Stephen Donnelly (Wicklow, Fianna Fail)
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Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

Medicine shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicine 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 medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

In many instances a shortage of a particular medicine is effectively addressed to ensure continuity of care for a patient including through the substitution for a generic version (in the case of a branded medicine short supply) or a generic version from a different manufacturer (in the case of a generic medicine in short supply). Under the Health (Pricing and Supply of Medical Goods) Act 2013 medicines which are deemed to be interchangeable can be directly substituted for one another by a pharmacist.

Where an interchangeable product is not available in Ireland, a pharmacist, in consultation with the prescriber, can source a medicine containing the same active ingredient in order to ensure that continuity of patient care is maintained, wherever possible. Such medicines may be sourced in another European Member State, or by a specialist wholesaler in a third country, and are known as exempt medicinal products (EMPs). EMPs have not been granted a marketing authorisation in Ireland by the HPRA but are sourced in response to a bona fide unsolicited order in order to fulfil the special needs of a patient. These medicines will however have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in another EU Member State or third country by the respective competent authority for medicines.

In other instances, where a medicine shortage occurs due to a more global issue affecting multiple countries, a patient may be directed to return to their clinician to consider prescribing an alternative medicine for the treatment of their condition.

The HSE maintains a reimbursement list of medicines that are provided under the General Medical Services (GMS) scheme or the Drugs Payment Scheme (DPS). These products are approved for the schemes by the HSE. In some cases, an alternative product sourced to maintain continuity of care in the event of a medicine shortage may be more expensive than the original medicine prescribed and will not ordinarily be included in the reimbursement list.

However, GMS medical card holders can apply to the local HSE health office to have these costs covered under the discretionary hardship arrangements. Under the DPS an individual or family will pay no more than €124 each calendar month for approved prescribed medicines. In certain cases, the cost of EMPs can be included in the total costs of medicines up to the threshold of €124. Patients are advised to consult with their pharmacist or clinician, who can make an application under the discretionary hardship arrangements on their behalf or to have the product covered by the relevant scheme.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.