Amending the Poisons Standard

An application to amend the Poisons Standard may be made to the Secretary under section 52EAA of the Therapeutic Goods Act 1989.

There are a number of different pathways to produce a decision by the Secretary to amend the Poisons Standard.

The applicant or proposer

Applications to amend the schedules and appendices may be made by:

• individuals
• stakeholder organisations
• government bodies

Proposals to change the regulatory provisions in Parts 1 - 3 (either new or amended) may originate from the:

• jurisdictions
• Secretary
• relevant regulator

Amendments initiated by the Secretary

Under section 52D(3) of the Therapeutic Goods Act 1989 the Secretary has power to amend the Poisons Standard on their own initiative. A decision to exercise this power would be made on the basis of information that, in the Secretary's opinion, supports an amendment to the Poisons Standard.

This includes, but is not limited to, an emergency scheduling decision needed to address an emerging public health issue (e.g. availability of a new psychoactive substance) or inclusion of a substance in Appendix K (i.e. sedation warning required). This information may be provided to the Secretary by a member of an advisory committee, the Department, or by AHMAC.

When the Secretary decides to amend the Poisons Standard on his or her own initiative, this is a final decision. The Poisons Standard is then amended in accordance with the procedures required to amend a legislative instrument.

However, the Secretary may decide to commence a new process by referring this amendment to an advisory committee for consideration and public consultation. In this case, no application for scheduling is required.

Application or proposal?

In some cases, a scheduling proposal will be made by the regulator as part of the registration process.

Chemical applications and proposals

Applications relating to agricultural and veterinary chemicals will, generally, be referred by the APVMA as part of their evaluation and product registration process. Alternatively, applicants may apply directly through the Chemicals Scheduling Secretariat.

In certain circumstances, an industrial or domestic chemical may be referred for scheduling based on the outcome of a risk assessment undertaken by the Department of Health.

Medicine applications and proposals

For new prescription medicines that are new chemical or biological entities, the registration applicant does not need to apply for scheduling: the regulator will make a scheduling proposal as part of the registration process.

For all other applications related to medicines, applicants apply directly through the Scheduling Secretariat.

Acceptance of the application

The Secretary will only accept your application if:

• it is in a form approved by the Secretary
• it is supported by sufficient information

The form includes details of information requirements, and applicants are advised to refer to details in the Scheduling policy and this handbook when preparing their application.

The scheduling factors to be addressed by applicants and considered by the Secretary, are part of the Scheduling policy.

The applicant is also required to submit a summary for publication outlining the nature of the scheduling proposal, including the name of the substance, the proposed schedule, and a brief description addressing the relevant scheduling factors. Failure to do this may result in the entire scheduling application (less commercially sensitive information) being published in the call for submissions.

Decision to refer to ACMS or ACCS

The Secretariat will receive and manage applications in accordance with the information below. However, the final decision regarding referral to advisory committees and finalisation of decisions is made by the Secretary.

To identify the likely scheduling path, please refer to the appropriate decision tree:

• Decision tree for the medicine scheduling process
• Decision tree for the chemical scheduling process

These decision trees are intended to illustrate the potential process for the medicines and chemicals and assist stakeholders in managing their applications.

Changes to Parts 1, 2 or 3

Changes to Parts 1, 2 or 3 will be undertaken in consultation with the states and territories. The Secretary may also wish to consult with the advisory committees.

The Secretary will refer an application to amend an existing substance in the introduction or Parts 1, 2 or 3 of the Poisons Standard, to the relevant advisory committee for advice.

Referral of amendments to Parts 1, 2 or 3 of the Poisons Standard will be referred to AHMAC at the Secretary's discretion.

Minor administrative amendments to the introduction or Parts 1, 2 or 3 may be made by the Secretary without referral to AHMAC or an advisory committee.

New prescription medicine

Substances evaluated by the TGA as part of the registration process for a new chemical or biological entity (Schedule 4) will not routinely be referred to a scheduling advisory committee.

If a new prescription medicine application results in a proposal for an appendix entry, or inclusion in Schedule 8, the TGA will refer this to ACMS for advice due to the significant implications for State and Territory regulation, monitoring and compliance activity.

New therapeutic chemical or biological entity: scheduling process diagram

New (non-therapeutic) chemical substances

New chemical scheduling proposals to include a new substance in Schedule 7 will be referred to the ACCS, given the compliance activities associated with in such applications.

Other new chemical scheduling proposals may be referred to the ACCS unless:

• the proposal is straight forward and the chemical has been subject to the APVMA registration process
• the proposal relates to a chemical with similar toxicological and use profiles to a chemical that is already scheduled and the safety and use profiles do not differ significantly from the already scheduled substance

Rescheduling

Rescheduling proposals (i.e. where the substance has previously been scheduled) are to be referred to the relevant scheduling advisory committee for advice. An exception to this may be appropriate if:

• the application relates to reclassification of a second (or subsequent) substance in a class where the safety and use profiles do not differ significantly from a substance of that class that has already completed a rescheduling process from, and to, the same schedules
• the proposal relates only to a new or amended entry in Appendix K of the Poisons Standard

Applications not referred to an advisory committee

When the Secretary chooses not to refer the proposed amendment to an advisory committee, the Secretary must follow the process detailed in Subdivision 3D.3 of Part 6 of the Therapeutic Goods Regulations 1990.

Where the decision is:

• to amend the Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision, taking into account the scheduling factors in section 52E of the Therapeutic Goods Act 1989
• not to amend the Poisons Standard in the manner set out in the application, the Secretary must make an interim decision. The Secretary must provide the applicant with the reasons for the interim decision and provide an opportunity to make a written submission in response. After considering any such submission from the applicant, the Secretary must make a final decision, taking into account the scheduling factors in section 52E of the Therapeutic Goods Act 1989

Scheduling decisions not referred to a committee: process diagram

Process when seeking advice from ACMS or ACCS

Where an application is referred to ACCS and/or ACMS, the Secretary is required to follow the process set out in subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990.

Scheduling decisions referred to an advisory committee: process diagram

Consultation phase 1

The Secretary must publish a notice on the TGA website outlining the proposed amendments to the Poisons Standard to be considered by the advisory committee(s) along with an invitation for public submissions. The summary provided by the applicant will also be published.

The consultation period will be open for at least 4 weeks.

• The Secretary may proactively seek advice from relevant bodies such as specialist medical colleges, health practitioner associations or professional and industry associations.
• The Secretary will make sponsors and other organisations that might be significantly affected by a scheduling proposal aware that a notice inviting public submissions has been published.

Committee advice

The relevant scheduling advisory committee(s) will consider the proposal together with the submissions received from the consultation, and will then provide advice or a recommendation to the Secretary.

Interim decision

An interim decision is not required if no public submissions are received in consultation phase 1 [Regulation 42ZCZO(1)].

If an interim decision is required, the Secretary must publish the interim decision and the reasons for the decision and include a call for further submissions in relation to the interim decision.

This publication will include the recommendations to the Secretary from the advisory committee and the reasons for the recommendations.

Consultation phase 2 (where relevant)

Following publication of an interim decision, there is a further consultation period of up to 4 weeks.

Final decision

The Secretary will take into account the following when making a final decision after an interim decision:

• the original application
• any risk-benefit assessment undertaken by the applicant if the proposal relates to downscheduling of a medicine
• relevant submissions received in any consultation phase, either from the applicant or the public (Regulation 42ZCZQ)
• any advice or recommendation of the advisory committees
• any guidelines of the Australian Health Ministers' Advisory Council

The Secretary may in making the final decision:

• confirm the interim decision
• vary the interim decision
• set the interim decision aside and make a new decision

Appealing the final decision

Scheduling decisions under subsection 52D(2) are legislative in character as they determine the future lawfulness of conduct as provided for under the Act and the Regulations, such as in relation to advertising, as well as State and Territory legislation. Changes to the Poisons Standard alter the content of the law, and have the indirect effect of imposing or varying obligations or rights. The Federal Court in Roche Products v National Drugs and Poisons Scheduling Committee [2007] FCA 1352 held that a decision by the NDPSC to amend the Poisons Standard was legislative in nature and the Court gave several reasons to support that decision which remain applicable.

As scheduling decisions are legislative in character, they cannot be the subject of an appeal under the Administrative Decisions (Judicial Review) Act 1977 in the Federal Court.

Scheduling decisions under subsection 52D(2) are not "initial decisions" which are open for reconsideration under section 60 of the Act, Therefore they are not reviewable by the AAT.

Reconsideration of substances from prescription to OTC classification

The following process has been developed to streamline and encourage the rescheduling of substances from Schedule 4 (Prescription Only) to Schedule 3/2 (Pharmacist/Pharmacy Only). The process is described below, and illustrated in the following flowchart.

1. Applications for re-scheduling are submitted to the Secretariat
   • These applications include the form approved by the Secretary, the proposed Over-the-Counter label, and proposed Required Advisory Statements for Medicine Labels (RASML) (new or existing statements).
2. As an application for rescheduling, it is expected that the proposal will be referred to the ACMS for advice. The public notice for first public consultation will include the proposed RASML statements.
   • The TGA will provide feedback on the RASML statements and the label to be included in the agenda papers for consideration by ACMS.
3. ACMS provides scheduling advice to the delegate, including advice on RASML and the proposed label. The advice may also include recommendations for Appendix M specifications.
4. Second public consultation - interim decision and proposed RASML statements.
5. Scheduling decision is finalised and the Poisons Standard is updated with the relevant implementation date.
6. Once the scheduling decision is finalised, the sponsor responsible for the scheduling application can submit an application to the OTC section of the TGA.
7. The market authorisation assessment for the sponsor responsible for the scheduling application will be completed as close as possible to the scheduling implementation date.

Parallel Process for pharmacy-only (S 2) and pharmacist-only (S 3) medicine applications and rescheduling: process diagram

Rescheduling of substances with potential Appendix M criteria

Applications to reschedule S4 substances to S3 with Appendix M criteria should generally follow the same procedure as for other substances. Early engagement with the Scheduling Secretariat is encouraged, noting that the Secretariat cannot anticipate the final decision of the Secretary. Only some applications to reschedule S4 substances to S3 will require Appendix M criteria.

There are seven Appendix M controls that may or may not be applied to S3 substances when considering rescheduling to S3 (see below). These controls are not prescriptive and some or all may be applied on a case by case basis, depending on the specific risks presented by the substance. These controls would be captured in a professional practice standard relating to the substance, with the Appendix M entry specifying that the substance must be supplied in accordance with that practice standard. Specific conditions applied would also be articulated in the final scheduling decision.

It is expected that applicants seeking to reschedule S4 substances to S3 with Appendix M conditions will conduct preliminary discussions with the pharmacy profession, to gauge interest in the supply of these goods over the counter. These discussions should include consideration of Appendix M conditions that may need to apply, and collaboration on the development of training or materials in support of those conditions. This would also require engagement to develop an appropriate professional practice standard that would encompass those conditions.

Appendix M criteria

One or several criteria may apply to a specific product and would be assessed by the Secretary.

1. Specific pharmacist training on the provision of the medicine

   A training package would be developed for the goods in question, covering the nature and use of the medicine, conditions being treated and alternative treatments where relevant, risk factors and guidance on when to refer for medical assessment. The training package would also provide guidance on the use of any supporting materials.

   Applicants are advised to work with an appropriate pharmacy body to develop a suitable training package and related support materials, for submission as part of their application to reschedule a substance to S3 with Appendix M conditions. Ideally, this would be done in tandem with the development of professional practice standards addressing expected Appendix M conditions. Accreditation of training through existing pharmacy profession pathways is desirable.

2. Suitability of the individual patient for supply of the medicine must be assessed by the pharmacist

   This condition provides the ability to require the use of clinical decision-making aids by pharmacists, such as questionnaires, checklists or guidelines, in determining the appropriateness of supply of the product as an S3, Appendix M good. This condition also provides the ability to specify, for example, that face to face interviews should be conducted and if appropriately private interview spaces are available and how frequently, whether internet or phone sales are not permitted, or that specific assessments, reasonably available in a pharmacy setting (e.g. blood pressure checks), must be conducted, where such conditions are considered appropriate for the substance in question.

3. Specific advice (patient education) is required on supply of the medicine

   This criterion covers information that may be considered essential to provide to patients, either verbally or in writing, at the time of supply. This could include information about side effects, drug interactions, health conditions that are contraindicated with the use of the substance, and education as to why supply might be restricted, the condition being treated and when to seek advice from a medical professional.

4. Limitations on duration/quantity and/or frequency of supply

   This criterion provides the ability to further refine the patient population and intended use of the substance, but specifying maximum durations of supply is beyond the existing capacity to specify indication, strength and quantity in the Poisons Standard. Any such restrictions would be tailored to the substance in question and incorporated into professional practice standards.

5. Need for formal diagnosis or periodic review of the condition by a medical practitioner

   This criterion would apply to substances where initiation of the medicine and/or changes to dosing or product should be best made after a diagnosis by a medical practitioner.

   Pharmacist supply is appropriate if the condition being treated can be stable for extended periods of time and ongoing supply of the medicine, once treatment has been established, does not require frequent monitoring by a medical practitioner.

6. Record keeping and information sharing

   Record keeping may apply to any substances for which Appendix M criteria were considered appropriate. In some cases, a record of supply of the goods by pharmacists (for example, through inclusion in dispensing software), would be considered a sufficient measure for record keeping purposes. The need for information sharing about the supply of a substance with other health practitioners (subject to patient consent) would be determined on a case by case basis, but could be achieved through use of My Health records.

7. Additional criteria may be imposed

   This criterion provides the flexibility for the Secretary to impose additional conditions on a substance to be rescheduled, if the need for a condition is identified that is not captured by the preceding criteria.