News

EU Falsified Medicines Directive

As one of the founding members of the European Stakeholder Model (ESM), the BAPW has been engaged for several years with the other UK ESM stakeholders, who are now working to set up the UK governance and decision-making body that will run the UK’s national database and verification system for the vast majority of all prescription medicines in the UK. This is because we expect the European Commission to endorse the European Stakeholder Model by the end of 2015. The resulting EU Delegated Act will then mandate ‘end-to-end’ verification procedures to implement the requirements of the already-adopted Falsified Medicines Directive. This will endorse manufacturer and pharmacy verification of all prescription products that carry the ‘safety features’ (2D matrix barcode), with wholesalers being required to carry out ‘risk-based’ verification.

The UK ESM stakeholders are now meeting monthly to agree representation and funding of the UK governing body. Both the Department of Health and the MHRA have been fully briefed at all stages, as have other healthcare parties, such as dispensing doctors. With the generic manufacturers now on board, we expect the priorities for 2015 will be ensuring that this governing body is truly representative and inclusive. For example, there is more work to be undertaken with the smaller manufacturers, wholesalers, pharmacies and the secondary care sector.  BAPW will be aiming in 2015, to organise an event that will be open to all types of distributors, both BAPW members and non-members, to explain all the detailed implications of the implementation of the Delegated Act in 2018, including the verification of products not obtained directly from the manufacturer and batch recording.

Joint work with Pharmacy Voice

In 2014, BAPW and Pharmacy Voice held two workshops as part of the agreement to work closer together on issues of joint concern. The first of these workshops examined the types of support that BAPW wholesalers could offer the pharmacy sector; the conclusion was that support for pharmacy when seeking Clinical Commissioning Group contracts was a priority, but other ideas included wholesaler management of pharmacy medical waste and support for pharmacy distribution affected by the abolition of the Section 10.7 exemption. BAPW is currently working with the Pharmacy Voice secretariat to road-test these proposals.

The second workshop was a joint seminar held in the Autumn of 2014 that examined the expected implications of the EU Falsified Medicines Directive on pharmacy. Around 70 delegates attended a presentation and discussion led by BAPW and NPA, as representatives of the European Stakeholder Model.

BAPW Secondary Care Forum

Aside from distributing to all 14,000 community pharmacies across the United Kingdom, BAPW member wholesalers also manage and distribute to all 400 plus NHS hospitals. We are pleased to report that this area of our members’ business is a growing segment. Indeed, the messages from on high within the NHS are very encouraging for wholesalers if they can be implemented on the ground.

Accordingly, in 2014, BAPW was running two joint working parties with the NHS examining how to make NHS secondary care procurement of medicines more efficient and useful to overall NHS performance. Hopefully, in 2015, if we can get this right in the context of the Carter Review of procurement, then the days of contract tendering based on price alone, will become a thing of the past.

Medicines in short supply

As readers will know, the issue of ‘shortages’ has been fraught over the years with megaphone diplomacy and misinterpretation of root causes, depending on where your own market incentives place you at any one particular time!  Having said this, I do not believe that the patient has had a fair chance to understand or explain his or her experiences and concerns/fears.  None of us engaged in getting much-needed medicines to patients would want any delay to be incurred, for that I am sure.

It seems to me though that the Department of Health Supply Chain Forum has not been able so far to exert enough ‘pressure’ on to the supply chain partners to improve business practices. That is why the BAPW has been taking the initiative in areas where it feels it can make a difference:

• Getting medicines to pharmacies and dispensing doctors within 24 hours was a BAPW proposal incorporated into the Department of Health Best Practice Guidance
• In 2014, BAPW set up a members’ working group to design national consistent PMR Codes for all wholesalers in the UK to use when communicating with pharmacies and dispensing doctors when products are unavailable at first order. In 2015, this wholesaler working group is now partnering with the Pharmacy Voice software providers group to take this work to implementation
• BAPW is working with the manufacturers’ representative body, the ABPI, on a ‘best practice’ document for stock