Clinical Notes : Pharmacology

98. Prescribing Controlled Drug 

Misuse of Drugs Regulations 2017

 

All Prescriptions

  • Can only be supplied on foot of an original valid prescription, which must be physically present and reviewed by the pharmacist prior to dispensing to the patient.

  • Faxed prescriptions are not an original prescription, and are not permitted.

  • A pharmacist supplying a controlled drug must be satisfied as to the identity of the patient and the signature of the practitioner.

  • Dispensed medication may only be supplied to the patient or to a bona fide representative of the patient.

 
 

Scheduled 2 and 3 Controlled Drugs

  • Prescription must be:

    • in ink or otherwise, so as to be indelible

    • signed and dated by the prescriber

  • The following details must be included on the prescription and may be typewritten:

    • Full name of the prescriber (including first name)

    • Address of the prescriber unless it is a health prescription (i.e. GMS prescription, methadone prescription)

    • The telephone number at which the practitioner issuing the prescription may be contacted

    • State whether the prescriber is a registered medical practitioner / dentist / veterinary practitioner / nurse /midwife

    • Prescriber’s registration number

    • Name (including first name) and address of the person for whom treatment is issued.

  • Addressographs (adhesive labels) are not permitted.

  • The prescriber is required to hand write the following particulars on the prescription:

    • Name of the drug (either common/generic name/INN or proprietary/brand name)

    • Pharmaceutical form and strength (where appropriate) of the preparation

    • Amount/total quantity prescribed in words and figures

    • Dose to be taken

  • Repeat prescriptions are not permitted.

  • Where a prescription is to be dispensed in installments

    • the prescription must contain a direction specifying the number of instalments and the intervals at which the instalments may be dispensed.

    • The first instalment must be supplied no later than 14 days from the date specified in the prescription.

    • No instalment can be supplied later than two months after the date specified in the prescription.

  • Pharmacist's obligations :

    • All prescriptions, including GMS duplicate prescriptions, must be endorsed by the pharmacist with the quantity dispensed and the date on which it was supplied and retained on the premises for two years.

 

Scheduled 2 and 3 Controlled Drugs - script requirements

 
 

Schedule 4 Part 1

  • Includes Benzodiazepines and the ‘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

  • Repeat prescriptions are permitted.

  • Prescriptions do not have to be dispensed within 14 days of the date of issue

  • Pharmacist obligations :

  • 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

  • Pharmacists are required to keep a copy of the prescription (including a copy of any endorsements made on the prescription) on the premises for two years after the date of supply.

  • Where the prescription for a Schedule 4 Part 1 controlled drug has been exhausted, the prescription (including GMS duplicate prescriptions) must be endorsed with:

    • the word “dispensed”

    • the date on which it was dispensed

 

Schedule 4 Part 1 Controlled Drugs - script requirements

 

Emergency supply :

  • Controlled drugs (CDs) may never be supplied under the emergency provisions, whether at the request of a patient or a prescriber.

  • This includes Schedule 2 (e.g. morphine), Schedule 3 (e.g. temazepam) and Schedule 4 (e.g. diazepam) controlled drugs.

  • The supply of controlled drugs is tightly controlled by the Misuse of Drugs Regulations 1988 (as amended) due to the dangerous nature of these medicines, their potential for abuse and the associated risks to patients and the public if they are supplied inappropriately

Record keeping requirements :

  • A CD Register (in bound book form) complying with regulations must be used to record incoming and outgoing Schedule 2 and 3 controlled drugs.

  • Records pertaining to all CDs must be retained for a minimum of two years, including registers, prescriptions (or copies of health prescriptions), requisitions , invoices etc.

 

Storage requirements :

  • All Schedule 2 and 3 controlled drugs must be stored in a locked fixed receptacle (safe or cabinet) which

    • Must be secured to a concrete wall or floor

    • Can only be opened by the person in lawful possession of the CD or a person authorised by that person.

    • If the safe does not bear the inscription I.S. 267:1985, the safe must be certified by a Garda Superintendent. Remember to retain this certificate at the pharmacy.

    • Ideally this safe should be located out of the line of sight of the public.

  • The safe custody requirements for Schedule 2 and 3 controlled drugs do not apply to Schedule 4 Part 1 controlled drugs.

 

Destruction requirements :

  • While awaiting destruction, patient-returned Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock and clearly labelled ‘Patient-returned CDs for destruction'.

  • The destruction of Schedule 2 controlled drugs, that are the subject of a record, must be witnessed by an authorised person who must record that the list of drugs  have been destroyed and sign it.  Authorised persons are defined by law.

 
 
 
 
 

1. ICGP

New Misuse of Drugs Regulations 2017 – Advice for GP prescribing

ICGP News

Published 24 August 2017

Access

2. Irish Medical Council

Misuse of Drugs Regulations 2017

Medical Council News

Access

 

3. Pharmaceutical Society of Ireland

Advice on Controlled Drugs (CD) Compliance

PSI - Advice on CD Compliance 

Access

 

4. Pharmaceutical Society of Ireland

Advice on Controlled Drugs (CD) Compliance

PSI - Advice on Emergency Supply

Access

 

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