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Submissions received and TGA response: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)

30 July 2019

Between 25 February and 1 April 2019, the TGA sought comments from interested parties on a proposed framework for the use of Appendix M of the Poisons Standard. Appendix M is intended to include substances that have formerly been scheduled as Schedule 4 (S4) and thus have required a prescription by a medical practitioner, but if rescheduled to Schedule 3 (S3) could be dispensed by a pharmacist with specific controls in place that help appropriate use.

It is not intended that Appendix M controls would be routinely required for medicines that are rescheduled from S4 to S3; however, the addition of Appendix M controls might facilitate down scheduling of S4 substances in circumstances where additional safeguards may be required.

Submissions received

The TGA would like to thank individuals and organisations who provided submissions in response to the consultation. 27 submissions were received from government and statutory bodies, medical bodies, pharmacy bodies, industry, academia, consumer groups, and individuals.

All submissions that were not marked as confidential are now available in PDF format.

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Analysis of submissions and TGA response

Out of scope

Several submissions raised concerns or objected to the down scheduling of antimicrobial substances, in particular trimethoprim. One submission was received in favour of down scheduling two specific substances. However consideration of the merits of specific substances for down scheduling is not in scope for this consultation.

Some stakeholders expressed concern around the current legislative framework for scheduling, and the lack of national consistency in implementation stemming from inconsistent adoption of the Poisons Standard by different States and Territories. This issue was also out of scope for this consultation. Generally speaking, medical groups oppose the use of Appendix M while pharmacy bodies, academia, consumer groups and industry are favourable, although there remain points of concern. The establishment of Appendix M is existing policy (approved by the Australian Health Ministers Advisory Council (AHMAC)) and law (contained within a Commonwealth legislative instrument) and the consultation was not about the existence of Appendix M or otherwise, but rather on the guidance for Appendix M.

There are three main themes to opposition to Appendix M:

  1. The justification for Appendix M is to facilitate down scheduling of substances from S4. Some submissions claimed that there is no evidence that Australia is significantly out of step with international practice in regards to the types of medicines available over the counter, compared to on prescription and therefore Appendix M is unnecessary;
  2. Many of the additional controls proposed are already part of pharmacists' scope of practice and are therefore redundant; or, conversely, that,
  3. To dispense any substance requiring additional controls beyond those stemming from inclusion in Schedule 3 is beyond the scope of practice for pharmacists.

TGA response: Appendix M was endorsed by AHMAC and is currently provided for in the Poisons Standard and Scheduling Policy Framework. While it is acknowledged that some stakeholders have differing views on the value of an Appendix M, it is now an existing piece of legislation. There are a number of major medicines that are available over the counter in countries such as the UK and New Zealand but not in Australia.

Legislative and regulatory framework

While most respondents were satisfied with the idea that some criteria could be directly legislated by States and Territories and some might more appropriately be dealt with as professional practice standards, there was not unanimity as to the most appropriate framework.

TGA response: Based on the submissions provided, the most appropriate regulatory model appears to be that Appendix M will provide for supply of a substance as S3 in accordance with specified professional practice standards. Some States and Territories may be able to legislate for supply of Appendix M substances in accordance with specified professional practice standards if their legislative frameworks provided for this.

Specific criteria

There was broad agreement by stakeholders that the seven criteria proposed in the consultation are appropriate, although there were varied opinions on the mechanics of each:

  1. Specific advice by the pharmacist (patient education) is required

    Respondents were in general agreement with this criterion. Some submissions noted that they consider this is already part of expected pharmacist practice for supply of S3 medicines.

    TGA response: It is understood that there are already professional obligations on pharmacists to provide certain advice to patients when dispensing S3 medicines. The requirement for, and specific content of, this criterion will be assessed on a case by case basis.

  2. Specific pharmacist training on the provision of the medicine may be required

    Respondents are in broad agreement with the requirement for specific training on Appendix M substances.

  3. Additional conditions may be imposed at the Delegate's discretion

    Most respondents agreed with this criterion. Industry submissions emphasised that if additional conditions are to be imposed this should be done early and with appropriate levels of consultation with the applicant to enable them to prepare supporting resources.

    TGA response: Early engagement with sponsors will be necessary to support down scheduling applications with potential Appendix M conditions. However, this engagement will not take the place of due diligence on the part of sponsors in preparing their application.

  4. Suitability of individual patient for supply of an S3, Appendix M substance to be assessed

    Respondents were in general agreement with this requirement. Some submissions emphasised the need for this to include consideration of when not to supply an S3, Appendix M medicine in favour of other (including non-drug) therapies. Other submissions noted that such assessments should be required to be conducted face-to-face in a private interview setting, thus excluding supply via internet or mail order.

    TGA response: Issues will be considered on a case by case basis, and incorporated into professional practice standards for specific down scheduled substances where appropriate.

  5. Record keeping and information sharing

    All respondents were in agreement with this criterion, with some suggesting that real-time data collection and sharing should be explored. My Health records were considered by most parties to be appropriate but some felt this to be insufficient. Some submissions suggested that supply of Appendix M goods could be captured electronically in dispensing software.

    TGA response: While a requirement for data collection and sharing will be an option open to the Delegate when considering possible Appendix M conditions, it is expected that this would be rarely applied, as the level of resources required for this would usually be disproportionate to the risk presented by an OTC medicine.

  6. Limitations on duration, quantity and/or frequency of supply

    Opinion was more varied for this criterion, although overall most respondents support it. The issue of patients circumventing limitations by visiting several pharmacies was raised by some respondents. Others considered that limitations on duration of supply might be difficult.

    TGA response: There is currently capacity to limit supply by directly scheduling a substance to only be S3 in certain quantities, pack sizes etc. However, States and Territories have advised that limits on frequency and duration of supply are not within their power to legislate.

  7. Need for diagnosis or periodic review of the condition by a medical professional

    There is was support for this criterion. However, several submissions consider it would be difficult to implement due to uncertainty as to how a pharmacist would verify that a diagnosis had been made or that a review had taken place.

    TGA response: The need for this criterion would be considered on a case by case basis. Where warranted, it would be covered in professional practice standards.

Equity and access

The voluntary nature of pharmacist participation in required training for the supply of Appendix M medicines may result in a lack of pharmacists able to supply them in regional areas.

TGA response: It is beyond the powers of the Poisons Standard to require all pharmacists to supply a S3 Appendix M substance and thus complete training. It is expected that, as part of their initial deliberations, sponsors seeking to down schedule S4 goods to S3 with Appendix M conditions will conduct preliminary discussions with the pharmacy profession to gauge interest in the supply of these medicines as OTC products.

It is common for substances to be listed in more than one schedule in different forms, and this will remain an available option if a pharmacy did not have pharmacists trained in the supply of a class of S3 Appendix M medicines. Issues relating to the cost and PBS status of medications are not considered in scheduling decisions.

Competency and training provisions

There was general agreement that specific training prior to provision of Appendix M medicines is required. Industry bodies agreed that there should be training for each Appendix M good and argued that sponsors should play a key role in developing patient education and support materials.

Several respondents disagreed that sponsors should be the ones to develop Appendix M training materials. Pharmacy bodies noted that there is an existing training development and accreditation framework for pharmacy professionals and that development of Appendix M training will fit within this. It was also suggested that accreditation of training programs should be done by an independent body and that the Australian Pharmacy Council standards for accreditation are appropriate for this purpose. Some pharmacy bodies stated they believe their current competency framework is a sufficient basis for supply of Appendix M medicines.

TGA response: It is planned that sponsors will work with an appropriate pharmacy body to develop a suitable training package as part of their application to down schedule a substance. Ideally, this would be done in tandem with the development of professional practice standards and accreditation of training through pharmacy profession pathways would be highly desirable.

Scheduling processes and the application form

Some issues identified include: emphasise that addressing Appendix M criteria in the application form is optional and not required for all down scheduling applications; confirmation that a proposal to include an Appendix M entry with a rescheduling application should not be perceived as an admission that the scheduling factors for S3 cannot be met; queries as to how Appendix H will apply to Appendix M substances; and requirements for subsequent sponsors of a down scheduled substance would be with respect to development of "new" materials to support compliance with Appendix M conditions.

TGA response: It is only necessary for applicants to address Appendix M criteria in their submission if they reasonably expect that such conditions will be applied, and that this will not be the case for all down scheduling applications. Notwithstanding the inclusion of potential Appendix M criteria in an application to down schedule, the Delegate may still decide that a substance is suitable for S3 without Appendix M conditions. The inclusion or not of a substance in Appendix H will be considered as part of the down scheduling process.

For subsequent sponsors wishing to market S3 medicines with Appendix M conditions, they will be required to meet the same Appendix M criteria as for the original sponsor's goods. They will need to work with the pharmacy profession to ensure that their application and supporting materials adequately address the established Appendix M criteria for that substance.

Compliance and enforcement

Most submissions were satisfied with the model of compliance and enforcement proposed. Several supported the development of a program evaluation process, with varying opinions on when and how this should be managed.

TGA response: The TGA recognises the role of state and territory regulators and the Pharmacy Board in responding to breaches of legislation and professional standards respectively. The level of response (and attendant resourcing) should be proportionate to the risk presented, given these will be provided as OTC medicines.

A focus on appropriate record keeping will form part of the Appendix M criteria, which should provide a basis for program evaluation.

Next steps

Updated guidance on the use of Appendix M, including elements for consideration for each criterion, is provided in the Scheduling Handbook on the TGA website. Updates to the Application form will be implemented shortly.