Description

Adverse Drug Events (ADEs), drug-induced toxicity, and side effects are major issues. ADEs are known to cause significant morbidity, mortality, and societal costs. ADEs are thought to be the fourth leading cause of death in the United States, trailing only pulmonary disease (prior to the COVID-19 pandemic), diabetes, AIDS, pneumonia, accidents, and automobile deaths. However, there is insufficient evidence to determine their exact impact. The FDA, for example, receives over 1 million adverse event and medication error reports per year, which greatly aids in monitoring post-market surveillance data. However, data from the FDA Adverse Event Reporting System (FAERS) do not always include all known safety information for a reported medication. As a result, before making any drug-related treatment decisions, all other relevant information should be considered. FAERS is a web-based public dashboard that practitioners, healthcare professionals, and the general public can use to search for information reported to FDA by the pharmaceutical industry, healthcare providers, and consumers. The primary goal of developing FAERS was to improve data access and transparency. However, before interpreting the data, exercise caution because reports on specific drugs or biologics may not reflect the cause of the ADEs by the concerned agents. Other data constraints include: I duplicate or incomplete reports; (ii) the mere inclusion of a report does not pinpoint causation; (iii) unverified information in the reports; and (iv) reports that do not necessarily reflect incidence rates. Over 1.1 million reports were received in 2020 alone, compared to over 2.19 million in 2019 and 2.15 million in 2018. Over 591 000 total reports were expedited in 2020, while over 473 000 were non-expedited. Approximately 42000 were direct reports (voluntarily submitted directly to FDA by consumers and healthcare professionals through the MedWatch programme). In this regard, an expedited report denotes at least one adverse effect that is not currently described in the product labelling and for which the patient outcome is serious; a non-expedited report denotes reports that do not meet the criteria for expedited reports, such as cases reported as serious and expected, non-serious and unexpected, and non-serious and expected. To Err is Human, a landmark 1999 Institute of Medicine (IOM) report, implicated ADEs in 7000 annual deaths at an estimated cost of $2 billion Similarly, a landmark 1995 study found that approximately 28% of ADEs could be avoided by optimising medication safety and distribution systems, providing and disseminating timely patient and medication information, and staffing assignments. Subsequent research indicates that these figures are most likely conservative estimates of ADE morbidity and mortality. This concern, however, has not been addressed, as evidenced by the National Patient Safety Foundation's report, Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After to Err Is Human. According to the findings, ADEs play a role in 50% of surgeries, and over 700,000 outpatients are treated in emergency departments each year for a drug-induced adverse event, with 120 000 of these cases requiring hospitalisation.  In 2001, the US Department of Health and Human Services estimated that 770 000 people were injured or died in hospitals each year as a result of ADEs, which cost up to $5.6 million per hospital per year excluding other incidental costs (e.g., hospital admissions due to ADEs, malpractice and litigation costs, or injury costs. Hospitals spend between $1.56 and $5.6 billion per year on ADE treatment in the United States. In response, the Department of Health and Human Services published the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan) in 2014, which identified methods for measuring and preventing ADEs as well as future goals for improving patient safe. ADE, ADR, side effect, and toxicity analysis, according to a recent study, approximately 30% of hospitalised patients experience ADEs and/or drug side effects Medication mishaps are defined by the American Society of Health-System Pharmacists (ASHP) as unexpected, undesirable, iatrogenic hazards or events in which a medication was involved These events can be broadly classified into two types: I Medication mistakes (ii) ADEs Lack of incorporation of pre-existing condition(s) or pharmacogenetics factors is another significant ADE-generating category that can be added to the list. This study focuses on adverse events; however, it should be noted that ADEs may or may not occur as a result of a medication error. The lack of more recent epidemiological data on the impact of ADEs is largely due to difficulties with low ADE reporting. The ASHP recommends that health systems implement Adverse Drug Reaction (ADR) monitoring programmes to I reduce ADR risks for specific patients and expedite reporting to clinicians involved in the care of patients who do experience ADRs, and (ii) improve patient safety. (ii) Collect pharmacovigilance data for reporting to pharmaceutical companies and regulatory bodies. Polypharmacy, multiple concomitant disease states, paediatric or geriatric status, female gender, genetic variance, and drug factors such as class and route of administration may all increase the risk of ADEs. The Institute for Medication Safety defines high-alert medications as those with a high risk of causing harm, particularly when used incorrectly. Antithrombotic agents, cancer chemotherapy, insulin, opioids, and neuromuscular blockers are examples of high-alert medications. A meta-analysis of intervention studies is also being conducted to reduce ADRs in specific populations.