×

Web site maintenance has been scheduled on 20/01/2022 from 9pm to 10pm AEDT, minor disruptions may occur.


Prescribing drugs of dependence in general practice

Part A - Clinical Governance Framework

Appendix D. Example practice policies

Last revised: 25 May 2021

These practice policies are examples only

They are not individually approved or endorsed by the RACGP Council, or by the Standards. They are based on policies and practices from national and international sources. If practices wish to adopt any of these policies, they may be modified for relevance and applicability to the local context.

Purpose

To inform patients about the practice’s standards regarding the prescription of drugs of dependence

Example policy

[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.

If you are a new patient 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 a contract 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.
  • Patients may need to acknowledge that their care requirements may be 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 on issues relating to staff abuse. Any threats to staff will result in transfer of your care.
 

Purpose

To specify the scope and limitations to prescribing of dependence by general practice registrars.

Example policy

[Insert practice name]

Date effective:

Review date:

POSITION STATEMENT REGARDING PRESCRIBING AUTHORISATION OF REGISTRARS
Registrars at the [Insert practice name] are restricted in prescribing drugs of addiction and drugs of dependence to levels determined by the [Insert practice name] clinical governance team or supervising general practitioner. Quality use of these drugs is an essential component of primary care. Ongoing experience, training and self-education in the use of these medications is required as part of training at the [Insert practice name].

Drugs restricted under this policy

  • Opioid analgesics
  • Benzodiazepines

Opioid (and other prescription) analgesics

Registrars are permitted to initiate opioid analgesics as specified below:

  1. To hospitalised and residential aged care facility patients:
    1. for acute analgesia – on call
    2. using the following medications:
      1. Tramadol (currently S4) – ceiling dose 200 mg a day
      2. Morphine – ceiling dose 40 mg a day

Note that combinations of drugs that result in higher than 40 mg morphine equivalent per day will require senior GP review.

  1. To general practice patients:
    1. using the following medications:
      1. paracetamol 500 mg codeine 30 mg – limited to 20 tablets
      2. tramadol 100 mg – limited to 20 tablets

Note that higher dose tramadol requires consultation with a senior practitioner within the practice. b. Paracetamol/dextropropoxyphene derivatives (paradex, capadex, digesic) are prohibited

  1. Codeine, oxycodone, buprenorphine patches, fentanyl patches and hydromorphone use requires discussion with a senior practitioner within the practice.


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

    1. Registrars are permitted to supply continuation therapy:
      1. to long-term patients of the practice who are on stable medication regimes, in the absence of their usual practitioner
        1. patients requesting increased analgesia will need to be referred back to their usual practitioner
      2. to patients requiring continued postoperative analgesia (ie patients discharge from hospital) provided:i. there is no increase in opioid analgesic requirements
        1. a  plan to reduce and cease all opioid analgesia within a fortnight for most surgery, but up to 6 weeks for joint replacement or thoracotomy is undertaken
        2. a consultation with a senior general practitioner at the [Insert practice name] has occurred.
    2. Registrars are not permitted to continue analgesic plans initiated at other practices or healthcare facilities without the review of a senior general practitioner at the [Insert practice name].


    Benzodiazepines

    Benzodiazepine initiation

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

    Benzodiazepine continuation:

    1. The continuation of alprazolam is restricted to the usual senior general practitioner in the practice.
     

    Refer to the RACGP opioid and benzodiazepine guides for other relevant information to include (eg driving ability).

Purpose

To clarify the management of patients in various risk categories with regard to drugs of dependence.

Example policy

[Insert practice name]

Date effective:

Review date:

HANDOVER OF PATIENTS IN MEDIUM- AND HIGH-COMPLEXITY GROUPS WITH REGARD TO DRUGS OF DEPENDENCE

It is our practice policy that all patients regularly using drugs of dependence have their problems/needs assessed based on levels of complexity (ie low, medium or high). Patients in medium- or high-complexity groups should have an appropriate specialist review. Practice policy requires that patients with medium- or high-complexity problems are managed in a manner consistent with the universal precautions of pain medicine. That is:

  • a clear diagnosis and reasons for prescription are documented
  • a full psychosocial assessment is conducted including risk of addictive disorders
  • informed consent for treatment plans is used
  • pre- and post-intervention assessment of pain level and function is undertaken
  • opioid therapy +/– adjunctive medication is commenced on a trial basis
  • levels of pain and function are constantly assessed
  • the ‘five As’ of pain medicine (analgesia, activity, adverse events, aberrant behaviour, affect) are constantly assessed
  • the diagnosis is periodically reviewed and comorbidities are managed appropriately
  • the level of documentation standards needs to be high.

These practice standards are required to ensure the ongoing provision of care in the event of the absence of the patient’s usual doctor.

_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________

With respect to new patients presenting to the practice, or being referred by other agencies, it is our practice policy that:

  • The practice reserves the right not to accept these patients if either the practice or the practitioner is of the view that the current treatment plan is inconsistent with evidence-based guidelines, and the level of complexity exceeds the practice’s capacity to manage the patient.

If a doctor feels that a referral letter from an external agency does not meet handover standards, then communication should be sent to the original referrer seeking additional information (refer to Appendix  E.2).

Purpose

To clarify the standards under which opioid management plans are continued (eg for patients with chronic non-malignant pain).

Example policy

[Insert practice name]

Date effective:

Review date:

CONTINUATION OF OPIOID MANAGEMENT PLANS INITIATED BY EXTERNAL PROVIDERS

The purpose of this policy is to document the standards under which this practice agrees to continue the management of opioid treatment programs.
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.

  • 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 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 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 intravenous or other injecting drug use, or drug or alcohol intoxication.
  • Evidence that 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 may be sought (for contact details, visit www.tga. gov.au/industry/scheduling-st-contacts.htm).
  • Information may be sought from the Prescription Shopping Information Service (PSIS) operated by the Pharmaceutical Benefits Scheme. This requires prior registration with the PSIS (telephone 1800 631 181 or, for more information, www.medicareaustralia.gov.au/provider/pbs/prescription-shopping/index.jsp).
  • A baseline urine drug test (UDT) will be performed 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.
  • A patient information leaflet regarding the practice policies and procedures for pain management should be provided.

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

  • offer remedial programs 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 to be high risk and in need of referral to public alcohol and drug facilities, or a general practitioner with advanced training in addiction medicine:

  • [Strike out or add as required]
  • patients with 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 correctional services facility
  • patients discharged from other general practices due to problematic behaviour.

Policy statement – In the event that 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, particularly 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. In the case of continuing prescribing, this should be sought immediately if the patient has been receiving opioid treatment for 8 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 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
  • a contractual approach to opioid use
  • 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.

Purpose

To inform patients about their responsibilities and expected behaviours regarding drugs of dependence.

Example agreement

Based on the Blaustein Pain Treatment Center/Johns Hopkins Medicine therapy agreement and to be modified by the practice to suit local circumstances
 

[Insert practice name]

Date effective:

Review date:

PATIENT AGREEMENT FOR DRUGS OF DEPENDENCE THERAPY

The purpose of this agreement is to give you information about the medications you will be taking for pain and/or mental health management at this practice, and to ensure that you and your doctor comply with all state, territory and Federal regulations concerning the prescribing of drugs of dependence.

The doctor’s goal is for you to have the best quality of life possible given the reality of your clinical condition. The success of treatment depends on mutual trust and honesty in the patient–doctor relationship and full agreement and understanding of the risks and benefits of using potentially addictive drugs to manage your condition.

A trial of long-term opioid therapy may be considered for moderate to severe pain with the intent of reducing pain and increasing function. A trial of long-term benzodiazepine therapy may be considered in very limited circumstances if other options have failed or are considered inappropriate.

In signing this agreement, you have agreed to a trial of long-term use of potentially addictive medications as part of your treatment. These drugs of dependence can be very useful, but have a high potential for misuse and are therefore closely controlled by state, territory and Federal governments. Because your doctor is prescribing such medication to help manage your condition, it is considered good practice to agree to the conditions outlined below.

My responsibilities as a patient

  • I agree to see one doctor at one practice for all my health needs and prescriptions.
  • I will have all my medications dispensed at one pharmacy.
  • I agree that this medication is prescribed as a trial. If it appears to my doctor that there is no improvement in my daily function or quality of life from the controlled substance, my medication may be discontinued. I will gradually taper my medication as prescribed by the doctor.
  • I will inform my doctor of all medications I am taking, including herbal remedies and illicit medication. Medications can interact with drugs of dependence and produce serious side effects.
  • I will communicate fully with my doctor to the best of my ability at the initial and all follow-up visits my pain level and functional activity along with any side effects of the medications. This information allows my doctor to adjust my treatment plan accordingly.
  • I will not request or accept drugs of dependence from any other doctor or individual while I am receiving such medication from my doctor at the [Insert practice name].
  • I understand the use of alcohol together with drugs of dependence is contraindicated.
  • I will not use any illicit substances, such as cocaine, amphetamines or marijuana, while taking these medications. Use of these substances may result in a change to my treatment plan, including safe discontinuation of my opioid medications when applicable or complete termination of the patient–doctor relationship.
  • If I have a history of alcohol or drug misuse/addiction, I must notify my doctor of such history since treatment with drugs of dependence may increase the possibility of relapse.
  • I agree and understand that my doctor reserves the right to perform random or unannounced urine drug testing. If requested to provide a urine sample, I agree to cooperate. If I decide not to provide a urine sample, I understand that my doctor may change my treatment plan, including safe discontinuation of my opioid medications when applicable or complete termination of the patient–doctor relationship. The presence of a non-prescribed drug(s) or illicit drug(s) in the urine can be grounds for termination of the patient–doctor relationship. Urine drug testing is not forensic testing, but is done for my benefit as a diagnostic tool and in accordance with certain legal and regulatory materials on the use of controlled substances to treat pain.
  • I agree to allow my doctor/healthcare provider to contact any healthcare professional, family member, pharmacy, legal authority, or regulatory agency to obtain or provide information about my care or actions, if my doctor feels it is necessary.
  • I understand my capacity to drive may be affected and I may be asked to cease driving. My prescriptions
  • I am responsible for my prescriptions. I understand that lost prescriptions will not be replaced.
  • I understand that opioid prescriptions will not be mailed if I am unable to obtain my prescriptions monthly.
  • Repeat prescriptions can be written for a maximum of 1 month supply and will be filled at the same pharmacy. Pharmacy: ____________________________ Phone number: ___________________________
  • It is my responsibility to schedule appointments for the next opioid prescription before I leave the clinic or within 3 days of the last clinic visit.

Taking my medications

  • I understand that the medication is strictly for my own use. My medication should never be given or sold to others because it may endanger that person’s health and is against the law.
  • I am responsible for keeping my pain medications in a safe and secure place, such as a locked cabinet or safe. I am expected to protect my medications from loss or theft. If my medication is stolen, I will report this to my local police department and obtain a stolen item report. I will then report the stolen medication to my doctor. If my medications are lost, misplaced or stolen my doctor may choose not to replace the medications or to taper and discontinue the medications.
  • I am responsible for taking my medications as directed. I agree to take the medication only as prescribed.
  • I understand that increasing my dose without the close supervision of my doctor could lead to drug overdose causing severe sedation and respiratory depression and death.
  • I understand that decreasing or stopping my medication without the close supervision of my doctor can lead to withdrawal. Withdrawal symptoms can include yawning, sweating, watery eyes, runny nose, anxiety, tremors, aching muscles, hot and cold flashes, ‘goose flesh’, abdominal cramps and diarrhoea. These symptoms can occur 24–48 hours after the last dose and can last up to 3 weeks.
  • Any evidence of drug hoarding, acquisition of any opioid medication or additional analgesia from other doctors (which includes emergency rooms), uncontrolled dose escalation or reduction, loss of prescriptions, or failure to follow the agreement may result in termination of the patient–doctor relationship.

Monitoring effects of treatment

  • I accept that drug of dependence therapy is only part of my care, and that I must be fully compliant with additional care interventions deemed appropriate for my health.
  • I accept that set appointments must be made to review ongoing therapy. This should be monthly and made at the last clinic appointment. No walk-in appointments for medication refills will be granted.
  • If an appointment is missed, another appointment will be made as soon as possible. Immediate or emergency appointments will not be granted.
  • I will be seen on a regular basis and given prescriptions for enough medication to last from appointment to appointment, and sometimes two to three days extra if the prescription ends on a weekend or holiday. This extra medication is not to be used without the explicit permission of the prescribing doctor unless an emergency requires your appointment to be deferred one or two days.
  • It is my responsibility to notify my doctor of any side effects that continue or are severe (eg sedation, confusion). I am also responsible for notifying my doctor immediately if I need to visit another healthcare provider or need to visit an emergency room or if I become pregnant.
  • I understand that during the time that my dose is being adjusted, I will be expected to return to the clinic as instructed by my clinic doctor. After I have been placed on a stable dose, I may receive longer term therapy from my doctor but will return to the medical centre for a medical evaluation at least once every 3 months.
  • I understand that a reduction of medication will occur if I have deterioration at home or work, or reduction of social activities because of medication, or due to medication side effects.
  • I understand that while physical dependence is to be expected after long-term use of opioids, any signs of addiction, abuse, or misuse shall prompt the need for substance dependence treatment as well as weaning and detoxification from the opioids.

My behaviour

I understand that there is a wide spectrum of drug misuse behaviours, including those documented below. I understand that cessation of the medication trial, or cessation of the patient–doctor relationship may occur if I display any of the following behaviours:

  • presenting to the clinic intoxicated, as assessed by clinical staff
  • making any physical threat to any member of staff or to other patients
  • aggressively complaining about a need for medication
  • persistently requesting to have my medication dose increased despite clinical advice
  • taking a few extra, unauthorised doses on occasion
  • visiting multiple doctors for controlled substances (doctor shopping)
  • hoarding medication
  • using a controlled substance for non-pain relief purposes (eg to enhance mood, sleep aid)
  • starting frequent unscheduled clinic visits for early refills
  • using consistently disruptive behaviour when arriving at the clinic
  • obtaining drugs of dependence from family members (including stealing from older relatives)
  • having a pattern of lost or stolen prescriptions
  • displaying anger or irritability when questioned closely about pain
  • being unwilling to consider other medications or non-pharmacologic treatments
  • escalating my dose without authorisation
  • testing positive for a non-prescribed drug(s) or illicit drug(s) in my urine
  • injecting an oral formulation
  • forging prescriptions
  • selling medications
  • refusing diagnostic workup or investigation
  • obtaining controlled substance analgesics from illicit sources.

I understand that non-compliance with the above conditions may result in a re-evaluation of my treatment plan and discontinuation of opioid therapy. I may be gradually taken off these medications, or even discharged from the clinic.
I ______________________________________________ have read the above information or it has been read to me and all my questions regarding the treatment of pain with opioids have been answered to my satisfaction. I hereby give my consent to participate in the opioid medication therapy and acknowledge receipt of this document.
Patient’s signature ______________________________________    Date_______________________

 

Doctor’s signature_____________________________________          Date_______________________

Purpose

To inform patients about practice policies regarding repeat prescriptions for drugs of dependence.

Example policy

[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 drugs of dependence 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.
  • All requests 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 the controlled substance, your medication may be discontinued.
  • As a patient, you agree to, and understand that, your usual doctor reserves the right to perform random or unannounced urine drug 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 1-month 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 3 days of the last clinic visit.
  • 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 repeats scripts will not be performed.

Patients have the responsibility to set appointments to review ongoing therapy. This should be monthly and made at the last clinic appointment. No walk-in appointments for medication refills will be granted.

Example policy

[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 a general practitioner with advanced training in addiction medicine:

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

[Strike out or add as required.]

Example policy

[Insert practice name]

Date effective:

Review date:

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

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

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

Policy statement – 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 is recommended at this practice.

Doctors at this practice are reminded that the patient has a medical condition (substance use disorder) and they often present with manipulative or deceptive behaviour. Some doctors get offended and upset with this sort of behaviour, but it is important to remember that these are the presenting symptoms of a condition, and the medical and social circumstances of these patients can often be complex.

All patients, including those with drug-seeking behaviour, have the right to good medical care. This patient will be someone’s son/daughter, sister/brother, etc. Their families 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. Doctors need to be non-judgemental, use a neutral ‘matter of fact’ tone of voice and be empathetic to the individual circumstances. Don’t be afraid to explore the issues around the patient’s substance use.

Use your rapport. Ensure confidentiality.  Acknowledge that it may be difficult for the patient to share this information. The less judgmental you are, the more likely the patient is to reveal information and long-term care can be facilitated.

Remember, this is a disorder that needs to be addressed in a professional manner. However, having a patient focus does not mean that you will continue prescribing drugs of dependence.
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 longterm harm for you or your health.
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, however I am happy to refer you to our [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.

 

Purpose

To detail safe limitations for prescribing opioid medication in this practice. The policy relates to indications other than malignant pain.

Example policy

[Insert practice name]

Date effective:

Review date:

SAFE LIMITS FOR OPIOID PRESCRIBING

The practice policy is to not prescribe more than an average daily morphine equivalent dose (MED) of 80–100 mg without further validation. Most patient’s pain will be controlled on MEDs far less than this. Prescribed opioids have accepted individual and a combined morphine equivalent threshold, after which the risk of adverse events significantly rises.

When opioids are used for acute pain, the lowest effective dose of immediate-release opioids should be prescribed in 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.

Modified-release opioids are not indicated to treat chronic non-cancer pain (other than in ‘exceptional circumstances’), or to be used for ‘as-needed’ (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 somatic or neuropathic pain conditions for which opioids have been shown to be effective.

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.
  • An opioid-risk tool should be used to determine if the patient is at risk of opioid misuse.
  • A contract defining treatment goals, length of treatment and an exit strategy should be signed with the patient.
  • There should be regular assessment of the patient using the 5As.

Dosing thresholds

  • The prescriber should routinely evaluate the safety and effectiveness of opioid therapy for chronic non-cancer pain.
  • Assessing the effectiveness of opioid therapy should include tracking and documenting both functional improvement and pain relief.
  • Compared with patients receiving 1–20 mg per day of opioids, patients receiving 50–99 mg per day had a 3.7-fold increase in overdose risk. Patients receiving 100 mg per day or more had an 8.9-fold increase in overdose risk. Most overdoses were medically serious, and 12% were fatal.74
1. If <100 mg MED:75
  • No assistance from a senior general practitioner or a pain management consultant needed if the prescriber is documenting sustained improvement in both function and pain.
  • Consider getting assistance if frequent adverse effects or lack of response is evident in order to address:
    • evidence of undiagnosed conditions
    • presence of significant psychological condition affecting treatment
    • potential alternative treatments to reduce or discontinue use of opioids.
2. Before exceeding 100 mg MED per day threshold:75
• Seek assistance from a senior general practitioner or pain management consultant to address:
  • potential alternative treatments to opioids
  • the risks and benefits of a possible trial with opioid dose above 100 mg MED/d
  • the most appropriate way to document improvement in function and pain – a possible need for consultation from other specialists.

Table D1. Calculation of morphine equivalent dose

Table D1.

 Calculation of morphine equivalent dose75
Table D2. Dosing threshold for selected opioids75

Table D2.

Dosing threshold for selected opioids75
Approximate* potencies of various opioids relative to 10 mg parenteral morphine

Table D3.

Approximate* potencies of various opioids relative to 10 mg parenteral morphine77 
Table D4. Morphine equivalent dose

Table D4.

Morphine equivalent doses78 


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. This policy details a protocol that [Insert practice name] feels is appropriate to make an informed evaluation of long-term opioid therapy.

[Insert practice name] believe this protocol should be considered for peer clinical review on a regular basis (eg every 2 years).

 
Evaluation criteria   Yes
1. Clinical diagnosis
  1. Is there a comprehensive documentation of the patient’s pain condition, general medical condition, psychosocial history, psychiatric status and substance use history?
  2. Is the indication/diagnosis for prescribing opioids clearly supported and documented?
  3. Is opioid medication clinically appropriate in this condition?
   
2. Opioid treatment
  1. Has opioid therapy produced and maintained a measurable improvement in the patient’s functional capacity?
  2. Are the total doses of all opioids below ‘ceiling’ dose levels? (ie for [Insert practice name] 80 mg morphine equivalent a day)
  3. Is the patient substantially free from adverse side effects of opioid therapy?
  4. Is there continued absence of inappropriate dose escalation, aberrant behaviour, misuse or abuse of opioids?
  5. Has a reduction in opioid therapy been trialled?
  6. Have urine drug screens been used to investigate possible diversion, compliance, or other illicit drug use? 3. Additional treatment
   
3. Additional treatment 
  1. Are non-drug therapies maximised?
  2. Given the clinical complexity and risk, is the current level of specialist care and multidisciplinary intervention adequate and appropriate?

In general the following scenarios are considered as complex and high risk by [Insert practice name], and indicated for specialist and multidisciplinary review:

  • those who use two or more psychoactive drugs in combination (polydrug use) (eg opioid, benzodiazepines, antipsychotic, anti-epileptics, and depressants)
  • patients with serious mental illness comorbidities, or antipsychotic medication
  • mixed use of opioids and illicit drugs
  • mixed use of opioids and benzodiazepines
  • recent discharge from a correctional services facility
  • patients discharged from other general practices due to problematic behaviour
  • signs of potential high-risk behaviours.
   
4. Compliance
  1. Is current opioid prescribing compliant with relevant state and territory laws and regulations for controlled substances?
   

Answering ‘no’ to any of the above options should prompt a consideration to alter the management plan. 
   


Recommendations


Continue therapy       
Reduce opioid dose     
Reduce and cease opioids   
Pursue alternate therapies           
Suggest specialist review
   
     
     
     

Purpose

To set a guideline for tapering or withdrawal of opioid medication.

Example agreement

[Insert practice name]

Date effective:

Review date:

TAPERING OR DISCONTINUING OPIOIDS

Not all patients benefit from opioids, and general practitioners frequently face the challenge of reducing the opioid dose or discontinuing the opioid altogether.

Reasons to discontinue opioids or refer for addiction management include:79

  • severe pain despite an adequate trial of several different opioids
  • no improvement in function and pain
  • opioid related complications (eg sleep apnoea, falls)
  • as a component of ‘structured opioid therapy’ for addicted patients with a pain condition who do not access opioids from other sources or alter the route of delivery
  • patient exhibits drug-seeking behaviours or diversion
  • if in the general practitioners judgement, the health risks outweigh the benefits.

From a medical standpoint, weaning from opioids can be done safely by slowly tapering the opioid dose and taking into account the following issues.

  • Precautions for opioid tapering
    • Pregnancy – Acute withdrawal can cause premature labour and spontaneous abortion.
    • Unstable medical and psychiatric conditions – While opioid withdrawal does not have serious medical consequences, it can cause considerable anxiety and insomnia that might exacerbate severe, acute medical or psychiatric conditions. Consider specialist review.
    • Opioid addiction – Outpatient tapering is unlikely to be successful if the patient regularly accesses opioids from other doctors or the street; methadone or buprenorphine treatment is advised.
    • Concurrent medications – Avoid sedative-hypnotic drugs, especially benzodiazepines, during the taper.
  • Opioid tapering protocol
    • Before initiation
      • Emphasise that the goal of tapering is to make the patient feel better (ie to reduce pain intensity and to improve mood and function).
      • Have a detailed treatment agreement.
      • Be prepared to provide frequent follow-up visits and supportive counselling.
      • Physical rehabilitation is an important factor that should be integrated into the opioid reduction program, with adequate attention and management of other psychological issues.
    • Type of opioid, schedule, dispensing interval
      • Use controlled-release morphine if feasible.
      • Prescribe scheduled doses (not as needed).
      • Prescribe at frequent dispensing intervals (daily, alternate days, or weekly, depending on patient’s control over opioid use); do not refill the prescription if the patient runs out.
      • Keep daily schedule the same for as long as possible (eg 3 times daily).
      • Rate of taper
        • Seek advice from a local drug and alcohol clinical advisory service or pain unit.
        • Can vary from 10% of the total daily dose every day to 5% every 1–4 weeks.
        • Slower tapers are recommended for patients who are anxious about tapering, those who might be psychologically dependent on opioids and those who have cardiorespiratory conditions.
        • Faster tapers may be used if the patient is experiencing serious adverse effects such as obvious sedation.
        • Once one-third of the original dose is reached, slow the taper to half of the previous rate.
        • Hold or increase the dose if the patient experiences severe withdrawal symptoms or worsening of pain or mood.
      • Switching to morphine
        • Consider switching patients to morphine if the patient is addicted to oxycodone or hydromorphone.
        • A person addicted to opioids should be referred to an addiction specialist or a general practitioner with relevant training for management.
        • Ongoing prescription of morphine to addicted patients requires an authority. Most jurisdictions will not grant an authority unless it is for treatment with methadone liquid or sublingual buprenorphine (film).
        • Calculate the equivalent dose of morphine.
        • Start the patient on half this dose (tolerance to one opioid is not fully transferred to another opioid).
        • Adjust dose up or down as necessary to relieve withdrawal symptoms without inducing sedation.
      • Monitoring during taper
        • See the patient frequently; at each visit, ask about the benefits of taper (eg improved pain, mood, alertness).
        • If a patient is not successfully reducing, or there is an escalation in dose beyond prescription, involve other practitioners.
        • Doses may need to be dispensed daily by pharmacy to assist wean process.
        • Use urine drug testing to ensure compliance.
      • Completion of taper
        • Taper can usually be completed in between 2–3 weeks and 3–4 months.
        • Patients who are unable to complete the taper may be maintained at a lower opioid dose if they are compliant with the treatment agreement.
      • A decrease by 10% of the original dose per week is usually well tolerated with minimal physiological adverse effects. Some patients can be tapered more rapidly without problems (over 6–8 weeks).
        If opioid abstinence syndrome is encountered, it is rarely medically serious although symptoms may be unpleasant.
      • Symptoms of an abstinence syndrome, such as nausea, diarrhoea, muscle pain and myoclonus can be managed with clonidine 0.1–0.2 mg orally every 6 hours or clonidine transdermal patch 0.1 mg/d (Catapres TTS-1) weekly during the taper while monitoring often for significant hypotension and anticholinergic side effects. In some patients it may be necessary to slow the taper timeline to monthly, rather than weekly dosage adjustments.
      • Symptoms of mild opioid withdrawal may persist for 6 months after opioids have been discontinued. Rapid reoccurrence of tolerance can occur from months to years after prior chronic use.
      • Consider using adjuvant agents, such as antidepressants to manage irritability, sleep disturbance or antiepileptic for neuropathic pain.
      • Do not treat withdrawal symptoms with opioids or benzodiazepines after discontinuing opioids.
      • Referral for counselling or other support during this period is recommended if there are significant behavioural issues.
      • Referral to a pain specialist or public health dependency centre should be made for complicated withdrawal symptoms.


        There are no foolproof methods for preventing behavioural issues during an opioid taper, but strategies implemented at the beginning of the opioid therapy are most likely to prevent later behavioural problems if an opioid taper becomes necessary

        An Opioid Taper Plan Calculator is available and makes it easier for prescribers to calculate safe and effective taper plans for patients who would benefit from lower opioid doses. Washington State Medicaid developed it in collaboration with the University of Washington pain management experts. It can be accessed at www.hca.wa.gov/medicaid/ pharmacy/pages/index.aspx and then click on Medical Opioid Taper Plan Schedule.

        Recognising and managing behavioural issues during opioid tapering
        Opioid tapers can be done safely and do not pose significant health risks to the patient. Special care needs to be taken by the prescriber to preserve the therapeutic relationship at this time. Otherwise, taper can precipitate doctor shopping, illicit drug use or other behaviours that pose a risk to patient safety. Extremely challenging behavioural issues may emerge during an opioid taper.75

        Behavioural challenges frequently arise when a prescriber is tapering the opioid dose and a patient places great value on the opioid they are receiving. In this setting, some patients may feel overwhelmed or desperate and will try to convince the prescriber to abandon the opioid taper. Challenges may include:

        • a focus on the right to pain relief (‘You don’t believe I have real pain’)
        • arguments about poor quality of pain care with threats to complain to administrators or licensing boards 
        • attributing their deteriorating psychological state, including suicidal thoughts, to opioid withdrawal.


What are benzodiazepines?
Benzodiazepines are a group of prescription-only medicines that have a sedating and calming effect on the brain and nervous system. They are also known as sedatives or tranquillisers. Examples of benzodiazepines include medicines containing one of the following active ingredients: diazepam, lorazepam, oxazepam, temazepam and alprazolam.
They come in tablet and capsule form, and some are available for intravenous use in hospital settings.

How do benzodiazepines work?
Benzodiazepine medicines differ in how quickly the active ingredient starts to work and for how long the effect lasts. The effect of the medicine also depends on the dose prescribed and on the individual; height, weight, health status and previous experience with benzodiazepines can all impact on how the benzodiazepine medication will work.

Benzodiazepines can help treat symptoms of anxiety and sleeping problems (eg insomnia). As nonmedicine therapies have proven benefit in these conditions, benzodiazepines are generally considered only if non-drug treatments are inappropriate or have failed.

If you have been diagnosed with an anxiety disorder, benzodiazepines can make you feel calmer. If you have insomnia, benzodiazepines may help you fall asleep. They are sometimes used for other reasons, such as before an operation to alleviate nervousness.

After taking benzodiazepines, people can describe feeling drowsy, relaxed, confused/fuzzy and having a heavy sensation in their arms and legs. Coordination and reflexes can be affected too, which means you should not take benzodiazepines if you need to be focused and coordinated (eg driving a car or operating heavy machinery).

Benzodiazepines are usually taken for a set period until the intended therapeutic effect is achieved, then the dose is reduced and plans to stop it are made.

If you take benzodiazepines for a prolonged time, the body may adapt and get used to the effects of the medication. Stopping the medication can lead to withdrawal symptoms that includes anxiety and restlessness. Withdrawal symptoms are often mild, but can be severe if you are on high doses of a benzodiazepine. Serious side effects, including seizures, can occur if you stop taking high doses suddenly.

Can benzodiazepines be addictive?
Although addiction (cravings, abuse, misuse, compulsive or uncontrollable benzodiazepine-seeking behaviour) is possible with benzodiazepines, it is rare in people who are taking therapeutic doses for a specific reason over a short period as prescribed by their doctor.

You may be at a greater risk of developing an addiction to benzodiazepines if you have a history of drug dependence or if you are currently misusing any substance including alcohol or strong pain killers (opioid drugs).

Before prescribing a benzodiazepine, your doctor will ask you questions about these sorts of things to help prevent addiction.

What are the possible side effects of benzodiazepines?
Benzodiazepine medicines are associated with a number of side effects including:

  • drowsiness and unsteadiness, potentially increasing the risk of a fall
  • impairment in judgement and dexterity, making tasks such as driving or using heavy machinery more difficult
  • forgetfulness, confusion, irritability
  • paradoxical aggression and excitability (although this is rare, it is the opposite effect to what is expected with these medicines).

Taking benzodiazepines in combination with other drugs or alcohol can be very dangerous and, in some cases, fatal.

Can I take benzodiazepines for a long time?
Benzodiazepines are usually taken for a short length of time. In rare instances, some patients will require long-term therapy with benzodiazepines. This is after a serious consideration of risks and benefits of long-term therapy between yourself and your doctor. If you and your doctor have decided that benzodiazepines are an important part of your long-term treatment, then you should continue to take them as prescribed and keep checking in with your doctor for review.

If you have been taking benzodiazepines regularly for longer than 4 weeks and wish to stop them, your doctor would be happy to advise you on how to do this. Do not stop or significantly alter the dose abruptly. Many people can stop taking benzodiazepines without difficulty. For others, gradual reduction helps prevent or reduce any withdrawal symptoms.

Where can I get more information?

Much of the information presented here comes from patient.co.uk, www.patient.co.uk/health/ benzodiazepines-and-z-drugs

Other sources of information include:

  • Reconnexion, www.reconnexion.org.au, an Australian not-for-profit organisation that offers programs, counselling, telephone information and support for people with anxiety, stress, depression and benzodiazepine dependency and related conditions.
  • The Victorian Government’s Better Health Channel website, www.betterhealth.vic.gov.au
The Australian Drug Foundation’s help and support page, www.druginfo.adf.org.au/contact-numbers/ help-and-support, lists sources of information and advice

Chronic opioid therapy safety guideline for patients with chronic non-cancer pain Opioid treatment fact sheet

Using opioid medicines to treat your pain

You and your doctor have decided that opioid pain medicine might help reduce your pain and improve your function. Opioids are not likely to make your pain go away completely.
It is important to understand that this treatment involves potential risks and benefits. It is also important that you follow the guidelines in this handout and let your doctor know what you expect from your treatment. Your doctor may ask you to sign an ‘Opioid patient care agreement’.

What are the goals and possible benefits of opioid treatment?
The goals of treatment are to reduce your pain and improve your daily function. The benefits of opioid medicines are different from person to person. Opioids typically reduce chronic pain by about 30%. Some people find that they can function better day to day, but research has shown this is not typical.

Experts agree that opioids may actually make pain worse, especially at high doses. ‘Flare-ups’ are common and should not usually be treated by increasing the dose or taking extra medicine.
Your doctor will monitor how you are doing by asking you to rate your pain level and your daily functioning. They may want to know how far you can walk, how long you can sit, whether you are able to work or do housework, and what kinds of activities you do alone or with family and friends.

What are the common side effects and risks of opioids?
Opioids cause common side effects that can be unpleasant. They can also increase risks of serious health effects that occur less often. Because opioids have risks that can be serious, your doctor may ask you for a urine or blood sample to help protect your safety.

Side effects vary from person to person. You and your doctor will work together to monitor how opioids affect you. Your doctor may need to adjust your dose until you find the right balance between pain reduction, improved function and side effects.

It is normal to develop physical dependence to opioids. Physical dependence means your body has adapted to the medicine and you will experience tolerance and withdrawal. Tolerance means you need to take more of the medicine to get the same effect. Withdrawal means you will have symptoms when you stop using the medicine.

Withdrawal symptoms are usually the opposite of the effects of the medicine. For example, if the medicine causes constipation, the withdrawal symptom would be diarrhoea. If the medicine reduces pain, the symptom would be increased pain. Withdrawal from opioids is temporary and usually not dangerous.

Babies born to mothers taking opioids will be dependent on opioids at birth. You should not take opioids if you are trying to get pregnant. If you do get pregnant while taking opioids, let your doctor know right away.

People who have had problems with mental health, drugs or alcohol are more likely to have problems with opioids. You must tell your doctor about any mental illness, substance abuse or addiction of any type you have experienced in the past. You must also tell your doctor if anyone in your family has had these problems. Research shows these problems sometimes run in families.
Experts agree that people with active substance abuse or addiction problems should not use opioids for chronic non-cancer pain. If you have problems with substance abuse or addiction, it is important to let your doctor know so you can get the help you need. Tell your doctor right away if you feel you are becoming addicted to opioids.

Common side effects

Other side effects

Withdrawal Symptoms

Constipation
Opioid medicines cause constipation. You may need to be treated for this while you are taking opioids.
Sedation
Many opioid medications can make you feel drowsy, slow your reaction time, and cause loss of coordination. They can also make it hard to concentrate and think clearly.
Do not drive or use dangerous equipment until you are sure that opioids do not affect your reaction time or thinking ability. It may take a week or longer before you know if you can drive safely while taking opioids. If you are in a traffic accident while driving on opioids, you may be considered to be driving under the influence.

  • Rash and/or itching
  • Dry eyes
  • Blurred vision
  • Nausea and vomiting
  • Inability to urinate
  • Low blood pressure
  • Slow heart beat
  • Depressed mood
  • Slowed breathing
  • Problems with balance
  • Decreased sex drive (decreased testosterone)
  • Decreased immune function
  • Swelling in hands and feet
  • Jerking of arms and legs
  • Increased sensitivity to pain
  • Disruption of normal sleep
  • Dental problems
  • Apathy
  • Falls resulting in fractures
  • Sweating
  • Nausea
  • Abdominal pain/cramping
  • Diarrhoea
  • Trouble sleeping
  • Muscle aches
  • Fast heart beat
  • Anxiety
  • Runny nose
  • Goose bumps
 

Risk of serious bodily harm or death

Opioid pain medicines can cause serious bodily harm or death. Higher doses appear to cause more side effects, some of which can lead to injuries like serious fractures due to falls. Higher doses increase the risk of overdose. An overdose of opioids, whether by accident or on purpose, can cause serious bodily harm or death. Research continues to show more and more problems with long-term opioid use, especially at high doses.

Using more opioids than your doctor prescribes can cause you to become dangerously sedated, stop breathing or overdose. Combining opioids with certain other medicines or with alcohol or drugs can have the same effect.

Some opioids have higher risks overdose.

It can also cause heart rhythm problems. Opioids that contain paracetamol, such as Panadeine Forte, can harm the liver when taken long term or at high doses.

Are there alternatives to opioid treatment for chronic non-cancer pain?

Your doctor may prescribe other treatments to help your pain and to help you do daily activities better. These may include exercise, psychological counselling and medicines that are not opioids. Please be sure to discuss these options with your doctor.

There are special problems with some opioids. For example, pethidine and tramadol are associated with increased seizure risk. Methadone stays in the body for many days, which increases the risk of


This simple checklist was developed from content in this guide. It is designed to enable general practices to evaluate their status in managing drugs of dependence for their respective populations. As each general practice is different, findings should be interpreted individually.

1. Quality and safety infrastructure
  1. Is your practice accredited to The Royal Australian College of General Practitioners’ (RACGP’s) Standards for general practices?
  2. Is there a clinical leader responsible for safety and quality within the general practice?
  3. Does the general practice support relevant training, education and resources for staff to be able to identify patients with more complex needs and those at higher risk?
  4. Does the general practice have policies regarding the management of patients according to their mental health status and use of drugs of dependence to provide the appropriate level of service internally and externally?
  5. If the general practice contains a general practice-based drugs of dependence management program, does it ensure suitably qualified staff, organised support and ongoing quality assurance arrangements?
  6. Does the general practice promote the development of competency in prescribing drugs of dependence for its clinical staff?
  7. Does the general practice have strategies to ensure the occupational health and safety of GPs and other members of the practice team?
 
2. Clinical policy
  1. Does the practice have agreed clinical policies regarding prescribing drugs of dependence? (Refer to Appendix D)
 
3. Organisation of services
  1. Does the general practice have an effective handover system to ensure safe and continuing healthcare delivery for patients (eg buddy system for continued care in the GP’s absence)?
  2. Does the general practice facilitate GPs’ access to information management data to monitor potential prescription drug abuse (eg state and territory health ministries’ drug units and Prescription Shopping Information Service [PSIS])?
  3. Does the general practice allow GPs the right to discontinue care of a patient who has behaved in a violent or threatening manner?
  4. If the general practice contains a general practice-based drugs of dependence management program, does the general practice have a system of care to maximise health outcomes?
4. Preventive health and screening
  1. Is there evidence that GPs use urine drug screening to detect misuse or abuse of drugs of dependence?
5. Clinical documentation
  1. Do GPs ensure patient records are clear, up to date and contain sufficient information for another practitioner to take over care?
6. Clinical assessment
  1. Is there evidence of an adequate assessment and management plan for each patient taking a drug of dependence?  
7. Clinical management
  1. Do GPs use principles of universal precautions to guide their approach to patients who require drugs of dependence?
  2. Do GPs use specialist support to manage problematic drug use in patients with more complex issues or if the clinical situation deteriorates?
8. Prescribing safety
  1. Do GPs prescribe within legislative frameworks and comply with professional standards and approved clinical guidelines?
  2. Do GPs ensure a permit or authority from the relevant state or territory health department when prescribing a Schedule 8 (S8) drug to a patient who is drug dependent?
  3. Do GPs inform patients that drugs of dependence are to be prescribed from one practice and preferably by one GP, and drugs should be dispensed from one pharmacy?
9. Clinical practice review
  1. Do GPs have a structured approach to reviewing opioid prescriptions after 12 months? (eg similar to Appendix D.10)
10. Populations for intervention
  1. Does the general practice engage in population interventions to reduce use of drugs of dependence? (eg reducing benzodiazepines use through a practice letter similar to Appendix E.1)

Advertising