Appendix B

[insert practice name]

Date effective:

Review date:

OPIOID PRESCRIBING POLICY

Many of our patients require strong, potentially addictive medication to help manage their condition(s). Of concern are ‘drugs of dependence’ (eg opioid medications and benzodiazepines), particularly when these are prescribed on an ongoing basis. Due to increasing reports of abuse of prescription drugs and patient behavioural problems, [insert practice name] has established a policy to ensure adequate treatment of your condition, while reducing the risk of problems with drug prescriptions.

The major points are described below.

For new patients to the practice:

• It may take time to get accurate medical information about your condition. Until such information is available, your GP may choose not to prescribe any medication. It is our policy that GPs do not prescribe drugs of dependence until they have a full clinical picture.
• Your GP may decide not to continue prescribing an opioid medication previously prescribed for you. It may be determined that such a medication is not suitable. It is our policy that GPs do not prescribe drugs of dependence if they feel that previous prescriptions were inappropriate.
• Your GP will evaluate your condition and only prescribe an opioid of the strength necessary for you. This may be different than what another doctor may have given you in the past.

General practice standards:

• If the decision to prescribe is taken after a shared discussion of goals, plans, risks and benefits, you may be required to confirm your consent in writing.
• You may be asked to sign an agreement that will detail our practice’s expectations when prescribing drugs of dependence. This contract details your responsibilities as a patient taking a drug of dependence, any prescriptions issues, advice on taking your medications, how we will monitor your care, and the standards of behaviour that are expected. The agreement is not a legally binding contract.
• You may need to acknowledge that your care requirements are complex, and that referral for ongoing care for all or part of your healthcare may be required. It is our practice policy that patient care is matched with the level of complexity.
• Patients are reminded that we have a zero tolerance policy on issues relating to staff abuse. Any threats to staff will result in transfer of your care.

[insert practice name]

Date effective:

Review date:

PATIENT AGREEMENT FOR DRUGS OF DEPENDENCE THERAPY

Treatment contract

for the use of an opioid medicine (morphine-like painkiller) for the management of chronic pain

Patient name:

Address:

Date of birth:

PLEASE COMPLETE ALL DETAILS

I, ......................................................................... , understand that an opioid medicine is to be prescribed to me in an attempt to improve my level of functioning and reduce my pain. My medical practitioner and I have discussed that strong opioid (morphine-like) medicines may only be partially helpful in achieving this goal and on occasion will not help at all. I understand that an opioid medicine is only one part of the management of my chronic pain. My medical practitioner and I agree to the following conditions regarding my treatment and the prescribing of an opioid medicine for my pain:

1. My medical practitioner is responsible for prescribing a safe and effective dose of an opioid medicine. I will not use an opioid medicine other than at the dose prescribed and I will discuss any changes in my dose with my medical practitioner.
2. I am responsible for the security of my opioid medicine. Lost, misplaced or stolen medicines or prescriptions for opioid medicines will not be replaced.
3. I will only obtain my opioid medicine from the medical practitioner who signs this contract, or other doctors in the same practice authorised to prescribe to me. I understand that no early prescriptions will be provided.
4. While most people do not have any serious problems with this type of medicine when used as directed, there can be side effects. My medical practitioner has explained the main ones to me, and I will tell him or her if I experience what could be side effects.
5. I am aware that my medical practitioner is required to gain authorisation from the Department of Health for continued prescription of an opioid medicine.
6. As possible dependence is an important consideration in the management of my pain, I have informed my medical practitioner of any present or past dependence on alcohol or drugs that I may have had, and of any illegal activity related to any drugs (including prescription medicines) that I may have been involved in.
7. I am aware that providing my opioid medicine to other people is illegal and could be dangerous to them.
8. My medical practitioner respects my right to participate in decisions about my pain management and will explain the risks, benefits and side effects of any treatment.
9. My medical practitioner and I will work together to improve my level of functioning and reduce my pain.
10. I understand that my medical practitioner may stop prescribing my opioid medicine or change the treatment plan if my level of activity has not improved, if I do not show a significant reduction in my pain, or if I fail to comply with any of the conditions listed above.

Patient’s signature:-------------------------------------------------------------------------------------------------

Patient’s name:---------------------------------------------------- Date:-------------------------------------------

Medical practitioner’s signature:---------------------------------------------------------------------------------

Medical practitioner’s name:--------------------------------------------------------------------------------------

Medical practitioner’s provider number:------------------------------- Date: --------------------------------

Please provide a copy of the signed contract to the patient.

[insert practice name]

Date effective:

Review date:

REQUESTS FOR REPEAT DRUG OF DEPENDENCE PRESCRIPTIONS

Patients should be aware of their responsibilities in requesting prescriptions for drugs of dependence. These responsibilities are explained in the practice ‘Opioid prescribing policy for patients’ and in the ‘Patient agreement for drugs of dependence therapy’.

Patients should note the following:

• All requests for repeat scripts for drugs of dependence will go to your usual doctor.
• Requests may require a clinical review by your doctor. If it appears to your doctor that there is no improvement in your daily function or quality of life from these medications, your doctor will suggest weaning and discontinuing the medication.
• As a patient you understand that your usual doctor reserves the right to perform random or unannounced urine drug testing, and you agree to comply with this testing. This is a safety issue.
• Patients are responsible for their prescriptions. Lost prescriptions will not be replaced.
• Repeat prescriptions are generally written for a maximum of one-month’s supply and will be filled at the same pharmacy.
• Patients have the responsibility to schedule appointments for the next opioid prescription before leaving the clinic or within three days of the last clinic visit. No walk-in appointments for medication refills will be granted.
• Patients have the responsibility for keeping medications in a safe and secure place, such as a locked cabinet or safe. If medications are lost, misplaced, or stolen your doctor may choose not to replace the medications or to taper and discontinue the medications.
• Patients have the responsibility for taking medications as directed and understand that increasing the dose without the close supervision of your doctor could lead to the cessation of prescribing. Early requests for repeat scripts will not be performed.

[Insert practice name]

Date effective:

Review date:

POSITION STATEMENT REGARDING PRESCRIBING AUTHORISATION OF REGISTRARS

Registrars at [insert practice name] are restricted in prescribing drugs of addiction and drugs of dependence to levels determined by [insert practice name] clinical governance team or supervising GP.

Quality use of these drugs is an essential component of primary care. Ongoing experience, training and selfeducation in the use of these medications is required as part of training at [insert practice name].

Drugs restricted under this policy:

• Opioid analgesics
• Benzodiazepines

Scope and limitations [may be changed according to individual practice circumstances.]

Opioid analgesics

Registrars are permitted to initiate opioid analgesics as specified below, informing a senior GP at the next most convenient time.

Registrars are permitted to provide opioid analgesic continuation as specified below.

Benzodiazepines

Benzodiazepine initiation:

• Initiation is limited to a single pack (25 tablets) of temazepam 10 mg tablets with no repeats for short-term intermittent use.
• This is in association with a full clinical assessment and documentation of indication for use as a therapy adjunct to addressing the primary causal issue.

Benzodiazepine continuation:

• Registrars are permitted to supply continuation therapy to long-term patients of the practice who are on stable medication regimes, in the absence of their usual practitioner.
• The continuation of alprazolam is restricted to the usual senior GP in the practice.

Refer to the RACGP’s Prescribing drugs of dependence in general practice, Part B: Benzodiazepines and Part C1: Opioids for other relevant information to include (eg driving ability).

[Insert practice name]

Date effective:

Review date:

MINIMISING INAPPROPRIATE PRESCRIBING OF OPIOIDS

1. In this practice, opioid medications should not routinely be prescribed for:

• uncomplicated back and neck pain
• uncomplicated musculoskeletal pain
• headache/migraine
• renal colic
• non-traumatic tooth pain
• self-limited illness (eg sore throat)
• dental pain
• trigeminal neuralgia
• primary dysmenorrhea
• irritable bowel syndrome
• shoulder pain
• any functional or mental disorder of which pain is a leading manifestation
• an exacerbation of chronic non-malignant pain
• chronic visceral pains (eg chronic pelvic pain, chronic abdominal pain).

2. When opioids are prescribed for acute pain, GPs should prescribe:

• the lowest effective dose of immediate-release opioids
• no greater quantity than needed for the expected duration of pain – three days or less will often be sufficient; more than seven days will rarely be needed. This often requires limits put on dispensed medication.

3. Patients with existing chronic pain sometimes present with acute pain, which is a specific area of pain management. GPs are strongly advised to be familiar with issues involving:

• acute exacerbations of existing chronic pain
• opioid withdrawal presenting as acute pain
• new painful presentation or diagnosis unrelated to chronic pain.

[Insert practice name]

Date effective:

Review date:

PATIENTS WITH COMPLEX NEEDS – RISK ASSESSMENT FOR ONGOING MANAGEMENT

This practice deems the following patients to be at high clinical risk and in need of referral to public alcohol and drug facilities, or to a GP with advanced training in addiction medicine:

• Patients discharged from other general practices due to problematic behaviour
• Patients recently discharged from a correctional services facility
• Patients with a past family or personal history of substance misuse
• Patients using drugs of dependence with serious mental health comorbidities, or who are on antipsychotic medication
• Patients using a mix of opioids and illicit drugs
• Patients using a mix of opioids and benzodiazepines

[Insert practice name]

Date effective:

Review date:

SAFE LIMITS FOR OPIOID PRESCRIBING

The practice policy is to:

• provide ongoing structured review in all patients on long-term opioid therapy (ie monitoring the 5As of pain management: analgesia, activity, aberrant behaviour, adverse effects, affect) before every prescription
• exercise caution in prescribing patients over 50 mg average daily oral morphine equivalent (OME) dose, particularly in those patients with significant comorbidities or at higher risk for opioid misuse
• not prescribe more than an average daily OME dose of 100 mg without further validation from specialist involvement.

When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.¹⁵

Modified-release opioids are not indicated to treat chronic non-cancer pain (other than in exceptional circumstances) or to be used for PRN pain relief. In addition, hydromorphone and fentanyl modified-release products should not be used in opioid-naïve patients.

Opioids should be reserved for patients who have not responded to non-opioid treatments and who have defined pain conditions for which opioids have been shown to be effective. Prescribed opioids have an accepted individual and combined morphine equivalent threshold, above which the risk of adverse events significantly rises.

Most patients’ pain will be controlled on a dose of less than 50 mg OME.

Before prescribing an opioid:

• a diagnosis of the source of the pain must be made
• simple analgesia and other appropriate treatments should have been trialled
• there should be regular assessment of the patient using the 5As.

Patients who have chronic pain and experience an exacerbation of pain or a new painful condition should preferably not be treated with additional opioids.

Calculation of OME dose

For patients taking more than one opioid, the morphine equivalent dose of the different opioids must be added together to determine the cumulative dose.

For example, if a patient takes four codeine 30 mg combined with paracetamol 500 mg and two 20 mg oxycodone extended-release tablets per day, the cumulative dose may be calculated as follows:

• Codeine 30 mg x 4 tablets per day = 120 mg per day
• Using the OME dose table, 120 mg of codeine = 15 mg morphine equivalents
• Oxycodone 20 mg x 2 tablets per day = 40 mg per day
• Using the OME dose table, 20 mg oxycodone = 30 mg morphine, so 40 mg oxycodone = 60 mg morphine equivalents
• Cumulative dose is 15 mg + 60 mg = 75 mg OME per day.

[Insert practice name]

Date effective:

Review date:

REVIEW OF OPIOID PRESCRIBING

If opioid therapy is required for longer than 12 months, the Pharmaceutical Benefits Scheme (PBS) requires clinical review of the case and support by a second medical practitioner. The standards required for evaluation for the PBS review have not been documented. [insert practice name] believes this protocol should be considered for peer clinical review on a regular basis (eg every two years).

[Insert practice name]

Date effective:

Review date:

CONTINUATION OF OPIOID MANAGEMENT PLANS INITIATED BY EXTERNAL PROVIDERS

Patients often arrive from other practices or institutions requesting continuation of their opioid management programs. These practices and institutions can have prescribing practices which are variable, and may not be evidence based or safe. To ensure the safety of these programs and the quality of services provided by this practice, the following standards are to be observed.

Policy statement – Doctors at this practice should not prescribe drugs of dependence until evidence of clinical need is established.

If opioids were commenced for acute nociceptive pain (eg after surgery or trauma) there is a need to give clear direction about the anticipated duration of therapy. Typically, opioids should be weaned and ceased as the acute injury heals. Even in complex cases this should be within 90 days.

If opioids were commenced for chronic pain:

• further 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
• and 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 is required.

Policy statement – Doctors at this practice should not continue to prescribe drugs of dependence until reasonable steps have been undertaken to exclude problematic drug use.

• Given that there is a high prevalence of drug-seeking behaviour for opioids, and there is a high risk that these drugs may be sought and diverted for misuse or trafficking, it is important that each doctor independently makes a thorough clinical assessment of each patient’s opioid use, and develops a pain management treatment plan consistent with clinical guidelines. Doctors must satisfy themselves that the full range of treatment options is used, which may or may not include opioid medications.
• Examination of the patient should include checking for evidence of IV or other injecting drug use, or drug or alcohol intoxication.
• Check if the state or territory drugs and poisons unit or pharmaceutical services unit has a notification of dependence or has issued a permit for long-term opioid prescribing (refer to TGA website).
• Seek information from the Prescription Shopping Information Service (PSIS) operated by the PBS. This requires prior registration with the PSIS (call 1800 631 181 or visit website.
• Perform a baseline urine drug test (UDT) at the initial visit, with a request to include detection of oxycodone and other drugs not usually recognised by immunoassay. Detection of oxycodone requires a gas chromatography– mass spectrometry (GC–MS) test.
• Schedule a follow-up visit for when UDT results and medical records are available.
• Provide a patient information leaflet regarding the practice policies and procedures for pain management.

Policy statement – In the event of problematic drug use being identified, doctors at this practice should:

• offer opioid replacement therapy if this is within the practitioner’s skill set
• offer referral to appropriate drug misuse agencies. Appropriate nearby referral agencies include:

[insert appropriate local agencies]

Policy statement – This practice deems the following scenarios to be high risk and in need of referral to public alcohol and drug facilities, or to a GP with advanced training in addiction medicine:

[Strike out or add as required]

• Serious mental illness, or antipsychotic medication
• Past family or personal history of substance misuse
• Mixed use of opioids and illicit drugs
• Mixed use of opioids and benzodiazepines
• Recent discharge from a correctional services facility
• Discharge from other general practices due to problematic behaviour

Policy statement – If clinical need for opioid therapy is justified, doctors at this practice should observe the following practice requirements:

• There is a comprehensive evaluation of the patient’s condition and analgesic modalities which are documented within a treatment plan and recorded in the notes.
• Doctors should prescribe opioids according to their best clinical judgement, including if this is less than the wishes of patients, the recommendations of consultants, or the practices of the patient’s previous doctors.
• Patients taking inappropriate doses should be advised that the dose will be tapered in the near future.
• Patients who are unwilling to comply with the taper should be referred to specialist or public health services.
• Relevant permits to prescribe should be obtained from the state or territory drugs and poisons unit or pharmaceutical services (see flow chart below). In the case of continuing prescribing, these permits should be sought immediately if the patient has been receiving opioid treatment for eight weeks or longer. This will enable coordination of treatment and reduce the risk that previous prescribers will continue prescribing concurrently.

Policy statement – Patients who satisfy the criteria and are accepted under the continued care of a single doctor will be prescribed ongoing medication according to the practice protocols. This includes:

• continued prescribing and management by a single GP within the practice
• a comprehensive assessment
• a continued use of allied therapies
• the adoption of universal precautions
• a treatment agreement based on informed consent regarding the risks of dependence
• clear boundaries surrounding the use of opioids
• registration with or under state or territory health laws.

[Insert practice name]

Date effective:

Review date:

Policy statement – All patients have the right to professional respectful care that promotes their dignity, privacy and safety.

In the event of problematic drug use being identified, doctors at this practice should offer:

• remedial programs if this is within their skill set
• referral to appropriate drug misuse agencies.

Rationale

All patients, including those with drug-seeking behaviour, have the right to respectful care that promotes their dignity, privacy and safety.

Patients with substance use disorders have diverse needs and often complex social and psychological issues. Respecting their circumstances and assisting in offering referral to other organisations for support and management of their substance use disorder is recommended at this practice.

These patients have a medical condition (substance use disorder) characterised by presentation with manipulative or deceptive behaviour. Some doctors get offended by and upset with this sort of behaviour, but it is important to remember that these are the presenting symptoms of a condition and a professional, non-judgemental approach is necessary.

This patient will be someone’s son or daughter, sister or brother, etc. Their family will be hoping that you will provide appropriate care for the patient. Getting upset, angry or being offended does not help with the rapport needed to facilitate appropriate care.

This presentation may be the one opportunity in which proper care can be organised for these patients.

Verbal scripts

Some doctors have difficulty in knowing what to say in these circumstances. The following is a suggestion only:

• [Patient name], I am very concerned about your health. From what you have told me today, and from what I can gather from the material you have here, I am concerned you may have a substance use disorder.
• This is quite concerning, as ongoing use of [drug of concern] in the manner you have described may result in long-term harm for you or your health.
• I do not have state authorisation. Under the state law, in these circumstances, it is actually forbidden for me to prescribe these medications to you.
• The level of care needed to properly manage your case is outside my area of expertise, but I am happy to refer you to [insert local drug and alcohol services] to ensure that you get the care you need. I am also quite happy to provide other care outside these medications. Are you interested in that? Unfortunately, I cannot prescribe any tablets in the interim.

[Insert practice name]

Date effective:

Review date:

TAPERING OR DISCONTINUING OPIOIDS

• If benefits do not outweigh harms of continued opioid therapy, this practice policy supports GPs to work with patients to taper opioids to lower dosages or to taper and discontinue opioids.
• Continued pain management, including optimised non-opioid regimens and interventional approaches, should be offered for patients undergoing tapering of opioids.
• Where there is no evidence of substance use disorder, tapers can be initiated using the patient’s usual long-term opioid treatment medication.
• Where there is evidence of substance use disorder, doctors are reminded of their obligations under state or territory legislation, and advised that referral to clinics experienced in substance use disorder or to GPs specifically trained in this area is required.

Details

Depression, high pain scores and high opioid doses are key predictors of opioid tapering dropout or relapse. Addressing these factors through pharmacologic and psychological support might improve outcomes, although there is no research yet to validate this hypothesis.

Withdrawal symptom management using a2-adrenergic agonists (eg clonidine) is well supported by the literature. These drugs reduce sympathetic activity and therefore reduce symptoms of withdrawal.

Where there is no evidence of substance use disorder

If weaning is required after a short period of opioid therapy, such as after failure to achieve the goals of an opioid trial, or after a negotiated treatment phase for acute pain, then a faster rate of weaning is generally appropriate. One option is a stepwise reduction of the daily opioid dose each week by 10–25% of the starting dose.

If weaning is required in response to significant adverse effects or opioid misuse, then daily stepwise reduction may be more appropriate. Alternatively, immediate opioid cessation and pharmacological treatment of withdrawal symptoms can be considered.

Otherwise, a decrease of 10% of the original dose every five to seven days until 30% of the original dose is reached, followed by a weekly decrease by 10% of the remaining dose, rarely precipitates withdrawal symptoms and facilitates adherence.

Where there are complex patient comorbidities

Discontinuing opioid therapy is often hindered by patients’ psychiatric comorbidities and poor coping skills, as well as the lack of formal guidelines for the prescribers. Depression, high pain scores and high opioid doses are key predictors of opioid tapering dropout or relapse.

If a previous attempt at opioid weaning has proven unsuccessful, then the rate of tapering can be slowed. This can be achieved by reducing the size of the dose reduction each month and/or by increasing the time spent at each dose level (eg two or three months between reductions).

Where there is evidence of substance use disorder

Doctors are advised to adhere to the legislative requirements of each state or territory regarding opioid therapy for patients with a substance use disorder (SUD).

Doctors should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioural therapies) for patients with opioid use disorder. Doctors are advised that referral to clinics experienced in SUD or to GPs specifically trained in this area is required.