Empowering you to meet regulatory and best practice requirements

We have become aware of several occasions whereby customers using systemic hormone replacement therapy (HRT) have requested Gina^® 10 microgram Vaginal Tablets to treat symptoms of vaginal atrophy and have been advised incorrectly that this combined use is contraindicated.

Gina^® may be used alongside systemic HRT; however, customers requesting this should only do so following a consultation with their GP. This is to ensure that the customer's total exposure to oestrogen is considered and the associated risks understood. If the customer has previously been prescribed vaginal oestrogen for concurrent use with systemic HRT, they can purchase Gina^® without needing to consult their GP again if it is suitable for them and their health status has not changed.

For more information, please refer to the appropriate Gina^® training. For pharmacists, this can be found on Boots Learning. Training for other pharmacy team members is available via Pharmacy School's Tutor On Demand programme.

A copy of the Pharmacy Checklist to support you with customers who are requesting Gina^® is available on BootsLive. 

Many HRT products indicated for patients with an intact uterus, and who do not have a contraceptive intrauterine system fitted, provide an oestrogen and a progestogen combination in the same formulation, e.g. a patch or tablet. However, formulations that contain only oestrogen or progestogen are also available. Occasionally, these are prescribed to be taken together instead of a combined formulation.

If you dispense these hormones as separate items for a patient, please be mindful that, should the progestogen-only product not be available, it may not be appropriate to provide the patient with a supply of the oestrogen-only product alone. This is because doing so could introduce a risk to the patient taking oestrogen-only (sometimes referred to as unopposed oestrogen), which may not be suitable for them. In any such circumstance, it is appropriate to consider speaking with the prescriber to determine an appropriate course of action. 

The Human Medicines Regulations (HMR) 2012 permit states that an emergency supply of a Schedule 4 and 5 Controlled Drug (CD) can be given to cover up to five days’ worth of medication, if the pharmacist determines the supply is clinically appropriate.

We are aware of a number of incidents whereby a supply of a Schedule 4 or 5 CD of an amount which would last longer than the permitted five days has been made in error. Examples include patient referrals into commissioned services that cover the provision of emergency supplies.

Both the Community Pharmacy Consultation Service in England and the Clinical Community Pharmacy Service: Emergency Medicines Supply in Wales allow the provision of a Schedule 4 or 5 CD item; however, both do so under the HMR and only a supply of up to five days is permitted.

Supplies of items from Schedule 4 Part 1 are not permitted under the terms of the Community Pharmacy Emergency Supply Service in Northern Ireland; however, a supply of up to five days under the HMR may be considered. Similarly, in Scotland, if the National Patient Group Direction for Urgent Provision of Medicines, Appliances and ACBS Products does not permit the supply of a particular Schedule 4 or 5 CD, it may still be appropriate to make a supply under the HMR.

A list of CDs with their schedule is available here. 

This month, The Pharmacy Helpdesk will be ten years old. The team have supported with thousands of queries over this period and are always happy to help.

The Pharmacy Helpdesk can be contacted via the One Number (0115 957 5555) by selecting options 2, 3, 2, via The Pharmacy Helpdesk group on Yammer or by emailing pharmacysupportgroup@boots.co.uk. Please contact The Pharmacy Helpdesk if you have any questions, or need support with any of the topics covered in this edition of The Professional Standard or any other professional queries.