Misuse of Drugs Regulations 2017
Significant changes to the Misuse of Drugs Regulations are proposed to be made by the Department of Health in the coming weeks. These changes are summarised below for ease of reference for pharmacists. The full legislation will be available at www.irishstatutebook.ie once this legislation has been signed into law. This is expected to occur before the beginning of April.
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 previously found in schedule 4 of these Regulations are now found in a new schedule 4 part 1 of the new 2017 Regulations. 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 now 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
- dose
- pharmaceutical form
- strength (where appropriate)
- the total quantity written 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 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 new Regulations come into force, shall continue to be valid. Prescriptions for all controlled drugs issued after the new Regulations come into force must comply with the new prescription requirements.
The PSI will send further notification once this legislation is made. In the meantime, it may be useful to consider how these changes will affect the procedures in your pharmacy and, in implementing these changes, to consider collaboration and communication with doctors and other prescribers with whom you work. We understand that the HSE will also communicate these changes to pharmacists, medical practitioners and other prescribers.
On a related note, we are currently working with the Medical Council on joint guidance that sets out the full controlled drug prescription writing requirements.