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. 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
1.4.1 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.
18.104.22.168 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.
22.214.171.124 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).