Laboratoires Besins International has advised of a shortage of Imvaggis 0.03 mg Pessary, impacting multiple markets. The company stated the reason is manufacturing delays and supply is expected towards the end of July 2023. Multiple countries, not just Ireland, are affected.
Novartis Ireland Limited, the company responsible for placing Estradot 100mcg/24 hour transdermal patch on the market, has notified of a shortage of this medication due to continued unexpected increased demand. The company has not yet provided information to confirm if this shortage impacts other markets. The expected return date for supply is the week ending 6 August 2023.
The supply Utrogestan Vaginal 200mg Vaginal Capsule which had been in short supply resumed on 20 June 2023.
Alternatives are available. Many Hormone Replacement Therapies (HRT) are authorised for use in Ireland in various formulations (e.g., oral tablets, transdermal patches, gels, and sprays) and strengths. For the vast majority of HRT products authorised, including transdermal patches and gels, the Health Products Regulatory Authority (HPRA) has not received any notifications of current shortages. This includes all but two of the above mentioned authorised products outlined in the HSE’s clinical guidance for HRT (hyperlink below).
MMP guidance for prescribers on HRT shortages – September 2022 (hse.ie)
Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, to prevent, wherever possible, and to manage medicine shortages when they occur. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.
The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients.
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.
It is important to note that the decision to prescribe or not prescribe any treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process and cannot interfere in the clinical decisions of a medical practitioner. Patients are advised to discuss their treatment and alternative options with their doctor, pharmacist or other healthcare professional as applicable.
