Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the impact of her Department's policy of prescribing alternative hormone replacement therapy medication when preferred medication is unavailable on the ability of menopausal women to manage changes in side-effects and drug interactions.

Clinicians are responsible for making prescribing decisions for their patients, working with them to decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration.

Serious shortages protocols (SSPs) are developed with input from expert clinicians but are only considered in exceptional circumstances. An SSP enables community pharmacists to supply a specified medicine or device in accordance with a protocol rather than a prescription, with the patient’s consent and without needing to seek authorisation from the prescriber.

Patient safety is a key factor in deciding whether to use an SSP to manage a shortage. As well as being agreed upon by clinical experts, every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and exclusions and raise any potential safety concerns about the SSP. At no point in the operation of the SSP policy has the Department yet received or been made aware of any concerns or negative effects on patient safety as a result of an SSP being in place.

All SSPs include a section on those patients who are excluded from being supplied in accordance with the SSP. Pharmacists must also use their professional judgement to decide whether it is appropriate for any patient to be supplied in accordance with an SSP. In addition, patients must consent to be supplied in accordance with an SSP. In the event that either the pharmacist or patient has any concerns, the pharmacist must refer the patient back to their prescriber, as would happen if an SSP was not in place.