Serious Shortage Protocols (SSPs) have been introduced by government to help pharmacists manage any serious shortages of medicines, should they occur.
Further information is available via the link to BSO above and through the CPNI contractor update emails, highlighted in the General Regulatory Matters section on our website .
Serious Shortage Protocols Briefing
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 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.
Amendments to the Human Medicines Regulations 2012 came into effect in February 2019 following consultation between the Department of Health and stakeholders, including CPNI and other pharmacy representative bodies. This legislation provides the legal basis for the introduction of SSPs.
CPNI is now working very closely with the Department of Health NI on relevant changes to the Pharmaceutical Services Regulations (Northern Ireland)1997