1270. Deputy Colm Burke asked the Minister for Health if he will provide details in respect of the approval process for Oxycontin and drugs containing oxycodone by the HPRA; if the guidance has changed since it was first approved on the Irish market; and if he will make a statement on the matter. [63635/22] 

Stephen Donnelly, Minister for Health: Oxycodone-containing medicines have been authorised by the HPRA since 1998.  These medicines are subject to non-renewable prescription, and are controlled under the Misuse of Drugs Regulations, 2017.  

The marketing authorisation holder for a medicine has a legal obligation to inform the medicines regulator (e.g. HPRA) of information which impacts on the risks and benefits of their medicinal product. They also have a responsibility to ensure that product information (Summary of Product Characteristics (SmPC) and the Package Leaflet (PL)) for each of their authorised medicines is kept up-to-date.  The role of the regulator is to ensure that the marketing authorisation for a medicine, as described in the product information, reflects the available data and outlines the terms under which the balance of benefits and risks of a medicine is positive. 

Oxycodone-containing medicines authorised for use in Ireland contain warnings in the approved product information detailing the risks associated with prescription opioids, including, abuse, misuse, dependence and advice to be followed by healthcare professionals and patients to mitigate against these risks. Specifically, the product information highlights the need for monitoring of patients prescribed oxycodone-containing medicines by healthcare professionals, especially for signs of drug-seeking behaviour associated with dependence. Patients are further advised to immediately speak to their doctor if they are concerned that they may become dependent or notice signs of dependency. 

Additionally, the European Medicines Agency’s safety committee known as the Pharmacovigilance Risk Assessment Committee (PRAC), of which the HPRA is a member, recently concluded a routine periodic review of the risk-benefit balance of oxycodone-containing medicines based on new and emerging safety information. Following this review, PRAC recommended further measures to improve awareness and recognition about the risks of abuse and dependence [opioid use disorder (OUD)]. Additional measures include establishing a treatment strategy prior to starting oxycodone-containing medication based on the agreement of treatment goals and a discontinuation plan with patients. PRAC recommended further strengthening of the warnings in the product information highlighting that patients are informed of the risks and signs of opioid use disorder before and during treatment. Strengthening of the package leaflet will further enhance patient awareness to the signs of dependence and addiction. 

The product information for oxycodone-containing medicines authorised in Ireland has been updated since authorisation and the most recent information is available on the ‘Find a medicine’ section of the HPRA website.