Advice on Controlled Drug (CD) Compliance

Compliance with the various requirements for safe custody, prescriptions and record-keeping for controlled drugs (CDs) are an important element of the PSI’s routine inspections of pharmacies. The CD register and destruction record books issued to all pharmacies by the PSI aim to facilitate pharmacists with these requirements and their own ongoing audit of the management of CDs within their pharmacy. The inspectors would like to highlight the following key points to pharmacists regarding the various requirements.

Prescriptions

Controlled drugs (Schedule 2 ,3, 4) can only be supplied on foot of legally valid prescription, which may be paper-based or transferred through Healthmail. Prescriptions received through Healthmail must be printed at the pharmacy. The prescription must be available in the pharmacy and reviewed by the pharmacists prior to dispensing to the patient.

Copies of prescriptions received by fax or by other electronic means are not legally valid prescriptions and must not be treated as such.

Pharmacists may provide an emergency supply of a controlled drug in Schedule 2, 3 and 4, in a quantity to up to 5 day’s treatment, in limited circumstances, where the pharmacist considers the supply to be necessary, safe and appropriate, and where specific additional conditions (above and beyond the conditions required for a prescription only medicines) are met,. Further information is available in the joint guidance produced by the Medicial Council and the PSI on Safe Prescribing and Dispensing of Controlled Drugs.

When supplying controlled drugs, pharmacists must remember to check for signs of unusual, excessive or inappropriate prescribing and bring concerns to the attention of the prescriber or the relevant statutory authority.

Prescription for Schedule 2 and 3 Controlled Drugs

The prescription is valid for fourteen (14) days from the date of issue indicated on the prescription. The prescription is not valid before the date specified in the prescription.

Paper-based prescriptions must be:

in ink or otherwise, so as to be indelible.
signed and dated by the prescriber.

Healthmail Prescriptions must be:

transmitted by the national electronic prescription transfer system
state the date of issue
state the professional registration number of the prescriber
traceable electronically back to the prescriber

The following details must be included on the prescription:

Full name of the prescriber (including first name)
Address (within Ireland) of the prescriber unless it is a health prescription (i.e. GMS prescription, opioid substitution 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. An addressograph (adhesive label) will not fulfil the requirement for this information to be indelible.

The prescriber must include the following particulars, and in the case of paper-based prescriptions, these must be handwritten 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 instalments, 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.
All prescriptions, including GMS duplicate prescriptions and printed Healthmail prescriptions, must be endorsed with the quantity dispensed and the date on which it was supplied and retained on the premises for two years. Electronic versions of Healthmail prescriptions must also be retained for two years.

Prescriptions for Schedule 4 Part 1 Controlled Drugs

Prescriptions for drugs in Schedule 4 Part 1 do not have to be dispensed within 14 days of the date of issue indicated on the prescription.

Paper-based Prescription must be:

in ink or otherwise, so as to be indelible
signed and dated by the prescriber

Healthmail Prescriptions must be:

transmitted by the national electronic prescription transfer system
state the date of issue
state the professional registration number of the prescriber
traceable electronically back to the prescriber

The following details must be included on the prescription:

Full name of the prescriber (including first name)
Address (within Ireland) of the prescriber unless it is a health prescription (i.e. GMS prescription,opioid substitution prescription)
The telephone number at which the practitioner issuing the prescription may be contacted
State whether 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. An addressograph (adhesive label) will not fulfil the requirement for this information to be indelible.

The specific criteria to be included on a prescription for Schedule 2 and Schedule 3 controlled drugs also applies to controlled drugs in Schedule 4 Part 1, however (similar to prescriptions for opioid substitution) they are not required to be handwritten:

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 permitted.
Where the prescription has been indicated by the prescriber to be repeated, and where the prescription is not exhausted, the prescription (including GMS duplicate prescriptions) must be endorsed with:

the quantity of each controlled drug supplied
the date on which the 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 paper-based prescription for a Schedule 4 Part 1 controlled drug 9 (or printed version of a Healthmail prescription) has been exhausted, the prescription (including GMS duplicate prescriptions) must be endorsed with:

the word “dispensed”
the date on which it was dispensed

The prescription must be retained on the premises for two years.

Emergency Supply

Pharmacists may provide an emergency supply of a controlled drug in Schedule 2, 3 and 4, in a quantity to up to 5 day’s treatment, in limited circumstances, where the pharmacist considers the supply to be necessary, safe and appropriate, and where specific additional conditions (above and beyond the conditions required for a prescription only medicines) are met. Further information is available in the joint guidance produced by the Medical Council and the PSI on Safe Prescribing and Dispensing of Controlled Drugs

Record keeping

Any corrections entered in the CD Register must be made by footnote (correction fluid and alterations to entries are not permitted).
Previously dispensed controlled drugs returned to the pharmacy must never be re-introduced into stock and/or re-used. The destruction of these medicines should be recorded in the designated ‘Controlled Drugs Destruction Record Book’ provided by the PSI.
Don’t forget to reconcile the balance indicated in the register against the physical stock located in the CD Safe on a regular basis. Pages 12/13 of the PSI CD register can be used to record regular accuracy checks by the supervising pharmacist.
CD Registers must be kept at the pharmacy premises (not offsite) for two years from date of last entry.
Invoices for Schedule 3, Schedule 4 Part 1 and Schedule 5 controlled drugs must be kept for a period of two years and it is recommended that they are kept on the pharmacy premises.
All prescriptions for Schedule 2 and Schedule 3 controlled drugs, including GMS duplicate prescriptions, and printed and electronic versions of Healthmail prescriptions, must be retained on the premises for two years.
Where a paper-based prescription for a Schedule 4 Part 1 controlled drug has been indicated by the prescriber to be repeated, and where the prescription is not exhausted, pharmacists are required to keep a copy1 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 must be retained on the premises for two years.
Further guidance on the record keeping requirements for drugs is contained in the Register of Controlled Drugs provided by the PSI and in the PSI Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business (Undergoing update to reflect 1 March 2024 legislative amendments). Relevant pharmacy and medicines legislation are available on the PSI website.

Safe Custody

All Schedule 2 controlled drugs (CD2s) must be stored in the safe. This includes Methadone preparations. See guidance on PSI Guidance for Pharmacists on the Safe Supply of Methadone and Buprenorphine for Opioid Substitution (Undergoing update to reflect 1 March 2024 legislative amendments).
All Schedule 3 controlled drugs (CD3) must be stored in the safe. This includes temazepam (e.g. Nortem®, Tenox®, etc) preparations.
The safe custody requirements for Schedule 2 and 3 controlled drugs do not apply to Schedule 4 Part 1 controlled drugs.
Expired or non-conforming (e.g. damaged) Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock and clearly labelled ‘CDs for destruction'. Expired or damaged Schedule 2 CDs should be destroyed in the presence of an authorised person i.e. member of An Garda Siochana or PSI Authorised Officer (Inspector).
Patient-returned CDs should be promptly destroyed. 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'.
To meet ‘Safe Custody’ requirements, all safes for the storage of controlled drugs must be secured to a concrete wall or floor. 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.

(This was first issued in the PSI Newsletter February 2012 and updated in March 2024)

*This may include a scanned copy