This webinar was recorded on 9th of October 2024
Speaker:
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Jennifer McCartan, Medicine Shortages Coordination Lead, Health Products Regulatory Authority
Resources:
Presentation: Here
Previous Webinar - Medicines Shortages: A multistakeholder framework approach to shortages May 10th 2023
Summary:
In this webinar Jennifer McCartan from the Health Products Regulatory Authority (HPRA) discusses medicine shortages, why they occur and the multi-stakeholder framework approach to handling medicine shortages in Ireland. She explains that medicine shortages occur when the supply is inadequate to meet patient needs. The causes are complex and multifactorial and include manufacturing-related issues, product quality problems, and unexpected increases in demand.
An overview of the many stakeholders in the multi-stakeholder framework including the HPRA, HSE, marketing authorisation holders (MAHs), manufacturers, wholesale distributors, healthcare professionals, and patient representative groups is provided. Jennifer also provides an overview of the coordination role of the HPRA.
The value of timely notification/reporting of potential or actual medicines shortages is emphasised and how this allows for effective coordination and stakeholder engagement and in helping to prevent or mitigate a shortage is outlined. An overview of impact assessments of medicines shortages is presented. Some trends and data relating to medicine shortages are presented including average time of notification, source of first notification and therapeutic area impacted.
The HPRA’s searchable list of medicines shortages function on its website is outlined as an overview of the Medicines Criticality Assessment Group (MCAG) with worked examples.
An overview of the European Medicines Agency (EMA) and its expanded mandate & EU strategy in this area is discussed in terms of the European activities focused on shortages, including legislation and regulations in place.