by Lyn McCarthy , Katie Nugent October-29-2024 in Healthcare Law
The Safe Prescribing and Dispensing of Controlled Drugs, a joint initiative between the Medical Council and the Pharmaceutical Society of Ireland (PSI), has recently been revised for 2024.
The guidance is a collaborative guide and part of a joint initiative between the two professional regulators relating to the prescribing and dispensing of controlled drugs. The guidance serves to drive standards and encourage best practice in the treatment of patients across both professions.
- Updated Guidance
The guide, first launched in 2017 following the enactment of the Misuse of Drugs Regulations 2017, has been updated to reflect legislative changes introduced by amendments to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended), including changes relating to the emergency supply of schedule 2, 3 and 4 controlled drugs and in light of changes introduced by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020.
- Controlled Drugs
In Ireland, controlled substances are governed by the Misuse of Drugs Acts and Regulations which impose strict legal obligations on pharmacists and prescribers charged with responsibility for the safe control of these substances. It is an offence for prescribers (including doctors) and pharmacists if they fail to adhere to these regulations. It is an offence for a medical practitioner to write or produce a controlled drug prescription that does not comply with the legislative requirements and it is an offence for a pharmacist to supply controlled drugs from a prescription unless it meet the requirements. Medical practitioners and pharmacists when registering with the Medical Council and the Pharmaceutical Society of Ireland (PSI) respectively, commit to adhering to professional standards and ethical guidelines set by their respective regulators.
The Misuse of Drugs Regulations categorise controlled drug substances into five schedules which range from the most tightly controlled in schedule 1 to the least tightly controlled in schedule 5. Schedule 4 is divided into part 1 and part 2. The updated guidance aims to facilitate safer prescribing and dispensing of controlled drugs with a particular focus on controlled drugs in schedules 2, 3 and schedule 4 part 1. All prescribers and pharmacists are required to familiarise themselves with and refer to the complete list of controlled drugs in each schedule.
- Key Provisions
In terms of the updated guidance, the key provisions of the guidance include:
- The circumstances in which a prescription can be written privately or on a ‘Health prescription”, those that can be sent via Healthmail and those which are required to be hand written;
- Specific guidance in respect of prescriptions which can be repeated, those which cannot and prescriptions which can be extended for a defined period by a pharmacist;
- The guidance provides very clear parameters in respect of the circumstances in which an emergency supply of a prescription only medicine is permissible i.e. in emergency situations where the prescriber is unable to supply the prescription immediately but undertakes to provide it within 72 hours.
- In addition, the guidance provides that a pharmacist can provide an emergency supply of a prescription only medicine based on a patient’s request where they have interviewed the patient and are satisfied that there is an immediate need for supply, where it is impracticable to obtain a prescription without undue delay and the treatment has previously been prescribed for the patient and the dose can be verified. In the case of controlled drugs in schedules 2, 3 and 4, pharmacists need to have regard to further specific conditions in accordance with the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended).
- In the context of the treatment of epilepsy, pharmacists can provide an emergency supply of methylphenobarbitone, phenobarbitone, phenobarbitone sodium, midazolam, clobazam, or clonazepam, at the request of either a prescriber or a patient, without having to satisfy the additional specific conditions.
- The guidance also provides that a prescription for a controlled drug which has been prescribed by a practitioner or prescriber in another EEA state or the UK is not valid for dispensing in Ireland. Prescribers as referred to in the guidance relate to those who are registered in Ireland.
The guidance aims to ensure the safe, collaborative and effective care of patients. It encourages pharmacists and medical practitioners to engage with each other without delay where there is any confusion around prescribing and dispensing controlled drugs and to communicate and collaborate in the care of patients in high-risk groups.
- Professional Standards
In addition to its use for pharmacists and medical practitioners alike, the guidance forms part of the applicable guidance and standards for the prescribing and dispensing of controlled medications. Accordingly, the updated guidance is of key importance to professional regulators and legal practitioners involved in determining the applicable standards against which allegations in respect of a registrant health professional ought to be assessed.
In conjunction with the guidance, pharmacists and prescribers are strongly advised to consult the relevant legislation and the updated guide to ensure their compliance with same. A link to the 2024 guide can be found here.
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About the Authors
Lyn McCarthy
Lyn is a partner in the Healthcare team at Hayes solicitors. Lyn advises clinical practitioners and indemnity bodies in respect of the defence of medical negligence claims and also in respect of the defence of professional disciplinary matters before Committees of inquiry.
Katie Nugent
Katie is an Associate on the Healthcare team at Hayes solicitors.
She specialises in the defence of medical and dental claims taken against both public hospitals and private clinicians. Prior to joining Hayes solicitors, Katie worked for four years in the area of insurance defence litigation with a particular focus on personal injury claims. She also trained in general practice with a particular focus on plaintiff personal injury claims.