Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - The Pharmacy Guild of Australia

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

Page last updated: 13 May 2013

Summary

While administrative changes implemented in 2010 have had little impact on the procedures of the Pharmacy Guild of Australia (Guild), we note that there appears to be a less risk-averse approach to scheduling decisions. We are concerned that there has been a push from industry for the de-scheduling of medicines which may increase public risk, particularly for the more vulnerable population groups such as the elderly, culturally and linguistically diverse, and the less health literate.

We also note that while the Scheduling Policy Framework for Medicines and Poisons (Framework) provides a solid basis for categorising medicines according to the level of public risk, there is a lack of guiding criteria for defining medicines that are exempt from scheduling. This is one area where we see the Framework could be improved.

The Guild also recommends the inclusion of a practising pharmacist on the Advisory Committee on Medicines Scheduling (ACMS) and that applications for changes to the Poison Standard should be publicised to enable interested stakeholders provide a more informed response.

The Guild also notes that since the ‘Final Report of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation’ (the ‘Galbally Report’) was presented to the Australian Health Ministers’ Conference (AHMC) in January 2001, there has been a significant level of concern in the pharmacy sector about attempts to undermine the two ‘over-the-counter’ (OTC) schedules. This consternation has been enhanced with repeated interim decisions while the Guild has had to use its resources to gather evidence to demonstrate the positive public health outcomes from having both a Schedule 2 and Schedule 3 medicine category. We believe there has been ample evidence provided to demonstrate the public benefits, particularly when there is an increased element of risk associated with OTC supply. With this in mind, The Guild and our members would welcome the certainty of a decision to continue on an ongoing basis the current scheduling arrangements of two OTC medicine categories.

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?
        • From the Guild perspective, there is little difference observed in the process between the old and new arrangements.

    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.

        • The Guild has observed that scheduling decisions now seem less risk averse, particularly with exempting medicines from scheduling. We are concerned that there has been a push from industry to de-schedule medicines and we are concerned this may increase public risk, particularly for the more vulnerable population groups such as the elderly, culturally and linguistically diverse, and the less health literate.
        • To exemplify the above, a proposal to exempt loperamide from scheduling was considered by the National Drugs and Poisons Scheduling Committee (NDPSC) in June 2009 and subsequently in June 2010. On each occasion, the proposal was not supported. The same proposal was then presented to the ACMS in June 2011 and supported for implementation from May 2012. This was then accompanied by a decision to change the labelling of loperamide to include seven warning statements compared to two statements when it was a Schedule 2 medicine.

          The use of warning statements does not replace the advice provided by a health care professional and the inclusion of such a large number of statements is particularly risky for people with poor health literacy. In considering a proposal for a schedule change, there appears to be a disconnect between relevant groups of the Therapeutic Goods Administration (TGA) that consider the scheduling of a medicine and those that consider labelling requirements.

        • The Guild is unconvinced about the need for greater access to medicines outside of the pharmacy sector, given that there are over 5200 pharmacies in metropolitan, regional and remote locations and the extensive hours of operation of community pharmacies.

          Medicines are not normal items of commerce and all medicines have some element of risk. However, when a medicine is exempted from scheduling, the public perceive it as having little or no risk. The supply of medicines through the non-pharmacy sector (supermarkets, service stations, corner shops) is not supported by any quality assurance framework. Although the scheduling exemption applies to a small quantity of a particular medicine, consumers can buy several packs (equivalent to a scheduled quantity) without any intervention to identify and manage potential risk.

          With this in mind, the Guild would like to see criteria included within the Scheduling Policy Framework for exempting medicines from scheduling. In addition, we would like regulations to limit the quantity that can be sold in any single transaction. While this will not completely resolve the safety issue associated with people buying multiple packs without access to professional advice or risk assessment, it would be a start.

    3. In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?
        • Regarding Section 52B (Advisory Committee on Medicines Scheduling), the new arrangements have removed the appointment of a ‘practising pharmacist representative’ on the scheduling committee. We are concerned that the lack of this ‘coal-face’ experience is to the detriment of the group. Pharmacy intervention in the supply of OTC medicines occurs every day in every pharmacy and we believe the current make-up of the advisory panel may not appreciate the significance of these interventions. Please refer to Attachment for some real-life examples of the interventions that occur in the supply of OTC medicines. We believe the inclusion of a practising pharmacist to the ACMS would enhance the decision making process.
        • Regarding Sections 52B and

          The Guild also notes the incidence of repetitive applications:

            • Jun 2011 – Appendix H listing of rabeprazole
            • Feb 2012 – Schedule change for pantoprazole
            • Jun 2012 – Schedule quantity change for omeprazole
            • Oct 2012 – Schedule quantity change for pantoprazole
            • Oct 2012 – Schedule change for transdermal diclofenac
            • Mar 2013 – Schedule change for transdermal diclofenac (even before interim-decision from previous application is known)

          This also happened under the previous arrangements with the NDPSC:

            • Feb 2009 – Proposed quantity change for OTC oral diclofenac
            • Jun 2009 – Proposal for scheduling exemption for loperamide
            • Oct 2009 – Proposed quantity change for OTC oral diclofenac
            • Jun 2010 – Proposal for scheduling exemption for loperamide

          Assessing and responding to repeat applications takes a significant amount of time, for both the scheduling committee and stakeholders who provide comment for consideration. Repeat applications for same or similar proposals should only be allowed if the application is introducing significant new evidence for consideration. While this may sometimes be the case, stakeholders do not know this as they do not have access to the application. Publishing the application along with the proposal notification would allow stakeholders to review the new evidence and understand the background for the updated proposal. Currently, as an interested stakeholder, the Guild must reiterate points of view previously put forward because we must take a ‘scatter-gun’ approach to providing comment. If we had access to the application, we could provide the scheduling committee with specific, pertinent comment for consideration. This may improve the efficiency and enhance the decision making capacity of the scheduling committee.

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?
        • While Section 52E clearly identifies the advice and matters which the Secretary must consider in making a scheduling decision, we believe one matter of relevance that is omitted from this list is ‘practice issues’. There are different practice issues to consider with a proposal to down-schedule a medicine that still remains scheduled and under pharmacist oversight versus a proposal to exempt a medicine from scheduling so that it available from the grocery sector in which the only risk management strategy is to include information on a product label.

          As an example, we believe the plans for professional support by sponsors and professional bodies such as the Guild has relevance in considering a proposal to down-schedule a medicine to either Schedule 2 or Schedule 3. Similarly, proposals for scheduling exemptions should consider the extent of warning advisories needed to mitigate risks, along with pack size (and capacity to accommodate all the mandatory labelling information) and managing the purchase of multiple packs and repeat purchases, contrary to the intent of exemptions for ‘short-term’ use.

        • One of the criteria the Secretary must consider is guidelines provided by the National Coordinating Committee on Therapeutic Goods (NCCTG) or its replacement. We note the consultation’s background discussion paper (Part B) indicates that the NCCTG may be replaced by short-term ad-hoc working groups rather than continue as a standing committee. With this in mind, there needs to be clarification as to which body will be responsible for managing the ongoing revision and maintenance of the NCCTG guidelines, particularly the Scheduling Policy Framework.
        • The Guild supports the intent within this section for the Secretary to have regard for recommendations by the ACMS, but we reiterate our concern about lack of practical pharmacy experience on the ACMS.

    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?

        • While there is clarity in the advice and matters to which the Secretary must consider, there is a lack of transparency in the process of this consideration, particularly in reporting on what basis the decision was made. Stakeholders provide comment on benefits or risks for a pa 52EAA (Application for amendment of the Poisons Standard), the Guild recommends that applications are published as part of the public notice for pre-meeting submissions for review by stakeholders in order to make informed comment. This currently happens in New Zealand. However, in Australia, only a summary of the proposed schedule change is published for comment.rticular proposal. It is assumed that either the applicant or stakeholder provides strategies to mitigate any risks associated with a particular proposal. Understanding the attitude of the ACMS and/or Secretary to both the risk and the mitigation strategy would be useful to inform future applications and stakeholder responses. As it is, published information is limited with regard to response to risk-mitigation strategies.

          As an example, we refer to the recent decision not to reschedule mometasone from Schedule 4 to Schedule 3 (Reasons for scheduling delegate's interim decision and invitation for further comment, January 2013 - External Link). In this case, a concise list of key issues was published. Compare this to the records of the final decision to exempt loperamide from scheduling (Reasons for scheduling delegates’ final decisions, September 2011 - External Link) which stated that the committee members ‘agreed that, on-balance, the overall benefit of access to small packs of loperamide as exempt from scheduling outweighed the potential risks’ and that ‘appropriate labelling would be required to ensure safe use of loperamide products’.

          With an implementation set for 1 May 2012 to exempt loperamide from scheduling, a consultation was released on 4 May 2012 (Proposed advisory statements for medicines - fexofenadine and loperamide - External Link) with a proposal to include seven (7) advisory statements on packs of loperamide compared to the existing requirement for two (2) advisory statements on Schedule 2 packs.

          The Guild was concerned that the large number of warning advisories may not address the identified risks as the consumers may have difficulty reading and understanding the information or may simply ignore this excess of warnings. In this instance, we believe that labelling recommendations should have been an important part of the consideration for scheduling exemption, and that applications should include proposed labelling examples that have been tested against consumer focus groups exemplifying the most at-risk population groups. Details of the consumer testing should also be included in the application.

        • Using the examples provided above, the Guild believes that there would also be value in including the committee’s regard for risk-mitigation strategies as part of the records for the scheduling decision. As an example, one of the reasons for not supporting the down-scheduling of mometasone was ‘inappropriate diagnosis of potentially severe skin conditions’. There would be value to the applicant and stakeholders in knowing if any proposed professional support was regarded as useful, unsatisfactory or requiring more development. This would assist interested parties in addressing key issues for further consideration.

    6. Is the Scheduling Policy Framework helpful in understanding the application and review process? If not, what amendments would you suggest? The Scheduling Policy Framework provides very clear guidance for factors to be considered for different scheduling categories. We reiterate that at times, there is a lack of transparency in how the ACMS or Secretary has applied the guidelines to their decision. We also reiterate that there is a lack of guidance for consideration of exempting medicines from scheduling. We do not accept that if a medicine falls outside the guiding criteria set for Schedule 2 then by default, it must be suitable for an exemption. We also note that the Scheduling Policy Framework lacks current guidance for the advertising of Schedule 3 medicines. It references the NCCTG’s Guidelines for brand advertising of substances included in Schedule 3 of the Poisons Standard (Nov 2000). This document is long overdue for review and the Guild would support a revision of this document along with a review into whether restricting the advertising of Schedule 3 medicines as a category remains appropriate. Again, given that the NCCTG is no longer operational, consideration needs to be given to which group should take responsibility for revising and maintaining the guidelines. [

    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?
        • No comment

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?
        • We reiterate that we believe the ACMS would be strengthened by the inclusion of a practising pharmacist. This would provide the opportunity for practice specific issues to be taken into account. As an example, a practising pharmacist would have an understanding of a community pharmacist’s capacity and capabilities and could provide advice on how useful clinical protocols or guidelines are, or whether training would be practical or effective in mitigating risks.
        • If the recommendation to include a practising pharmacist on the ACMS is supported, the Guild would welcome the opportunity to be able to nominate potential candidates.

    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?

        • No significant change noticed.

    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.

        • We reiterate that under the new arrangements, decisions appear to be less risk averse. While not necessarily a bad thing, the lack of transparency associated with the decision making process means that there appears to be inconsistency in the decision making, particularly when considering proposals for down-scheduling a medicine to Schedule 3 versus proposals for schedule exemptions.

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

        • We reiterate that as per arrangements in New Zealand, applications for scheduling changes should be published at the time of the public notice for pre-meeting submissions to enable stakeholders to make more targeted comments for consideration. If required, sensitive information can be removed.
        • We also reiterate our recommendation for greater transparency in how the ACMS and Secretary apply the guiding principles from the Scheduling Policy Framework to their recommendation/ decision. This would provide particularly useful information as to what the scheduling committee and Secretary regard as the most appropriate risk mitigation strategies.

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?
        • No comment

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

        • No comment

    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.

        • No comment

    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.

        • No comment

    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.

      • No comment

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)?

      • Consistent with our position that proposals for scheduling changes should be published as part of the notification process to better enable stakeholders prepare a more targeted response, electronic formats would be easier for publication.

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?
        • No difficulty

    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?

        • No difficulty

    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?

        • While we have no difficulty is accessing decisions, we re-iterate the lack of transparency in how the decision is made in relation to the guidelines set out in the Framework. Such information would be useful to inform future applications and submissions.

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?

        • The publication of the Secretary’s interim decision provides an avenue for reviewing the proposed decision. However, while the reports for making an interim decision are much more concise than the minutes provided from NDPSC meetings, we feel there is a lack of information on issues or risk management strategies presented in submissions. The information currently presented is a brief summary as to whether the submissions supported the proposal or not. Interested stakeholders who have commented on the proposal have the opportunity to provide new evidence for consideration, but there is no opportunity to rebut the approach taken because we don’t know whether the ACMS considered the position put forward in the original submission as justified or lacking.
        • We do feel that once a decision is made, there is little opportunity for the decision to be reversed.

          As an example, when the decision to exempt loperamide from scheduling was made, labelling recommendations were then sought from another area of the TGA. The consultation for these statements was not released until after the implementation of the new scheduling arrangements. We question whether the scheduling exemption would have been supported if the ACMS and Secretary were aware that seven (7) warning statements would be needed to attempt managing associated risks. Below is an intervention recently made by a pharmacist involved in the sale of loperamide with all the warning statements. The outcome for this patient may have been significantly different if they were purchasing the loperamide from a non-pharmacy outlet:

          It is very difficult to reverse a poor scheduling decision. Requirements such as the extent of advisory statements needed to mitigate patient risks should be available at the time of scheduling decision, not after the scheduling change has been implemented.

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?
        • No comment

    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?

        • No comment

    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?

          i. Retention of Schedule 2 and Schedule 3

          Since the Galbally Report in 2001, there has been a level of uncertainty about the retention of the two OTC medicine schedules – Schedule 2 (Pharmacy Medicines) and Schedule 3 (Pharmacist Only Medicines). During the 12 years since the Galbally Report, the Guild has invested considerable time and money collecting evidence to demonstrate the value in retaining the two OTC schedules.

          Using data collected as part of the Quality Care Pharmacy Program (QCPP) Mystery Shopper Program, the Guild has presented evidence to the NCCTG to demonstrate the value in retaining the two OTC medicine schedules. Irrespective of all the evidence collected and analysed, in June 2006 and again in April 2010, the NCCTG advised the Guild that only 5-yearly interim retention periods for the OTC schedules have been endorsed by the Australian Health Ministers’ Conference. We are at a loss to understand the need for this to continue, particularly when the Guild has had to bear significant ongoing costs to collect and present the supporting evidence. While some evidence was collected through a research project funded under the Fourth Community Pharmacy Agreement (Fourth Agreement), the remainder has been determined from the data collected under the QCPP Mystery Shopper Program. The operations of the QCPP Mystery Shopper Program were revised specifically to respond to NCCTG requests with costs associated with extended data collection and analysis covered by the Guild.

          This uncertainty has been a burden on the pharmacy sector, particularly as this has been in addition to changes to the Pharmaceutical Benefits Scheme impacting the viability of many community pharmacies.

          With consideration of the financial burden and uncertainty this issue has had on the pharmacy sector, the Guild would welcome closure of this matter with a recommendation for the permanent continuation of the two OTC schedules.

          Below is a summary of our justification:

          The Guild considers the availability of OTC (Schedule 2 and Schedule 3) medicines via community pharmacy to be in the best public health interest of the Australian community. Medicines are not normal items of commerce. If used incorrectly or inappropriately, they have the potential to do significant harm. Given the generally low level of health-literacy of many Australians, access to pharmacist advice for OTC medicines provides protection for consumers. This is particularly so for the more vulnerable groups such as children, the elderly, those from poorer socio-economic backgrounds or those who do not speak or understand English well. The high prevalence of poly-pharmacy also warrants consideration by a pharmacist to ensure there are no interactions between any prescribed, complementary or OTC medicines.

          The Scheduling Policy Framework outlines from a population based perspective, the risk/benefit balance for consumers according to different levels of access to medicines, categorised by the schedule. Schedule 2 medicines are essentially safe for self-diagnosis and self-treatment, with access to a pharmacist for information and advice if needed. Schedule 3 medicines are safe to treat health conditions identified by the consumer and verified by the pharmacist. When responding to requests for OTC medicines, pharmacy staff apply a professional supply protocol (e.g. Ask, Assess, Advise - External Link) to assess an individual’s needs and risks.

          The tables provided in Attachment B cross-reference the population-based factors for Schedule 2 and Schedule 3 medicines defined in the Scheduling Policy Framework with the role of pharmacy staff in managing supply to identify and address individual risk factors. These tables differentiate the level of involvement of pharmacy staff in supplying Schedule 3 medicines versus Schedule 2 medicines. The level of involvement reflects the intent of obligatory involvement with the supply of higher risk Schedule 3 medicines, with optional involvement for lower-risk Schedule 2 medicines, available for self-selection in all jurisdictions except Western Australian and Queensland.

          While consumers self-selecting Schedule 2 medicines have the option to seek advice, pharmacy staff are trained to promote and facilitate interaction with a pharmacist if the consumer has questions or if any potential risks are identified.

          Attachment A provides examples of where pharmacy staff have responded to and managed an individual’s risk with OTC medicine supply.

          The Fourth Agreement Research Project (The Guild 2007 - 08-02 - External Link) demonstrated that consumer access to OTC medicines was not an issue and that for the main part, consumers were satisfied with the level of pharmacy advice provided and wanted this advice to remain available.

          The extent of pharmacy staff involvement in responding to requests for OTC medicines is promoted by the professional supply protocols and determined by the type of request from the consumer. The Mystery Shopper data demonstrates that almost all consumers receive some advice in pharmacy and the pharmacy role of supporting consumers with the purchase of OTC medicines is being largely fulfilled. By contrast, there is no information gathering or provision of professional advice available to consumers when purchasing medicines through non-pharmacy outlets.

          Irrespective of schedule category, the Mystery Shopper Program has identified greater involvement of pharmacy staff associated with symptom based requests as compared to direct product based requests.

          Since commencing in October 2002, under the QCPP, until February 2013 the Guild has conducted 31,645 mystery shopper assessments. Below is a summary of evidence gathered to date as part of the QCPP Mystery Shopper Program that demonstrates the value added by community pharmacy in the supply of Schedule 2 and Schedule 3 medicines. Should the panel require further information about the reports provided to the NCCTG, the Guild would be pleased to assist.

          Key findings identified from the Quality Improvement in Pharmacy – NCCTG 2012 Report (reporting on data collected in 2011), included:

            • There is greater pharmacy intervention for symptom based requests (SBR) compared to blended product requests (BPR) or direct product requests (DPR)
            • With respect to information gathered, data indicated the following rank order: SBR > DPR (Schedule 3) > BPR > DPR (Schedule 2)
            • There is greater information gathering when the pharmacist is referred to by the pharmacy assistant
            • The quality of advice given is higher when both pharmacy assistant and pharmacist are involved in the supply
            • Improvement in the quality of advice given is related to:
                • improvements in the scope or amount of information gathered (in particular, information associated with risk and inappropriate use of medicines)
                • increasing awareness of the implications of key information factors and their sequelae and the need for pharmacy assistants to refer to and involve the pharmacist
                • improving the decision making skill of the pharmacy staff member through the availability of training, professional protocols and tools and support from the pharmacist

          While the 2012 Report was the final report the Guild provided to the NCCTG, the Guild still conducts mystery shopper assessments as part of a quality improvement element to QCPP. An analysis of Mystery Shopper results from data collected in 2012 has demonstrated:

            • scenarios involving an element of risk continue to score more highly than those with less risk
            • there has been greater access to the pharmacist, either directly or via referrals from pharmacy assistants
            • referral by pharmacy assistants to the pharmacist continues to result in improved scores for the supply of Schedule 2 medicines
            • the significantly higher scores achieved with referral to the pharmacist indicates this is an important quality improvement process
            • there is a greater number of mystery shopper scenarios with an element of risk in which the mystery shopper is being referred to the pharmacist by the pharmacy assistant
            • pharmacy assistants are an effective triage point for requests involving OTC medicines with an element of risk
            • there is little jurisdictional difference in scores for the supply of Schedule 2 medicines indicating minimal effects of restricting access for product selection within the pharmacy
            • there is generally a greater incidence of questions asked and advice given associated with the supply of Schedule 3 medicines

          It should be noted that since the Galbally Report, there have been a number of significant changes to how community pharmacy manages the supply of OTC medicines:

            • Under QCPP, there is a mandatory requirement for pharmacy assistants to complete the training module – ‘Support the sale of Pharmacy and Pharmacist Only Medicines’
            • Since April 2010, OTC medicine refresher training of pharmacy staff has also been mandated for QCPP re-accreditation
            • Community pharmacy has introduced and trained against OTC medicine protocols such as ‘Ask, Assess, Advise’
            • Over 92% of community pharmacies are accredited under QCPP

          Based on this evidence, the Guild believes two separate OTC schedules remains appropriate. We also consider that access to OTC medicines via a pharmacy, as opposed to the grocery sector, to be fundamental to the government’s health reform agenda. Health reform efforts to make better use of the health dollar include the drive for consumers to be central to and take personal responsibility for their health. There is strong international evidence, such as in the United Kingdom, that self-care substantially improves the efficiency of the health system, leading to better individual and public health outcomes. Self-care embraces both curative and preventive health. It does not imply that individuals are left to treat themselves in isolation, but rather, are empowered to take personal responsibility for their health through the support of a multidisciplinary team of healthcare professionals, including pharmacists. Access to both Schedule 2 and Schedule 3 medicines via the pharmacy sector is a fundamental underpinning of the self-care concept.

          ii. Modified Schedule 3

          The Guild considers that the current Scheduling Policy Framework for OTC medicines could be further strengthened by modifying the Schedule 3 medicine category to include a ‘notifiable’ sub-schedule. Given the availability of Schedule 3 medicines that are at risk of misuse or abuse, a S3-Notifiable system would provide a decision support tool for pharmacists and a real-time management resource for regulatory bodies. Such a system is exemplified by Project Stop being used to manage the supply of pseudoephedrine products.

          An S3-Notifiable system applied more broadly would provide the following opportunities to the health system:

          A broader scope of health care intervention by pharmacists, including the monitoring and management of more serious and chronic health conditions in collaboration with other members of the health care team.

          Facilitated collection and analysis of critical health care and supply data through an IT-enabled system to monitor the management of chronic health conditions.

          Enabling the recording and review of Schedule 3 medicines used for chronic health conditions as part of the eHealth medicines repository.

          Creating a greater level of accountability for pharmacists to ensure that a risk-based approach is employed with the supply of Schedule 3 medicines.

          iii. Changes to cough and cold medicines

          We would also like to draw the panel’s attention to the outcome of the review into the use of cough and cold medicines in children. The end result was a significant amount of confusion and angst for consumers and community pharmacy. After recommendations from both the NDPSC and ACMS to amend the scheduling of cough and cold medicines, a decision was made that the issue could be adequately managed through packaging and labelling. What resulted was a situation in which products with the old packaging and labelling remained available for resale while pharmacy was requested to comply with the new recommendations in not providing these products for use in children under six years of age. Interestingly, the grocery sector was not impacted at all. Products remained on sale for age groups according to the old labelling information from the grocery sector without any requirement for additional action. This demonstrated the double standards in managing identified safety risks. Acknowledging the responsibility of pharmacy as guardian of OTC medicines to manage such risks, these changes have demonstrated its capacity and ability to respond professionally and responsibly. The public should expect the non-pharmacy sector to also meet its responsibilities if it wants to sell medicines that are exempt from scheduling. Overseas, similar changes to the use of cough and cold medicines required over-labelling of the products in both the grocery and pharmacy sectors.

          Pharmacists were also confused by the messages about the supply of cough and cold medicines for children under six years of age, particularly with regards to managing prescriptions for this age group. On one hand, the TGA was advising that they should not be used because of the risks requiring medical intervention, and on the other they were advising that there was no change to the scheduling and that prescriptions were not needed for supply. The advisory was subsequently updated to advise health care professionals that prescribing or supply of cough and cold medicines for children under six years of age constituted 'off-label’ supply.

          This situation should not have happened. A decision should have been made to accept the scheduling recommendation of the two expert advisory groups, coupled with amendments to the labelling and packaging in which over-labelling should have been mandated for the ongoing sale of products with the old labelling. Timelines for introducing the changes should also have been determined in consultation with the affected sectors, particularly community pharmacy as the main retail supply sector.

          iv. Packaging exemptions

          Packaging exemptions for products that have schedule changes has presented challenges for community pharmacy which could be addressed by more co-ordinated communication. It would be particularly useful for pharmacists to have access to the information from a central location such as the TGA website.

          As an example, when the schedule changed in May 2010 for combination analgesics containing codeine, there were exemptions in place for products on the market allowing them to be sold with the old Schedule 2 packaging. At the same time, pharmacists were required to treat the products as Schedule 3 with regards to storage, assessing therapeutic need and the quantity that could be supplied in one pack. While the packaging and labelling exemptions are coordinated through the states and territories, it would be useful for pharmacists to have accurate information in a timely manner to be able to readily identify which products have exemptions and for what period of time and whether there are any additional requirements or restrictions (e.g. re-labelling or re-packing).

          Likewise, when chloramphenicol was down-scheduled to Schedule 3 for use in conjunctivitis, companies supplying chloramphenicol eye products had packaging and labelling exemptions to allow OTC supply of the product with Schedule 4 labelling. It would have been useful for pharmacists to be able to access information explaining the exemption and how supply should be managed. Professional bodies such as the Guild would be useful allies in conveying this information.

          v. Standardised legislation

          The application of the Poisons Standard has standardised how medicines are scheduled throughout Australia. As a legislative instrument referenced by States and Territories, it has also simplified how changes are simultaneously implemented in all jurisdictions throughout Australia. With this in mind, the Guild proposes the development of a standardised legislative instrument for reference by States and Territories that regulates the supply and use of medicines and poisons. There are a number of inconsistencies between jurisdictions which impacts consumer access to medicines (e.g. which professional groups can prescribe, how Schedule 3 medicines are handled). Developing and maintaining a national legislative instrument similar to the Poisons Standard would effectively and easily address such issues. It would also facilitate the national implementation of initiatives such as (Please see standarts and guidelines - External Link) :

            • The Continued Dispensing of PBS Medicines in Defined Circumstances
            • Supply and PBS Claiming from a Medication Chart in Residential Aged Care Facilities
            • Electronic Reporting and Recording of Controlled Drugs

          vi. OTC supply of Prescription Medicines

          Finally, we also note an anomaly that causes significant confusion for pharmacists. A medicine may be listed in an OTC schedule but is marketed only as a Schedule 4 medicine. Many pharmacists are confused as to whether the Schedule 4 medicine can be re-labelled and supplied OTC. The Guild’s understanding is that the Schedule 4 medicine is registered, labelled and packaged as a Schedule 4 medicine and therefore cannot be supplied OTC, even if a pharmacist attaches a dispensing label with directions. As national legislation regulates labelling and packaging as part of the registration process but jurisdictional legislation regulates supply arrangements to consumers, clarification is sought from all parties on this issue, including the TGA and jurisdictional medicines and poisons units.

          An example is mometasone which is listed in Schedule 2 for nasal preparations for hayfever in adults and children over 12 years of age. The only mometasone nasal product available is Nasonex™, which is a registered Schedule 4 product. The Guild is often contacted by pharmacists seeking information on whether they can supply Nasonex as an OTC medicine. While our advice is to seek clarification from the relevant jurisdictional pharmacy services unit, we believe the information should be publicly available for reference by pharmacists or consumers. We would welcome working with relevant bodies to ensure any information to clarify this situation was circulated to community pharmacists.

Attachment B – Scheduling Policy Framework Cross-Reference with pharmacy’s role

Scheduling Policy Framework – Factors for Schedule 2 medicines and role of pharmacy staff

Factors for Schedule 2 medicinesPharmacy staff role
1. The quality use of the medicine can be achieved by labelling, packaging, and/or provision of other information; however access to advice from a pharmacist is available to maximise the safe use of the medicine. The medicine is for minor ailments or symptoms that can easily be recognised and are unlikely to be confused by the consumer with more serious diseases or conditions. Treatment can be managed by the consumer without the need for medical intervention. However, the availability of a pharmacist at the point of sale supports the consumer in selecting and using the appropriate medicine.Assist consumer in selection and use of product if requested

Supplement information provided on product label if requested

2. The use of the medicine is substantially safe for short term treatment and the potential for harm from inappropriate use is low. Suitable for diagnosis and treatment by the consumer in the management of minor ailments.Provide advice to the consumer regarding use and length of treatment before they should seek further advice if requested

Monitor and assess inappropriate use

3. The use of the medicine at established therapeutic dosage levels is unlikely to produce dependency and the medicine is unlikely to be misused, abused or illicitly used. Monitor and assess inappropriate use
4. The risk profile of the medicine is well defined and the risk factors can be identified and managed by a consumer through appropriate packaging and labelling and consultation with a medical practitioner if required. There is a low and well-characterised incidence of adverse effects; interactions with commonly used substances or food and contra-indications.Assess potential for drug interaction and contra-indications (if requested by consumer)

Supplement information provided on product label if requested

5. The use of the medicine at established therapeutic dosage levels is not likely to mask the symptoms or delay diagnosis of a serious condition. Appropriate labelling and packaging can manage any risks.Provide advice to the consumer regarding use and length of treatment before they should seek further advice if requested

Supplement information provided on product label if requested

Scheduling Policy Framework – Factors for Schedule 3 medicines and role of pharmacy staff

Factors for Schedule 3 medicinesPharmacy staff role
1. The medicine is substantially safe with pharmacist intervention to ensure the quality use of the medicine. There may be potential for harm if used inappropriately. The consumer can identify the ailments or symptoms that may be treated by the medicine but counselling and verification by a pharmacist is required before use. Pharmacist-consumer dialogue is necessary to reinforce and/or expand on aspects of the safe use of the medicine. Confirm suitability of product to treat ailment or symptoms identified by consumer

Provide advice on safe use of medicines

Monitor and assess inappropriate use

2. The use of the medicine at established therapeutic dosages is not expected to produce dependency. Where there is a risk of misuse, abuse or illicit use identified, the risk can be minimised through monitoring by a pharmacist.Monitor and assess inappropriate use
3. The risk profile of the medicine is well defined and the risk factors for adverse effects and interactions are known, identifiable and manageable by a pharmacist. Assess potential for drug interactions and adverse effects

Provide or highlight additional information (e.g. product label, CMI)

4. Where the medicine is intended for recurrent or subsequent treatment of a chronic condition, pharmacist intervention is required to monitor safe use of the medicine following recommendation by a medical practitioner or a pharmacist. The consumer may not be able to self-monitor the safe ongoing use of the medicine. The condition does not require medical diagnosis or only requires initial medical diagnosis, and the consumer does not require close medical management.Monitor and assess appropriate/ safe use

Review and/or refer if ailment deteriorates

5. The use of the medicine at established therapeutic dosage levels may mask the symptoms or delay diagnosis of a serious condition. Pharmacist-consumer dialogue is required to detect the risk of masking a serious disease or compromising medical management of a disease, and to deal with it appropriately.Assess symptoms and monitor doses used

Review and/or refer if ailment deteriorates