Serious Shortage Protocols (SSPs): Issue of guidance.
In early 2019, following consultation, changes to the Human Medicines Regulations were made to allow the introduction of Serious Shortage Protocols (SSPs) in the event of a serious shortage of medicines. The necessary changes to the Northern Ireland Pharmaceutical Regulations came into force on 31 October 2019.
CPNI has previously notified contractors of the general principles behind SSPs: CPNI-Summary-Serious-Shortage-Protocols-SSPs (issued 27 June 2019)
Further detailed guidance has now been issued by the Department of Health: www.hscbusiness.hscni.net/services/3063.htm
This guidance includes form SSP/F/01 which can be downloaded to facilitate the notification of prescribers where necessary. (Remember that notification of the prescriber is only required where a supply is made to a patient for a therapeutic equivalent or when notification of the prescriber is required under the terms of a specific SSP). It is not a requirement to use this form and other means of notifying prescribers may be used. Contractors should consider keeping a record of all such notifications. A copy of FAQs and a patient information leaflet will also be made available on the BSO website.
The intention is that an SSP will be issued only if a medicine has been judged by Ministers to be in serious short supply. The SSP will set out a clear protocol for community pharmacists to follow if they are unable to source that medicine for patients who have been prescribed it.
Contractors will be notified of the issuing of SSPs applicable to Northern Ireland in a number of ways:
• Business Service Organisation’s website http://www.hscbusiness.hscni.net/services/3063.htm – this dedicated section on the BSO website will contain details of all SSPs. For ease, new SSPs or amended existing SSPs will be flagged; • Contractors will be advised by the HSCB when a new SSP is published, or when an amendment is made to an existing SSP, and this will include a link to the BSO website; • Information on SSPs is expected to appear within Trade journals (for example, Chemist and Druggist or the Pharmaceutical Journal) and their associated websites; and • CPNI website – issue of, and updates to, SSPs operating in Northern Ireland will be highlighted on the CPNI website.
Action Contractors and pharmacists are advised to:
• Familiarise themselves with the guidance and to take any actions which they may need to prepare their dispensing teams; and
• Check with their professional indemnity insurance providers to ensure that cover applies to supplies made in accordance with SSPs.