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Hormone replacement therapy – why are we running short?

Nada Khan is an Exeter-based NIHR Academic Clinical Fellow in general practice and GPST4/registrar, and an Associate Editor at the BJGP. She is on Twitter: @nadafkhan

Medication shortages are no new thing.  It’s not uncommon to see alerts from our friendly pharmacy team warning us of shortages in antidepressants, or medications such as H2-antagonists.  But I can’t think of a more prolonged or complex shortage than what we have seen with hormone replacement therapy (HRT).  The most recent HRT shortage relates to Oestrogel, but years of HRT shortages have left patients frustrated and GPs scrambling to find alternatives.  Recent newspaper headlines warned that some women are turning to the black market to access HRT medications.  How have we ended up here, and what should we as clinicians be doing about it?

NICE guidance published in 2015… recommended prescribing HRT as first line treatment for patients under the age of 60 with menopausal symptoms.

HRT used to have a relatively unfavourable reputation.  This was in some part due to early findings from the Women’s Health Initiative study and confusion over using combined (oestrogen and progesterone) HRT and the risk of stroke, breast cancer and thrombosis.1  NICE guidance published in 2015, however, recommended prescribing HRT as first line treatment for patients under the age of 60 with menopausal symptoms.2  Given the increasing coverage of menopause in the media and societal shifts in prescribing and taking HRT, rates of HRT use have increased substantially; OpenPrescribing data demonstrates an increase of over 200,000 prescriptions for HRT medications from January 2017 to January 2022.3

So, whilst women are increasingly requesting HRT to help manage symptoms of their menopause, and GPs gain confidence in prescribing for different menopausal symptoms, manufacturers have said that this pressure has caused a supply and demand problem.  Besins Healthcare, which manufactures Oestrogel, blames the ‘exceptionally high demand’ for Oestrogel over recent months for a depletion of stocks4.  Pharmaceutical companies need to forecast which medications will be in demand 12-18 months into the future,5 but have not been able to keep up with the demand in HRT.  In some ways this is puzzling, especially as international supply shortages of HRT have been ongoing since 2018; and it is unclear when they will ease.

Fear not; the British Menopause Society regularly publishes updates on HRT supplies, and provides guidance on HRT preparations and equivalents…

Where does that leave clinicians?  At the coalface, shortages in HRT mean that the scripts we issue for specific HRT preparations might not be available to the women who need them.  And this is a problem; the effects of menopause can be debilitating and for many women, HRT is part of the solution to navigating this stage of their reproductive health.  There are plenty of alternatives to each specific HRT mediation, and women should be offered these medications.  For some clinicians, prescribing HRT can be a murky challenge; there are numerous preparations, and it can be difficult to work through equivalent preparations.   Fear not; the British Menopause Society regularly publishes updates on HRT supplies, and provides guidance on HRT preparations and equivalents,6 which is a handy tool when dealing with prescription queries.  I have personally found the advice of pharmacists exceedingly helpful when prescriptions bounce back.  However, like other hormonal preparations (contraceptives spring to mind) some women will prefer specific brands to others.  Menopause is a time of life where individualised care must take precedence; working with a patient to find a solution or alternative formulation that suits them.

It is a good thing that we are all talking about menopause more, and although it is frustrating that HRT availability is yet to fully catch up, it is a problem we can try to solve through working through the issues openly with women and supported, but creative prescribing.

References

  1. Robinson L. HRT: The history: Women’s Health Concern; 2020 [Available from: https://www.womens-health-concern.org/help-and-advice/factsheets/hrt-the-history/.
  2. Menopause: diagnosis and management. 2015.Contract No.: NICE guideline NG23.
  3. Prescribing O. 6.4.1: Female sex hormones and their modulators[Available from: https://openprescribing.net/bnf/060401/.
  4. British Menopause Society update on HRT supply 2022 [Available from: https://thebms.org.uk/news/british-menopause-society-update-on-hrt-supply/.
  5. Backhouse T. HRT: Why are some women finding it so hard to access Hormone Replacement Therapy? Women’s Hour: BBC Radio 4; 2022.
  6. Society BM. HRT preparations and equivalent alternatives 2022 [Available from: https://thebms.org.uk/wp-content/uploads/2022/03/15-BMS-TfC-HRT-preparations-and-equivalent-alternatives-01D.pdf.

Featured image by @danilo.alvesd on Unsplash

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Prescribing before The 2002 HRT crash

I was a prescriber of HRT in the 1990’s before the massive decline due to scientifically proven health risks in 2002 . A new generation of GP clinicians will now have to take up HRT prescribing due to pressures from celebrity endorsement and muddled NICE guidelines. I have memories from this past when once again oestrogens were the popular female anti-ageing drugs of the time.

On the positive side HRT provided excellent relief from night flushes ( no other treatment is effective) and also symptoms of vaginal atrophy. I breathed a sigh of relief when a woman without a uterus chose to have HRT to relieve her symptoms as this bypassed endometrial hypertrophy and endometrial cancer issues. Erratic vaginal bleeding could be problematic in younger patients, with intact uterus around the menopause, so combined HRT oral preparations were most prescribed. This was said to reduce endometrial hyperplasia risks. This gave a monthly to three monthly light bleed so sanitary protection was needed . In fact oestrogen dermal applications were unpopular and rarely added to the repeat prescription list at my practice. A Mirena IUS as contraceptive was sometimes used to reduce any risk of endometrial thickening and provided contraceptive cover. Some private patients had oestrogen implants but there were examples of patients having supra-physiological levels due to to too frequent injections as symptoms returned earlier than the date of their next injection. There was no availability of endometrial thickness ultrasound in the 1990’s to GPs. Bone density scans which were available often showed poor bone density gain on HRT but excellent with the bisphosphonates

Some patients did very well on their HRT and preferred to remain on the medication with some well past 70 years. When the new scientific risks were spelt out most gave up the medication but of course still had to weather a period of hot flushes as a consequence of withdrawal. Those few who did not wish to stop had to sign a practice form saying that this was against current medical advice. Testosterone dermal preparations did not have a licence for female health conditions in my time so did not have to be considered as an add on to HRT.

Of course other patient health issues can muddy the HRT prescribing waters but this requires even more careful management. There was no doubt this was considerable extra work but was very useful in a targeted way.

I wish my modern day GP colleagues all the best as they add HRT once again to the GP prescribing task.

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