Severe Shortages of Hormone Replacement Therapy Impacting on Women’s Lives
The National Secretary of the political party Aontú, Sarah Beasley, is being personally affected by a national shortage of Hormone Replacement Therapy right across Ireland. Users of HRT have noticed that the supply of the medication had been disrupted on occasion since 2019 but the supply chain issues have escalated over the past few months.
Aontú recently submitted a Parliamentary Question to the Department of Health, the reply acknowledges that there is a shortage HRT medication and that many patients face anxiety due to this, the Health Products Regulatory Authority (HPRA) has warned that Ireland is facing shortages in several different HRT medication, citing an “unexpected increase in demand” as the cause.
Speaking today, Ms Beasley said; ‘’HRT medication is prescribed to women going through a range of menopausal symptoms, of which I am one. It is prescribed to alleviate what are often the life-altering symptoms we are experiencing. It is very exhausting for women, we often take a long time to pluck up the courage to come and speak our GP, acknowledging what is happening to our bodies is not an easy thing. I have been a victim of the HRT shortages, even one day missing my treatment will bring on an onslaught of severe hot flushes and mood swings.’’
Ms Beasley continued; ‘’HRT comes in a number of forms; Gels, Patches and tablet-based treatment, the shortages are across all types, I am part of Facebook group, the group has over 35,000 members across the country. Within the group people post where they found a supply and there’s almost a race to get the particular pharmacy before the stock is gone. We live a 21st century western democracy, these are the types of medical shortages you’d imagine and expect in the former USSR 50 years ago.
‘’We have members in the group that live in the North of Ireland, they are not experiencing the shortages we are, one of the major irritations is that any of us can travel to the north of Ireland to get it, It’s hard to fathom what is the supply issue in Ireland, why is the Republic out of supply when the north of Ireland isn’t, Brexit can’t be blamed for this shortage.’’
“If there was a shortage of any other vital life enhancing medication there would be a real urgency to get the supply chain back to normal, we’ve had to endure over three years of disruption with no sign of improvement, its actually getting worse, we are being let down by the HPRA (Health Products Regulatory Authority) and we are being ignored by the government’, concluded Ms Beasley.
For Written Answer on : 28/04/2022
Question Number(s): 267 Question Reference(s): 21510/22
Asked by: Peadar Tóibín T.D.
To ask the Minister for Health the reason for the shortage of HRT medication for women in this country at the present time.
Unfortunately, medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects.
Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. Ireland has a multi-stakeholder medicines shortages framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.
The HPRA is aware of the current challenges regarding the intermittent supply of some hormone replacement therapies (HRT). The HPRA has had regular and ongoing engagement with suppliers in this regard. The companies that place the products on the market have indicated that the current supply difficulties are due to a significantly increased demand for these medicines in Ireland in recent years. To illustrate, the supply of one range of HRT patches has increased by between 77% and 117%, for the three most-used strengths, compared to 2020. In addition, based on demand in recent months, the company expects a similar increase in the demand for all strengths during 2022. This would mean that the usage of this patch in Ireland would be approximately 4.5-7.5 times higher in 2022 (depending on the strength) compared to 2019.
Regarding the HRT patches, the suppliers have confirmed that they have increased the planned supply of HRT patches to Ireland during 2022 in response to this increased demand. In the case of one brand (Evorel/Evorel Conti), the supply of HRT patches has resumed. For another brand (Estradot), some strengths are available currently and, based on manufacturing availability, the re-supply of the full range is expected to be in July. With respect to the gels, Divigel was received by the wholesaler on 25th March and was released for sale the following week. An alternative gel product (Oestrogel) has recently gone short and is expected to resume supply in late April/early May. In the interim, the company is working to find solutions to the immediate supply issues.
The current supply situation has arisen due to significant increases in demand for HRT medicines and is not linked to regulatory matters. However, the HPRA continues to review available options within their regulatory remit to facilitate increased supply where at all possible. In particular, the HPRA has advised the companies that they are open to providing accelerated regulatory approval to supply a product originally intended for other markets if available. The HPRA are awaiting further information from the companies in this regard.
The HPRA publishes a medicinal product shortages list on its website, with the reason for the shortage, the expected dates for the return of supply and in some cases, such as HRT shortages, the HSE’s clinical guidance on the management of patient treatment in response to medicine shortages. The information is made available to assist healthcare professionals in managing medicine shortages when they do arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.
The HPRA will continue to liaise with suppliers of HRT medicines over the coming weeks with a view to securing updates and commitments regarding the restoration of normal supplies for patients as soon as possible.