Prescribing drugs of dependence in general practice

Part A - Clinical Governance Framework - Chapter 2

Laws and regulations

Part A - Clinical Governance Framework
    2. Laws and regulations
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Last revised: 25 May 2021

Introduction

There are strict legal requirements around the prescription of drugs of addiction or controlled drugs, known as Schedule 8 (S8) medicines. The legislative requirements vary in each state and territory. Importantly, the legislative requirements for prescribing S8 drugs vary depending on the person’s dependence:

  • For drug dependent persons, S8 medications (and in some states and territories some benzodiazepines) cannot be prescribed without a permit or an appropriate approval from the relevant state or territory health department’s pharmaceutical services unit (PSU), via an authority/permit/approval, to patients who are known or suspected to be drug dependent.22
  • For non-drug-dependent persons, S8 medications cannot be prescribed for a period greater than 2 months without an appropriate approval in some states or territories.22

There are strict legal requirements around the prescription of drugs of addiction or controlled drugs, known as Schedule 8 (S8) medicines.

Inappropriate S8 prescribing may result in criminal prosecution, financial penalties, the loss of a doctor’s authority to prescribe S8 drugs or disciplinary action.

 The legislative requirements vary in each state and territory. Importantly, the legislative requirements for prescribing S8 drugs vary depending on the person’s dependence:

  • For drug dependent persons, S8 medications (and in some states and territories some benzodiazepines) cannot be prescribed without a permit or an appropriate approval from the relevant state or territory health department’s pharmaceutical services unit (PSU), via an authority/permit/ approval, to patients who are known or suspected to be drug dependent. 22
  • For non-drug-dependent persons, S8 medications cannot be prescribed for a period greater than 2 months without an appropriate approval in some states or territories. 22

Before prescribing an S8 drug, GPs must take all reasonable steps to ensure a therapeutic need exists.

In 2020 changes were made to the approved indications of immediate and modified release opioids as part of opioid reforms by the Therapeutic Goods Administration (TGA) to help address opioid misuse and abuse.

Immediate release products should only be used for the management of severe acute pain, where patients must be unresponsive or intolerant, or have achieved inadequate relief of their acute pain to maximum tolerated doses on non-opioid treatments.

Immediate release opioids play an important role in the short-term management of severe acute pain, although many forms of acute pain subside in 24-72 hours, and it is important that the opioid course is not continued when the pain is no longer severe. Provision of smaller quantities without repeats reduces the quantity of unused opioid medicine available for diversion or inappropriate use at a later stage.

Modified-release products should only be used for the management of severe pain where:

  • other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain; and
  • the pain is opioid-responsive and the patient requires daily, continuous, long-term treatment.

Modified-release opioids are not indicated to treat chronic non-cancer pain (other than in exceptional circumstances), or to be used for ‘as-needed’ (PRN) pain relief. In addition, hydromorphone and fentanyl modified release products should not be used in opioid naïve patients. The new indications can be found on the TGA web page.

The TGA has deliberately not defined ‘exceptional circumstances’ as it is acknowledged there may be a range of potential situations where they might apply to an individual patient, subject to the clinical judgment of the prescriber. However, the overall outcome of the indication change is to narrow the circumstances in which opioids are prescribed for chronic non-cancer pain and for prescribers to rule out other potential treatment modalities before determining ‘exceptional circumstances’ apply.

Once a therapeutic need is established, GPs are required to comply with state- or territory-specific health legislation (refer to Appendix C.1) and the fact sheets listed below and, where necessary, obtain an authority/permit from the relevant PSU. These authorities are distinct from, and in addition to, any authority under the PBS for scripts.23

Patients who require long-term treatment of chronic pain with opioids may access larger pack sizes and repeat prescriptions in line with Pharmaceutical Benefits Scheme (PBS) restrictions.

Pharmaceutical Benefits Scheme (PBS) and Repatriation Pharmaceutical Benefits Scheme (RPBS) requirements:

The PBS requires that if opioid use exceeds or is expected to exceed 12 months, patients’ pain management and continuing opioid treatment must be reviewed by another medical practitioner.

For palliative care patients the secondary review can be by a palliative care nurse practitioner. Further, the requirements for the annual secondary reviews have been removed for palliative care patients whose clinical condition is such that a secondary review is rendered not possible.

Under the PBS or RPBS the maximum quantity for chronic pain is generally for one month’s treatment (through telephone / electronic authority) or up to 3 months treatment (electronic / written authority)

Opioid medications under this guidance include:

  • Tramadol
  • Tapentadol
  • Codeine
  • Buprenorphine
  • Hydromorphone
  • Morphine
  • Oxycodone
  • Fentanyl
  • Methadone

When a PBS or RPBS authority application is for an S8 medicine (other than dexamphetamine sulphate or methylphenidate), the following guidelines apply:24

  • the maximum quantity is generally for 1 month’s supply (eg 1 week’s therapy with three repeats)
  • where supply for a longer period is warranted, quantities are usually for up to 3 months’ therapy
  • telephone approvals are limited to 1 month’s supply.

Prescribers need to state the interval of repeat where repeats are called for and ensure state or territory health authorities are notified about ongoing treatment. Review by a second doctor is required for PBS prescription of an opioid beyond 12 months.24

Inappropriate S8 prescribing may result in criminal prosecution, financial penalties, the loss of a doctor’s authority to prescribe S8 drugs or disciplinary action.22

Refer to the appropriate state and territory legislation and contacts at Appendix C.2.

Additional information

There are useful fact sheets available at:

Pharmaceutical Benefits Scheme

Recent changes to PBS listings for opioid medicines for the treatment of pain came into effect on 1 June 2020. A summary of these changes including new indications and pack sizes can be found at Summary of PBS opioid listings.

Therapeutic Goods Administration

All products for therapeutic use are controlled by the Therapeutic Goods Administration (TGA), which is a division of the Federal Department of Health. The TGA controls regulated (or scheduled) medicines and listed medicines, which are unscheduled.

Scheduled medicines are included in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard). The Poisons Standard is maintained by the TGA, but is implemented as state-level legislation.

To view the Poisons Standard, visit the Federal register of legislatation website. 

Drugs of dependence units (state and territory based)

State and territory departments and government-funded drugs of dependence units provide information for medical practitioners in each state and territory.

Refer to Appendix C for details.

Australian Health Practitioner Regulation Agency

The Australian Health Practitioner Regulation Agency (AHPRA) and the associated state or territory medical boards have the power to take disciplinary action, including immediate suspension of a doctor’s registration or impose conditions, in the case of inappropriate S8 prescribing.22

For further information, vist the AHPRA website.

The RACGP

The RACGP’s Standards, are standards developed by the profession for the profession. The Standards are designed as a template for safe, high-quality care in the increasingly complex environment of Australian general practice.

Accreditation by an independent body against the Standards demonstrates that a practice is serious about providing high-quality, safe and effective care to standards of excellence determined by the general practice profession.

Accreditation is an important component of the regulatory framework for quality and safety in health.

The Standards requires practices to comply with jurisdictional requirements on Schedule 4 (S4, prescription only) and S8 medicines.20

The Standards is available on the RACGP website.

Australian Medical Association

The Australian Medical Association (AMA) provides resources to help prescribers navigate laws and regulations.

For more information, visit the AMA website. 

Medicare

Medicare Australia regularly reviews PBS prescribing data, looking for inappropriate prescribing by doctors.25

  1. Leong M, Murnion B, Haber PS. Examination of opioid prescribing in Australia from 1992 to 2007. Intern Med J 2009;39(10):676–81.
  2. United Nations Office on Drugs and Crime. World Drug Report 2014. New York: United Nations; 2014.
  3. Dobbin MD. Pharmaceutical drug misuse in Australia. Australian Prescriber 2014;37(3):79–81.
  4. National Drug Strategy. National pharmaceutical drug misuse framework for action 2012–2015 – A matter of balance. Canberra: NDS, 2011. [Accessed 22 May 2015].
  5. Nicholas R, Lee N, Roche A. Pharmaceutical Drug Misuse in Australia: Complex Problems, Balanced Responses. Adelaide: National Centre for Education and Training on Addiction (NCETA), Flinders University; 2011.
  6. Office of National Drug Control Policy (ONDCP). Epidemic: Responding to America’s Prescription Drug Abuse Crisis. Washington DC: Executive Office of the President of the United States; 2011.
  7. College of Physicians and Surgeons of Ontario. Avoiding Abuse, Achieving a Balance: Tackling the Opioid Public Health Crisis. Toronto: CPSO; 2010.
  8. Medicare Australia Statistics. Pharmaceutical Benefits Schedule Item Reports.
  9. [Accessed January 2014].
  10. Nicholas R, Lee N, Roche A. Pharmaceutical Drug Misuse in Australia: Complex Problems, Balanced Responses. Adelaide: National Centre for Education and Training on Addiction (NCETA); 2011.
  11. National Drug Strategy Household Survey Canberra: AIHW; 2014. [press release].
  12. Fitzroy Legal Service. Harms caused by drugs. Melbourne: Fitzroy Legal Services; 2014. [Accessed January 2014].
  13. Harris KM, Edlund MJ. Self-medication of mental health problems: new evidence from a national survey. Health Serv Res 2005;40(1):117–34.
  14. Nielsen S, Bruno R, Lintzeris N, Fischer J, Carruthers S, Stoove M. Pharmaceutical opioid analgesic and heroin dependence: how do treatment-seeking clients differ in Australia? Drug Alcohol Rev 2011;30(3):291–9.
  15. Nielsen S, Bruno R, Degenhardt L, et al. The sources of pharmaceuticals for problematic users of benzodiazepines and prescription opioids.Med J Aust 2013;199(10):696–99.
  16. Healy J, Braithwaite J. Designing safer health care through responsive regulation. Med J Aust 2006;184(10 Suppl):S56–9.
  17. Haines F. Regulatory failures and regulatory solutions: a characteristic analysis of meta-regulation. Proceedings, Annual Meeting. Baltimore,MD: Law and Society Association; 2006.
  18. Parker C. The open corporation: effective self-regulation and democracy. Cambridge: Cambridge University Press; 2002.
  19. Scally G, Donaldson LJ. The NHS’s 50 anniversary. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ 1998;317(7150):61–5.
  20. Healthdirect Australia. Clinical Governance Framework. Sydney: Healthdirect Australia; 2013.
  21. The Royal Australian College of General Practitioners. Standards for general practices, 4th edition. Melbourne: RACGP; 2013.
  22. Harris S, Taylor S, Agency NT. Clinical governance in drug treatment: A good practice guide for providers and commissioners. London: NTA; 2009.
  23. MDA National. Things to Think About Before You… Prescribe Schedule 8 Drugs MDA National. [press release].
  24. Cran A. Misuse of opioid drugs. Defence Update: A quarterly publication for MDA National Members [Internet]. Sydney: MDA National; 2013. [Accessed January 2014].
  25. Prescription Benefits Scheme. 2. Prescribing Medicines – Information for PBS Prescribers Canberra: Department of Health. January 2014].
  26. Medicare. Practitioner Review Program Canberra: Australian Government; 2013 [updated 1 August 2013, January 15, 2014]. [Accessed January 2014].
  27. The Royal Australian College of General Practitioners. What is General Practice? Melbourne: RACGP; 2012. [Accessed September 2013].
  28. Keckley PH, Hoffmann M, Underwood HR. Medical Home 2.0: The Present, the future. Washington, DC: Deloitte Centre for Health Solutions; 2010.
  29. American Academy of Family Physicians (AAFP) AAoPA, American College of Physicians (ACP), American Osteopathic Association (AOA). Joint Principles of the Patient-Centered Medical Home. Washington, DC: Patient Centred Primary Care; 2007.
  30. Saultz JW, Albedaiwi W. Interpersonal continuity of care and patient satisfaction: a critical review. Ann Fam Med 2004;2(5):445–51.
  31. Grumbach K, Grundy P. Outcomes of implementing patient centred medical home interventions: A review of the evidence from prospective studies in the United States Washington DC: Patient-Centred Primary Care Collaborative; 2010.
  32. Geisinger Health System. Presentation at White House Roundtable on Advanced Models of Primary Care: August 10, 2009. Washington DC; 2009.
  33. Steiner BD, Denham AC, Ashkin E, Newton WP, Wroth T, Dobson LA, Jr. Community care of North Carolina: improving care through community health networks. Ann Fam Med 2008;6(4):361–67.
  34. Scholle SH. Developing and testing measures of patient centred care. New York: The Commonwealth Fund; 2006.
  35. Beal A. Closing the divide: how medical homes promote equity in Health care. New York: The Commonwealth Fund; 2007.
  36. Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial combined with agonist maintenance treatments versus agonist maintenance treatments alone for treatment of opioid dependence. Cochrane Database Syst Rev 2011;(10):CD004147.
  37. Heit HA, Lipman AG. Pain: Substance Abuse Issue in the Treatment of Pain. In: Moore RJ, editor. Biobehavioral Approaches to Pain. New York: Springer Science+Business Media, LLC; 2009. p. 363–81.
  38. National Drug Stategy amd National Mental Health Strategy. National Comorbidity Project. Canberra: of Health and Aged Care; 2001.
  39. Australian Commission on Safety and Quality in Health Care. Safety and Quality Improvement Guide Standard 6: Clinical Handover (October 2012). Sydney: ACSQHC; 2012.
  40. Medicare Australia. Prescription Shopping Program 2014. [Accessed January 2014].
  41. Gorgels WJ, Oude Voshaar RC, Mol AJ, et al. Discontinuation of long-term benzodiazepine use by sending a letter to users in family practice: a prospective controlled intervention study. Drug Alcohol Depend 2005;78(1):49–56. Mugunthan K, McGuire T, Glasziou P. Minimal interventions to decrease long-term use of benzodiazepines in primary care: a systematic review and meta-analysis. Br J Gen Pract 2011;61(590):e573–78.
  42. Department of Health (England) and the devolved administrations. Drug Misuse and Dependence: UK Guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Govenment and Northern Ireland Executive; 2007.
  43. Travaglia J, Debono D. Clinical audit: a comprehensive review of the literature. Sydney: Centre for Clinical Governance Research in Health, Faculty of Medicine, University of New South Wales; 2009.
  44. Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012;6:CD000259.
  45. Morden NE, Schwartz LM, Fisher ES, Woloshin S. Accountable prescribing. N Engl J Med 2013;369(4):299–302.
  46. Walter J. Prescribing for self and family: one national system, eight different rules. Sydney: MDA National; 2012. [Accessed January 2014].
  47. General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC; 2013.
  48. Aronson JK, Henderson G, Webb DJ, Rawlins MD. A prescription for better prescribing. BMJ 2006;333(7566):459–60.
  49. Wolfert MZ, Gilson AM, Dahl JL, Cleary JF. Opioid analgesics for pain control: Wisconsin physicians’ knowledge, beliefs, attitudes and prescribing practices. Pain Med 2010;11(3):425–34.
  50. Kamarudin G, Penm J, Chaar B, Moles R. Educational interventions to improve prescribing competency: a systematic review. BMJ Open 2013;3(8):e003291.
  51. de Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA. Guide to Good Prescribing: A practical manual. Geneva: World Health Organization Action Programme on Essential Drugs; 1994.
  52. Ross S, Loke YK. Do educational interventions improve prescribing by medical students and junior doctors? A systematic review. Br J Clin Pharmacol 2009;67(6):662–70.
  53. Longo LP, Parran T, Jr., Johnson B, Kinsey W. Addiction: part II. Identification and management of the drug-seeking patient. Am Fam Physician 2000;61(8):2401–8.
  54. Majumdar SR, Soumerai SB. Why most interventions to improve physician prescribing do not seem to work. CMAJ 2003;169(1):30–1.
  55. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med 2005;6(2):107–12.
  56. Drugs and Alcohol Services South Australia. Opioid prescription in chronic pain conditions. Adelaide: DAAS SA, the Flinders Medical Centre Pain Management Unit and the Royal Adelaide Hospital Pain Management Unit; 2008.
  57. Liu Y, Logan JE, Paulozzi LJ, Zhang K, Jones CM. Potential misuse and inappropriate prescription practices involving opioid analgesics. Am J Manag Care 2013;19(8):648–65.
  58. Fries Taylor E, Genevro J, Peikes D, Geonnotti K, Wang W, Meyers D. Buiding Quality Improvement Capacity in Primary Care: Supports and Resources. Decisiomaker Brief: Primary Care Quality Improvement No. 2. Rockville: AHRQ; 2013.
  59. Elliott RA, Woodward MC, Oborne CA. Improving benzodiazepine prescribing for elderly hospital inpatients using audit and multidisciplinary feedback. Intern Med J 2001;31(9):529–35.
  60. Clubb B. The drug seeking patient. Brisbane: Professor Tess Cramond Multidisciplinary Pain Clinic, Royal Brisbane and Women’s Hospital; 2009.
  61. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th edition. Arlington: American Psychiatric Publishing; 2013.
  62. Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev 2006;26(1):17–31.
  63. Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2003;(1):CD003161.
  64. Mitchell MD, Gehrman P, Perlis M, Umscheid CA. Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review. BMC Fam Pract 2012;13:40.
  65. Kierlin L. Sleeping without a pill: non pharmacological treatments for insomnia. Journal of Pscychiatric Practice 2008;14(6):403–7.
  66. Hasora P, Kessmann J. Nonpharmacological management of chronic insomnia. Am Fam Physician 2009;79(2):125–30.
  67. Gunter RW, Whittal ML. Dissemination of cognitive-behavioral treatments for anxiety disorders: Overcoming barriers and improving patient access. Clin Psychol Rev 2010;30(2):194–202.
  68. Morin CM, Vallieres A, Guay B, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA 2009;301(19):2005–15.
  69. Patient Safety and Quality Improvement Service. Guide to Informed Decision-making in Healthcare. Brisbane: Queensland Health; 2012.
  70. World Health Organization. Lexicon of alcohol and drug terms published by the World Health Organization Geneva: WHO; 2014.
  71. O’Regan R. Drug Seeking Behaviour: Identifying and dealing with the issues. Perth: North Metro Community Drug Service; 2012.
  72. The Royal Australasian College of Physicians. Precription Opioid Policy: Improving management of chronic non-malignant pain and prevention of problems associated with prescription opioid use. Sydney: RACP; 2009.
  73. Therapeutic Goods Administration. Scheduling basics Canberra: Department of Health; 2011. [Accessed January 2014].
  74. Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85–92.
  75. Agency Medical Directors’ Group. Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy. Washington: AMDG; 2010.
  76. Rossi Se. Australian Medicines Handbook 2011. Adelaide: Australian Medicines Handbook Pty Ltd; 2011.
  77. eTG complete [Internet]. Melbourne: Therapeutic Guidelines Limited; 2013 [Accessed December 2013].
  78. WA Cancer and Palliative Care Network. Opioid Coversion Chart. Perth: Department of Health and Ageing; 2010. [Accessed July 2014].
  79. National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. Hamilton: McMaster University; 2010.
  80. Robinson G. Prescription drug misuse: How to identify and manage drug seekers. BPJ 2008;(16):18–23.
  81. Friese G, Wojciehoski RF, Friese A. Drug seekers: do you recognize the signs? Emerg Med Serv 2005;34(10):64–7, 88–9.
  82. Rull G. Assessment of Drug Dependence. Leeds: Egton Medical Information Systems; 2011.
  83. Ford C, Halliday K, Lawson E, Brown E. Guidance for the use of substitute prescribing in the treatment of opioid prescribing in the treatment of opioid dependence in primary care. London: RCGP; 2011.
  84. Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc 2008;83(1):66–76.
  85. National Opioid Use Guideline Group. Canadian Guideline for Safe and Effective Use of Opioid for Chronic Non-Cancer Pain: NOUGG; 2010.
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