Last week (1 July), the Serious Shortage Protocols (SSPs) came into force across England.
The protocols, passed under the Human Medicines (Amendment) Regulations 2019, give community pharmacists the power to provide appropriate alternatives to patients in the event of serious medicine shortages without having to go back to the patient’s GP for an updated script.
It comes after months of stock shortages, which became the focus of The Pharmacist’s #WarOnShortages campaign.
However, clear criteria will be provided and medicines must be prescribed within the strict boundaries of each individual protocol.
Here’s our roundup of everything you need to know before dispensing under an SSP, according to the Pharmaceutical Services Negotiating Committee (PSNC).
What is the scope of an SSP?
The legislation broadens SSPs from prescription only medicines to cover all medicines and appliances and brings them into the terms of service for NHS community pharmacies.
An SSP will specify one or more of an alternative quantity, strength, or formulation of a product, or a therapeutic or generic alternative that may be supplied. For example, if there is a serious shortage of a medicine in 20mg tablets, twice as many 10mg tablets may be specified by the SSP so that the dose originally prescribed by the doctor remains the same.
All SSPs will have specific start and end dates, which are subject to change, and may have geographical restrictions.
When will an SSP be issued?
The issuing of SSPs has been legally allowed since 1 July, however it will only be considered – and therefore put into practice – by the health secretary in the case of a ‘serious shortage’ of a specific medicine or appliance.
For an SSP to come into force, all other measures such as the agreement of concession prices will have been exhausted.
In a briefing for community pharmacists, PSNC outlined how all prospective SSPs will be carefully considered before being issued.
It said: ‘The Department of Health and Social Care (DHSC) has indicated that SSPs will be introduced only with the involvement of clinicians (doctors and pharmacists); and, as appropriate, after consultation with relevant patient groups, the devolved administrations, NHS England and Improvement, relevant manufacturers and relevant pharmacy organisations including PSNC.’
How will I know that an SSP has been issued?
Any new SSPs or amendments to existing SSPs will be published by the NHS Business Services Authority (NHSBSA) on a dedicated section of its website. NHS England and Improvement will alert contractors to its publication, for example by sending an email to pharmacies’ shared NHSmail account.
PSNC will also alert contractors via a dedicated page on their website and email newsletter as soon as an SSP is issued.
Do I have to dispense according to an SSP?
PSNC confirmed that contractors ‘must consider’ whether dispensing under an SSP is appropriate for any individual patient’s relevant prescriptions, but that they are ‘not obliged’ to do so.
It said: ‘Community pharmacy contractors must consider the SSP and, if, in the supervising pharmacist’s opinion – exercising his or her professional skill and judgment – the alternative product or quantity is reasonable and appropriate for the patient, they may supply the alternative product or quantity (only as specified in the SSP and subject to any conditions in the SSP).’
PSNC added: ‘Pharmacists will always have the professional discretion not to supply an alternative to any individual patient.’ For example, SSPs may not be suitable for certain patient groups, such as those with epilepsy, and such considerations may be outlined as part of the SSP.
However, if pharmacists decide to supply under an SSP, they must follow the strict criteria the protocol specifies and do so with ‘reasonable promptness’.
Once a prescription has already been fulfilled via an SSP, it is no longer valid and contractors must refuse to supply either the originally supplied product or the SSP alternative.
Do I have to obtain consent from the patient?
Yes, contractors must obtain the consent of the patient before they supply an alternative product or quantity under an SSP.
What if supply under an SSP is not ‘reasonable or appropriate’?
If the supervising pharmacist decides that supply under an SSP is unreasonable or inappropriate for a specific patient, contractors can supply according to the original prescription if it is possible ‘within a reasonable timescale’. Although not defined, it is acknowledged that this may take longer than supply under an SSP, which must be done with ‘reasonable promptness’.
Alternatively, if this is not possible, the contractor may refuse to supply the patient. However, the patient or patient representative requesting the medicine must be provided with any necessary and appropriate advice about returning to the original prescriber for a review of the patient’s treatment. If a patient can be directed to a community pharmacy that has stock of the originally prescribed medicine, it might not be necessary to send the patient back to the prescriber.
Do I have to inform the prescriber?
Contractors must always notify the patient’s GP if they supply a therapeutic alternative according to an SSP or if the health secretary and PSNC have recommended that this is necessary – likely specified in the SSP.
GPs can be notified via NHSmail if the SSP does not specify a communication route and there are no local preferences.
Are prescription charges still applicable?
If the patient is not usually exempt from prescription charges, these remain payable for medicines or products supplied under an SSP. However, if the patient receives a smaller quantity than that originally ordered on their prescription, they are exempt from paying prescription charges. Contractors will need to apply a prescription charge or exemption declaration as usual.
How will I be reimbursed?
Contractors will be reimbursed for the medicine actually supplied under the SSP rather than what was originally prescribed and the same fees and allowances will apply as for normal prescriptions. PSNC confirmed that an ‘additional fee’ for dispensing under SSPs is ‘under discussion’ between the negotiator and the DHSC.
To claim remuneration and reimbursement, contractors must endorse prescriptions fulfilled under an SSP with ‘NCSO’ (No Cheaper Stock Obtainable), as if the product had been supplied against a prescription.
How do I show a supply has been made according to an SSP?
Contractors must indicate that the product was supplied under an SSP on the dispensing label by identifying the SSP number. For example, they can free type ‘Supplied under Serious Shortage Protocol number 002’ in the directions field of the label.
For worked examples of dispensing and endorsing according to an SSP, see PSNC’s guide.