Serious Shortage Protocols in UK Pharmacies

A Serious Shortage Protocol (SSP) is a written protocol issued by UK Ministers when they think the UK, or part of it, is or may be facing a serious shortage of a prescription-only medicine. While it is in force, a pharmacist may supply what the SSP specifies in place of what was prescribed, without going back to the prescriber ^[1]. The NHSBSA register lists eight SSPs as active, the most recent being lansoprazole orodispersible tablets (SSP088/SSP089) ^[2][3].

Approach: I read the Human Medicines Regulations 2012, the NHSBSA SSP register (including the signed SSP forms) and the DHSC one-year policy review, plus the official NHSBSA and GOV.UK pages. I couldn't open the NHSBSA operational guidance, the NHSBSA Q&A or the text of the 2019 and 2023 NHS amending regulations, so I don't cover fees or endorsement detail.

Legal basis: regulation 226A, Human Medicines Regulations 2012

Regulation 226A was inserted on 9.2.2019 by S.I. 2019/62, with a parallel insertion for Northern Ireland by S.R. 2019/10. It lifts the normal prescription-only medicine sale and supply rule (regulation 214(1)) for a retail pharmacy business when three conditions are all met ^[1]:

• Condition A: the medicine is supplied for administration in accordance with an SSP.
• Condition B: the SSP's requirements on who may receive it, and on what conditions, are satisfied.
• Condition C: the supply is made by or under the supervision of a pharmacist who, using professional skill and judgement, considers:
  • a different strength, quantity or form "reasonable and appropriate"; or
  • for a different medicine, that the substitution is reasonable and the medicine is appropriate, with the directions for use the pharmacist specifies.

An SSP must also meet these requirements:

• It must be issued by "the Ministers" (either acting alone or both jointly).
• It can allow one of two kinds of change:
  • a different strength, quantity or form of the same medicine; or
  • a different medicine, which must be one of:
    • a generic version (or both products are generics of the same medicine);
    • for a biological, a similar biological medicinal product; or
    • a medicine with a similar therapeutic effect.
• It must specify how long it runs and which parts of the UK it covers.
• The Ministers "must" review how the rule works after its first year, then publish a report.

In this set of Regulations, regulation 226A is the only provision I found that refers to SSPs.

Wider NHS framework

• Who issues them: NHSBSA says DHSC issues SSPs for a serious shortage of a specific medicine or appliance.

• 2019 NHS changes: NHSBSA notes further changes in July 2019 through the NHS (amendments relating to serious shortage protocols) Regulations 2019 (NHSBSA; made text at legislation.gov.uk, S.I. 2019/990, which I couldn't open).

• VAT: NHSBSA says the VAT allowance paid with product reimbursement for SSP supplies stopped from 1 June 2023.

• Devolved nations: the DHSC review says the devolved administrations made equivalent changes to their NHS legislation from 1 October 2019 (DHSC review).

• Territorial scope varies by SSP. In the first year:

  • SSP001-SSP003: England only.
  • SSP004: England and Wales.
  • SSP005: England, Wales and Northern Ireland.
  • SSP010: England, Wales and Scotland.

  ^[4][5][6][7]

How a pharmacy uses one (signed SSP form, SSP014 example)

Each SSP is a fixed template signed off by a minister. SSP014 was ratified on 26/11/2021 ^[8]. The form sets out:

• What is supplied: the alternative and the quantity, plus whether the substitution changes licensed use. Under SSP014, each prescribed Salazopyrin EN-Tab 500mg is replaced by 1 x sulfasalazine 500mg gastro-resistant tablet, for the same number of days as the prescription.
• Scope: for SSP014, "All NHS and private prescriptions" in England and Wales.
• Inclusion criteria: a valid prescription for the named medicine, and the patient or carer consents.
• Exclusion criteria: for example previous adverse reaction or hypersensitivity, age or dose limits, or the pharmacist judging the patient unsuitable.
• Referral: excluded patients, and patients who decline, "should be referred back to their prescriber promptly".
• Operating conditions:
  • The decision to supply "rests with the individual registered pharmacist who must abide by the protocol".
  • Staff may help, but under the pharmacist's supervision.
  • Pharmacists "must" use the SSP only within its dates and criteria, and must check they have the current version.
  • Users "must not alter, amend or add to" the SSP; doing so invalidates it.
• Telling the GP (addendum):
  • NHS supplies "also needs" to comply with the NHS Pharmaceutical and Local Pharmaceutical Services Regulations.
  • Where a therapeutic equivalent is supplied, the pharmacist "will need to inform" the patient's GP practice, generally by the next working day.
  • For a different quantity, form, strength or a generic, telling the prescriber "may not always be necessary".
  • Feedback goes by NHSmail unless there is a preferred local channel.

NHSBSA adds that the patient must agree to the alternative "for that dispensing month".

How SSPs are made, and the first-year review

The DHSC review (published 27 May 2021) found:

• Clinical sign-off: every draft SSP is reviewed by NHS England's National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and exclusions and raise safety concerns.
• Consultation: 47 responses were received in December 2018. Patient groups and doctors' representatives raised concerns about substitution for high-risk groups such as people with epilepsy.
• Outcome: DHSC had not been made aware of any negative effect on patient safety or on the market across the first 12 SSPs (DHSC review).

In the first year, recorded use was 2,844 for SSP001-SSP003 together and 2,065 for SSP004 ^[9][5].

Lifecycle in practice

SSPs are often extended, varied, amended, withdrawn early or reactivated:

• SSP002 was extended twice and its permitted alternative was changed ^[10].
• SSP014 was reactivated for a second period ^[11].
• SSP084-SSP086 were withdrawn early on 23 January 2026 ^[12].

Some products have three separate SSPs for "substitution", "restriction" and "substitution and restriction", for example quetiapine 150mg (SSP062-SSP064) ^[13].

The register runs from SSP001 to SSP089. The eight it marks active:

SSP	Medicine	Valid
SSP061	Creon 25000 capsules	24 May 2024 to 8 Jan 2027 (amended 2 Oct 2026) [14]
SSP079	Estradot 50 microgram patches	19 Dec 2024 to 8 Jan 2027 (amended 2 Oct 2026) [15]
SSP080	Estradot 75 microgram patches	19 Dec 2024 to 8 Jan 2027 (amended 2 Oct 2026) [16]
SSP081	Estradot 100 microgram patches	19 Dec 2024 to 8 Jan 2027 (amended 2 Oct 2026) [17]
SSP082	Estradot 25 microgram patches	3 Apr 2025 to 8 Jan 2027 (amended 2 Oct 2026) [18]
SSP087	Ramipril 1.25mg capsules	22 Apr 2026 to 30 Oct 2026 (amended 23 Jul 2026) [19]
SSP088	Lansoprazole 15mg orodispersible tablets	9 Sep 2026 to 15 Jan 2027 [2]
SSP089	Lansoprazole 30mg orodispersible tablets	9 Sep 2026 to 15 Jan 2027 [3]

The NHSBSA page lists the same eight as active. SSP087's listed end date (30 October 2026) was yesterday, so it should no longer be used unless NHSBSA posts an extension.