Please refer to RACGP’s Prescribing drugs of dependence in general practice, Part A – Clinical governance framework for further information on clinical governance and its role in improving safety and quality for the use of drugs of dependence in general practice.
Laws and regulations
Most benzodiazepines are Schedule 4 (S4) ‘prescription only’ medicines. The exceptions are flunitrazepam and alprazolam, which are classed as S8 drugs.
Each state and territory has laws regulating the prescription of these medicines. Generally, there are tighter controls around the prescribing of S8 drugs and for prescribing to patients with known addiction. For example, GPs must seek a permit or an authority from the relevant state or territory health department when prescribing an S8 drug to persons who are drug dependent.
Some states have subsets of S4 drugs that involve prescribing restrictions or additional requirements; benzodiazepines often fall into this category.
GPs must be familiar with the relevant legislative requirements associated with writing prescriptions for S4 and S8 drugs.
State and territory departments and government-funded drugs of dependence units (or equivalent) can provide information regarding prescribing. Refer to Resource C.
General practice systems of care
The quality and safety of patient care is no longer confined to the individual practitioner. General practices have responsibilities to work collaboratively with practitioners to address the safety and quality of health services provided in their facilities.
Practice systems of care around benzodiazepines can be put in place to maximise health outcomes and social functioning for patients while minimising drug and alcohol misuse, abuse, diversion and crime. Systems of care also provide the necessary infrastructure and support for GPs to perform their job efficiently and effectively.
Staff education and competency
Practices should ensure they have the level of knowledge among team members and practice capacity to address the issues associated with benzodiazepine prescribing (eg identification of patients with more complex needs and those at higher risk). Prescriber education is particularly important. The risk of benzodiazepine misuse and dependence is lower when the first-time prescriber is a specialist in general practice compared to a prescriber without specialty training.76 GPs who are regularly involved in managing patients with problematic use of benzodiazepine or other drugs and alcohol should consider further training and developing good working relationships with addiction specialists.
Practices should promote the development of competency in prescribing benzodiazepines. Where potentially inappropriate and suboptimal prescribing is identified, practices and GPs have an opportunity to engage in education and support, and improve patient outcomes.
Access to relevant programs is limited in some areas of Australia. Practices may wish to consider supporting GP-based benzodiazepine detoxification programs in-house. Benzodiazepine detoxification typically requires significant and frequent communication with patients, more regular visits with the GP and other clinical staff, on-call mechanisms and management of patients who are often highly anxious.86 Suitably qualified staff, organised support and ongoing quality assurance arrangements may be required. GPs involved in this type of program should feel comfortable prescribing adjunct medications.86
Balancing patients’ needs with practice capacity (risk stratification)
Patients should be appropriately evaluated to determine the complexity of services required.
One of the goals in the initial assessment of a patient is to obtain a reasonable assessment of clinical complexity/risk in the context of concurrent SUD or psychopathology. In this context, patients can be stratified into three basic groups. The following will offer a practical framework to help determine which patients may be safely managed in the primary care setting, should be co-managed with specialist support and should be referred on for management in a specialist setting.
GPs with advanced training in addiction medicine and/or mental health management are suited to taking on higher responsibilities under this model.
- Group I – Managed in primary care: Patients with no evidence of past or current history of SUD or mental illness, apart from the presenting problem.
- Group II – Managed in primary care with specialist support: Patients may have a past history of a treated SUD or a significant family history of problematic drug use. They may also have a past or concurrent psychiatric or chronic pain disorder. While not actively addicted, patients are at increased risk, which may be managed in consultation with appropriate specialist support.
- Group III – Managed by specialist services: This group of patients represents the most complex cases to manage because of an active SUD or major, untreated psychopathology. These patients are either actively misusing prescription drugs or pose significant risk to both themselves and to the practitioners, who may lack the resources or experience to manage them.
It is important to remember that all groups can be dynamic. Group II can become Group III with relapse to active addiction, while Group III patients can move to Group II with appropriate treatment. In some cases, as more information becomes available to the practitioner, the patient who was originally thought to be low risk (Group I) may be reclassified as Group II or even Group III. It is important to continually reassess risk over time.87
A key message from inter-professional dialogue is that all health professionals (eg psychiatrists, pharmacists, GPs, nurses) have difficulties when dealing with high-risk patients and prescribing benzodiazepines.88 There should be an agreed set of professional standards regarding communication and transfer of care. In particular, the responsibility of ongoing prescribing duties should be explicit.
Prescribing may be initiated and recommended by other specialists, or during hospital in-patient care. When prescribing is transferred from secondary to primary care, the following information should be relayed to the GP:
- indication for use
- expected length of treatment
- when the treatment will be reviewed and by whom
- advice about withdrawal if indicated
- clear indications of the GP’s role
- clear agreement on roles of all clinicians between GP and secondary care
- clear indications of support and referral pathways to the secondary service.
GPs should take care when patients on high doses of benzodiazepines are transferred from secondary care without a therapeutic rationale for clinical benefits or planned withdrawal schedule. GPs are not required to continue prescriptions commenced elsewhere if they are not comfortable doing so. However, GPs should not undermine the professional advice of colleagues, and should attempt immediate contact by telephone to clarify the management plan when there are concerns.
With continued monitoring of care, issues may arise which should prompt specialist review or immediate transfer to hospital (refer to RACGP’s Prescribing drugs of dependence in general practice, Part A – Clinical governance framework). The following should prompt consideration for referral to specialist mental health services:89
- insufficient experience to manage the patient’s condition requiring benzodiazepine therapy, or insufficient practice infrastructure to provide ongoing recall and review
- multiple attempts at treatment have not resulted in sustained improvement
- severe coexisting depressive symptoms or a risk of suicide
- evidence of problematic drug use
- comorbid physical illness and concomitantly prescribed treatments which could interact with prescribed psychotropic medication
- proposed interventions are not available within primary care services.
Practice policies and standards
General practices should have agreed clinical policies regarding prescribing benzodiazepines to improve the quality and consistency of prescribing, and improve safety for patients and practice staff.
Practices should consider having policies regarding:
Simple, practice-based interventions can be quite effective. Practice-based letters sent to a general practice population have repeated proven effectiveness in reducing benzodiazepine use in older patients.90 A 10-year follow-up in the Netherlands after such an intervention revealed 60% of these patients remained abstinent of benzodiazepine use.91 Those who returned to benzodiazepine therapy often did so at lower doses. Simple educational interventions may also reduce inappropriate benzodiazepine use.90,92
Benzodiazepine misuse might not be a highly visible problem in every practice, however all practices should be involved in supporting steps to reduce inappropriate benzodiazepine use in their practice and community. Each general practice should assess their own needs and develop policies that suit their circumstances.
Using and managing information
To help GPs manage prescribing risks, practices should have infrastructure (computer based or other) that provides:
- standardised patient information on benzodiazepines, including the effects on driving and operating machinery (refer to Resource D.1 in the PDF version)
- a treatment plan when there is a clinical decision to continue benzodiazepines. The plan should clearly outline the responsibilities of the patient and the practice, and include an agreement to review and monitor clinical progress against therapeutic goals
- access to high-quality information systems and/or prescription shopping hotlines to assist in curtailing prescription abuse
- mechanisms/processes within the practice to share information regarding benzodiazepine abuse/misuse
- formalised benzodiazepine withdrawal guidelines within the practice (refer to Resource D.2B in the PDF version)
- standardised patient information on sleep hygiene methods (refer to Resource D.4 in the PDF version).
Quality improvement measures around benzodiazepine prescribing include developing policies or an audit, communicating with patients and managing risks.
Further information about quality improvement can be found in the RACGP’s Prescribing drugs of dependence in general practice, Part A – Clinical governance framework.
Accountable prescribing of benzodiazepines
- Prescribing benzodiazepines, as with any treatment, should be based on a comprehensive medical assessment, a diagnosis, thoughtful consideration of the likely risks and benefits of any medication as well as alternative interventions, and a management plan derived through shared decision making and continual clinical monitoring.
- GPs should be aware of the concerns associated with benzodiazepines such as potential dependence, withdrawal, problematic drug use (including diversion and misuse), and known harmful effects, including falls, potential cognitive decline and motor vehicle accidents. These risks should be discussed with patients.
- GPs may wish to use the diagnosis of SUD rather than dependence, addiction or abuse. This is based on the DSM-5 sedative, hypnotic or anxiolytic use disorder criteria. This is a more neutral term that may reduce stigmatisation of patients with problematic use of benzodiazepines and other drugs/alcohol.
- Treatment seeks to maximise outcomes for the health and social functioning of the patient while minimising risks. To minimise risks, benzodiazepines should be prescribed at the lowest effective dose, for the shortest clinical time frame.
- Once started, some patients find it hard to stop benzodiazepines. Therefore, prescription should be accompanied with a plan to reduce and cease benzodiazepines.
- Patients who use two or more psychoactive drugs in combination (polydrug use), and those with a history of substance misuse may be more vulnerable to major harms. Significant caution should be taken if prescribing benzodiazepines to patients with comorbid alcohol/substance abuse or polydrug use. GPs should consider seeking specialist opinion in management of these patients.
- Benzodiazepines are generally regarded by clinical practice guidelines as a short-term therapeutic option. Long-term use, beyond 4 weeks, should be uncommon, made with caution and based on thoughtful consideration of the likely risks and benefits of benzodiazepines.
- If alternatives to benzodiazepine treatment fail, have limited benefit or are inappropriate (either psychologically or pharmacologically), supervised benzodiazepine treatment may remain an acceptable long-term therapeutic option.
- Long-term benzodiazepine prescriptions should be at the lowest effective dose, preferably given intermittently, and regular attempts at reduction should be scheduled. Continued professional monitoring of health outcomes is required.
- Benzodiazepines should be prescribed from one practice and preferably one GP, with prescriptions dispensed from one pharmacy.
- GPs should develop strategies to manage inappropriate requests for benzodiazepines by patients.
Evidence-based prescribing of benzodiazepines
The evidence base for benzodiazepine use continues to evolve, but despite the length of time they have been used in clinical practice, the evidence remains incomplete in many areas.93 The clinical recommendations and practice points presented in this guide are based on the best available evidence.
With respect to benzodiazepine therapy, recommendations based on these randomised controlled studies do not always reflect clinical reality. It is recognised that randomised controlled trials are generally a maximum of 12 weeks and performed in restricted patient groups with little comorbidity or other features resembling conventional clinical samples.94
Practical prescribing decisions
Good prescribing practice involves careful and considered diagnosis; clear therapeutic goals; the use of non-drug therapies where suitable; prescribing appropriate types, formulations and amounts of medication; explaining the effects of medications and any risk of dependence; and implementing regular medication reviews.
The risks of problematic use and diversion make prescribing benzodiazepines more challenging.
The short-term use of benzodiazepines can be helpful for symptomatic relief across a wide range of clinical conditions. Given the potential for harm with benzodiazepine use, clinical discipline is required. The immediate relief with benzodiazepines is tempting, yet the best outcomes are often achieved with non-drug treatment. However, these interventions take time, may not be available in a timely fashion, and involve engagement and effort from patients.
While the thrust of this guide is that benzodiazepines should generally be prescribed less, care should be exercised when changing from one psychoactive substance to another or when using combination therapies. All psychoactive drugs have risks and benefits. Some non-benzodiazepine drugs also have problems with dependence and problematic use (eg quetiapine). There is consensus that although benzodiazepines have been problematic, when prescribing is placed in the broader historical context and the types of patients prescribed benzodiazepines are considered, it is apparent that other psychotropic drugs have raised similar problems.58,95–99
Patients who previously misused drugs (eg opioids, anti-alcohol or smoke cessation treatments) have a higher risk of becoming excessive users compared to patients who have not previously misused drugs.76 Greater challenges exist for patients already prescribed benzodiazepines for some time. Once a benzodiazepine prescription has been started, it may be harder to stop.
To minimise harms associated with prescription drug misuse, GPs need to maintain vigilance in identifying SUDs, assist patients in recognising disordered use where it exists, set goals for recovery and assist patients to seek appropriate treatment.
Recognising patients with problematic benzodiazepine use
There are several behaviours that indicate a patient may have problematic benzodiazepine use, such as escalating use patterns, drug-seeking behaviour and doctor or prescription shopping.77
Drug-seeking behaviours that indicate risk, but are less predictive of problematic use include:
- attending early for prescription renewal
- complaining aggressively about the need for higher doses
- hoarding drugs during periods of reduced symptoms
- requesting specific drugs
- acquiring similar drugs from other medical sources
- escalating unsanctioned doses 1–2 times
- using the drug to treat other symptoms
- selling prescription drugs.
Drug-seeking behaviours that are highly predicative of problematic use include:
- forging prescriptions
- stealing or borrowing another patient’s drugs
- injecting oral formulations
- obtaining prescription drugs from non-medical sources
- abusing illicit drugs concurrently
- escalating unsanctioned doses multiple times
- losing prescriptions repeatedly.
Patients may be extremely convincing, using plausible stories and even manipulating a GP’s discomfort with confrontation to obtain medication.77
For ways to manage patient who may be drug seeking, refer to patient scripts in Resource A in the PDF version.
Patients with previous substance use problems, or those who use antipsychotic medication, are at increased risk of disordered benzodiazepine use.76 However, any patient can develop problematic use, and so universal precautions are important when considering prescribing.
Assessment of substance use disorder
The DSM-5 criteria combine the old DSM-IV categories of substance abuse and substance dependence into a single condition of SUD, measured on a continuum from mild to severe.40
The essential feature of SUD is a cluster of cognitive, behavioral and physiological symptoms indicating the individual continues using the substance despite significant substance-related problems.40
Using the term SUD 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)
- be more acceptable to patients and their carers – a diagnosis of being ‘drug dependent’ may be confronting and create stigma.
Diagnosis of 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 substance use disorder 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 help to clarify treatment options (refer to Table 3).
Although the term SUD is a helpful addition, the term dependence will necessarily be used when discussing any ‘drug of dependence’.
Reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (Copyright 2013). American Psychiatric Association. All Rights Reserved.
- All patients, including those who use benzodiazepines and other drugs and alcohol problematically, have the right to respectful care that promotes their dignity, privacy and safety.
Sharing prescribing decisions
Treatment and care of patients should take into consideration their needs and preferences. Clinical options and patient information should be culturally appropriate. It should be accessible to people with individual needs including those with physical, sensory or learning disabilities, and those who do not speak or read English.
Fully informing patients about the benefits and drawbacks of benzodiazepines may improve shared decision making between the patient and doctor. While there are time constraints in a consultation, this approach may reduce GPs’ workload with fewer patients returning for repeat prescriptions.8
Non face-to-face methods of communication can also be useful. For example, a study involving direct delivery of an educational tool on benzodiazepines to older patients increased their risk perception of inappropriate prescriptions.100
Exploring patient preferences, ideas and expectations during a consultation may lead to fewer benzodiazepine prescriptions. Evidence suggests doctors sometimes assume patients want drug treatment and/or would be resistant to withdrawal, whereas some patients prefer not to use medication or wish to discontinue drugs.8
Patients need good information and access to alternative treatments including CBT for insomnia and anxiety. These interventions may be made available in the practice or through local services. There are many resources available on the internet (eg computer-based anxiety therapies).
Clinical responsibility in shared decision making
While most patients’ involvement with drugs of dependence is clinically driven, there can be elements of manipulation (and rarely criminal intent) behind patients’ requests for benzodiazepines.
The important caveat when prescribing drugs of dependence relates to healthcare benefits. Some patients with drug dependency may request higher doses on the basis that they are making a choice as an informed patient, or as harm minimisation.
Patients have a right to good healthcare, but not a right to drugs of dependence. Patients need to be informed of this at the beginning of any trial using drugs of dependence. If the clinician feels further therapy is detrimental to a patient’s health, then clinical withdrawal of medication should begin.
Doctors typically have a strong desire to alleviate a patient’s distress and suffering. The psychological phenomenon of transference in addiction, pain and mental illness can result in doctors having difficulty in these clinical areas. Some GPs may find it difficult to set boundaries for patients, and are therefore at risk of being pressured to prescribe inappropriately. Other GPs may have difficulty saying ‘no’ or believe they are ‘helping’ or taking a harm minimisation approach by giving in to a patient’s requests for drugs.
All practitioners express difficulty responding to patients who use manipulative behaviour (eg threatening to self-harm if they do not receive medication). GPs should educate themselves about appropriate responses to common manipulative behaviours used to access drugs of dependence. To aid GPs’ negotiation skills, scripted replies have been developed to help with appropriate responses in difficult situations (refer to Resource A in the PDF version).
Aboriginal and Torres Strait Islander peoples
There is very little literature on benzodiazepine use in Aboriginal and Torres Strait Islander peoples. While the clinical recommendations in this guide are the same for all patients, there is a need to understand the complex cultural context of Aboriginal and Torres Strait Islander peoples to build an effective therapeutic alliance. Working with local, respected Aboriginal Health Workers and/or drug and alcohol workers is crucial for comprehensive bio-psychosocial care.
The Working Together book is relevant in understanding and providing mental health care to Aboriginal and Torres Strait Islander peoples.
The Handbook for Aboriginal Alcohol and Drug Work includes useful information on benzodiazepines.