David Cullinane (Waterford, Sinn Fein)
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413. To ask the Minister for Health his plans to change prescribing rules to better empower community pharmacists; and if he will make a statement on the matter. [33344/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The system of controls around prescribing and dispending of prescription controlled medicinal products for human use (excepting those products subject to additional parameters under the Misuse of Drugs Acts and Regulations) is derived from the framework of Directive 2001/83/EC and Regulation (EC) No 726/2004, and is implemented nationally by the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2022. These regulations apply an up-to-date and comprehensive system of control to medicinal products and particularise those products which may be supplied on medical prescription, and those that may be supplied without prescription by or under the supervision of a registered pharmacy from a registered retail pharmacy business. I have no current plans to change this framework.

This framework is underpinned by the activity of the Health Products Regulatory Authority, being the competent authority responsible for the designation of the legal supply category for a medicine, with such categorisation being particular to the product and an integral part of the marketing authorisation.  A marketing authorisation for any product is granted after an assessment process undertaken to assure the safety, quality and efficacy of the product on the basis of the review of an application submitted by the pharmaceutical company involved.

The Department of Health is committed to the ethos of ensuring that the right care is delivered in the right place and at the right time for all citizens and recognises that all healthcare professionals have a role to play in optimising patient care and service delivery in line with this vision. In delivering on this I recognise that pharmacists are integral to the safe supply of medicines to patients and to the promotion of rational medicines utilisation. Pharmacists provide a clinical service through an accessible network of Registered Retail Pharmacy Businesses operated in accordance with the clinical governance framework outlined in the Pharmacy Act. They work to deliver on specific professional obligations provided for in the Regulation of Retail Pharmacy Business Regulations, SI 488 of 2008, relating to the supply of both prescription controlled and prescription exempt medicinal products to patients, to assure best patient outcomes.     

David Cullinane (Waterford, Sinn Fein)
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414. To ask the Minister for Health if he will allow pharmacists to substitute hormone replacement therapy products without a prescription and without having to resort to a general practitioner; and if he will make a statement on the matter. [33345/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Colleagues in the department and across the health sector continue to work to resolve the issues around supply of Hormone Replacement Therapies. On 19th May, I met with representatives of Marketing Authorisation Holders (MAHs) of products implicated in the recent HRT shortages, together with Health Products Regulatory Authority (HPRA), Pharmaceutical Society of Ireland (PSI), Health Service Executive, Irish Pharmaceutical Union (IPU) representatives and clinical representative from the National Women and Infants Health Programme (NWIHP). An additional stakeholder meeting was held earlier this month with representatives from the Department, HPRA and HSE to discuss and assess the supply of HRT medicines.

Based on information provided by companies involved in the recent HRT shortages, supply of HRT products has largely been restored with more regular supply to resume on the remaining products from July. Each of these companies has confirmed that they have increased their forecasting to meet increased demand.

The Department plans to continue managing medicines shortages through the established multi-stakeholder medicines shortages framework that is coordinated by the HPRA. This framework was established to prevent, wherever possible, and manage medicines shortages.

The system of controls around prescribing and dispensing of human prescription controlled medicinal products (excepting those products subject to additional parameters under the Misuse of Drugs Acts and Regulations) is derived from the framework of Directive 2001/83/EC and Regulation (EC) No 726/2004, and is implemented nationally by the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2022. These regulations apply an up-to-date and comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription. They define what a “prescription” is with reference to those healthcare professionals who are entitled to prescribe.

Pharmacists are experts in medicines and are the professionals optimally placed by virtue of their training to optimise the rational use of medicines in the health system for best patient outcomes, and in partnership with prescribing colleagues, to maximise the benefits and minimise the potential for patient harm when using medicines and pharmacological interventions. Pharmacists supply and dispense prescription controlled medicinal products in accordance with the authority conferred to supply, underpinned by a validly issued prescription.

The Department of Health is committed to the ethos of ensuring that the right care is delivered in the right place and at the right time for all citizens and recognises that all healthcare professionals have a role to play in optimising patient care and service delivery in line with this vision.

David Cullinane (Waterford, Sinn Fein)
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415. To ask the Minister for Health if he has plans to allow pharmacists to be able to supply additional drugs and medications without a prescription and without having to resort to a general practitioner; if so, the name of the drug and the medication; and if he will make a statement on the matter. [33346/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority (HPRA) is the Competent Authority in Ireland responsible for deciding the legal supply category for a medicine. The supply category is specific to the product and is part of the marketing authorisation.

The system of controls around prescribing and dispending of prescription controlled medicinal products for human use (excepting those products subject to additional parameters under the Misuse of Drugs Acts and Regulations) is derived from the framework of Directive 2001/83/EC and Regulation (EC) No 726/2004, and is implemented nationally by the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2022. These regulations apply an up-to-date and comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription. They define what a “prescription” is with reference to those healthcare professionals who are entitled to prescribe.

Pharmacists are experts in medicines and are the professionals optimally placed by virtue of their training to optimise the rational use of medicines in the health system for best patient outcomes, and in partnership with prescribing colleagues, to maximise the benefits and minimise the potential for patient harm when using medicines and pharmacological interventions. Pharmacists supply and dispense prescription controlled medicinal products in accordance with the authority conferred to supply, underpinned by a validly issued prescription.

The Department of Health is committed to the ethos of ensuring that the right care is delivered in the right place and at the right time for all citizens and recognises that all healthcare professionals have a role to play in optimising patient care and service delivery in line with this vision.