Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly managing and mitigating medicine shortages is the subject of several workstreams across the Department and wider health service.

Department officials have reached out to our medicines regulator, the Health Products Regulatory Authority (HPRA), who have provided the following information regarding the shortages of medicinal products of interest to the Deputy:

Mundipharma, the Marketing Authorisation Holder for OxyNorm 10?mg/ml solution for injection or infusion, notified the HPRA on the 16th of June of a shortage of the 1?ml presentation which is expected to return to stock end of July/beginning of August. The HPRA was also notified on the 1st of July of a shortage of the 2?ml presentation which is expected to return to stock in September.

Shortages were also notified in March for the following AS Kalceks medicines. Resupply for each is currently anticipated mid to late August:

• Oxycodone hydrochloride 10 mg / ml solution for injection / infusion (1ml) PA2165/005/001
• Oxycodone hydrochloride 10 mg / ml solution for injection / infusion (2ml) PA2165/005/001
• Hydromorphone hydrochloride 20 mg / ml solution for injection / infusion PA2165/023/001
• Hydromorphone hydrochloride 50 mg / ml solution for injection / infusion PA2165/023/002

A medicine shortage is when the supply of a medicinal product is inadequate to meet the needs of patients. In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. When the HPRA receives a shortage notification, its role is to coordinate a multistakeholder response via the National Medicines Shortages Framework ("the framework"). The notification of possible shortages to the HPRA is the basis for triggering the framework and the associated coordinated multi-stakeholder response as required, including preventative or mitigation strategies.

The HPRA maintains a list of current shortages on its website and is in regular contact with suppliers in relation to these shortages with a view to minimising their duration and impact on patients. The webpage of the HPRA is updated daily as the HPRA receives new information related to ongoing and newly notified shortages. All notified hydromorphone and oxycodone shortages are currently listed on the dedicated HPRA notified shortages webpage and updates are published contemporaneously as they are received. Due to the critical nature of these medicines, these cases are being closely monitored and prioritised by the HPRA and mitigative strategies are actively being explored and pursued. These include, but are not limited to, liaising with suppliers of alternative marketed opioid analgesic intravenous medicines and expediting any outstanding regulatory issues that are causing delays in resupply.

An exempt medicinal product (EMP) is a medical product which is not licensed in Ireland but is prescribed by a doctor in the event of a lack of a licensed alternative. If a valid prescription is issued for an EMP in line with regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient. This will occur via the patient’s chosen pharmacy in line with their prescription.

Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 includes an exemption which enables practitioners to prescribe a medicine as an EMP under that practitioner’s direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.

Wholesalers and manufacturers are required by law to notify the HPRA in relation to any exempt products they source.

An EMP may not be prescribed or supplied in situations where an authorised or registered equivalent (i.e. same active substance(s), strength and dosage form) is available in Ireland. Healthcare professionals will attempt to source an alternative licenced medication prior to prescribing EMPs.