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Recent months have seen serious shortages of certain HRT products, antibiotics, antidepressants, and other essential medicines, due to a complex interplay of factors, including global supply and distribution issues, high demand, and longer prescription cycles.

Although the Department of Health and Social Care (DHSC) has processes in place to prevent and mitigate the issues, the MIMS live tracker shows that drug shortages have risen markedly during 2022–23.

The problems bring concerns about potential harms to patients: a risk of worsening symptoms, withdrawal symptoms and other complications, if access to treatments is delayed. They also add to the pressure on pharmacists and primary care teams, who report increasing workloads, stress, as well as abuse by frustrated patients.

Serious shortage protocols (SSPs) allow pharmacists to substitute prescription medicines in short supply

Community pharmacies and dispensing doctors receive regular updates and follow national guidance to implement management plans in case of drug supply issues. They should share information with prescribers and patients as appropriate, and work to obtain or locate stock from suppliers or at other pharmacies.

SSPs, first introduced in 2019, may be issued if the DHSC determines that there is a serious shortage of a specific medicine or appliance. The protocols allow community pharmacists to use their professional judgement to decide whether it is appropriate to substitute the patient’s prescribed order according to the protocol. They must obtain the patient’s valid consent for this, and check their allergy status and Summary Care Record, but they do not have to refer the patient back to the prescriber. This ought to help patients access treatment sooner and save time for clinicians.

SSPs are developed with advice from expert clinicians and specialist societies, and specify:

  • Actions pharmacists can take to substitute the prescription with an alternative quantity, strength, or pharmaceutical form, a generic equivalent, a therapeutic equivalent, or an alternative device product.
  • The appropriate circumstances, suitable patients, relevant dates, and geographic locations.

In the case of a therapeutic substitution, the pharmacist should inform the prescriber, ideally by the following working day. This information may need to be entered into patients’ records.

Dispensing doctors may also follow SSPs if necessary, but generally they can amend the FP10 prescription form to supply an available medicine.

The NHS Business Services Authority provides a list of currently active SSPs and SSP Operational Guidance.

When is referral back to the prescriber required?

Even where an SSP exists, there are situations in which the pharmacist must refer the patient back to their GP for an alternative prescription:

  • If the patient does not consent to the substitution.
  • In case of concerns regarding the patient’s medical history or individual circumstances.
  • For patients with complex medical regimens or complex health needs.
  • For patients with certain conditions, such as epilepsy, where generic or therapeutic substitution would not be appropriate.

Limitations of SSPs

A recent survey of UK pharmacists suggested that despite SSPs, medicines shortages are having a worsening impact on patient care. Not all drug shortages are subject to an SSP, and supply issues may occur before advice on alternative medications is available. Where SSPs exist, pharmacists report that they are bureaucratic and inflexible – leading to extra workload and financial risk.

The Royal Pharmaceutical Society has called for pharmacists across the UK to be allowed to make minor amendments (for example, changes to quantity, strength, formulation, or generic substitution) to allow the prescription to be dispensed in the absence of an SSP, without having to contact the prescriber. In Scotland, this is already the case.

The prescriber’s role in managing supply issues

GPs may be notified of shortages by local communication networks, or, in the case of high- or critical-impact shortages, by ‘Supply Disruption Alerts’ via the Central Alerting System. All nhs.net email users can also register to access the Specialist Pharmacy Service website to find communications from the DHSC about specific medicine shortages and their management.

Once GPs are aware of a supply issue, they may request suitable alternative drugs or formulations on prescriptions, thus reducing the pharmacist’s work and the need for prescription amendments.

For example, as shortages of HRT products continue to cause frustration for all concerned, prescribers should refer to the advice of the British Menopause Society (BMS) to find suitable alternatives. MIMS also provides an HRT comparison table for hormone doses, formulations and costs.

Note that from April 2023, GPs are required to write listed HRT items on separate prescriptions, to facilitate use of annual HRT Prescription Prepayment Certificates, which may help to ease supply pressures.

Please contact us at Medical Defense Society for advice if you have concerns about the impact of medicines shortages on your practice or the wellbeing of your patients.