Information for prescribers 2015.1
This document has been prepared by Drugs and Poisons Regulation (DPR) to assist prescribers to understand the key legislative requirements associated with treating a drug-dependent person. For simplicity of reading, this document does not refer to all legislative requirements; merely those that may be relevant to the majority of general practitioners. For full details, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Drugs Poisons and Controlled Substances Regulations 2006 (at www.legislation.vic.gov.au). Documents dealing with other key legislative requirements, may be found on the DPR website (at www.health.vic.gov.au/dpcs/reqhealth)
Clinical advice
Whilst this document includes references to treatment strategies and options, it relates primarily to legislative issues associated with the prescribing of drugs of dependence for drug-dependent persons. Clinical advice, relating to the treatment of drug-dependent persons (including other treatment options), should be sought from authoritative sources.
To obtain clinical advice from specialist consultants, registered health practitioners (only) may phone the Drug and Alcohol Clinical Advisory Service (DACAS) on 1800 812 804 (at any time).
For 24-hour confidential drug and alcohol counselling and treatment information; patients, family members or health practitioners may phone Direct Line - 1800 888 236.
What is a drug-dependent person?
Whilst the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) lists criteria to assist medical practitioners to diagnose the condition, the Drugs Poisons and Controlled Substances Act 1981 does not define the term “drug-dependent person”. It refers instead to when a practitioner has reason to believe a patient is a drug-dependent person.
The following list contains examples of circumstances that might (or should) represent a reason to believe a patient is a drug-dependent person, especially when multiple circumstances apply:
· Admitted current misuse or abuse of pharmaceutical drugs and/or illicit drugs
· Prescription-shopping and/or obtaining prescription drugs from illicit sources
· Physical signs of intravenous drug use
· Forging prescriptions or obtaining drugs of dependence by false representation
· Multiple unsanctioned dose escalations of prescribed drugs
· Is being treated with opioid-replacement therapy for opioid-dependence
Drugs of dependence
The term “drug of dependence” is used to describe drugs from Schedule 8 plus some Schedule 4 poisons that are subject to misuse and trafficking. The Schedule 4 poisons in this category include all benzodiazepines that are not in Schedule 8, propoxyphene (Digesic®), phentermine (Duromine®), testosterone and other anabolic steroids.
Before prescribing a drug of dependence, a medical practitioner must take all reasonable steps to ensure a therapeutic need exists and to confirm the identity of the patient. Issuing a prescription, merely because another prescriber has done so, is unlikely to satisfy these requirements.
Treating a drug-dependent person
It is an offence to prescribe a drug of dependence merely to support the drug-dependence of a person.
Treatment of a drug-dependent person should involve meaningful objectives and appropriate strategies to reduce the risks associated with providing drugs of dependence to a drug-dependent person. Such strategies typically include limiting a patient’s access so that drugs of dependence are prescribed by a single practitioner and supplied, in a controlled manner, by a single pharmacy. A collegiate approach between prescriber and pharmacist often represents an important component of sound treatment of a drug-dependent person.
Unless a prescriber holds a current Schedule 8 treatment permit to treat a drug-dependent person, he/she must notify DPR if there is reason to believe a patient is a drug-dependent person and the patient seeks a drug of dependence or the medical practitioner intends to prescribe a drug of dependence.
Schedule 8 poisons
Note: The following lists are not exhaustive and show only some brand names (in brackets). There are other Schedule 4 and Schedule 8 poisons and there may be lesser-known brand names of the listed drugs.
Schedule 8 poisons (labelled Controlled Drug) have stricter legislative controls than other commonly available drugs, including but not limited to morphine (Kapanol®, MS-Contin®), pethidine, oxycodone (OxyContin®, OxyNorm®, Endone®), buprenorphine (Subutex®, Suboxone®, Norspan®), fentanyl (Durogesic®) and hydromorphone (Jurnista®) plus two benzodiazepines, alprazolam (Kalma®, Alprax®) and flunitrazepam (Hypnodorm®).
Where there is reason to believe a patient is a drug-dependent person, a medical practitioner must obtain a permit before prescribing a Schedule 8 poison – unless a specific exception applies. Please refer to the DPR website (at www.health.vic.gov.au/dpcs/reqhealth) and the document, “Schedule 8 treatment permits” for details of requirements and exceptions.
Permit application forms
Permit application forms and notification forms may be submitted online or downloaded from the DPR website (at www.health.vic.gov.au/dpcs/reqhealth)
Treating opioid-dependence
Methadone and buprenorphine (Suboxone®, Subutex®) are the Schedule 8 poisons that have been registered in Australia for opioid-replacement therapy (ORT).
To address the inherent risks, associated with the vulnerability of the patients and the potential toxicity of the drugs (especially methadone), most Schedule 8 treatment permits to prescribe ORT are issued only to medical practitioners who have completed the training and assessment required to become an ‘approved prescriber’.
However, an exception now exists that enables general practitioners who are not approved prescribers to obtain a Schedule 8 treatment permit to prescribe Suboxone® ORT for up to 5 patients (see below).
For more information, Victoria’s current “Policy for maintenance pharmacotherapy for opioid dependence” and the National Clinical Guidelines for Methadone plus the National Clinical Guidelines for Buprenorphine may be accessed on the department’s website at: www.health.vic.gov.au/dpcs/pharm
Suboxone® prescribing by general practitioners
Whereas Subutex® contains buprenorphine as the only active ingredient; Suboxone® also contains naloxone, which was added to the formulation to deter injection of the drug.
In recognition of the lesser risk of diversion and less complicated pharmacokinetics of Suboxone® use, any medical practitioner (after first obtaining a Schedule 8 treatment permit in relation to each patient) may prescribe Suboxone® (sublingual films) for up to 5 patients without completing the training or assessment required to prescribe methadone or Subutex®.
To ensure that prescribing of Suboxone® is safe, appropriate and consistent with the current policy and guidelines, medical practitioners who are not approved ORT prescribers should seek advice from an approved prescriber (or DACAS) before prescribing to a patient. Guides (in document and video format) are also available on the DPR website (at www.health.vic.gov.au/dpcs/pharm).
Notification of drug-dependence
A prescriber must notify DPR if there is reason to believe a patient is a drug-dependent person and the patient seeks a drug of dependence or the medical practitioner intends to prescribe a drug of dependence.
This notification is a legislative requirement, which provides information to DPR. Notification enables DPR officers to assist prescribers who might seek advice or apply for a permit to treat a person or to intervene to address concurrent prescribing, when it is identified.
The notification also serves to inform DPR when a medical practitioner intends to treat a drug-dependent person with a drug of dependence, in which case the corresponding box must be ticked.
The Notification Form, which is on the DPR website (at http://www.health.vic.gov.au/dpcs/reqhealth.htm), may be submitted online.
Obtaining information for patients under treatment
In addition to its Prescription Shopper Information Service (PSIS), Medicare Australia is able to provide a patient’s treating medical practitioner with detailed information about that patient’s consulting and prescription history with other medical practitioners. Obtaining such information requires the consent of the patient but it might be essential to the safe management of the patient.
See the Medicare Australia website:
www.medicareaustralia.gov.au/about/information/request-yourinfo.jsp (for further information)
http://www.humanservices.gov.au/spw/customer/forms/resources/2690-1003en.pdf (patient consent form)
For further information about patients who are suspected of drug-seeking activities, please refer to the DPR website (at www.health.vic.gov.au/dpcs/reqhealth) and the document, “Obtaining information in relation to drug-seeking patients”.
Other drugs
Medical practitioners should also consider the possibility that a patient might develop dependence to medications that have not been classified as drugs of dependence. Similar problems and concerns have also been identified in relation to patients receiving regular prescriptions for zolpidem (Stilnox®), tramadol, plus Panadeine® Forte and other analgesics containing codeine.
For further information
Department of Health & Human Services (DHHS)Drugs and Poisons Regulation
GPO Box 4057
Melbourne 3001
Tel: 1300 364 545
Fax: 1300 360 830
Email:
Web: www.health.vic.gov.au/dpcs
To receive this publication in an accessible format contact Drugs and Poisons Regulation on 1300 364 545. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.
July 2015
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