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Nurse practitionersKey legislative requirements 2015.1
This document has been prepared Drugs and Poisons Regulation (DPR) to assist nurse practitioners to understand key legislative requirements that are not applicable to other nurses. Reference should be made to the Drugs, Poisons and Controlled Substances Act 1981 (the Act) and Regulations 2006 (at www.legislation.vic.gov.au) for full details.
Note: For simplicity of reading and comprehension, this document does not refer to the many circumstances that are covered by the legislation; it focuses on issues that might apply to nurse practitioners. For details relating to legislative issues that are applicable to all nurses and midwives, please refer to the document “Nurses and midwives” on the DPR website (at www.health.vic.gov.au/dpcs/reqhealth).
Registered nurses
A registered nurse is authorised, under the Drugs Poisons and Controlled Substances Regulations 2006, to possess and administer Schedule 4 and 8 poisons in accordance with the provisions of regulation 5 and regulation 47, respectively.Nurse practitioners
A registered nurse whose registration is endorsed under section95 of the Health Practitioner Regulation National Law is defined as a ‘nurse practitioner’. It is a term that is not to be confused with other nursing classifications, such as ‘nurse immuniser’ and ‘authorised registered nurse’.In addition to the authorisation applicable to other nurses, a nurse practitioner is authorised to obtain, possess, use, supply or prescribe the substances in Schedules 2, 3, 4 or 8 that are ‘approved by the Minister’ (for Health) in relation to the relevant category of nurse practitioner in the lawful practice of his or her profession as a nurse practitioner (section 13 of the Act). This authorisation does not extend to:
· activities unrelated to his or her endorsed practice
· supplying medicines that have been prescribed by another registered health practitioner (e.g. for self, spouse or employees); that is the role of a pharmacist
· supplying scheduled poisons by wholesale, an activity that requires a wholesale licence
A nurse practitioner’s scope of practice might be supported by an employer’s clinical governance framework and will be guided by the Nursing and Midwifery Board of Australia’s professional practice framework, which details how professional decision-making within a sound risk management, professional, regulatory and legislative framework is to be managed.
Approved List of scheduled poisons
The Minister (for Health) has approved a list of a Schedule 2, 3, 4 and 8 poisons for each of several nurse practitioner categories.The Approved List, which identifies specific substances and classes of scheduled poisons, is located on the DPR website (at www.health.vic.gov.au/dpcs/prescriber/nurse) under the ‘Approved by the Minister’ link.
Note:
· The lists do not authorise nurse practitioners in relation to all drugs in a poisons schedule; some lists include opioid analgesics in Schedule 8; some lists might include other Schedule 8 poisons; some lists might not include any Schedule 8 poisons.
· In the event of an inconsistency, between the Approved List and the Nursing and Midwifery Board of Australia’s prescribing formulary, the (gazetted) Approved List represents the lawful situation in Victoria.
Key terms
Schedule 8 poisons (labelled Controlled Drug) are drugs with strict legislative controls, including opioid analgesics and ketamine. Pethidine, fentanyl, morphine (MS-Contin®, Kapanol®), oxycodone (OxyContin®, Endone®), methadone (Physeptone®), buprenorphine (Suboxone®, Subutex®) and two benzodiazepines (flunitrazepam and alprazolam) are other examples of Schedule 8 poisons.Schedule 4 poisons (labelled Prescription Only Medicine) include most other drugs for which prescriptions are required, e.g. local anaesthetics, antibiotics, vaccines, naloxone, strong analgesics (e.g. Panadeine Forte®) that are not classified as Schedule 8 poisons and benzodiazepines (other than flunitrazepam and alprazolam; both Schedule 8 poisons).
To avoid possible confusion, please note that, in Victoria, the term ‘drug of dependence’ is used to describe substances, listed in Schedule 11 to the Act, which are known to be subject to misuse and trafficking. It is not limited to Schedule 8 poisons and includes some Schedule 4 poisons (e.g. benzodiazepines). However, most regulations relate primarily to whether a drug is in Schedule 4 or Schedule 8 (rather than Schedule 11).
Schedule 2 and 3 poisons (over-the-counter medicines - labelled Pharmacy Medicine or Pharmacist Only Medicine, respectively) must only be supplied in an open shop by pharmacists.
However, nurse practitioners may use, prescribe or supply Schedule 2 and Schedule 3 poisons that are specified in their Approved List in a manner similar to Schedule 4 poisons, i.e. for medical treatment, consistent with their scope of practice, of persons under their care. Schedule 2 and Schedule 3 poisons must not be supplied for any other purpose or to any other person.
Prescribing and supplying Schedule 4 and Schedule 8 poisons
Nurse practitioners must not prescribe or supply Schedule 4 and Schedule 8 poisons other than for the medical treatment of persons under their care and then only after taking all reasonable steps to ensure that a therapeutic need exists (regulation 9).When writing prescriptions, the prescription must:
· contain the full details of the prescriber (including address and phone number)
· contain the patient’s name and address
· identify the medicine unambiguously
· show the quantity and number of repeats (in words and figures for Schedule 8 poisons)
· be signed and dated by the prescriber
· contain precise directions for the use (except where complex directions are provided separately in writing- or if administration is to be carried out by the prescriber)
· be in the nurse practitioner’s own handwriting or in a manner of writing approved by the Secretary (of the Department of Health and Human Services (DHHS)), e.g. computer-generated prescriptions that comply with specified criteria
Supplying medicines
Nurse practitioners who supply Schedule 4 or Schedule 8 poisons must personally ensure that the correct medicine is selected and supplied in the required manner. This responsibility cannot be delegated to another person.A nurse practitioner is responsible for ensuring that the container is labelled in accordance with the provisions of regulation 29, plus Appendix L of the Poisons Standard (aka Standard for the Uniform Scheduling of Medicines and Poisons). Required components of a label include:
· the name of the patient;
· the date on which the transaction is recorded and/or a reference number that clearly shows the date;
· the name, address and telephone number of the practitioner;
· the name of the poison or controlled substance or a trade name that unambiguously identifies the poison or controlled substance plus its strength, form (e.g. tablets) and quantity;
· the words ‘KEEP OUT OF REACH OF CHILDREN’ in red on a white background;
· adequate directions for use;
· if the medicine is intended for external use only, the word ‘POISON’, or the words ‘FOR EXTERNAL USE ONLY’, in red on a white background;
· the mandatory ‘sedation warning’ for drugs listed in Appendix K of the Poisons, a link to which is located in the ‘Related sites’ section of the DPR website.
Containers must be impervious to the contents, sufficiently sturdy to prevent leakage and capable of being securely re-closed.
Note: The roles of prescribing and supplying medicines have traditionally been separated, to allow a pharmacist to check for possible contraindications and to assess the safety and appropriateness of prescribed medicines.
Pharmacists have well defined standards, including the use of ancillary labels, to ensure that medicines are labelled in a manner that maximises the likelihood that the medicines will be administered in a safe and effective manner. Nurse practitioners who choose to supply Schedule 4 or Schedule 8 poisons are advised to do so in a manner that is of a comparable standard to that required of pharmacists.
Permits and notifications
This section might not apply to the majority of nurse practitioners, as they will be limited in the Schedule 4 and Schedule 8 poisons for which they are authorised. However, if and when relevant medicines are included in a nurse practitioner’s Approved List, the nurse practitioner will be subject to the same requirements as medical practitioners who wish to prescribe, supply or use those medicines, as follows:A Schedule 8 treatment permit might be required in relation to a Schedule 8 poison - in some cases a permit is required before a Schedule 8 poison may be prescribed.
Notification of treatment with a Schedule 8 poison might be required when a permit is not needed.
Notification of a drug-dependent person - A nurse practitioner must notify DPR if there is reason to believe a patient is drug-dependent and the patient seeks a drug of dependence or the nurse practitioner intends to prescribe a drug of dependence for the patient.
For a detailed explanation of permit and notification requirements plus exceptions to those requirements, please refer to the documents, “Schedule 8 treatment permits” and “Treating a drug-dependent person”, which are located on the DPR website at www.health.vic.gov.au/dpcs/reqhealth beneath the sub-heading for medical practitioners. Permit application forms and notification forms, which may be downloaded or completed online, are also to be found in that location.
Important clarification
In general, regulatory requirements are applicable to each nurse practitioner but circumstances of employment need to be considered to ensure compliance with the regulations.Hospitals (and some other health services providers) are authorised to possess and use scheduled poisons in accordance with the conditions of a Health Services Permit (HSP) and in compliance with the contents of a Poisons Control Plan (PCP), which is specific to each permit holder and will contain details relating to the manner in which medicines are to be obtained, stored, used, recorded and destroyed.
In some cases, a PCP will contain requirements that are more specific or additional to regulatory requirements that relate, in general, to nurse practitioners. The current version of the PCP, which is commonly controlled by the Director of Nursing or Director of Pharmacy, should be available for perusal by relevant staff; in some cases, it is available on a hospital’s intranet.
However, if a nurse practitioner is not practising under the auspices of a health services provider, issues relating to the manner in which scheduled poisons are obtained, possessed, used, recorded and destroyed will be the sole responsibility of the nurse practitioner to whom the medicines are supplied.
Obtaining Schedule 4 and Schedule 8 poisons
Licensed wholesalers and pharmacists must only supply scheduled poisons to an authorised person (or permit holder) and must record the details of the person (e.g. nurse practitioner) to whom supply is made, regardless of to whom an invoice for payment might be directed (e.g. a corporate entity or business name). The supplier might also require the provision of a written order before supply is made.The authorised person to whom supply is made is responsible for the secure storage of the scheduled poisons and must be able to account for all transactions in the corresponding scheduled poisons.
Storage of Schedule 4 and Schedule 8 poisons
Schedule 8 poisons must be stored in a locked facility, fixed to the floor or wall, which provides not less security than a (10 mm thick) mild steel drug cabinet. Schedule 8 poisons must not be stored with any other items other than other drugs of dependence.· Note: Regulation 35 makes provision for alternative lockable facilities for storing Schedule 8 poisons that are being transported for use in another place and for small quantities (e.g. up to 6 ampoules of morphine) for use in an emergency.
Schedule 4 poisons (including professional samples) must be stored in a lockable storage facility (e.g. cupboard, drawer, fridge, filing cabinet).
Access to Schedule 4 and Schedule 8 poisons
Storage facilities for Schedule 4 and Schedule 8 poisons must be secured to prevent access by persons not specifically authorised under the Act (including the conditions of a Health Services Permit) or Regulations unless the nurse practitioner is present. Accordingly, keys and combination codes should not be accessible to unauthorised staff members.Records of transactions
A nurse practitioner must make true and accurate records of all scheduled poisons administered or supplied, retain them for 3 years and produce them, on demand, to an authorised officer.Patients’ treatment records (retained for at least 7 years to satisfy other legislative requirements) showing full details of medicines administered or supplied may be sufficient for Schedule 4 poisons but for Schedule 8 poisons a separate record is almost certainly required.
Records for Schedule 8 poisons must be in a form that shows the true balance remaining after each transaction and that cannot be altered without detection. Note: A computer spreadsheet is unlikely to comply with this requirement; manual records, in a bound book with consecutively-numbered pages, are a common option.
Destruction of Schedule 8 poisons
Regulation 51 authorises a nurse practitioner to destroy a Schedule 8 poison in the presence of a medical practitioner, nurse practitioner, pharmacist, dentist, nurse or midwife.Regulation 51 specifically allows a Schedule 8 poison to be discarded or destroyed without a witness in the case of the remaining, unused contents of a previously sterile container (e.g. a partially used ampoule) – provided an appropriate record in made. Note: Although a witness is not mandated by regulation, many establishments or their PCP require a witness when a suitably qualified person is available.
Self-administration prohibited
Self-administration of Schedule 4 and Schedule 8 poisons is prohibited unless the medicines have been lawfully prescribed and supplied by a registered health practitioner (e.g. medical practitioner) or supplied by a pharmacist on a prescription from a registered health practitioner (regulation 48). Note: This does not mean that, where medicines have been prescribed by another registered health practitioner, a nurse practitioner may continue the treatment with medicines obtained from an authorised supplier.For further information
Department of Health & Human Services (DHHS)
Drugs and Poisons RegulationGPO Box 4057
Melbourne 3001
Tel: 1300 364 545
Fax: 1300 360 830
Email:
Web: www.health.vic.gov.au/dpcs
For information relating to Schedule 8 treatment permits and notification of drug-dependent persons
· Please refer to the documents, “Schedule 8 treatment permits” and “Treating a drug-dependent person”, which are located on the DPR website at www.health.vic.gov.au/dpcs/reqhealth beneath the sub-heading for medical practitioners.· Permit application forms and notification forms, which may be downloaded or completed online, are also located on the DPR website at www.health.vic.gov.au/dpcs/reqhealth beneath the sub-heading for medical practitioners.
For similar documents relating to other categories of nurses and midwives
· For information relating to registered nurses and midwives, authorised midwives or nurse practitioners, please refer to the corresponding document on the DPR website at www.health.vic.gov.au/dpcs/reqhealth· For information relating to nurse immunisers, please refer to the DPR website and the section “Approved by the Secretary” at www.health.vic.gov.au/dpcs/approve
Other possible sources of information