Prescribing drugs of dependence in general practice

Part A - Clinical Governance Framework - Chapter 3

General practice systems of care

Last revised: 01 Nov 2019

Introduction

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 continuously improve care for their patients. Practice systems of care and treatment should seek to maximise health outcomes and social functioning for all patients prescribed drugs of dependence while minimising drug and alcohol misuse, abuse, diversion and crime.

Recommendation
General practices should undergo and attain accreditation according to the Standards

Recommendation
General practices should have clinical leaders who have designated areas of responsibility regarding safety and quality improvement systems
Reference to the Standards
(Criterion* 3.1.3 Flagged indicator A)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommedation
Practice systems of care and treatment should seek to maximise health outcomes and social functioning for all patients prescribed drugs of dependence while minimising drug and alcohol misuse, abuse, diversion and crime

Recommendation
General practices should promote the development of competency in prescribing drugs of dependence – this may have particular relevance to registrars
Reference to the Standards
(Extrapolated from Criteria 4.1.2, 3.1.2 and 5.3.1)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommendation
General practices should support relevant training, education and resources for staff to be able to identify patients with more complex needs and those at higher risk.

Recommendation
General practices should support GP-based dependency programs with suitably qualified staff, organised support and ongoing quality assurance arrangements
Reference to the Standards
(Extrapolated from Criteria 3.1.2, 3.1.3, 3.2.1 and 3.2.3)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommendation
General practices should have agreed clinical policies regarding prescribing drugs of dependence
Reference to the Standards
(Extrapolated from Criterion 5.3.1. Flagged indicator D)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommendation
General practices should consider having policies regarding the management of patients according to mental health status and use of drugs of dependence to provide the appropriate level of service internally and externally

 

Recommendation
General practices should have an effective handover system that ensures safe and continuing healthcare delivery for patients
Reference to the Standards
(Criterion 1.5.2)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommendation
General practices and GPs should insist on timely, high-standard referral and discharge letters for clinical handover or shared-care arrangements from secondary care
 

Recommendation
General practices must implement strategies to ensure the occupational health and safety of GPs and other members of the practice team
Reference to the Standards
(Extrapolated from Criterion 4.1.2. Flagged indicator B)
*Criteria from The RACGP’s Standards for general practice (4th edition)

Recommendation
General practices should facilitate GP access to information management data designed to monitor potential prescription drug abuse (eg state and territory health ministries’ drug units and PSIS)

The healthcare system is complex and often fragmented. The complexity can be barrier to patients seeking or continuing treatment. The lack of cohesiveness, especially with information sharing, can facilitate doctor or prescription shopping. To counter this, regular contact with a GP helps patients navigate the various systems and creates a chance to explore needs in more depth, while building rapport and continuity.

The medical home model of care aims to provide patients with continuous, accessible, high-quality and patient-centred care. Australian general practice encapsulates the medical home model.26 This model is a way of organising primary care so that patients receive care coordinated by their GP, supported by information technology, delivered by a multidisciplinary team and adherent to evidence-based practice guidelines. Each patient’s medical home is individualised to meet their needs and may change over time.

A central principle of the medical home is the ‘personal doctor’, where one GP provides the patient with first contact, and then continuous and comprehensive care.27 The medical home is responsible for the patient’s healthcare across their whole life journey, including acute, chronic, preventive and end-of-life care. This approach results in better health outcomes for patients and their families.28

The medical home model has measurable benefits, including improved continuity of patient care,29 and improved quality and cost effectiveness of care for patients with a chronic disease.30 Additionally, medical homes reduce disparities in access to quality care among traditionally difficult to reach groups,31,32 leads to improved overall population health33 and lower overall healthcare spending.34

Practices should undergo and attain accreditation according to the Standards. Accreditation is a basic risk management strategy. Accreditation ensures that the practice is ‘fit for purpose’ in delivering high-quality, safe primary care services. Accreditation is an important component of the regulatory framework for quality and safety in health.

All practices should have clinical leaders who have designated areas of responsibility regarding safety and quality improvement systems (eg drugs of dependence, infection control). In small practices, one person may be the clinical leader of multiple areas. Appointment of a clinical leader is designed to ensure:

  • an organisational culture that resources, supports, recognises and rewards participation and leadership in safety and quality improvement
  • staff involved in monitoring and improving care and services are held accountable
  • a problem solving, multidisciplinary team approach, that promotes a climate of safety and quality, as opposed to a blame culture.

Practices could consider appointing a drugs of dependence coordinator, who is responsible for developing strategies (policies, procedures and activities) to prevent harm, manage harm when it occurs and provide a safe, supportive work place and work culture.

The Standards requires all GPs in the practice to be appropriately qualified and trained, have current Australian medical registration and participate in continuing professional development (CPD).20 All doctors must provide medical care to a standard that could reasonably be expected of clinicians in their positions. Practitioners should only prescribe drugs of dependence when they have demonstrated competency. This may have particular relevance to general practice registrars.

General practices should promote and support GPs to use non-pharmacological interventions. This may include simple interventions including patient drug information in the GP software, or promoting different cognitive and behavioural strategies and other allied health therapies as part of multidisciplinary care.

Practices should consider the needs of registrars. While some may view registrar exposure to these issues as an expected part of training, others may view this as a management of an occupational risk. It may not be beneficial for the registrar, or the patient, for a registrar to act without close supervision in highly complex situations, particularly early in their training.

Experiences, practices and training received by registrars in hospital may not always be appropriate for general practice. Before prescription of any benzodiazepines or opioid analgesia, all registrars should complete basic training on orientation to the medical practice. This will enable registrar prescribing rights and responsibilities to be individually negotiated and agreed with GP supervisors. Prescribing is to be monitored until an agreed training program has been completed.20

Examples of practice policy regarding limited prescribing rights are available in Appendix D.2.

Other staff members may need training regarding identification of a high risk situation. For example, reception staff who are able to identify potential drug-seeking behaviour can ensure those patients are scheduled to see doctors experienced with this level of risk.

Dependency programs

GPs who wish to offer an addiction/opioid treatment program need to be suitably qualified and trained in addiction medicine. They should also have organised support from colleagues, including addiction specialists and services, and be involved in ongoing professional development.20

Dependency programs often require advanced administrative support services, care coordination, advanced clinical teams (eg case managers, nursing and allied health staff to support appropriate care provision) and quality assurance programs. However, for relatively straightforward cases there is no evidence that extensive on-site support is needed35 and, therefore, depending on community need, practices may consider encouraging GPs to get training and authority to prescribe for opioid substitution. 

Practices should have policies regarding identification and stratification of patients with more complex problems and at higher risk to manage patient needs, clinical and occupational risks.

Often practices have to make clinical decisions regarding how to achieve the best outcome for the patient based on the capacity of the total practice, not just a single practitioner. This may mean developing referral standards that ensure patients can access services that exceed the capacity of the practice such as counselling, addiction agencies, mental health agencies and medication-assisted treatment of opioid dependence programs.

For example, a practice may deem the following populations or situations to be higher risk and in need of referral to public alcohol and drug facilities, or a GP with advanced training in addiction medicine, to support ongoing management:

  • patients with serious mental illness comorbidities, or antipsychotic medication
  • mixed use of opioids or illicit drugs
  • mixed use of opioids and benzodiazepines
  • recent discharge from correctional services facility
  • patients discharged from other general practices due to problematic behaviour
  • signs of potential high-risk behaviours.

Some practices, especially those in rural and remote locations, face significant issues accessing these services (Refer to Appendix I.3 in the PDF version).

Patient management according to mental health and drugs of dependence use

One of the goals in an initial assessment of a patient is to obtain a reasonable assessment of clinical complexity and risk in the context of concurrent SUD or mental illness. In this context, patients’ needs can be stratified into three basic groups. The following offers a practical framework to help determine which patients may be safely managed in the primary care setting, those who should be co-managed with specialist support and those who should be referred on for management in a specialist setting.36

GPs with advanced training (eg in addiction medicine, pain medicine) are suited to taking on higher responsibilities under this model.

Group 1 – Managed in primary care

Patients with no past or current history of SUDs. Patients in this group have a non-contributory family or past history with respect to SUDs and do not have a major or untreated mental illness. This group clearly represents the majority of patients who will present to primary care.36

Group 2 – Managed in primary care with specialist support

In this group, there may be a past history of a treated SUD or a significant family history of problematic drug use. They may also have a past or concurrent mental illness or chronic pain disorder. These patients are not actively addicted, but do represent increased risk, which may be managed in consultation with appropriate specialist support. This consultation may be formal and ongoing (co-managed) or simply with the option for referral back for reassessment should the need arise.36

Group 3 – Managed by specialist services

This group of patients represents the most complex cases. Patients may have a mix of diagnoses that include pain and addiction as well as mental illness and other medical comorbidities. These patients may be actively misusing prescription drugs and pose significant risk to themselves and to the practitioner.

It is important to remember that Groups 2 and 3 can be dynamic; Group 2 can become Group 3 with relapse to active addiction, while Group 3 patients can move to Group 2 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 1) may become Group 2 or even Group 3. It is important to continually reassess risk over time.36

According to the National Comorbidity Project, the evidence suggests that an integrated mental health and drug and alcohol treatment for people with a range of dual diagnoses is beneficial across both mental health and substance use outcomes.37

Clinical handover needs to occur whenever care is to be delivered by different providers. Within general practices there should be an effective handover system that ensures safe and continuing healthcare delivery for patients in the event of staff absences.

Failure of, or inadequate transfer of, care is a major risk to patient safety and a common cause of serious adverse patient outcomes. Inadequate handover can also lead to wasted resources, delayed treatment, delayed follow up of significant test results, unnecessary repetition of tests, medication errors and increased risk of medico-legal action.20

It is recommended that general practices and GPs insist on high standards for referral letters for clinical handover or shared care arrangements from secondary care before accepting the ongoing care of a patient. This facilitates the continuity of care and transfer back to higher levels of care if the need arises.

A practice or GP should not accept the ongoing management of a high-risk patient referred from a public sector facility, unless there is:

  • a medical summary consistent with the Australian Commission on Safety and Quality in Health Care (ACSQHC) handover standards38
  • a clear management plan
  • patient-specific instructions, including specific clinical issues that would prompt referral back to secondary care
  • contact details of a case manager and a clinically responsible person
  • documentation that details mechanisms for rapid transfer back to specialty care if deterioration occurs.

This requirement should be supported by practice policies and communicated to referral agencies if information does not meet required standards.

It may be useful to document non-attendance by patients.

Refer to Appendix E.2 for a sample letter to referral agencies.

Good clinical governance is supported by comprehensive practice clinical policies aimed at a unified approach to drugs of dependence, which support individual GPs to prescribe these drugs safely and appropriately. Practices may choose to flag some of these policies to patients via a sign in the waiting room.

General practices should consider having, at minimum, agreed clinical policies regarding:

  • conditions for registrars prescribing drugs of dependence
  • handover standards from specialists and secondary care units
  • first presentations of new patients requesting drugs of dependence continuation from another provider
  • ‘repeat’ scripts for drugs of dependence
  • appropriate triaging and management of patients who are assessed as high risk (eg referral to specialised services)
  • practice standard approach/management to patients displaying drug-seeking behaviour
  • providing standard information on harms and risks to patients who are prescribed drugs of dependence
  • setting ceiling limits for opioid prescribing in the practice (above which triggers review)
  • standards for the 12-month review of patient opioid use
  • prescription pad security
  • staff safety – adopting a zero tolerance to violence towards staff.

In the clinical context of chronic pain, mental illness and addiction medicine, it can be difficult to balance benefits and harms. Some practitioners may be more vulnerable to excessive patient expectations – this can be prevented by agreed practice policies (eg setting opioid reiling limits).

Refer to Appendix D for examples of practice policies.

Staff safety

All practices must implement strategies to ensure the occupational health and safety of GPs and other members of the practice team. Concerns about violence in general practice continue to be raised by the profession, particularly following the deaths of GPs, and assaults and threats to general practice staff. To deal with these uncommon but distressing situations, the practice should have a risk management strategy that details the necessary steps to protect doctors and practice staff.

A doctor duress system is recommended in each consulting room and doctors should feel confident to use it in any situation where they feel under threat.

Practices can refer to General Practice – A safe place for tips and tools on minimising risks of violence.

Advice on managing aggressive, violent or threatening patients.

Practices should facilitate GP access to information management data designed to monitor potential prescription drug abuse.

Prescription Shopping Program

The Medicare Australia Prescription Shopping Program (PSP) is designed to identify those who are obtaining PBS pharmaceuticals in excess of medical need.39

There are two key elements to the PSP:

  • The Prescription Shopping Information Service (PSIS) is available to registered prescribers 24 hours a day, seven days a week. It provides information on the prescription history of people identified by the program and is accurate up to the last 24 hours. The phone number is 1800 631 181.
  • The alert service provides GPs with a letter and a PBS Patient Summary Report notifying them when they have prescribed to a patient of concern. The patient is notified when PBS medicine may have been supplied in excess of medical need.

The PSP can disclose some details to the prescriber if their patient has been identified. Once registered with the scheme, prescribers can call a hotline to find out if their patient has been identified under the PSP.39

The PSP does not provide real-time medication history nor does it provide information about private prescriptions or those written by specialists. Some coroners’ reports detail how prescription shoppers do not meet the reporting thresholds of the scheme in some cases, and hence may falsely reassure GPs.

Medicare and PBS information releases

The Department of Human Services (DHS) holds information such as PBS and Medicare claim history for up to 5 years. GPs can request consent for release of this information by completing a freedom of information form along with a written letter to Medicare Australia, providing the same information as required on the form. This must be on appropriate letterhead and must include patient consent. Further consent is required for Medicare Australia to release this information to a third party (eg an insurance company).

Note that there may be significant delays in receiving requested material.

For further information, visit:

Pharmaceutical services units

Local PSUs may be able to inform GPs if a patient is listed as drug dependent. The duty pharmaceutical officer can provide general advice on handling drug-seeking patients and whether another doctor holds an authority to prescribe an S8 medication for a patient. PSU websites contain information about handling drug-dependent patients.

Doctors are encouraged to phone both the PSIS and their local PSU to obtain information about a patient's drug prescription history - especially when it is a new patient.

Refer to Appendix C.2 for PSU contact details.

Activities such as audit and feedback, educational outreach visits, educational meetings and the provision of educational materials such as guidelines may have some clinically beneficial effect on improving the quality of prescribing. These initiatives are supported particularly if messages are tailored to those practitioners identified as over-prescribing and address individual barriers to change.5

Given the increasing problem of prescription drug abuse, it is relevant that all general practices consider undertaking quality improvement activities in this area. For example, after performing an audit of patients prescribed benzodiazepines, practices can send out a letter outlining the harms and risks, and inviting patients to have a consultation to explore alternative ways of managing their symptoms.40-42

Refer to Appendix E.1 for a sample letter to patients.

Quality improvement activities should be more frequent and extensive if the practice has higher levels of drugs of dependence prescribing, opioid substitution therapy and mental illness or pain issues.

Practices should consider appropriate monitoring systems to ensure early alert and sentinel systems are in place. This would include simple systems for reporting adverse events (eg staff abuse, patient overdose, misuse) or system failings (eg patient not getting appropriate continued medication), to more complex auditing of practice populations (eg patients above therapeutic dose ceilings).

A simple checklist to assist practices in examining their quality management of drugs of dependence is available in Appendix D14 .

Clinical audit

Clinical audit is a broad term that encompasses several of the other quality improvement strategies such as record reviews, peer review, standard reviews (to see if standards are being met, guidelines followed and/or evidence-based practice used) and patient satisfaction surveys.43 The purpose of clinical audits is to improve the quality of healthcare services by systematically reviewing the care provided against set criteria.43

The gap between the criteria and the assessed performance provides guidance for priority improvement strategies.43 Clinical audit of prescribing drugs of dependence (eg new patients prescribed drugs of dependence, repeat prescriptions without review), patients at risk of problematic use (eg prior or current substance misuse) and patients misusing drugs of dependence may help practices improve or monitor safety of prescribing.

Evidence suggests that in terms of improving professional practice, audit and feedback leads to small (but potentially important) improvements.44 The relative effectiveness of audit and feedback is likely to be greater when baseline adherence to recommended practice is low and when feedback is delivered more intensively.44

There are several clinical audit tools available. However, there are broad limitations to the effectiveness of clinical audit which may be relevant to prescribing drugs of dependence, these include clarity and measurability of the criteria and standards chosen, data quality, engagement of practitioners, and translation of findings into quality improvement strategies.43

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