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FMD event summary – 30 September 2020

Event summary of “Patient safety and the implementation of the Falsified Medicines Directive (FMD)  in the hospital environment” held as a live webinar on 30th September 2020 1400-1600 CEST

A live webinar hosted by the Socialists & Democrats MEP Manuel Pizarro introduced this important topic by stating clearly that the COVID pandemic had highlighted the issue of falsified medicines as COVID 19 web scams have been preying on the fear and anxiety of the public. He reminded us that whilst the FMD protects the legitimate supply chain, we need to be aware that patients and consumers can be duped in to buying medicines from websites selling medicines illegally. So we must all play our part to educate the public and encourage public facing campaigns. He mentioned that it was indeed very good that at this morning’s plenary conference by the European Union Intellectual Property Office’s Observatory, that the governance of the Internet, which will be addressed by the new Digital Services Act. Pizarro went on to commend the good work of all those stakeholders and hospitals who were overcoming the complexities of implementing the FMD in hospitals.

Mike Isles Executive Director of the EAASM outlined three major patient safety projects namely: a major pan European medication error and traceability safety project (ECAMET), citing a metanalysis in the UK revealing no less than 237 million medication errors in a year which underlined the importance of this patient safety project. The second project revolved around the need for regulatory clarity of the new and evolving area of nanomedicines which can be likened to the regulatory evolution of biosimilars. Thus nanosimilars also face the same challenges to provide robust regulatory approval to ensure equivalent quality, efficacy and safety. Thirdly the new EU Commissions Digital Services Act which provides a major opportunity to pass legislation to enable greater governance of the Internet actors is being closely followed by the EAASM and its sister organisation The Alliance for Safe Online Pharmacy in the EU (ASOP EU). Mike said Europe has the chance to be in the vanguard on new digital legislation and thus pass laws to oblige the Internet Intermediaries to be more accountable as this would result in curtailing the influx of falsified medicines and devices via the web.

Ms Agnes Mathieu-Mendes Deputy Head of Unit B4 Medical products: quality, safety, innovation at DG Health and Food Safety of the EU Commission commended the good work of all the parties involved saying “Of particular note is the significant drop in the alert rate and all the hard work by all those parties involved is not to be under-estimated. We are not over the finish line yet but undoubtedly the progress to date via the various FMD phases which have made the medicines safer and of a better quality and with the online logo and the safety features this has greatly enhanced the security of the supply chain and thus greatly enhanced patient safety which was the primary objective of the FMD.”

The status of the implementation of the FMD was first outlined by Fanny Trenteseaux, Project & partner manager, Legal partner Engagement of the European Medications Verification Organisation (EMVO) who gave a pan European overview. The key take home messages can be summarised as follows: the number of “Alerts” (this is where on de-commissioning of a pack the system does not authenticate the unique serialised data matrix on the prescription pack) still varied greatly between countries with 4 countries having alert rates of greater than 1%. The positive news being that the overall trend was downwards as more and more technical issues were resolved. Of concern, was the number of pharmacies not connected to the NMVO hubs with 68% in Lithuania, 63% in Spain, 42% in the UK, and 35% in France to name four countries. Those manufacturers who had signed Participant Agreements and who were connected to the hubs were steadily rising. The estimated number of product codes to cover all prescription packs across Europe was believed to have been achieved notwithstanding the fact that this number will be in constant flux. Of further concern were 22 countries that were now beyond their “Stabilisation” periods and so theoretically open to national fines.

The Finland situation was described by Maija Gohlke-Kokkonen of the Finnish National Medication Verification Organisation (NMVO). Looking first at the percentage of alerts starting from February 2019 this was very was a low at 0.08%. These alerts are not due to falsified medicines but because of scanning, data management and non-EU serialised packs’ issues. Transactions though had stabilised at just below 15,000 per month. A final room-for-improvement slide focused on the area of aggregation, quality issues (e.g. packs with poor 2D quality, backgrounds) combined with a precautionary warning around the need for forward planning pending the arrival of a COVID-19 vaccine.

To conclude this section the status of the implementation of the FMD, Andras Sule of the European Association of Hospital Pharmacies (EAHP) stated that the role of the hospital pharmacists was key to patient safety and the aspect of safe product was highlighted in the context of the conference subject. Reflecting on one and a half years since the introduction of the FMD safety features, Sule highlighted that additional improvements were anticipated in stock management and the possibility to better trace medicines. However, there were ongong current practical issues and barriers. These ranged from infrastructure not compatible, software providers were not at times capable of providing all of the needs. Challenges included the difficulties of intergrating the FMD in to existing hospital procedures and limited support being provided from authorities. These issues combined with ongoing day to day challenges such as medicine shortages, IT problems, readability of data, storage of packs, alert rates added to the problem. However, the EAHP was supporting its members by having regular discussions with EMVO combined with regular exchanges of intelligence and data collection via surveys of its members.

Practical solutions to the implementation in hospitals commenced with Grant Courtney of the Be4ward expert supply transformers consultancy. Here he gave an overview of a comprehensive report commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The report looked beyond the prevention of falsified medicines to help understand what other benefits can be gained in the hospital setting.

The report clearly illustrates how benefits can be drawn out at all points across the hospital supply chain. This is because the EU FMD pack acts as data anchor within the hospital and so enables greater visibility both from a logistics perspective but more importantly allows for greater traceability and thus enhancing patient safety. In one hospital significant cost savings to the value of 4.4 million euros per annum had been achieved due to better management of inventory and ordering patterns. Most importantly the report stated that an FMD implementation exercise provides a platform for better inventory and procurement, ability to recall accurately and efficiently, dealing with local shortages and repacking identification.

Courtney concluded that “the application of a standardised 2D barcode goes beyond improving supply chain efficiencies and increasing patient safety, having also an impact on clinical effectiveness and new payment models.  These barcodes are also opening up the opportunity to digitally web-enable products, allowing the provision of live data and services directly to the healthcare provider”.

Presentation by two hospital pharmacies, who had seen change and implementation at the front line, clearly described the challenges and ultimate benefits of implementing the FMD in the hospital environment. Julia Asplin, Pharmacy Logistics Lead and Purchasing Team Manager, the Lister hospital Stevenage UK. Julia described the challenges starting with the need to present a business case and a clear project plan to obtain funds and resources. A proven robotics system was chosen to spearhead the implementation. Julia described how the implementation gave the opportunity to reconfigure and thus optimise workflows. There were 10 phases which took one year to complete (despite the difficulties presented by COVID-19). The benefits and remaining challenges can be summarised:

  • Using an automated solution, this reduced the manual scanning burden by up to 63%
  • The opportunity to review and Improve the workflow footprint as part of project resulted in greater teamwork and cohesion and efficiency gains in many areas
  • The new technology can be developed as traceability systems are improved
  • The relationship and support given by the commercial provider was seen as crucial in the development of the new system.
  • Recycled/returned products process could be better reviewed and improved
  • Improved ordering schedules for bulk lines with overall reduction is inventory
  • Learning every day how to investigate and manage ‘Red Alerts’ – time consuming task with no dedicated/funded resource to complete
  • Continue to adapt existing processes to meet both FMD requirement and local operational challenges
  • Practical aspect of managing continuity of supply where stock is in ‘FMD quarantine’
  • Working in partnership with FMD software provider to develop system in line with NHS process and practices

The concluding presentation was given by Valerie Pelletier, hospital pharmacist, Supply Chain Manager, Rouen University Hospital, France which is a 2,429 bed hospital. Here there are on average 100,000 boxes stored with a shelving system and automated dispensing system which manages 63% of the medicines covered by the Directive. The use of an automated dispensing system means that decommissioning is done automatically, and no extra staff were needed. Whilst this has greatly enhanced the efficiency within dispensing, issues such as lack of a data matrix on packs, medicines wrapped in plastic film has been encountered. There is also still the need to unpack each carton, one pallet alone can have 675 packs. Other problems were sited such as computer network and bar code reading issues. In conclusion Valerie indicated that few university hospitals have commenced an implementation programme citing funding as the main issue. She also recommended that more attention and support is needed on decommissioning errors and a European national guide to explain the issues and provide solutions would be of great value.

All presentations can be found at the EAASM website here.