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September 2019

HRT and contraceptive shortages expected to continue until next year



Around half of HRT products in use in the UK are reported to be out of stock at pharmacies causing shortages for thousands patients – and headaches for prescribers.

Issues first emerged last year when manufacturers experienced problems with the supply chain in China, leading them to cease making HRT patches. This in turn led to increased demand for alternative products, which also became scarce.

Clinicians have been advised to prescribe equivalent alternatives, by checking the oestrogen and progestogen components and matching as closely as possible to another brand. Where an exact match cannot be identified, oestrogen and progestogen can be prescribed separately to make up the closest match.

Pharmacies are shopping around between wholesalers to try to obtain stocks of products in short supply, but when these attempts fail, are having to refer patients back to their GP or practice nurse. One pharmacist said: ‘Unfortunately we aren’t able to give alternatives because the alternatives are out of stock as well.’

The Telegraph reported that HRT was ‘being rationed’ and women ‘warned that they would struggle to get HRT patches for nearly a year’.

Novartis, which makes Estradot patches, has rationed UK stocks to avoid selling out, and Janssen, the suppliers of Evorel, has warned that stocks will be exhausted by next month (October). Janssen says that demand in the UK so far this year has already exceeded demand for the whole of 2018, depleting all surplus stock. Return to full supply is not expected until mid-2020.

The British Menopause Society has produced an update on current availability of HRT products at https://thebms.org.uk/2019/08/british-menopause-society-further-update-on-hrt-supply-shortages/ It lists products that are out of stock or still available, with contact details for manufacturers for healthcare professionals experiencing difficulty obtaining supplies. Prescribers are advised to clarify equivalent doses using the Menopause Matters prescribing decision tree at https://www.menopausematters.co.uk/tree.php

Shortages of several contraceptives, including combined oral contraceptive pills, progestogen-only and long-acting preparations have also been reported. Among the contraceptive pills affected are Loestrin, Norimin, Ovranette, Maexeni, Akizza, Zoely, Yiznell and Noriday. The depot injection Sayana Press is also currently unavailable.

RCGP chair Professor Helen Stokes-Lampard said: 'Medication shortages have always occurred occasionally – but shortages of certain HRT preparations and oral contraceptives have become significantly worse in recent months.

'This is very concerning. Not only does this add to workload, as looking for suitable alternatives is very time consuming, but it is also very inconvenient and can be distressing for patients if they can't get the treatments they are used to.

'It's not entirely clear why we are currently experiencing shortages of some oral contraceptives and HRT preparations – it seems as though there are several factors at play – and we don't know how long the shortages will last. However, the shortages are already having a massive impact on our patients' lives – as well as workload – and need to be addressed as a matter of urgency'.

NEW WARNING ON BREAST CANCER RISK WITH HRT USE

The Medicines and Healthcare products Regulatory Agency (MHRA)1 has issued new advice to prescribers, to discuss breast cancer risks for women using HRT at their next routine appointment. The advice follows publication of a new meta-analysis in The Lancet that shows the risk of breast cancer is increased during use of all types of HRT, except for vaginal oestrogens, with greater increased risk with combined oestrogen-progestogen HRT than with oestrogen-only HRT.2 The Lancet’s analysis of studies in more than 100,000 women with breast cancer also revealed that risks persister longer after stopping HRT than previously thought. The analysis showed:

  • 1 extra case per 200 women who use oestrogen-only HRT
  • 1 extra case per 70 women for women using sequential or cyclical HRT (oestrogen with progestogen for part of each month)
  • 1 extra case per 50 women using oestrogen combined with daily progestogen (continuous HRT)
  • Some excess resist persists for more than 10 years after stopping.2

In the UK about 1 in 16 women who have never used HRT will be diagnosed with breast cancer between the ages of 50 and 69 years.1 There is little or no increased risk with current or previous use for less than 1 year.2

References

1. MHRA Drug Safety Update. https://www.gov.uk/drug-safety-update/hormone-replacement-therapy-hrt-further-information-on-the-known-increased-risk-of-breast-cancer-with-hrt-and-its-persistence-after-stopping#counselling-patients-about-the-updated-information-on-risk-of-breast-cancer-with-hrt

2. Collaborative Group on Hormonal Factors in Breast Cancer. The Lancet. ePub 29 August 2019. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31709-X/fulltext