**4. Discussion**

To our knowledge, this is the first study to explore the effects of regulatory scheduling of medicines and its impact on pharmacists' in terms of workload or professional behaviors. This review has illustrated the impact of up-scheduling medicines, using codeine as an example, and it was conducted with a view for theoretically extrapolating to other medicines, specifically to CMs. The findings of this study suggested there was a lack of quantitative data to provide specific outcomes relating to the schedule change. The majority of the literature was comprised of exploratory qualitative studies on the perceptions and opinions of pharmacists in relation to codeine.



The intent of up-scheduling codeine was to minimize codeine misuse. When codeine was up-scheduled from Schedule 2 to Schedule 3, a pharmacist's involvement in the supply of codeinecontaining medicines became a legal requirement. Pharmacists had a legal obligation and professional responsibility to ensure that codeine use was therapeutically appropriate for a patient before permitting sale. In such circumstances, pharmacists uphold an important role as a "gatekeeper" by counseling and, if required, intervening in OTC CCP misuse. In the qualitative study by Hamer et al., it was reported that there was an increase in the workload on pharmacists due to these new legal obligations [25]. Pharmacists also noted that they became more aware about misuse as a result of the increase in patients requesting codeine [25]. Some pharmacists felt that it gave them confidence to discuss with patients any codeine-related problems [25]. Some pharmacists would attempt to address a patient's concerns and recommend alternatives to minimize codeine use [13,23]. Other pharmacists felt that rescheduling to Schedule 3 prompted them to upskill in the area of pain managemen<sup>t</sup> [23]. Following the second up-scheduling to Schedule 4 for any product containing codeine, it was reported that the up-scheduling actually created an opportunity for patients to openly discuss their pain issues with the pharmacist and seek non-codeine strategies to manage their pain [23,24].

Whilst CMs and codeine (which has potential for misuse) are very di fferent classes of medicines, we propose that the fundamental principles that prompted changes to the up-scheduling of codeine are the same, i.e., pharmacists' responsibility to engage in patient care that ensures the appropriate and safe use of medicines. Currently, CMs are categorized as unscheduled medicines, and, as such, there is no legal implications for pharmacists if they do not directly engage in the supply of CMs. However, there is growing evidence of adverse reactions between certain medicines and some CMs, which potentially have serious e ffects on patient safety [27,28]. Therefore, there is a gap between the regulation of supply of CM products and pharmacy personnel's, including pharmacists', professional responsibilities. To date, up-scheduling of CMs has not been discussed in the literature.

Shifting CMs to Schedule 2 could theoretically increase pharmacy personnel's involvement in supply. When codeine was up-scheduled to "Pharmacist-only medicine", Hamer et al. reported that pharmacists' awareness about patients' request for codeine increased, which prompted for identification of codeine misuse and changes in pharmacists' practices with regard to supplying of CCPs [25]. Again, while CMs are overall a lower risk than CCPs, they are not without risk.

Therefore, we hypothesize that, by having an established legal framework, subjecting CMs to up-scheduling to at least Schedule 2, and educating pharmacy assistants, technicians, and pharmacists in the handling of CMs will enable closer monitoring [11] of CM use and identification of drug–herb interactions. With heightened regulation, pharmacy personnel would be required by law to interact and engage with the patients during the sale of CMs. This will create an opportunity for patients to make more informed decisions about the CMs of interest and encourage appropriate and safe use. At the same time, having CMs available exclusively through the pharmacy could be a strong message to consumers to be aware of and comply with advice o ffered with respect to the safety of CMs, as they would have with other medicines or prescription medicines. Consumers' perceived need to consult with pharmacy personnel when deciding on the use of CMs would, therefore, also be prompted. As indicated by a consumer advocacy group representative, "*it would be ideal to have pharmacists to deal with consumers' use of CMs*". Initiating the regulatory scheduling of CMs might be the remedial policy needed to correct consumers' belief systems about the safety of CMs.

Furthermore, in a study conducted by Emmerton in 2003, it was noted that Schedule 3 medicines have higher rates of in-store interventions and pharmacist engagement, as compared to unscheduled medicines [8]. A probable conclusion drawn from this study could be that medicines assigned with higher risk value would be prioritized by pharmacy sta ff [13]. While CMs are commonly perceived by the public to be safe medicines [5], adverse reactions, drug-herb interactions and serious toxicities, if used inappropriately have been reported [27,28]. Increased risk of drug and CMs interaction is present in physiologically-compromised individuals and the elderly that are on polypharmacy [29,30]. Up-scheduling of CMs can encourage more patient-pharmacist/pharmacist technician interactions on the use of CMs. This may also potentially increase the reporting of drug-herb interactions and raise awareness among CM users and pharmacy personnel about interactions and, even more importantly, add to building the evidence-base about CM safety.

Another significant finding of this study was that one of the major challenges reported by pharmacists with the scheduling of codeine to Schedule 3 was having to establish a "therapeutic need" as required by law. Due to time constraints in real-time pharmacy practice, pharmacists felt that they were unable to perform a detailed consultation session with patients to determine a therapeutic need [13]. Based on the codeine example, we might be able to extrapolate that pharmacists might see it as a challenge to conduct a comprehensive consultation with their patients on their conventional medications and CMs, with time being the limiting factor. This provides an opportunity for pharmacy assistants/technicians to extend their role and be trained in CMs counseling. Doucette reported that pharmacy technicians were willing to perform new tasks that are needed to support emerging patient care services within community pharmacies [31]. The need for pharmacist assistants' or technicians' roles to evolve through appropriate education and collaborative working relations with pharmacists has been suggested [32]. Such an evolution would be suited to filling the current gap in the provision of professional care related to CMs use.

Despite legal obligations for the supply of Schedule 3 codeine, there was a reported lack of conformity between Australian pharmacies [13]. Inconsistencies in pharmacists' practices were found in different pharmacies, which can also become a potential barrier between patient and pharmacist. Some patients reported that pharmacists were not able to provide the information about CMs' they needed and therefore decided not to ask the pharmacist's assistance in making a decisions about CMs again [11]. Other patients may become confused and interpret the behavior of pharmacists exercising a duty of care as being unnecessarily prohibitive in comparison to other pharmacists who do not exercise professional behaviors related the provision of CM products [13]. With that in view, if CMs were to be up-scheduled, we might also be faced with varying pharmacy practices in the supply of CMs. Perhaps some of this inconsistency would be reduced if Schedule 2 was applied to CMs and well-trained pharmacy assistants and technicians could 'absorb' the professional responsibility of the counseling session and refer to the pharmacist only when necessary.

In addition, it was reported that when codeine was regulated to Schedule 3, some pharmacists were concerned about their clinical competence not being sufficient to help patients with pain managemen<sup>t</sup> without the aid of over-the-counter CCPs [24]. It was consistent in most of the studies that the up-scheduling of codeine required additional educational training for pharmacists in the area of pain management, counseling skills, and the handling of drug misuse [13,23,24]. This could imply that, if a change in CMs scheduling were to eventuate, pharmacists, pharmacy assistants, and pharmacy technicians would need to undertake professional training in the area of CMs to build on their evidence-based CMs knowledge. In the study by Ung et al., education is identified as one of the solutions to facilitate the integration of CMs into pharmacy practice [33].

We sugges<sup>t</sup> that up-scheduling of CMs should be based on an evidence-based model and conducted in a step-up approach. Suggestions include up-scheduling CMs that are associated with high interactions-risk and used as a therapeutic agent. Some Australian CMs companies have attempted to promote practitioner-only CMs. Yet little is known about the impact on improving pharmacy personnel engagemen<sup>t</sup> with consumers who are buying these products. With that in mind, scheduling of medicines should be explored in depth in relation to the possible implications for other healthcare professionals, retail outlets owners, and, more specifically, CMs practitioners. The aim of such research would be to promote a coordinated approach to supporting the appropriate and safe use of CMs across different sectors.

This study does have some limitations. As this is a newly emerging topic, there is limited research to date and lack of sufficient opportunity to compare with previous studies. Hence, it may not be an adequately comprehensive study to fully inform readers and policy makers on the impact of rescheduling. However, the findings of our study have clearly flagged several suggested initiatives that are worthy of consideration.

As codeine is a drug of addiction, we also need to be mindful that the purpose and e ffects of up-scheduling could be di fferent to the case of CMs; although patient safety is of the essence of the approach taken and clearly has become applicable to CMs. Further research to inform enhancement of the role of pharmacy personnel engagemen<sup>t</sup> in the sale of CMs in view of the position statement from PSA may be required.
