Medicines Criticality Assessment Group (MCAG)

The Medicines Criticality Assessment Group (MCAG) is a collaborative working group of relevant government, regulatory and healthcare agency bodies that is convened by the Department of Health and chaired by the Health Service Executive (HSE) to facilitate ad hoc rapid assembly of nominated representatives to assess and address emerging human medicinal product (prescription and non prescription) supply issues. MCAG enables collaborative work and system wide perspective on non routine, potentially high impact events.

Following notification of a supply issue from a relevant health service stakeholder (Department of Health, HSE, HPRA and/or PSI) that is requiring more extensive and more immediate cross health-service input and is considered necessary to effectively prevent and/or mitigate a high impact supply issue, the Secretariat liaises with the Chair of the Group to convene an MCAG.

The Medicines Criticality Assessment Group (MCAG) will:

• Discuss the impact of any identified or expected supply chain issues on medicines availability, including, but not limited to, increased demand brought about by public health threats, regulatory or manufacturing issues, geopolitical factors.
• Assess implications of identified specific medicinal product supply issue on the healthcare system and patients and escalate any key concerns to Ministerial level.
• Identity, develop and implement specific shortage mitigation strategies.
• Identify any further actions required and assign responsibility for completion of said actions.
• Assist in the development of clinical guidance for mitigation of impact of specific medicinal product supply issues, as necessary, and where appropriate to do so. This workstream will be led by relevant HSE clinical personnel who will hold responsibility for final output.
• Prepare coordinated communication plan to support dissemination of the recommendation(s)/clinical guidance to relevant health system stakeholders and patients/patient groups, as required.
• Disseminate communication(s) via a mechanism agreed by the group.