Case scenario

Sylvia, 67, has lived in a residential aged care home for several years. She has bipolar disorder and is currently taking olanzapine to control manic symptoms. In the late afternoon, she often becomes agitated and restless, so is charted for prn oxazepam 7.5 mg. She is given this several times a week on average.

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

  • Recognise the classifications of restrictive practice
  • Recognise when medicine use is classified as chemical restraint
  • Outline monitoring requirements after chemical restraint is used.

Competency standards (2016) addressed: 1.1, 1.4, 1.5, 3.1

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Background

‘Chemical restraint’ was a term many pharmacists tried to avoid for years, especially those who worked to recruit aged care homes for deprescribing interventions or who educated nursing staff about psychotropic use. They often sought to be neutral, so as not to imply that staff were deliberately restraining or sedating residents.

And yet Directors of Nursing (DONs) were much more upfront about the topic. Many would categorically say there was no chemical restraint used. Yes, they had high rates of psychotropic use, but all the prescribing was for residents diagnosed with dementia. Likewise, all benzodiazepines prescribed were to treat anxiety or insomnia. To them, if you could attribute a diagnosis to psychotropic use, it was not considered ‘chemical restraint’.

Despite a multitude of state and federal parliamentary inquiries reporting high and prolonged psychotropic use in aged care,1–3 targeted research on this topic,4,5 and a dedicated Human Rights Watch report on chemical restraint,6 culminating in the Royal Commission into Aged Care Quality and Safety’s recommendation for the Federal Government ‘to respond to the significant over-reliance on chemical restraint’,7 the view that ‘we have no chemical restraint’ persists in many homes. This attitude may largely stem from a poor understanding of what chemical restraint actually is.

Legislation

On 1 July 2021 the Aged Care and Other Legislation Amendment (Royal Commission Response No. 1) Act, 2021 (Principles) came into force. The amendments introduced by the Principles are aimed at clarifying and strengthening the responsibilities of approved providers of residential aged care.8 The legislation also explicitly details what residential aged care providers must do whenever restrictive practices are considered and used, including in an emergency.8,9

Pharmacists working in aged care homes can help aged care providers understand the implications and intent of the new legislation, and in meeting their legislative obligations.

Restrictive practice

The Principles now classify chemical restraint as one of five ‘restrictive practices’, aligning with the terminology and legislation of the National Disability Insurance Scheme (NDIS).9

‘Restrictive practice’ means any practice or intervention that has the effect of restricting the rights or freedom of movement of the person.8 Each of the following is a restrictive practice: chemical restraint, environmental restraint, mechanical restraint, physical restraint and seclusion (see Table 1).9

Table 1 – Classification and examples of restrictive practices

Chemical restraint

Environmental restraint

Mechanical restraint

Physical restraint

Seclusion

Antipsychotics

Benzodiazepines

Z-drugs

Sedating antidepressants

Anticonvulsants

Opioids

Androgen blockers

Locked doors

Keypad access

Restricting access to outside or an activity

Meal tray locked for extended time

Limited access to walking frame

Lap belts

Hand mitts

Bed rails

Bumpers

Low beds

Concave mattresses

Rockers/recliners

Restrictive clothing

Physical force

Pinning someone down

Pulling someone in a direction they do not want to go

‘Basket’ holds around upper or lower limbs

Locked alone in room

Imposing ‘time out’

Limiting access to call bell and/or walker

Locking a person in a car/vehicle

Reference: Aged Care Quality and Safety Commission9

What is chemical restraint?

According to the legislation, chemical restraint involves the use of medicine for the primary purpose of influencing a care recipient’s behaviour, but does not include the use of medicine prescribed for8,9:

(a) the treatment of, or to enable treatment of, the care recipient for:
(i) a diagnosed mental disorder, or
(ii) a physical illness, or
(iii) a physical condition, or
(b) end-of-life care for the care recipient.

On a practical level, the medicines referred to are usually psychotropics – i.e. medicines that act on the central nervous system to affect mood, cognition and behaviour. Psychotropic medicines include antidepressants, antipsychotics, anxiolytics, hypnotics and anticonvulsants.10

Mental health disorders and chemical restraint

Many residents in residential aged care have a mental health disorder. A recent study found that nearly 60% of residents have at least one.16 The prevalence of depression, phobia/anxiety and psychosis among residents was approximately 46%, 15% and 10% respectively.16

Consider the case of Sylvia, above, to determine if the medicine being used is chemical restraint.

If a patient has a mental health disorder, this does not mean that all their psychotropic use is exempt from being chemical restraint. In Sylvia’s situation, the olanzapine treats the psychosis associated with her bipolar disorder, so it IS NOT chemical restraint. The oxazepam, however, is used on a prn basis to manage her agitated behaviour, so it IS chemical restraint.9

Further, whether a medicine is prescribed as regular or used as prn has no bearing on whether it is considered chemical restraint.

Whenever a medicine is given or prescribed with the main intention to influence a person’s behaviour, it is considered chemical restraint, unless it is used in end-of-life care or to enable medical or dental treatment.9

The flow chart below (Figure 1) has been developed to assist staff of residential aged care facilities to recognise chemical restraint.

Figure 1 – Flowchart to assess if a medicine is used as chemical restraint

Reference: Aged Care Quality and Safety Commission9, adapted by J Breen.

Dementia and chemical restraint

Dementia is a syndrome characterised by cognitive decline (e.g. memory, language or judgment) with functional impairment. Causes include Alzheimer’s disease, vascular dementia and Lewy body dementia. It is not one specific medical condition or mental health disorder. Presentation depends on many factors, including the type/s of dementia (as people age they can develop several types, or ‘mixed dementia’) and parts of the brain affected.11–13

Many people living with dementia develop behavioural and psychological symptoms (formerly referred to as ‘BPSD’, but now referred to as ‘changed behaviours’). These can include depression, anxiety, delusions, hallucinations, insomnia, aggression, agitation, calling out, wandering and sexual disinhibition. Changed behaviour in people with dementia has several causes, including changes in the brain associated with dementia, infections or metabolic disturbances resulting in a delirium, or most commonly, unmet needs that cannot be communicated (e.g. pain, hunger, boredom or loneliness).12,13

Consider these cases of Nigel and Arun, below, to determine whether a medicine is being used as chemical restraint:

Both residents have a diagnosis of dementia. Does this mean the antipsychotic use is not chemical restraint?

Both residents have a diagnosis of dementia. Does this mean the antipsychotic use is not chemical restraint?

Nigel and Arun are demonstrating changed behaviour symptoms. Clearly, chemical restraint will not fix loneliness, hunger or, perhaps in Nigel’s case, misunderstanding of the need for a shower, or the identity of the person showering him. When antipsychotics are prescribed with the main aim of managing these behaviours, as for Nigel, it IS chemical restraint.8,9

However, Arun’s case is entirely different. Dementia-related psychosis is a mental disorder, common across the different types of dementia, manifesting as delusions (fixed false beliefs) and/or hallucinations. Although the exact mechanisms are unknown, dysregulation (imbalance) of neural pathways is implicated.13 This is typified by Arun’s case, in which visual hallucinations predominate and cause him distress (this distinction is important as psychotic symptoms don’t always cause distress and therefore don’t always require treatment). When antipsychotics are prescribed with the main aim of treating a mental disorder, as for Arun, it IS NOT chemical restraint.8,9

Case scenario

Nigel, 88, moved into an aged care home shortly after his wife passed. He was diagnosed with mixed dementia 2 years ago. Staff complain that Nigel becomes agitated and disorientated when he is showered. They have asked his GP to prescribe a small dose of risperidone an hour before he has a shower.

Case scenario

Arun, 79, has Lewy body dementia. He has complained to staff and relatives that he sees cockroaches burrowing into his arms. This distresses him greatly and impacts his sleep. Although the staff constantly reassure him there are no cockroaches, he spends a lot of time trying to pick the insects off. The geriatrician decides to trial 50 mg of quetiapine twice a day.

Psychotropic medicines in general have a modest effect for many behavioural and psychological symptoms of dementia, including psychosis and aggression.10,13,14 This needs to be weighed up against the significant adverse effects these medicines can cause, such as increased risk of death, stroke, falls and movement disorders.13,14 When psychotropics are prescribed for behavioural and psychological symptoms, the ability of the resident to function and engage with others may be lessened, reducing their quality of life. A systematic review of 16 meta-analyses of antipsychotics in dementia concluded that their use was limited by their adverse effect profile, and that they should be reserved for severe symptoms that have failed to respond to non-pharmacological strategies.15 International and Australian professional bodies strongly support this stance but also recognise their use in situations where a resident is extremely distressed and their safety or that of others is at risk.13,14

Box 1 – Legislative requirements for chemical restraint use

Chemical restraint must not be used unless8:

  • the prescriber has assessed the person as being at risk of harming themselves or other persons, that the restraint is necessary and that the medicine is for the purpose of chemical restraint (i.e. the main reason is to address behaviour)
  • the assessment, prescriber’s decision to use restraint, behaviours requiring restraint, reason why the restraint is necessary, and the information provided by the practitioner that informed their decision to prescribe the medicine are documented in the consumer’s care and services plan, and
  • the provider is satisfied that informed consent has been given by the care recipient or if they lack capacity, their restrictive practice substitute decision-maker.

In emergency situations: the provider must document the assessment that resulted in the emergency use of the chemical restraint as soon as practicable after the emergency situation has passed, and also inform the substitute decision- maker as soon as practicable about the emergency use of the chemical restraint.9

Reference: Australian Government8

Anxiety, insomnia and chemical restraint

Symptoms of anxiety (e.g. restlessness) and insomnia (e.g. difficultly falling asleep) commonly occur in residents of aged care facilities. Benzodiazepines are often prescribed to help manage these symptoms.4 Is this chemical restraint? This depends on whether the anxiety or insomnia meet the criteria for diagnosis of an anxiety or insomnia disorder.

An anxiety disorder is a mental health disorder characterised by persistent or excessive anxiety or worry that interferes with a person’s ability to function or carry out day-to-day activities.17 There are several types of anxiety disorders, including generalised anxiety disorder (GAD), obsessive compulsive disorder and phobia. Effective treatment includes psychosocial interventions, such as counselling, psychoeducation and cognitive behavioural therapy, and pharmacological interventions, such as antidepressants or short-term benzodiazepine use.17,18

Consider the case of Rosa, below, to determine if the medicine being used is chemical restraint.

Case scenario

Rosa, 84, has GAD and worries about everything. Her GP has prescribed sertraline 100 mg daily, with additional prn diazepam on a short-term basis when she has a severe anxiety attack.

Prescribing an antidepressant for the management of an anxiety disorder IS NOT chemical restraint, nor is the occasional prn use of diazepam when Rosa experiences severe anxiety.8,9

Insomnia can be defined as being unable to fall asleep or stay asleep. Women and older people are more likely to experience insomnia.19 Insomnia can be related to poor sleeping habits, mental health disorders (e.g. anxiety or depression), stimulating substances (e.g. caffeine or tobacco), stress, or a lack of exercise.19 Determining the cause and addressing these contributing factors is the first step of management. Psychological and behavioural measures, such as sleep hygiene, are first-line and should be tried before pharmacotherapy.20

Consider the case of Gui-Ying, below, to determine if the medicine being used is chemical restraint.

Case scenario

Gui-Ying, 92, lives with her husband in a large metropolitan aged care facility. She has taken two temazepam 10 mg tablets every night for over 12 years. When she wakes up in the early morning, she requests another tablet.

Although benzodiazepines have been shown to be effective for insomnia in the short term (2–4 weeks), tolerance can develop after a few weeks, leading to loss of effect.17,18 This appears to have happened with Gui-Ying. Benzodiazepines should be used cautiously in older people as use causes daytime sedation, confusion and falls.17–19 Just because Gui-Ying may be dependent on the temazepam for sleep does not exclude them from being considered as chemical restraint, nor does the fact that she asked for them to be given. The use of temazepam in this instance is to manage sleep behaviour, not to treat insomnia; therefore Gui-Ying’s use IS chemical restraint.8,9

Prescribing a hypnotic with the main aim of stopping a resident from disturbing other residents or fitting in with the schedule of the home IS chemical restraint. Prescribing a hypnotic for insomnia for short-term treatment (up to 2 weeks) after psychological and behavioural therapies have been tried IS NOT chemical restraint.8,9

When a resident requires a benzodiazepine to allow them to comfortably undergo a medical or dental procedure, the medicine is being used to enable treatment of a physical illness or condition. The use of a benzodiazepine in this situation IS NOT chemical restraint.8,9

Requirements of aged care homes when restrictive practice is proposed and used

The Principles place requirements on providers of residential aged care services when a restrictive practice is proposed.8 These include8,9:

  • that restrictive practice is used as a last resort to prevent harm to the resident or others
  • that best-practice alternative strategies are used before restrictive practices and documented
  • that the restrictive practice is used in the least restrictive form, for the shortest time necessary
  • that informed consent is given by the resident or substitute decision-maker when the resident lacks capacity to make this decision
  • that use complies with state and territory law in the place where restrictive practice is used
  • that (as of 1 September 2021) a behavioural support plan is included in the care and services plan if behaviour support is needed for the resident.

In summary, residential homes must assess residents to identify causes for behaviours and develop individualised behaviour support plans. They must consider whether the risk of harm can be managed using non-pharmacological strategies and use these options to their best effect before any restrictive practice is used. Services such as Dementia Support Australia are available to provide homes with support for staff and carers, including for individual client-focused assessment advice and information.21 Contact can be made via online referral (dementia.com.au/contact/referral) or telephone 1800 699 799.

There may be times when a chemical restraint is appropriate to ensure the safety of the care recipient or others, including in emergencies. However, the Principles specify this is a measure of last resort when all other interventions have been employed and excluded.8

Specific obligations related to the use of chemical restraint

The Principles require residential aged care providers to satisfy several conditions before chemical restraint is used.8 The legislative requirements are set out in Box 1.

Only a medical or nurse practitioner can assess whether chemical restraint is needed, not staff, residents or relatives, although information from these sources should be taken into account. The provider must be satisfied that the prescriber has assessed the resident in their current circumstances and that use at this time is necessary. They must ensure that they document the reason for the chemical restraint and that they have obtained informed consent from the resident or their substitute decision-maker.22

The Principles do not regulate medical or nurse practitioners; however, professional codes of conduct set expectations for gaining informed consent. Before prescribing any scheduled medicine medical and nurse practitioners are responsible for obtaining informed consent.22

Informed consent

Informed consent requires an open discussion of the purpose, risks, benefits and alternatives to any medical intervention, as well as the absence of coercion in reaching a decision. The provision of treatment without informed consent goes against the law and the basic human rights of dignity and liberty.6

All adults are presumed to have the capacity to make their own decisions unless there is reason to challenge that presumption. There are different arrangements across states and territories regarding who is the appropriate ‘substitute decision-maker’ for those who lack capacity to make their own decisions in relation to scheduled medicine and restrictive practices.8,9

Additional responsibilities

When a chemical restraint is in use the Principles clearly define the responsibilities of aged care providers. These are8,9:

  • that the resident is monitored for signs of distress or harm, adverse effects, changes in wellbeing, and changes to their ability to be independent and engage in activities of daily living
  • that the necessity for use and its effectiveness are regularly monitored, reviewed and documented
  • that information about the effectiveness and adverse effects of the medicine
    for the care recipient is provided to the prescribing medical or nurse practitioner.

Monitoring and reviewing ensures that chemical restraint is still needed and is the least restrictive form. It assesses effectiveness. Reviews must be carried out in collaboration with the person’s medical or nurse practitioner. Psychotropic medicine use should also be reviewed by an accredited pharmacist as part of a detailed medication review.

The review process should trigger re-evaluation of the need and, where possible, the use of alternative strategies. It should include review of the behaviour management, effectiveness of the medicine, harms, distress, adverse / effects and concerns or views of the person consenting.

Conclusion

New legislation now places clear obligations on providers to ensure that chemical restraint is used only as a last resort, implemented for the least amount of time possible, and recorded, monitored and reviewed.

Many aged care providers are unsure what constitutes chemical restraint and how they can fulfil their obligations when restraint is proposed and used. Pharmacists working in this setting can assist facilities to recognise chemical restraint, recommend alternative strategies before use, and ensure timely monitoring and review of these medicines when used.

Key points:

  • New legislation was introduced in July 2021 for residential aged care providers around the use of ‘restrictive practice’, formerly known as chemical restraint.
  • Chemical restraint is now classified as one of five restrictive practices.
  • Pharmacists can assist residential aged care providers to recognise chemical restraint and to follow their legislative obligations in the event that chemical restraint is considered and used, including in an emergency.
  • Providers must ensure ‘informed consent’ is obtained from the care recipient or the appropriate ‘substitute decision-maker’ before a chemical restraint is administered, unless in an emergency.

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References

  1. NSW Health. Psychotropic medication use in nursing homes: report of the NSW ministerial taskforce. NSW Government. 1997.
  2. Parliament of Australia. Senate Community Affairs Committees for Inquiry and Report. Care and management of younger and older Australians living with dementia and behavioural and psychiatric symptoms of dementia (BPSD). Parliament of Australia. 2014.
  3. Parliament of Australia. Parliamentary Joint Committee on Human Rights. Quality of care amendment (minimising the use of restraints) principles inquiry report. AUPJCHR 88. 2019.
  4. Westbury J, Gee P, Ling T, et al. RedUSe: Reducing antipsychotic and benzodiazepine prescribing in residential aged care facilities. Med J Aust 2018;208:398–403.
  5. Jessop T, Harrison F, Cations M, et al. Halting Antipsychotic use in Long-Term care (HALT): a single-arm longitudinal study aiming to reduce inappropriate antipsychotics. Int Psychogeriatr 2017;29(8):1391–1403.
  6. Human Rights Watch. Fading away: how aged care facilities in Australia chemically restrain older people with dementia. 2019. At: www.hrw.org/report/2019/10/15/fading-away/how-aged-care-facilities-australia-chemically-restrain-older-people
  7. Royal Commission into Aged Care Quality and Safety. Restrictive practices. In: Interim report: neglect, volume 1. Canberra: Commonwealth of Australia, 2019. At: https://agedcare.royalcommission.gov.au/sites/default/files/2020-02/interim-report-volume-1.pdf
  8. Australian Government. Federal Register of Legislation. Aged Care and other Legislation Amendment (Royal Commission Response No. 1) Bill 2021. 2021. At: www.legislation.gov.au/Details/C2021B00068
  9. Aged Care Quality and Safety Commission. Regulatory bulletin. Regulation of restrictive practices and the role of the senior practitioner, restrictive practices. RB2021–13. 2021. At: www.agedcarequality.gov.au/sites/default/files/media/rb-2021-13-regulatory-bulletin-regulation-restrictive-practices-role-snr-practitioner.pdf
  10. Peisah C, Skladzien E. The use of restraints and psychotropic medications in people with dementia. Position paper 38. Alzheimer’s Australia. 2014. At: www.dementia.org.au/sites/default/files/Publication_38_A4_print_version_Web.pdf
  11. Dementia Australia. What is dementia? 2021 At: www.dementia.org.au/about-dementia/what-is-dementia
  12. Mayo Clinic. Dementia. 2012. At: www.mayoclinic.org/diseases-conditions/dementia/symptoms-causes/syc-20352013
  13. International Psychogeriatric Association (IPA). The IPA complete guides to the behavioral and psychological symptoms of dementia: specialists guide. 2015. At: www.ipa-online.org/UserFiles/file/IPA_BPSD_Specialists_Complete_Guide_Online_2015_Final.pdf
  14. Royal Australian and New Zealand College of Psychiatrists. Antipsychotic medications as a treatment of behavioural and psychological symptoms of dementia (Professional Practice Guideline 10). 2016. At: www.ranzcp.org/files/resources/college_statements/practice_guidelines/pg10-antipsychotic-medications-for-dementia.aspx
  15. Tampi D, Rajesh R, et al. Antipsychotic use in dementia: a systematic review of benefits and risks from meta-analyses. Ther Adv Chronic Dis 2016;7(5):229–45.
  16. Amare A, Caughey G, Whitehead C, et al. The prevalence, trends and determinants of mental health disorders in older Australians living in permanent residential aged care. Aust N Z J Psychiatry 2020;54(12):1200–11.
  17. Anxiety and Depression Association of America. SSRIs and benzodiazepines for general anxiety disorders (GAD) 2020. At: https://adaa.org/learn-from-us/from-the-experts/blog-posts/consumer/ssris-and-benzodiazepines-general-anxiety
  18. Royal Australian College of General Practitioners. Prescribing drugs of dependence in general practice, Part B – Benzodiazepines. 2015. At: www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/drugs-of-dependence/part-b
  19. Healthdirect (2021). Insomnia. At: www.healthdirect.gov.au/insomnia
  20. Insomnia. In: eTG complete. Melbourne: Therapeutic Guidelines; 2021.
  21. Dementia Support Australia. ReBOC: Reducing behaviours of concern. 2012. At: https://dementia.com.au/downloads/dementia/Resources-Library/Understanding-Responding-Behaviour/ReBOC-guide_full%20document.pdf
  22. Australian Government. Aged Care Quality and Safety Commission. Frequently asked questions about consent. 2021. At: www.agedcarequality.gov.au/resources/frequently-asked-questions-about-consent

ASSOCIATE PROFESSOR JUANITA BREEN BPharm, MSc(Dist), GradDip CommPracPharm, PhD has an extensive background in community pharmacy and aged care research. After gaining a PhD at the University of Tasmania, lectured at the Wicking Dementia Centre. She presented her work at the Royal Commission into Aged Care in 2019 and now consults for the Aged Care Quality and Safety Commission and continues to research psychotropic and restraint use in older people.

The author would like to acknowledge UNSW Professor Carmelle Peisah MBBS (Hons), MD FRANZCP, and Dr Melanie Wroth MBBS, FRACP, who contributed significantly to this article.

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