Adverse drug reactions

Ferner, Robin E; McGettigan, Patricia

doi:10.1136/bmj.k4051

Cited by 18 publications

(11 citation statements)

References 52 publications

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“…Additionally, the risk of ADRs increases in patients administered multiple drugs [15], contributing to the clinical burden of (potentially inappropriate) polypharmacy. ADRs differ in severity with the majority of adverse events considered mild (e.g., headaches, fatigue, constipation and/or nausea), although the overall number of cases is believed to be underreported [16]. Nevertheless, non-severe and non-serious cases still present an avoidable burden to healthcare systems.…”

Section: Background To Pharmacogenomicsmentioning

confidence: 99%

A Review of the Important Role of CYP2D6 in Pharmacogenomics

Taylor

Crosby²,

Yip

et al. 2020

Genes

150

101

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Cytochrome P450 2D6 (CYP2D6) is a critical pharmacogene involved in the metabolism of ~20% of commonly used drugs across a broad spectrum of medical disciplines including psychiatry, pain management, oncology and cardiology. Nevertheless, CYP2D6 is highly polymorphic with single-nucleotide polymorphisms, small insertions/deletions and larger structural variants including multiplications, deletions, tandem arrangements, and hybridisations with non-functional CYP2D7 pseudogenes. The frequency of these variants differs across populations, and they significantly influence the drug-metabolising enzymatic function of CYP2D6. Importantly, altered CYP2D6 function has been associated with both adverse drug reactions and reduced drug efficacy, and there is growing recognition of the clinical and economic burdens associated with suboptimal drug utilisation. To date, pharmacogenomic clinical guidelines for at least 48 CYP2D6-substrate drugs have been developed by prominent pharmacogenomics societies, which contain therapeutic recommendations based on CYP2D6-predicted categories of metaboliser phenotype. Novel algorithms to interpret CYP2D6 function from sequencing data that consider structural variants, and machine learning approaches to characterise the functional impact of novel variants, are being developed. However, CYP2D6 genotyping is yet to be implemented broadly into clinical practice, and so further effort and initiatives are required to overcome the implementation challenges and deliver the potential benefits to the bedside.

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Section: Background To Pharmacogenomicsmentioning

confidence: 99%

A Review of the Important Role of CYP2D6 in Pharmacogenomics

Taylor

Crosby²,

Yip

et al. 2020

Genes

150

101

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“…Observations of ADRs in clinical practice and during postmarketing use of drugs constitute 1 of the bases of PV: reports of new, rare and serious suspected ADRs where causation can be reasonably established in individuals are the basis for signal generation and has supported or contributed to many regulatory actions; voluntary reports also can provide additional information on already identified ADRs. However, spontaneous reporting systems largely depend on the active participation of reporters: underreporting—significant in most countries and critical in some regions—makes it challenging to assess the burden of drug‐related problems . Two decades ago, a more focused approach on patients as the central part of the healthcare and PV systems has led to the inclusion of patient reporting, to the search for adverse effects in social media and other strategies; enriching PV with the patient's views –up to then, an unheard voice .…”

Section: Hcps' Reporting As a Source Of Pv Informationmentioning

confidence: 99%

“…However, spontaneous reporting systems largely depend on the active participation of reporters: underreporting—significant in most countries and critical in some regions—makes it challenging to assess the burden of drug‐related problems . Two decades ago, a more focused approach on patients as the central part of the healthcare and PV systems has led to the inclusion of patient reporting, to the search for adverse effects in social media and other strategies; enriching PV with the patient's views –up to then, an unheard voice . However, patients may not link symptoms with their medicines, and HCPs—either physicians, community and hospital pharmacists, nurses among others—should have the technical expertise to describe and interpret adverse events and assess possible causality.…”

Section: Hcps' Reporting As a Source Of Pv Informationmentioning

confidence: 99%

“…27 Two decades ago, a more focused approach on patients as the central part of the healthcare and PV systems has led to the inclusion of patient reporting, to the search for adverse effects in social media and other strategies; enriching PV with the patient's views -up to then, an unheard voice. 27 However, patients may not link symptoms with their medicines, and HCPs-either physicians, community and hospital pharmacists, nurses among others-should have the technical expertise to describe and interpret adverse events and assess possible causality. HCPs are in contact with patients of all social status and cultural level, even those with the lower level of education-which prevents them from reporting-or with no access to the Internet and related technologies.…”

Section: Hcps' Reporting As a Source Of Pv Informationmentioning

confidence: 99%

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Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content

Comoglio

2020

Brit J Clinical Pharma

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Background Adverse drug reactions (ADRs) are common, often preventable, and a leading cause of morbidity and mortality. Pharmacovigilance (PV) involves detection, assessment, understanding, and prevention of adverse effects or any other drug‐related problem. Education of healthcare professionals (HCPs) involved in drug prescription, dispensing and administration is essential to help prevent and mitigate both ADRs and medication errors and has to be focused on 3 pivotal aspects: •Awareness: All medicines can produce adverse effects. ADRs should always be considered as part of the differential diagnosis if any new adverse condition, symptoms or signs appear after a drug administration or during or after pharmacological treatment. •Knowledge: HCPs must have a sound understanding of the most frequently prescribed drugs and over‐the‐counter medications, factors that make patients more likely to benefit or more susceptible to harm, as well as of causes of medication errors. •Reporting: HCPs should know how to report ADRs and the role of reporting on regulatory aspects and scientific knowledge. Undergraduate curricula must provide, at a minimum, sufficient skills that warrant the appropriate and safe prescription/dispensing/administration of medications in clinical practice, focusing both on therapeutic effects and prevention of harm. Clinical appraisal skills must include ADRs as differential diagnosis, taking accurate medication history, basic individual causality assessment, identification and proper management of ADRs, and informing patients of possible ADRs. Postgraduate periodic PV training should be mandatory as part of continuing education. Specialised postgraduate education should include advanced contents.

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“…The adverse effects of a drug may “hide” behind common presenting symptoms 1. Prescribing cascades occur when a healthcare provider misinterprets an adverse drug event as a new medical condition and provides a second drug to address the side effect, as described in 1997 by Rochon and Gurwitz in the BMJ 2.…”

mentioning

confidence: 99%