Opioid prescribing – Know your state's Law, reduce your risk Q&A

Can I refuse altogether to prescribe S8s to new patients as a rule to avoid drug seekers, is it within my rights?

According to the RACGP Prescribing drugs of dependence in general practice guidelines, opioids should not be prescribed until satisfactory evidence of need is established. Such evidence may be in the form of a full clinical assessment, medical records or direct communication with the previous prescriber. This is necessary to avoid the risk of outdated records, recent changes to therapy or aberrant drug-seeking behaviour.

If it is difficult to confirm prior appropriate prescribing, you may request that the patient ask previous prescribers or pharmacists to contact you before you will continue the purported prescribing. Difficulty in obtaining this information may signal that the patient may be involved in deceptive behaviour. Drug-seeking patients often attend a practice after hours or when such information is difficult to obtain. Do not allow the patient to pressure you into prescribing. Politely inform the patient that a prescription will be considered only when the information becomes available.

All records are required to enable a comprehensive evaluation of the patient. A signed release of information form will be required.

In many, if not most, cases, it will likely be difficult to establish satisfactory evidence of a need for opioid prescribing at the first consultation with a new patient, and a practice policy declining provision of opioids to new patients may be appropriate. 

The RACGP guidelines referenced above provide general practice policies regarding opioid prescribing, including an opioid prescribing policy for new patients which may be displayed in the waiting room of a practice. The sign may indicate that no schedule 8 medication will be provided on the first appointment, or until ‘a full clinical picture’ has been established.

Doctors should still engage in effective good and clear communication with patients with respect to explaining the reason why they cannot prescribe to any new patients at the first consultation.  That is, it may be communicated as a general policy of the practice and also because the doctor does not possess all of the information they may require before prescribing or do not yet have the approval to prescribe.

If you find it too hard to say ‘no’ to a patient, you could consider referring the patient to a colleague or to the hospital for further assessment.  If you are satisfied that there is an acute injury for which a patient requires pain relief, and are satisfied that they are not a drug-dependent patient, you could consider providing only a limited supply of a couple of days of tablets. 

Who is responsible for safe disposal of unused opioids? Patient, prescriber, or dispensing pharmacy?

As recommended by the TGA, strong pain medicines such as opioids shouldn’t be kept around 'just in case'. The storage of expired and unwanted medicines in the home can be dangerous, and unsafe disposal of unwanted medicines can lead to environmental harm. The TGA encourages the public to return their unused opioids to their local pharmacy for safe disposal.  The Return Unwanted Medicines (RUM) program provides a free and convenient way for patients to dispose of unwanted medicines responsibly by way of their local pharmacy.

In Queensland, the Health (Drugs and Poisons) Regulation 1996 (Qld) provides that a person must not destroy a Schedule 4 or Schedule 8 controlled drug unless endorsed to do so, or in a way that endangers the life or safety of a person or domestic animal, creates a risk of contamination, or allows access to someone not endorsed to possess it.  Neither a prescriber nor dispensing pharmacy are endorsed to destroy controlled drugs, which must instead be returned to Queensland Health Forensic and Scientific Services by courier, accompanied by the requisite form. Pharmacists, but not prescribers, are otherwise endorsed to destroy Schedule 4 restricted drugs.  The regulation is silent as to whether patients may destroy Schedule 4 or Schedule 8 drugs.

In NSW, the Poisons and Therapeutic Goods Regulation 2008 (NSW), provides that a drug must not be disposed of in any manner likely to constitute a risk to the public.  A Schedule 8 drug may be destroyed by a patient or a pharmacist (who may destroy unwanted Schedule 8 drugs of a medical practitioner or dentist, either at the pharmacy or the practitioner’s practice, in the presence of the practitioner).  A prescriber is not authorised to destroy a Schedule 8 drug. 

In Victoria, the Drugs, Poisons and Controlled Substances Regulation 2017 (Vic) provides that a registered medical practitioner, pharmacist, dentist, nursing practitioner or authorised registered midwife may destroy a Schedule 8 drug if witnessed by another registered medical practitioner, pharmacist, dentist, nurse or registered midwife. The names of the person and witness carrying out the destruction must be recorded, together with details of the drug destroyed and the method and place of destruction.

How can one access/who can prescribe medicinal cannabis as an alternative to opioids?

The Australian Federal Government legalised access to medicinal cannabis in 2016.

Any registered medical practitioner can prescribe medicinal cannabis for any patient with any condition, provided they believe it is clinically appropriate and have obtained the necessary approvals. 

In Queensland, a doctor may prescribe a Schedule 4 cannabidiol (CBD) or Schedule 8 tetrahydrocannabinol (THC) or tetrahydrocannabinol: cannabidiol (THC:CBD) product in the same manner as other Schedule 4 or Schedule 8 drugs. The usual approval from the Chief Executive is required when prescribing to a ‘drug dependent’ person.

In NSW, a NSW Authority is required to prescribe a Schedule 8 cannabis medicine to a drug dependent person, or where it is a compounded medicine or for a clinical trial.

In Victoria, an authority is required to prescribe a Schedule 8 cannabis medicine to any patient, unless the patient is in hospital, an aged care service or prison, or the indication for treatment is palliative care (although such requirement is currently suspended pursuant to a COVID-19 public health emergency order, except in the case of drug-dependent persons, provided the practitioner check’s the patient’s SafeScript profile before prescribing).

In addition, as most medical cannabis products are unregistered drugs, prescribing will often require additional approval under the Therapeutic Goods Administration Special Access Scheme-B or Authorised Prescriber Scheme.

What does the law define as palliative care?

The definition of palliative care varies between each Australian State and Territory. Generally however palliative care is an act or omission, medical procedure or other measures to maintain or improve the comfort of a person who is, or would otherwise be, subject to pain and suffering.

Some definitions also refer to it as the relief of pain, suffering and discomfort.

In practice, palliative care is broad and can include pain medication, oxygen, intravenous or nasogastric feeding, delivery of blood products, anti-nausea medication, and anti-anxiety medication. Counselling and spiritual interventions may also provide palliative care ¹.

^[1]Palliative Medication

What is considered therapeutic need? Sometimes patients claim pain when very little medical evidence of any pathology exist. Is that enough to prescribe?

The Pharmacy Board of Australia, recommends keeping abreast of the Australian professional literature and the public media relating to drugs of abuse, and engagement with colleagues. Requests for drugs to which this guideline relates are to be treated cautiously because of manipulative behaviour on the part of drug seekers. A genuine therapeutic need is to be established by careful questioning. The MBA Code of conduct states that only recommending treatments when there is an identified therapeutic need and/or a clinically recognised treatment, and a reasonable expectation of clinical efficacy and benefit for the patient.

The RACGP Prescribing drugs of dependence in general practice guidelines provide that therapeutic need means that there is a clinical basis for the prescription of opioids to a patient, namely, objective symptomology of the patient that is causing the patient’s pain. This therapeutic need may only be diagnosed from appropriate examination of the patient and undertaking appropriate investigations, such as referral for radiology and specialist input.

The ongoing treatment of pain, addiction and mental illness comorbidities is a complex undertaking. Initial referral to pain and/or mental health specialists may be needed to obtain a comprehensive evaluation or to clarify the optimal therapeutic strategies and should be considered for patients who have indeterminate pathology. Further, the presence of non-cancer pain itself is not enough to prescribe opioids without further knowledge of the medical condition that is being treated. There may in fact be an appropriate non-opioid medication that may effectively treat a patient’s pain.

There should also be appropriate consideration of issues surrounding tolerance and opioid-induced hyperalgesia – that is, it is now known that administration of opioids can also result in opioid-induced hyperalgesia (OIH), which is at sensitisation of pro-nociceptive pathways leading to pain hypersensitivity. Both tolerance and OIH can significantly reduce the analgesic effect of opioids. Consequently, the ongoing prescription of opioids itself can cause the patient to experience ongoing pain.

How can one access/who can prescribe medicinal cannabis as an alternative to opioids?

The Australian Federal Government legalised access to medicinal cannabis in 2016.

As most products are unregistered drugs, prescribing requires approval under the Therapeutic Goods Administration Special Access Scheme-B or Authorised Prescriber Scheme.

Are there particular legal issues when prescribing opioids to nursing home patients?

As recommended by the RACGP, a comprehensive pain assessment is important to design a tailored pain management program for a patient in an aged care facility. Correct diagnosis of the cause of pain is needed as different types of pain are more responsive to certain treatments and the underlying cause of the pain may be remediable. Assessment of persistent pain includes evaluating current and past pain history, concurrent medical conditions, current medications, mood and quality of life. If the pain seems disproportionate or systemic, then consider whether it is being amplified by central nervous system sensitisation. Neuropathic symptoms, patients’ reports of multifocal pain and/or comorbid somatic symptoms may be indicators of centralised pain. A physical examination should be conducted with the patient at rest and during mobilisation, which should include weight-bearing, walking, sitting and getting up, as well as a full range of articulated limb movements. Diagnostic investigations may be indicated but care is needed as radiographic changes, particularly in joints, are common with increasing age, but correlate poorly with the experience of pain in conditions such as osteoarthritis.

In Victoria, is there a threshold amount of daily opioid before a permit is required?

No, opioid prescription guidelines and permit requirements are not based on the amount of S8 medicine prescribed on a daily basis. According to the Victorian Department of Health, there are 4 basic circumstances when a medical practitioner must obtain or apply for a permit from the department.

1. Prescribing for a drug-dependent person – A medical practitioner must obtain a permit before treating a drug-dependent person with any Schedule 8 medicine. Permits to prescribe methadone or buprenorphine (Subutex® or Suboxone®) as opioid replacement therapy (ORT) to treat opioid dependence also fall into this category.
2. Prescribing a special Schedule 8 medicine – In most circumstances, a medical practitioner must obtain a permit before prescribing methadone (Physeptone®), nabiximols (Sativex®), amphetamine, dexamphetamine, lisdexamfetamine (Vyvanse®), methylamphetamine or methylphenidate (Ritalin®, Concerta®).
3. Prescribing treatment for a period greater than 8 weeks – A medical practitioner does not need a permit to initiate treatment of a person (who is not drug-dependent) with any other Schedule 8 medicine, but must obtain a permit to prescribe treatment for a continuous period greater than 8 weeks. Note: the 8-week period relates to the duration of prescribed treatment and not the dates of consultations.
4. Prescribing for transient and/or occasional patients – A medical practitioner who prescribes a Schedule 8 medicine (other than where a permit must be obtained before prescribing) must immediately apply for a permit if there is reason to believe that their prescription will contribute to a patient being treated for a continuous period greater than 8 weeks (including any preceding period of treatment by any prescriber). To avoid delaying treatment for a patient with a genuine therapeutic need, a medical practitioner is authorised to continue treating the patient until the outcome of their permit application has been determined, but they must submit a permit application immediately – even if there is no intention to prescribe again.

How do the matters differ for dentists, regarding prescribing opioids?

In all Australian states and territories, dentists are legally permitted to prescribe Schedule 2, 3, 4 and some Schedule 8 medicines if they are for dental treatment of persons under their care. A list of approved medicines can be found in the PBS Dental Schedule page.

If a dentist wishes to prescribe a drug not on the PBS dental schedule or for a use different from that which it is PBS-listed, the prescriber must write a non-PBS private prescription. A standard PBS prescription form can be used for this purpose, but the ‘PBS/RPBS’ text must be clearly struck out and the words ‘non-PBS’ should be clearly endorsed on the form. Be aware that the patient will pay the full cost of a private prescription¹.

What are the analgesics (opioids/others) that general dentists can prescribe in Australia?

Dentists

Dentists are authorised under relevant legislation in the respective states and territories to prescribe medication.

For example, in Victoria, it is Drugs Poisons and Controlled Substances Act 1981 which provides that dentists can obtain, possess, use or supply scheduled poisons for the lawful practice of their profession, i.e. for the dental treatment of patients under their care.

In NSW, it is the Poisons and Therapeutic Goods Act 1966 and Regulation 2008.

These instruments contain the majority of regulatory requirements, relating to scheduled medications, with which dentists must comply. For example: in Victoria dentists are not authorised to possess or prescribe methadone (Physeptone®), a special Schedule 8 medicine. In NSW, they cannot prescribe dexamphetamine, lisdexamfetamine or methyphenidate.

Registered dental practitioners - other than dentists

Registered dental hygienists, dental therapists and oral health therapists are authorised to possess and have access to a limited range of specific Schedule 4 medicines to provide dental care. However, these dental practitioners are not authorised to supply or prescribe Schedule 4 medicines.

Schedule 4 medicines approved for use by other registered dental practitioners

The Secretary has given general approval for a dental hygienist, dental therapist or oral health therapist, registered under the Health Practitioner Regulation National Law to have in their possession and use the Schedule 4 medicines listed below that are required for the provision of dental care.

• adrenaline
• articaine
• demeclocycline and triamcinolone in combination for topical endodontic use
• felypressin
• lignocaine
• mepivacaine
• mercury (metallic) for human therapeutic use

Would a script issued in one state be legal in another state (eg a doctor in NSW writes a script to be faxed to QLD because the patient temporarily in QLD).

State Interstate prescription rules

Where do you find the list of S8 drugs that a dentist can prescribe in NSW?

On the PBS Dental Schedule website.

Is the legislation in NSW the same as ACT?

In regard to opioid prescribing and regulations, NSW and the ACT have different legislative frameworks that apply to the prescription and dispensing of S8 medicines. Specific information about each jurisdiction can be found at:

ACT: Controlled Medicines

NSW: NSW legal requirements for an authority to prescribe drugs of addiction

One of the problems we have in the ACT is that the NSW border is very close. We can use DORA (online opioids prescribing) to check whether patients have had previous opioid scripts, but once patients cross the border, we do not have access to an NSW similar online record. Is there such a thing in NSW, and can we in ACT get access for it?

NSW does not have an equivalent of DORA. There is the limited Commonwealth Prescription Shopping Program. The NSW Pharmaceutical Regulatory Unit is a good resource.

In relation to patients on the NSW Opioid Treatment Program, the currently available monitoring system in NSW is a customised Electronic Recording and Reporting of Controlled Drugs (ERRCD). It also records client admissions to, and exits from, treatment, the details of prescribers and dosing points. The reporting is done on a monthly basis.

Which States and Territories have implemented a Real-Time Prescription monitoring system for high-risk medicines?

As of April 2021, the following jurisdictions have an online system to monitor in real-time the history of the high-risk medicines (monitored drugs) that patients’ have been prescribed and supplied.

Australian Capital Territory: DORA

South Australia: ScriptCheckSA

Victoria: SafeScript

Tasmania: DORA

Which medicines are monitored in each jurisdiction?