Brexit Contingency Planning: Update for Community Pharmacies

Brexit Contingency Planning: Update for Community Pharmacies

December 7, 2018

“I want pharmacists to be able to do more in our health system”

Matt Hancock, Secretary of State for Health and Social Care

BBC Radio 4, The Today Programme, 7th December 2018

Community pharmacy teams may have seen national media coverage today (December 7th) about the ongoing contingency planning that is taking place in preparation for the UK’s exit from the European Union.

PSNC is continuing to work closely with officials at the Department of Health and Social Care (DHSC), as well as with the other pharmacy organisations via the Brexit Forum, to try to minimise the impact of Brexit on the medicines supply chain.

In particular, PSNC and others have been considering what measures might need to be in place in addition to the six-week stockpile that the Government has asked the manufacturers of prescription medicines to hold in the UK.

We believe that in addition to this stockpile, there will need to be processes in place to help community pharmacies and other healthcare providers to work together to manage any shortages that do occur. Community pharmacists and GPs in particular will need to work together with clear guidance on the steps to follow in the event of a drug shortage. There will also need to be flexibility in the regulatory, contractual and reimbursement structures.

DHSC Priorities

DHSC has undertaken an exercise to identify any further actions that could support the continuity of medicines supply in a no-deal scenario. The actions range from trying to increase the manufacture or packaging of products in the UK to attempting to control distribution (wholesaling) and introducing dispensing flexibilities; and most of them do not need any change to legislation.

However, two steps that would require legislation change are:

  • The introduction of a national ‘serious shortage protocol’ to provide dispensers with more flexibility in case of serious shortages of POMs, to be introduced whether there is a Brexit deal or not; and
  • An amendment to the Human Medicines Regulation 2012 to allow regulation making powers, to safeguard the continuity of supply in case of a no-deal (this change is required as the current regulation making powers come from EU legislation).

DHSC is consulting with members of the Brexit Forum on these two matters, as well as on the wider proposed secondary measures, including the proposed ability for community pharmacists to make substitutions in certain situations, both generic and therapeutic substitutions. [UPDATE: You can now view the PSNC response to the Informal consultation on urgent changes to the Human Medicines Regulations 2012 to ensure the continuity of supply of medicines (including in a ‘no deal’ Brexit)]

PSNC Position on Secondary Measures

PSNC broadly supports the DHSC proposals, to be used if necessary to help ensure the continuity of supplies of essential medicines to patients when there are shortages.

Where actual shortages of branded medicines occur, our preferred option would be to allow pharmacies to generically substitute certain medicines. Generic substitution would see pharmacies dispensing cheaper generic equivalents in place of certain prescribed branded products that have been agreed at a national level. This would mitigate issues caused by shortages for selected products which can be easily substituted with an equivalent generic product. However, the feasibility of enabling generic substitution within a short space of time may make this option difficult to implement.

In the short term, as well as working towards giving pharmacists appropriate professional discretion to dispense an alternative equivalent medicine to patients, it makes sense to relax the NHS Terms of Service obligation on pharmacists to allow pharmacists to refuse supply if necessary.

This would allow pharmacies to avoid dispensing drugs at a significant loss and incurring costs that their business could not survive, but it would also allow pharmacies to refuse to dispense complete prescriptions where, for example, patients were seeking several months’ worth of a medicine at once, or where they already had sufficient stock from a previous prescription. Again, this would allow pharmacists to use their professional discretion to manage the demand for medicines better and to prioritise stock for patients who need it most in a shortage situation.

Speculative Shortages and Medicines Pricing

PSNC is also concerned about the potential impact of Brexit on medicines pricing and the ability of pharmacies to source medicines at Drug Tariff or concession prices.

As well as potentially impacting on patient safety and care, further medicines shortages could destabilise the already fragile medicines pricing and reimbursement systems operated by DHSC. If a large number of drugs remain unavailable at Drug Tariff prices, the current system for setting price concessions could be at risk in the immediate post-Brexit era.

If medicine prices increase significantly post Brexit, there could be a huge impact on individual pharmacies which dispense large volumes of any affected lines, particularly where the difference between purchase price and concessionary price is significant. PSNC is concerned about the impact that shortages on a significant scale could have on pharmacies’ cashflow and workload at a time when many pharmacies are already under significant pressure following funding cuts to the sector.

To help to mitigate against some of these risks, we would like to continue to work with DHSC to put in place:

  • measures to ensure that community pharmacies have quicker and clearer reimbursement and stock availability information;
  • greater responsiveness of the concession pricing system so that pharmacies can ensure the supply of prescription drugs to patients; and
  • reimbursement for pharmacies of any additional costs incurred to help them to cover their costs and continue to offer the full range of patient services.

To help manage speculative shortages, we would like DHSC to use the new Information Disclosure Regulations to monitor and communicate stock availability issues to pharmacies so that timely interventions can be made to minimise delays in procurement.

Drug Tariff pricing also needs to be more responsive to market prices to avoid a lag in price setting so that pharmacies’ reimbursement is reflective of actual purchase prices. We also suggest that the Department could relax the restrictions on pharmacy-to-pharmacy wholesale dealing without wholesaler dealers licenses. This would allow pharmacies to trade stock between them at a local level, helping to allow medicines to reach those patients who most need them without regulatory barriers.

We would also like to explore with DHSC how pharmacies could be reimbursed for what they have dispensed to avoid dispensing at a significant loss.

PSNC is in regular dialogue with DHSC officials on these matters and is also briefing MPs about Brexit and the potential impact on community pharmacies and the supply of medicines to UK patients.

We are pleased that DHSC is now consulting on legislative changes which, in the event of a no-deal Brexit, would assist with implementing many of the measures that we have suggested. We will continue to work closely with them on the detail of that and we have committed to assisting their work in the event of there being a significant impact on the medicines supply chain after Brexit.

Brexit Forum Meeting

Last week (November 30th) the PSNC-led Brexit Forum met to consider the latest developments and discuss them with the Department of Health and Social Care (DHSC).

Organisations at the meeting included AIM, the CCA, NPA, PDA and RPS from the pharmacy sector, as well as the Dispensing Doctors Association, Healthcare Distribution Association and Proprietary Association of Great Britain.

A significant portion of the meeting was allocated to discussing the possible secondary measures as outlined above. The Forum also discussed the fact that the DHSC may need to engage additional pharmacists to support its work in the event of a no-deal Brexit – in principle Forum members agreed to support this by encouraging community pharmacy to make pharmacists available to DHSC if required.

The Community Pharmacy Brexit Forum encourages community pharmacy contractors to follow DHSC guidance, especially in relation to the letter sent by the DHSC to frontline healthcare professionals in August, where community pharmacies were told they ‘do not need to take any steps to stockpile additional medicines, beyond their business as usual stock levels’.

PSNC set up the Community Pharmacy Brexit Forum to provide a platform for stakeholders to share thoughts and compile advice for community pharmacy teams. The Forum will continue to liaise with DHSC to ensure that the supply of medicines to community pharmacy patients is maintained. The Forum is pleased that dialogue with Government is already happening and that contingency planning to safeguard access to medicines after Brexit has begun.

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