Frequently Asked Questions

Controlled Drugs

Expand all Collapse all

• 1. What are the legal requirements for a controlled drug prescription to be valid for dispensing?

  The prescription writing requirements for schedule 2, 3 and 4 Part 1 controlled drugs are set out in Regulation 15 of the Misuse of Drugs Regulations 2017.
  
  Prescriptions which meet the prescription writing requirements of Regulation 15 of the Misuse of Drugs Regulations, are valid for dispensing under Regulation 16 of the Misuse of Drugs Regulations, where they meet the additional criteria set out under Regulation 16.
  

  Controlled Drug Prescription Requirements

  
  [Click on the table to view large version and print]
  
  For further information please refer to Appendix 1 of the PSI Guidelines on the Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business.

  We have also issued Advice on Controlled Drug Compliance, which you may find helpful.

• 2. Do you have a list of controlled drugs and their schedules?

  The Health Products Regulatory Authority (HPRA) is the regulator of medicinal products, and the body that determines the legal classification of each medicinal product on the Irish market. You can check the legal classification of a medicinal product through the ‘Find a medicine’ facility on HPRA’s website. If you search for a particular medicine, the legal classification of the individual medicinal product is then provided under the heading ‘Status’ and the subheadings ‘Dispensing Status’ and ‘Conditions of licence’.

  Alternatively you can contact the HPRA on +353 1 676 4971 or info@hpra.ie.

• 3. Where can I get a Register for Controlled Drugs and a Controlled Drugs Destruction Record Book?

  
  

  The PSI provides controlled drugs registers to registered pharmacies and pharmacists to assist them in complying with the requirements set out in the Misuse of Drugs Regulations 2017. The PSI does not supply controlled drug registers to other organisations.

  
  

  The end of the PSI Controlled Drugs Register includes a section for recording the destruction of schedule 2 controlled drugs, which require witnessed destruction (e.g. schedule 2 controlled drugs which have expired or been damaged).  The PSI also provides a Controlled Drugs Destruction Record Book for recording the destruction of schedule 3 or 4 controlled drugs or ‘patient-returned’ schedule 2, 3 or 4 controlled drugs (i.e. controlled drugs that do not require witnessed destruction). 

  
  

  Pharmacists can order a controlled drug or duty register by filling out an online form. All orders received will be processed within seven working days.

  
  

  Some pharmacies have developed their own customised registers which better suit their particular needs and these are equally acceptable, provided they meet all relevant legislative requirements detailed in the Misuse of Drugs Regulations 2017.

• 4. What are the record keeping requirements for controlled drugs?

  Record	Retention Period	Where
  Prescriptions	Two years	On the pharmacy premises
  Orders and invoices, or a copy of these, relating to the supply of medicinal products to a registered medical practitioner, registered dentist, or registered veterinary surgeon for administration to a patient in the course of their professional practice	Two years	On the pharmacy premises
  Prescription Register i.e. the daily dispensing report signed and dated by the pharmacist on duty	2 years from date of the last entry made in the register, or date the print out was signed by the pharmacist on duty	On the pharmacy premises
  Register of Controlled Drugs	2 years from date of the last entry made in the register	On the pharmacy premises
  Orders, prescriptions or requisitions against which a controlled drug is supplied	Two years	On the pharmacy premises
  Scanned or physical copies of Schedule 4 Part 1 controlled drug repeatable prescriptions which are dispensed in part and any endorsements made	Two years	On the pharmacy premises
  Invoices, or other like record, issued in respect of all Schedule 3 and Schedule 4 Part 1 controlled drugs obtained or supplied from the pharmacy	Two years	Recommended to be kept on the pharmacy premises, but not specified in legislation
  Invoices, or other like record, issued in respect of all Schedule 5 controlled drugs obtained by the pharmacy	Two years	Recommended to be kept on the pharmacy premises, but not specified in legislation
  Records in relation to sale or supply of exempt medicinal products	Five years	On the pharmacy premises
  A record of the registered pharmacist responsible for the personal supervision of the sale and supply of medicinal products at the premises i.e. the Duty Register	Recommended minimum 2 years, but not specified in legislation	Recommended to be kept on the pharmacy premises, but not specified in legislation
  Records to show the safe operation of the pharmacy e.g. fridge and storage room temperature records, invoices for medicinal products not listed above	Recommended minimum 2 years, but not specified in legislation	Recommended to be kept on the pharmacy premises, but not specified in legislation

  
  Detailed 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 (Version 2, May 2017).
  
  The following advice may also be useful:
  

  • 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.
  • 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, must be retained on the premises for two years.
  • Where the 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 copy of the prescription (including a copy of any endorsements made on the prescription- this may include a scanned copy) 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.

• 5. What are the custody requirements for controlled drugs and how can I adhere to them?

  All Schedule 2 controlled drugs (CD2s) must be stored in the safe. This includes Methadone preparations. See PSI guidance on methadone. 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 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. These requirements can be found in SI 321/1982 - Misuse of Drugs (Safe Custody) Regulations, 1982.

• 6. If a prescription for a Schedule 2 or Schedule 3 controlled drug is written for 3 instalments of 28 tablets can I dispense all 3 instalments?

  
  

  Regulation 16 of the Misuse of Drugs Regulations 2017 states that all instalments must be dispensed at stated intervals within 2 months from the date of the prescription.
  
  Therefore, if all instalments are dispensed at the specified intervals and the final instalment is within the 2 month time frame, it is acceptable to dispense all 3 supplies to the patient. It is important to remember the first instalment must always be dispensed within 14 days from the date on the prescription.

• 7. How do I manage the destruction of controlled drugs?

  Information on the destruction of controlled drugs can be found in the PSI Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business.

  Section 3.2 of these guidelines outlines the specific requirements for the destruction and disposal of schedule 2, 3 and 4 controlled drugs.