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
Correspondence
27 Mar 24 CPNI CU#240327C RE: Serious Shortage Protocol (SSP059) – Monomil® XL 60mg Tablets
13 Dec 23 CPNI CU#231213A RE: Update: SSP053 clarithromycin 125mg/5ml oral suspension expiry date extension
04 Dec 23 CPNI CU#231204A RE: SSP057 Estradiol 100mcg/24 hour patch expiry date extension
03 Nov 23 CPNI CU#231103A RE: SSP057 Estradiol 100mcg/24 hour patch expiry date extension
25 Oct 23 CPNI CU#231025B RE: SSP058 Jext 300mcg/0.3ml soln for injection expiry date extension
16 Oct 23 CPNI CU#231016A RE: SSP057 Estradiol 100mcg/24 hour patch expiry date extension
02 Oct 23 CPNI CU#231002A RE: Update: SSP053 and SSP054 Clarithromycin Products Expiry Date Extension
11 Sep 23 CPNI CU#230911A RE: Serious Shortage Protocol SSP058: Extension of expiry date
05 Sep 23 CPNI CU#230905A RE: SSP update: SSP056 Utrogestan 100mg capsules; extension of expiry date
25 Aug 23 CPNI CU#230825A RE: Early withdrawal of SSP052
17 Aug 23 CPNI CU#230817A RE: Serious Shortage Protocol – Utrogestan® 100mg Capsules – Expiry Date Extension
21 Jul 23 CPNI CU#230721B RE: SSP Expiry Date Extensions – Clarithromycin Preparations
26 Jun 23 CPNI CU#230626A RE: SSP Expiry Date Extensions – Clarithromycin preparations
12 Jun 23 CPNI CU#230612C RE: SSP Expiry Date Extension – Progynova TS 100mcg/24hours Transdermal Patches
26 May 23 CPNI CU#230526B RE: Weekly Summary
23 May 23 CPNI CU#230523A RE: Serious Shortage Protocol – Utrogestan® 100mg Capsules
02 May 23 CPNI CU#230502A RE: Serious Shortage Protocols – Extension to Expiry Dates
17 Apr 23 CPNI CU#230417A RE: Serious Shortage Protocols – Clarithromycin Oral Suspensions
14 Apr 23 CPNI CU#230414A RE: Weekly Summary
03 Apr 23 CPNI CU#230403A RE: Further Updates to Serious Shortage Protocols – Penicillin V Preparations
31 Mar 23 CPNI CU#230331C RE: Weekly Summary
28 Feb 23 CPNI CU#230228A RE: Penicillin V Preparations – Extension of Expiry Dates
22 Feb 23 CPNI CU#230222B RE: Hormone Replacement Therapy (HRT) Medication – Extension of Expiry Dates
06 Feb 23 CPNI CU#230206A RE: Weekly Summary Amendments
02 Feb 23 CPNI CU#230202B RE: Further Updates to Serious Shortage Protocols – Penicillin V Preparations
27 Jan 23 CPNI CU#230127A RE: Correspondence on Two New Serious Shortage Protocols for HRT
06 Jan 23 CPNI CU#230106B RE: Weekly Summary
06 Jan 23 CPNI CU#230106A RE: RPS Illustration of SSP Supply Options for Antibiotics
24 Dec 22 CPNI CU#221224A RE: Important Update (23 December 2022) to Serious Shortage Protocols – Penicillin V
23 Dec 22 CPNI CU#221223C RE: Weekly Summary
20 Dec 22 CPNI CU#221220A RE: Further Serious Shortage Protocols (SSPs) – Penicillin V Preparations
19 Dec 22 SSP043 Phenoxymethylpenicillin 125mg/5ml Oral Solution
19 Dec 22 SSP044 Phenoxymethylpenicillin 125mg/5ml Oral Solution Sugar Free
19 Dec 22 SSP045 Phenoxymethylpenicillin 250mg/5ml Oral Solution
19 Dec 22 SSP046 Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free
19 Dec 22 SSP047 Phenoxymethylpenicillin 250mg Tablets
19 Dec 22 Letter from Cathy Harrison CPO RE: Penicillin V Preparations
16 Dec 22 CPNI CU#221216A RE: Serious Shortage Protocols (SSPs) – Penicillin V Preparations
15 Dec 22 SSP042 Phenoxymethylpenicillin 250mg/5ml Oral Solution
15 Dec 22 SSP041 Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free
15 Dec 22 SSP040 Phenoxymethylpenicillin 125mg/5ml Oral Solution Sugar Free
15 Dec 22 Letter from Cathy Harrison CPO RE: Penicillin V Preparations
16 Sep 22 CPNI CU#220916D RE: Serious Shortage Protocols (SSPs) – Hormone Replacement Therapy (HRT) Medication
19 Aug 22 Serious Shortage Protocols: Submission Information for Contractors
05 Aug 22 CPNI CU#220805B RE: Weekly Summary
15 Jun 22 CPNI CU#220615B RE: Medicine Shortages Information
08 Jun 22 HRT SSPs Flowchart
08 Jun 22 Letter from Cathy Harrison RE: SSP HRT Medicines
24 May 22 Letter from Cathy Harrison RE: SSP HRT Medicines May 2022
24 May 22 CPNI CU#220524B RE: Serious Shortage Protocols (SSPs) – Hormone Replacement Therapy (HRT) Medication
05 May 22 CPNI CU#220505B RE: Serious Shortage Protocols (SSPs) – HRT Medication
19 May 21 Letter from Cathy Harrison (CPO) – Ending of SSP – Fluoxetine 40mg Capsules
02 Feb 21 CPNI CU#210202A RE: Serious Shortage Protocol Fluoxetine 40mg Capsules
13 Oct 20 CPNI CU#201013C RE: Cessation of Serious Shortage Protocol (SSP) – Fluoxetine 40mg Capsules
02 Oct 20 CPNI CU#201002C RE: SSP Extension – Fluoxetine 40mg Capsules
25 Sep 20 CPNI CU#200925B RE: SSP Extension – Fluoxetine 40mg Capsules
04 Sep 20 CPNI CU#200904A RE: SSP Extension – Fluoxetine 40mg Capsules
11 Aug 20 CPNI COVID19 CU#118 RE: Further Update to Serious Shortage Protocols – Fluoxetine 40mg Capsules
21 Jul 20 CPNI COVID19 CU#116 RE: SSP Update – Fluoxetine 40mg Capsules
27 May 20 CPNI COVID19 CU#100 RE: SSPs – Submission Information for Contractors
20 May 20 CPNI COVID19 CU#096 RE: Serious Shortage Protocols
01 May 20 CPNI COVID19 CU#081 RE: Amendments to the Misuse of Drugs Regulations (Northern Ireland) 2012
07 Apr 20 CPNI COVID19 CU#044 RE: Serious Shortage Protocols
13 Mar 20 CPNI CU#200313A RE: Serious Shortage Protocol (Fluoxetine 10mg Tablets) Important Information