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Misuse of Drugs Regulations 2017

There have been significant changes made to the Misuse of Drugs Regulations by the Department of Health which has come into effect since the 4th of May 2017. We ask all healthcare professionals to comply with these changes in their practice.

Changes for Scheduled 2 and 3 Controlled Drugs

The non – handwritten requirements for the specific criteria to be included in the prescription include:

  • Name and address of the patient for whom the treatment is being issued
  • For clarification and identity purposes the first name of the prescriber
  • The prescriber’s registration number on the prescription

The handwritten requirements for the specific criteria to be included in the prescription include:

  • The name of the controlled drug must be included in either brand name or the generic name of the drug
  • The dose
  • Pharmaceutical form
  • Strength ( where appropriate )
  • The total quantity of drug to be dispensed written in both words and figures

Changes for Schedule 4 Part 1 Controlled Drugs

The most significant effect of the new regulations is in relation to benzodiazepines and ‘z-drugs’, zopiclone and zaleplon. Benzodiazepines will be removed from the Misuse of Drugs Exemption Order and, as result; restrictions will be in place on the possession of controlled drugs and will apply to all benzodiazepines. The Benzodiazepines previously found in Schedule 4 are now found in Schedule 4 Part 1 of the new 2017 regulations. The ‘z-drugs’ are now subject to control under the Misuse of Drugs Act and will also be listed in Schedule 4 Part 1.

The specific criteria to be included on a prescription for Schedule 2 and 3 controlled drugs now also apply to controlled drugs in Schedule 4 Part 1 which includes most benzodiazepines and ‘z-drugs’. These prescriptions ( similar to prescriptions in methadone ) do not have to be handwritten, however they must include:

  • The name ( including the first name ), and registration number of the prescriber
  • The name of the drug ( either common/generic name/ INN or proprietary/brand name )
  • Dose
  • Pharmaceutical form
  • Strength ( where appropriate )
  • The total quantity of drug to be dispensed in both words and figures

Current Medicinal Products ( Prescription and Control of Supply ) Regulations ( specifically Regulations 7 ) will continue to apply for controlled drugs in Part 1 of Schedule 4. Prescriptions for drugs in Part 1 of Schedule 4 will not have to be dispensed within 14 days of the date of issue and may be repeated.

Where the prescriptions are to be repeated, the pharmacists are required to keep a copy of all prescriptions and any endorsements shall be made and retained on the premises from which the drug was supplied for two years from the date of supply. The Pharmacists must keep a record of:

  • The quantity of each controlled drug supply
  • The date on which supply was made
  • The name and address of the pharmacy where the controlled drug was supplied from

In order to minimise the impact of the changes to both patients and healthcare professionals, prescriptions for drugs listed in the new Schedule 4 Part 1 issued before these new Regulations came into force will still be valid. Prescriptions issued on or after the 4th of May 2017 must adhere to the new prescription requirements. The 2017 Regulations are not yet available on the Irish Statute Book but when they are they can be accessed on www.irishstatutebook.ie. For more information about the details on the commencement of the regulations, please see the Department of Health website at: www.healthgov.ie.