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Serious Shortage Protocols: Draft legislation laid

Monday, January 21, 2019

Draft legislation on Serious Shortage Protocols (SSPs) has been laid before UK Parliament and should come into force in early February 2019. This is reserved legislation that will apply to all the Home nations. This follows consultation between the Department of Health and Social Care (DHSC) and stakeholders across the UK, including CPS 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.

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. The draft legislation now laid is intended to provide the legal basis for the introduction of these SSPs.

CPS 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
  • 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 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 is available to download.

CPS responded to the DHSC consultation on SSPs and we are pleased to see that our comments and observations have 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.

We will continue to work closely with other stakeholders and are taking part in UK level discussions including DHSC to ensure that the introduction of any SSP is practical for community pharmacy.

The introduction of SSPs also has implications for community pharmacy contractor’s Terms of Service, which CPS will liaise with Scottish Government (SG) on. We will continue to work with SG to acknowledge what needs to be considered north of the border when appropriate.