Written answers

Wednesday, 18 January 2023

Department of Health

Medicinal Products

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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1270. To ask 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]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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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.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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1271. To ask the Minister for Health the number of opioids licensed for use in Ireland that have been dispensed as part of a public drug scheme or in a HSE hospital, psychiatric facility or primary care setting and by a private GP from 2011 to date in tabular form; and if he will make a statement on the matter. [63636/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly in relation to the data available in respect of the community drug schemes, as soon as possible. 

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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1272. To ask the Minister for Health his views on whether clinical guidance and licensing guidance should be reviewed on oxycontin in the context of litigation in other countries; and if he will make a statement on the matter. [63637/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regultory Authority (HPRA) are responsible for the regulation of medicines, medical devices and other health products and does not provide clinical guidance concerning medicines.

Guidance on the licensing of medicines is harmonised across the EU.  Licensing guidance for the medicines intended for the treatment of different types of pain outlines the clinical trials that should be conducted depending on the severity of pain, the efficacy and safety requirements that need to be met, and the need for long-term safety data (12 months).  Licensing guidance is reviewed, updated and agreed by EU member states, depending on clinical circumstances.

Oxycodone-containing medicines authorised in Ireland are indicated for the treatment of severe pain, that is uncontrolled by other pain medicines.  The lowest effective dose for pain-relief should be used, and should only be used for duration of time when they are considered necessary.  Oxycodone-containing medicines are subject to non-renewable prescription, and are controlled drugs.  Such medicines cannot be promoted to the public.  Therefore, the regulation of oxycodone-containing medicines in Ireland, and across the EU, is strict.  The conditions of authorisation in other jurisdictions may be different.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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1273. To ask the Minister for Health the total number of new medications licensed in the State for dealing with depression, stress and anxiety medications since 1 January 2019 to date; and if he will make a statement on the matter. [63638/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The World Health Organisation (WHO) classifies medicines according to the main therapeutic use of the main active ingredient of the medicine.  The classification system is known as the Anatomical Therapeutic Chemical (ATC) classification system. 

Medicines for the treatment of depression, stress, anxiety and related nervous system conditions are classified by WHO ATC under the broad categories N05 (psycholeptics including antispsychotics, anxiolytics, hypnotics and sedatives) and N06 (psychoanaleptics including antidepressants, psychostimulants, psycholeptics and psychoanaleptics in combinations and anti-dementia medicines).

The ‘Find a medicine’ section of the HPRA website provides information on each authorised medicine and the ATC code.  Lists of medicines authorised since 1 January 2019 under each of the ATC codes, N05 and N06, are attached. 

Please note the following:

- the lists include generics of previously authorised innovator medicines

- due to the broad categories explained above, the medicines listed may be authorised for conditions other than depression, stress or anxiety

- each strength of a medicine has a separate entry on the lists

- medicines on the lists may not be marketed

- each of these medicines are subject to non-renewable prescription.

Medicines authorised since 1 January 2019 under ATC code N05 (psycholeptics including antispsychotics, anxiolytics, hypnotics and sedatives).  A total of 72 medicines: Find a Medicine Results (hpra.ie)

Medicines authorised since 1 January 2019 under ATC code N06 (psychoanaleptics including antidepressants, psychostimulants, psycholeptics and psychoanaleptics in combinations and anti-dementia medicines).  A total of 27 medicines: Find a Medicine Results (hpra.ie)

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