The new Appendix M category added to the Standard for Uniform Scheduling of Medicines and Poisons from February 2019 offers optimism that additional medicines might be considered for down‑scheduling from S4 to S3
But what do pharmacists think of the potential down‑scheduling of specific S4 medicines? A team of Griffith University academics have been researching pharmacists to build a picture of the profession’s views.
Here the researchers—Denise Hope, Amary Mey, Fiona Kelly and Michelle King—summarise their findings and overview the potential implications:
Click here to access a PDF of the full paper
Appendix M is intended to facilitate such down-scheduling “where, for example, there is a community need for access to a medicine that has previously only been accessible with a prescription, but where it is considered that additional controls and oversight by a dispensing pharmacist are needed, in the interests of protecting public health”.
This suggests medicines that down-schedule to S3 Appendix M could be provided by a pharmacist without prescription, if specific controls are in place.
Conceptually, Appendix M shares similarities with Appendix D in that it articulates additional controls required for the supply of medicines. While Appendix D specifies controls for certain S4 and Schedule 8 (S8) medicines, Appendix M will apply only to S3.
For Appendix M, the objective is to outline conditions for supply by pharmacists of substances which, while grouped under S3, carry additional risk to public safety that exceed the level considered acceptable for substances in this Schedule.
The potential candidates
A Scheduling Working Group, comprising of state and territory representatives and industry, health professional and consumer representatives, has been tasked with identifying candidates for the new schedule and criteria for the use of Appendix M, which will include definitions for controls and oversights.
In its identification of potential candidates for down-scheduling, the working group reviewed medicines available without prescription internationally and the results of a 2018 survey undertaken by the Pharmaceutical Society of Australia (PSA). The study identified the relative priorities of 211 pharmacists for potential down-scheduling to over-the-counter (OTC) from a list of 15 medicines/medicine classes.
The resultant list of suggested priority substances comprises seven medicines/medicine classes: oral contraceptives, triptans, melatonin, ondansetron, trimethoprim, adapalene and sildenafil.
Additionally, the Australian Self Medication Industry (ASMI) provided the Working Group with a list of 18 medicines available OTC in other countries, that included all of the PSA list except ondansetron, and additional medicines such as oseltamivir, statins and azithromycin. While these substances give indication to potential additions to S3 in the revised SUSMP, the definition of the additional controls and oversight alluded to in Appendix M are, as yet, unconfirmed.
A look at the criteria
In February 2019, the TGA called for feedback on the proposed criteria for Appendix M.
At present, the proposed criteria outline seven key aspects of Appendix M, three of which pertain to pharmacists’ responsibility to provide medication advice and counselling (patient education), the training on the provision of the medicine that may be required and any additional conditions that may be imposed to safeguard public safety.
According to the TGA, these aspects of the new appendix could potentially be legislated for at the state and territory level.
The remaining four items relate to aspects of pharmacists’ competency that the TGA suggests could be managed by the profession’s governing bodies. These items pertain pharmacists’ competency to assess the patients’ symptoms/needs, limitations on quantity/frequency of supply and need for formal diagnosis and/or review by medical practitioners to determine the suitability for supply as well as pharmacists’ duties pertaining to record keeping and information sharing.
As the profession awaits the final decision that will undoubtedly have significant impact on the practice landscape, this article offers insights from recent research that may contribute to the TGA consultation.
Talking to the profession
In 2015, our team undertook preliminary interview research with 15 community pharmacy staff (9 pharmacists, 4 dispensary technicians and 2 pharmacy assistants), which revealed that the pharmacists were keen for medicines rescheduling, supported by a desire to facilitate consumers’ management of minor illnesses and promote adherence by reducing treatment disruption to those on long-term therapies.
Research participants identified a broad range of medicines as potential candidates for down-scheduling, with oral contraceptives, blood pressure and cholesterol-lowering medicines being the most dominant.
Access to OTC oral contraceptives were linked to the desire to mitigate possible barriers to supply such as prescriber access or religious issues. They also suggested that OTC availability of erectile dysfunction medicines could save patients from embarrassment.
Importantly, participants expressed their desire for the establishment of protocols and training resources to support their transition from the status quo.
While the study provided new and insightful information about the opinions and readiness of pharmacists and support staff, it was acknowledged that the generalisability of the findings were limited by the small sample size and the confinement of the research to the Gold Coast region of Australia.
We then conducted a national survey of pharmacists in 2015 and 2016 on the perceptions of the profession regarding medicines down-scheduling. One aspect of the research asked Australian pharmacists for their opinions on the scheduling of 17 medicines/medicine classes, that had been defined from overseas OTC availability and from the interview results.
Two hundred and eighty seven Australian pharmacists (126 male and 161 female) completed an online survey. Pharmacists represented all Australian states and territories and a variety of practice contexts, including community, hospital, academia and consultant pharmacy.
The majority of pharmacists agreed that anti-nausea medicines (for indications other than migraine), oral contraceptives and statins should be available without prescription.
Although more than two thirds agreed that there should be OTC access to key therapeutic agents used in the management of migraines, asthma and hypertension, the majority preferred that this be under specified conditions, primarily for the purpose of continuing therapy.
Agreement on increased consumer access to the anti-infectives azithromycin, trimethoprim and oseltamivir with established symptoms contrasted with less favourable views on expanding this to other anti-infectives.
Trimethoprim and inhaled corticosteroids were the medicines that pharmacists considered most important to have available OTC and felt most confident to supply in this context. Oral contraceptives were ranked fourth in importance and fourth in pharmacists’ confidence to supply. Calcipotriol was ranked least important for OTC access and also the medicine pharmacists were least confident to supply OTC.
Sticking to the protocol
Protocols were the most frequently suggested requirement (1939 selections), with the highest suggestion of protocols reported for anti-nausea medicines (for indications other than migraine) by 185 (75.8%) of 244 pharmacists who answered, followed by oral contraceptives, with protocols suggested by 179 (74.0%) of 242 pharmacists.
Training was also frequently suggested (1839 selections), with the most frequently suggested medicine candidates for training being calcipotriol (n=120 of 164, 73.2%) and dermal corticosteroids (n=152 of 208, 73.1%).
Pharmacist accreditation was the least often suggested requirement for OTC supply (1135 selections), with other anti-infectives (excluding azithromycin, oseltamivir and trimethoprim) the most frequently suggested medicines for pharmacist accreditation (n=36 of 64, 56.3%).
So, what does it mean?
This study provides valuable insights for policy makers on the importance that Australian pharmacists place on increased consumer access to selected medicines and their associated confidence in managing OTC provision.
The major findings of the research are an increased understanding of pharmacists’ opinions on the candidate medicines for potential down-scheduling, guided by their confidence to supply and judgement on the importance of OTC supply, which should help to guide further TGA consultation.
While this research generated important commonalities with the candidate medicines lists provided by AHMAC and ASMI, there are also some significant differences.
Additionally, this research gives voice to pharmacists’ opinions regarding the additional controls, or OTC requirements, that they will need to safely and effectively provide down-scheduled medicines. These findings should guide the development of Appendix M.
The medicines at the crux of the intersection of the three candidate lists, that were also identified as a priority by AHMAC are: oral contraceptives, trimethoprim, sildenafil and triptans.
The pharmacists surveyed in this Griffith University study considered oral contraceptives, trimethoprim and triptans important candidates for down-scheduling and self-reported being confident to manage these. This was less evident for erectile dysfunction medicines, such as sildenafil.
Also at the centre of the intersected candidate lists are: statins, calcipotriol and oseltamivir. This means these medicines are available OTC overseas and have been reported by Australian pharmacists as candidates but not an AHMAC priority.
Participants of this Griffith University study rated oseltamivir and statins as both important to have OTC access and that they are confident to supply. In contrast, calcipotriol was rated least important with least pharmacist confidence.
While there was commonality between the AHMAC/PSA and Griffith studies with regards ondansetron, the difference identified in both Griffith studies was that pharmacists were focused on a broader range of anti-nausea medicines.
In the pilot study interviews pharmacists additionally identified domperidone, metoclopramide and prochlorperazine as potential candidates. The survey research revealed that anti-nausea medicines (for indications other than migraine) were the highest rated medicine class that should be available OTC.
While ranked 12th in importance to down-schedule, pharmacists ranked them fifth in confidence to supply. This may be explained by the fact that pharmacists are already familiar with supplying metoclopramide and prochlorperazine as S3 medicines, for nausea associated with migraine. They are therefore more confident to extend that provision to non-migraine indications.
The results of our research suggest that the TGA look at a broader range of anti-nausea medications for Appendix M, beyond just ondansetron.
Even though ASMI did not identify combination preventer asthma inhalers as potential candidates, because they are not available OTC overseas, Australia is one of the few countries in which beta agonist reliever inhalers are available without prescription.
It is unsurprising that pharmacists identified corticosteroid inhalers as the second most important medicine class for OTC access. Likewise, they report confidence in being able to supply these inhalers OTC. As with current S3 anti-nausea medicines, pharmacists are familiar with managing consumers’ asthma OTC through the provision of the S3 reliever inhalers.
The Griffith University research was the only one to report pharmacists’ desire to see an extension of the available dermal corticosteroids OTC. Again, pharmacists are used to supplying S2 and S3 corticosteroids and expressed confidence in being able to supply more potent corticosteroids if they down-schedule.
Australian pharmacists are clearly ready to embrace OTC availability of a wide range of medicines, which reflects a person-centred approach to meet consumer needs through increased access in the context of quality use of medicines.
Denise L Hope,1,2 Amary Mey,1,2 Fiona S Kelly,1 Michelle A King1,2
1. School of Pharmacy and Pharmacology, and Quality Use of Medicines Network, Griffith University, Queensland
2. Menzies Health Institute Queensland, Griffith University, Queensland
The research team acknowledge and thank the pharmacist participants for their time and opinions. We wish to thank our colleagues A/Prof Gary Grant, Dr Phill Woods, James Townshend and Lyndsee Baumann-Birkbeck for their contributions to this project.
The study was funded by The Griffith University School of Pharmacy and Pharmacology Project Grant Scheme, where all authors were employed at the time of the study.