611. Deputy Roderic O'Gorman asked the Minister for Health the policy with respect to a prescription for a ‘months’ worth of drugs; whether this represents a generic 28 days work of drugs, or can it represent 29, 30 or 31 days of the drug depending on the month; and if it can only represent 28 days, is it acceptable that this will require a second dispensing during that month. [66799/26]

The system of legislative controls around prescribing and dispensing of prescription-only medicines is implemented nationally by the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2026.

These regulations apply a comprehensive system of control to medicinal products and identify those products which may only be supplied on foot of a medical prescription. They define what a “prescription” is with reference to those healthcare professionals who are entitled to prescribe, and detail the legal requirements as to how a prescription must be written and the dispensing rules in place.

In general, pharmacists must ensure that the dispensing of quantities of all prescription-only medicines in their pharmacy is in accordance with the particular prescription which a medical practitioner has issued.

However, in 2011, the European Commission published the Falsified Medicines Directive (which aims to prevent falsified medicines getting into the supply chain). This Falsified Medicines Directive has been transposed into Irish legislation by

www.irishstatutebook.ie/eli/2022/si/270/made/en/print.

which imposes additional requirements when dispensing in respect of scanning and authenticating all products dispensed. Pharmacists must also comply with this legislation by ensuring that verification and decommissioning of all packs of medicinal products takes place, at the point of dispensing and supply to the patient.

Breaking bulk of a particular medicine (e.g. breaking bulk of a pack of 28 tablets in order to add 2 or 3 more tablets for a month’s supply) is discouraged. Dispensing in original packs is preferable as it enables easier compliance with the Falsified Medicines Directive.

Some manufacturers package their medicinal products in 28- day pack sizes ,while others do so in 30-day pack sizes. If a patient is taking multiple medications per month, it is unlikely that all of them will be packaged in the same pack size.

Pharmacists must also comply with any guidance issued by the pharmacy regulator (the Pharmaceutical Society of Ireland) and act in accordance with the statutory Code of Conduct for pharmacists.

Pharmacists must also ensure that dispensing complies with the requirements of the State Community Drug Schemes (for example , Medical card, Drugs Payment Scheme, Long Term Illness Scheme etc). For example, under the Drugs Payment scheme, patients are entitled to receive a 13-month supply of their medicines per year in circumstances where those medicines are dispensed in 28-day quantities. Alternatively, where a 30 or 31-day supply is dispensed, then 12 months’ supply per year can be dispensed under the scheme. In this example, it is acceptable that a second dispensing happens in a month, but this must only occur once per year (i.e. a maximum of 13 dispensings per year if 28-day quantities are dispensed each month).

For the supply of "controlled drugs" such as morphine, methadone or oxycodone, there is a stricter system of control in place. In addition to the aforementioned legislation, these medicines are also subject to the Misuse of Drugs Acts 1977 to 2016 and the Misuse of Drugs Regulations 2017 (as amended). This legislation sets out specific ways in which the quantities of these controlled drugs must be written on the prescription by the prescriber.

As set out in the www.psi.ie/sites/default/files/2024-07/Joint_Guidance_Final_0.pdf.

On the safe prescribing and dispensing of controlled drugs (which was published as a joint initiative by the Medical Council of Ireland and the Pharmaceutical Society of Ireland), it is an offence for medical practitioners to write or produce a controlled drug prescription that doesn’t comply with the legislative requirements, and it is an offence for a pharmacist to supply controlled drugs from a prescription unless it meets the requirements. Quantities of the controlled drug dispensed must be in strict accordance to the quantities prescribed by the medical practitioner in these cases. It is incumbent upon both medical practitioners and pharmacists to ensure they are aware of their responsibilities and obligations under the Misuse of Drugs legislation to ensure the safe and appropriate supply of controlled drugs to their patients.