Prescribing drugs of dependence in general practice

Part A - Clinical Governance Framework - Chapter 1

Introduction

Last revised: 25 May 2021

Introduction

Prescription medication misuse is a worldwide problem. In Australia, there are growing concerns about the increasing misuse and associated harms of a range of pharmaceuticals.1 Many types of medications are misused,2 particularly drugs of dependence. Of particular concern is the problematic use of benzodiazepines and prescription opioids.1,3

Reducing misuse of pharmaceutical drugs and associated harms is a national priority.4 The Royal Australian College of General Practitioners (RACGP) has developed a series of guides on drugs of dependence to help GPs play an important role in tackling the problem.

Part A – Clinical governance framework, describes the overarching principles and strategies for use with the individual drugs of dependence guides.

In 2020, changes to approved opioid indications were made across the class to help address misuse and harms in Australia. Significantly, the use of modified release opioids is not indicated in chronic non-cancer/malignant pain, except in ‘exceptional circumstances’.

Additional warnings and precautions for use were also added to Product Information and Consumer Medicine Information.

Pharmaceutical Benefits Scheme (PBS) restrictions and authority requirements have also been updated to reflect the new indications.

More detailed information on the changes is provided at Section 2 Laws and regulations.

Throughout the guide, minor updates have been made to align with 2020 changes to opioid prescribing regulations. Guideline recommendations have not been updated with new evidence.

This guide aims to improve the quality and safety of prescribing of drugs of dependence in general practice by:

  • helping practices develop a clinical governance framework for prescribing drugs of dependence that complements the Australian regulatory framework
  • supporting practices and GPs in the development of an environment of quality improvement and best practice with regard to drugs of dependence
  • promoting safer prescribing and non-prescribing within general practices
  • enabling the recognition of higher risk situations and offering solutions to manage these appropriately
  • bringing together tools and evaluation processes for patients with more complex problems
  • providing solutions to enable general practice to prevent and manage prescription drug misuse.

The intended impact is a reduction in adverse events associated with prescribing drugs of dependence.

This guide is designed to assist GPs in the management of drugs of dependence. It is not a set of mandatory rules. General practice has varying degrees of exposure to issues surrounding drugs of addiction. Each practice needs to determine which features of this guide are relevant for their circumstances.

General practices need to consider the recommendations and implement these according to their local circumstances.

The appendices contain examples of some practice policies. These examples 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 should be adapted or modified for relevance and applicability to the local context. 

Who will use this guide and why?

This guide may be used by practice owners, managers and support staff who:

  • are concerned about prescription drug abuse in their practice area and want to prevent a mishap
  • service a population with a high prevalence of mental illness, pain and/or addiction problems and want to ensure they provide the best possible care
  • have had an adverse event associated with prescription drug abuse and want to know how to prevent a recurrence
  • have doctors who have expressed concerns about what is happening regarding drugs of dependence
  • want to contribute toward reducing prescription drug abuse in their community.

This guide may be used by GPs who:

  • rarely sees patients who abuse prescription medication, but want to know more about the proper management and treatment of these patients
  • occasionally sees patients who abuse prescription medication, but uncertain of their legal responsibilities
  • felt unsafe during a consult with a patient with drug-seeking behaviour, and would like to take something to their practice manager to address this
  • saw an adverse event with a colleague, and would like to know how their practice and colleagues can manage this problem better
  • is starting in a new practice and would like a way of talking about the issues of prescribing drugs of dependence at the next practice meeting
  • works with other GPs who frequently prescribe drugs of dependence for conditions where other (safer/more effective) evidence-based therapies exist (eg insomnia), and is concerned about this practice and the risks associated with it, and would like some guidelines to discuss with them and implement in their practice
  • would like the support of professional colleagues and the RACGP in advising patients on the risks and benefits of use of prescribed opioids and be able to make an assessment that weighs the risks versus the benefits of continued prescribing and the skills to taper and terminate opioids when appropriate.

This guide may be used by medical students who:

  • were taught the harms associated with the use of benzodiazepines and opioids, yet have seen this in some practices.
  • This guide may be used by general practice registrars who:
  • are starting in a practice in their first GP rotation and want advice on how to prescribe safely
  • want assistance in implementing a policy of one prescriber for any drug of dependence
  • want to feel confident and supported in advising senior colleagues that they will not provide ongoing prescriptions for drugs of dependence to patients they do not know.

This guide may be used by a psychiatrist, alcohol and drug addiction specialist, chronic pain specialist, other medical practitioner, practice nurse, nurse practitioner, credentialed mental health nurse, psychologist, social worker, or allied health professional who:

  • is concerned about the prescribing habits of the doctors they work with and would like some guidelines to discuss with them.

Drugs of dependence have an important and valuable role in patient care. In recent years, the number of psychoactive drugs and formulations available in Australia has increased substantially.3 Many of these drugs have provided significant benefits to patients. However, the evidence demonstrates that pharmaceutical misuse is rapidly emerging as a drug problem.5

GPs need to be aware of the extent of the problem of pharmaceutical drug misuse, the factors involved and the role of general practice in potential solutions.

The extent of the problem

How Australia compares

he US6 and Canada7 acknowledge there is a serious problem with the misuse of prescription opioids.3 Prescriptions in the US account for 99% of the worldwide consumption of oxycodone, while it only comprises 4.7% of the world’s population.5 This may make Australia’s issues seem minor in comparison, however, Australian data shows a high prevalence of misuse of prescriptions opioids.2 According to the 2014 World Drug Report, the annual prevalence of misuse of prescription opioids is:2

  • Australia 3.1%
  • Canada 1%
  • Nigeria 3.6 %
  • Pakistan 1.5%
  • US 5.2 %.

While benzodiazepine prescribing has remained reasonably steady (approximately 7 million prescriptions per year8), there has been a dramatic change in the profile of the benzodiazepines prescribed and alprazolam use has increased by one-third.4

There is an understanding that the pattern of substance misuse changes over time as the types and availability of illicit and pharmaceutical drugs change.3 However, there are still a number of gaps in our understanding of problematic use of prescribed drugs of dependence in Australia.9 Research in this area continues.

Key findings of the National Drug Strategy Household Survey 201310 indicate:

  • the number of people participating in any illicit use of drugs, including pharmaceutical misuse, in Australia is increasing
  • the proportion of people using most illegal drugs has remained relatively stable and the use of some illegal drugs has even slightly decreased over the last three years
  • in 2013, nearly 8 million (42%) people in Australia aged 14 years or older had ever illicitly used drugs, including misuse of pharmaceuticals; almost 3 million (15.0%) had done so in the last 12 months, compared to approximately 2.7 million (14.7%) in 2010
  • non-medical use of pharmaceuticals in the previous 12 months had increased overall since 2007 and was at the highest level of use since 1998 (from 3.7% in 2007 to 4.7% in 2013) (Figure 1)
  • the increase in pharmaceutical misuse in 2013 was mainly due to significant increases in recent use by men aged 30–39 (from 4.5% to 6.9%) and women aged 40–49 (from 3.1% to 4.5%)
  • among people who reported recent misuse of any kind of painkiller/analgesic (3.3%), about three-quarters had misused over-the-counter pain killers and half had misused prescription pain killers.
Figure 1. Misuse of pharmaceuticals by people aged 14 and over, 1995–2013

Figure 1

Misuse of pharmaceuticals by people aged 14 and over, 1995–2013
Source: Australian Institute of Health and Welfare.


The harms

Drug-related harm is experienced by both sexes and across all ages and levels of use (experimental, recreational, dependent) and with therapeutic use. Harms includes loss of life through overdose and accidents, negative mental and physical health effects, family and social problems, psychological and emotional difficulties, and legal and financial problems.11

The factors involved

Problematic use is widespread

Pharmaceutical drug misuse problems exist on a spectrum ranging from inadvertent misuse associated with inappropriate prescribing practices through to deliberate misuse.5 There are numerous reasons people deliberately misuse prescription medications. Self-medication (pain, anxiety, insomnia), drug substitution, enhancement of other drugs and enjoyment are common examples. Vulnerable individuals may use substances including psychoactive prescription drugs to make themselves feel better.12 This new, hidden population13 may differ from the usual drug user stereotypes as they may be more highly functioning and may have higher socioeconomic status, better education and more social support.3

More drugs are being prescribed (and diverted)

Prescription rates of opioids have substantially increased: between 1997 and 2012, oxycodone and fentanyl supply increased 22-fold and 46-fold respectively.3 Oxycodone is now the seventh leading drug prescribed in Australian general practice.3 The number of opioid prescriptions subsidised by the Pharmaceutical Benefits Scheme (PBS) increased from 2.4 million in 1992 to seven million in 2007.3

Not all prescriptions will lead to improved patient outcomes.

Sources of drugs

In a 2012 study of participants in an Australian methadone and buprenorphine treatment program (ie people representing the more ‘severe’ end of the spectrum of problematic pharmaceutical drug users), most regular prescription opioid users reported buying their opioids from others. In contrast, a medical practitioner was the main source of benzodiazepines (Table 1).14

Being part of the solution

General practice prescribing practices are a key to minimising the harms from drugs of dependence.

If prescribers do not rise to the challenge of appropriate and accountable prescribing, there is a risk Australia will experience the high rates of the prescription drug abuse of other countries or face oppressive regulatory responses.

This guide encourages general practices and GPs to be part of the solution by reducing prescription drug abuse through clinical governance at a practice level and accountable prescribing at the GP level. Both levels are supported by formal and informal controls around drugs of dependence.

Good clinical governance in prescribing drugs of dependence is supported by a comprehensive practice policy and a unified approach to drugs of dependence, and these, in turn, support individual GPs to prescribe these drugs safely and appropriately.

The health sector is characterised by complexity, multiple stakeholders (national and state/territory governments, public and private providers, professions and consumer groups) and numerous regulatory agencies and regulatory standards.15 Policy makers, regulators and professional bodies all have roles to play in developing an environment for quality improvement that supports general practice in its quest for quality.

Multiple levels of regulation surround the prescription of drugs of dependence. The overarching control mechanisms are legislation and regulation. Legislation focuses on the drug, who can prescribe it, which patient is eligible and the legal penalties for non-compliance. Regulators license prescribers and can apply penalties. They provide an important level of protection for patient safety. However, legislation offers limited scope for ensuring patient-centred care or clinical effectiveness, and has little ability to drive quality improvement.

Self-regulation by GPs around quality and safety has improved.15 Although important for quality improvement within individual general practices, self-regulation is not sufficient to realise improvements across the whole of primary care.15 Media scrutiny and scandals in healthcare settings mean the public no longer accept doctors’ self-regulation of safety and quality.15

Between overarching frameworks and practitioner self-regulation is regulation at the practice level. Meta-regulation is a reasonably recent level, which evolved in response to regulatory failures (not necessarily within the health sector, although they have occurred here). Clinical governance falls within the level of meta-regulation.

Meta-regulation is enforced self-regulation.15 It enhances the self-regulatory capacity of general practices by requiring risk management and quality improvement strategies, which achieve more than legally required.16 That is, external standards are used to drive internal quality improvement.

Meta-regulation brings together general practice’s understanding of the issues and its capacity to manage them with demands and expectations of government agencies and professional bodies such as the RACGP.

Figure 2

Figure 2

Levels of practice regulation

Adapted from Healy J, Braithwaite J. Designing safer health care through responsive regulation. MJA 2006;184:S56–S59.

A ‘softer’ version of practice regulation involves learning models such as triple-loop learning17 in which practitioners evaluate their outcomes (first loop) and feed this learning into the practice (second loop).15 The third loop occurs when a regulator, such as an accreditation agency or a health department, learns from monitoring the practice’s double-loop learning and revises its regulatory goals for the whole field.15

Clinical governance

Clinical governance should ensure patient care is accessible, approachable and responsible, and a practice environment is developed that provides quality improvement in prescribing of drugs dependence.

What is clinical governance?

Clinical governance is a ‘system through which organisations are responsible for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’.18 It involves a number of interlinked structures and activities designed to ensure that managers, clinicians, pharmacists and those who govern health services are aware of their roles and responsibilities, and have the appropriate arrangements and processes in place to effect robust governance.19 For the system to work effectively, each level of service must properly take on their responsibilities

Clinical governance is a framework for quality improvement that coordinates interactions between patients, healthcare providers and the healthcare system. Each practice has tailored policies and procedures that coordinate with other healthcare services (eg pharmacies, alcohol and drug services) and align with local and national health policy (eg National Drug Strategy 2010–2015).

Clinical governance is a process made up of a large number of elements. In the context of drugs of dependence, elements of clinical governance include:20,21

  • lines of responsibility and accountability (clinical leaders)
  • risk management – practice policies and general standards to support patient safety and clinical effectiveness
  • education on clinical effectiveness – evidence-based practice
  • clinical audit – important for identifying patients at risk of dependence
  • research and development.

For many of these elements there is a range of criteria or recognised standards of good practice that can be used in audit and benchmarking.

While GPs have direct accountability for prescribing drugs of dependence, the whole practice team has a responsibility to engage in activities to improve patient safety and reduce problematic use of prescription medication in the community.

Clinical governance within a general practice

Clinical governance is achieved through effective leadership and commitment to excellence within general practice and across the healthcare sector.

Full implementation of clinical governance in any general practice may take time as policies and procedures are developed and partnerships with other providers are formed.

There are considerable gaps in available services, such as pain medicine and dependence treatment programs, and in many areas, general practice may need to take on broader care roles with complex patients. In this case, GPs may need additional training and should seek advice from distant specialist services (eg addiction medicine specialists).

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