Misuse of Drugs Regulations 2017 (as amended)

The PSI provided a practice update on significant changes made to the Misuse of Drugs Regulations (as amended) when they first came into effect in May 2017. This information was updated in March 2024, following changes to legislation which were made in response to the COVID-19 pandemic and additional legislative changes made in the post-pandemic period. Key changes are outlined below, with further information available in the joint guidance produced by the Medical Council and the PSI on Safe Prescribing and Dispensing of Controlled Drugs.

Changes for Schedule 2 and 3 Controlled Drugs

Key Points:

• Prescriptions for Schedule 2 and 3 controlled drugs can be paper-based or transmitted through Healthmail.
• Prescriptions for Schedule 2 and 3 controlled drugs sent through Healthmail are not required to be signed by the prescriber in his/her usual signature in so far as they are traceable electronically to the prescriber.
• Prescriptions sent through Healthmail for Schedule 2 and 3 controlled drugs must comply with the prescription requirements, however the particulars do not need to be handwritten.
• Prescriptions for Schedule 2 and 3 controlled drugs cannot be repeated. Prescriptions for Schedule 2 and 3 controlled drugs must be retained at the pharmacy premises for 2 years. Healthmail prescriptions must be printed and treated as the original, and the electronic version must also be retained for 2 years.
• Pharmacists are permitted to provide emergency supplies of Schedule 2 and 3 controlled drugs in a quantity of up to five day’s treatment, on foot of a request from a patient or a prescriber, in limited circumstances, and where additional conditions (above and beyond those required for emergency supply of prescription only medicines) are met.

Schedule 4 Controlled Drugs including Methadone and Buprenorphine for Opioid Substitution

Key Points:

• Prescriptions for Schedule 4 controlled drugs can be paper-based or transmitted through Healthmail. 
• Prescriptions for opioid substitution, whether paper-based or sent through Healthmail, must be written on the opioid substitution prescription form. 
• Prescriptions for Schedule 4 controlled drugs sent through Healthmail are not required to be signed by the prescriber in his/her usual signature in so far as they are traceable electronically to the prescriber. 
• Prescriptions for Schedule 4 controlled drugs must comply with the prescription requirements, however the particulars do not need to be handwritten. 
• Pharmacists will be required to keep a copy of all prescriptions and any endorsements made for drugs in part 1 of schedule 4 for two years after the date of supply and mark prescriptions accordingly. Pharmacists are also required to keep a copy of this record of dispensing made on the prescription. 
• Pharmacists are permitted to provide emergency supplies of Schedule 4 controlled drugs in a quantity of up to five day’s treatment, on foot of a request from a patient or a prescriber, in limited circumstances, and where additional conditions (above and beyond those required for emergency supply of prescription only medicines) are met. 
• Prescriptions for drugs in Schedule 4 do not have to be dispensed within 14 days of the date of issue indicated on the prescription.

Note: Pharmacists can provide an emergency supply of methylphenobarbitone, phenobarbitone, phenobarbitone sodium, midazolam, clobazam, or clonazepam, at the request of either a prescriber or a patient, without having to satisfy the additional conditions above, where it is for the treatment of epilepsy.