Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Pharmaceutical Society of Australia

The submission period for this review commenced on 2 April 2013.

Page last updated: 09 May 2013

Summary


Please provide a short summary, up to half a page, outlining the key points of your submission.
PSA's key recommendations from this submission are as follows:

a. Include a mandatory requirement for a regulatory impact statement to be prepared for all rescheduling proposals.
b. Include a mandatory requirement for applicants to incorporate in their rescheduling proposal, an implementation plan which is appropriate for the likely needs of health professionals and consumers in the event of a positive rescheduling decision.
c. Enhance information provision and access through:
  • judicious use of an inclusion list of all substances listed/affected/considered when reference is made to a group or class of substance;
  • enabling access (with release of pre-meeting notice) to the complete application (or similar) for all rescheduling proposals including information on the purpose, rationale and evidence-base supporting the rescheduling;
  • timely post-meeting release of a summary of scheduling decisions to facilitate communication and implementation of outcomes;
  • a less wieldy record of reasons document;
  • regularly incorporating amendments to the Poisons Standard and reconsidering the method of listing by exception.

d. Consider scheduling matters in the context of other regulatory activities and outcomes to prevent inconsistencies in practice for consumers and health professionals.
e. Establish a pharmacovigilance program for recently rescheduled substances.
f. Develop explicit criteria for substances to be classified as 'unscheduled' (rather than be considered exempt from scheduling requirements because a substance does not meet listed factors for any (other) schedule).
g. Report on the types of circumstances when the Secretary has exercised power under subsection 52D(2) on own initiative.
h. Consider a less onerous process for the scheduling secretariat to release public submissions.

Specific areas you may wish to address


Respondents should refer to the document Review of Arrangements for Scheduling Substances - PRT 6.3 of the Therapeutic Goods ACT 1989, Information for stakeholders, Part A - What this review is about for more detailed information about these questions.

You are not required to respond to every question.

Objectives of the amendments:


1. Have the new arrangements met the objectives of providing a more flexible, efficient and effective operation of the scheduling of substances? Have the objectives of the amendments been met?

PSA believes there is scope for further amendments or enhancements to enable more efficient and effective operation of the scheduling of substances. Further details are provided at relevant places in this submission.

2. Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.

Please see our response under Question 10.

3. In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?

We have provided a number of suggestions for improvement throughout this submission.

System of access controls for goods containing scheduled substances


Section 52E Secretary to take certain matters into account in exercising powers


4. Are the matters to which the Secretary must have regard when amending the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?

The matters (described under Section 52E of the Act) which the Secretary must take into account when amending the Poisons Standard generally relate to the inherent characteristics of the substance under consideration (eg. risks and benefits) and the presentation of the substance/product (eg. packaging and labelling).

Other relevant matters are presumably captured through subsection (1)(f):

any other matters that the Secretary considers necessary to protect public health

however, this is clearly at the Secretary's discretion and PSA is not aware of the types of matters that have been considered under this clause.

PSA believes there is scope for the scheduling process to be significantly enhanced by including a requirement for a regulatory impact statement (or similar) to be included. It is disappointing that this is currently not required even though rescheduling decisions will have a flow-on effect and in most, if not all, cases impact on pharmacy practice and will always affect health consumers.

5. Is the process whereby the Secretary has regard to the Scheduling Policy Framework, the recommendations or advice by the ACMS and/or ACCS or another relevant committee or expert clear and transparent? If not, how could the arrangements be improved?

The process described is relatively clear.
However, PSA believes it would be useful to be able to access information on the types of circumstances under which the Secretary may exercise a power under subsection 52D(2) on the Secretary's own initiative. This would provide greater transparency which we believe is warranted given the power vested to the Secretary.

6. Is the Scheduling Policy Framework helpful in understanding the application and review process? If not, what amendments would you suggest?

(a) Exemption from scheduling. PSA has previously suggested that the Scheduling Policy Framework could be improved if criteria are developed for substances to be exempted from scheduling requirements. PSA believes that granting an exemption from scheduling requirements should only occur if a substance meets designated criteria for an 'unscheduled' class. We believe this would strengthen the scheduling system over the existing model which is that a substance is exempt from scheduling if it does not meet the listed factors for any schedule.

Pharmacists have generally noted that the section titled 'Schedule 1' in the SUSMP remains 'intentionally blank' and could be a logical place to accommodate the listing of unscheduled substances.

(b) Education program for health professionals and consumers. Under the previous arrangements, the NDPSC guidelines for applications included a statement that 'if a program for education of distributors, professionals and users or consumers is proposed then details should be provided'. PSA previously suggested that this clause did not adequately facilitate education programs for these audiences because the wording was such that applicants were encouraged to provide details to the Committee, only if they had a proposal. In other words, it would have been less onerous to simply state that no such plans existed.

When the new Scheduling Policy Framework was being developed, PSA expressed significant concern that the equivalent section in the consultation paper at the time had been shortened and did not include any statement about the applicant's requirements for education programs.

PSA accepts that applicants (usually sponsor companies) will often, if not always, submit rescheduling applications for commercial reasons. However, from a quality use of medicines perspective PSA is firmly of the view that the applicant must give consideration to implementation issues should their application result in a rescheduling of a substance. The applicant must be able to demonstrate they have appropriately considered the impact of a rescheduling on health professionals and consumers.

This is an area where PSA can work in partnership with the applicant and regulator to provide professional advice and expertise in the context of implementation of a rescheduling decision. PSA has been involved in a number of successful initiatives relating to scheduling decisions in partnership with government and industry. However, these types of initiatives tend to be rather ad hoc and therefore, we would welcome a more consistent process or approach.
In summary, PSA believes it should be mandatory for applicants to:

(i) include information in their application about the likely impact the new schedule will have on health professionals and consumers;

(ii) propose an education and communication program for health professionals and consumers to facilitate appropriate use, quality use and minimise any possible misuse of the product; and

(iii) demonstrate an ongoing commitment to work with relevant stakeholders.

We strongly believe these requirements should be integrated into all rescheduling applications.

Outcomes of administration


52A Definition


7. Does the definition of 'substance' appropriately reflect the substances that may be considered for scheduling by the Secretary and which the committees may consider and advise the Secretary on? If not, how should the definition be amended? What would be the material impact on your organisation if it were to be amended in this way?

Although PSA believes the current definition is generally acceptable, it is not clear whether it adequately covers instances when a group of multiple substances are considered as a whole. We believe there is merit in including a term which refers to a 'group' of similar substances. The following are two example illustrations.

(a) Listing in the SUSMP. For example mestranol, oestradiol, oestriol and stilboestrol have individual entries under Schedule 4 but they would also be captured through the entry for 'oestrogens'. We believe this method of listing may also be used to include substances that may not yet be known or registered but are likely to have similar properties or activity to their parent compounds which are already listed. This appeared to occur in Committee considerations of analogues of phosphodiesterase type 5 inhibitors (eg. sildenafil, vardenafil, tadalafil). For any entry representing a class or group of substances, we believe there should be some form of cross-reference between the class and the individual substances (where known) included in that entry.

(b) Proposal to amend the Poisons Standard. We cite a recent example where one of the proposed amendments for consideration by the ACMS at the March 2013 meeting was 'to reschedule benzodiazepines from Schedule 4 to Schedule 8'. No other information was provided with this invitation for public comment. We re-iterate that the definition of 'substance' may be adequate under Section 52A of the Therapeutic Goods Act 1989 (the 'Act') but when multiple substances are grouped together for consideration by the ACMS or for other administrative processes, PSA believes greater clarity is needed regarding which specific substances the matter relates to. This could be achieved through cross-referencing, footnotes, or inclusion under Section 52A of a separate (new) term with accompanying definitions which refers to a group or family of similar substances.

Section 52B and Section 52C and Section 52CA Functions of the ACMS and ACCS and associated Regulations


8. Are the establishment, functions and membership of the ACMS and/or ACCS appropriately described in the Act? If not, how could they be better described? What would be the material impact on your organisation if the Act were amended in this way?

PSA is not aware of any problems in relation to how the establishment, functions and membership of the ACMS/ACCS are described in the abovementioned sections of the Act.

9. Have the new arrangements for the ACMS and/or ACCS met the objective to provide for more flexible, efficient and effective operation of the scheduling of substances? Have the objectives of the amendments been met?

PSA understands that one of the difficulties experienced by the NDPSC was the significant workload. Although we are unable to provide direct comment, anecdotally we do believe the separation into two committees and refinement of the expertise required for each committee have resulted in less unnecessary burden to enable more appropriately focused consideration of agenda items.

10. Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.

PSA's involvement with the scheduling process is generally two-fold: (a) making submissions in response to items which are listed for public comment; and (b) guiding and supporting the pharmacy profession in the implementation of the outcomes of rescheduling decisions. Our work therefore is usually constrained by the timelines which are set for the processes linked to the operation of the ACMS as well as amendments made to the Poisons Standard.

The current timeline structure does impact, for example, on our ability to consult with our constituents and members on any submission we make on their behalf. While this can vary from meeting to meeting, when a forthcoming meeting agenda consists of many rescheduling proposals for human medicines, the short period available for consultation within our organisation and membership can be challenging.

More critically, the long post-meeting time period before the formal release of rescheduling decisions and, consequently, the short timeframe to prepare for implementation is a significant disadvantage for the pharmacy profession.
We made several suggestions in the past to help improve on these issues, however they have not been evident in the new arrangements. We therefore re-iterate these points in this submission.

11. In terms of the operation of the committees do you have any suggestions how the arrangements can be improved?

PSA is not in a position to provide comment on the operation of the committees.

Section 52D Amendments to the Poisons Standard and associated Regulations


12. Is the process by which the Secretary makes amendments to the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?

Medicines scheduling has a core and direct impact on the professional practice of pharmacists. The process, through which applications are lodged to amend the Poisons Standard and decisions made by the relevant Committee, is reasonably tedious for the average grass roots practitioner to track consistently. As the professional organisation for all pharmacists, PSA acts as the intermediary body ie. we make submissions to regulators on behalf of the profession and communicate outcomes of rescheduling and other regulatory matters to pharmacists.

The process by which amendments are made to the Poisons Standard may be described adequately. However, we believe there is scope to improve how effective the process is. Our suggestions are provided under Questions 19 and 21.

13. Is the process whereby the Secretary makes amendments to the Poisons Standard clear and transparent? If not, how could the arrangements be improved?

PSA believes there is scope to improve the processes in making amendments to the Poisons Standard. Our views are further articulated under Questions 19 to 21.

14. How have the new administrative arrangements benefited your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative data for the following two periods: June 2008-June 2010 and October 2010-October 2012.

Overall, PSA has not seen any improvements resulting from the new administrative arrangements for proposals to amend the Poisons Standard. See later in this submission.

15. Have the new administrative arrangements had any negative impact on your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative costs for the following two periods: June 2008-June 2010 and October 2010-October 2012.

Any negative impact on PSA as an organisation, or the pharmacy profession more broadly, are not necessarily due to the new administrative arrangements. They may arise in areas where there is a lack of substantive change from the previous arrangements. These are described in further detail under Questions 19 to 21.

16. Have the new administrative arrangements had an impact on the time taken between your proposal to amend the Poisons Standard and the final decision to amend (or not) the Poisons Standard? Where possible, please provide comparisons in timeframe relevant to decisions made during the following two periods: June 2008-June 2010 and October 2010-October 2012 and how they have impacted on your organisation or sector.

PSA generally does not provide proposals to amend the Poisons Standard. We have provided other relevant comments below.

Section 52EAA Application for amendment of the Poisons Standard


17. Are the administrative arrangements for applications (including the template application form) to be made to the Secretary sufficiently clear and transparent?

No comment

18. What would be the material impact on your organisation if the Secretary mandated that all applications for amendment of the Poisons Standard be submitted electronically (and on the template application form)?

No comment

Division 3D of the Regulations Proposed amendments to the Poisons Standard


19. Have you had any difficulty accessing notices regarding the intention of the Secretary to amend the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?

The notices for proposed amendments to the Poisons Standard are easily publicly accessible. However PSA's greatest concern is the lack of detail provided on the listed proposals. This is a significant and ongoing concern which we have expressed consistently for over a decade. The new scheduling arrangements have not altered this in any way and therefore remain ineffective. We understand indirectly through interactions with the scheduling secretariat that the legislation precludes the release of any further information.

By way of example, an item listed for the March 2013 ACMS meeting was:

Proposal to reschedule benzodiazepines from Schedule 4 to Schedule 8.

When an invitation for public comment is issued, PSA firmly believes it is inappropriate to expect the respondent to do so without information that adequately explains the purpose of, and justification for a proposal. We do not regard this as an open and transparent public consultation process. Presentation of the rationale or evidence base which underpins any proposal must surely be necessary and warranted. Without this vital information and relevant context, it is not possible to provide appropriate consideration of the issues which may impact on public safety and quality use of medicines.

The benzodiazepine case above was of particular concern to PSA as the proposal was substantially more restrictive than current and longstanding arrangements (ie. Schedule 4 to Schedule 8) and further, had the potential to apply to the entire class of substances rather than a single substance.

PSA does understand and accept that where a pharmaceutical company has applied for a reschedule there may be commercial-in-confidence information. However we would strongly refute that this means that no information can be provided. If a sponsor is seeking a reschedule and has provided their findings or justification of the likely positive health outcomes, we need to have access to that new information and have the opportunity to assess the proposal.

As a minimum, PSA would request consideration of an arrangement similar to that adopted by Medsafe in New Zealand for items considered by the Medicines Classification Committee (MCC). It is usual for the agenda items for forthcoming MCC meetings to be published on the web site and a summary of background information provided for each item. Where the item originates from a company (or other) submission, the complete application document is made available through a hyperlink. PSA believes this type of arrangement is appropriate and must be implemented as a high priority.

20. Have you had any difficulty accessing public submissions received in response to a proposed amendment of the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?

PSA has not experienced any difficulties in accessing public submissions which are made available on the TGA web site.
We understand the need to 'vet' these submissions before making them publicly available, however, we do find it somewhat unusual with the steps taken to black out from all parts of each submission any information which can identify the author (individual or organisation). This must be a considerable burden for the scheduling secretariat.

As an organisation that regularly makes submissions on scheduling matters as well as to other regulatory and government bodies, we would be happy with an alternative arrangement whereby prior permission to publish is sought with any confidential information marked for exclusion at the time by the submitter.

21. Have you had difficulty accessing decisions made by the Secretary to amend the Poisons Standard and/or the reasons for the decision and/or the date of effect of the decision? If so, what was that difficulty and how did it affect your organisation or sector?

In 2009, PSA commented on the then proposed new arrangements for the scheduling of medicines and poisons. Many of our recommendations then related to how we believed the usefulness and timeliness of scheduling decisions could be improved to assist a smooth and informed process for pharmacists thereby delivering benefits and timely access to consumers.
Disappointingly, most of these suggestions have not been implemented and therefore PSA continues to have concerns, particularly with regards to the communication of scheduling decisions.

(a) Communication of outcomes. Although the 2009 consultation suggested that outcomes of scheduling decisions would be published on the TGA web site 'as soon as practicable after a decision is made', no other detail was provided about how this might be implemented in practice. We felt this could reflect the status quo with no resulting changes, and this has largely been our experience.

PSA suggested that the timeframe and mechanism through which scheduling meeting outcomes and the reasons for decisions are made public needed to be reconsidered. This is in fact critical for our organisation as we have a role in supporting pharmacists who need to ensure responsible and accountable control and supply of the substances in accordance with any new scheduling decision.

PSA therefore strongly advocates for a summary of the outcomes of a scheduling meeting to be published on the TGA web site within a week of an ACMS meeting. We envisage this could be similar to the type of post-meeting summary reports published by the Pharmaceutical Benefits Advisory Committee. This will facilitate communication to all stakeholders including pharmacists and assist PSA (and other relevant stakeholders) to commence preparation of professional practice support materials for implementation in a timely manner. If this arrangement is in place, we believe the publication of the reasons for decisions and the formal gazettal of outcomes can follow in a timeframe similar to what occurs currently.

(b) Implementation of scheduling decisions. It is our experience that the timeframe to implement the required changes as a result of a scheduling decision is not always adequate. As explained above, this could be improved through the publication of a summary of outcomes shortly after the meeting.

PSA also has a primary role and responsibility to support practitioners in the implementation of any scheduling change. PSA's 'support' needs to be tailored to the final rescheduling outcome and some of the factors considered include: direction of reschedule (eg. up-schedule or down-schedule); extent of the reschedule (eg. Schedule 4 to Schedule 3, or Schedule 2 to unscheduled); other outcomes (eg. Appendix H listing, amended warning statement); nature and type of the affected substance; affected product range in pharmacies; and other products with similar indications. Thus, PSA's initiative can range from issuing a simple communication through to developing a new education or resource kit which could include training for pharmacists and non-pharmacist staff, practice support tools and consumer materials.

The lack of adequate time to implementation is particularly relevant to scheduling decisions which significantly impact on the professional practice of pharmacists, for example, rescheduling from Schedule 4 to Schedule 3. In these cases, while pharmacists are already familiar with the product through supply as a prescription (Schedule 4) item, the new Schedule 3 supply arrangement will have different implications for consumers and their interaction with pharmacists. From a pharmacist's perspective, this may include more detailed consideration of the person's health status, making appropriate assessments prior to supply, responding to consumer requests in an appropriate manner, providing education and training to pharmacy staff for appropriate referral, and other in-pharmacy (premises) considerations.

(c) Record of reasons. Although the publication of a Record of Reasons after each meeting can provide important information for the basis of a scheduling decision, PSA has always commented that the document is unwieldy in length and detail. It would be preferable to have a more succinct and informative document to replace the Record of Reasons and to also implement a new post-meeting summary of outcomes document (as suggested under part (a) above).

(d) Poisons Standard. The legislative nature of the Poisons Standard does pose limitations to its use in practice by pharmacists (and presumably other health professionals who may need to access scheduling information) due to the elaborate language and expressions as well as the method of presentation. PSA aims to assist practitioners by presenting the information in a way that facilitates understanding and responsible practical application. However, several factors contribute to the confusion.

Listing by exception. It is often the case that a substance is listed in the Poisons Standard under a particular schedule but associated with a list of 'exceptions'. For example the entry for aspirin in Schedule 2 of the Poisons Standard 2012 is as follows:

ASPIRIN except:

(a) when included in Schedule 4, 5 or 6;

(b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when:
(i) enclosed in a primary pack that contains 12 or less such powders or sachets of granules; and
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(c)in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325 mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500 mg or less of aspirin; and|
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack containing 100 or less tablets or capsules, each containing 100 mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

This is clearly very difficult for health practitioners to navigate through.

Unincorporated amendments. It is somewhat of a nuisance that a consolidated Poisons Standard is only issued once a year and the amendments remain unincorporated. It is a burden to have to trawl through all of the amendments in order to obtain the complete and up to date information. It is not clear to us whether this is a characteristic common to all legislative instruments.

There is added complexity due to the numbering of amendments relating to when they are issued, rather than being a sequentially numbered set of amendments issued under the name of the parent standard.

Finally, reference is also made to the 'SUSMP' which uses yet another numbering system since it originates from the 'first Poisons Standard' as defined under Section 52A of the Act.

To illustrate these points, as an example, the current complete standard consists of a consolidation of the following six documents:

Poisons Standard 2012 (this provides the SUSMP No. 3)
Poisons Standard Amendment No. 2 of 2012
Poisons Standard Amendment No. 3 of 2012
Poisons Standard Amendment No. 4 of 2012
Poisons Standard Amendment No. 5 of 2012
Poisons Standard Amendment No. 1 of 2013


In summary, PSA would welcome consideration of possible changes to the way in which scheduling decisions are communicated publicly or otherwise made available to health professional organisations and practitioners.

Avenues for review


22. What has been the impact on your organisation or sector of the lack of an administrative review process, if any? Please provide a specific example.

No comment

23. Should there be avenues for review of decisions made by the Secretary and by the committees? If so, what avenues for review of decisions should be included and why?

No comment

Other matters


24. In addition to the above, have you realised any other benefits or adverse impacts as a result of the amendments? If so, what were they and how did they affect your organisation or sector?

PSA believes it is essential that scheduling systems and controls are regularly monitored in the context of other associated regulatory controls for therapeutic goods.

One example we provide here is the set of decisions which affected cough and cold medicines (covering numerous substances) for children last year following a comprehensive TGA review which mirrored similar reviews globally.

Various experts and TGA committees were involved in considering all aspects (eg. safety, risks and benefits) of these substances. One component of this review related to scheduling and it was deemed that the existing scheduling of all of the substances/products was appropriate. Therefore the availability of these products through pharmacies and/or general retail outlets (depending on the schedule) remained unchanged. However, through other parts of the review several recommendations/restrictions were issued, mostly based on the age of the patient, and these were communicated to health professionals and consumers.

Although pharmacists responsibly and judiciously implemented these restrictions when these medicines were supplied through pharmacies, the same did not (and could not be expected to) occur in outlets such as supermarkets. This led to many instances of consumer confusion and potentially impacted on patient safety. It also created situations where consumers believed the pharmacist had made an error by not supplying a particular cough and cold medicine (or had deliberately withheld supply) as the consumer was able to purchase the same product without intervention (or appropriate advice) from a supermarket.

This type of inconsistency is entirely unacceptable from the perspective of pharmacists and potential patient safety issues.

25. What key measurable performance indicators do you think are important for monitoring the efficiency and effectiveness of the system for the scheduling of substances? How should the relevant data be collected? How often?

(a) Post-rescheduling monitoring. Rescheduling of a substance can have an impact on many factors including consumer access and cost, professional practice of pharmacists, available product range and advertising. While it may not be possible to monitor all affected issues, PSA is particularly concerned that there is no formal system to monitor or evaluate the outcomes of implementing a rescheduling decision from a perspective of patient safety and quality use of medicines.

The purpose or reason behind rescheduling applications can be complex and diverse as they could be driven by commercial decisions of the applicant or be due to public health and safety interests. However the key issue is that all applications for rescheduling must be accompanied by relevant data or evidence to support each case. It should not be unreasonable to expect that the outcomes of a rescheduling have been positive and met the initial objectives outlined in the application.

PSA would suggest therefore that the establishment of a pharmacovigilance program is warranted for substances which have been recently rescheduled. We would not necessarily expect this to be an evaluation of medium or long term health outcomes but could perhaps have a primary focus on immediate patient safety issues. This might include close monitoring of possible adverse events that could be attributed to the rescheduled substance or any unintended consequences (eg. trends of misuse of a different substance in place of the rescheduled substance). We also strongly believe that the impact on professional practice of pharmacists is another key consideration as this can help inform whether the continuation of the recent rescheduling is workable and if not, there is opportunity to refine and resolve any practice setting issues. Information garnered could also inform future similar rescheduling applications.

(b) Proposed Appendix N. In the 2009 consultation paper for the new Scheduling Policy Framework, the creation of Appendix N was flagged as a means to facilitate the listing of substances shown to pose a significant risk of diversion to the illicit market. The public health benefits of recording the supply of these substances had reportedly been adequately established to warrant this proposal.

While supportive of this proposal, PSA felt the criteria may be too restrictive and suggested broader consideration around the use of such an appendix. As an example, we suggested the new appendix could be linked to the establishment of a comprehensive national electronic data system to enable the collection of robust data on the quality use and possible misuse of various substances. We believe that such a system, once established, will provide useful and necessary information to guide decision-making on scheduling and other associated issues in the future.

PSA would be keen to be informed about the status of the proposed Appendix N and would welcome the opportunity to contribute to any implementation plans.

26. Are there any other matters relevant to the terms of reference for this review which you would like to make the panel aware of?

As a result of Recommendation 5 of the Galbally Report which relates to 'Medicines schedule and associated professional support', several research projects have been undertaken (not by PSA) and a number of reports published around risk assessment and evaluation of the standards of access control of S2 and S3 medicines by pharmacists. The National Coordinating Committee on Therapeutic Goods (NCCTG) has acted as the intermediary body to receive research reports, compliance data and information from the pharmacy profession and to subsequently report to the Australian Health Ministers' Conference. With the NCCTG no longer in existence, PSA is uncertain about future work and reporting in this area.