Medical Council & PSI Guidance on Safe Prescribing and Dispensing of Controlled Drugs

This year, the Medical Council and Pharmaceutical Society of Ireland (“PSI”) updated the joint Guidance on Safe Prescribing and Dispensing of Controlled Drugs (the “Guidance”), which was first published in 2017. The Guidance seeks to aid safer prescribing and dispensing of controlled drugs.

As per the Guidance, Controlled Drugs are defined as “substances, products, or preparations, including certain medicines, that are either known to be, or have the potential to be, dangerous or harmful to human health, including being liable to misuse or cause social harm, are subject to control under the Misuse of Drugs Acts 1977 to 2016.” Under the Misuse of Drugs Regulations 2017, as amended, controlled drugs are categorised into five separate schedules, with the Guidance placing focus on controlled drugs specified in schedule 2, schedule 3 and schedule 4, part 1. However, it is important that Practitioners utilise the Health Products Regulatory Authority website for up-to-date information concerning the classification of authorised medicines containing controlled drugs.

Prescriber/Medical Practitioner obligations include:

• Provide a valid prescription which meets the requirements of the legislation;
• Be satisfied as to the identity of the person for whose treatment the prescription is to be issued;
• Follow relevant national and international prescribing guidelines;
• Within reason, be available to confirm or discuss any matters related to the prescription and the patient;
• Ensure the safekeeping of prescription pads to reduce the risk of theft and forgery;
• Facilitate appropriate withdrawal of controlled drugs and follow-up and refer as necessary.

Pharmacist obligations include:

• Only supply controlled drugs based on a legally valid prescription (be it paper or transferred via Healthmail), or, by way of an essential and legally compliant emergency supply;
• Be satisfied that the signature of the prescriber is genuine, and in the case of a prescription transferred by Healthmail, that it contains the professional registration number of the person issuing it, and can be traced back to the prescriber;
• Prior to supply, be satisfied as to the identity of the person or bona fide representative presenting the prescription or collecting controlled drugs;
• Be vigilant for forgeries or unusual prescribing patterns;
• Store controlled drugs in a safe manner, in accordance with the relevant legislation;
• Record all supplies of schedule 2 controlled drugs (CD2) in the pharmacy’s Controlled Drugs Register;
• Communicate with the medical practitioner if there is any query about the prescription, or; care of the patient;
• Adhere to national guidelines and facilitate appropriate withdrawal of controlled drugs;
• Ensure follow-up and referral to other healthcare professionals/services as necessary.

It is important that both Doctors and Pharmacists have regard to the Guide to Professional Conduct & Ethics for Registered Medical Professionals (2024) and the Code of Conduct – Professional Principles, Standards and Ethics for Pharmacists (2019) in relation to their obligations when prescribing.

The Guidance can be accessed here Safe Prescribing and Dispensing of Controlled Drugs: Medical Council/PSI Joint Guidance | PSI

*This information is for guidance purposes only and does not constitute, nor should be regarded as, a substitute for taking legal advice that is tailored to your circumstances.