Catherine Byrne (Dublin South Central, Fine Gael)
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I propose to take Questions Nos. 508 and 509 together.

I think it is very important to monitor trends in the prescription of psychotropic drugs in Ireland including to children and young adults. It is also important to ensure that prescribing policies are evidence based thereby ensuring safe use of these medicines.

The Deputy will be aware that all medicines have side effects. However before being made available to the public a medicine undergoes an authorisation process where the medicine’s safety, quality and efficacy is assessed, based on the results of clinical trials. It is only when the risk benefit analysis is positive, i.e. that the potential benefits to the patient outweigh the potential risks that the medicine receives an authorisation.

Once available a medicine is then subject to ongoing monitoring and evaluation through a process of pharmacocovigilance which operates at EU wide level to monitor the use of the medicines in large numbers of patients and manage and analyse information on suspected adverse reactions to medicines.

European reviews of certain antipsychotics, antidepressants, stimulants and opioids have resulted in updates to product information in order to support better informed prescribing and use of these medicines in various patient groups including children. Important safety updates are communicated by the Health Products Regulatory Authority (HPRA) to healthcare professionals via their Drug Safety Newsletter. The HPRA, in conjunction with its European counterparts continues to review the safety of authorised medicines and take appropriate regulatory action when necessary.

In Ireland there are a number of sources of prescribing guidelines. More recent guidelines include a Consensus Statement issued by the College of Psychiatry on the use of benzodiazepines in specialist mental health services (2012), Guidance issued by the Irish College of General Practitioners on Child and Adolescent Mental Health: Diagnosis and Management (2013), and the Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners 2016. Section 42 of the Medical Council Guide states for example that doctors should keep up to date with developments in medication safety and seek independent, evidence-based sources of information on the benefits and risk of the medicine. It also states that doctors should be aware of the dangers of drug dependency when prescribing benzodiazepines, opiates and other drugs with addictive potential and should take reasonable steps to make sure they are not inappropriately obtaining drugs from multiple sources.

The Health Service Executive (HSE) has also been actively involved in ensuring appropriate prescribing of psychotropic drugs. Reports are sent to GPs on a regular basis setting out the number of benzodiazepine and ‘z’ drug prescriptions dispensed to their patients and these reports allow GPs to compare their prescribing patterns to their peers. The reports also highlight where patients are on these medications for longer than the recommended period. The HSE Medicines Management Programme has also written to hospital consultants recommending that where a patient is not being treated with benzodiazepines or z drugs on entering hospital that the discharge summary should not contain such medication.

The Misuse of Drugs legislation imposes tight controls on all controlled drugs. A number of changes to the Misuse of Drugs Regulations are due to be implemented shortly. One of the most significant effects of the new Regulation in relation to benzodiazepines and z drugs is that the restrictions in place on the possession of controlled drugs will now apply to these medicines. A form of controlled drug prescription will now be required for these medicines.