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Pharmacies suffered shortages in every major HRT brand pre-COVID-19

Survey respondents said they experienced shortages in the Estradot, Estraderm and Elleste ranges

Community pharmacy staff reported shortages across all 30 brands of hormone replacement therapy (HRT) medicines included in a C+D survey between October 2019 and March 2020

Pharmacy teams have been shorter on time over the last couple of months than ever before, battling through a tide of demand for medicines during the COVID-19 pandemic. Shortages of these medicines only add to the daily stress.

Shortages of HRT drugs have been rife throughout the UK for some time. In 2019, HRT items caused the most shortages frustration for pharmacy professionals. A new survey from C+D pre-dating the outbreak of COVID-19 dives into the long-standing severity of the problem.

The reasons why shortages happen are complex and wide-ranging: from an unexpected increase in demand, to problems with patch adhesive. To better understand how they affect the pharmacy workload, C+D surveyed 537 community pharmacy professionals based in the UK about their experiences handling HRT shortages. The responses pre-date the onset of the COVID-19 lockdown, underlining how deep the crisis ran before the extra stresses on the supply chain from the virus outbreak.

The community pharmacy professionals who responded to C+D’s survey – which ran from February 24 to March 23 – reported shortages in every listed category over the previous six months. The number of respondents who experienced shortages of brands ranged from five with AndroFeme (making up 1% of respondents) to 365 (68% of respondents) with Evorel.

Shortages across all brands

The brands that most respondents to C+D’s survey experienced shortages of between October 2019 and March 2020 were Evorel (68%) FemSeven (54%) and Elleste (52%).

Brands where fewer than 1% of respondents reported shortages over the time period were Oestrogel, Utrogestan, Tridestra, Novofem, Trisequens, Mirena, Ovestin, Livial, Gyneva, AndroFeme, Duavive and Estring.

See below for manufacturer responses.

It feels like HRT shortages have been part of pharmacy life for years. But only half of respondents (51%) said they began to affect their working lives between March and September 2019. However, one fifth (18%) said HRT shortages hit their workload between March 2018 and March 2019.

Almost all pharmacy professionals surveyed (99%) reported problems sourcing HRT over the previous six months. This marked a significant increase from a C+D survey in September last year, when 84% of 402 respondents said they had struggled to source HRT over the previous six months.

Time wasting

HRT shortages inflict stress on pharmacy teams. Many respondents to the survey noted the demoralising frustration at sometimes having to spend hours calling GPs to ask them for an alternative treatment, often fruitlessly. 

“A large amount of time is wasted sourcing HRT and explaining the availability to patients,” one respondent said. “The lack of information on availability also largely inconveniences the team as we have to answer to the patients, who are already unhappy. It often results in complaints [on an issue] that the team has no control over.”

Another respondent said HRT shortages add “so much more unnecessary pressure – we have to keep apologising for something that is not our fault and some people just do not understand”.

One said they felt they were in a “never-ending situation” with “continuous phone calls to GP surgeries” when trying to track down the medicine.

Another said: “Staff members are having to act as gatekeepers and deal with understandably stressed and disgruntled customers – there doesn't seem to be a lot of information for us to share and this is negatively impacting the team's relationships with customers.”

These shortages impact patients' trust in pharmacies. Many respondents noted how patients were angry at not being able to get their medicines, with some customers incensed to the point of abusing pharmacy staff. “Some patients get abusive even when we bend over backwards to help them,” one respondent said. “We’ve been verbally abused by a few customers and told we are ‘rubbish’”, said another.

Despairing patients  

Some patients lash out at pharmacy staff because they are concerned about the effect on their health of not taking their HRT medication, with some in “despair”. Numerous respondents noted how upset their patients had become due to the shortages – with some pushed to extremes.

“They get anxious and panicking about the situation. Patients are even trying abroad and online to get supplies,” said one respondent.

Another said: “Some patients have been very distressed and have gone abroad for [supplies]. Many have been very selfish and have obtained prescriptions for very large amounts and have stockpiled.” One respondent reported that some of their patients had visited A&E to try to access HRT stocks.

“They are stressed, disappointed, anxious, angry,” said one respondent. “Some patients are heavily reliant on these HRT products [so their absence] may cause mood swings,” said another.

COVID-19 has placed unprecedented pressure on the medicines supply chain. Respondents to another C+D survey – which received 745 responses from April 1 to May 11 – said medicine shortages was the biggest factor affecting their business for 77% of respondents since the virus hit.

Although other issues related to COVID-19 have drowned out the HRT conversation in pharmacy, it remains a problem for the sector. Around the beginning of the virus outbreak in the UK on March 18, the HRT clamour reached the House of Lords. Lord James Bethell, the Conservative parliamentary under-secretary of state for the Department of Health and Social Care, admitted there were “ongoing supply issues” with HRT, which had been a “persistent problem for more than a year”.

Lord Bethell also claimed that the supply of HRT had not been affected by the COVID-19 outbreak. This point of view was not disputed by British Generics Manufacturers Association director general Warwick Smith, who told C+D he had not heard of any further deterioration of HRT supply during the pandemic. 

However, an update from the British Menopause Society, published on May 4, says that some HRT medicines will continue to have stock issues until the second half of 2020.

Although the supply chain has begun to recover following the onslaught of demand in March following the COVID-19 outbreak, HRT shortages remain a reality that pharmacy teams and patients must contend with.

Manufacturer responses

C+D asked HRT manufacturers whether they had experienced shortages of their HRT products in the time period C+D surveyed its readers on and if so, why.

Besins – Oestrogel, Utrogestan, Testogel

Besins claimed in February that it has “sufficient stocks” of its HRT range and has “not experienced any shortages”.

Orion – Sandrena, Indivina, Tridestra

Orion said in February that it was experiencing stock shortages of its Indivina range, which contains estradiol and medroxyprogesterone acetate, due to its contract manufacturer having issues implementing Falsified Medicines Directive (FMD) packaging requirements.

Theramex – Evorel and FemSeven

The Evorel range of oestrogen-only HRT patches suffered shortages at the end of last year. Manufacturer Janssen said this was because of "an unusual increase in demand", and a "lack of availability of alternative HRT products not produced by Janssen".

Around the same time, the Evorel range was acquired from Janssen by Theramex, meaning the supply chain had to be restarted. Theramex says that at this point “a number of products were unavailable,” for which it “suffered the consequences”.

Since the acquisition, Theramex has taken steps to get Evorel products back on pharmacy shelves “months ahead” of schedule, it says.

According to Theramex, actions taken include: restarting manufacturing; increased output to 20% more than expected demand; making packaging faster; and working with the Medicines and Healthcare products Regulatory Agency (MHRA) to fast-track products.

Read more on Theramex’s response to its supply issues here.

Novartis – Estradot, Estraderm

Novartis said in February that in light of “global supply shortages”, it is “supplying as much Estradot stock as possible into our UK wholesalers,” it says.

Novartis added that it “is not able to fill the increased demand created by shortages of products from other manufacturers”.

Mylan – Femoston, Zumenon, Elleste

Mylan said in February that shortages in its Elleste range of HRT tablets were due to an “interruption in production” with its third-party manufacturing partner last year.

It was “now transferring the production of Elleste to a Mylan-owned and operated facility” and anticipates production to resume in the second half of 2020, it says.

Novo Nordisk – Kliovance, Kliofem, Novofem, Trisequens, Vagifem

Novo Nordisk said in a statement in March that its stock was unaffected by supply issues.

“Novo Nordisk is in a good position, with high stock levels in the UK, to continue to ensure patients get access to the medicines and treatments they need.”

Bayer – Progynova, Mirena

Bayer said that some of its Progynova 50mg transdermal patches were in shortage in January 2020, and its Progynova 1mg tablets were in shortage from November-December 2019, because “overall market shortage triggered short-term supply interruption”.

However, its supply of HRT products had been unaffected by the COVID-19 outbreak and it did not foresee any future impact, it added.

Aspen – Ovestin

Aspen said it was “unable to confirm that Aspen UK has been in full supply of Ovestin cream [from October 2019 to March 2020] and supply has not been affected by the pandemic”.

Merck Sharp and Dohme (MSD) – Livial

Merck Sharp and Dohme has not responded to C+D.

Marlborough Pharmaceuticals – Gynest  

Responding to the HRT survey findings, Marlborough said: “Wewe have sufficient stock and no anticipated shortages for Gynest cream.”

Kyowa Kirin – Tostran

Kyowa Kirin said: “Although stock ran low in January 2020, we have been able to supply the market uninterrupted since then. Our supply of Tostran has not been affected by COVID-19 so far and we do not anticipate supply chain disruptions at this time.”

Lawley – AndroFeme

Lawley has not responded to C+D.

Pfizer – Premique, Duavive, Premarin, Estring, Provera

Pfizer said in February that the reasons for shortages of HRT products in the UK are “wide-ranging and multifaceted”. It is “working to minimise the impact” of shortages, it added.

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