What is an SSP, and where does it sit in law?
A Serious Shortage Protocol lets a community pharmacist supply a specified medicine under a protocol, rather than under the prescription presented, without seeking the prescriber's authorisation. It exists because the ordinary rule — dispense as written or refer back — becomes actively harmful during a severe shortage. It turns a supply problem into thousands of individual conversations with prescribers who cannot resolve it either.
The Human Medicines Regulations 2012 were amended in February 2019 to introduce the instrument, with further provision made in July 2019 through separate regulations addressing the NHS arrangements. An SSP may be issued where the Department of Health and Social Care determines that a serious shortage of a specific medicine or appliance exists. Each protocol is numbered, dated and limited to the substitution it specifies.
Two characteristics distinguish it from everything else a dispensary handles during a shortage. It is time-limited: it runs from a stated date to a stated date, is frequently extended by further notice, and expires rather than lapsing quietly. And it is specific: a protocol permitting one substitution confers no permission for any other, however clinically comparable a pharmacist may consider an alternative to be.
Why do most shortages never produce one?
The most common error in a dispensary is to treat every shortage communication as though it altered what may be supplied. Most do not. Understanding the distinction prevents both unlawful substitution and unnecessary prescriber contact.
| Medicine Supply Notification | Serious Shortage Protocol | |
|---|---|---|
| What it is | Notification that a supply disruption exists, with clinical advice | A legal instrument permitting specified substitution |
| Issued by | DHSC, following notification by a manufacturer or supplier | DHSC, where a shortage is determined to be serious |
| Effect on what may be supplied | None, since the prescription still governs | Permits supply in accordance with the protocol instead |
| Prescriber contact | Still required where the prescription cannot be met | Not required for the substitution the protocol permits |
| Frequency | Common, and tiered by severity | Comparatively rare, and reserved for the most severe cases |
The practical consequence: a supply notification tells a dispensary what is happening and what the clinical options are, while leaving the legal position unchanged. An SSP changes the legal position — for the specific substitution it describes and for no other. A team that conflates the two will either refer patients back unnecessarily while a protocol is in force, or substitute without authority while only a notification exists. The second error is considerably more serious than the first.
What forms does an SSP take?
Four, and the form determines what a pharmacist may actually do.
A different quantity. Supplying less than the quantity prescribed. This is used where the objective is to spread limited stock across more patients rather than exhaust it on fewer.
A different strength. Supplying an alternative strength with the dosage adjusted accordingly. This places a calculation and a counselling obligation on the pharmacist, which the protocol itself will address.
A different pharmaceutical form. Supplying capsules where tablets were prescribed, or an alternative presentation, where the two are clinically interchangeable for the purpose. Recent protocols have addressed exactly this, including modified-release presentations where the form rather than the molecule was unavailable.
A different medicine. The furthest-reaching form: supply of a specified therapeutic alternative. Recent shortages in hormone replacement therapy and pancreatic enzyme replacement have each required it.
Each protocol states its own scope, and multiple protocols may run at once for related products — as occurred where individual strengths of a transdermal preparation each required separate provision. So read the protocol that applies, rather than reasoning from one previously encountered.
Which three conditions must be satisfied?
Three conditions must each be satisfied before a supply is made under a protocol, and the second and third are the ones most often overlooked. First, the Department must have issued the protocol. It must be in force on the date of supply, and the substitution must fall within what it specifies. Second, the contractor must apply professional skill and judgement to decide whether substitution is reasonable and appropriate for the individual patient in front of them. The protocol authorises; it does not direct. A pharmacist reaching the opposite conclusion for a particular patient is exercising the judgement the regulations require, not declining to follow an instruction. Third, the patient must agree to the alternative supply for that dispensing month. That makes the conversation a condition of lawfulness, not a courtesy. A supply made under a protocol without the patient's agreement is not a supply made under the protocol at all.
The framing matters operationally as well as legally. A dispensary treating protocols as automatic will apply them to patients for whom substitution is unsuitable, and will make supplies that patients did not accept. A dispensary treating them as permissions to be exercised individually will use them frequently, decline them occasionally, and record both.
When should a pharmacist decline?
Declining is a legitimate and anticipated outcome, and several circumstances recur.
Where the patient's clinical circumstances make the alternative unsuitable — allergy, intolerance, interaction, swallowing difficulty or a condition affecting the alternative's suitability. Where the patient is stabilised on a presentation for reasons the protocol's general approach does not accommodate; this arises particularly with narrow therapeutic index medicines and with patients whose control has been difficult to establish. Where the substitution would create confusion the patient cannot manage safely, as with compliance aids, cognitive impairment and complex regimens. And where the patient does not agree, which requires no clinical justification at all.
Declining does not end the matter, because the patient still needs treatment. The alternatives are sourcing the prescribed product elsewhere, contacting the prescriber, or supplying an interim quantity where clinically appropriate and lawful. The protocol removes one obstacle; it does not remove the pharmacist's responsibility for the outcome.
How is the supply endorsed and paid?
A supply made under a protocol needs the Serious Shortage Protocol endorsement to submit a valid claim. The endorsement should record the product actually supplied, including its strength, pharmaceutical form and quantity. The detailed requirements are set out in the Drug Tariff.
Two matters deserve particular attention. Where endorsement functionality does not accommodate every element of a supply, check the position against current NHSBSA guidance rather than resolving it by assumption. An incorrectly endorsed SSP supply is a claim that may not be paid as expected. And the VAT allowance formerly paid alongside product reimbursement for protocol supplies ceased from 1 June 2023 — a change distant enough to have been forgotten and recent enough to survive in systems and spreadsheets that were never updated.
The reimbursement position interacts with the wider funding mechanism examined in our price concessions guide. A product in shortage severe enough to warrant a protocol is frequently also a product whose market price has departed from its Tariff price, so both instruments may be engaged for the same shortage.
What records, and what conversation?
The record should give a later reader everything needed to understand the supply. Which protocol was applied, identified by its number and date. What was prescribed and what was supplied. That the pharmacist's judgement was exercised and, where the circumstances were not straightforward, on what basis. And that the patient agreed.
The patient conversation deserves preparation, not improvisation. It happens at a counter, often with others waiting, about a change the patient did not request and may find alarming. Four elements make it work. Explain that the prescribed product is unavailable nationally, not just at this pharmacy — that stops the patient touring other pharmacies fruitlessly. Explain what is being supplied instead and how it differs practically, including any change to how it is taken. State that the arrangement applies to this supply, so the patient does not assume a permanent change. And confirm agreement explicitly rather than inferring it from the absence of objection.
Where a compliance aid is involved, or a carer rather than the patient collects, the conversation needs extra care. The person receiving the explanation may not be the person taking the medicine.
What about PGDs, controlled drugs and appliances?
Three boundaries warrant stating precisely.
Patient Group Directions. Protocols do not apply to supplies made under PGDs — a position the Specialist Pharmacy Service states directly. A service supplying under a PGD that hits a shortage of the specified product must address it through the PGD's own arrangements and its own governance. It may not rely on a protocol issued for the prescription route.
Controlled drugs. Nothing in a protocol displaces the Misuse of Drugs Regulations, which continue to govern prescription requirements, records and safe custody in full. Where a protocol touches a controlled drug, check the interaction between the two frameworks against current guidance rather than resolving it by analogy with an ordinary supply. The record architecture set out in our Schedule 2 guide continues to apply.
Appliances. The instrument extends to appliances as well as medicines: the Department's power arises where a serious shortage of a specific medicine or appliance is determined. Dispensaries thinking only in terms of tablets straightforwardly overlook this.
How does a dispensary know a protocol exists?
The recurring operational failure is not misuse of protocols but ignorance of them. A dispensary refers patients back for a fortnight, then discovers a protocol had been in force throughout. Four arrangements prevent it.
A named person and a daily check. Someone whose responsibility it is checks the active protocol list and the supply notifications, at a stated point in the day — not whoever happens to hit a problem.
A visible current list. Record whatever is checked somewhere the whole team sees. The person who benefits from knowing a protocol exists is the one at the counter, not the one who read the notice.
Expiry tracking. Protocols end, and a protocol relied on after expiry is an unauthorised substitution. Dates belong on the same visible list, and extensions are announced separately from the original issue.
A written procedure. The three conditions, the endorsement requirement, the record and the patient conversation belong in a standard operating procedure, in the terms our SOP guide describes. Then a locum meeting a protocol on a Saturday reaches the same position as the regular team.
A note on the devolved nations
Protocols have been issued on a UK-wide basis, while the surrounding arrangements differ across the four nations. Reimbursement, endorsement and the circulars communicating each protocol are handled separately. Scotland communicates protocols to health boards and contractors through its own circular route, and equivalent arrangements operate in Wales and Northern Ireland. An operator working across borders should rely on the guidance issued for the nation where the supply is made, not the arrangements applying elsewhere.
Key takeaways
- A Serious Shortage Protocol permits supply under a protocol rather than the prescription, without prescriber authorisation, under amendments made to the Human Medicines Regulations 2012 in 2019.
- Most shortages produce a supply notification rather than a protocol, and a notification carries clinical advice without altering what may lawfully be supplied.
- Protocols take four forms — a different quantity, strength, pharmaceutical form or medicine — and each protocol authorises only the substitution it specifies.
- Three conditions must each be satisfied: a protocol in force covering the substitution, the pharmacist's judgement that it is reasonable and appropriate for that patient, and the patient's agreement for that dispensing month.
- Declining is a legitimate outcome where the alternative is clinically unsuitable, where stability would be disturbed, where confusion would result, or where the patient does not agree.
- The SSP endorsement is required for a valid claim, recording the product actually supplied with strength, form and quantity. The VAT allowance for such supplies ceased from 1 June 2023.
- Protocols do not apply to PGD supplies, do not displace controlled drug requirements, and do extend to appliances. The recurring operational failure is not misuse but ignorance that a protocol exists.
Sources and further reading
FAQs
The protocol, found on the day.
A protocol is only useful to the person at the counter on the day it applies. Dataforge PMR records which protocol was used against which supply, with the product actually dispensed, the endorsement and the patient agreement on the same record. A claim is defensible, and an expired protocol is not relied on in error.
See Dataforge PMR