Clinical Practice Guideline for Medicines Management Services by Pharmacy Guild of Australia

Clinical Practice Guideline for Medicines Management Services

Therapeutic Adaptation, Therapeutic Substitution and Continued Dispensing

Executive Summary

Introduction

Guideline scope

About medicines management

Service delivery

• Privacy and confidentiality

• Informed patient consent

• Financial consent Documentation

• Communicating medicines management outcomes

• Follow up and clinical review

Therapeutic adaptation: Practice guide

Eligibility criteria: Which prescriptions may be adapted up therapeutic adaptation?

• Assessing the appropriateness of a therapeutic adaptation Patient assessment and history

• Recommending an appropriate therapeutic adaptation

• Safety and appropriateness

• Dispensing and documentation

Communicating with other members of the patient’s healthcare team

• Follow up and clinical review

Therapeutic substitution: Practice guide

• Eligibility criteria: Which prescriptions may be substituted under therapeutic substitution

• Assessing the appropriateness of a therapeutic substitution

• Patient assessment and history

• Recommending an appropriate therapeutic substitution

Deciding which medicines to substitute Safety and appropriateness

• Dispensing and documentation

Communicating with other members of the patient’s healthcare team Follow up and clinical review

Continued dispensing: Practice guide

• Eligibility criteria: Which prescriptions may besupplied through the medicines management continued dispensing arrangements

• Patient assessment and history

• Safety and appropriateness

• Dispensing and documentation

Communicating with other members of the patient’s healthcare team

• Follow up and clinical review

Executive summary

Recent changes in jurisdictional arrangements have enabled pharmacists to practice at the top of their scope and provide patients with timely access to treatment for commonly encountered medical conditions[2]. Queensland was the first jurisdiction to initiate a pilot that included Medicines Management services, with occasions of service beginning in April 2024 and the pilot services becoming permanent practice in July 2025. Other jurisdictions are now enabling similar arrangements, with services building on the expanding role of community pharmacists seen over the past several years and the models of practice seen in similar countries overseas.

Developed in collaboration with Pharmaceutical Defence Limited (PDL), the Australasian College of Pharmacy (ACP) and the Pharmacy Guild of Australia (PGA), this guideline is intended to provide support for pharmacists undertaking state and territory Medicines Management services, specifically in the scope of Therapeutic Adaptation, Therapeutic Substitution and Continued Dispensing.

Therapeutic Adaptation

Refers to changing the dosage, formulation, strength or instructions of a Schedule 4 medicine without the prior approval of the prescriber. Under specific state and territory arrangements, a pharmacist can adapt a prescription based on clinical need and patient safety, ensuring that the change is therapeutically equivalent[3, 4].

Therapeutic Substitution

Allows a pharmacist to substitute one medicine for another in the same therapeutic class, without prior approval of the prescriber[4]. This may occur in the instances of medicines shortages, intolerance or allergy to a medicine, or when a change may result in better patient outcomes[5, 6].

Based on international experience, this guideline recommends therapeutic substitution at no greater than Level 4 of the World Health Organisation Anatomic Therapeutic Chemical (ATC) classification of medicines.

Continued Dispensing

Through state and territory arrangements, continued dispensing Enables the supply of a manufacturer’s quantity of a Schedule 4 medicine to ensure ongoing treatment where the patient is unable to obtain a prescription in a timely manner. The patient’s condition should be stable and treated with the medicine in the previous six months, with ongoing need for treatment.

The medicine may be supplied through these arrangements only once every 12 months and the pharmacist should use the available sources of information to check previous supply history, including the pharmacy’s dispensing and clinical records and, with the patient’s consent, the patient’s My Health Record (MyHR).

Where a pharmacist isn’t satisfied with the visibility of the patient’s medication history, they should use their professional judgement to assess the clinical need to supply, consider other supply options available, and refer the patient back to their regular medical practitioner if other options have been exhausted.

The Scope of the Guideline

In accordance with the National Medicines Policy [36], ‘Quality Use of Medicines (QUM)’ centres on judicious meeting of patients’ clinical needs and ensuring timely access to treatment. In considering medicines supply under any of these state and territory arrangements, the pharmacist should take into consideration patient

need, privacy and confidentiality, consent, including financial consent as the medicines provided under these arrangements are exempt from PBS subsidy, clinical documentation and communication with the other members of the patient’s care team. Drawing on a range of evidence and references, including from jurisdictions where pharmacists are delivering comparable services, most notably Canada and the United Kingdom, this guideline for Medicines Management Services is designed to support Australian pharmacists providing these services.

For each of the three areas of Medicines Management, pharmacists are provided with practical guidance, including examples and case studies, to service provision, including:

• Eligibility criteria for supply of medicines under the service arrangements

• Assessing the appropriateness of the service

• Undertaking patient assessment and history

• Recommending a medication management service

• Ensuring safety and appropriateness

• Dispensing and documentation process, including the use of a separate clinical information software

• Communication with other members of the patient’s care team

• Follow up and clinical review

This guideline is designed to be used in conjunction with any jurisdictional resources that have been developed, applicable legislative authority and/ or instruments, Professional Practice Standards’[7], ‘National Competency Standards Framework for Pharmacists in Australia’[8], Pharmacy Board of Australia guidelines, Ahpra Shared Code of Conduct, and relevant clinical resources.

Introduction

The role of community pharmacists in Australia has continued to expand over the last few years, following the models of practice and healthcare services offered in pharmacies seen in similar developed countries[9-11]. The broader service offering has followed the sector’s response to the COVID-19 pandemic[12], resulting in growing patient demand and expectations, thus helping to position community pharmacies as healthcare hubs and key providers of primary care services into the future [13-16].

The medicines management component of state and territory pharmacist services enable participating community pharmacists to amend and dispense prescriptions for the purpose of therapeutic adaptation and substitution, and to supply medicines under continued dispensing arrangements. This provides patients with timely and uninterrupted

Guideline scope

access to medicines, which is key to ensuring optimal treatment and health outcomes for many acute and chronic health conditions.

Providing medicines management services under state and territory arrangements provides pharmacists the opportunity to demonstrate their value as medicines experts to their community and the primary healthcare system in Australia, while directly playing a greater role in the clinical care of their patients[17]. Pharmacists must use their professional judgement to decide whether supplying medicines under these arrangements is within their personal scope of competency and in the best interest of their patient. Pharmacists must also undertake any required training.

It is important to note that medicines supplied under state and territory arrangements are not eligible for PBS subsidy and do not contribute to a patient’s safety net[4].

The guideline is intended to provide clinical support to pharmacists providing services as part of state and territory arrangements in the scope of Medicines Management. The guideline was developed collaboratively by the Australasian College of Pharmacy (ACP), Pharmaceutical Defence Limited (PDL) and the Pharmacy Guild of Australia (PGA). This document should be read in conjunction with any jurisdictional resources, applicable legislative authority and/or instruments, Professional Practice Standards’[7], ‘National Competency Standards Framework “ for Pharmacists in Australia’[8] and relevant clinical resources.

About medicines management

As medicines experts, pharmacists play a crucial role in ensuring safe and reliable access to medicines and healthcare services in the community. With evolving scope of practice, pharmacists are now involved in all phases of the medicines management cycle[7]. Through state and territory arrangements, pharmacists are supported to practice at the top of their scope and to be actively involved in decisions on appropriate prescribing of medicines, through therapeutic adaptation, substitution and continued dispensing[2]. In the context of the state and territory arrangements, these medicines management services are defined as follows:

Therapeutic Adaptation

Refers to changing the dosage or formulation of a Schedule 4 medicine, based on clinical need and patient safety, without the prior approval of the prescriber, while ensuring that the change is therapeutically equivalent and allows for equivalent dosing[3, 4]. Pharmacists can alter the formulation, strength or instructions for a prescribed medicine[4]. An example of this may be substituting a capsule or tablet formulation of an antibiotic for the equivalent medicine, strength and dose of the liquid form, to aid administration in a patient with swallowing difficulties.

Therapeutic Substitution

Refers to substituting one medicine for another in the same therapeutic class, without prior approval of the prescriber, where the substituted medicine is expected to be of equivalent dose[4]. Some of the instances when medicines may be substituted include drug shortages, drug intolerance or allergy or when a change may result in better patient outcomes[5, 6]. An example of this may include substituting one angiotensin-converting-enzyme (ACE) inhibitor antihypertensive for an equivalent dose of another ACE inhibitor, due to supply shortage of the former medicine.

Continued Dispensing

Enables the supply of a manufacturer’s quantity of a Schedule 4 medicine to ensure ongoing treatment where the patient is unable to obtain a prescription in a timely manner. The patient must have been taking the medicine in the previous six months, their condition should be stable, and they have an ongoing need for treatment. The pharmacist must be satisfied that the medicine has not been supplied by other continued dispensing arrangements in the past 12 months, by checking the available patient records, including the pharmacy’s own dispensing and clinical records, and with the patient’s consent, their MyHR. Before supplying any medicine under the pilot arrangement, the pharmacist should check whether the medicine is listed under the Commonwealth’s Continued Dispensing arrangements (Schedule 1) as this would ensure PBS subsidy for the patient. An example of a medicine that is not available under the Commonwealth’s Continued Dispensing arrangements (Schedule 1) but that may be considered for supply under state and territory arrangements is valaciclovir for the prevention of herpes simplex infections.

Service delivery

Prior to commencing service delivery, pharmacies wishing to offer Medicines Management services will need to meet the requirements of participation set out by their state and territory regulators, usually the health department. This guideline provides practical advice to pharmacists to deliver Medicines Management services under state and territory arrangements.

Privacy and confidentiality

• Pharmacists should ensure that the services delivered respect the patient’s privacy and confidentiality, in line with pharmacists’ professional standards and Code of Conduct. Any further obligations of state and territory arrangements are referenced in the resource materials available from jurisdictional websites[2].

• To receive services, best practice is that a patient must be physically present in the pharmacy and directly consult with the pharmacist. Where a third party is present, such as a carer or an interpreter, this should be noted in the consultation notes.

Informed patient consent

• Patients choosing to access services under the pilot arrangements are required to provide three types of informed consent: 1) clinical, 2) financial and 3) evaluation consent. All three types of consent must be obtained from the patient or their carer prior to the provision of services. Please refer to the relevant pilot resources[4] and Clinical and financial consent information sheet[19] for more information.

• Under permanent arrangements in some states and territories, patients must provide consent for the pharmacist to make changes to their original medicine and be informed of the implications of any amendment.

Financial consent

• While this guideline does not intend to replicate existing state and territory resources, it is important to highlight the need for the pharmacist to gain explicit financial consent from patients or carers wishing to access services. This is because it may be the first time

the patient has been asked to pay for professional consultation fees in a pharmacy. Moreover, they will need to pay privately for medicines that they would normally receive through PBS subsidy. It is essential that the pharmacist explains what the service entails and is confident in obtaining informed financial consent for the consultation.

• As mentioned above, the patient should be explicitly made aware that the medicines supplied under the state and territory arrangements are not subsidised under PBS arrangements and will not contribute to their safety net.

• An official pharmacy receipt for the medicines supplied under the Medicine Management services should be offered to patients with private health insurance, who can then confirm with their insurer any policy cover and ability to claim.

Documentation

Thorough, accurate and timely documentation is essential for the delivery of safe, high-quality healthcare. Healthcare records form a critical source of information to ensure continuity of care and to minimise risk[20], in line with the principles of clinical governance[21] embedded in community pharmacy through the Quality Care Pharmacy Program.

It is important to accurately and promptly record patient communications and the rationale for the decision to alter a prescription under the Medicines Management services. These records may also be used as evidence to support a pharmacist in case of a professional complaint or legal proceedings. To support clinicians, the Australian Commission on Safety and Quality in Health Care has outlined principles of high-quality clinical documentation[20]. These include documentation that is “person-centred,

compliant, complete and accurate, integrated and upto-date, accessible, readable and enduring”[20].

A bespoke Clinical Information System (CIS) has been specifically developed to support community pharmacists to collect, store and share patient records under the state and territory arrangements. All episodes of care provided must be recorded in the software, at the time or as soon as practicable after the episode of care. For Medicines Management services, the CIS enables the pharmacist to record:

• A clinical note

• Details of the original medicine

• Details of the new medicines

• Notifications and referrals

• Reason for adaptation/substitution/continuation

Pharmacists should also record any explicit information communicated to the patient and any planned and conducted follow ups. Please refer to the relevant jurisdictional resources for any additional requirements and examples of information that should be recorded in the CIS.

Communicating medicines management outcomes

As with any clinical interaction with patients, clear communication of the treatment plan is essential in ensuring that the care delivered is patient-centred and respectful of the patient’s needs and decisions, and in line with the principles of quality use of medicines. It also leads to improved treatment adherence and partnership between the pharmacist, the patient and other members of their care team.

In addition to explaining the changes made to their medicines, the pharmacist should ensure that

the patient has understood these changes, using techniques such as the teach-back method, whereby the patient or their carer is asked to repeat the instructions and information they have been given, explicitly checks for understanding[22]. Where patient cognition or ability to understand may be of concern, the pharmacist should refer the patient to their regular medical practitioner and if required, provide only a small amount of medicine to ensure continuity of care.

The pharmacist must offer to communicate the change with the relevant members of the patient’s healthcare team, after obtaining the patient’s consent to do so.

Follow up and clinical review

Routine follow up of every episode of service under the Medication Management arrangements is not mandatory. However, pharmacists should use their clinical expertise and professional judgement, working together with the patient to share decisions on the follow up process and agree on the care plan, in line with the principles of person-centred care[21].

The follow up process should be guided by the patient circumstances, the complexity of treatment and other contributing clinical considerations. A follow up plan setting out what should be done and by whom should be agreed between the patient, the pharmacist and other members of the patient’s healthcare team. Any reminders or subsequent follow up appointments should be scheduled at the time of the medication management interaction.

The pharmacist should ensure that the agreed follow up is undertaken as per the plan and where appropriate, that the outcomes are communicated back to the patient’s regular general practitioner.

Therapeutic Adaptation: Practice guide

Under state and territory arrangements, pharmacists can alter the formulation, strength or instructions for a prescribed Schedule 4 medicine. Examples of this may include altering a dosage form to aid swallowing, improve drug delivery or simplify dosing instructions to improve medication adherence.

Eligibility Criteria:

Which prescriptions may be adapted under therapeutic adaptation?

• Prescriptions for an unrestricted Schedule 4 medicine may be adapted.

• Diversion-risk, Monitored Medicines, Controlled Drugs (S8) and restricted Schedule 4 medicines may not be adapted.

Assessing the appropriateness of a therapeutic adaptation

The pharmacist must undertake a thorough assessment of the patient’s need for and the likely benefit of offering the medication adaptation service. The pharmacist should base their decision upon a thorough understanding of the patient, their medication and health history, an understanding of the medical condition(s) being treated and the context in which the patient will be using the medicine [3, 10, 17].

Patient assessment and history

• Review the patient’s medication history available through the pharmacy’s own dispensing records, medication management apps, or by consulting the patient’s My Health Record, with the explicit consent of the patient. When possible, at least two sources of information should be used to obtain a comprehensive and complete medication history.

• Review prior treatment with the medicine, including specified formulation type, strength and directions.

• Assess for any difficulties in taking or using the medicine in the prescribed formulation type e.g. patient has difficulty swallowing tablets or capsules and a liquid form of the medicine may be available (propriety or compounded).

• Assess for changes to the patient’s ability to take the prescribed dosage form e.g. recent diagnosis with swallowing difficulties requiring dose form adjustment.

• Assess for changes to patient’s medication management arrangements e.g. commencing the use of a dose administration aid, which may require a different formulation type.

• Ascertain if there is a history of non-adherence to medicines, which may require a simplified dosing regimen, adjustments to strength, dosing instructions or dose form.

• Assess for changes to the patient’s personal circumstances, such as living arrangements, noting whether they live alone or with a carer, and how these might impact on their ability to manage their medicines.

Recommending an appropriate therapeutic adaptation

• The pharmacist must have sufficient knowledge about the patient’s health status and the disease or condition being treated to inform the decision about the proposed therapeutic adaptation.

• The pharmacist must explain the proposed change, in language that the patient and carer can understand, referring to the evidence from the consulted references. Consider using interpreting services for patients for whom English is not the first language.

• Based on all available evidence, the pharmacist should be satisfied that the proposed therapeutic adaptation will maintain or enhance patient treatment, ensuring that the patient and/or their carer is explicitly in agreement with the proposed change and is likely to comply with the treatment plan. The rationale for the change and patient agreement should be documented in the CIS.

• The pharmacist must be satisfied and document their rationale as to why the therapeutic adaptation cannot reasonably be expected to cause a medicationrelated problem or place the patient at increased risk of adverse events.

Safety and appropriateness

• The pharmacist must ensure that any drug adaptation is safe and appropriate for the patient, taking into consideration all the patient factors gathered through the patient consultation.

• The pharmacist must have access to and consult as needed the current versions of professional references including the Australian Medicines Handbook (AMH), Australian Pharmacy Formulary (APF), the approved Product Information (PI), Therapeutic Guidelines (TG or eTG) and Don’t rush to crush when assessing the most appropriate way to adapt a prescription.

Dispensing and documentation

• The smallest available size of a manufacturer’s pack of the medicine can be supplied.

• The medicine must be dispensed through the pharmacy’s standard dispensing software, as a private prescription.

• All episodes of care provided must be recorded in the CIS at the time of the consultation.

Communicating with other members of the patient’s healthcare team

Timely communication with other members of the patient’s healthcare team is important to ensure continuum of care and quality outcomes for the patient.

The patient must be provided a verbal summary and offered a written summary of the service provided, which can be printed from the CIS. The same summary can be securely shared with the patient’s nominated general practitioner through the CIS’s secure messaging feature. Where a patient does not have a regular general practitioner, they may choose to share the printed service summary with other practitioners of their choice.

Interprofessional communication should occur as soon as is practicable, but usually within 48 hours of the episode of care.

Follow up and clinical review

Pharmacists should use their professional judgement to decide whether to follow up a patient after an episode of care. They will be guided by the patient circumstances, the complexity of treatment and other contributing clinical considerations. Routine follow up of every episode of service under the Medication Management arrangements is not mandatory. The pharmacist should communicate any planned follow up with the patient and also record the follow up interaction.

Case study: Therapeutic Adaptation

Patient Mrs AS presents with a new prescription for fluticasone + salmeterol 250/50mcg accuhaler 1 inhalation twice daily. Mrs AS has been on this medicine for several years. She has come in with her daughter who has recently become her full-time carer and who reports that Mrs AS is struggling to use the accuhaler® device.

“She’s finding the coordination of breathing and inhaling more challenging as she seems to be cognitively declining and sometimes even refuses to use the device because she finds it difficult to use.”

Mrs AS has an appointment with a geriatrician scheduled for three months as the GP and daughter both suspect onset of dementia in Mrs AS.

You explain to Mrs AS and her daughter that you may be able to change her prescription to a different dosing device that might be easier for her to use. You consult Mrs AS’s dispensing record and ask her permission to check her MyHR as a second source of medication history. You proceed to obtain patient consent – clinical, financial (and evaluation, if applicable) - to alter the prescription, from both carer and patient.

In making your recommendation, you consult relevant current references, including the AMH[23], eTG[24] and Asthma Australia use of spacer guides[25].

You dispense the fluticasone+ salmeterol 125/25mcg MDI, 2 puffs via spacer twice daily. You explain the rationale for the therapeutic adaptation to the patient and carer: you have recommended a dosing device that has half the dose of the corticosteroid and long-acting reliever medicine components when compared to the accuhaler, by using 2 inhalations the patient receives a therapeutical equivalent dose as previously. However, by using the MDI device with a spacer, a lot more of the medicine will be delivered into the lungs. Because there is no need to co-ordinate breathing and inhalation, it will be easier to use the medicines (self-administered or by the carer) and may be less stressful/anxiety-producing for Mrs AS, thereby helping to improve adherence to treatment. You provide standard counselling and utilise patient support resources from Asthma Australia in your counselling.

You record the episode of care in the CIS immediately and notify the patient’s general practitioner through the CIS secure messaging system.

Therapeutic Substitution: Practice guide

Under state and territory arrangements, a pharmacist may substitute one Schedule 4 medicine for another in the same therapeutic class to meet the clinical needs of a patient. Therapeutic classes refer to medicines with similar chemical structure and mode of action e.g. statins, ACE inhibitors, beta blockers, proton pump inhibitors. When making a therapeutic substitution, the substituted medicine must be dose equivalent, have the same pharmacological mechanism of action, the same approved indication, and be dispensed for an equivalent duration as the original medicine[4]. Pharmacists should consult current approved reference resources, including the AMH, APF or the TG or eTG[24].

Eligibility Criteria:

Which prescriptions may be substituted under therapeutic substitution?

• Prescription for an unrestricted Schedule 4 medicine may be substituted.

• Diversion-risk, Monitored Medicines, Controlled Drugs (S8) and restricted Schedule 4 medicines must not be substituted.

• Medicines being used for non-approved (off-label) indications must not be substituted.

• An expired or a previously substituted prescription must not be substituted, and the patient should be referred to their regular medical practitioner for review.

Assessing the appropriateness of a therapeutic substitution

The pharmacist must undertake a thorough assessment of the patient’s need for and the likely benefit of offering the medication substitution, basing their decision on a thorough understanding of the patient, their medical and medication history, an understanding of the medical condition being treated and the context in which the patient will be using the medicine[3, 10, 17].

Patient assessment and history

The following factors should be taken into consideration:

• Reviewing relevant medication history available through the pharmacy’s own dispensing records, any medication management apps, or by consulting the patient’s My Health Record, with the explicit consent of the patient. A comprehensive and complete medication history must be obtained.

• Reviewing prior treatment with any medicine in the therapeutic class.

Recommending an appropriate therapeutic substitution

• Recommendations to substitute a medicine should be evidence based, referencing the current versions of recognised professional resources including but not limited to the AMH, APF, the approved PI and TG or eTG.

• The pharmacist should explain the proposed change in language that the patient and carer can understand, referring to the evidence from the consulted reference. Consider using interpreting services for patients for whom English is not the first language.

• The pharmacist must be satisfied that the proposed therapeutic substitution will maintain or enhance patient treatment, considering whether the change is in the best interest of the patient or whether not providing the medication change leaves the patient with less than the optimal treatment [26].

• The pharmacist must ensure that the patient or their carer agrees with the proposed change and is likely to comply with the treatment plan. This rationale and patient agreement should be documented in the CIS.

• The pharmacist must be satisfied and document their rationale as to why the therapeutic substitution cannot reasonably be expected to cause a drug therapy problem or place the patient at increased risk of adverse events.

Deciding which medicines to substitute

• Therapeutic substitution of medicines must occur at the chemical subgroup level (ATC Level 4)[27] only. Substitution at a higher ATC level is outside the parameters of the therapeutic substitution service.

• In selecting a substitute medicine, reference headto-head drug comparator studies where available. This data is often presented in commonly used reference texts such as AMH and Therapeutic Guidelines. For anti-infectives, refer to the recommendations presented in the above reference texts to ensure judicious use of antimicrobials and antimicrobial stewardship.

• The pharmacist must ensure their professional competence and knowledge of the condition, treatment, the patient and other circumstances allow them to make a recommendation for substitution that will ensure optimal patient outcomes, while not adding to potential patient harm, such as from known medication side-effects.

• Substituting medicines with a narrow therapeutic index or requiring therapeutic drug monitoring should be avoided [28].

• Substituting antiepileptics, antineoplastics, psychotropics, antiretrovirals and immunosuppressants should be avoided [29]. The pharmacist should refer to the prescribing physician, usually a specialist, if considering substitutions in these classes of drugs.

• Substituting biologics should be avoided without first consulting the prescriber[30, 31].

ATC Classification

The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) is a World Health Organisation (WHO)developed categorisation system designed to help drug utilisation and consumption research[32].

In the ATC classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels[27].

The five ATC levels are:

1st level: Anatomical or pharmacological main group

2nd level: Pharmacological or Therapeutic subgroup

3rd and 4th level: Chemical, Pharmacological or Therapeutic subgroup

5th level: Chemical substance

A Alimentary tract and metabolism (1st level, anatomical main group)

A10 Drugs used in diabetes (2nd level, therapeutic subgroup)

A10B Blood glucose lowering drug, excl. insulins (3rd level, pharmacological subgroup)

A10BA Biguanides (4th leve, chemical subgroup)

A10BA02 Metformin (5th leve, chemical substance)

Figure 2: 5 level ATC classification of metformin[1]

Safety and appropriateness

• Pharmacist must ensure that any drug substitution is safe and appropriate for the patient, taking into consideration all the patient factors gathered through interaction with the patient. Consider:

1. Any contraindications, allergies or adverse reactions

2. Likely adherence with the treatment, including any significant changes to the patient’s healthcare status that would preclude or limit their ability to comply with the therapy

3. Duplication of medicines/medicines classes

4. Dispensing and documentation

• The smallest available size of a manufacturer’s pack of the medicine can be supplied, unless other state or territory quantity restrictions apply.

• The medicine must be dispensed through the pharmacy’s standard dispensing software, as a private prescription.

• All episodes of care provided should be recorded in the CIS software at the time of the consultation.

Communicating with other members of the patient’s healthcare team

Timely communication with other members of the patient’s healthcare team is important to ensure continuum of care and quality outcomes for the patient.

Interprofessional communication should occur as soon as is practicable, but usually within 48 hours of the episode of care.

Follow up and clinical review

Pharmacists should use their professional judgement to decide whether to follow up a patient after an episode of service. They will be guided by the patient circumstances, the complexity of treatment and other contributing clinical considerations. Routine follow up of every episode of service under the Medication Management arrangements is not mandatory. The pharmacist should communicate any planned follow up to the patient and record it at the time of performing the follow up.

Case study: Therapeutic Substitution

Patient Mr JS presents with a script for simvastatin 20mg. He saw a new GP at his usual medical clinic as his regular GP is overseas on leave. He tells you that his cholesterol has been elevated for the past six months, despite modifications he’s made to his diet and that he has decided to try treatment with medicines. He has no family history of cardiovascular disease, but reports that a friend (not a relative) had a heart attack recently and this has given him a scare and prompted him to reduce his cholesterol.

Mr JS has been coming to your pharmacy for several years. He is 65 years old, with well controlled hypertensionhe monitors his blood pressure at home and has recently purchased a new blood pressure device, which he has calibrated against his GP’s device. Mr JS’s medication history includes regular dispensing of trandolapril 2mg, verapamil SR 180mg (Tarka® 2/180) for hypertension, semi-regular dispensing of esomeprazole 20mg for reflux and occasional antibiotics.

In processing the prescription for simvastatin, your dispensing software’s clinical decision support (CDS) pops up with an interaction warning between Tarka® and simvastatin. You consult your clinical references and note that verapamil increases risk of myopathy or rhabdomyolysis in combination with simvastatin. As verapamil is a CYP3A4 inhibitor while simvastatin is a CYP3A4 substrate, concomitant use can cause simvastatin plasma levels to elevate and so increase the risk of this statin dose-related adverse effect. The use of an alternative statin that is not metabolised via CYP3A4 e.g. rosuvastatin or pravastatin is recommended. Alternatively, if the combination cannot be avoided, the lowest effective dose of simvastatin should be used (not >20 mg daily) with monitoring for adverse effects and measuring creatine kinase if indicated (per AMH statins monograph).

You discuss your concerns about the new prescription with the patient, explaining that you may be able to substitute his medicine without him needing to go back to the prescriber. You proceed to obtain patient consent - clinical, financial and evaluation.

In making your recommendation, you consult current versions of clinical reference texts, including the statin dose equivalence chart in the AMH, eTG and Managing Lipids NPS Clinical Tools[33]. You alter the prescription to rosuvastatin 5mg, explaining your reasoning to the patient: this dose of rosuvastatin is equivalent to the prescribed dose of simvastatin, meaning that it should reduce lipid levels by a similar amount. Changing to this statin doesn’t mean that you won’t experience muscle pains, but it is less likely as this is the lowest dose of the medicine. However, you explain the symptoms he should look out for in your counselling, as well as providing a written consumer medicines information (CMI) leaflet. You schedule a follow up consultation at the next dispensing, in four weeks’ time.

You record the episode of care in the CIS immediately and notify the patient’s general practitioner.

Continued Dispensing: Practice guide

Continued Dispensing arrangements introduced under the state and territory pilots, and transitioned to permanent practice arrangements, are consistent with processes for current continued dispensing arrangements for PBS-funded medicines. The continued dispensing arrangements under state and territory Medicines Management services are distinguishable from the current Commonwealth arrangements as a broader range of medicines may be supplied to eligible patients.

It is important to note that Continued Dispensing of medicines enabled only under specific state and territory arrangements are not subsidised under the PBS and eligible patients requiring medicines covered by PBS Continued Dispensing should have their medicine dispensed as a Pharmaceutical Benefit in accordance with PBS rules, which are set out under the National Health (Continued Dispensing) Determination 2022[34].

Existing support materials and guidelines, namely the ‘Guidelines for the continued dispensing of eligible prescribed medicines by pharmacists’[35] will be referenced in this guideline document to avoid duplication of resources.

Eligibility Criteria: Which prescriptions may be supplied through the Medicines Management continued dispensing arrangements?

• The medicine is not covered by PBS Continued Dispensing Arrangements

• The medicine has been dispensed regularly within the last six months

• The patient’s condition is stable and there is an immediate and ongoing need for the supply

• The medicine is safe and appropriate and has not been supplied without a prescription in the past twelve months

• Unrestricted Schedule 4 medicines may be supplied under the state and territory arrangements

• Some Diversion-risk, Monitored Medicines, Controlled Drugs (S8) and restricted Schedule 4 medicines may be supplied, depending on state and territory regulations.

Patient assessment and history

The pharmacist must undertake a thorough patient assessment to determine the appropriateness of medicines supply through these arrangements.

• Review dispensing history available through the pharmacy’s own dispensing and clinical records, any medication management apps, or by consulting the patient’s My Health Record, with the explicit consent of the patient.

• Assess whether the patient has been taking the medication regularly and whether an interruption to treatment could be detrimental to their condition.

• Assess whether the patient has seen their regular prescriber in the past 12 months to ensure that the prescription was not supplied without a consultation.

• Confirm that the most recent prescription contained the same but not fewer number of repeats than is usually prescribed.

• Confirm that the patient has not had a hospital admission related to the condition for which the medicine being sought is indicated, since last prescribing.

Safety and appropriateness

The pharmacist must ensure that there is a clear indication for continuing the therapy, including:

• The dose and frequency

• The dose form

• There are no contraindications including allergies or adverse reactions

• The patient has been taking the medicine as prescribed

• There is no duplication of medicines/ medicines classes

• No new medicines have been commenced or ceased that would indicate a contraindication to continuation

• There have been no significant changes in the patient’s healthcare status including ability to comply with the therapy[35].

Dispensing and documentation

• The smallest available size of a manufacturer’s pack of the medicine can be supplied, unless other state and territory quantity restrictions apply.

• The medicine should be dispensed through the pharmacy’s standard dispensing software, as a private prescription.

• All episodes of care provided should be recorded in the CIS software at the time of the consultation.

Communicating with other members of patient’s healthcare team

Timely communication with other members of the patient’s healthcare team is important to ensure continuum of care and quality outcomes for the patient.

Interprofessional communication should occur as soon as is practicable, but usually within 48 hours of the episode of care.

Follow up and clinical review

Pharmacists should use their professional judgement when considering whether to follow up a patient after an episode of service. They will be guided by the patient circumstances, the complexity of treatment and other contributing clinical considerations. Routine follow up of every episode of service under the medication management arrangements is not mandatory. The pharmacist should communicate planned follow up to the patient and record it in the CIS.

Case study: Continued Dispensing

It’s a Monday morning in the pharmacy and you have been asked if you have time to see Mr and Mrs Jones, a couple in their 70s who are regular customers of your pharmacy. Mrs Jones is the carer for her husband, Mr Jones, and today they have come to ask for your help with Mr Jones’s medicines, stating that they are about to run out of his Parkinson’s disease medicines. They don’t have any repeats left and cannot get into his GP or any other doctor in the practice until next week. They had an interstate trip planned for later this week but are thinking of cancelling since they don’t have enough medicine to take with them.

You believe that you may be able to supply ongoing treatment under continued dispensing arrangements introduced as a state and territory service but need to assess the patient and their circumstances further.

From your dispensing records, you can see that Mr Jones has had Kinson® and Madopar HBS® dispensed consistently, for the past three years. You don’t see any changes to the dose or the directions. You confirm that there have been no recent changes to Mr Jones’s treatment with the patient and carer.

Upon questioning you find out that he’ll run out of his medicines with tonight’s dose. Interrupting treatment is likely to have negative consequences for this patient, including inability to walk and will also impact his ability to travel interstate.

Noting that the arrangements in your state or territory do not allow PBS subsidy for these medicines, you check the list of medicines available through PBS-subsidised Continuing Dispensing arrangements, but note that neither of the medicines is listed.

Considering whether to supply these medicines under emergency supply arrangements, you know that you can only supply three days’ worth of treatment but that this would still leave Mr Jones short of medicines until he’s able to see his GP.

You explain to Mr and Mrs Jones that you may be able to supply them with one shelf pack of each medicine under your state or territory arrangements. You thoroughly explain the financial implications of this supply arrangement, noting that these medicines will have to be paid for in full and won’t count towards their safety net. They tell you that they are happy to pay, as it means not running out and suffering from treatment interruption, which was debilitating in the past. The patient and carer are also both happy that they will not have to cancel their trip and be able to go interstate for their granddaughter’s wedding. You proceed to obtain patient consentclinical, financial and evaluation, if consent for evaluation is required under state and territory arrangements).

You dispense and label the medicines, record the episode of care in the CIS immediately, and notify the patient’s general practitioner via secure messaging through the CIS.

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Clinical Practice Guideline for Medicines Management Services