Thomas Gould
Ceist:660. Deputy Thomas Gould asked the Minister for Health if consideration has been given to the removal of the prescription requirement for naloxone. [6792/23]
Amharc ar fhreagraTuesday, 14 February 2023
Ceisteanna (660)
Freagraí scríofa
The Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended sets out the system of control which applies to medicinal products, and identifies those products which may only be supplied on medical prescription.
Naloxone is an active substance contained in a number of medicinal products authorised for use, in both single and combination active substance products (see www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine/results?query=Naloxone&field=ACTIVESUBSTANCES), which are subject to prescription control and may only, in normal circumstances, be supplied on foot of the presentation of a prescription by a patient for whom it is prescribed, and dispensed under the supervision of a pharmacist from a pharmacy. Once so supplied to an individual patient the product can be administered by any person.
In 2015 however the Medicinal Products Regulations were amended with the purpose of this being to allow for the supply and administration of specified prescription-only medicinal products, including Naloxone hydrochloride dihydrate 1 mg/ml pre-filled injection and Naloxone hydrochloride dihydrate 1.8 mg Nasal Spray Solution, without a prescription to a person by:
- a pharmacist, or
- by an individual appointed by a listed organisation,
for the purpose of saving life or reducing severe distress in emergency situations, where that pharmacist or individual has completed an approved course of training regarding the administration of such products and the management of any adverse reaction.
The training to be completed in the case of pharmacists must be delivered by a body recognised by the Council of the Pharmaceutical Society of Ireland (PSI) and approved by the Registrar of that organisation. In the case of the person appointed by a listed organisation, the training to be completed must approved by the Pre-Hospital Emergency Care Council (PHECC) or another body nominated by the Minister for Health for that purpose.
These Regulations provide for the creation of a list of organisations that may procure the specified medicinal products for supply and administration in an emergency, by trained persons in the organisation. This list is maintained by the Health Products Regulatory Authority (HPRA) and is available at www.hpra.ie/homepage/medicines/emergency-medicines/emergency-medicines-search .
The PSI has published an Explanatory Note for Pharmacists on the Supply of ‘Emergency’ Prescription-Only Medicines to a Listed Organisation. The HPRA also have guidance on their website in relation to their role on this matter (see www.hpra.ie/homepage/medicines/emergency-medicines).
In order to procure any of the permitted listed products (Products listed in the Tenth Schedule of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended) as a listed organisation, a number of criteria must be satisfied (Regulation 4D), including the appointment of an accountable person(s) for that organisation. The legislation also sets out a list of responsibilities that the accountable person must meet on behalf of the listed organisation. These relate to:
- overseeing the storage requirements for the product,
- ensuring that the product is sourced appropriately,
- ensuring that the product is only supplied to a person to supply and administer in an emergency,
- maintaining confidential records,
- ensuring that person(s) with responsibility for supplying and administering the product in an emergency is trained in accordance with the framework specified in the regulations,
- assisting in any necessary investigation in the event of an adverse event.
The Regulations set out the records to be kept by pharmacists, pharmacy owners, persons who supply and administer medicinal products in emergencies, listed organisations and accountable persons in such organisations, in respect of each supply and administration of a specified prescription-only medicinal product without a prescription in accordance with these Regulations.
In relation to training for persons employed by a listed organisation, the Pre-Hospital Emergency Care Council have information on their website about training providers and courses available (see www.phecit.ie/PHECC/Publications_and_Resources/Newsletters/Newsletter_Itmes/2016_Summer/Emergency_life-saving_medicines.aspx).
The relevant legislation is S.I. No. 449/2015 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015, (available at: www.irishstatutebook.ie/eli/2015/si/449/made/en/print?q=medicinal+&years=2015.