National Health (Continued Dispensing) Determination 2022

The Determination builds on a narrow set of legal concepts drawn from the National Health Act, its Regulations, and a separate Listing Instrument. Key concepts and their operational role in the instrument are:

• Approved pharmacist: used throughout the Determination as the authorised supply agent. The instrument imports the term as defined for the purposes of Part VII of the Act (1.05(2)). The approved pharmacist is the decision-maker required to be satisfied of the conditions in Part 3 before supplying a pharmaceutical benefit without a prescription (see e.g. 3.02-3.10).

• Pharmaceutical benefit, pharmaceutical item, and Schedule equivalent: the Determination relies on the Part VII definitions of “pharmaceutical benefit” and “pharmaceutical item” (1.05(2)). Section 2.01 determines that each pharmaceutical benefit that has a drug listed in Schedule 1 is a benefit that may be supplied without a prescription. The Determination also expressly covers pharmaceutical benefits that are “Schedule equivalent” where relevant (3.01(2)(b); 3.09(2)).

• PBS prescriber: the prescriber who most recently prescribed the supply of the pharmaceutical benefit to the patient (3.01(2)(a)). Multiple obligations reference the PBS prescriber: the pharmacist must attempt to contact the PBS prescriber (or be satisfied the prescriber cannot provide an electronic prescription) (3.02), must be satisfied the PBS prescriber previously prescribed in the circumstances determined under paragraph 85(7)(b) of the Act (3.03), and must have regard to the PBS prescriber’s prior clinical assessment of the need for ongoing treatment (3.05).

• Continued dispensing regime under s 89A of the Act: the Determination implements paragraph 89A(3)(a) and (b) by specifying the benefits and the conditions for supply (2.01; 3.01). The Determination therefore operationalises the continued dispensing power in s 89A by listing eligible medicines and specifying mandatory conditions.

• Relevant purpose and increased maximum quantity: where an “increased maximum quantity” has been determined for a pharmaceutical item under paragraph 85A(2)(a) of the Act, the Determination allows supply of that increased quantity only where the last prescription for the patient was written for a “relevant purpose” defined in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (3.09(2)). This imports purpose-specific clinical constraints from the Listing Instrument.

• Stability, prior clinical review, and prior prescription validity: the Determination repeatedly requires the approved pharmacist to be satisfied the patient has a stable therapy (3.04), has been on uninterrupted regular treatment and reviewed by the PBS prescriber who determined ongoing need (3.05), and that the last supply was under a valid Part VII prescription (3.06).

• Recordkeeping and notice: the approved pharmacist must record the information that supported the decision and prepare information to be sent to the PBS prescriber, and the instrument specifies the statements the record must include (3.10).

• Declaration: the patient or their agent (not the pharmacist) must sign a declaration acknowledging that the supply is being made without presentation of a valid prescription (3.08).

These concepts combine clinical gatekeeping (stability, prior assessment, prior prescription), procedural prerequisites (contact attempt, declaration, non-repetition within 12 months), quantitative limits (maximum quantities as set under s 85A), and transparency/notification duties (recording and sending information to the PBS prescriber). The Determination therefore establishes a framework intended to permit short-term continuity of treatment while preserving links to prescriber oversight and PBS quantity controls.

The Determination allocates decision-making authority, obligations and informational flows among a narrow set of actors. The principal affected parties are:

• Approved pharmacists: the instrument places responsibility squarely on approved pharmacists to determine whether the statutory conditions are satisfied before supplying an eligible pharmaceutical benefit without a prescription. Sections 3.02-3.10 set out multiple matters the pharmacist must be satisfied of, plus recording and notification obligations (3.10). The pharmacist must ensure a declaration is signed by the patient or the patient’s agent (3.08), and must limit the quantity supplied to the maximum determined under paragraph 85A(2)(a) of the Act (3.09). The pharmacist is therefore the principal decision-maker and compliance custodian under the regime.

• PBS prescribers: the Determination assumes a recent prescriber who prescribed the patient’s most recent supply. The PBS prescriber is the reference point for several conditions: the pharmacist must attempt to contact the PBS prescriber (3.02); the pharmacist must be satisfied the PBS prescriber previously prescribed in the circumstances determined under paragraph 85(7)(b) (3.03); the pharmacist must be satisfied that the PBS prescriber assessed the patient and decided there was a need for ongoing treatment (3.05); and the pharmacist must prepare information about the continued dispensing supply to send to the PBS prescriber (3.10). The prescriber therefore receives notification and provides the forensic basis for the pharmacist’s judgement about ongoing treatment. The Determination does not change the prescriber’s statutory responsibilities under Part VII, but it conditions pharmacist supply on prior prescriber action and assessment.

• Patients (or patient agents): patients who request continued dispensing are the recipients of the supply and must provide an acknowledgment by signature that they are being supplied the pharmaceutical benefit without presentation of a valid prescription (3.08). The patient must have previously been supplied the pharmaceutical benefit on a PBS prescriber’s prescription and have an uninterrupted period of regular use for which the PBS prescriber has determined ongoing treatment is required (3.03; 3.05). The instrument also bars repeated use of the continued-dispensing route within 12 months (3.07). Agents may sign the declaration on behalf of the patient, except the approved pharmacist cannot act as the signing agent (3.08).

• The PBS/system administrators: while the Determination does not itself set payment rules, it operates within the PBS regulatory framework by naming PBS-listed benefits (2.01) and by referencing the maximum quantities determined under paragraph 85A(2)(a) of the Act (3.09). Administrators who maintain listing instruments and quantity determinations must ensure that listings and associated “relevant purpose” coding are accessible to pharmacists, because the Determination requires pharmacists to rely on those determinations for increased maximum quantities (3.09(2)).

• Suppliers and manufacturers indirectly affected: inclusion of a drug in Schedule 1 opens the possibility that approved pharmacists will supply it without a present prescription when conditions are met. That potential affects market access at the pharmacy counter for listed drugs relative to non-listed ones. The Determination, however, does not itself create subsidy or reimbursement terms; it simply identifies benefits that may be supplied under s 89A.

• Entities monitoring compliance and enforcement: the Determination imposes recordkeeping obligations (3.10). Whoever enforces Part VII of the Act or audits PBS compliance will need to account for the continued dispensing records and the requirement that prescribed conditions were satisfied at the time of supply.

In short, the instrument centrally affects approved pharmacists’ operational practices and recordkeeping, anchors continued dispensing on prior PBS prescriber decisions and assessments, and constrains patients by requiring prior prescription history, stability, and a signed acknowledgment. The scope of affected pharmaceutical benefits is limited to the drugs listed in Schedule 1 and their schedule equivalents (2.01; 3.01(2)(b)).

The Determination specifies duties and constraints that an approved pharmacist must observe before supplying a listed pharmaceutical benefit without a prescription. It does not create novel rights to payment or explicit indemnities; it defines permitted supply and the conditions that must be satisfied. Key duties and operational requirements are:

• Duty to ensure eligibility of the pharmaceutical benefit: the pharmacist must make sure the pharmaceutical benefit has a drug mentioned in an item in Schedule 1 (2.01). Section 2.01 determines that each pharmaceutical benefit with a drug in Schedule 1 may be supplied without a prescription.

• Duty to be satisfied the PBS prescriber cannot supply a prescription: the pharmacist must be satisfied either that the PBS prescriber is unable to be contacted, or that the PBS prescriber is unable to provide an electronic prescription (3.02). The instrument therefore requires a contemporaneous assessment of prescriber accessibility and electronic-prescription availability.

• Duty to verify prior prescription history and circumstances: the pharmacist must be satisfied the patient has previously been supplied the pharmaceutical benefit on the basis of a prescriber’s prescription, and that the PBS prescriber prescribed in at least one of the circumstances determined under paragraph 85(7)(b) of the Act (3.03). The reference to paragraph 85(7)(b) imports statutory circumstances that the pharmacist must check (the Determination references them but does not reproduce them).

• Duty to be satisfied of stability and prior clinical review: the pharmacist must be satisfied the patient’s therapy is stable (3.04). Additionally, the pharmacist must be satisfied the patient has been taking the pharmaceutical benefit regularly for an uninterrupted period and that the PBS prescriber has, since the start of that period, assessed the patient and decided there is a need for ongoing treatment with the pharmaceutical benefit (3.05).

• Duty to confirm last supply was on a valid Part VII prescription: the pharmacist must be satisfied the last supply of the pharmaceutical benefit to the patient was on a valid prescription under Part VII of the Act (3.06).

• Duty to ensure no continued dispensing in previous 12 months: the pharmacist must be satisfied the patient was not supplied under subsection 89A(1) in the 12 months before the requested supply (3.07).

• Duty to obtain a signed declaration: the pharmacist must ensure the patient, or an agent (other than the pharmacist), signs a declaration acknowledging the supply without a valid prescription under Part VII (3.08). The instrument disallows the pharmacist from acting as the signing agent.

• Duty to respect maximum quantity rules: the pharmacist must supply only the maximum quantity or number of units of the pharmaceutical item determined under paragraph 85A(2)(a) of the Act (3.09(1)). If an increased maximum quantity has been determined for the pharmaceutical item, the pharmacist may supply that increased maximum only if the last supply to the patient was on the basis of a prescription written for a “relevant purpose” as specified in the Listing Instrument 2024 (3.09(2)).

• Duty to prepare and record information: when the pharmaceutical benefit is supplied, the pharmacist must record the information used to support the decision to supply and prepare information about the supply to send to the PBS prescriber (3.10(1)). The information to be recorded and prepared must include: a statement that the supplied benefit is covered by Schedule 1; a statement that the conditions in sections 3.02 to 3.05 are satisfied; and a statement that the pharmacist is satisfied the supply is necessary to facilitate continuity of treatment (3.10(2)(a)-(c)).

Rights and limits under the Determination:

• Right to supply, conditional on compliance: an approved pharmacist has the statutory authority under this Determination to supply specified PBS medicines without a prescription, but only after satisfying the enumerated conditions (see 2.01 together with Part 3). The Determination does not grant an unrestricted right to supply; it creates a conditional permission.

• No express change to payment or PBS listing: the Determination does not itself set PBS subsidy or payment entitlements in its text. It operates within the existing framework of Part VII of the Act and the Regulations; questions of reimbursement, pricing, or pharmacist remuneration are outside the Determination’s expressed duties.

• Information-transmission duty but no procedural form mandated: the Determination requires the pharmacist to prepare and send information to the PBS prescriber (3.10), and to record the decision rationale. It does not prescribe a specific electronic form or timeline for forwarding the information in the text; operational details would be determined by implementation procedures or other instruments.

Collectively, these duties create an operational compliance regime for pharmacists: clinical assessment (stability and prior review), administrative verification (prior valid prescription and prescriber-accessibility), documentation (declaration and records), and quantitative limitation (maximum quantities). The Determination ties pharmacist discretion tightly to prior prescriber involvement and statutory quantity determinations.

The Determination itself does not contain express penalty provisions or enforcement schedules. The text prescribes conditions that "must" be satisfied when supplying a pharmaceutical benefit without a prescription (3.01(1)), but it does not set out sanctions, administrative penalties, or criminal offences in the instrument’s body.

Because the Determination is made under subsection 89A(3) of the National Health Act 1953 (1.03), enforcement, compliance oversight and any disciplinary or sanctioning mechanisms that apply to continued dispensing will depend on the enforcement mechanisms in the Act, other instruments, or administrative arrangements that govern Part VII activities. The Determination references other statutory provisions (for example paragraph 85A(2)(a), paragraph 85(7)(b) and subsection 84ABA(3)) and the National Health (Pharmaceutical Benefits) Regulations 2017 for definitions such as electronic prescription (1.05). Any enforcement consequences for non‑compliance with the Determination’s requirements are therefore likely to arise under the Act’s general enforcement and regulatory apparatus rather than by penalty clauses contained in this Determination.

Practical implications from the Determination’s silence on penalties:

• Accountability via recordkeeping: the Determination makes recordkeeping and preparation-of-information mandatory (3.10). That creates a documentary trail by which compliance can be assessed. The absence of express penalties does not prevent other regulatory regimes or the Act from using those records in audits, inquiries or disciplinary proceedings.

• Administrative enforcement sits outside the instrument text: practitioners and compliance officers must therefore consult the National Health Act 1953, associated Regulations, and departmental guidance to determine the precise enforcement mechanisms, reporting obligations, or possible sanctions that may apply for failing to comply with the Determination’s conditions. The Determination itself does not enumerate those mechanisms.

• Regulatory risk for pharmacists is practical and reputational as well as legal: failing to comply with the Determination could expose an approved pharmacist to review under Part VII frameworks, potential consequences regarding PBS supply authorisations, and possible action under professional regulation or contractual arrangements. Those pathways are not set out in the Determination but are implicated by the conditions that the instrument imposes (3.02-3.10).

• Monitoring and audit capability is enabled: the requirement to record the information used to support the decision and to prepare information for the PBS prescriber (3.10) means regulators and administrators can audit continued dispensing episodes against the Determination’s required statements (3.10(2)). The Determination therefore creates a basis for retrospective compliance checking.

In short, the Determination prescribes mandatory conditions and documentary duties but does not itself specify penalty or enforcement provisions. Compliance scrutiny and sanctions must be sought by reference to the Act, Regulations, professional standards or administrative enforcement mechanisms that operate alongside Part VII.

The Determination explicitly imports terms and points to other instruments and statutory provisions. The instrument cannot be read in isolation. Key interactions:

• National Health Act 1953: the Determination is made under subsection 89A(3) of the Act (1.03). It uses express cross-references to the Act, notably paragraph 85A(2)(a) for maximum quantity determinations (3.09), paragraph 85(7)(b) for the circumstances in which a PBS prescriber may have prescribed the supply (3.03), subsection 84ABA(3) regarding the meaning of a pharmaceutical benefit having a drug (note to 2.01), and Part VII definitional provisions for terms such as “approved pharmacist”, “PBS prescriber”, “pharmaceutical benefit”, “pharmaceutical item” and “schedule equivalent” (1.05(2)). Section 3.06 also requires the pharmacist be satisfied the last supply was made under a valid Part VII prescription. These cross-references mean the Determination’s operative effect is controlled by the Act’s definitions, quantity determinations, and the circumstances identified by the Act.

• National Health (Pharmaceutical Benefits) Regulations 2017: the Determination imports the meaning of “electronic prescription” from subsection 5(1) of the Regulations (1.05). The prescriber-access condition in 3.02 specifically references the prescriber’s ability to provide an electronic prescription, so the Regulations’ definition matters to the pharmacist’s assessment of prescriber capability.

• National Health (Listing of Pharmaceutical Benefits) Instrument 2024: the Determination references the Listing Instrument for the meaning of “purposes code” and for the list of “relevant purposes” that include the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient” (1.05; 3.09(2)). The Determination therefore depends on coding and purpose statements contained in the Listing Instrument to determine when an increased maximum quantity may be supplied under continued dispensing. Although the Determination is titled 2022, it expressly brings in a 2024 Listing Instrument for purpose definitions.

• Part VII definitional framework: the Determination imports expressions defined for the purposes of Part VII (1.05(2)). This means interpretive questions about terms such as “approved pharmacist”, “PBS prescriber”, “pharmaceutical benefit” and “schedule equivalent” must be resolved by reference to the Act’s Part VII definitions.

• PBS quantity and listing apparatus: by tying the allowed quantity to the maximum determined under paragraph 85A(2)(a) of the Act and by referring to circumstances under paragraph 85(7)(b), the Determination is substantively interdependent with the Act’s listing and quantity regime. Pharmacists must therefore reconcile the Determination’s limits with the PBS quantity determinations and any relevant purpose codes in the Listing Instrument.

• Administrative and professional regulation: the Determination creates duties for pharmacists (recordkeeping, declaration, verification of prior prescription and stability). Those duties will intersect with professional obligations under pharmacy licensing, corporate governance, privacy laws (in relation to patient records), and any administrative obligations tied to PBS approvals, even though the Determination does not itself cite those regimes. Practitioners must therefore consider privacy and record retention obligations when implementing the Determination’s recordkeeping duties.

In practical terms, the Determination is an implementing instrument that operationalises a subsection of the Act by listing eligible medicines and attaching conditions. Its effective operation requires pharmacists to consult the Act, the Regulations’ definition of electronic prescription, and the Listing Instrument 2024 to determine relevant purposes and whether an increased maximum quantity applies.

The Determination identifies itself as the National Health (Continued Dispensing) Determination 2022 and notes the instrument may also be cited as PB 59 of 2022 (1.01). The instrument is made under subsection 89A(3) of the National Health Act 1953 (1.03). The text provided does not include any amendment clauses, schedules of variations, transitional provisions or a recorded chain of prior amendments to this Determination.

What the instrument does show about interactions with other instruments is that later or contemporaneous instruments are relevant to its operation: it imports meanings and lists from instruments including the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (1.05) and the National Health (Pharmaceutical Benefits) Regulations 2017 (for the definition of electronic prescription) (1.05). The appearance of the Listing Instrument 2024 in a Determination labelled 2022 indicates that the Determination’s operation depends on later or external coding instruments to define “relevant purpose” and other listing details. The Determination itself does not record any historical amendments in the provided text.

Practical consequences for amendment and version control:

• The Determination will operate alongside changes to the Listing Instrument and the Act: because it references external instruments for definitions and purpose-codes, material changes to those instruments (for example, changes to purpose codes or quantity determinations under s 85A) will alter how the Determination is applied in practice even if the Determination text itself is unchanged.

• Absence of amendment detail within the text: users must consult the Federal Register of Legislation or departmental instruments to identify if the Determination has since been amended, revoked, or superseded. The provided text does not include footnote amendment history or a schedule indicating dates of effect beyond its identification as PB 59 of 2022.

• Effective date and transitional arrangements: the instrument does not set out an effective date within the provided text, nor does it provide transitional provisions for prior supplies. To establish the operative date and any grandfathering or transitional rules, practitioners must consult the instrument’s formal gazettal or the Federal Register entry.

In sum, the Determination as given identifies its citation and authority, but the text provided contains no internal amendment history, no effective-date clause, and no transitional rules. Its practical operation will depend on the contemporaneous content of the Listing Instrument and the Regulations referenced in the Determination.

The Determination text contains no reference to litigation, court decisions, or legal challenges. It does not name any judicial authorities or reported proceedings that interpret or apply its provisions. The instrument therefore provides no litigation history within its text.

Implications:

• No recorded judicial interpretation in the instrument: given the absence of case law references, questions of statutory interpretation,such as what constitutes being “satisfied” for each condition, what amounts to being “unable to be contacted” for a PBS prescriber, how to determine “stability of therapy”, or how to apply the Listing Instrument’s “relevant purpose” language to an increased maximum quantity,have not been addressed in the Determination itself.

• Potential for later litigation: the instrument’s conditions create factual and legal determinations that could give rise to disputes about compliance, particularly where recordkeeping is deficient or where the pharmacist’s subjective satisfaction is challenged. The Determination’s silence on enforcement means adjudicating bodies will likely be the place where contested interpretations arise, but there is no litigation record in the provided text.

• Reliance on Act and Regulations for legal remedies and disputes: any enforcement action, regulatory review, or dispute resolution will be embedded in the broader statutory and regulatory framework of the National Health Act, professional regulation of pharmacists, and administrative law. The Determination itself does not create a novel court jurisdiction or dispute resolution procedure.

For practitioners seeking precedents or clarifying authority, the Determination does not provide judicial guidance. Those relying on it will need to draw on the Act, Regulations, departmental guidance and any subsequent administrative or judicial decisions that interpret the continued dispensing regime.

The Determination contains several practical traps and detail-sensitive points that can create compliance risk if overlooked. These are factual mechanics embedded in the text rather than policy critiques.

• Schedule limitation: only pharmaceutical benefits that have a drug mentioned in an item in Schedule 1 are eligible (2.01). Pharmacies must map product presentations and schedule-equivalent items to the Schedule 1 entries. The Determination notes that a pharmaceutical benefit has the referred drug or medicinal preparation as per subsection 84ABA(3) (note to 2.01). Confusion between brand, generic, formulation or schedule-equivalent products could lead to incorrect continued dispensing.

• “Schedule equivalent” coverage requires careful identification: sections 3.01(2)(b) and 3.09(2) include pharmaceutical benefits that are Schedule equivalent. Pharmacists must confirm whether a specific PBS item is a schedule equivalent, which may require consulting the PBS listings and the Act’s Part VII definitions.

• Electronic prescription link: the prescriber-access condition in 3.02 includes inability to provide an electronic prescription. The meaning of “electronic prescription” is imported from subsection 5(1) of the Regulations (1.05). Pharmacists must be clear about what counts as an “electronic prescription” under the Regulations before concluding a prescriber is unable to provide one.

• Prior prescriber circumstances (paragraph 85(7)(b)): section 3.03 conditions supply on the PBS prescriber having prescribed in at least one of the circumstances determined under paragraph 85(7)(b) of the Act. The Determination does not reproduce those circumstances; pharmacists must consult the Act to confirm the prior prescribing circumstance, creating an extra step in the compliance process.

• Increased maximum quantity is conditional and purpose-specific: although the Determination permits supply only up to the maximum determined under paragraph 85A(2)(a) of the Act (3.09(1)), an “increased maximum quantity” may exist and be supplied only if the last supply was on a prescription written for a “relevant purpose” as set out in the Listing Instrument 2024 (3.09(2)). Pharmacists must check the Listing Instrument and the coding for the benefit to determine whether the last prescription had that relevant purpose. Failure to check could mean supplying an increased quantity when it is not permitted.

• 12‑month cap on repeated use: section 3.07 prevents a patient from receiving the benefit under subsection 89A(1) within the prior 12 months. Pharmacists must have access to dispensing history or trustworthy records to verify whether the patient has already used continued dispensing within that window.

• Declaration cannot be signed by the pharmacist: section 3.08 expressly prohibits the approved pharmacist from signing the acknowledgment. The pharmacist must ensure the patient or an appropriate agent signs; in practice, this requires a process for agent authority verification while ensuring the pharmacist does not act as the agent.

• The “must be satisfied” standard is subjective but audit-able: many conditions use the phrase “must be satisfied” (for example 3.02-3.06). While this grants discretionary judgement to the pharmacist, the instrument mandates recording the information used to support the decision and statements meeting 3.10(2). That documentary requirement transforms subjective satisfaction into an auditable factual record; inadequate records will expose the pharmacist to compliance queries.

• Timing and format of notifications not specified: the Determination obliges the pharmacist to prepare information to send to the PBS prescriber (3.10(1)(b)) and to include certain statements (3.10(2)), but it does not specify the timeframe or the permitted medium (electronic, fax, post). Operational policy will determine the practical deadline and method. Until such guidance is provided, pharmacists face uncertainty about how quickly the prescriber must be informed.

• Interaction with the prescriber’s ongoing obligations is implicit: the Determination requires the pharmacist to be satisfied the PBS prescriber assessed the patient and decided on ongoing treatment (3.05). The Determination does not alter or specify the prescriber’s duties at the time of subsequent clinical review, but prescriber actions are material to pharmacists’ ability to continue dispensing. Discrepancies in prescriber records or differing clinical interpretations could create disputes.

• Record content: 3.10(2) prescribes required statements but not exhaustive content. Pharmacists must retain the information they used to support the decision (3.10(1)(a)), so they should document attempts to contact the prescriber, evidence of therapy stability, prior prescription details, and proof the patient has not had a continued dispensing supply within 12 months. Failure to store these materials in retrievable form may breach the spirit of 3.10.

• Dependence on external instruments: the Determination’s operation depends on the Listing Instrument 2024 and on quantity determinations under the Act. Changes to either can affect which supplies are permissible and whether an increased maximum can be provided. Pharmacies must maintain processes to monitor relevant instrument changes.

These “gotchas” are operational and legal implementation issues arising directly from the deterministic language of the Determination.

The Determination sets out a sequence of satisfactions and recordkeeping tasks an approved pharmacist must complete before making a continued-dispensing supply. The steps below follow the order of the conditions in Part 3 and align with the instrument’s specific recording requirements.

1. Confirm the pharmaceutical benefit is eligible:

   • Verify the drug/medicinal preparation appears in Schedule 1 (2.01). If the product is a schedule equivalent, confirm equivalence under Part VII definitions (3.01(2)(b)). Use the PBS listing to match the patient’s product to a Schedule 1 item.

2. Check prior prescription history:

   • Confirm the patient was previously supplied the pharmaceutical benefit on the basis of a PBS prescriber’s prescription, and that the PBS prescriber issued the prior prescription in circumstances determined under paragraph 85(7)(b) of the Act (3.03). Retrieve and inspect prescription history or dispensing records to evidence the prior supply.

3. Establish prescriber access or inability:

   • Attempt to contact the PBS prescriber. Document the contact attempts. If the prescriber cannot be contacted, record how and when contact was attempted. Alternatively, if the PBS prescriber is unable to provide an electronic prescription, document the prescriber’s inability consistent with the Regulations’ meaning of “electronic prescription” (3.02; 1.05).

4. Confirm therapy stability and prior clinical review:

   • Be satisfied the patient’s therapy is stable (3.04). Document clinical indicators of stability relevant to the medicine (for example, adherence patterns, absence of adverse effects, clinical monitoring results where appropriate). Verify and record that the patient has been taking the pharmaceutical benefit regularly for an uninterrupted period and that, since the start of that period, the PBS prescriber assessed the patient and decided there was a need for ongoing treatment (3.05). Keep the prescriber’s notes or the patient’s clinical summary that demonstrate the prescriber’s assessment.

5. Confirm last supply was on a valid Part VII prescription:

   • Verify that the last supply to the patient was made on a valid prescription under Part VII of the Act (3.06). Retain a copy or reference to that prescription in the patient file.

6. Check the 12‑month continued dispensing rule:

   • Confirm the patient has not been supplied the pharmaceutical benefit under subsection 89A(1) in the previous 12 months (3.07). Consult dispensing records or central pharmacy records to verify.

7. Obtain required declaration:

   • Ensure the patient or an authorised agent (not the pharmacist) signs a declaration acknowledging the supply without presentation of a valid Part VII prescription (3.08). Create a standard declaration form that captures this acknowledgement and keeps verification of the agent’s authority where applicable.

8. Determine allowable quantity:

   • Supply no more than the maximum quantity or number of units of the pharmaceutical item determined under paragraph 85A(2)(a) of the Act (3.09(1)). If there exists an increased maximum quantity, confirm whether the last prescription for the patient was written for a “relevant purpose” as defined in the Listing Instrument 2024 (3.09(2)). Retain evidence of the relevant purpose coding for the prior prescription before supplying an increased maximum.

9. Prepare and record required information:

   • At the time of supply, record the information used to support the decision to supply (3.10(1)(a)). This should include contemporaneous notes of prescriber contact attempts, evidence of therapy stability, prior prescription reference, and confirmation of the 12‑month rule.
   • Prepare the information to send to the PBS prescriber (3.10(1)(b)). The information must include: a statement that the supplied pharmaceutical benefit is covered by Schedule 1; a statement that the conditions in 3.02 to 3.05 are satisfied; and a statement that the pharmacist is satisfied the supply is necessary to facilitate continuity of treatment (3.10(2)). Determine an administrative procedure for sending this information and retain proof of transmission.

10. Retain and secure records:

• Maintain the records necessary to demonstrate compliance with all the Determination’s conditions. Ensure record storage complies with applicable privacy and retention requirements, noting that the Determination itself mandates recording but does not specify retention periods.

11. Implement internal procedures and staff training:

• Develop internal standard operating procedures for screening eligibility, documenting contact attempts, completing the declaration, quantity checks, and sending notifications to prescribers. Train pharmacy staff on who may sign the declaration, how to document clinical stability, and how to map products to Schedule 1 or to schedule equivalent items.

12. Monitor external instruments and updates:

• Because the Determination depends on quantity determinations and Listing Instrument purpose codes, establish processes to monitor changes to the Act, the Listing Instrument, and the Regulations. Changes may affect whether an increased maximum is permissible and which items are eligible.

13. Audit and quality control:

• Periodically audit continued dispensing episodes to ensure compliance with the Determination’s statements in 3.10(2) and to check that records of prescriber contact attempts, validity of last prescription, and stability assessments are complete and retrievable.

Following these steps aligns pharmacy practice with the Determination’s conditions (3.02-3.10). The core compliance principle is that an approved pharmacist may exercise the continued dispensing discretion only after documenting prescriber-access attempts, prior prescription validity and prescribing circumstances, stability of therapy and prior clinical review, collection of the required patient declaration, observance of the 12‑month limit, adherence to maximum quantity rules, and the preparation and retention of the mandated statements for transmission to the PBS prescriber.