Draft legislation on Serious Shortage Protocols (SSPs) has been laid before Parliament and should come into force in early February 2019. This follows consultation between the Department of Health and Social Care (DHSC) and stakeholders, including PSNC and other pharmacy representative bodies.
SPPs are protocols for pharmacies that will be put in place in the event of a serious shortage of a medicine; they may give pharmacies the ability to dispense less medicine, a different strength or pharmaceutical form of the medicine or an alternative medicine to that prescribed; following appropriate discussions with the patient. SSPs are part of the work being carried out by Government and the NHS in case there is a no-deal exit from the EU, summarised by Dr Keith Ridge here.
It is envisaged that where serious shortages occur, each medicine would have its own SSP which will need to be developed carefully to ensure that it can be implemented in practice. PSNC will be working closely with DHSC on this. The draft legislation now laid is intended to provide the legal basis for the introduction of these SSPs.
PSNC supports this legislation as part of the measures that will help to manage any serious shortages of medicines, such as those which may occur if the UK exits the EU without a ratified deal (a no-deal Brexit).
Key aspects of SSPs are that they will be:
- proposed only if in the opinion of the Minister there is a serious shortage;
- developed with the involvement of clinicians;
- issued only in exceptional circumstances;
- more likely to be for alternative quantity, strength or pharmaceutical form;
- less likely to be for generic or therapeutic substitution; and,
- while introduced due to the possibility of a no-deal exit from the EU, their introduction is not dependent on it.
SSPs will link to a patient’s prescription although, formally, supply to the patient will be against the SSP.
The draft legislation can be found here and is included in (but separate to) UK legislation implementing the final provisions of the EU Falsified Medicines Directive and Delegated Regulation. The DHSC consultation response can be found here.
PSNC responded to the DHSC consultation on SSPs and were pleased to see that their comments and observations had been taken on board. The changes should help by giving DHSC a framework to follow to manage serious shortages of medicines, as and when they do occur.
PSNC has also welcomed the speed with which DHSC has consulted on the proposed legislation and that the legislation is likely to come into force in early February 2019, but work to address the practical issues associated with any introduction must now begin.
The practical issues are considerable and PSNC has sought to identify them here. They will continue to work closely with DHSC to ensure that the introduction of any SSP is practical for community pharmacy and that any costs incurred are recognised.
The introduction of SSPs also has implications for community pharmacy contractor’s Terms of Service, which PSNC will be discussing with the Department.