How SSP pharmacy rules work for serious shortages in the UK
SSP means Serious Shortage Protocol in pharmacy. It can allow a specified alternative only within the protocol, and only with professional judgment.
In pharmacy, SSP is the medical abbreviation for Serious Shortage Protocol. An applicable SSP can let a pharmacist supply a specified alternative without first obtaining a changed prescription, but only within that protocol's conditions and only with professional judgment. That power is regulation 226A of the Human Medicines Regulations 2012.
But a shortage alone does not permit substitution.
Before you supply, check the current protocol and its amendments: the dates, and the parts of the UK it covers. NHSBSA tells contractors to check its table, because validity can change.
How an SSP protocol works in pharmacy
An SSP defines one permitted supply during one shortage. It does not let the pharmacist choose any replacement. The supply must meet the protocol's rules on who may receive it and on what conditions. A pharmacist must make the supply or supervise it, using professional skill and judgment. For a different strength, quantity or form, that pharmacist must judge the supply reasonable and appropriate. For a different medicine, they must judge the substitution reasonable, and the replacement appropriate with the directions they specify. Those tests are in regulation 226A.
A protocol may specify a different strength, quantity or pharmaceutical form of the same medicine. It may instead allow a different medicine, and only in the categories the law lists: specified generic relationships, a similar biological medicinal product, or a medicine with a similar therapeutic effect. The categories are not a dispensing menu. The protocol names what may be supplied. Regulation 226A.
For an actual supply, read the protocol against these questions:
- Is it in effect, including any amendment to its dates?
- Does it cover the part of the UK where the supply will happen?
- Does the patient meet its requirements, and does the proposed supply match its terms?
- Do its exclusions or referral instructions apply?
These are boundary checks. They are not a full dispensing checklist. The law requires each protocol to state its period of effect and the parts of the UK it covers. A protocol can cover the whole UK. It need not. Regulation 226A.
NHSBSA says the patient must agree to the alternative supply for that dispensing month. Don't treat a valid protocol as an instruction to substitute automatically. NHSBSA SSP guidance.
English NHS requirements are a separate check
English NHS pharmaceutical services add duties that regulation 226A does not impose. Schedule 4, paragraph 5A requires the registered pharmacist to endorse the prescription or the associated batch issue. Where the Drug Tariff specifies the manner, follow it. Schedule 4.
Notification is not required on every SSP supply. Where the patient is on a patient list, paragraph 5A requires notification of that primary medical services provider if the supply is a different prescription-only medicine with a similar therapeutic effect. For any other type of supply, notification is required only where the specified recommendation to notify for clinical reasons has been issued and publicised. Schedule 4, paragraph 5A.
Those duties sit in the English terms of service. They are not a UK-wide operating procedure. For the endorsement format, use the Drug Tariff next to the protocol. The paragraph does not replace those instructions. Schedule 4.
What changed in 2019
The legal power, the English NHS terms and the first protocols do not share a start date. The Human Medicines (Amendment) Regulations 2019 came into force on 9 February 2019. Annotations on regulation 226A record that insertion, and a parallel Northern Ireland insertion that also came into force on 9 February 2019.
Paragraph 5A was inserted with effect from 1 July 2019. Schedule 4. The DHSC one-year review says the devolved administrations made similar changes to their NHS legislation with effect from 1 October 2019. Treat that date as the review's historical statement, and check the devolved instrument if you need the local commencement. The first protocols were issued on 3 October 2019. Do not use July, or that October issue date, as the start of the February legal power. Annex A.
The first fluoxetine protocols and an early HRT example
DHSC Annex A, published 27 May 2021, records the first three SSPs as issued on 3 October 2019. They were fluoxetine 10mg, 30mg and 40mg capsules, and they covered England only. A later HRT row in the same annex covers England and Wales, so do not assume every protocol stops at England.
| Historical protocol | Issue date recorded by DHSC | Coverage |
|---|---|---|
| First three: fluoxetine 10mg, 30mg and 40mg capsules | 3 October 2019 | England |
| Estradot 75 microgram patches | 29 April 2021 | England and Wales |
For that Estradot entry, the annex lists Evorel 75 microgram patches or Estraderm MX 75 microgram patches as the alternatives. These are historical examples, not a current permission to dispense. The annex records issue dates. It does not say what is valid today. Annex A.
What the one-year policy review found
DHSC published the review on 27 May 2021. Officials had not received, and had not been made aware of, concerns or negative effects on the prescription-only medicines market as a result of an SSP. The same limit is stated for patient safety. That is what was known then. It is not proof that harm was absent, and it is not a finding about safety now. DHSC review.
The review consultation ran from 3 to 24 November 2020. It went to 16 organisations and received eight responses. None of those respondents had, or had been made aware of, concerns about the market or patient safety. Eight responses do not make this a full outcomes study. DHSC review.
The review also said the pharmacist must refer the patient back to the prescriber if either the pharmacist or the patient has concerns. For a supply now, use the current protocol's exclusions and referral instructions. A 2021 summary is not those instructions. DHSC review.
RegAffairs AI explains the policy in its answer to how serious shortage protocols work in UK pharmacies. For an actual supply, use the NHSBSA register and the applicable protocol: validity can change.