Serious Shortage Protocols (SSPs)

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, see correspondence below. 


The following three links may also be useful:

Serious Shortage Protocols: Outline of Operational Guidance for Dispensers

Serious Shortage Protocols: FAQs

Serious Shortage Protocols: Patient information


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.
  • Pharmacists will need to consider whether supply against the SSP is both reasonable and appropriate, subject to the SSP protocol conditions.

Regulatory provisions

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


CPNI Training Webinar : SSPs

Prof Mike Mawhinney gives an update on SSPs

Correspondence

Letter from Cathy Harrison (CPO) – Ending of SSP – Fluoxetine 40mg capsules 19 May 2021

CPNI CU 210202A RE: Serious Shortage Protocol Fluoxetine 40mg Capsules 2 Feb 2021

CPNI CU 201013C RE: Cessation of Serious Shortage Protocol (SSP) – Fluoxetine 40mg capsules 13th Oct 2020

CPNI CU 201002C RE: SSP Extension – Fluoxetine 40mg Capsules 2nd Oct 2020

CPNI CU 200925B RE: SSP Extension – Fluoxetine 40mg Capsules 25th Sep 2020

CPNI CU 200904A RE: SSP EXTENSION – Fluoxetine 40mg Capsules 4th Sep 2020

CPNI COVID19 CU#118 RE: Further Update to Serious Shortage Protocols – Fluoxetine 40mg Capsules 11th Aug 2020

CPNI COVID19 CU#116 RE: SSP Update – Fluoxetine 40mg Capsules 21st Jul 2020

CPNI COVID19 CU#100 RE: SSPs – Submission Information for Contractors 27th May 2020

CPNI COVID19 CU#96 RE: Serious Shortage Protocols 20th May 2020

CPNI COVID19 CU#81 RE: Amendments to the Misuse of Drugs Regulations (Northern Ireland) 2012 1st May 2020

CPNI COVID19 CU#44 RE: Serious Shortage Protocols 7th April 2020

CPNI CU 200313A RE: Serious Shortage Protocol (Fluoxetine 10mg Tablets) Important information 13th Mar 2020