Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024

The instrument uses a small set of recurring legal concepts. Each concept is defined in the instrument or referenced back to the Act; anyone using it must map these concepts onto practice.

Scarce medicine: Section 5 delegates a declaration that the medicines in column 2 of Schedule 1 are subject to a “serious scarcity” across Australia. The list in Schedule 1 names specific registered products (for example, ESTRADERM MX 25 with registration number 67089 and ESTRADOT 25 with registration number 338056 in item 1). The label “scarce medicine” in the instrument therefore is a statutory designation tied to those products and that declared scarcity.

Substitutable medicine: Section 6 and column 3 of Schedule 1 describe the class of products that may be used instead. The substitutable medicine for each item is defined by formulation and release rate: it must either be a registered medicine, or a medicine subject to an approval under s 19A of the Act, that “contains estradiol as the only active ingredient”, “is manufactured in the dosage form of a patch”, and “releases [X] micrograms of estradiol per day” (see each Schedule 1 item). That is, the instrument ties interchangeability to the patch dosage form and daily release rate rather than to brand, excipients or total reservoir content.

Dose unit equivalence: Column 4 of Schedule 1 states the equivalence of dose units between scarce and substitutable medicines (for example, “one patch of the scarce medicine is equivalent to two patches of the substitutable medicine in paragraph (b)” for certain items). The instrument therefore contemplates substitution that may change the count of dose units dispensed while preserving “equivalent dosage regimen” (see Schedule 2 item 5).

Specific and general permitted circumstances: The instrument requires two concurrent condition sets. Column 5 of each Schedule 1 item contains item-specific requirements (for example, the pharmacist must advise the patient of the number of dose units and provide suitable instructions). Schedule 2 contains eight general permitted circumstances (for example, evidence of a valid prescription (item 1); pharmacist lacks access to the scarce medicine (item 2); prescriber has not prohibited substitution (item 3); pharmacist’s professional judgement that the patient is suitable (item 4); patient consent (item 6); making a record at time of dispensing (item 7); and an established procedure to notify the prescriber (item 8)).

Prescriber and pharmacist roles: The instrument defines prescriber with reference to state or territory authorisation (s 4) and references pharmacist as defined in subsection 30EK(6) of the Act (s 4). Substitution is expressly limited to a pharmacist acting under the statutory permission and to a prescription where the prescriber has not indicated substitution is prohibited (Schedule 2 item 3).

Temporal scope and legal basis: The instrument is made under s 30EK of the Therapeutic Goods Act 1989 (s 3) and is time-limited to 28 February 2027 (s 7), automatically repealing at the start of 1 March 2027 unless earlier repealed (s 8).

Practically, the main conceptual shifts are: a statutory scarcity declaration that triggers a pharmacist substitution permission; substitution defined by release rate and dosage equivalence; dual-condition authorisation design (specific plus general permitted circumstances); and mandatory procedural duties on pharmacists (advice, record-keeping, notification).

The instrument identifies three discrete groups with direct duties or affected interests and several others with indirect exposure.

Pharmacists: The primary decision-maker under the instrument is the pharmacist. Section 6 permits pharmacists to dispense substitutable medicines in substitution for scarce medicines, but only where the specific permitted circumstances in Schedule 1 column 5 and the general permitted circumstances in Schedule 2 are met (s 6). The pharmacist must: determine whether the scarce medicine is unavailable (Schedule 2 item 2); confirm the patient has evidence of a valid prescription (Schedule 2 item 1); ensure the prescriber has not prohibited substitution (Schedule 2 item 3); exercise professional judgement about suitability (Schedule 2 item 4); ensure the dispensed amount gives equivalent dosage regimen and duration (Schedule 2 item 5); obtain patient consent (Schedule 2 item 6); make a contemporaneous record (Schedule 2 item 7); and have and use an established procedure to notify the prescriber at or soon after dispensing (Schedule 2 item 8). Column 5 of Schedule 1 further requires advising the patient on dose unit count and administration instructions.

Prescribers: The instrument limits pharmacist substitution where the prescriber has indicated substitution is not permitted (Schedule 2 item 3). Prescribers therefore hold a negative control: they can prevent substitution by annotating the prescription. The instrument also requires pharmacists to notify prescribers of substitutions (Schedule 2 item 8), creating an information flow to prescribers after substitution.

Patients (and persons acting on their behalf): Substitution is conditional on the patient (or person acting on their behalf) having evidence of a valid prescription (Schedule 2 item 1) and on consent to receive the substitutable medicine (Schedule 2 item 6). Patients may receive different counts of patches (per dose equivalence in Schedule 1 column 4) and will be given administration instructions (Schedule 1 column 5 and Schedule 2 item 5).

Manufacturers and sponsors: The instrument’s substitutable medicine definition requires either registration or an approval under s 19A (Schedule 1 column 3). Manufacturers/sponsors of estradiol-only patches that meet the release characteristics set out in column 3 therefore become eligible suppliers for substitution. Manufacturers of the scarce registered products are directly affected by the scarcity declaration in s 5, as it applies to named registration numbers.

Regulators and compliance officers: The instrument is made under the Therapeutic Goods Act and interacts with the Register and s 19A approval framework (see s 4 definitions and Schedule 1 references). Enforcement and oversight of compliance will fall to those exercising the Act’s regulatory powers; the instrument itself contains procedural duties for pharmacists that will be relevant in regulatory review.

Other healthcare actors and payers: The instrument does not speak to reimbursement arrangements, PBS listings or state dispensing remuneration, but changes to the number of dose units dispensed or to brand may affect pharmacy stock management, patient co-payments, and prescriber follow-up workloads. Those indirect costs are borne by patients, pharmacies and potentially funders, but the instrument itself imposes no funding rules.

In short, pharmacists are the central actors required to make availability and suitability determinations and to carry out specified communications and record-keeping; prescribers retain a limited veto over substitution; patients must provide a prescription and consent; manufacturers of qualifying patches become potential supply sources; and regulators will be the ultimate enforcers of the Act under which this instrument is made.

The instrument creates a network of conditional rights to substitute and corresponding duties, concentrated on pharmacists and involving prescribers and patients.

Pharmacist rights: Under section 6, a pharmacist is permitted to dispense a defined substitutable medicine in substitution for the scarce medicine listed in Schedule 1, but only when both the specific and general permitted circumstances exist (s 6). That is a statutory permission to perform an act which otherwise might not be permitted absent standard regulatory pathways.

Pharmacist duties: The instrument imposes several mandatory operational duties, drawn from Schedule 1 column 5 and Schedule 2:

• Verify valid prescription evidence (Schedule 2 item 1). The pharmacist must ensure the patient or person acting for them “has evidence of a valid prescription for the scarce medicine”.
• Confirm lack of access to the scarce medicine (Schedule 2 item 2). Substitution is conditioned on the pharmacist not having access to the scarce medicine.
• Check prescriber directions (Schedule 2 item 3). If the prescriber has indicated substitution is not permitted on the prescription, substitution must not occur.
• Exercise professional judgement (Schedule 2 item 4). The pharmacist must determine the patient is suitable to receive the substitutable medicine.
• Ensure equivalence of regimen and duration (Schedule 2 item 5). The amount dispensed must result in an “equivalent dosage regimen and duration” to that prescribed for the scarce medicine.
• Obtain consent (Schedule 2 item 6). The patient or agent must consent to receive the substitutable medicine.
• Make a contemporaneous record (Schedule 2 item 7). The pharmacist must record dispensing the substitutable medicine “at the time of dispensing”.
• Notify the prescriber (Schedule 2 item 8). The pharmacist must have an established procedure to notify the prescriber “at the time of, or as soon as practical after, dispensing”.
• Provide information and instructions to the patient (Schedule 1 column 5). For each item, the pharmacist must advise the patient (or agent) of: (a) the number of dose units that must be administered based on the dose unit equivalence set out in column 4; and (b) “suitable instructions for administering the substitutable medicine”. For some items substituting with the paragraph (b) substitutable medicine also requires that the pharmacist “dispenses patches that are of the same brand” and does so only when the pharmacist does not have access to the paragraph (a) substitutable medicine (Schedule 1 column 5, items 2-4).

Prescriber rights and duties: The prescriber may prevent substitution by indicating on the prescription that substitution is not permitted (Schedule 2 item 3). The instrument otherwise imposes no duties on prescribers; pharmacists must notify prescribers under Schedule 2 item 8, creating an obligation on pharmacists to inform, but not to seek pre-authorisation.

Patient rights and duties: Patients have the right to be advised and to consent (Schedule 1 column 5 and Schedule 2 item 6). The patient also has the duty to produce evidence of a valid prescription (Schedule 2 item 1) and to follow administration instructions provided by the pharmacist.

Scope limits and conditions: Substitution is only lawful where both the specific permitted circumstances in the relevant Schedule 1 item and all applicable Schedule 2 general permitted circumstances are satisfied (s 6, note). The substitutable medicine must meet the technical definition in column 3 (for example, “releases 25 micrograms of estradiol per day”), and dosage equivalence rules in column 4 determine how many substitute units should be dispensed.

Records and procedures: The instrument requires contemporaneous recording (Schedule 2 item 7) and an “established procedure” for notifying prescribers (Schedule 2 item 8). Those impose practical documentation and systems duties on pharmacies.

Absence of explicit penalties in the instrument: The text prescribes duties but does not itself set out penalties for non‑compliance; the enforcement consequences will therefore arise from the underlying Act and regulatory regime (the instrument does not create new fines or offences within its text). See further at Penalties and enforcement.

In sum, the instrument creates a conditional legal permission to substitute, circumscribed by a set of affirmative verification, counselling, consent and record-keeping duties that the pharmacist must discharge before substitution is lawful.

The instrument does not itself specify civil or criminal penalties, infringement notices, or a specified enforcement regime. It is made under s 30EK of the Therapeutic Goods Act 1989 (s 3 Authority), and therefore any enforcement action for non-compliance would be taken under the powers and offences established by the Act and associated regulations rather than by this instrument alone.

What the instrument does: it imposes duties (for example: Schedule 2 items 1-8; Schedule 1 column 5 obligations). Failure to meet those duties would represent non‑compliance with the statutory permission for substitution and could therefore be relevant to regulator action under the Act. The instrument itself states no penalty amounts, no civil pecuniary order power, and no infringement option in its text.

Consequences by implication: Because the instrument creates a statutory condition permitting pharmacists to substitute otherwise non-standard products, regulatory bodies exercising the Therapeutic Goods Act’s enforcement powers may treat contraventions as breaches of the Act’s requirements or conditions relevant to market authorisation and supply. The instrument refers to registered goods, the Register, and approvals under s 19A , all concepts that sit within the Act’s regulatory architecture (s 4 Definitions). Enforcement responses under the Act could include compliance notices, suspension of authorisations, or other remedies available to the regulator, but the instrument does not itself enumerate or amend those powers.

Practical enforcement considerations for pharmacists and sponsors: The instrument requires contemporaneous records (Schedule 2 item 7) and an established prescriber-notification procedure (Schedule 2 item 8). From an enforcement perspective, the existence, completeness and accessibility of those records are likely to be the principal evidentiary basis on which compliance is assessed. The instrument’s silence on evidentiary standards (for example, what counts as “evidence of a valid prescription”, Schedule 2 item 1) creates potential administrative discretion in enforcement: regulators may scrutinise whether a pharmacist reasonably satisfied the conditions.

Implementation risks and compliance exposure: Because the instrument binds operational practice (patient advice, consent, dose-equivalence calculations, brand-dispensing rules), pharmacies that substitute without following both the specific and general permitted circumstances would be exposing themselves to regulatory scrutiny under the Act. The instrument provides the permission to substitute; misuse of that permission may be judged under the Act’s general compliance tools. The instrument does not provide an express indemnity to pharmacists; potential liability in civil claims (for example, negligence or consumer claims) is not addressed in the instrument.

In short: the instrument imposes duties but leaves enforcement to the Act’s existing framework. It contains no standalone penalty schedule; regulators and compliance officers will rely on the Act, the Register, sponsor/registration conditions and ordinary statutory powers to address breaches.

This instrument is tightly integrated by reference with provisions and concepts in the Therapeutic Goods Act 1989 and by mention of other regulatory instruments. The interplay is explicit in the instrument’s definitions and operational clauses.

References to the Act: Section 3 of the instrument states it is made under s 30EK of the Act (s 3 Authority). The instrument relies on definitions in subsection 3(1) of the Act , it notes that “medicine”, “Register”, “registered goods”, and “registration number” are defined there (s 4 Definitions). It also refers to subsection 30EK(6) for the meaning of “pharmacist” (s 4). Therefore the instrument must be read alongside the Act’s definitions and the powers conferred by s 30EK.

Registered goods and approvals under s 19A: Schedule 1 column 3 limits substitutable medicines to “a registered medicine, or a medicine subject to an approval under section 19A of the Act” that meets the estradiol-only patch criteria. This makes the instrument operate within the existing registration and approval regime. Where a substitutable product is not registered but is subject to a s 19A approval, that product may be treated as eligible. Therefore the instrument interacts directly with the Act’s registration and provisional approval mechanisms.

State and Territory prescribing law: The instrument defines “prescriber” to mean a person authorised under a law of a State or Territory to prescribe medicine (s 4). That explicitly links substitution permissions to the varying frameworks that govern who can prescribe in each jurisdiction. The prescriber’s right to annotate a prescription to prevent substitution (Schedule 2 item 3) depends on those state/territory prescription formats and legal rules.

Therapeutic Goods Regulations 1990: The instrument refers to “generic product” having the same meaning as in the Therapeutic Goods Regulations 1990 (s 4). While the instrument does not otherwise use the term “generic product”, this cross-reference signals that interpretation of any such reference will follow the Regulations.

PBS, reimbursement and other funding laws: The instrument is silent on reimbursement frameworks, Pharmaceutical Benefits Scheme listings, co-payments, or subsidy arrangements. Where substitution changes the number of dose units dispensed (Schedule 1 column 4 equivalence), that may have practical implications for PBS dispensing rules, pack sizes and patient co-payments; however, any legal consequences under PBS or other funding laws are not addressed in the instrument and would require separate administrative or legislative measures.

Professional regulation: The instrument places a duty on the pharmacist to exercise “professional judgement” (Schedule 2 item 4) and to provide counselling and instructions. That duty intersects with professional standards and indemnity obligations under pharmacy registration and professional conduct regimes in states and territories. Pharmacists will need to ensure compliance with both the statutory conditions in this instrument and their professional obligations under state/territory regulatory frameworks.

Records and evidence: The requirement to make a contemporaneous record (Schedule 2 item 7) and to have an established procedure to notify prescribers (Schedule 2 item 8) interacts with existing obligations under record-keeping laws and privacy legislation when personal health data are processed. The instrument does not reference privacy or data security standards, so compliance with privacy law remains an independent obligation.

In summary, the instrument is an overlay on the existing Therapeutic Goods Act framework: it creates a scarcity declaration and conditional substitution permission that must be reconciled with registration/approval statuses (including s 19A approvals), state prescribing laws, professional standards, and external funding schemes. The instrument is silent on several of those external frameworks, so practitioners must coordinate compliance with multiple legal regimes.

The instrument itself contains a self-contained timeline and makes no express internal amendments to other instruments. The text provides the following history-relevant mechanics:

• Name and date: It is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024 (s 1 Name). The instrument as provided contains no schedule or notes indicating prior versions or amending instruments.

• Authority for creation: Made under s 30EK of the Therapeutic Goods Act 1989 (s 3). The instrument does not purport to amend the Act; it exercises a power under an Act to declare scarcity and permit substitution.

• Period in force and repeal: Section 7 sets the instrument to remain in force until 28 February 2027. Section 8 states that, unless repealed earlier, the instrument is repealed at the start of 1 March 2027. No transitional or grandfathering clauses are included. Therefore the instrument has a fixed expiry consistent with the Act’s delegated-power design.

• Absence of amendment entries: The instrument text contains no sections that amend, revoke or vary previous instruments, and it contains no schedule listing repeals of earlier similar instruments. The only repeal mechanism specified is the automatic expiry at the stated date. If earlier amendments or instruments exist, they are not recorded in this instrument.

Practical effect for users: Any changes to the declared scarcity list, the permitted substitutions or the general permitted circumstances would require a subsequent instrument under s 30EK (or amendment to this instrument). Because the instrument sets a clear expiry, a later instrument would be needed to extend or renew the substitution permissions beyond 28 February 2027. There is no implied continuity beyond that date from this instrument itself.

Recordkeeping for compliance: In environments where multiple scarcity instruments are issued over time, practitioners should track instrument numbers and effective dates carefully. This instrument’s silence on prior or subsequent instruments means that to determine the current legal permissions beyond 28 February 2027, users must consult the Register or other official sources to see whether a successor instrument has been made.

In sum, the instrument has a discrete, dated lifespan and contains no amending history within its text. Any amendment, revocation or extension would require a separate instrument under the Act.

The instrument contains no references to litigation, and it does not name any court decisions or dispute outcomes. It does not provide any precedent citations, transitional judicial determinations, or references to pending proceedings. There are two implications:

1. No cases are cited in the instrument: The text contains no legal citations or references to judicial interpretation. It is a delegated statutory instrument that operates on its own terms and does not record or incorporate judicial findings.

2. No internal dispute-resolution mechanism is specified: The instrument sets out rights and duties but does not create a dispute resolution clause, administrative appeal route specific to this instrument, or a special tribunal process. Any disputes about compliance, interpretation or the underlying Act would be resolved through ordinary administrative law remedies or the courts under the Act’s framework.

For practitioners seeking litigation context: Because the instrument names specific operational terms such as “does not have access to”, “evidence of a valid prescription”, and “professional judgement”, these terms could become contested in litigation, but there is no litigation history set out within the instrument itself to guide interpretation. Any legal challenges to substitution decisions would therefore proceed on the basis of the Act and the usual administrative law principles; the instrument provides the statutory predicates that would be interpreted by courts if contested.

Users should therefore treat the instrument as a fresh, regulation‑level authorisation without an embedded litigation record. If a dispute arises about whether the pharmacist met the conditions (for example, whether the record‑keeping was adequate, whether consent was properly obtained, or whether the prescriber’s direction was valid), the resolution would likely require factual enquiry under established administrative or civil law processes. The instrument itself does not identify precedents or adjudicative guidance.

The instrument establishes substitution permissions but leaves several operationally important matters undefined or conditioned in ways that create practical ambiguity. These points are potential pitfalls for pharmacists, prescribers, sponsors and compliance officers.

Dual-condition requirement: Substitution is only permitted where both the specific permitted circumstances in Schedule 1 column 5 and the general permitted circumstances in Schedule 2 exist (s 6). Practically insurers, dispensary software and pharmacy staff may mistakenly treat either set as sufficient. The instrument requires both; failing to satisfy any single item renders substitution unauthorised.

Undefined evidentiary standards: Schedule 2 item 1 requires “evidence of a valid prescription for the scarce medicine” but does not specify acceptable documentary forms (paper prescription, electronic prescription token, fax, or recorded verbal order where allowed by state law). Pharmacies must map this to state/territory prescription law, but the instrument itself offers no standard. That raises implementation risk where systems or auditors apply different evidentiary thresholds.

“Does not have access to the scarce medicine”: Schedule 2 item 2 and several Schedule 1 column 5 conditions require that the pharmacist “does not have access to the scarce medicine” or, for certain substitutions with paragraph (b) patches, “does not have access to the substitutable medicine in paragraph (a)”. The instrument provides no definition of “access” (on-shelf stock, available from supplier same day, available in another branch) or required efforts to obtain it. Pharmacies must document their stock position and supplier communications to justify the substitution decision; the instrument leaves the necessary standard open.

Professional judgement and suitability: Schedule 2 item 4 requires the pharmacist to have “exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine”. The instrument does not define suitability criteria. Pharmacists must therefore apply professional standards (and consider comorbidities, interactions and patient history) without statutory checklists; that heightens reliance on professional training and risk of disagreement about what constituted adequate judgement.

Dose unit equivalence limited to release rate: Schedule 1 column 3 defines substitutable medicines by “releases X micrograms of estradiol per day” and column 4 sets equivalence on a per-patch basis (for example, “one patch of scarce = two patches of substitutable (b)”). The instrument bases equivalence on release rate, not on brand-specific pharmacokinetics, adhesive characteristics or total reservoir content. This creates a technical “gotcha” where two patches with the same stated daily release might differ in clinical delivery; the instrument does not provide for clinical exceptions or additional pharmacist obligations to consider pharmacokinetic differences.

Brand-dispensing rule for multi-patch substitution: For substitutions where two patches of a lower-release patch replace one higher-release patch, Schedule 1 column 5 requires that the pharmacist “dispenses patches that are of the same brand” when substituting with paragraph (b) patches and only if the paragraph (a) substitute is not accessible. This can complicate procurement where multi-packs or mixed brands are typical, and may require pharmacies to ensure same‑brand supply of at least two patches per substitution event.

Patient consent and counselling content: The instrument requires that the pharmacist advise the patient of the number of dose units to administer and provide “suitable instructions for administering the substitutable medicine” (Schedule 1 column 5). The instrument does not specify minimum content for “suitable instructions” (for example, skin site rotation, adhesion issues, disposal). In absence of a statutory checklist, pharmacies must rely on professional standards, which could vary.

Record-keeping technicalities: Schedule 2 item 7 requires making a record “at the time of dispensing”. The instrument does not prescribe the format, retention period, or specific data fields. Pharmacy IT systems will need configuration to capture the necessary evidence. Failure to record contemporaneously could be treated as non-compliance.

Notification procedure timing ambiguity: Schedule 2 item 8 requires an “established procedure to notify the prescriber ... at the time of, or as soon as practical after, dispensing”. The phrase “as soon as practical” is open-ended. Where notification is delayed, pharmacy staff should document why to defend the delay; absent documentation, regulators may question whether the notification was timely.

PBS and funding silence: The instrument is silent on funding, pack sizes and reimbursement. Changes in the number of patches supplied (for example replacing one 50 mcg patch with two 25 mcg patches) could affect costs to patients or interactions with subsidy rules. The instrument does not resolve these financial effects.

Cross-jurisdictional prescribing formats: Because “prescriber” is defined by state/territory authorisation (s 4), different jurisdictions’ prescription requirements could affect capacity to show “valid prescription” or to record a prescriber’s directive against substitution. Pharmacies operating across borders must manage variations carefully.

In summary, the instrument leaves several practical thresholds and definitions unspecified. Pharmacies should document policies for defining “access”, acceptable prescription evidence, suitability checks, recording fields, and notification methods to reduce enforcement risk.

Complying with this instrument requires integrating its dual-condition test (specific and general permitted circumstances) into dispensing workflows, record systems and staff training. Below is a practical compliance checklist derived directly from the instrument’s text.

1. Confirm scarcity applicability

• Verify the prescription is for a scarce medicine listed in Schedule 1 column 2 (for example, ESTRADERM MX 25, registration number 67089, or ESTRADOT 25, registration number 338056; see Schedule 1 items). Substitution permission only applies to those listed items pursuant to s 5.

2. Determine substitutable product eligibility

• Ensure the proposed substitutable medicine meets the Schedule 1 column 3 definition for the relevant item: it must be a registered medicine or have a s 19A approval; contain estradiol as the sole active ingredient; be manufactured as a patch; and release the specified micrograms per day (for example, 25, 50, 75 or 100 mcg/day where stated).

3. Confirm both specific and general permitted circumstances

• Specific circumstances: Follow Schedule 1 column 5. For example, advise the patient (or agent) of the number of dose units required (based on column 4 equivalence) and provide suitable instructions for administration. If substituting with a paragraph (b) product where relevant, ensure the paragraph (a) product is not accessible and dispense patches of the same brand (Schedule 1 column 5 for items 2-4).
• General circumstances: Satisfy all Schedule 2 items:
  • Evidence of a valid prescription for the scarce medicine (Schedule 2 item 1).
  • Pharmacist lacks access to the scarce medicine (Schedule 2 item 2).
  • Prescriber has not indicated substitution is not permitted on the prescription (Schedule 2 item 3).
  • Pharmacist’s professional judgement that the patient is suitable (Schedule 2 item 4).
  • Dispensed amount results in an equivalent dosage regimen and duration (Schedule 2 item 5).
  • Patient (or agent) consents to receiving the substitutable medicine (Schedule 2 item 6).
  • Record the substitution at the time of dispensing (Schedule 2 item 7).
  • Follow the established procedure to notify the prescriber at or soon after dispensing (Schedule 2 item 8).

4. Calculating dose units

• Use Schedule 1 column 4 equivalence rules to calculate how many patches to dispense. For example, where a 50 mcg/day scarce patch maps to two 25 mcg/day substitutes, dispense two patches for each prescribed scarce patch, ensuring that the total regimen and duration remain equivalent (Schedule 1 column 4; Schedule 2 item 5).

5. Patient counselling and consent

• Provide the dose-count explanation and “suitable instructions for administering” per Schedule 1 column 5. Obtain and document explicit patient consent to the substitution (Schedule 2 item 6). Consider developing standard counselling scripts that address application site, adhesion, rotation, disposal and what to do if a patch detaches.

6. Record-keeping and evidence

• Make contemporaneous records at the time of dispensing: record the name of the scarce medicine on the prescription, the substitutable product dispensed (including brand and batch if applicable), the dose-equivalence calculation, the fact that the scarce product was unavailable, the patient’s consent and the counselling provided (Schedule 2 item 7). Ensure the record is timestamped and retained in accordance with general pharmacy record retention obligations.

7. Notification of prescriber

• Have an established, documented procedure to notify the prescriber “at the time of, or as soon as practical after, dispensing” (Schedule 2 item 8). Notification should include the name and strength of the scarce medicine prescribed, the substitutable product dispensed, the number of patches supplied and confirmation that the patient consented.

8. Stock management and “access” evidence

• Document attempts to obtain the scarce medicine to support a finding of “does not have access to the scarce medicine” (Schedule 2 item 2). Maintain supplier communications, backorder notices, and internal stock checks to justify substitution decisions.

9. Brand rules for multi-patch substitution

• Where Schedule 1 requires dispensing patches “of the same brand” when using paragraph (b) substitutes (see Schedule 1 column 5 items 2-4), ensure the two patches supplied are from the same brand and record brand details. Only substitute with the paragraph (b) product when the paragraph (a) alternative is not accessible (Schedule 1 column 5).

10. SOPs, staff training and system changes

• Update Standard Operating Procedures and train pharmacists and dispensary staff on the dual-condition test, dose-equivalence logic, consent and counselling scripts, record fields, and prescriber-notification process. Configure dispensing software to capture the required data at the time of dispensing and to produce audit trails.

11. Professional judgement and medical exceptions

• If the pharmacist reasonably determines the patient is unsuitable for substitution (Schedule 2 item 4), do not substitute. Document reasons for unsuitability (for example, allergy to an excipient, adherence concerns, or potential interactions).

12. Liaise with prescribers and sponsors

• Where substitution will involve significant changes to regimen or cost to the patient (for example doubling patch count), consider discussing alternatives with the prescriber where practicable, documenting any pharmacist-initiated contact attempts.

13. Privacy and data protection

• Ensure that notifications to prescribers and internal records comply with applicable privacy and data security obligations; the instrument does not address privacy protections.

14. Review and audit readiness

• Maintain an audit file with samples of contemporaneous records, supplier communications and notification confirmations to demonstrate compliance in the event of regulatory review.

Following these steps aligns pharmacy practice directly with the instrument’s requirements: substitution permitted under s 6 only after satisfaction of both Schedule 1 specific circumstances and all Schedule 2 general circumstances, recording at the time of dispensing (Schedule 2 item 7), and notifying the prescriber under an established procedure (Schedule 2 item 8). Ensure policies reflect the time-limited nature of the instrument (expires 28 February 2027; s 7-8).