Dáil Éireann Debate, Tuesday - 8 September 2020
1179. Deputy David Cullinane asked the Minister for Health his views regarding the changing of the status of naloxone hydrochloride from Schedule 1a to Schedule part 1 under the S.I. No. 540/2003; if the change of status has been considered; and if he will make a statement on the matter. [21498/20]
Amharc ar fhreagraNaloxone is a medicine used to reverse the effect of opioid drugs such as heroin, morphine and codeine. It is contained in a number of medicinal products and presentations authorised on the Irish market for different indications including: in combination with opioid analgesics to counteract opioid-induced constipation; emergency treatment for respiratory depression associated with known or suspected opioid overdose or intoxication; or in combination with another drug to treat opioid dependence in persons who are also receiving medical, social and psychological support. Based on these authorised indications, use of naloxone on a regular basis should be subject to ongoing medical supervision.
Naloxone is listed in Part A of the First Schedule to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I No. 540 of 2003), as amended (the ‘Prescription Regulations’). This essentially means that where it is supplied against a prescription, it may be dispensed one occasion only, also known as being non-repeatable.
Following the making of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), as amended, the criteria for the determination of the classification of a medicinal product, is no longer ultimately determined by reference to the First Schedule to ‘Prescription Regulations’. The classification decision is now a matter for the marketing authorisation holder and the appropriate regulatory authority.
For a medicinal product to be available on the market in Ireland it must be granted a marketing authorisation by the Health Products Regulatory Authority (HPRA) or by the European Commission, following a recommendation by the European Medicines Agency (EMA).
Regulation 9 of the 2007 Regulations requires that the marketing authorisation holder, at the time of application or renewal of a marketing authorisation should indicate whether the medicinal product is one which should be available either: on foot of a prescription; only from a pharmacy; or on general sale.
Regulation 12 of the 2007 Regulations then outlines the criteria that the HPRA must consider when making a determination of this supply classification. These criteria are transposed from EU requirements detailed in the Pharmaceutical Directive, Dir 2001/83/EC.
Therefore, it is up to the marketing authorisation holder to apply for a reclassification for its medicinal product and to supply the necessary evidence to support the safety of any such reclassification.
For injectable forms of naloxone, under EU law, any medicinal products which are typically prescribed by a doctor to be administered parenterally (injected) shall be subject to a prescription. For intranasal forms of naloxone, indicated for emergency treatment for respiratory depression associated with known or suspected opioid overdose or intoxication, it would again be up to the marketing authorisation holder to seek a reclassification from the appropriate regulatory authority.
The only intranasal naloxone product currently marketed in Ireland, Nyxoid® is authorised via the centralised procedure by the European Commission and is currently subject to prescription. Any applications to a change in supply classification would have to be made by the marketing authorisation holder to the EMA on behalf of the Commission. It could not be reclassified at a national level.
The marketing authorisation for Nyxoid® states that it, “should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established. Patients or any other person who might be in a position to administer Nyxoid® must be instructed in its proper use and the importance of seeking medical assistance.”
In addition, the Nyxoid® marketing authorisation requires that a post-authorisation efficacy study on the effectiveness of intranasal naloxone administration by lay people in reversing opioid overdose be conducted. This study is scheduled for completion by the end of 2022. Therefore, it is unlikely that the EMA would consider any application for reclassification without a positive review of this data.
Nevertheless, in Ireland, there are mechanisms to ensure access to naloxone in emergency situations. The HSE operates a take home naloxone scheme- where naloxone can be prescribed to a person who is at risk of overdosing on opioids and the person who uses drugs and a friend or family member will be trained in its safe and appropriate use.
Additionally, naloxonecan be sourced and held by listed organisations and administered for suspected opioid overdose by suitably trained persons as provided for by Regulations 4C-E of the 'Prescription Regulations'.
People who use drugs, or their family members, are encouraged to speak to their doctor about naloxone. Organisations interested in accessing and holding naloxone for emergency administration are encouraged to follow the information in the following links:
http://www.hpra.ie/homepage/medicines/emergency-medicines
https://www.phecit.ie/PHECC/Publications_and_Resources/Newsletters/Newsletter_Itmes/2016_Summer/Emergency_life-saving_medicines.aspx
