Accountable prescribing

Professional boundaries

The public and health professions have an expectation that the therapeutic context is safe for patients. It is the health practitioner’s responsibility to behave ethically at all times and maintain professional boundaries.

With decreasing formality in medicine, GPs are more likely to encourage the use of first names and to develop a relaxed, collaborative relationship with their patients. All GPs should be mindful of simultaneously maintaining clear professional and personal boundaries.

Boundaries represent the edge of appropriate behaviour and serve two important purposes: they structure the professional relationship in ways that maintain the identity and roles of the patient and the professional and they separate the therapeutic relationship from social, sexual, romantic and business relationships.

Setting professional boundaries may include:⁴⁶

• practitioner behaviour standards
• using universal precautions
• not prescribing or dispensing controlled substances for self or family.

Legal obligations

All practitioners have a duty to act within state, territory and national legislative frameworks, and to manage their prescribing practices within the laws and clinical and professional standards.

Practitioners who are unaware of their legal obligations risk being the subject of legal prosecution and/or disciplinary action by the medical board.

GPs need to be aware of their obligations regarding the impact of medication on the patient’s ability to safely perform usual activities such as driving (eg Jet’s Law in Queensland ).

Medical defence organisations provide support and information on prescribing drugs of dependence. For more information, visit:

• Avant
• MDA National
• Medical Indemnity Protection Society

Evidence-based medicine

Doctors should use evidence-based interventions where they are available.

Occasionally, doctors prescribe drugs of dependence to address perceived patient expectations, but without necessarily improving health and potentially resulting in harm.

Unfortunately, there are few quality measures for accountable prescribing.⁴⁵ Protocols may be useful to ensure consistent provision of good practice. The practice team should work within a clinical governance framework and be prepared to justify their clinical decisions, particularly when operating outside guidelines. Doctors should keep comprehensive notes to support their decisions and monitor the effectiveness of their care using clinical audit.

Skills and knowledge

GPs are expected to update their knowledge and skills according to emerging evidence and developments in professional practice. It is each practitioner’s responsibility to ensure competency in the areas they choose to manage. Practitioners should also be aware of their clinical limitations.⁴⁷

Doctors who are untrained⁴⁸ or become ‘dated’ in their clinical competencies can be at higher risk for inappropriate prescribing.⁴⁹

Numerous educational interventions have been conducted to improve prescribing competency.⁵⁰ The World Health Organization’s (WHO) Guide to good prescribing⁵¹ has the largest body of evidence to support its use in a wide variety of settings.^50,52

Doctors prescribing drugs of dependence should review their pharmacology, including pharmacokinetic and pharmacodynamic properties, drug–drug interactions and signs of intoxication and withdrawal. They should also be aware of the epidemiology of abuse and appropriate treatment indications and contraindications, and they should be able to perform basic alcohol and drug addiction screening assessments.⁵³

Community pharmacists may be a valuable resource.⁵⁴

Universal precautions

Adoption of a universal precautions approach (used in pain medicine) may improve patient care and minimise the risk of harm and medico-legal issues. The following universal precautions are a guide to the proper evaluation and management of patients, and are applicable to all drugs of dependence:⁵⁵

• Make a diagnosis with appropriate differential diagnoses.
• Undertake a psychosocial assessment that includes risk of addictive disorders.
• Use informed consent.
• Use treatment agreements.
• Undertake a pre- and post-intervention assessment that includes pain score and level of function.
• Commence a trial of appropriate opioid therapy with an appropriate combination of adjunctive medications.
• Reassess pain score and level of function.
• Routinely assess the five As of pain medicine (analgesia, activity, adverse events, aberrant behaviour, affect).
• Periodically review the diagnosis and comorbid conditions, including addictive disorders.
• Carefully document initial assessment and each follow-up.

Prescription writing

GPs should use prescription-writing techniques to minimise misuse and abuse.

When writing prescriptions for drugs of dependence, GPs must:⁵³

• prescribe the appropriate amount to carry through to the next appointment
• write out the number dispensed in letters and numerals (ie 14 and fourteen)
• draw a large ‘Z’ at the bottom of the prescription so that further items cannot be added (if using paper prescription stationery).

Prescribers can decrease the risk of misuse by reducing access and temptation to overuse medication through much more frequent dispensing of smaller quantities of medications. This can range from weekly, twice weekly to daily (supervised) dispensing. This is aided by a one-practice and, preferably, one-GP approach, and the dispensing of medication through one pharmacy.

The ‘prescription traps’

The following is a compilation of prescription issues that have been noted in coroners’ proceedings. GPs are advised to consider these in reviewing their own prescribing habits.

• Patients requesting private scripts for drugs of dependence.
• Patients presenting with out-dated doctor’s letter requesting medication.
• Excessive prescribing without proper assessment of potential psychiatric conditions.
• Excessive prescribing without proper assessment of pain management options, including specialist referral.
• Prescribing contrary to statutory guidelines or regulations.
• Prescribing dangerous (high-risk) medication to unknown patients, particularly opioids and benzodiazepines.
• Prescribing benzodiazepines as a first-line treatment for psychiatric disorders.
• The inappropriate use of benzodiazepines in pain management.
• The inappropriate use of opioids in pain management, particularly chronic non-malignant pain.
• The inappropriate combined use of benzodiazepines and opioids in pain management.
• The use of pethidine in pain management (particularly for the treatment of migraines).
• The use of injectable medication, particularly opioids, by GPs for pain treatment.
• Prescription of medications with potentially dangerous interactions, particularly, tramadol and antidepressant medication (risk of serotonin syndrome).
• The use of quetiapine to treat insomnia and anxiety.

Working collaboratively

Doctors need to work with a range of other professionals and may work as part of a wider organisation or in a multidisciplinary team. It is usually good practice to ensure that clinical practices are standardised through local area policies and protocols. Depending on the setting and nature of the organisation (eg community drug treatment, primary care–led drug treatment service, hospital-based drug treatment service), doctors should be aware of accepted best practice protocols and work in accordance with these.

Patients who are at higher risk for dependency or have more complex issues need to be jointly managed between primary care and specialised drug and alcohol/addiction services, and require the input of mental health and/or pain specialists as required.

Managing issues between multiple providers

Circumstances occasionally arise when GPs feel uncomfortable about continuing care from other practitioners. GPs are under no obligation to continue another prescriber’s action if they deem this to be unsafe, inappropriate or impractical, such as:

• drugs being prescribed off label, particularly drugs used for mental illness
• disagreement between the GP and specialist about whether a drug of dependence is warranted
• excessive prescribing that the GP is uncomfortable continuing.

There needs to be provision within the system for case conference and collaborative discussion of evidence-based treatment where all views are taken into consideration. When a GP does not feel happy to provide a prescription, they should not feel pressured to do so. The ideal situation is to have an independent drug and alcohol specialist review the case. Alternatively, referral back to the original provider for scripts may be warranted.

If taking over the care of an inherited patient, the GP should ask the following questions:⁵⁶

• Does this patient have a clear chronic pain disorder and/or mental illness diagnosis?
• Is there justification for the drugs that have been prescribed?
• Are the prescribed amounts appropriate?
• If a patient is displaying drug-seeking behaviours, is this a sign of under-treated pain, addiction, or involvement in abuse or diversion of S8 opioids?

Getting support

Prescribing decisions around drugs of dependence can be difficult and new evidence is constantly emerging. GPs need to keep up to date with best prescribing practices. Formal and informal professional support (eg mentoring, clinical review, education, joining professional networks, using decision support tools) is important for all GPs and may be particularly relevant for GPs working in isolation.

There is some evidence that sole practitioners who are not affiliated with any professional college (ie not actively engaged in ongoing professional development programs) and treating opioid-dependent patients over a long period are at risk of inappropriate prescribing.⁵ Inappropriate prescribing can be the result of not taking a drug history, not conducting a physical examination and not asking if patients have had these drugs prescribed for them before, and, if so, when. Quality improvement activities such as continuing audit, clinical review and educative support may help reduce inappropriate prescribing.^57–59

Deciding when to seek advice or consider referral to a psychiatrist or pain/addiction specialist

The ongoing treatment of pain, addiction and mental illness comorbidities is a complex undertaking. Initial referral may be needed to obtain a comprehensive evaluation, or to clarify the optimal therapeutic strategies.

Referral is typically considered for patients who are at higher risk, who have more complex needs or in patients at risk of adverse events. For example, patients who:⁵⁶

• are relatively young (eg <35 years old)
• have a comorbid psychiatric or psychological disorder
• have previous or current opioid, or SUDs
• have indeterminate pathology.

Once an optimal regimen and monitoring approach has been implemented, referral may be warranted for the following reasons:⁵⁶

• unexpected drug dose escalation
• ceiling drug dosages reached
• suspected abuse or misuse
• risk category change
• high levels of patient distress
• unusual opioid requirements or suspicions of drug diversion
• poorly controlled comorbid psychiatric or psychological disorder.

Deciding when to refer a patient for hospital admission (through emergency departments)

Patients may need referral to hospital if they are at risk to themselves, pose risks to others or at risk by others.

Table 2

Identifying patient risk

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Record keeping

GPs must maintain adequate, accurate and timely records regarding pain assessment, treatment plan, informed consent, ongoing assessment and consultation of the patient.

‘Adequate records’ refers to legible records containing, at a minimum, sufficient information to identify the patient, support the diagnosis and justify the treatment; adequate documentation of the results; advice and risks provided to the patient; and sufficient information for another practitioner to assume continuity of the patient’s care at any point in the treatment.

GPs also need to document the process of shared decision making and what information is shared.

All drugs of dependence have the potential to be misused. Even when used as prescribed, they can cause harms. Before prescribing or continuing to prescribe them to any patient, the patient should be assessed and their needs and risks determined.

More detailed information will be available in the RACGP’s separate guidelines on benzodiazepines and opioids.

General assessment

Drug-seeking patients can often provide well-developed clinical histories which may seem very ‘real’. There is often a strong aim to work on the desire of doctors to minimise the distress of patients. Rather than being aggressive, many will be very pleasant with a credible story.

In addition, not all drug-seeking patients are faking symptoms. They may have a legitimate complaint and, over time, have become dependent or tolerant and require larger doses of medication to function in their daily life.

In patient presentations where drugs of dependence may be indicated, a full assessment includes:

• a full history, including the use of alcohol and other drugs (including over-the-counter medications medicines containing codeine combined with ibuprofen or paracetamol), psychiatric comorbidity, family history and family/social situation – this also helps identify people at higher risk of developing problems
• adequate physical examination (including looking for signs of intoxication or withdrawal or intravenous drug use)
• problem/diagnosis list
• management plan
• communication with other providers (eg methadone prescriber, pharmacist, other GP)
• prescription shopper communication (refer to Section 3.8  of the PDF version for more information)
• consider urine drug screening/testing (refer to Appendix H of the PDF version).

This should enable a diagnosis of a patient with genuine medical need and no dependence, a patient with genuine medical need and dependence,* or a patient that may be looking for drugs of dependence for non-medical use.

Once a full assessment, including assessment of dependence (refer to Assessment of substance use disorder), has been carried out, a care or treatment plan can be established.

*This may also be pseudo-addiction where a patient with undiagnosed and/or inadequately treated painful condition adopts drug-seeking behaviour in an attempt to achieve relief.⁶⁰

Assessment of substance use disorder

Patients who have current or previous substance-related problems have a greater risk of harm and ongoing problematic use, therefore specialist support and advice should be considered as part of ongoing management.

The new Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria combine the old DSM-IV categories of substance abuse and substance dependence into a single condition of SUD, which is measured on a continuum from mild to severe.⁶¹ This diagnosis can be applied across all drugs of dependence (as well as drugs such as nicotine and alcohol) and should reduce confusion associated with the terms dependence, addiction and abuse (which have been inconsistently and often incorrectly used to describe points on a spectrum of disordered use).

The essential feature of SUD is a cluster of cognitive, behavioural and physiological symptoms indicating the individual continues using the substance despite significant substance-related problems.⁶¹

Diagnosing SUD requires the presence of at least two of 11 criteria, across four categories: impaired control, social impairment, risky use and pharmacology. Based on the total number of criteria the patient has, the SUD can be classified as mild (2–3 symptoms), moderate (4–5 symptoms) or severe (6 or more symptoms). It is hoped these severity classifiers may potentially help clarify treatment options (Table 3).

Although the term SUD is a helpful addition, the term addiction will necessarily be used when discussing any drugs of dependence.

Table 3

DSM-5 criteria for diagnosing an SUD

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Prescribing drugs of dependence should be seen as an adjunct to care, and not regarded as the primary treatment regimen.

For many of the conditions which drugs of dependence are used, non-drug interventions are often more effective and have sustained results.^62–67 Where there is good evidence for non-drug interventions, GPs should consider these as first-line therapy. GPs need to be aware of the evidence for allied health treatments and be able to offer these (in-house or through referral) to patients when they need them.

There is substantial evidence that anxiety, depression, sleep and chronic pain problems, including headache and migraine, can be effectively treated with cognitive behaviour therapy (CBT) and other psychological approaches.⁶² Further, there is evidence that in many cases, psychological therapies are at least equivalent and sometimes superior to the use of medicines to address these issues.^62–67

In cases where the use of medicines is indicated, concurrent psychological therapy is typically superior to either therapy alone.⁶⁸

Refer to individual drug guides for further information.