ORIGINAL A bitter pill to swallow: registered nurses and medicines regulation in remote Australia

: Introduction : Access to essential medicines is a human right and an objective of the National Medicines Policy in Australia. Health workforce distribution characteristics in remote Australia implies registered nurses (RNs) may find themselves responsible for a broader range of activities in the medication management cycle than they would be elsewhere in the nation. The regulation of health professionals and their training requirements provides essential but complex protections for the public. These protections include the National Registration and Accreditation Scheme for health practitioners and the Australian Health Practitioner Regulation Agency. Other levels of control or regulation are also exerted over health professionals via mechanisms such as salaries and funding arrangements, insurance requirements, admitting rights to healthcare facilities, and legislation controlling the use of medicines and therapeutic devices. This study aimed to examine national legislation and regulations concerning the use of medications from a nursing perspective, focusing on the context of health service delivery in remote areas. Methods : Australian state and territory medicines legislation and regulations was interrogated for answers to the questions ‘Can an RN prescribe a medication?’, ‘Can an RN dispense a medication?’, ‘Can an RN supply or issue a medication?’ and ‘Can an RN administer a medication?’ Results : Inconsistencies elements of the medication management cycle. Administrations of Schedule 4 and 8 medicine according to an order from an authorised prescriber are the only nationally consistent roles RNs are authorised to undertake with regards to medicines. Twenty-eight variations were identified with regards to additional authorisations for RNs. Conclusion : RNs make up more than half of the registered Australian health professional workforce and are the most consistently distributed across the nation, yet their legislated responsibilities in relation to working with medicines are inconsistent. Given the inconsistencies, RNs providing health care in remote Australia may be unable to undertake aspects of the medication management cycle that their work environment demands in the best interest of their patients and absence of other healthcare providers. The lack of legislative consistency nationally for medicines in Australia is likely to impede timely access to medications for patients. Regulatory inconsistencies may also result in RNs working well below or beyond their legal scope of practice, thereby creating clinical and workforce risks. Such risks are a significant matter for remote health service provision. Resolving these issues will require a collaborative national approach with consideration given to how the health workforce is distributed, current nursing responsibilities and relevant service delivery models for remote Australia.


Introduction
The regulation of health professionals and their training requirements provides essential but complex protections for the public . In Australia, these protections include the introduction of   Health Service program, enabling the free supply of PBS medications without a prescription at designated facilities in remote areas . This removed a barrier to accessing affordable medicines due to a lack of local medical practitioners for obtaining prescriptions and pharmacies for the dispensing of medications. Despite this, it is unclear if nurses in these areas, whose roles have in common some elements of work usually undertaken by general practitioners or pharmacists and may therefore include supplying and/or initiating medications, are also supported to do this by state or territory legislation governing the practices of health practitioners with regards to medicines.
Despite the significance of these advanced practice roles for RNs and the crucial position they therefore hold in the quality use of medicines there has, been little research outside of Queensland into RNs and the MMC in remote Australia or the legislative and practice frameworks that might best support quality use of medicines by nurses in remote Australia.
The objective of this study was to examine medicines and poisons legislation nationally from a nursing perspective, with a focus on the context of health service delivery in remote areas of Australia.

Instrument and format
The title of legal instruments and location of legislative details

Scheduling of medicines
All Australian states and territories are party to a federal legislative instrument, the Poisons Standard (2019), also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The terminology used to describe and refer to the different schedules of medicine within both state and territory legislation differs from the SUSMP (Table 1). Endorsements and training requirements relating to RNs who are immunisation providers were not included in this analysis due to their multitude and complexity.

Prescribe, prescriber, prescription
Prescribing traditionally relates to stages 1-3 of the MMC.

Dispense
The dispensing of medications traditionally involves stages 4-6 of the MMC.
Definition: The ACT defines dispense in the Act, and SA and WA within the Regulations similarly as being to supply a drug according to a prescription. Queensland also defines the term within its Regulations but specifies that dispensing is to sell a drug in accordance with a prescription. The NT makes no reference to the term. Victoria does not define the term. NSW and Tasmania do not define the term but in these states supply includes the act of dispensing, with Tasmania specifying that dispensing occurs in accordance with a prescription (Table 3). Authorised actions for RNs: Table 3 summarises differences in authorised actions for RNs in relation to the supply of medicines. Twenty-one variable provisions relating to supply authorisations were identified.

Schedule 2 and 3 medications
There is no national consistency relating to the supply of Schedule 2 or 3 medications by RNs (Table 3).

Schedule 4 medications
There is no national consistency relating to the supply of Schedule 4 medications by RNs (Table 3).

Schedule 8 medications
There is no national consistency relating to the supply of Schedule 8 medications by RNs (Table 3).

Administer
Traditionally administering a medication is stage 8 of the MMC.
However, similar to the situation with supply of medications, where administration is authorised without an order from an authorised prescriber then steps 1-6 of the MMC may also be occurring.
Definition: Administer is a frequently used term in legislation. It is not defined in the Acts or Regulations of SA, WA, NSW, ACT, Victoria or Tasmania (Table 4).

Schedule 2 and 3 medications
There is no national consistency relating to the administration of Schedule 2 or 3 medications by RNs (Table 4).  (Table 4).  (Table 4).  practice in relation to all aspects of the medication management cycle via nationally consistent medicines legislation will improve equity of access to health care and medications. This will enhance the quality of care provided to those Australians whose health is generally poorest. However, this demands of decision makers a nationally collaborative approach and a willingness for policy and legislative reform efforts. An appetite and ambition for such reform has been characteristic in some areas of Australian health care, so it is really now just a question of the desire of decision-makers to act on this practical issue that will lead to improvements in health outcomes in remote Australia. to not only RNs working in remote areas but all RNs whose roles with medications exceed these two defined actions. A lack of uniformity between Australia's medicines and poisons legislation means RN practice will vary across Australia and patients may not receive a standard or universal level of care.

Limitations
It is imperative to acknowledge that in Australia a health professional's individual scope of practice is defined jointly by legislation; their level of educational preparation, knowledge, skills and experience; the needs of the community; and the policies and procedures of their employing organisation. Any or all of these elements may be either broader or more limited than legislated roles with medicines. With Australia's highly mobile workforce and high turnover rates in remote areas , inconsistencies in legislated authorisations regarding medicines may result in RNs working either suboptimally or outside their legal scope.
Little has been published about the effects of legislative requirements on nursing practice and health service delivery in remote Australia, where health status is generally poorer and where access to health services and health professionals is more limited than in other parts of the country . Additionally, although RNs who are not NPs are known to have been working in extended roles in remote Australia, little is known about how they are supported to undertake these roles involving medications. Further research is warranted to investigate the legislative models that best facilitate timely access to medicines in remote Australia and the education and experience that best prepare RNs to work in extended MMC roles within a quality use of medicines framework.
Access to essential medicines is a key component of the National Medicines Policy . A lack of consistency between state and territory legislative instruments may affect people's timely access to medicines in remote Australia and have significant implications for their health.
Health service delivery involving medicines in remote areas needs to be consistent across Australia to ensure health outcomes and health professionals in remote areas are not unnecessarily compromised. The present situation poses a considerable risk to the health and rights of many Australians, particularly those living in very remote areas where the vast majority of the population is Aboriginal or Torres Strait Islander.
It also poses a considerable risk to the nursing workforce who may knowingly or not be undertaking aspects of medication management that are not authorised in their state or territory.
Significant collaborative effort cognisant of models of healthcare delivery and the needs of people in remote Australia is required to address the issues identified.