Medicine safety – opportunities for practice, policy and research

Unsafe medicine practices and medicine errors are leading causes of preventable harm.

Health Minister Greg Hunt’s announcement that medicine safety and quality use of medicines (QUM) will become Australia’s 10th National Health Priority is a landmark moment for pharmacy practice, research and education in this country. Unsafe medicine practices and medicine errors are leading causes of preventable harm estimated to cost more than US$42 billion globally each year.¹

The PSA report Medicine safety: Take Care (2019) estimated that medicine-related problems are implicated in up to 250,000 hospital admissions each year in Australia.² While different classification systems exist, medicine-related problems are broad and include events or circumstances that actually or potentially interfere with achieving the optimum therapeutic outcome. They range from adverse events through to improper medicine selection and failure of patients to receive clinically indicated medicines.³

Medicine safety is a broad concept that the Institute for Safe Medication Practices (ISMP) Canada has defined as ‘freedom from preventable harm with medication use’.⁴ The Health Minister’s announcement follows the launch of the World Health Organization (WHO) Third Global Patient Safety Challenge on Medication Without Harm in March 2017.¹ WHO chose to focus on high-risk situations (e.g. high-risk medicines, high-risk population groups), polypharmacy and transitions of care.¹ The Challenge recognised the need for broad improvement across all stages of the medicines management cycle including prescribing, dispensing, administering, monitoring and use.¹

Good communication and empowered consumers will underpin all practice, policy and research initiatives. There are practice, policy and research domains to improving medicine safety, but these domains are not mutually exclusive. Practice and policy should be informed by research and research should address consumer, practice and policy priorities. Similarly, practice, policy and research initiatives should be routinely and transparently evaluated to ensure they continue to meet medicine safety needs. The 11 Actions for Change outlined in PSA’s Pharmacists in 2023 report outlines the importance of ensuring that pharmacists and other healthcare professionals are utilised to their full scope of practice, as this will be important for optimising medicines safety.⁵

Practice initiatives

Practice improvement can be achieved through wider implementation of existing evidence-based programs (e.g. Australia’s Home Medicines Reviews),⁶ and development of new initiatives. Contextualising international best practice models to the Australian health system, and extending hospital-based programs to primary and aged care will also be valuable. This may include, for example, systems for comprehensive no-blame medication incident reporting, benchmarking and quality improvement similar to the Canadian system that was highlighted at PSA19.⁷

Practice initiatives that seek to optimise the management of high-risk medicines will be important. The Clinical Excellence Commission uses the acronym APINCH (Anti-Infectives, Potassium and other electrolytes, Insulin, Narcotics and other sedatives, Chemotherapeutic agents and Heparin and anticoagulants) to define high-risk medicines.⁸ However, this list is not exhaustive nor tailored to all practice settings, and more than two-thirds of emergency hospitalisations among people aged 65 years and older in the United States are linked to four medicine classes: warfarin, insulin, oral antiplatelets and oral hypoglycaemic agents.⁹ Opioid prevalence, persistence and dose escalation is of concern in Australia, with one in every 13 people who start weak opioids transitioning to strong opioids.¹⁰ The overuse of antipsychotics in aged care led to the emphasis of initiatives to minimise the use of antipsychotics in the recent Royal Commission into Aged Care Quality and Safety’s Interim report: neglect.¹¹ The President of the Royal Australian College of General Practitioners Dr Harry Nespolon has also highlighted the lack of good national data on benzodiazepine use.¹²

As highlighted by WHO,¹ practice initiatives should address high-risk situations. Even widely used medicines can be linked to harm when prescribed and dispensed to people who have limited capacity to self-manage their medicine regimen due to factors such as poor health literacy, cognitive impairment, frailty and limited dexterity. Other examples of high-risk population groups include the culturally and linguistically diverse, Indigenous peoples, residents of aged care homes and children. Tools to assess a person’s capacity to self-manage their own medicine regimen have been developed but are rarely used in routine clinical practice.¹³ Furthermore, there is a paucity of pharmacy practice programs that seek to support carers to manage medicine regimens. Medicine safety is likely to be enhanced by initiatives that promote consumer health and medicine literary. WHO has developed the 5 Moments of Medication Safety to assist consumers and carers in discussing key questions about medicines, one of the questions addressing the maintenance of an up-to-date medicine list.¹⁴ Such initiatives may improve medicine adherence, a leading cause of preventable hospital admissions.

Choosing Wisely Australia has worked with key professional associations to develop recommendations so health professionals and consumers can avoid potentially harmful treatments.

Regulatory and policy initiatives

Regulatory and policy initiatives are under-researched as tools to improve medicine safety. Examples of regulatory and policy interventions include changes to pack sizes, labelling, warning labels on medicine boxes, rescheduling, prescribing restrictions, and pay-for-performance schemes. Evaluation of these interventions is important to determine effectiveness and to monitor for possible unintended consequences.

At the PSA-Consumers Health Forum Medicine Safety Forum in December last year, the Deputy Secretary of the Department of Health Adjunct Professor John Skerritt described opioid misuse as a particular medicine safety challenge. In February 2018, non-prescription codeine-containing medicines were up-scheduled to prescription-only, and Australia’s Chief Medical Officer Brendon Murphy wrote to the top 20% of opioid prescribers in June that year, warning about the harms associated with opioid use. The Society of Hospital Pharmacists of Australia produced a key report – Reducing opioid related harm – in November 2018.¹⁵

Research by the University of Sydney’s Dr Kelly Cairns suggests codeine rescheduling appears to have reduced misuse without a corresponding increase in high-strength sales.¹⁶

However, reducing the pack size and delisting of 2 mg alprazolam from the Pharmaceutical Benefits Scheme (PBS) in 2017 may have shifted people to nonsubsidised private prescriptions.¹⁷

Interventions that promote connectedness of consumers and health professionals, including across transitions of care, are promising. My Health Record and Real Time Prescription Monitoring of opioids and other high-risk medicine in states including Tasmania, Victoria and the Australian Capital Territory are examples of recent initiatives. The new template for Consumer Medicines Information recently released by the Therapeutic Goods Administration should better assist consumers in assessing the benefits and risks of medicines.¹⁸

Research

Pharmacovigilance is the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.’¹⁹ Spontaneous adverse drug event (ADE) reporting has been a fundamental component of medicine safety; however, it is widely acknowledged that spontaneous reporting is subject to biases and underreporting. Delivering the PSA Lecture at the Australasian Pharmaceutical Science Association (APSA) Annual Conference in December, Professor Olaf Klungel from Utrecht University in The Netherlands described the high percentage of medicines with one or more post-marketing safety alerts.

Prescribing recommendations in clinical practice guidelines are typically based on results of randomised controlled trials (RCTs). However, RCT participants do not necessarily reflect the characteristics of people prescribed medicine in routine clinical practice. Often it is our most vulnerable population groups at high risk of ADEs who are excluded from RCTs. Lack of evidence leads to prescribing decisions based on assumed benefits and risks, or reliance on evidence extrapolated from other populations or settings. Just 2% of research involving older people is conducted in residential aged care where people are at high risk of preventable medicine-related harm, for example.²⁰ Despite people with dementia being at high risk of stroke, people with dementia have 52% lower odds of being prescribed oral anticoagulants than those without dementia.²¹ For these reasons, a new world-class system of medicine safety will likely involve greater use of routinely collected administrative data (e.g. PBS, Medicare Benefits Schedule, hospital admission and discharge data) and electronic medical record data for high quality observational research to address evidence gaps.

Commonwealth and state initiatives that promote data linkage and research capacity-building are important for filling the evidence gap for vulnerable populations.

Developments in digital health, data science and health informatics hold considerable promise. Collecting data on patient-reported outcomes using wearable devices and machine learning approaches to identify ADEs from coded hospital data are good examples.²² Community pharmacies already collect and hold large volumes of individual patient-level medicine dispensing data with potential to improve quality use of medicines. Also speaking at the APSA Annual Conference, Dr Lisa Kalisch-Ellet from the University of South Australia described how Prescription Sequence Symmetry Analyses, a method of identifying asymmetry in the dispensing order of two medicines in large volumes of dispensing data, had been applied at a national level in Denmark to identify previously unrecognised ADEs worthy of further investigation. The PSA’s Connecting the dots: Digitally empowered pharmacists report describes important digital innovation in pharmacy that can improve the tools and information available to both healthcare providers and consumers, to enhance practice and medicine safety.²³

Preclinical and clinical research into safer treatments and formulations are also important. For example, non-opioid analgesics that are less dangerous in overdose, and formulations that discourage diversion, may be effective for reducing prescription opioid misuse. Safer and more acceptable dose forms that are less prone to errors or promote greater medicine adherence may reduce risks of preventable medicine-related hospitalisations.

Conclusions

Medicine safety will be improved through empowering consumers and a combination of practice, policy and research initiatives. Change will be best achieved when consumers and all health professional groups continue to work together.

This will include fostering a blame-free culture of error and near-miss reporting that informs a cycle of ongoing quality improvement. Pharmacists are ideally placed to develop and implement new programs that promote the safer use of high-risk medicines, particularly when prescribed to high-risk population groups, and this should be a key priority.

Likewise, developing a better understanding of how regulatory and policy measures can be used to promote medicine safety will be important. Addressing evidence gaps in relation to the benefits and harms of medicine used by our most vulnerable population groups will help ensure that medicines are prescribed, dispensed and administered safely and effectively.

Developing a culture of innovation and practice-improvement among current and future pharmacists will help ensure all aspects of medicine safety are improved.

References

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2. Pharmaceutical Society of Australia. Medicine safety: take care. Canberra: PSA; 2019. At: psa.org.au/wp-content/uploads/2019/01/PSA-Medicine-Safety-Report.pdf
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18. Therapeutic Goods Administration. Improved medicines information for consumers. TGA; 2019. At: tga.gov.au/media-release/improved-medicines-information-consumers
19. World Health Organization. Pharmacovigilance. WHO; 2020. At: who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
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21. Fanning L, Ryan-Atwood TE, Bell JS, et al. Prevalence, safety, and effectiveness of oral anticoagulant use in people with and without dementia or cognitive impairment: a systematic review and meta-analysis. J Alzheimers Dis 2018;65(2):489– At: www.ncbi.nlm.nih.gov/pubmed/30056420
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Professor Bell would like to thank Lorenna Reynolds, Monash University, for assistance in preparing this essay.