The pharmacist’s guide to the different regulations and protocols across Australia.
Opioid substitution has been recognised globally as an effective harm minimisation strategy for the treatment of opioid addiction.1 Key principles behind opioid substitution are to reduce or cease licit and illicit opioid use, to reduce the risk of overdose, to reduce blood-borne disease transmission associated with needle use, and to improve general health and social functioning of the individual, including a reduction in crime.2
In Australia, opioid substitution is available through pharmacotherapy programs delivered through specialist services, public and private clinics and community pharmacies. Pharmacotherapy options are methadone liquid and tablets, buprenorphine sublingual tablets and buprenorphine-naloxone sublingual film.3 Patients are stabilised on one of these options, and either will remain on a maintenance dose or weaned off the pharmacotherapy and initiated on other post-withdrawal options, which include antagonist (naltrexone) treatment, counselling, case-management and peer support programs.3
Since 1985, community pharmacies have delivered opioid substitution pharmacotherapies in Australia.4 The National Guidelines for Medication-Assisted Treatment of Opioid Dependence directs national policy on the provision of opioid substitution programs delivered in all settings, while individual state guidelines define the specific use of programs delivered in each state.5
Each state and territory has individual training requirements for pharmacists in order to supply opioid pharmacotherapy. Differences in state legislation and guidelines related to the provision of opioid treatment programs have the capacity to cause confusion and errors, particularly for pharmacists who move interstate or practise in multiple states. Lack of awareness and knowledge, stigma and fear, and a professional’s perceived moral responsibilities have all been identified as barriers to pharmacists providing opioid treatment in the community pharmacy setting.4 In addition, pharmacists who have training in chemical dependency are more likely to provide information to individuals and the community regarding addiction, as well as counsel and refer patients to clinics or prescribing doctors.
This article provides an overview of differences in legislation associated with the provision of opioid treatment within community pharmacy in states and territories of Australia, and avenues for accessing training and credentialing for pharmacists.
International and national legislation and guidelines
The World Health Organization (WHO) is responsible for producing the Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence which states, ‘Staff dispensing methadone and buprenorphine should have specific training in opioid-dependence treatment (pg15)6.’
The Australian National Guidelines for Medication-Assisted Treatment of Opioid Dependence are based on the National Pharmacotherapy Policy for Opioid Dependence.7 These guidelines reflect international recommendations, which state that ‘all service providers contributing to the treatment of opioid dependence should receive adequate orientation, training, support and supervision. This includes nurses, pharmacists and counsellors’.8
As outlined below, there is a large amount of interstate variability in the execution of this recommendation.
State and territory legislation and guidelines
Australian Capital Territory
The Opioid Maintenance Treatment in the ACT: Local Policies and Procedures 2018 document requires all pharmacists and pharmacy staff, including registered nurses and dispensary assistants, involved in the administering or dispensing of opioid maintenance treatment to complete a training program and short assessment. Refresher courses are required every five years for a pharmacist to maintain the ability to provide opioid pharmacotherapy in the ACT.9 The Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval 2018 specifies training requirements for both prescribers and pharmacists, which is provided through ACT Health.10 For prescribers, the NSW Opioid Treatment Accreditation Course is also recognised for the purpose of ACT training. Pharmacies must hold a license as an Opioid Dependency Treatment Centre, which is processed by Pharmaceutical Services, and pharmacy owners are responsible for ensuring that all dispensing staff involved in opioid treatment have successfully completed the ACT Health training program. A number of resources, templates and guidelines are available in the appendices of the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures 2018 document.
New South Wales (NSW)
The NSW Clinical Guidelines: Treatment of Opioid Dependence acknowledge that pharmacists provide an integral role in working collaboratively with prescribers and other Opioid Agonist Treatment (OAT) providers, such as case workers, in the provision of OAT. In the section ‘Training and Continuing Professional Development’ it is stated that ‘although accredited training for pharmacists in the delivery of OAT is not mandatory, individual pharmacists are encouraged to participate in the training regarding OAT and relevant continuing professional development (CPD). CPD opportunities are available through PSA, the Pharmacy Guild of Australia (The Guild), and Local Health District Primary Health Networks.’11 It goes on to describe the training objectives, and refers readers to the Australian Pharmaceutical Formulary and Handbook (APF) as an essential resource.11 The APF is a resource based on national guidelines and information and, therefore, much of the information regarding the provision of OAT is general in nature, providing no state-specific guidance.
PSA does not currently provide training, guidelines, policies or position statements within NSW on OAT. The Guild has produced tools and resources such as an Opioid Substitution Program Manual, Opioid Program checklist and sample opioid substitution therapy procedure; however, there is no reference to training or CPD regarding opioid replacement therapy.12 Section 3.1.2 of the NSW Guidelines addresses the importance of quality assurance and accreditation of the OAT service against standards, highlighting the relevance of the QCPP process. However, there is no mention of quality assurance related to training and education of pharmacists.
Northern Territory (NT)
The NT Department of Health specifies that medications used in opioid substitution be Restricted S8 Substances, for which supply restrictions are applied. In the case of opioid substitution, these supply restrictions include that a medical practitioner or nurse must be specially trained and accredited by the Chief Health Officer in order to prescribe.
To maintain accreditation, medical practitioners must also undertake refresher training and demonstrate continued clinical involvement in the supply of opioid dependence pharmacotherapies. A two-page document entitled Medicines and Poisons Control Information Sheet No310.3; Summary of Requirements for Pharmacists provides a brief summary on the provision of Schedule 8 substances by pharmacists, which is derived from the Code of Practice; Schedule 8 substances V1 – Issuing prescriptions, supplying schedule 8 substances.13 This document outlines the legislative requirements of providing opioid treatment, but does not provide specific guidelines or templates. The Community Pharmacy OPP Quick Reference Guide is not a publicly available document, however it is available on request through the Northern Territory Government Alcohol and Other Drug Services.
If practising in the central Australia area of the NT, the Alcohol and Other Drugs Services Central Australia (ADSCA) can be contacted to provide a copy of the guide, whereas if practising in the northern regions of the NT, referred to as the ‘Top End’, it would be provided by the Top End Alcohol and Other Drug Service (TADS).8 The Community Pharmacy OPP Quick Reference Guide provides useful information specifically for pharmacists providing opioid substitution in community pharmacy; however, there is no reference to further training of pharmacists practising in the NT in any of the documents related to the supply of opioid pharmacotherapy.14
The Queensland Medication-assisted Treatment of Opioid Dependence: Clinical Guidelines 2018 supports the ‘Queensland Health (Drugs and Poisons) Regulation 1996: Drug Therapy Protocol – Pharmacist Opioid Treatment Program.’ The Queensland guidelines make no reference to education or training; however, there is one reference to pharmacists participating in the Queensland Opioid Treatment Program (QOTP) which states that, ‘Pharmacists interested in participating in QOTP should contact MRQ (Medicines Regulation and Quality). MRQ will send documentation to the pharmacist to complete and return; with a pharmacist self-assessment forming part of this process’.15
Neither the Queensland branch of the Guild nor the Queensland branch of PSA provide training on QOTP, nor provide CPD on QOTP. There are no additional publically available resources on the Queensland Health website; however, the Queensland Clinical Guidelines contain various resources, including templates and guides, within the appendices of the document.
South Australia (SA)
Two distinct opioid dependence treatment programs are defined by the SA Health Department. The Medication Assisted Treatment of Opioid Dependence program (MATOD) allows trained and accredited prescribers to provide methadone and buprenorphine, with or without naloxone, to patients through public providers, community prescribers and forensic prescribers.
The MATOD Suboxone Program allows a prescriber to treat a patient using suboxone without prior training or accreditation in certain circumstances.16 The Guidelines for South Australian Pharmacists Dispensing Medication Assisted Treatment for Opioid Dependence (MATOD) by SA Health provides in-depth information for pharmacists, including pharmacokinetic profiles of opioid pharmacotherapy and guidelines on dosing. The appendices contain templates and guides on the provision of opioid pharmacotherapy within community pharmacy.17 Training and accreditation requirements for pharmacists or other suppliers of MATOD are not referred to on the government website or within any of the publicly available documentation.
Pharmacists practising in Tasmania are required to undertake accreditation before being able to provide opioid pharmacotherapy. The Tasmanian Opioid Pharmacotherapy Program: Policy and Clinical Practice Standards states that ‘dosing without accreditation will place the pharmacist working outside accepted standards of practice and this is not recommended’.18 All accreditation, training and support for dosing opioid pharmacotherapy is developed and provided by the Alcohol and Drug Service (ADS). A short professional development program and completion of a brief assessment are recommended during a pharmacist’s provisional registration period to become accredited to dose opioid pharmacotherapy.
For pharmacists who have not completed accreditation during their provision registration period, or who have moved from interstate, an open-book exam for methadone and buprenorphine is required and organised through the ADS. The ADS also provides ongoing training and support to opioid pharmacotherapy-accredited pharmacists through the provision of information relating to topical issues and regular newsletters. The ADS pharmacy is contactable to provide advice to pharmacies that provide opioid pharmacotherapy. Training for pharmacy staff, advice, resources for establishing safe dosing processes, and onsite visits to the ADS pharmacy to facilitate supportive and interactive learning experiences are available through the ADS.18
The Victorian guideline document, the Policy for Maintenance Pharmacotherapy for Opioid Dependence, states that ‘the department funds training that is available free of charge to pharmacists involved in providing pharmacotherapy services, including pharmacists wishing to attend for a clinical update or refresher training’.19 The guideline document then refers the reader to the Victorian Health Department website,20 which provides information on training for ‘prescribers’ and ‘dispensers’. Prescribers are provided training that is conducted by the Royal Australian College of General Practitioners, whereas dispensers, defined as pharmacists and their support staff, receive training available through the Victorian branch of PSA.
Both of these training courses are funded by the Victorian Health Department and are free of charge for participants. The courses are delivered in two modules, the first of which is available online, with the second involving a face-to-face, small-group workshop. A number of templates and resources are available on the Victorian Department of Health website to support the provision of opioid pharmacotherapy.20
Western Australia (WA)
The website of the WA Department of Health has a section entitled ‘Dispensing Opioid Substitution Therapy’, which indicates that pharmacists wanting to dispense Opioid Substitution Therapy (OST) must complete the Community Program for Opioid Pharmacotherapy (CPOP) online pharmacist training.21
The CPOP training is provided by the Community Pharmacotherapy Program (CPP), an organisation responsible for the training and credentialing of medical practitioners seeking to prescribe opioid pharmacotherapy, and pharmacists seeking to supply it. CPP also provides training and support to staff employed at medical practices and pharmacies involved in the opioid pharmacotherapy program. The mode of training is optional (face-to-face or online) and can be accessed along with other support information and materials through the CPP Coordinator of Provider Support.22 The Clinical Policies and Procedures for the Use of Methadone and Buprenorphine in the Treatment of Opioid Dependence is produced by CPP and provides detailed information about the program, including regulatory requirements, administration of opioid pharmacotherapy within community pharmacies, and templates and guidelines are available in the appendices.23
The suggested purpose of pharmacist training and education is to increase confidence, competence and uptake of opioid pharmacotherapy4 in accordance with the respective state or territory laws applicable to the place of practice.
Each state and territory has their own pathways and requirements for training and accreditation in the provision of opioid pharmacotherapy, and are delivered by different governmental and non-governmental bodies. As stated in the National Competency Standards 2016, it is a pharmacist’s individual responsibility to ensure that they practise within the applicable legal framework, including complying with statute law, guidelines, codes and standards and responding to common law requirements.24
The level of support and the complexity of each state and territory’s differing requirements in training and education may lead to state-based differences in the level of access and quality of care a patient receives through the community pharmacy opioid treatment program, as well as expose pharmacists to legislative risks.
A national approach to the provision of OTP may reduce potential inequalities between states and territories, and may simplify the delivery and standardisation of OTP training and education to pharmacists within Australia.
- Sullivan S. Opioid substitution: improving cost-efficiency. Bulletin of the World Health Organisation 2013;19(2):83. At: https://www.who.int/bulletin/volumes/91/2/13-117374/en/
- Australian Government. National Drug Strategy. National Guidelines for Medication-Assisted Treatment of Opioid Dependence, 2014. At: http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/Publishing.nsf/content/AD14DA97D8EE00E8CA257CD1001E0E5D/$File/National_Guidelines_2014.pdf
- NSW Government. Ministry of Health. NSW Clinical Guidelines: Treatment of Opioid Dependence – 2018 2018 (cited 2018 31 October). 31 October 2018. Available from: health.nsw.gov.au/aod/Pages/nsw-clinical-guidelines-opioid.aspx.
- Chaar BB, Wang H, Day CA, Hanrahan JR, Winstock AR, Fois R. Factors influencing pharmacy services in opioid substitution treatment. Drug Alcohol Rev. 2013;32(4):426-34. At: https://www.ncbi.nlm.nih.gov/pubmed/23442133
- National Guidelines for Medication-Assisted Treatment of Opioid Dependence, (April 2014). At: http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/Publishing.nsf/content/AD14DA97D8EE00E8CA257CD1001E0E5D/$File/National_Guidelines_2014.pdf
- Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. In: Abuse DoMHaS, editor. Geneva: World Health Organisation; 2009. At: https://www.who.int/substance_abuse/publications/opioid_dependence_guidelines.pdf
- Drugs ICo. National Pharmacotherapy Policy for People Dependent on Opioids. Canberra: Australian Government; 2007. At: http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/publishing.nsf/Content/pharmacotherapy
- Government NT. Alcohol, Drugs and Tobacco; Alcohol and Drug Rehabilitation Services: Northern Territory Government of Australia; 2018 (updated 03/07/2018). At: https://nt.gov.au/wellbeing/health-conditions-treatments/alcohol-drugs-and-your-body/alcohol-drug-rehabilitation-services
- Opioid Maintenance Treatment in the ACT: Local Policies and Procedures, (2018). At: http://www.health.act.gov.au/sites/default/files/Opioid%20Maintenance%20Treatment%20in%20the%20ACT%20-%20Local%20Policies%20and%20Procedures%202018.pdf
- Medicines, poisons and therapeutic goods (Guidelines for treatment of opioid dependency) Approval 2018, (2018). At: https://www.legislation.act.gov.au/ni/2018-81/
- Health CfP. NSW Clinical Guidelines: Treatment of Opioid Dependence – 2018. In: Health NMo, editor. Sydney, Australia: NSW Ministry of Health; 2018. At: https://www.health.nsw.gov.au/aod/Publications/nsw-clinical-guidelines-opioid.pdf
- Branch TPGoAN. Opioid Substitution Program Resource Manual. 206 ed. Sydney: The Pharmacy Guild of Australia; NSW Branch; 2011. At: https://www.guild.org.au/__data/assets/pdf_file/0030/5979/opiod-substitution-resource-manual.pdf
- Lavery G. Code of Practice Schedule 8 Substances Volume 1 – Issuing prescriptions supplying schedule 8 substances. In: Health Do, editor. Northern Territory: Northern Territory Government; 2014. At: https://digitallibrary.health.nt.gov.au/prodjspui/bitstream/10137/897/3/Issuing%20Prescriptions%20and%20Supplying%20Schedule%208%20Substances%20%28Volume%201%29.pdf
- Territory TEN. Community Pharmacy OPP Quick Reference Guide. In: Health NT, editor. Northern Territory: Top End Health; 2016. At: https://www.ntphn.org.au/practitioner-resources
- Queensland Medication-Assisted Treatment of Opioid Dependence: Clinical Guidelines 2018, (2018). At: https://www.health.qld.gov.au/__data/assets/pdf_file/0032/718952/qld-matod-clin-gdln-2018.pdf
- Health S. Opioid Dependence Treatment: Department for Health and Wellbeing; 2018 (updated 14/11/2018). Available from: sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/health+topics/health+conditions+prevention+and+treatment/medicines/opioid+dependence+treatment.
- SA Health. Guidelines for South Australian Pharmacists Dispensing Medication Assisted Treatment for Opioid Dependence (MATOD). In: Ageing DoHa, editor. Adelaide: Government of SA; 2018. At: http://www.sahealth.sa.gov.au/wps/wcm/connect/8875c9804008e393b7ffbf4826472d56/Pharmacist+Guidelines+for+SA+Pharmacists+Dispensing+MATOD+FINAL+Jan+2016.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-8875c9804008e393b7ffbf4826472d56-lztg2QA
- Service TAaD. Tasmanian opioid pharmacotherapy program, policy and clinical practice standards. In: services Dohah, editor. Hobart, Tasmania: Tasmanian Government; 2012. At: https://www.dhhs.tas.gov.au/__data/assets/pdf_file/0018/112527/2012_TOPP_Document.pdf
- Policy for maintenance pharmacotherapy for opioid dependence, (2016). At: https://www2.health.vic.gov.au/about/publications/policiesandguidelines/policy-for-maintenance-pharmacotherapy-for-opioid-dependence
- Health VDo. Pharmacotherapy Training Victoria: Department of Health and Human Services; 2018 Available from: health.vic.gov.au/public-health/drugs-and-poisons/pharmacotherapy/pharmacotherapy-training
- Health Do. Dispensing Opioid Substitution Therapy Perth: Government of Western Australia; Available from: health.wa.gov.au/Articles/A_E/Dispensing-OST
- Commission MH. Community Pharmacotherapy Program Perth: Government of Western Australia Available from: mhc.wa.gov.au/about-us/our-services/community-pharmacotherapy-program/
- Program CP. Clinical Policies and Procedures for the Use of Methadone and Buprenorphine in the Treatment of Opioid Dependence. In: Health WDo, editor. 3rd ed. Mt Lawley: Western Australian Alcohol and Drug Authority; 2014. At: https://www.health.gov.au/internet/main/publishing.nsf/Content/D7138B36FFD6F4A6CA257BF000209CC4/$File/methadone_cguide.pdf
- National Competency Standards Framework For Pharmacists in Australia. About the 2016 Framework. Canberra: Pharmaceutical Society of Australia; 2016. At: https://www.psa.org.au/wp-content/uploads/2018/06/National-Competency-Standards-Framework-for-Pharmacists-in-Australia-2016-PDF-2mb.pdf