The DHSC has restricted the exportation of all HRT products and put in place further restrictions for all adrenaline auto-injectors and hepatitis B vaccines to safeguard stocks for patients. Shortages of several widely prescribed brands of HRT were reported by MIMS in July and a total of 15 HRT products are currently out of stock according to the MIMS drug shortages tracker.
Further informationView HRT drug records
The government has also activated a 'serious shortage protocol' (SSP) in response to shortages of fluoxetine 10mg, 30mg and 40mg capsules. Under legislation introduced earlier this year, the SSP allows pharmacists to supply an alternative strength or pharmaceutical form of the antidepressant without needing to go back to the prescriber.
The DHSC said restrictions on HRT exports had been imposed because some HRT drugs are being 'parallel exported' - whereby companies buy medicines meant for UK patients and sell them on for a higher price in another country.
BMA GP committee executive team member Dr Farah Jameel told GPonline that HRT shortages had been going on for 'far too long' and said it was 'encouraging that the government is finally taking steps to resolve it by limiting HRT exports from the UK'.
Dr Jameel added: 'Thousands of women rely on HRT in the UK, and we know that many patients have been needlessly suffering as a result of recent manufacturing and supply issues.
'Drug supply issues are common, and while clinicians can prescribe alternative medication, amending a patient’s prescription takes time and this can significantly add to our already heavy workload – particularly if the issue is ongoing.'
She cautioned, however, that 'prescribing alternative interim medication might not always help to fully relieve a patient’s symptoms, further delaying their treatment and causing avoidable, unnecessary distress'.
The government said that the SSP for fluoxetine would remain in place while manufacturing issues mean the drug is temporarily in short supply, to alleviate pressure on the supply chain.
Dr Jameel added: 'While this protocol is a sensible measure in theory, patients must have the reassurance that changing the strength or form of their much-needed medication – in this case commonly used for mental health-related conditions – won’t have any adverse effects. Furthermore, we have to be sure that it won’t add to GP workload or cause unnecessary confusion among practice teams.'
The MIMS drug shortages tracker now lists more than 100 medicines prescribed in primary care that are currently out of stock in the UK - and GP leaders have warned that shortages are having a serious impact on both GPs and patients.
The DHSC says the parallel export restrictions and the SSP are additional tools to reinforce current measures it has in place to combat medicine shortages, which include working closely with affected suppliers to resolve the issues quickly and ensure alternative supplies remain available for all patients.
The Department says the medicine supply chain is complex and highly regulated, so problems can arise for a variety of reasons, including manufacturing issues or problems with raw ingredients.