Additional stocks of hormone replacement therapy products could be shipped from France and Poland to the UK next week, a major manufacturer has said after crisis meetings were held to address the nationwide shortage.
Tina Backhouse, the UK general manager at Theramex, which makes a dozen HRT drugs, including Bijuva pills and Femseven patches, said the company needed special permission to bring in products from France that are not licensed in the UK. had. Theramex products are mainly made in Germany, and some are only licensed in other European countries.
Backhouse met with the UK’s newly appointed HRT Czar Madelaine McTernan and the Medicines and Healthcare products Regulatory Agency this week and expects to receive clearance after a further meeting with the agency on Monday.
“We are working with MHRA to get special clearance. It’s not uncommon, other companies are doing it,” she said. “I don’t think it will last long, we got it” [the stock] finished.”
Theramex, a London-based private equity pharmaceutical company, is also preparing to bring in HRT patches from Poland, which are licensed in the UK but require English labels.
“We’re looking for short-term solutions and longer-term solutions in terms of bringing in other products from other countries,” Backhouse said.
The UK appears to be the only country with a shortage of HST products. It was triggered by a surge in demand after TV hosts Davina McCall and Mariella Frostrup spoke about their menopausal experiences.
Besins Healthcare, a privately-owned company based in Brussels that makes the most popular estrogen gel product, said on Thursday it was “looking at all options to increase short-term supplies of Estrogel to the UK”.
The British Menopause Society and HRT manufacturers are calling for other measures, including a national list or ‘formulary’ of approved HRT medicines that would allow all doctors and pharmacists to prescribe all available products.
When local clinical principal groups were established in England in 2013, many previously national decision-making and budgetary powers were transferred to them. This means that in certain parts of the country there may be delays in obtaining a license for new drugs.
Backhouse said: “We have brand new products in this country that are licensed but not used due to formulation restrictions. At this stage, we should definitely have a national formulary of HSTs available and in stock, rather than waiting for each individual place to do so. It would be so easy to do.”
She said Theramex had a new MHRA-approved product that was only prescribed in three areas, or used privately by women who paid for it themselves.
The National Pharmacy Association has also lobbied for pharmacists to have the power to change prescriptions from general practitioners when certain products are not available.