Third Time’s the Charm: Strengthening Global Efforts to Reduce Medication-Related Harm

I begin every day taking the same pill regimen: a cholesterol-lowering agent for familial hyperlipidemia, a proton-pump inhibitor for gastrointestinal reflux, and an over-the-counter antihistamine for chronic allergies. (AW) I am not exceptional. Over half of US adults take two or more pills a day, and nearly half take three prescription medications a week, putting me squarely in the middle of the road.¹ Worldwide, numbers are slightly lower but comparable.² For older adults the numbers are greater: three out of five older adults in the US take five or more prescriptions a day.

Prescription medications help people around the world treat medical conditions, but they can also cause harm if overused, underused, not monitored, or otherwise misused. Since the beginning of the patient safety era, unsafe medication practices and medication errors have been the leading cause of injury and avoidable harm in health care systems across the globe.³ But most people, most of the time, fail to appreciate the potential downsides of medication use. The need to take multiple medications can be just as problematic, resulting in frequent health care contacts and an increased likelihood of medication related harm. These risks proliferate in specific situations, and at transition points at different levels, locations, and settings of care.

Medication errors occur at every point in the labyrinthine medication use system. At the center lie prescribing, ordering, storage, dispensing, preparation, administration, and monitoring practices. Medication errors are multi-dimensional and may occur because of the weak medication systems and practices, which face increasing numbers of medications, routes of delivery and formulations, human factors, complexity of use, and broader system issues. In many cases, unsafe medication practices can result in severe harm, disability and even death. Although countless strategies have been developed to address the frequency and impact of medication errors, their implementation has been variable. We assert that patients and families can play a key role in taking medications safely and effectively. Healthcare professionals need to ensure that patients are empowered to do this.

The COVID-19 pandemic highlighted many areas where medications were used inappropriately. Some were not supported by scientific studies, such as ivermectin and hydroxchloroquine, and caused significant harms.^4,5 There were conspicuous examples of inappropriate antibiotic prescribing. Antibiotic use has been described in more than 70% of cases of COVID-19, often for the suspicion of bacterial superinfection - in one series this was judged inappropriate in over a third.^6,7 There were many cases related to the use of complementary and alternative medicines, used despite limited evidence for their effectiveness.⁸ Moreover, the disruptions in the health care systems caused by the pandemic resulted in more frequent self-care practices, which also has implications for medication safety.

There were many other examples of inappropriate medication use, which is synonymous with increased risk of harm. For example, medications for non-communicable disease were not reviewed - In particular, medications for anxiety and depression were used without review or monitoring.⁹

Recognizing the scale of avoidable harm linked with unsafe medication practices, the third WHO Global Patient Safety Challenge: Medication Without Harm was launched in Bonn, Germany in 2017.^10,11 The Strategic Framework of the Challenge calls for a systemic approach to address medication safety, by acting across four key domains: patients and the public, health care professionals, medicines and systems and practices of medication.¹² As part of the Challenge, WHO has asked key stakeholders worldwide to prioritize and take early action in three key areas associated with significant patient harm due to unsafe medication practices:

High-risk situations - specific circumstances associated with higher risk of medication-related harm. These may be related to the medication (e.g., high-risk (high-alert) medication with a low therapeutic index), the individual patient or health professional, or the environment or system (e.g., emergencies, neonatal care).

The initial aim of the Challenge has been to reduce severe avoidable medication related harms by 50% globally in the next 5 years. Much of the impetus for the Challenge was lack of progress in the decade that followed the US National Academy of Medicine’s landmark report Preventing Medication Errors, released in 2006.³ In 2019, global advocacy around patient safety in general has culminated in the adoption by the 72^nd World Health Assembly (WHA) of a landmark resolution called ‘Global action on patient safety’, that paid specific attention to the issues related to medication safety, among others.¹³

Furthermore, the Global Patient Safety Action Plan 2021-2030 adopted by the 74^th WHA, provides a framework for action with the goal to achieve the maximum possible reduction in avoidable harm due to unsafe health care globally, with medication safety being one of the critical areas to be addressed in coming decade.¹⁴ One of the core indicators to monitor implementation progress is significant reduction of medication-related harm.

Attention towards medication safety since 2020 has been distracted somewhat by the COVID-19 pandemic. This could not have been forecasted. At the same time, the COVID-19 pandemic highlighted specific safety issues related to medication use, including inappropriate medication initiation, inadvertent stopping, and the lack of review of existing medications.⁹ Considering this, WHO, in collaboration with partners and stakeholders, has selected medication safety to be the theme of World Patient Safety Day 2022.

It is constructive to ask, what else has gotten in the way? One barrier is the vastness and complexity of the medication use system. That system involves different categories of stakeholders, who must be induced to work together. A more pedestrian reason maybe that medication harm never grabbed the spotlight. It never seemed like a crisis. Almost everyone takes medications, with very little monitoring for effectiveness and safety. Although WHO has identified “patients and the public” as one of the key domains for action, there is still insufficient patient empowerment and engagement in shared decision making and their own care.

If complacency is an important barrier at the level of the patient, an important first step is to raise awareness of the problem. Patients need to understand that safe medication use is of personal relevance to them. It is also a precondition for creating a shared value of medication safety with members of their health care team – and to function as a member of that team. This can help cue to the team to action at times of heightened risk.

This kind of patient engagement can be improved by use of simple tool, such as The 5 Moments for Medication Safety - a patient engagement tool designed for use by the patient or caregiver to reduce the risk of medication-related harm (Figure 1). Although it should be used in partnership with health care professionals, its primary aim is to engage and empower patients. The Moments signpost starting, taking, adding, reviewing and stopping a medication. Each moment, in turn, incorporates 5 critical questions, some of which are self-reflective for the patient, while others may require support from health professional or facilitate specific action.

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Figure 1.

WHO 5 Moments for Medication Safety.

The most important things about using the tool are to encourage and welcome questions from patients and their family members, and engage them proactively in communication, in addition to engaging them in shared decision-making and emphasizing their own responsibility in their care.

The role of the patient in working with policy makers and healthcare professionals is crucial to designing systems and processes to address medication safety. Examples include establishing and implementing reporting systems, where patients can raise concerns or ask questions. Health and care professionals can encourage patients to raise concerns and ask questions using the “know check ask” approach.

In order to achieve results that can be sustained over years and contribute to the overall reduction of harm in health care, systematic and systemic approaches should be taken into consideration by policy makers, organizational leaders, health care professionals, and other stakeholders. This means that all domains and priority areas of the Challenge are equally important and need to be implemented in parallel. However, there has been a fundamental conceptual shift of health care systems all over the world towards developing strategies and implementing interventions that are designed around the patient and for the patient. Taking this into consideration, the focus in the coming years perhaps should be placed on engaging and empowering patients and their families. While there is no one-size-fits-all approach, due to factors such as cultural aspects, societal norms, literacy levels and others, the conceptual approach should be directed towards the patient.

Since 2019, World Patient Safety Day has been observed annually on 17 September. The WHA endorsed its establishment and urged countries to mark the date to increase public awareness and engagement, enhance global understanding, and work towards global solidarity and action to ensure patient safety.¹⁵ Participation and commitment to the theme of the WPSD 2022 - Medication Safety - will help this under-appreciated issue finally get the attention it deserves from those with the most at stake – the patient.