Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action

Abstract

Adverse drug reactions (ADRs) are estimated to be between the fourth and sixth most common cause of death worldwide, taking their place among other prevalent causes of mortality such as heart disease, cancer, and stroke. ADRs impact a broad range of populations across a wide variety of global geography and demographics, with significant mortality and morbidity burden in vulnerable groups such as older people, pediatric populations, and individuals in low-income settings. Too large a share of medicines risk management remains limited to signal detection in big ADR databases (USFDA, EMA, WHO, etc.) This resource allocation is antiquated and applied statistical signal detection methodologies have reached their limits of usefulness. In addition, existing databases are designed for short-term reactions, closely related to medication use and, thus, can only partially assess important broader consequences across geography, time, and clinical relevance. There is an urgent need change the dynamic. We need to identify (earlier and more regularly) many of the important but often overlooked or missed ADRs. Rather than assigning blame, we need to identify the root causes of the problem so they can be clearly addressed and fixed. The public health implications are profound—particularly as we recognize the importance of predicting and mitigating the next pandemic. Consequently, medicines risk management must be integrated within a broader global public health vision. To accomplish this, we need to develop the new tools and methodologies critical to assessing these public health imperatives.

Pharmacoepidemiologic study of antipsychotics safety

“…Они влияют на результаты лечения, увеличивают частоту госпитализаций и стоимость терапии, повышают показатели заболеваемости и смертности, влияют на качество жизни и удовлетворенность пациентов оказываемой им медицинской помощью [2]. По оценкам экспертов, НЛР занимают четвертое-шестое место среди наиболее распространенных причин смерти, находясь в одном ряду с сердечно-сосудистыми заболеваниями, злокачественными новообразованиями и инсультом [3]. Бремя НЛР еще более усугубилось в связи с пандемией COVID-19 [4].…”

Patterns of Adverse Drug Reactions: A Study in a Tertiary Care Hospital

“…In addition to human health, side effects also have a significant impact on health-care costs [2]. Harmful adverse effects affect populations globally with significant mortality and morbidity [3]. All drugs can cause side effects, but not all patients experience the same level or type of side effects.…”