The Medicine Digital Network. Solution Report

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1 The Medicine Digital Network Solution Report 2015

2 Contents 1. Introductions Aegate Operational Context and Opportunities to leverage Aegate s experience and live systems Critical success factors Associations Project planning and serialisation Data Aegate End to End system Medicine Verification 7 4. Ecosystem software partners System Structure Status System Performance System Availability Good Authentication Practice (GAP TM ) Impact of EU FMD on Hospital Authentication Major Hospital Authentication Challenges Major Hospital Authentication Opportunities Oxford Pilot Background Good Authentication Practice Offices

3 1. Introductions About Aegate Aegate has been active since 2004 and remains an entity totally dedicated to the fight against falsified, recalled, expired or suspicious medicines. To date Aegate has verified over 3.4 billion packs of serialised medicines in many European countries from 20,000 medical pharmacy dispensing points as well as conducting major innovation activities on hospital dispensing processes with University Hospitals. Aegate is a private company formed out of the spin-off from a Pharmacy Association (PA) Consulting Group, whom were advising both the UN and the European Union on practical issues which need to be considered when deploying a medicine verification of authenticity service across Europe and individual countries. Since 2007 Aegate has collaborated with the Belgian Pharmacy Association (APB) with verification of medicines at the point of dispensing in order to leverage the existing serialised packs to improve patient safety ahead of the mass serialisation of packs from the manufacturers. Aegate and the APB have been precursors in establishing a National Medicine Verification service which would show the way in which the Falsified Medicine Directive could be implemented practically. In 2007 Aegate extended its services to operate the service in Italy and Greece as these two EU Member States had also serialised their packs because of national legislation. From 2011 Aegate has worked with the European Stakeholders and the EU Commission as a subject matter expert in the way in which the European Stakeholders could safely and practically implement the directive in their medicine verification service. In 2014 Aegate signed the contract to technically implement the connection to the European Hub which it has now connected to. After the formation of the EMVO (European Medicine Verification Organisation) and a complete contract negotiation in June 2015 Aegate was officially named as a National Blueprint Provider within the EMVO governance model. Five key elements in the system design of Aegate are: 1) Patient safety for recalled, expired or suspicious/falsified medicines identified before the dispensing act. 2) End to End response speed experienced from the pharmacists viewpoint within tolerances which do not alter the workflow of the pharmacist (250 Milliseconds or 0.25 seconds for the entire verification and message pop-up viewed from the viewpoint of the pharmacists) 3) Security, confidentiality, scalability, availability, performance and anonymity for all stakeholders through modern reliable information security services tools. 4) Immediate safety alerts for the pharmacists when medicines are returned or when the recall occurs after the medicine has been dispensed. 5) Avoidance of False Positive when errors of scanning are made at the pharmacy and the medicine is scanned twice by the same pharmacist within a few seconds. 2

4 Falsified Medicines Directive and the European Medicine Verification Organisation The Falsified Medicines Directive (FMD) is EU-wide legislation being introduced to protect patients from counterfeit medicines a fast growing worldwide threat to safety. The FMD requires all 28 Member States to have a system in place to detect falsified medicines: uniquely serialised medicine packs, tamper-proof seals and their authenticity verified before being dispensed to patients. In all EU and EEA Member states, retail and hospital pharmacy dispensing points and wholesalers must have a fully operational system in place to verify medicines authenticity by the end of A key element of a successful system is the ability to support their national system with safety verification in less than 250 milliseconds from time of scanning by the pharmacists. European Commission Skateholder s Presentation 3

5 Aegate has now been formally recognised as a Blueprint Provider by the European Medicine Verification Organisation which has created a clear European Governance for the European National Medicine Verification System. The European Organisations of EFPIA (Branded Pharmaceutical), EGA (Generics), PGEU (Pharmacies), GIRP (Wholesalers), EAEPC (Parallel Traders) has recognised Aegate through an in-depth technical and commercial verification process as a National Blueprint Provider in order to implement the Medicine Verification System in each country. 1.1 Aegate Operational Context and Opportunities to leverage Aegate s experience and live systems. To date, Aegate has been operational in live environments with multiple pharmacy software providers, multiple hospital software providers, multiple wholesale software providers, and real life conditions of the Belgian, Italian, Greek, British, Dutch markets. Given the voluntary nature of the Aegate efforts, Aegate has achieved a very large amount of pharmacy participation as well as manufacturer participation. Because the system is live in many markets, manufacturers have been able to test, both existing serial codes, and the newer 2D serial codes where and when implemented. Thus, having a live Aegate Service allows for the simple introduction of serialised codes when the specific manufacturers are ready. In the countries where Aegate is operational, because it is already a live system, the manufacturers will immediately be able to see their verification occurring across all the pharmacies that have activated. 1.2 Critical success factors Associations The experience of Aegate working with the European Stakeholders is that the European Associations managing the entire European Medicine Verification System must be sure that the National Systems managed by the National Medicine Verification Organisations behave according to a common set of technical and governance standards. For this reason they have created a National Blueprint Service provider qualification that identifies service providers that have already operated with success and at the same time they have constructed a European Hub that guarantees a single point of entry for the manufacturer serialised codes. In each country National Associations are meeting to form their National Medicine Verification Organisation in order to put in place the National Medicine Verification System. There are over 180,000 pharmacies in Europe and over 15,000 Hospitals which all will need to be part of the system. Each association for manufacturers, pharmacy, wholesalers, hospital pharmacists or parallel traders will require a complete plan in each country which ensures that the system and all its participants perform as to the standards required for success. 4

6 Project planning and specialisation No project of this nature can have a guarantee of success if the main technology service provider is not selected early in the cycle so as to ensure that the service is operational in time for all manufacturers, dispensing and verification points to test the system to their satisfaction. The timelines are very tight as the time between the present and the end of 2018 is very short in order to ensure that the service quality and the operational costs fall within the affordability required. The specialist service provider needs to have the demonstrated ability to deliver a live verification system within the required timeline and the experience factor is key to the successful implementation. Without any doubt Aegate has demonstrated that it can deliver a multi-national, multi-stakeholder medicine verification service with quality, reliability, scalability, availability and security. Aegate is considered the world leading expert in this area. The costs need to be kept in focus as the measurements of the performance of the medicine verification service cannot be greater than the resources running the service itself. When selecting a world expert like Aegate, one can limit the cost of the governance organisation and focus on the governance SLAs (Service Level Agreements). It is the responsibility of the service provider to provide the service level agreements reports and dashboard to a very clear set of users within the Associations that make up the National Medicine Verification Organisation as well as the NMVOs themselves Data The data of the National Medicine Verification System is clearly regulated by the European Laws in this matter. The data in the system belongs to those entities who create the data. Thus the sum of all stakeholders are collectively owning the data. The system provider does not own the data and thus it is only a technical enabler to support the National Medicine Verification Organisation. No simple segregation of databases will stop the inappropriate use of information by market participants. The National Medicine Verification System must not allow any of the market participants to have unauthorised access to the information. Nor should the National Medicine Verification System limit its patient safety mandate to satisfy the concerns fuelled by historical collaboration issues among the stakeholders. 5

7 2. Aegate End to End System Aegate, the principal active market leader in medicines verification, operates a highly secure real time system to verify the authenticity of medicines. The Aegate system operates seamlessly from manufacturer to pharmacy, and fully meets the requirements of European legislation for falsified medicines. The Aegate system operates alongside existing pharmacy software and does not require any new equipment. It is free of charge to the pharmacist or pharmacy software provider assuming that the pharmacist has a bar code reader that can read 2D matrices. The pharmacist benefits from an uninterrupted workflow and guarantee of patient safety at point of dispense against counterfeit medicines. End to end authentication service 6

8 Aegate has been appointed by the European Medicines Verification Organisation (EMVO) as a selected Service Provider for implementation of the FMD in all European countries. Whilst pilots have been trialled for this critical activity, the leading example is the Aegate system, active in Belgium, Greece and Italy, scanning serialised codes since 2007, as well as The Netherlands and the UK in Aegate is currently operational in over 20,000 dispensing points and the system has scanned over 3.3 billion medicine packs from branded and generics manufacturers, and flagged up over 2.4 million potential issues to safeguard patients. Aegate s experience and expertise demonstrate the reason why it is the proven, trusted and secure choice for pharmacies. 7

9 3. Medicine Verification THE COSTS AND SERVICE BENEFITS FOR THE PHARMACEUTICAL INDUSTRY OF A SINGLE END-TO-END SERVICE VERSUS A MULTIPLE PROVIDER SERVICE Executive Summary This comparison paper details the impact on the pharmaceutical industry of two different approaches in the delivery of a medicine verification service. The two approaches Single End-to End Service and Multiple Provider Service can be best differentiated by comparing where the responsibility of the verification service provider ends, as well as the number of different providers engaged in the delivery of the service. Each of these approaches has significant cost, performance and service issues, with a corresponding impact on manufacturers (as the group identified to pay for such a system). Single End-to-End Service. In this approach, one service provider is responsible for providing a complete medicine verification service. Here the service provider takes responsibility for the entire service, from the verification of each medicine pack from the time that the medicine is scanned in either a dispensary or a wholesaler to the processing of the response in the database and the display of the pack status to the dispensary or wholesaler. A critical differentiator of this service is the integration of the medicine verification service, through an encrypted software library placed directly into the patient medication record software at the dispensing point, or the inventory control software at the wholesaler. Multiple Provider Service. In this approach, while one service provider is responsible for the central verification database, multiple other third party software providers are needed to interface with the central verification database. Consequently, the verification of each medicine pack is handled by at least two providers and there are at least two handover events: one from when the medicine is scanned in either a dispensary or a wholesaler, and then handed over to the central database; the other after the response is processed in the database and the subsequent pack status is handed back to the software at the originating dispensary or wholesaler. This paper highlights the differences between these two approaches and shows that the most cost effective for the pharmaceutical industry is a Single End-to-End Service. A further benefit is that this approach closely aligns with the legislative requirements defined in the Falsified Medicines Directive (FMD) and the detailed service requirements soon to be published in the Delegated Acts (DA). Additional value added can also be generated through the service offerings that only a network structured around a Single End-to-End Service makes possible. Single End to End Service The Single End-to-End Service is one where the service provider takes full responsibility for the entire round trip of the journey of each medicine that is verified using the system. The key advantages of this approach are:- Response Time: The service provider can measure the complete end-to-end round trip response time for each transaction. This is critical to ensuring that users are not delayed and service levels can be monitored and maintained. The DA will highlight the need to provide a verification service which will meet a 300 millisecond end-to-end response time. As such, response times will need to be monitored closely. 8

10 Cost: Under a Single End-to-End Service, the cost of integrating into multiple patient medication record systems is actually lower than the equivalent cost of providing separate interface specifications in the Multiple Service Provider approach and dealing with the software interface problems this entails. This is due to the standard software agent placed seamlessly into the PMR systems. Security: The security of the Single End-to-End Service is far higher than that experienced with a Multiple Service Provider. Additional security can be embedded into the software used by the service provider. This approach has the ability to abstract the security interface and handle it inside the service providers code, without exposing the security logic to external interfaces. Continuity: A Single End-to-End Service is less exposed to software changes within the individual patient medication record software these generally suffer from frequent release changes. This results in a more robust service which benefits all users and avoids the situation where the system may well be down through an error made by a third party software provider. Standardisation: The Single End-to-End Service approach provides a standardised Graphical User Interface which can be used to generate alert messaging across heterogeneous software applications, lowering the training costs of users and standardising the alerts across multiple Pharmacy and Wholesale systems. Support: The Single End-to-End Service approach allows for the centralised administration of support services to all connected devices, reducing help desk calls and allowing the system to monitor service levels. The integration within the patient medication software also allows for the easy identification of the patient in the event that a serious recall is initiated. Apart from needing a service provider who has the necessary experience, expertise and capability to interface and integrate with numerous patient medication software companies in a market, there are no disadvantages to this approach. Multiple Provider Service The Multiple Provider Service approach is one where there is a single service provider for the verification database. However, connection to this database is reliant on individual software companies, each of which provide different dispensing software services and wholesaling services. As a result in this approach, there could easily be over ten different companies delivering a medicines verification alerts and messages in a single market. This approach has a number of disadvantages:- Response Time: In a Multiple Provider Service approach there is no practical way of measuring the complete end-to-end response time for each transaction. This means users can be delayed and be discouraged from operating the service as response time increases, without a centralised knowledge or monitoring of the service levels. Cost: Costs are higher when you need to rely on multiple third parties to write, test and implement the software required to interface with the verification database. These increased costs are a function of longer process times and may be prone to delay if individual software companies fail to perform as promised. Delays of this nature coupled with the subsequent software issues all add cost to the operator of the verification database. Security: The security of the Multiple Provider Service approach is increasingly compromised as more software companies interface to the verification service. Continuity: The Multiple Provider Service approach relies very heavily on the technical, process and project management capabilities of each individual company interfacing to the verification database. Here errors are often made which will then have a negative impact on the service operation. Standardisation: There is no standard approach across different software applications. 9

11 Support: The Multiple Provider Service approach increases the complexity of the support operation to users. In these cases, a user may well direct their questions directly to the manufacturer due to the uncertainty of knowing who can answer their question. In the event that a suspicious item is found, different service providers will have different approaches to resolution. This can also increase the burden on the manufacturer. Hidden Costs: Without a single point of issue resolution, the service delivered by a Multiple Provider Service will not be able to address any remedy to either systemic issues or temporary faults since it lacks the required visibility. This will multiply the costs to the MNVOs, the EMVOs and even the single Pharmaceutical Companies. Additionally the Multiple Provider Service approach is not aligned to the principles of operation outlined in the FMD and the expected detail to be contained within the DA. Certainly the need to measure and show round trip response time performance of 300 milliseconds would be impossible with this approach. Conclusion The Single End to End Service approach to the Medicine Verification System reduces drastically the time and costs for the service provider to implement and run the service compared to a Multiple Provider Service approach. In addition, it significantly reduces complexity, and requires less support from pharmaceutical companies and the National Medicine Verification Organisations. 10

12 4. Ecosystem software partners Aegate is running the Aegate Safe Medicine Ecosystem partner program in several European Countries to ensure that the Software Houses and Service Providers working with both Pharmacies and Hospitals are able to integrate the Aegate service in their software. We currently have 72 partners independent software vendors in the programme. For the latest more see 11

13 5. System Structure Aegate s verification system is constructed as a single central verification system with a client agent that is integrated with the software already running in pharmacy. This has many technical and operational advantages including: A single integrated end to end system that can be engineered, audited and tested for performance, reliability and data security. The system as a whole can be considered with a single design authority rather than having a series of parts with complex interactions and multiple responsible parties. The system allows subtle and nuanced messaging to be relayed back to pharmacy users. This means that for product recalls the full nature of the recall can be provided to pharmacy with appropriate judgements being made by pharmacists with complete information. Since one system is responsible for storing, activating and displaying the message the integrity of the message can be guaranteed compared to systems where information must flow through distinct un-integrated systems. As the system has a complete view of where and when a serial code has been scanned there is no need for reconciliation between multiple systems and abnormalities such as the rate of scanning unexpectedly changing can be quickly and efficiently investigated to correct system or user errors. As an ISO certified organisation and as a dedicated pharmaceutical verification vendor Aegate takes data security as a business critical requirement. 12

14 Transactions The Aegate Solution Report 2015 Data security starts by not capturing any information that is not essential to the carrying out of verification services. So the only sensitive data that Aegate holds are the serial code associated with each medicine pack and the details of each pharmacy. As each pharmacy scans a medicine pack the pack details are passed to the Aegate client agent for verification at the central service, the clear delimited boundary with the Aegate client agent ensures that no patient data ever enters the Aegate system or indeed leaves the pharmacy. The only data leaving the pharmacy is the serial code of the medicine pack being scanned. The end to end nature of the Aegate system ensure that even this data is securely protected all the way from pharmacy to the central verification service and back. 5.1 Status Aegate has been operating in multiple European countries for more than 7 years. It is operational in 6 European countries and has carried out over 3.3 billion verifications. A key aspect of the verification system is to not interfere with the pharmacist workflow, unless the medicine has failed verification in some way. So it is essential that the system work effectively instantaneously to the pharmacist. 5.2 System Performance The first part of this performance is to see the response time at the central service averages < 9 ms % 70.00% 60.00% Central Server Response Time Histogram 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Milliseconds However this is only a small part of the response to the pharmacy. We can see in the graph below that the operational Aegate system produces a response in the vast majority of cases in less than 300 ms across Europe. In the case of Belgium the average response time in pharmacy is 180 ms. To the pharmacist this is effectively instantaneous. 13

15 Pharmacies The Aegate Solution Report % 50.00% 40.00% Pharmacy Average Response Times 30.00% 20.00% 10.00% 0.00% Other Milliseconds 5.3 System Availability So as not to interfere with pharmacy workflow the system must also always be available, Aegate has achieved a 100% availability over the last 2 years, with availability being 99.95% before this. 6. Good Authentication Practice (GAP TM ) Aegate Hospital Authentication: Experience and Collaborative Opportunities 6.1 Impact of EU FMD on Hospital Authentication The EU FMD will mandate that all prescription medicines must be authenticated prior to prescription to a named patient Unlicensed medicines will be excluded At risk medicines, including high-risk medicines undergoing a POM-OTC switch may be included Authentication should be performed by a pharmacist and/or accredited technician Medicines that are dispensed without authentication will be in breach of the FMD and be recorded as a dispensing error Clear procedures will be required to ensure that all falsified, expired and/or suspicious medicines are quarantined and investigated Training and accreditation programmes are required for current and future staff to ensure FMD compliance and to reduce and/or prevent dispensing errors The highest value and highest risk medicines typically flow through hospital pharmacies, and thus are a critical environment for FMD implementation 14

16 6.2 Major Hospital Authentication Challenges Split Packs: In the event of split packs, all original packaging should remain in the hospital dispensary; and only blister packs with a clearly embossed batch number and expiry date re-dispensed to patients. Hospital Robots: Awareness of the EU FMD is very limited amongst manufacturers of pharmacy robots. Additionally, some robots are unable to scan 2D data matrices and/or over-sticker, obscuring the 2D data matrix. Where possible, robotic authentication is preferred to minimise human error. Unit Dispense: Where unit dispense systems are used, clear records of the provenance of all medicines should be maintained, and the distribution of all repackaged medicines monitored to facilitate a recall if required. Pharmacist Awareness of FMD: In all sites surveyed, the awareness of hospital pharmacists pertaining to the FMD has been very poor. Consequently, making FMD compliance challenging and necessitating a robust training programme for current and future staff. Active Pharmaceutical Ingredients: It is challenging to determine the exact nature of an active pharmaceutical ingredient and thus subject to the EU FMD for complex therapies, including autologous cell based immunotherapies. Heterogeneity of Hospital Workflows: Hospital workflows are inherently heterogeneous; therefore, it is challenging to determine the optimal point at which to authenticate medicines in the supply chain to patients. Inevitably, this will be a trade-off between the potential disruption to pharmacy workflows and the risk of a falsified medicine reaching a patient. Undo Dispense: Due to the nature of patient flows in hospitals, it may be necessary on occasion to undo the authentication of a dispensed product. For example, where an out-patient no longer requires medication and/or clinicians change prescription content(s). 6.3 Major Hospital Authentication Opportunities Patient Adherence Anti-Microbial Resistance Synergy with E-Prescriptions Optimisation of Pharmacy Procedures New Product Introductions Clinical Trial Recruitment 15

17 6.4 Oxford Pilot Background The Oxford University Medicines Authentication pilot aims to determine optimal authentication practices for hospitals throughout Europe, and is being rolled out across all Oxford University NHS Trust Hospitals. It is important to note that the Aegate system has been used for multiple years in other EU countries; however, this is the first time the system has been used in secondary care. Due to the limited number of manufacturers choosing to serialise products to date, the study utilises externally manufactured and validated 2D data matrices meeting the requirements outlined in the EU FMD including a number of random dummies to test the system. For example, 2D data matrices that have been deliberately programmed to generate a dispensing error message. However, in all cases, an authentic product is contained within the product packaging, and as such, there is not a risk to patient safety. 16

18 To date, average system response times have been ~ 150ms. And the technical detection rate [reliability of the Aegate system] has been 100%. Data pertaining to the human detection rate, any reduction in detection rate attributable to human error will be unblended shortly, and inform current and future training strategies. 6.5 Good Authentication Practice (GAP TM ) 1. Manual authentication should be performed by an accredited pharmacy technician or pharmacist as the last step in the checking process 2. Robotic authentication should be favoured over manual where possible to reduce the risk of dispensing without authentication whilst facilitating lean workings 3. Medicines Identified as falsified or recalled should be quarantined for the inspection of suitably qualified professionals to investigate 4. Medicines should only be removed from original containers for administration of medicines directly to the patient 5. If dispensing from split packs does occurs, the original container should not leave the dispensary until its entire contents have been used 6. Medicines that are removed from split packs should be verified by scanning the 2D data matrix on the original container and decanted into a suitable container 7. Medicines returned to pharmacy, intended for re-use, outside of their original container should be reverified by entering the drug batch number onto the system to manually re-verify the product 8. Authentication should be incorporated into departmental procedures. Incidents where medicinal products leave a dispensary without authentication should be classed as a dispensing error. 9. Authentication of extemporaneously prepared medicines should occur at product assembly before final product preparation. 10. Authentication includes checking that the tamper proof seal has not been altered 17

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