In 2017, the World Health Organization (WHO) announced its third global patient safety challenge, Medication Without Harm, which aims to reduce the global burden of iatrogenic medication-related harm by 50% within five years. Adverse drug events (ADEs) are considered to be among the leading causes of morbidity and mortality. An estimated 5–25% of hospital admissions are due to ADEs, and 6–15% of hospitalized patients experience serious ADEs, causing significant prolongation of hospital stay. Moreover, fatal ADEs are estimated to occur in 0.31% of hospitalized patients. At present, most hospitals participate in pharmacovigilance through spontaneous reporting systems of ADEs. However, spontaneous reporting systems have limitations such as under-reporting. Active pharmacovigilance programs, may supplement such systems.
THE EARLY IDENTIFICATION
ADEs mimic natural disease states and may thus go undetected. Because ADEs are difficult to detect, practitioners may also prescribe pharmacotherapy for an unrecognized ADE, increasing the risk of additional ADEs. ADEs may also cause patients to lose confidence in or have negative emotions towards their physicians and seek self-treatments options, which may consequently precipitate additional ADEs. In addition, ADEs are rarely specific for a drug, diagnostic tests are usually absent and a re-challenge is rarely ethically justified. On the other hand, misdiagnosis may impose unnecessary restrictions. The evaluation of the causality in an ADE is fundamental to carry out an appropriate handling of the patient, since it allows avoiding a possible re-exposure to the drug in the future. A few years ago, causality assessment was completely dependent on expert judgment (known as global introspection) but with great variability in the results. The algorithms of causality have lower variability and a very high sensitivity, but have a low specificity when there are several suspicious drugs. Therefore, it is necessary to carry out studies that allow the development and implementation of increasingly precise tests, to an early identification of the culprit drug of an ADE and in general the knowledge of the safety of drugs.
PREVENTION
Safe and appropriate prescribing is a complex process, involving issues of over-prescription, under-prescription, inappropriate prescription, prescription in high risk situation, interaction prescription, rechallenge to a drug that causes harm, and transitions of care. Special populations, including women, children, the elderly, pregnant women and patients with concurrent disease states, are also at risk because of changes in pharmacokinetics, pharmacodynamics, pharmacogenetics, genomics or metabolomics. The initiatives to reduce the harm of medication span multiple levels, such as: (a) empowerment of patients, caregivers, and the general public; (b) health information systems; (c) clinical decision-making across health care provider and professional groups; (d) health and social policies related to prescribing appropriateness; and (e) research and innovation related to a better prescribing. Each of these actions/initiatives constitutes an important cross-cutting element to bring about health system change to promote a medication without harm.
The aim of this Research Topic is to assemble review and original research of ADE early detection, identification of the culprit drug and treatment strategies. ADE reporting programs around the world are collected. Strategies in preventing ADEs are very welcome.
In 2017, the World Health Organization (WHO) announced its third global patient safety challenge, Medication Without Harm, which aims to reduce the global burden of iatrogenic medication-related harm by 50% within five years. Adverse drug events (ADEs) are considered to be among the leading causes of morbidity and mortality. An estimated 5–25% of hospital admissions are due to ADEs, and 6–15% of hospitalized patients experience serious ADEs, causing significant prolongation of hospital stay. Moreover, fatal ADEs are estimated to occur in 0.31% of hospitalized patients. At present, most hospitals participate in pharmacovigilance through spontaneous reporting systems of ADEs. However, spontaneous reporting systems have limitations such as under-reporting. Active pharmacovigilance programs, may supplement such systems.
THE EARLY IDENTIFICATION
ADEs mimic natural disease states and may thus go undetected. Because ADEs are difficult to detect, practitioners may also prescribe pharmacotherapy for an unrecognized ADE, increasing the risk of additional ADEs. ADEs may also cause patients to lose confidence in or have negative emotions towards their physicians and seek self-treatments options, which may consequently precipitate additional ADEs. In addition, ADEs are rarely specific for a drug, diagnostic tests are usually absent and a re-challenge is rarely ethically justified. On the other hand, misdiagnosis may impose unnecessary restrictions. The evaluation of the causality in an ADE is fundamental to carry out an appropriate handling of the patient, since it allows avoiding a possible re-exposure to the drug in the future. A few years ago, causality assessment was completely dependent on expert judgment (known as global introspection) but with great variability in the results. The algorithms of causality have lower variability and a very high sensitivity, but have a low specificity when there are several suspicious drugs. Therefore, it is necessary to carry out studies that allow the development and implementation of increasingly precise tests, to an early identification of the culprit drug of an ADE and in general the knowledge of the safety of drugs.
PREVENTION
Safe and appropriate prescribing is a complex process, involving issues of over-prescription, under-prescription, inappropriate prescription, prescription in high risk situation, interaction prescription, rechallenge to a drug that causes harm, and transitions of care. Special populations, including women, children, the elderly, pregnant women and patients with concurrent disease states, are also at risk because of changes in pharmacokinetics, pharmacodynamics, pharmacogenetics, genomics or metabolomics. The initiatives to reduce the harm of medication span multiple levels, such as: (a) empowerment of patients, caregivers, and the general public; (b) health information systems; (c) clinical decision-making across health care provider and professional groups; (d) health and social policies related to prescribing appropriateness; and (e) research and innovation related to a better prescribing. Each of these actions/initiatives constitutes an important cross-cutting element to bring about health system change to promote a medication without harm.
The aim of this Research Topic is to assemble review and original research of ADE early detection, identification of the culprit drug and treatment strategies. ADE reporting programs around the world are collected. Strategies in preventing ADEs are very welcome.
