%).(1) The World Customs Organization
(WCO), in its Customs & IPR Report of June 2012, brings forth additional statistics reinforcing the worrying trend. The report highlights in particular that there has been: (i) an increase in the seizures of counterfeit pharmaceutical products both with respect to the number of cases (33.1% increase) and to the quantity (129% increase); and (ii), an increase in counterfeit items moved by means of small parcels (55% increase in terms of seizures made at mail centres).(2) To fight this growing threat to public health and enhance patient safety, EFPIA (European Federation of Pharmaceutical Industries & Associations), EAEPC (the European Licensed Parallel Distribution Industry), GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the respective European organisations of research-based manufacturers, parallel distributors, wholesalers and pharmacists at EU level, have joined forces to secure pharmaceutical distribution through 2D barcoding at
the level of secondary medicinal packaging. The four stakeholders are in regular dialogue with hospital pharmacies, represented by HOPE (European Hospital and Healthcare Federation) and EAHP (European Association of Hospital Pharmacists) and aspire to establish a more formal relationship, in order to ensure that all dispensing points are taken duly into account, including hospital pharmacies. Protecting the legal supply chain: Falsified Medicines Directive Following adoption by the Council and the European Parliament, the Falsified Medicines Directive (FMD; 2011/62/EU) was published on 1 July 2011 in the Official Journal of the European Union. It aims to prevent the entry of counterfeit medicines in the legal distribution chain, a major threat to public health and patient safety. One of the main concerns of the FMD is to increase responsibilities of all actors in the supply chain, for example, including wholesalers, community and HPN • February 2016
24
CPD 18: Patient Medication Safety
packs, and the accessibility of national product databases or repositories to verify each dispensed pack. At EU level, the FMD is an important step in better protecting patients from counterfeit medicines. Our objective, as ESM stakeholders, is to develop a system that provides a high level of security for patients while being cost effective and integrating into existing structures and practices in the distribution chain.
professionals at the point of dispensing (Figure 1) and provides a modern technology solution, using 2D barcoding, that will enhance patient safety as well as having the potential to generate additional spillover benefits in the future. Potential advantages include the possibility of allowing for the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns and improved stock management processes for pharmacies.
Pharmacy level verification at the point of dispensing with an interface for wholesalers is a robust and cost-effective way to improve patient protection. Systems should be configured so that pharmacists and parallel distributors can undertake checks at any point after receipt of goods, as well as performing the check-out operation at point of dispensing/repackaging. To this end, EAEPC, EFPIA, GIRP and PGEU have, since early 2011, been proactively engaged in developing a project to identify concrete options for establishing a system for the verification of pharmaceutical products in Europe to secure the legal supply chain, in compliance with the FMD. This pan- European product verification system is to be run by stakeholder organisations on a non-profit basis.
Irrespective of the model chosen, since the technical challenges of point of dispensing verification may initially vary across the EU, The pharmacists should project builds extensively the experience gained be permitted initially to check out medicines as they enteron the pharmacy, until from a previous EFPIA pilot, which ran successfully from such time as any technical issues with regard to point of dispensing September 2009 until February verification have been resolved. 2010 in Sweden. Key learnings hospital pharmacists and parallel distributors. To reach this goal, the European Commission asks for an EU-harmonised system of mandatory safety features for prescription-only medicines allowing verification of the authenticity and identification of individual packs by a 'unique identifier'. Finally, the FMD calls for the application of tamper
evidence to the outer packaging of individual medicine packs. The European Commission will define the mechanics of how this system will work in Delegated Acts that are to be adopted by mid 2014. The Delegated Acts will define the characteristics and technical specifications of the unique identifier, which will enable identification of individual
from the pilot pertain amongst others to system availability and performance allowing the pharmacists to work at a normal pace and without any significant additional effort. The pilot used a 2D datamatrix encoded with a product code, serial number, batch number and expiry date. Amongst key takeaways, pharmacists expressed high
The process of verification and checking out in the pharmacy should be European efficient Stakeholder Model virtually instantaneous in order to ensure pharmacy workflow and EAEPC-EFPIA-GIRPavoid delays. In order to ensure that The products are verified in one scanning PGEU serialisation project, the action, verification software should be integrated European Stakeholder Modelwith existing pharmacy (ESM), ensures verification software. of product authenticity by Figure 1
February 2016 • HPN
Point-of-Dispensing System
and PGEU, is composed of a series of national data repositories (linked via a European Hub and together forming the European Medicines Verification System, EMVS), that serve as the verification platforms which pharmacies and other registered parties can use to check a pack’s authenticity. The system will be interoperable between EU Member States with flexibility to account for national needs.
25
Figure 3
European Medicines Verification System (EMVS)
ESM working in Partnership with National Governments interest in getting expiry date registered parties can use to The proposed system should information on a variety of issues check a product’s authenticity andImportantly, batch number in machineaccommodate different needs Model in orderwill to increase and in line with the FMD, the European Stakeholder be mutual (Figure 3). The system will be readable form, as this can in different regions, while being understanding and advance developed in as partnership withbetween governments andonpublic as well interoperable the facilitate product recalls, well based common agencies principles to –patient safety as in hospital care. various countries and will allow as prevent the dispensing of ensure mandatory coding and Exchanges have so far evolved all other relevant actors along the supply chain. As a fundamental principle, for the reconciliation of products out-of-date medicines. verification of products in line around the country-by-country the stakeholder governance atEUnational level always run in partnership traded between Member with awill harmonised practice of bedside scanning States (known as parallel traded coding system. in European hospitals, the A number issues are public authorities. with ofnational products) through the European regulatory and non-regulatory critical to the success of a hub. In addition, it will also offer solutions to the problem, and product verification system Following our ESM joint countries that do not want the opportunityto for the ESM at European level. Such asystem those submission to the European and procured The national may be established by the stakeholders to set up their own national medicines verification system to system must be robust, able Commission public consultation local specifications through a tender Alternatively a ready-made system the opportunity to joinprocess. facilitate single unit bar codes to handle many thousands on the Delegated Act for safety an existing product verification future. EFPIA recognises of queries simultaneously, features (April this year), we areon in system will be available to implement at national level based a the standard infrastructure (Figure 3). the potential for patient safety and be based on harmonised now looking forward to further blueprint developed together with the European Hub. This option is the improvement that could be standards. Fragmentation engaging with interested parties The verification system made by using medicines bar will “National limit the ability toBlueprint” verify a such above as additional supplywill chain under (nBPS) in the diagram and certain incorporates the requirements coding in this way, and we stand product’s provenance and may actors, patients and national set out economies in the FMD as regards circumstances generate of scale and thus a more cost-effective ready to cooperate with hospital cause problems in identifying public authorities in order to repackaging of products for sale pharmacists in exploring ways to counterfeit products that each EU explore opportunities for system versus Member State creating its own national repository. into other EU markets. Where achieve systematic single unit cross borders. further collaboration. a product is repackaged, the bar coding. original serial number should The verification system In this respect, EFPIA and be replaced in the database Global solutions for a proposed by EAEPC, EFPIA, EAHP have recently stepped up with a new one by the parallel global threat GIRP and PGEU comprises communication with a view to distributor. The original and a European hub connected jointly explore ways forward to new packs should be linked to a series of national data EFPIA is actively following electronically at the batch level in ensure patient safety in hospital 15 beyond repositories that serve as care under the ESM system. The serialisation initiatives order to ensure that the product the verification platforms, two organisations have been the EU and stands ready to work can be traced in the event of a which pharmacies and other safety issue arising or a recall. and will continue exchanging in partnership with international
HPN • February 2016
26
CPD 18: Patient Medication Safety
stakeholders on establishing interoperable systems, based on internationally recognised standards such as GS1, securing the pharmaceutical supply chain in the interest of greater patient safety. It is important to note that serialisation can only help to protect the distribution chain against penetration of counterfeits when operating together with other measures that provide clarity and transparency over the roles and responsibilities of all players in the supply and distribution chain. Without these conditions being in place serialisation is unlikely to provide robust protection and may indeed introduce a false sense of security for patients. Conclusions At EFPIA, and within the ESM partnership, we are convinced that patient safety must come
February 2016 • HPN
first. Using counterfeit medicine represents a health risk and there is therefore an inherent need to focus on ensuring that the supply chain is as safe as possible and encourage patients to buy from reliable sources. EFPIA is proactively engaged in ensuring patients have access to safe medicines. Key points • The threat of counterfeit medicines is substantive and growing and counterfeit medicines have been documented in every therapeutic category and in every region of the world. • Following adoption by the Council and the European Parliament, the Falsified Medicines Directive (FMD) was published on 1 July 2011. It aims to prevent the entry of counterfeit medicines in
the legal distribution chain, a major threat to public health and patient safety. • To this end, EAEPC, EFPIA, GIRP and PGEU have, since early 2011, been proactively engaged in developing a project to identify concrete options for establishing a system for the verification of pharmaceutical products in Europe to secure the legal supply chain, in compliance with the FMD. • Via a central European hub and based on internationally recognised standards, the ESM ensures interoperability across the EU. • The ESM will apply to all EEA Member States, allowing for flexibility at national level to accommodate specific situations.
• The ESM is being built on thorough cost estimates and will, based on know-how from supply chain players involved, avoid gold-plating and set up the most cost-effective system for the benefit of patient safety. References 1.European Union. Report on EU Customs Enforcement of Intellectual Property Rights, 24 July 2012. http://ec.europa.eu/ taxation_customs/resources/ documents/customs/customs... (accessed 5 November 2012). 2.World Customs Organization. Customs and IPR report; July 2011.