Source: https://www.medicalcouncil.ie/Professionalism/Safe-Prescribing-and-Dispensing-of-Controlled-Drugs/
Timestamp: 2018-03-23 20:34:05
Document Index: 574998569

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Medical Council - Safe Prescribing and Dispensing of Controlled Drugs
Safe Prescribing & Dispensing of Controlled Drugs
The Medical Council and the PSI, the pharmacy regulator, have launched a joint initiative aimed at doctors and pharmacists, entitled ‘Safe Prescribing and Dispensing of Controlled Drugs’. The guidance will provide a useful resource to facilitate safer prescribing and dispensing of controlled drugs. It also serves to encourage best practice and raise and promote high levels of professional standards in the treatment of patients.
Click on the image below to print a PDF version of this useful Controlled Drug Prescription Requirements table.
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What is a Controlled Drug and what are Schedules?
Substances, products or preparations, including certain medicines, that are either known to be, or have the potential to be, dangerous or harmful to human health, including being liable to misuse or cause social harm, are subject to control under the Misuse of Drugs Acts 1977 to 2016. They are known as “controlled drugs”.
The Misuse of Drugs Regulations categorise controlled drug substances into five schedules (ranging 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 controlled drugs in each of these schedules, in practice and in this document, may be referred to as CD1s, CD2s, CD3s, CD4 Part 1s, CD4 Part 2s and CD5s, respectively.
Each schedule contains various drug substances and drug products based on their perceived medical benefit and their risk to public health. There are different restrictions to control the supply of each schedule of controlled drugs. CD1s have the most restrictions and CD5s have the least restrictions. Some CD5s are available to patients without a prescription.
In this guidance we focus primarily on the controlled drugs found in schedule 2, schedule 3 and schedule 4 part 1. The supply of these controlled drugs is subject to more specific requirements than those in schedule 4 part 2 and schedule 5.
We do not specifically refer to schedule 1 controlled drugs as they are not commonly prescribed or supplied as they are normally not regarded as having any therapeutic purposes. They may only be prescribed subject to Ministerial Licence.
“Health prescription” and “health service requisition” are a prescription or a requisition issued in connection with arrangements made under section 59 of the Health Act, 1970 upon a form supplied by or on behalf of a health board.
From a practical perspective, this relates to GMS (General Medical Services) prescriptions.
“Medical practitioner” refers specifically to doctors.
“Prescribers” refers to healthcare professionals with prescriptive authority for controlled drugs i.e. doctors, nurse prescribers, dentists, veterinary practitioners and midwives.
Schedule 2 and schedule 3 controlled drugs cannot be repeated.
Schedule 4 (part 1 and part 2) and schedule 5 controlled drugs may be repeated.
“Instalments” allow the total quantity of the medicine prescribed to be dispensed in smaller, specified amounts, at specified intervals.
All controlled drugs can be legally dispensed in this manner, however, in accordance with the Misuse of Drugs Regulations 2017, ‘the number of instalments and the intervals at which the instalments may be dispensed’ must be specified on prescriptions for schedule 2, schedule 3 and schedule 4 part 1 prescriptions. Please see Appendix 1a for an example of correctly-specified instalment directions.
There is a strict system of control in place, both nationally and internationally, around the movement and supply of controlled drugs. These controls are intended to enable safe access to these medicines in light of the serious nature of the drugs concerned and substantial potential for abuse and misuse of these medicines.
In Ireland, these medicines are controlled by the Misuse of Drugs Acts and Regulations. These controls include restrictions on the people who can obtain or possess controlled drugs, and the strict legal obligations placed on pharmacists and prescribers charged with responsibility for the safe control of these substances.
The Misuse of Drugs Regulations 2017 are statutory instruments which came into force on 4th May 2017. They are vital in protecting patient health and safety. Failure to adhere to this legislation may result in patients receiving inadequate care and unnecessary and unacceptable burden and stress.
All prescribers (including doctors) and pharmacists must adhere to these regulations. It is an offence not to adhere to these regulations. Additionally, medical practitioners and pharmacists, when registering with the Medical Council and the Pharmaceutical Society of Ireland respectively, commit to adhering to professional standards and ethical guidelines set by their regulator.
Medical practitioners adhere to the Medical Council's Guide to Professional Conduct and Ethics for Registered Medical Practitioners, which explicitly states that they must obey the Misuse of Drugs legislation.
Pharmacists must adhere to the PSI's Code of Conduct. The Code of Conduct states that pharmacists must ‘comply with medicines legislation’.
Any patient requiring a controlled drug for their treatment is entitled to a correctly written prescription in order for them to lawfully access them. It is also an offence for medical practitioners to incorrectly write a controlled drug prescription, and it is an offence for a pharmacist to supply controlled drugs from an incorrectly written prescription. It is therefore incumbent upon both medical practitioners and pharmacists to ensure they are aware of their responsibilities and obligations under the Misuse of Drugs legislation to ensure the safe and appropriate supply of controlled drugs to their patients.:
Provide a valid prescription which meets the requirements of the legislation
Be satisfied as to the identity of the person for whose treatment the prescription is to be issued
Follow relevant national and international prescribing guidelines
Within reason, be available to confirm or discuss any matters related to the prescription and the patient
Ensure the safe keeping of prescription pads to reduce the risk of theft and forgery
Only dispense on the basis of a legally valid prescription
Be satisfied that the signature of the prescriber is genuine
Prior to supply, be satisfied as to the identity of the person or bona fide representative presenting the prescription or collecting controlled drugs
Be vigilant for forgeries or unusual prescribing patterns
Store controlled drugs in a safe manner, in accordance with the relevant legislation
Record all supplies of schedule 2 controlled drugs (CD2) in the pharmacy’s controlled drugs register
Communicate with the medical practitioner if there is any query about the prescription, or care of the patient
Adhere to national guidelines and facilitate appropriate withdrawal of controlled drugs and follow-up and refer as necessary
Methadone prescriptions and prescriptions for schedule 4 part 1CDs:
The following information must be included on the prescription, but does not need to be in the doctor's own handwriting i.e. can be computer generated or handwritten.
Form (e.g. liquid/oral solution)
Strength (e.g. 1mg/ml)
Dose (e.g. 50 mls daily)
Total quantity or total number of dosage units (words and figures) (e.g. 350 mls (three hundred and fifty mls))
Prescription Validity and Instalments
Prescriptions are usually valid for a period of six months from the date of issue; however, there are additional restrictions in the context of controlled drug prescriptions:
The first instalment or supply on prescriptions for CD2 or CD3 drugs cannot be dispensed before the date of the prescription or later than 14 days after that date.
The address of the prescriber must be within the State for CD2, CD3 and CD4 part drugs.
Repeat prescriptions are not permitted in the case of CD2 or CD3 drugs.
Prescriptions for CD2, CD3 and CD4 part 1 may be dispensed in instalments, provided that the intervals between instalments and the number of the instalments are specified.
For CD2 and CD3 the first instalment must be dispensed within 14 days and the last instalment must be dispensed no later than two months from the date on the prescription.
‘Emergency supplies’ of CD2, CD3 or CD4 drugs, including those requested by prescribers, are not permitted under the legislation (with the exception of methylphenobarbitone, phenobarbitone and phenobarbitone sodium for the treatment of epilepsy).
For ease of reference, Appendix 7 contains a table which clearly shows the prescription requirements for schedule 2, schedule 3 and schedule 4 part 1 controlled drugs.
Controlled drugs may also be obtained and supplied through the use of a requisition (or order), for administration by the medical practitioner in the course of their professional practice. Such a requisition must contain the following information:
Name, address and profession
Signature of the medical practitioner
Name of the controlled drug
Total quantity of the medicine(s) to be supplied
The medical practitioner obtaining drugs through the use of a requisition should be asked by the pharmacist to produce identification.
1. Communication: Good communication is essential to the effective functioning of healthcare teams11. The existence of good, open communication channels between pharmacists and prescribers is of particular importance in assuring the safe and efficient supply of controlled drugs to patients.
2. Identifying Risk Factors/High Risk Patients: As part of this collaborative relationship, pharmacists and prescribers should, in particular, communicate and collaborate in the care of patients in high risk groups.
Patients with drug dependency issues
Patients receiving addiction treatment services
Patients under the management of multiple doctors
Patient population who attend pain clinics
Patients transitioning from one place of care to another
Patients in residential care settings
Patients at risk of developing sleep disordered breathing
Patients with additional care requirements
3. Relevant National Resources and Professional and Clinical Guidance: It is essential in the prescribing, dispensing and supply of controlled drugs that pharmacists and prescribers are aware of and have access to national resources, and adhere to current national and international guidelines. For example:
The Health Products Regulatory Authority (HPRA) website for the confirmation of the scheduling of medicines containing controlled drugs (e.g. is a medicine a CD2 or CD3)(See Appendix 6)
The online registration databases of both the Medical Council and the Pharmaceutical Society of Ireland: to confirm registration, find contact details and be aware of any conditions attached to the registration of healthcare professionals
Resources or advice from relevant healthcare regulators, including the Medical Council, the PSI and the Health Information and Quality Authority (HIQA)
National Clinical Guidelines from the National Clinical Effectiveness Committee and relevant faculties
HSE Clinical Guidelines for Opioid Substitution Treatment (OST)
HSE Medicines Management Programme Guidance on appropriate prescribing of Benzodiazepines and Z Drugs (BZRA) in the treatment of anxiety and insomnia
Relevant international Guidelines from bodies such as the National Institute for Health and Care Excellence (NICE)
All relevant legislation is available at www.irishstatutebook.ie
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