Serious Shortage Protocols (SSPs)
Serious Shortage Protocols (SSPs)
One of the diverse range of measures to prepare for a no-deal Brexit which will directly impact on community pharmacies is the possible introduction of Serious Shortage Protocols (SSPs).
The protocols, for use in the event of a serious shortage of a medicine, may give community pharmacies the ability to dispense less, or give a different strength, or pharmaceutical form, or provide an alternative generic product, or provide an alternative product; following appropriate discussions with the patient. It is envisaged that where a serious shortage of a medicine occurs, it would have its own SSP which will need to be developed carefully, involving senior clinicians.
How SSPs will operate
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. SSPs may be used to reduce the quantity of medicine dispensed, to save community pharmacy stock, or may be used to provide a different strength product, a product of a different formulation (e.g. a capsule instead of a tablet) or a generic instead of a branded product; or rarely an alternative product. Contractors will need to consider whether supply against the SSP is both reasonable and appropriate, subject to the SSP protocol conditions.
Contractors would be reimbursed according to the Drug Tariff for the medicine supplied, with the usual dispensing fees also paid.
For further information, please see our Interim Briefing: PSNC Briefing 012/19: An Introduction to Serious Shortage Protocols (March 2019)
Legislation on SSPs was laid before Parliament in early 2019 and is included in (but separate to) UK legislation implementing the final provisions of the EU Falsified Medicines Directive and Delegated Regulation. This followed consultation between the Department of Health and Social Care (DHSC) and stakeholders, including PSNC and other pharmacy representative bodies. This legislation provides the legal basis for the introduction of SSPs.
PSNC is now working very closely with the Department of Health and Social Care (DHSC) on relevant changes to The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
A consultation was held on urgent changes to the Human Medicines Regulations 2012 to ensure the continuity of supply of medicines (including in a ‘no deal’ Brexit).
PSNC 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.
PSNC also welcomes 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 in our response. We 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.
PSNC supports the introduction of the SSPs as a way to help community pharmacists manage medicines shortages and is working with DHSC to ensure that they are implemented safely and effectively.