Dispensing Practice Guidelines 2019 JUNE

1 Dispensing Practice GuidelinesPSA Committed to better healthJUNE20192 Dispensing Practice Guidelines I Pharmaceutical Society of Australia Pharmaceutical Society of Australia Ltd. 2019 This publication contains material that has been provided by the Pharmaceutical Society of Australia (PSA), and may contain material provided by the Commonwealth and third parties. Copyright in material provided by the Commonwealth or third parties belongs to them. The PSA owns the copyright in the publication as a whole and all material in the publication that has been developed by PSA. In relation to PSA owned material, no part may be reproduced by any process except in accordance with the provisions of the Copyright Act 1968 (Cth), or the written permission of PSA. Requests and inquiries regarding permission to use PSA material should be addressed to: Pharmaceutical Society of Australia, PO Box 42, Deakin West ACT 2600. If you would like to use material that has been provided by the Commonwealth or third parties, contact them PSA, nor any person associated with the preparation of this document, accepts liability for any loss that a user of this document may suffer as a result of reliance on the document and, in particular, for: use of the Guidelines for a purpose for which they were not intended any errors or omissions in the Guidelines any inaccuracy in the information or data on that the Guidelines are based or which is contained in them any interpretations or opinions stated in, or that may be inferred from, the of any inaccuracy or ambiguity found in this document should be made without delay so that the issue may be investigated and appropriate action taken.

2 Please forward your notification to: Program Delivery, Pharmaceutical Society of Australia, PO Box 42, Deakin West, ACT : 978-0-908185-20-7 Title: Dispensing Practice GuidelinesDate of publication: June 2019 Date of endorsement by PSA Board: June 2019 Publisher: Pharmaceutical Society of AustraliaDigital 978-0-908185-06-13 Dispensing Practice Guidelines I Pharmaceutical Society of Australia Summary 4 Acknowledgements 4 About the Guidelines 5 Purpose 5 Scope 5 Version history 5 Terminology 6 Introduction 8 The Dispensing process 9 Reviewing prescribed medicines 11 Correctly identifying the patient 11 Obtaining relevant patient information 12 Considering supply arrangements 13 Scheduling of medicines 13 Emergency supply 13 PBS-subsidised supply 14 Indirect Dispensing 14 Supporting medicine administration 15

3 Accessing unapproved medicines 15 Declining to supply 15 Communicating with prescribers 16 Non-medical prescribers 16 Recording and documentation 17 Maintaining patient privacy 17 Documenting medication-related problems 18 Contributing to the My Health Record system 18 Security and access to patient information 19 Selecting or preparing the medicine 20 Barcode scanners 20 Compounding 20 Repackaging medicines 20 Labelling 21 Labelling compounded medicines 21 Placement and legibility of labels 21 Cautionary advisory labels 22 Supplying and counselling 23 Final checking 23 Correctly identifying the patient 23 Patient counselling 23 Delegation and supervision in the Dispensing process 25 Supervision of dispensary assistants/technicians 25 Risk management 26 Standardised Dispensing process 26 Workloads 26 Incident management 27 Standard operating procedures 27 Indemnity insurance 27In the event of an incident 27In the event of a data breach 28 Appendix 1: Brand substitution of PBS medicines 29 Appendix 2: Other supply arrangements 31 Appendix 3: Sensitive information 32 Appendix 4.

4 Counselling with Consumer Medicines Information leaflets 33 References 354 Dispensing Practice Guidelines I Pharmaceutical Society of Australia summary Dispensing is a fundamental component of pharmacy Practice , facilitating the safe provision of prescription Guidelines provide information and guidance to assist pharmacists to meet their professional responsibilities, exercise professional judgement and manage risks associated with Dispensing . They provide information and advice to pharmacists on professional issues related to Guidelines highlight contemporary considerations for pharmacists from the point of receiving a prescription, including: reviewing prescribed medicines effectively using the breadth of information sources available recording and documenting information to support decision making, taking into account the need to protect patient information selecting or accurately preparing the medicine labelling Guidelines do not replace the need for pharmacists to exercise professional discretion and judgement when performing these tasks in their own Practice environment.

5 The Guidelines do not include clinical information or detailed legislative requirements. Pharmacists must at all times comply with relevant Commonwealth, state and territory legislation, as well as relevant standards, codes and The revision of the Dispensing Practice Guidelines has been funded by the Australian Digital Health work to update the Guidelines has included review by experts, stakeholder feedback, and the consensus of organisations and individuals involved. The Pharmaceutical Society of Australia thanks all those involved in the review process and, in particular, gratefully acknowledges the contribution of the following individuals and Advisory Group Sam Keitaanpaa, Chair Richard Brightwell, Consumers Health Forum of AustraliaHelen Dowling, Medicines Safety Program Steering GroupAllan Groth, Indigenous Allied Health AustraliaDr Steve Hambleton, Medicines Safety Program Steering GroupGrant Martin, Australian Association of Consultant Pharmacy Andrew Matthews, Australian Digital Health Agency Jarrod McMaugh, Pharmaceutical Society of AustraliaVincent O Sullivan, Pharmacy Guild of Australia Mike Stephens, National Aboriginal Community Controlled Health Organisation Ben Wilkins, Pharmacy Board of Australia Gilbert Yeates, Pharmaceutical Defence LimitedJerry Yik.

6 Society of Hospital Pharmacists of Australia Project Team Jan RiddEmma AbateDaniela GagliardiTracy LeungPeter Guthrey Kylie Woolcock 5 Dispensing Practice Guidelines I Pharmaceutical Society of Australia Ltd. Legislation Commonwealth, state and territoryA Pharmacy Board of Australia Registration standards, codes and guidelinesB Codes of ethics / codes of conductC Competency standardsD Professional Practice / quality standardsE Professional / Practice guidelinesFAbout the guidelinesPurpose The Dispensing Practice Guidelines describe the professional obligations of pharmacists when Dispensing medicines. These Guidelines provide guidance on expected professional Practice to provide optimal patient outcomes. This guidance includes (where relevant): appropriate and effective processes desired behaviour or minimum standards of good Practice how duties and responsibilities may best be Guidelines can be used as a tool to support balanced and professional decision making, and ensure that patients needs, beliefs and preferences are met.

7 They can be used as an educational resource to inform quality assurance processes, and to provide support when resolving legal disputes and ethical Guidelines are applicable to all Practice settings in which pharmacists dispense medicines, including non-prescription medicines. Some specialised Dispensing activities ( continued Dispensing , Staged Supply, opioid substitution therapy) may also be covered by other produced by the Pharmaceutical Society of Australia (PSA) are not definitive statements of correct procedure but represent agreement by experts in the field. The Guidelines do not set a prescribed course of action or a mandatory standard to which pharmacists must adhere. Pharmacists are expected to exercise professional judgement when adapting the guidance provided in these Guidelines to specific Guidelines sit within a broader hierarchy of guidance underpinning and supporting the Practice of pharmacists (see Figure 1).Figure 1.

8 Broad hierarchy of guidance and regulation of pharmacy practiceIt is important to review these Guidelines in conjunction with the: Pharmacy Board of Australia Code of Conduct for Pharmacists1 and PSA Code of Ethics2 relevant PSA Professional Practice Standards,3 particularly Standard 3: Dispensing and Other Supply Arrangements Pharmacy Board of Australia Guidelines for Dispensing of Medicines4 Pharmaceutical Defence Limited Guide to Good Dispensing5 PSA My Health Record Guidelines for of legislative requirements are not addressed in these Guidelines . At all times, pharmacists must comply with relevant Commonwealth and state or territory legislation. No part of the Guidelines should be interpreted as permitting a breach of the law or discouraging compliance with legal historyVERSIONCHANGES2017 Incorporated update to Pharmacy Board of Australia Guidelines for Dispensing of Medicines (2015) and PSA Professional Practice Standards (2017).

9 Consolidated and superseded three separate Guidelines : Dispensing Practice Guidelines (1999), Guidelines for Pharmacists on PBS Brand Substitution (2004) and Consumer Medicine Information and the Pharmacist (2007).February 2019 Integrated pharmacist access to My Health Record following release of PSA My Health Record Guidelines for Practice advice following Coroner s recommendation.** Pharmaceutical Defence Limited. Medication misadventure: methotrexate. 2018. At: (PDL member-only access)6 Dispensing Practice Guidelines I Pharmaceutical Society of Australia some terms used in these Guidelines , other terms with equivalent or similar meanings may be equally appropriate in certain contexts. TERMDEFINITIONEQUIVALENT OR RELATED TERMSOURCEA uthorised representativeA person who can act on behalf of another person for the purposes of the My Health Record system, including viewing information, setting access controls and making registration decisions, as defined by the My Health Records Act 20127 Clinical incidentAn event or circumstance that resulted, or could have resulted, in unintended and/or unnecessary harm to a person, and/or a complaint, loss or damage.

10 A clinical incident can be related to safety, usability, technical, privacy or security specific guidance on clinical incidents associated with the My Health Record system, refer to the latest version of the PSA My Health Record Guidelines for Pharmacists6 Controlled drugA medicine in Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons or designated as a Schedule 8 substance by state and territory regulationSchedule 8 medicine, Schedule 8 poison8 CounsellingA two-way communication process between the pharmacist and the patient in which the pharmacist ascertains the needs of the patient, and provides them with the information required to safely and effectively use medicines and therapeutic devicesCommunication with patients or carers3 Dispensary assistant/technicianA suitably trained individual who assists a pharmacist in the preparation, Dispensing and supply of medicines, and other tasks in a pharmacy business or pharmacy department4 DispensingThe review of a prescription, and the preparation, packaging, labelling, record keeping and transfer of the prescribed medicine.