Misuse of Drugs Regulations 2017 

Updated 4 May 2017

The significant changes made to the Misuse of Drugs Regulations by the Department of Health are in effect from 4 May 2017.

Details on the commencement of the regulations is available on the Department of Health website.

Changes for Schedule 2 and 3 Controlled Drugs

The name and address of the patient no longer has to be handwritten by the prescriber, however a number of additional elements are required on the prescription in order to aid identification and ensure clarity:

  • the first name of the prescriber (not required to be handwritten)
  • the prescriber’s registration number (not required to be handwritten)
  • the name of the controlled drug (required to be handwritten). This can be either the brand name or the generic name of the drug.

Changes for Schedule 4 Part 1 Controlled Drugs

The benzodiazepines and z-drugs previously found in schedule 4 of these Regulations are now found in a new schedule 4 part 1 of the new 2017 Regulations. Zolpidem is an example of a z-drug that was previously found in schedule 4 of these Regulations and is now found in schedule 4 part 1. The new Regulations also state that the z-drugs zopiclone and zaleplon are now subject to control under the Misuse of Drugs Act and will also be listed in schedule 4 part 1.

One of the most significant effects of the new Regulations, 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 also be required for these medicines.

The specific criteria to be included on a prescription for schedule 2 and 3 controlled drugs will now also apply to drugs in schedule 4 part 1, however (similar to prescriptions for methadone) these will not have to be handwritten. The details required are:

  • the name (including first name) and registration number of the prescriber
  • name of the drug (either the brand name or the generic name of the drug)
  • dose
  • pharmaceutical form
  • strength (where appropriate)
  • the total quantity in both words and figures

Prescriptions for drugs in schedule 4 part 1 will not have to be dispensed within 14 days of the date they are issued on the prescription and may be repeated.

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.

Prescriptions for drugs listed in schedule 4 part 1, issued before the 4 May 2017, shall continue to be valid. Prescriptions for all controlled drugs issued after this date must comply with the new prescription requirements.

On a related note, we have been working with the Medical Council on joint guidance that sets out the full controlled drug prescription writing requirements, with new legislative changes now incorporated. Please see the consultation section of our website to read the draft joint guidance and the invitation to provide your feedback on its content and usefulness.

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