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Health Bulletin 9 June 2022

The latest insights from our Health Law team: 

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Benefits of pharmaceutical intervention at aged care facilities

Medicines are the most common treatments used in health care, particularly amongst the older population. However, when not used correctly, medicines may lead to harmful and sometimes fatal outcomes. It is estimated that between 5% and 20% of aged care residents experience an adverse medicine event every month and that the global costs of medication-related harm exceed $40 billion annually.

A recent study undertaken by researchers from the University of South Australia reviewed the effectiveness of pharmacist-led intervention. The study, which ran for 12 months, involved pharmacists working with 248 aged-care residents across 39 aged care facilities. As part of the study, pharmacists would meet with participants every 8 weeks to record any new illnesses or conditions and to monitor any adverse effects or symptoms. Pharmacists also reviewed residents’ medicines and monitored cognitive and physical health.

At each visit, pharmacists recorded that 60% of participants had problems with their medication. Pharmacists made 309 recommendation to change participant’s medication, or to monitor medication with a view to change. A recommendation to reduce medicine use was made for two-thirds of participants. Critically, the study found a significant change in participants’ cognitive scores and those monitored by pharmacists were less likely to experience negative medication-related effects.

For more information about the study, click here.

Health service sector reporting highest number of data breaches

The Office of the Australian Information Commissioner (OAIC) established the Notifiable Data Breaches Scheme in February 2018. The OAIC periodically publishes statistical information about data breaches arising from the Scheme, with the aim to protect consumers and businesses by tracking the leading source of data breaches and highlight emerging issues for ongoing attention. 

According to the OAIC’s report for the period of July-Dec 2021, health service providers reported 83 instances of data breaches, making up 18% of the 464 total breaches in that period. There were 39 instances of malicious or criminal attack, 39 instances of human error and 5 instances of system faults.

Malicious or criminal attacks were the leading source of all breaches for all sectors, accounting for 256 notifications (55% of the total) followed by human error accounting for 190 notifications (41% of the total).

Maintaining privacy is one of the key principles of delivering safe and quality healthcare. Health service providers are advised to have robust policies and procedures in place to address inadvertent data breaches, which are usually due to a breakdown in processes. With increasing digitisation and automation of services, the risk of data breaches has increased.

Data breaches can be reduced by the use of cloud-based system or daily backing-up and removal of the backed-up data from the practices. Health service providers need to use best practice to minimise data breaches and, when they do occur, put individuals at the centre of their response to build trust.

Should we engage in formal advance care planning?

According to a recent paper titled Cognitive and behavioural bias in advance care planning (the Study), only 14% of the Australian population currently have an advance health directive in place.

The key benefits of implementing an advance care plan (ACP) include improving the experience of end of life for the individual by assuring the wishes of the person are explicitly met and they are comfortable. The study also found that implementing an ACP can alleviate the anxiety and confusion for the loved ones of the person facing their final days. On the professional side of the experience, ACPs also reduce the psychological, emotional, administrative, and economic burden on healthcare professionals and systems.

The Study provides new empirical findings from both frontline health professionals and potential future patients with regards to ACP communication and preferences. Notably, the Study included data collected from 1253 members of the Australian public aged 18–80, along with 117 nurses and GPs.

End of life discussions are important as there is no ‘one size fits all’ approach to healthcare. People will have diverse and specific views about end of life care, which may derive from a religious or cultural background. As stated by Associate Professor Rhee, ‘for example, a person of Jehovah’s Witness faith … might decline treatment involving blood transfusion’. This example illustrates the importance of open and frank discussions between doctors (primarily GPs) and patients.

Russell Kennedy has recently written an alert “Incapacity: Choose Who Makes Decisions for You” which may provide some additional information.  

Psychedelics to treat depression: clinical trial to begin

Macquarie University will launch a world-first clinical trial to test small and consistent doses of a psychedelic drug on depression.

The university will partner with Woke Pharmaceuticals, which has developed a new low-dosage, synthetic formulation of the active ingredient in magic mushrooms, psilocybin. Previous studies have indicated the effectiveness of high doses of psilocybin in conjunction with psychotherapy as a mental illness treatment. This trial is the first to test consistent, “sub-hallucinogenic” doses of the drug to treat depression.

Psilocybin remains a controlled substance in Schedule 9 of the Poisons Standard, after the Therapeutic Goods Administration rejected applications to “downschedule” the drug. This means it is only available for research in highly controlled settings.

The trial will not rely on volunteers for participation, but rather referrals from participating mental health practitioners. Participants will be split into two groups, one group receiving a placebo and the other group receiving two 5mg doses of psilocybin per week. Brain scans, psychological assessments and blood tests will monitor the effect of the substance.

Participants in the trial are expected to commence early next year.

TGA fines individual $39,960 for unlawful importation

An individual without a prescription has been issued with 15 infringement notices by the Therapeutic Goods Administration (TGA), with fines of $39,960, for the unlawful importation of prescription-only medicines invermectin and doxycycline in a one month period.

The individual did not have an authority or exemption to import over 2,500 invermectin or almost 10,000 doxycycline tablets, which is far in excess of the limits permitted by the personal importation scheme. 

After recent claims regarding the use of invemectin in relation to treatment of COVID-19, the TGA has cautioned consumers over counterfeit products, as well as non-compliant advertising regarding its therapeutic use.

For more information on TGA enforcement or other updates, see the TGA website here.

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