The government has clarified its guidance relating to the Hormone Replacement Therapy (HRT) pre-payment certificate (PPC), while supply of HRT products continue to be affected by shortages and a product recall this week.

The updated guidance advises prescribers to make their patients aware that they can get a PPC for any listed HRT product, regardless of the clinical reason, emphasises that listed HRT items should be issued with a separate prescription, and reminds dispensers that the PPC can be backdated for up to one month.

Pharmacies have been instructed to stop supplying a certain batch of Evorel Sequi after several cartons were found to contain the incorrect combination of the HRT patches.

They have also been told to inform patients of a change to the priming instructions for Tostran (Testosterone 2% gel), which is sometimes used off-label in menopausal women, although it is not currently listed as a HRT item covered by the PPC.

And a Serious Shortage Protocol (SSP) for Utrogestan 100mg capsules has been further extended until the end of this month, continuing to restrict supply of the product to just two months at a time.

Manufacturing issues hit HRT products

Pharmacy teams have been instructed to stop supplying batch number 6029403 of Evorel Sequi, which should contain four Evorel 50 patches (containing estradiol only) and four Evorel Conti patches (containing estradiol and norethisterone).

And they should quarantine all remaining stock from this batch and return it to their supplier using the supplier’s approved process.

If a patient presents at the pharmacy with the incorrect patches from a prescription issued within the last six months, they can be supplied with a correct patch from another batch, which manufacturer Theramex has confirmed are all unaffected.

The Medicines and Health products Regulatory Agency (MHRA) has also recently issued a class 4 medicines defect information notice for Tostran (Testosterone 2% gel), requiring pharmacy teams to give further guidance to their patients supplied with affected batches of this item distributed this month.

In order to achieve an accurate first dose, patients will have to use more pumps to prime the gel dosage pump/dispenser system ahead of its first use than are currently listed on the priming instructions.

This is due to a manufacturing change with the patient information leaflet (PIL) not yet being updated.

But to avoid a shortage of this product, the affected batches are not being recalled, and community pharmacies should continue supplying the affected batches while passing on further instructions to patients, the MHRA said.

Utrogestan supplies still limited

The government also announced this month that it has further extended the SSP for Utrogestan 100mg capsules that was due to expire 1 September 2023, to Friday 29 September 2023.

In response to ‘significant ongoing disruption’ of the progestogen drug, pharmacy teams are restricted to supplying just two months of the product to each patient at a time.

But patients will not be charged if they receive a smaller quantity of the medicine than the quantity originally ordered on the prescription, when it is supplied in accordance with an SSP for reduced quantity, Community Pharmacy England (CPE) clarified.

Medicines supply issues have also continued to affect non-HRT products, with the final August reimbursement price for Atomoxetine 18mg capsules recently set at £29.94 for a pack of 28, following reports that pharmacies have been unable to source the item at the Drug Tariff price of £14.72.

And a batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) were recalled last week as some products have the potential to appear cloudy and/or contain crystalline particles.

Packaging and labelling errors have been on the rise in recent years, with the MHRA confirming the increase but saying that there was ‘no established reason’ for it.

And CPE recently told The Pharmacist that its own records showed an increase in notices that required community pharmacy action, which it said was ‘important but ultimately unfunded work’ and resulted in ‘additional workload being placed on already overstretched pharmacy teams’.

The Association of Independent Multiple Pharmacies (AIMp), has called for an inquiry into the cause of the issue.

HRT PPC guidance updated

The government also issued updated guidance relating to the HRT PPC this week.

It highlighted that the PPC can be backdated for up to one month, meaning that prescribers must always issue HRT items as a separate prescription, regardless of whether the patient has a PPC at the time of prescribing or not.

And any medicine on the NHS Business Services Authority (NHSBSA)'s list of eligible HRT items should be listed separately, regardless of the clinical reason for prescribing, the guidance said.

It added that prescribers should make patients aware of the HRT PPC if time allows during their consultation.

If patients have already been issued an electronic repeat dispensing (eRD) prescription that contains any of the listed HRT items, community pharmacy teams can supply them using the options for mixed prescriptions.

This might mean charging the patients for all the items, supplying just the HRT PPC or non-HRT PPC items, or asking the prescriber to issue a new mixed prescription.

And future eRD prescriptions must be separated, the guidance emphasised.