Medication oversight, governance, and administration in intellectual disability services: legislative limbo

Abstract

Medication administration remains a central component of support for people with intellectual disabilities, yet there is limited guidance for providers regarding their obligations for policy and practice. This article reviews the issue and offers a summary of the information available for disability support providers and their obligations pertaining to medication administration. Medication administration in disability services in Australia has been left in a legislative limbo with no government body taking overall responsibility for providing clear guidelines. Given the current focus on abuse and neglect, this issue requires urgent consideration and debate, with clear policy guidelines an urgent need.

Keywords:

• Disability
• medication
• legislation
• nursing
• disability support worker
• delegation
• Australia

A transition in the delivery of most residential care for people with intellectual disabilities has occurred over recent decades. From oversight and, oftentimes direct service delivery, by qualified health professionals in segregated settings, the shift to a largely de-professionalised (Judd et al., 2017) and highly casualised disability support workforce, where staff turnover is a noted problem (National Disability Services [NDS], 2018), in community settings is now the norm. In these segregated residential settings, which were historically operated by health departments, medication administration was regulated by the same medication legislation for all health settings. Although health departments no longer have any oversight role for disability services, medication administration – which can be defined as “the process of giving a dose of medication to an individual or an individual taking a medication” (Tasmanian Government Disability and Community Services, 2017, p. 41), remains a critical policy and practice issue as, regardless of the care and support model, it is well documented that people with intellectual disabilities have significantly increased likelihood of polypharmacy (McMahon et al., 2020; Hobden et al., 2013), which corresponds to their increased likelihood of multi-morbidity (Cooper, et al 2015; Tyrer, 2019) and poorer health outcomes (Cocks et al., 2016). This issue is even more critical today as increased life expectancies from a range of medical and pharmacological advances has led to a new cohort of people with intellectual disabilities who are living longer, but who often develop multiple morbidities in the middle life years.

In Australia, there are around 250,000 hospitalisations (or 2–3% of hospitalisations) annually that relate to medication related problems, with 50% of this harm being preventable (Pharmaceutical Society of Australia, 2019). It is well documented that there are risks in relation to medication administration, with the World Health Organization stating that “unsafe medication practices and medication errors are a leading cause of avoidable harm in health care systems across the world” (World Health Organization, 2017, p. 5). Factors noted by the World Health Organization that may influence medication errors include lack of therapeutic training, inadequate drug knowledge and experience, inadequate perception of risk, complexity of clinical case, including multiple health conditions, polypharmacy and high-risk medications. Many of these factors apply to people with intellectual disabilities and the staff supporting them.

New South Wales – a contextual example of legislative changes

Although we acknowledge that all Australian states have differences with respect to the provision of disability services, New South Wales provides an interesting insight into how historical changes have affected the provision of care and support as it relates to the task of medication administration. Dating back to 1994, the New South Wales Poisons Regulation defined a hospital as “a public hospital, public institution, private hospital, nursing home, day procedure centre or residential centre for disabled persons” (New South Wales Government, 1994, p. 76). Not only did this clearly apply to both residential disability services, but also the residential centres for the people with disabilities it related to were clearly listed in Appendix F. Over time as various centres closed, this list likewise diminished and by 2002, the definition remained the same but only applied to the Stockton Centre. By 2008, no disability services were covered and reference to disability disappeared from the Act and Regulation.

Parallel to this, came change in New South Wales Health Policy. Originally, residential centres for people with disabilities were covered under the “Medication Handling in Community-based Health-services/residential facilities” policy (New South Wales Health, 2005), which related to the Poisons and Therapeutics Goods Regulation of 2002. This policy provided guidelines “for the handling of medication by persons employed in community-based health services and in residential facilities such as group homes, boarding houses and hostels” (New South Wales Health, 2005, p. 5). Likewise, the various disability centres listed matched Appendix F of the Poisons Regulation. This policy was then superseded by the “Medication Handling in Public Health Facilities” policy (New South Wales Health, 2013), which replaced a number of other New South Wales Health policy documents. This policy applied only “to all Public Health Organisation health facilities including hospitals, institutions, clinical services, outpatient clinics, community health centres, day centres and domiciliary services within the New South Wales Health system’s jurisdiction” (New South Wales Health, 2013, p. 1). This was a pivotal shift as the policy now only applied to services run directly by New South Wales Health. At this point, medications were prescribed to people with intellectual disabilities who lived in their own home, (which could include group homes) and was covered under legislation only until it left the pharmacy. Thus, disability services in New South Wales no longer have legislation determining medication management and while they can adopt New South Wales Health policy as far as is appropriate to the individual setting, they are not legislatively obligated to do so.

Recent studies have identified concerns pertaining to disability-related health support practice within contemporary disability services, which were practices formerly the exclusive domain of nurses (Wilson et al., 2020), and even specialist nurses (O’Reilly et al., 2018) in intellectual and developmental disabilities. In these new models of care, the role of registered nurses has gradually decreased, replaced by the variously named residential care workers, social educators, and more recently disability support workers. The presence of registered nurses in frontline roles in intellectual disability services has further reduced with the introduction of the National Disability Insurance Scheme (NDIS), where “health” matters are legislated to be managed by health departments. Over time, some disability-related health matters (including subcutaneous injections) were later recognised and funded by the NDIS under “high intensity supports” (NDIS Quality and Safeguards Commission, 2018a). Nevertheless, most health matters and the majority of medication administration in disability services is carried out by non-health professionals.

Although recent studies (e.g., Wilson et al., 2020, 2021) have identified specific needs of people with complex support requirements and risks to them and their support teams during this transitional period in Australia, none focus explicitly on legislative frameworks governing medication administration. Where the NDIS Quality and Safeguards Commission (2020) (hereafter the NDIS Commission) provides guidance regarding the management of medication, it is ambiguous and lacks detail beyond stating that “all workers responsible for administering medication understand the effects and side-effects of the medication and the steps to take in the event of an incident involving medication” (NDIS Quality and Safeguards Commission, 2020, p. 14). Although the NDIS Quality and Safeguards Commission (2018b) provides some additional description of knowledge required by staff providing what they deem “high intensity supports,” this is limited to seizure medication in epilepsy management, aperient use in bowel management, and subcutaneous injections, with the latter requiring involvement of a “health practitioner” for variable and measured doses. Polypharmacy is also mentioned on a practice alert. However, despite stating that “polypharmacy increases the risk of drug-related adverse effects” (NDIS Quality and Safeguards Commission, n.d., p. 2), it does not feature in their practice standards, or (quality indicators) guidelines made under the NDIS Act 2013. Not only is the scope of types of medications with extra description quite limited, but it also leaves service providers responsible for individually determining content and implementation of training, policy, and guidelines for these areas, with this lack of exact parameters to define best practice, which would, if present, provide protection from harm for people with intellectual disabilities. Also, most disability support workers within the NDIS lack any health-specific training, and certainly have limited to no insight into pharmacological agents and side-effects, and the effect of pathophysiological processes within the human body.

With respect to medications, national legislation includes the Therapeutic Goods Act (1989) and the Poisons Standard (2021), but neither relate to the administration of medication. On the other hand, state and territory legislation regulate the use and possession of poisons and medications in specified settings, although most predate the NDIS, and there is considerable variability regarding relevance or reference to disabilities.

Aim

In the absence of concrete guidelines and vague government accountability, this article addresses the question: who is responsible generally for legislation in relation to medication administration within disability services?

Method

An Internet search was undertaken of government websites and Google for all current state or territory legislation pertaining to medication to identify where disability and medication administration intersect. Once an electronic copy of each Act and Regulation was compiled, to determine applicability to disability in each of the Acts and Regulations, an electronic search using the search function in Word/pdf was conducted to locate any instances of the key words: “disability” or “disabilities” or both.

Results

A number of Acts and Regulations were identified for each state and territory across Australia, which are listed in Table 1. However, only four of the state/territories had searchable content within these Acts and Regulations specific to disability (see Table 2).

Table 1. State and Territory medicines, poisons, and therapeutic goods legislation.

State/Territory	Act	Regulation
Australian Capital Territory	Medicines, Poisons and Therapeutic Goods Act 2008	Medicines, Poisons and Therapeutic Goods Regulation 2008
New South Wales	Poisons and Therapeutic Goods Act 1966	Poisons and Therapeutic Goods Regulation 2008
Northern Territory	Medicines, Poisons and Therapeutic Goods Act 2012	Medicines, Poisons and Therapeutic Goods Regulations 2014
Queensland	Health Act 1937	Health (Drugs and Poisons) Regulation 1996
South Australia	Controlled Substances Act 1984	Controlled Substances (Poisons) Regulations 2014
Tasmania	Poisons Act 1971	Poisons Regulations 2018
Victoria	Drugs, Poisons and Controlled Substances Act 1981	Drugs, Poisons and Controlled Substances Regulations 2017
Western Australia	Medicines and Poisons Act 2017	Medicines and Poisons Regulations 2016

Table 2. State and territory medicines, poisons and therapeutic goods legislation and their application to disability services.

State/Territory	Keywords (disability, disabilities) found within definitions	Applicable to disability services?
Australian Capital Territory	Residential disability care facility—means a residential facility that provides disability care to people with disabilities	Yes
New South Wales	Not found	No
Northern Territory	Not found	No
Queensland	Nursing Home means a facility, other than a hospital or private residence, at which accommodation and nursing or personal care is provided to persons who, because of disabilities, disease, illness, incapacity or infirmity, have a continuing need for care	Yes
South Australia	Health Service Facility means a hospital, nursing home or other facility at which a health service is provided for the public or any section of the public for the purpose of curing, alleviating, diagnosing or preventing the spread of any mental or physical illness, disease, injury, abnormality or disabilities	No
Tasmania	Persons who are substantially and permanently handicapped by illness, injury or congenital deformity, or by any other disability	Yes
Victoria	Not found	No
Western Australia	Not found	No

Some notable differences across Australia

Tasmania, the Australian Capital Territory, and Queensland currently do have legislation that applies to disability services with Tasmania a notable stand-out that incorporates a definition of accommodation services for people with disabilities in their definition of Medical Institutions. In addition, Tasmania offers a Disability Services Medication Management Framework based on this legislation intended for use by Disability Services Providers funded by (or run directly by) Disability and Community Services. The Australian Capital Territory regulation provides a concrete definition of disability support as meaning “care that is provided to a person with a disability in a residential facility” (Australian Capital Territory Government, 2021, p. 269), defining residential disability care facility as “a residential facility that provides disability care to people with disabilities” (Australian Capital Territory Government, 2008, p. 172). The Queensland Health (Drugs and Poisons) Regulation 1996 defined institution to include “detention centre, hospital, nursing home or prison” (Queensland Government, 1996, p. 207) and their definition of nursing homes means a “facility, other than a hospital or private residence at which accommodation and nursing or personal care is provided to persons who, because of disability, disease, illness, incapacity or infirmity, have a continuing need for care” (Queensland Government, 1996, p. 208). Notably, the Queensland Act is the oldest and is due to be replaced with the Medicines and Poisons Act, and Regulation, 2019 where the word disability no longer appears.

The South Australian legislation defines a health service facility as a “hospital, nursing home or other facility at which a health service is provided for the public or any section of the public for the purpose of curing, alleviating, diagnosing, or preventing the spread of any mental or physical illness, disease, injury, abnormality or disability” (South Australian Government, 2021, p. 4). Although disability is mentioned, it would not adequately cover a disability group home or other contexts of contemporary disability support such as a day program. Further, a definition for “hospital,” “nursing home,” or “other facility” is not provided. The legislation of Western Australia, Northern Territory, and Victoria make no mention of disability and references to “residential care” (Western Australia and Victoria) and “residential facility” (Northern Territory) refer to services provided under the Aged Care Act 1997 (Commonwealth).

Discussion

Correct medication administration is a vital part of practice for anyone supporting people with intellectual disabilities as medication errors have the potential to be fatal. Salomon and Trollor (2019) noted that various preventable deaths have some relationship with medications, such as risk factors for choking, including high rates of psychotropic medication and polypharmacy; for epilepsy including subtherapeutic dosages of anticonvulsant medications and medication reviews; and psychotropic medications and their impact on lifestyle risks. Although there are a range of causes of medication errors, such as prescribing, monitoring, and drug-drug interactions errors (Assiri et al., 2018), human error is central to any fault in the practice of medication administration (Gluyas & Morrison, 2014) and, therefore, demands due attention with respect to policy and practice.

Medication administration in disability services has been left in a legislative limbo with no government department agency taking overall responsibility for providing clear guidelines in this area. For those with more severe intellectual disabilities who are unable to self-administer, even with support, guidelines are difficult to locate or are absent. This support may be either assisted – where physical support or prompting, or both, are required – or a person may require another to undertake full administration of a medication.

Where there is a legislative framework for the administration of medication in disability services (such as Tasmania), the level of qualification for the administration of different types of medications, the competency and training requirements, as well as limitations are made clear, albeit that it assumes a level of capacity that would be limited, or absent, for many people with intellectual disabilities.

Further, the qualification and training required from the disability workforce by the different states varies. For instance, in Tasmania, the qualification is clear, appropriate, and mandatory – three units of vocational competency are required, those being HLTAID003 Provide first aid; HLTAAP001 Recognise healthy body systems; HLTHPS006 Assist clients with medication, prior to the disability support worker providing any assistance to someone with their medication. Victoria and Queensland provide a checklist (Victorian Government Health and Human Services, n.d.) and guideline (Queensland Government, n.d.) respectively, which recommend training in line with the now superseded unit of competency CHCCS305A Assist client with medication. However, this is not clearly mandated as in Tasmania. Other states and territories have no clear mandate or even guidelines on completion of a national unit of competency, instead leaving individual disability service providers to determine their own arrangements.

Many disability service providers require or request particular qualifications for disability support worker positions. These qualifications are generally Certificate III in Individual Support or Certificate IV in Disability. Some disability service providers do not require any of these qualifications, requiring only a First Aid Certificate and, usually, a driver licence. Critically, none of these vocational qualifications have HLTHPS006 Assist Clients with Medication as a core subject and although it is offered as an elective, none of them require its completion.

“Administration by others” is now largely ignored both in legislation and other guidelines but is the reality for some people with more severe degrees of intellectual disabilities. Recommendations on this topic can be found both in the limitations found within the HLTHPS006 descriptors, which “describes the skills and knowledge required to prepare for and provide medication assistance, and complete medication documentation. It also involves supporting a client to self-administer medication” (Australian Government, 2021a, p. 2), and in position statements of some professional bodies. For instance, the Australian Nursing and Midwifery Federation (2018), although a pro-nursing body, posits “to promote safe care and competent practice a suitably qualified nurse or midwife must administer medicines to individuals who are: unable to self-administer; unable to take responsibility for decisions about when to take medicines and when not to take medicines” (Australian Nursing and Midwifery Federation, 2018, p. 1). Where clinical judgement is required in the administration of medication, in the majority of instances this should be undertaken by (or consultation should take place with) a health professional (such as a registered nurse). This is supported both by states that legislate on medication administration in disability services such as Tasmania (Tasmanian Government Disability and Community Services, 2017), and by the Australian Pharmaceutical Advisory Council (2006) guiding principles for medication management in the community. This seldom mandatory unit of vocational competency HLTHPS006 does not include competency for clinical decision making. However, there is a higher unit of vocational competency HLTHPS007 “Administer and monitor medications” available, which can be completed as an elective as part of Certificate IV in Disability; however, the three states that either mandate or recommend completion of a national unit of competency related to medication do not make reference to this higher level of competency. This unit remains a trades-level vocational unit where the trained person works under the delegation of a health professional: “This unit describes the skills and knowledge required to administer medications to people and monitor them, as per the delegation from a relevant health professional, in accordance with legislation and the employing organisation’s medication and delegation policies and practice.” (Australian Government, 2021b, p. 2). Hence, only a registered nurse has the appropriate skills, scope of professional practice, and professional qualifications to make clinical decisions regarding medication administration, which includes knowledge of side effects and the various physiological and metabolic pathways involved.

What is left to govern medication administration?

As a means to start to establish national standards to support safe medication of administration among people with intellectual disabilities who need that support, to assist with medication administration, the nationally recognised unit of competency “Assist clients with medication” should be held by all disability support workers to set the national standard for basic medication administration skills in disability settings. For administering to a person, the higher unit of competency “Administer and monitor medications” should be held and the disability support worker should administer “as per the delegation of a health professional” (Australian Government, 2021c, p. 2), such as a Registered Nurse. Where clinical decisions are required, a health practitioner (i.e., a Registered Nurse) should be responsible for the administration of the medication. For safe medication administration in disability services to be suitably supported, there should be clear policy that should ideally be based on legislation so that a standard is set and expectations made clear. That is, in the absence of legislated standards, policies and procedures would vary widely and would likely result in an ad-hoc set of practices that increases the risk to all concerned.

Currently, there is increased media scrutiny and oversight into Australian disability services, not just with respect to abuse and neglect, but also regarding issues of service management. Disability service providers are required to establish “robust governance and operational management systems,” which needs to meet “legislative, regulatory and contractual responsibilities” (NDIS Quality and Safeguards Commission, 2020). The production of these organisational policies is then left to each disability service where they need to investigate the legislative framework on which, along with the evidence base, to establish their policy and procedures. In the case of medication policy and procedures, in the absence of legislative basis, there is a hiatus.

Disability support workers, in administering medications, are made responsible for potentially life-threatening actions with no need for professionally, or nationally recognised training. Some disability support workers are left feeling underprepared for medication administration (Davis et al., 2015) and are at risk of disciplinary action (and job loss) in the event of making medication errors for which they are arguably ill-equipped to avoid and could be constituted as neglect in a court or tribunal. registered nurses working for disability services have different, but also significant risks in relation to medication administration. In disability services, registered nurses may either administer medications directly or they may “supervise” others administering medication. As per Registered Nurse Standards of Practice, “as part of practice, RNs are responsible and accountable for supervision and the delegation of nursing activity to enrolled nurses and others” (Nursing and Midwifery Board of Australia, 2016, p. 2). Assistants in nursing are not regulated and work under the supervision and direction of registered nurses (Australian Nurses and Midwives Federation, 2018; Australian College of Nursing, 2016; New South Wales Nurses and Midwives Association, 2017). Registered nurses work under organisational policy and procedures, their training and professional standards, not under clear medication legislation. Sometimes the registered nurse’s role is to supervise and delegate the responsibility of medication administration to disability support workers. The term “supervise” is ambiguous and can be direct or indirect. In the event of a medication incident, the responsibility of the registered nurse is unclear, but they arguably have a degree of responsibility for the medication administration they are “supervising” by an unqualified and likely undertrained disability support worker.

Conclusion

With a long history of well-researched risks in the administration of medication, and with people with intellectual disabilities more often having chronic and multiple health conditions, as well as being more likely to need alternate routes or modified medications compared to the general population, this omission of responsibility in this area is alarming. Disability services are left with a messy mix of legislation. This leaves medication management in legislative limbo, putting people with intellectual disabilities, disability support workers, and nurses responsible for medication administration at risk. A review of state and territory legislation where this area has been neglected is recommended, with reinstatement of regulations for disability services (of all types) to occur. Finally, more research is needed in this space. A useful starting point would be to conduct a retrospective audit of medication omissions and errors within disability services, and to explore which models of service provision and what degree of staff training predicts fewer omission and errors, and subsequently better outcomes.

Disclosure statement

No potential conflict of interest was reported by the author(s).