What is an SSP, and where does it sit in law?
A Serious Shortage Protocol permits a community pharmacist to supply a specified medicine in accordance with a protocol rather than in accordance with the prescription presented, without seeking authorisation from the prescriber. It exists because the ordinary rule, under which a prescription must be dispensed as written or referred back, becomes actively harmful during a severe shortage, since it converts 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, and 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, running from a stated date to a stated date, frequently extended by further notice, and expiring rather than lapsing quietly. And it is specific, in that 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 within a dispensary is to treat every shortage communication as though it altered what may be supplied. Most do not, and 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 is that a supply notification tells a dispensary what is happening and what the clinical options are, whilst leaving the legal position unchanged, whereas an SSP changes the legal position for the specific substitution it describes and for no other. A team which conflates the two will either refer patients back unnecessarily whilst a protocol is in force, or substitute without authority whilst only a notification exists, and 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, which is used where the objective is to distribute limited stock across more patients rather than to exhaust it upon fewer.
A different strength. Supplying an alternative strength with the dosage adjusted accordingly, which places a calculation and a counselling obligation upon 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, permitting supply of a specified therapeutic alternative, which recent shortages within hormone replacement therapy and pancreatic enzyme replacement have each required.
Each protocol states its own scope, and multiple protocols may operate simultaneously for related products, as occurred where individual strengths of a transdermal preparation each required separate provision. A pharmacist should therefore read the protocol which applies rather than reasoning from a protocol 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 those most frequently overlooked. First, the Department must have issued the protocol, it must be in force on the date of supply, and the substitution contemplated must fall within what it specifies. Second, the contractor must apply professional skill and judgement to determine whether substitution is reasonable and appropriate for the individual patient in front of them, which means the protocol authorises rather than directs, and a pharmacist reaching the opposite conclusion for a particular patient is exercising the judgement the regulations require rather than declining to follow an instruction. Third, the patient must agree to the alternative supply for that dispensing month, which makes the conversation a condition of lawfulness rather than 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 which 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, whether through allergy, intolerance, interaction, swallowing difficulty or a condition affecting the alternative's suitability. Where the patient is stabilised upon a presentation for reasons which the protocol's general approach does not accommodate, which arises particularly with narrow therapeutic index medicines and with patients whose control has been difficult to establish. Where the substitution would create confusion which the patient cannot manage safely, which arises with compliance aids, with cognitive impairment and with complex regimens. And where the patient does not agree, which requires no clinical justification at all.
Declining does not conclude the matter, since the patient still requires treatment. The alternatives comprise sourcing the prescribed product elsewhere, contacting the prescriber, or supplying an interim quantity where clinically appropriate and lawful. The point is that the protocol removes one obstacle rather than removing the pharmacist's responsibility for the outcome.
How is the supply endorsed and paid?
A supply made under a protocol requires the Serious Shortage Protocol endorsement in order to submit a valid claim, and the endorsement should record the product actually supplied, including its strength, pharmaceutical form and quantity, with the detailed requirements set out within the Drug Tariff.
Two matters warrant particular attention. Where endorsement functionality does not accommodate every element of a supply, the position should be checked against current NHSBSA guidance rather than resolved by assumption, since an incorrectly endorsed SSP supply is a claim which may not be paid as expected. And the VAT allowance formerly paid alongside product reimbursement for supplies made in accordance with protocols ceased from 1 June 2023, which is a change sufficiently distant now to have been forgotten and sufficiently recent to remain within the working memory of systems and spreadsheets which were never updated.
The reimbursement position interacts with the wider funding mechanism examined in our price concessions guide, in that a product in sufficiently severe shortage to warrant a protocol is frequently also a product whose market price has departed from its Tariff price, such that both instruments may be engaged in respect of the same shortage.
What records, and what conversation?
The record should establish what a subsequent reader would need in order 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, upon what basis. And that the patient agreed.
The patient conversation warrants preparation rather than improvisation, since it occurs at a counter, frequently with others waiting, and concerns a change which the patient did not request and may find alarming. Four elements make it work. Explain that the prescribed product is unavailable nationally rather than merely at this pharmacy, which prevents the patient from 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 that 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 where a carer rather than the patient collects, the conversation requires additional care, since 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 which the Specialist Pharmacy Service states directly. A service supplying under a PGD which encounters a shortage of the specified product must therefore address it through the PGD's own arrangements and its own governance, and may not rely upon a protocol issued for the prescription route.
Controlled drugs. Nothing within 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, the interaction between the two frameworks warrants checking against current guidance rather than resolving by analogy with an ordinary supply, and the record architecture set out in our Schedule 2 guide continues to apply.
Appliances. The instrument extends to appliances as well as medicines, since the Department's power arises where a serious shortage of a specific medicine or appliance is determined, which is straightforwardly overlooked by dispensaries thinking only in terms of tablets.
How does a dispensary know a protocol exists?
The recurring operational failure is not misuse of protocols but ignorance of them, in that a dispensary refers patients back for a fortnight before discovering that a protocol had been in force throughout. Four arrangements prevent it.
A named person and a daily check. The active protocol list and the supply notifications should be checked by someone whose responsibility it is, at a stated point in the day, rather than by whoever happens to encounter a problem.
A visible current list. Whatever is checked should be recorded somewhere the whole team sees, since the person who benefits from knowing a protocol exists is the one at the counter rather than the one who read the notice.
Expiry tracking. Protocols end, and a protocol relied upon 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 within a standard operating procedure, in the terms our SOP guide describes, so that a locum encountering 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, whilst the surrounding arrangements differ across the four nations, with reimbursement, endorsement and the circulars communicating each protocol 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 upon the guidance issued for the nation in which the supply is made rather than reasoning from the arrangements applying elsewhere.
Key takeaways
- A Serious Shortage Protocol permits supply in accordance with 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, comprising a different quantity, strength, pharmaceutical form or medicine, and each protocol authorises only the substitution it specifies.
- Three conditions must each be satisfied, comprising 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, and 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, whilst the recurring operational failure is not misuse but ignorance that a protocol exists.
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 held on the same record, so that a claim is defensible and an expired protocol is not relied upon in error.
See Dataforge PMR