Clinical and economic burden of adverse drug reactions

Sultana, Janet; Cutroneo, Paola Maria; Trifirò, Gianluca

doi:10.4103/0976-500x.120957

Cited by 419 publications

(317 citation statements)

References 64 publications

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“…[1][2][3] This is because the duration of the study was short; the nature of patients were different; the disease treated was not the same; when compared to use after approval and once more the majority of testing were conducted in animal-models which cannot guarantee human-safety. [1][2][3][4] In addition, information is lacking on drug-interactions, chronic-toxicity studies as well as use in neonates, pregnant and lactating women, geriatric patients, and patient with kidney or heart failure. 2 Therefore, in order to detect exceptional and unforeseen ADRs and ensure patient safety post-marketing surveillance has become indispensable Research reported that only 6-10% of the ADRs detected are reported to the authorities.…”

Section: Introductionmentioning

confidence: 99%

Drug Safety Surveillance: Modern Trends and Industrial Action

Abubakar¹,

Simbak²,

Haque³

2015

JYP

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The primary aim of patient care is to provide the best medication that can produce the best treatment with minimal or no harm. This is only possible when the entire health care workers play their card well through correct prescription, dispensing, drug administration and adequate patient monitoring. However, the outcome is not always favorable because of the limited time undergone by the drug during premarketing studies as well as the bias by the pharmaceutical-industries to get approval from regulatory-agencies. As a result of this many safety data and information are lacking. Therefore, in order to preserve patient confidence and integrity of pharmaceutical products, post-marketing surveillance has become necessary. The methods commonly used in post-marketing surveillance include spontaneous reporting, data mining and active reporting which have meaningfully contributed to patient safety. Despite the improvement made, spontaneous reporting have some disadvantages such as underreporting, poor quality of reports, and cannot be used to determine risk rate. Pharmaceutical companies as owners of the drug have noteworthy role to play in adverse drug reactions monitoring and can adopt similar techniques used by the regulatory-agencies and academic research. Unfortunately, this has led to reporting bias. This has suggested the need for more awareness and educational intervention for health care professionals at all levels. The curriculum of training medical and health related students should be incorporated with PV programme. This appraisal has described how to identify adverse drug reactions and methods used in reporting, current developments in pharmacovigilance and role of pharmaceutical-industries in drug safety studies.

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Section: Introductionmentioning

confidence: 99%

Drug Safety Surveillance: Modern Trends and Industrial Action

Abubakar¹,

Simbak²,

Haque³

2015

JYP

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“…Questo rischio è determinato da svariati fattori quali, ad esempio, la dose e la frequenza di somministrazione, oppure le caratteristiche farmacocinetiche di specifiche popolazioni (pediatrica, geriatrica, con insufficienza renale ecc.) (39). Data l'elevata incidenza e le potenziali gravi conseguenze, gli EA generano un forte impatto sia clinico che economico.…”

Section: Discussioneunclassified

Il Costo Degli Eventi Avversi Associati ad Afatinib, Erlotinib e Gefitinib Nel Trattamento del Tumore del Polmone non a Piccole Cellule con Mutazione EGFR

Favaretto

Grossi

Morabito

et al. 2017

Global & Regional Health Technology Assessment

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ORIGINAL RESEARCH ARTICLEL'85% dei tumori del polmone è rappresentato dal tumore polmonare non a piccole cellule (Non-Small Cell Lung Cancer, NSCLC), di cui la maggior parte sono adenocarcinomi (2). Recenti analisi hanno evidenziato che in circa la metà degli adenocarcinomi sia identificabile una mutazione genetica (3, 4). In particolare, nel 10-15% di questi casi, la mutazione viene attivata dal recettore per il fattore di crescita dell'epidermide (Epidermal Growth Factor Receptor, EGFR) (5-8).L'utilizzo di inibitori orali della tirosin-chinasi (Tyrosine Kinase Inhibitor, TKI) nel trattamento di pazienti con NSCLC con mutazione EGFR si è dimostrato predittore di elevati tassi di risposta (70%) e di sopravvivenze mediane superiori a 20 mesi (5, 9).I risultati di una serie di studi clinici randomizzati hanno affermato il ruolo centrale dei TKI nel trattamento di prima linea dei pazienti con mutazioni attivanti di . Sia i TKI di prima (erlotinib e gefitinib) che di seconda (afatinib) generazione, confrontati rispetto alla chemioterapia standard (combinazioni a base di cisplatino o carboplatino) nel trattamento di prima linea del NSCLC con mutazione EGFR, hanno evidenziato, in modo uniforme, un significativo aumento del tasso di risposta e della sopravvivenza libera da progressione (Progression Free Survival, PFS) (10-20). In questi stessi studi non è stata però osservato un aumento significativo della DOI: 10.5301/grhta.5000270 Il costo degli eventi avversi associati ad afatinib, erlotinib e gefitinib nel trattamento del tumore del polmone non a piccole cellule con mutazione EGFR Costs of adverse events associated with afatinib, erlotinib, and gefitinib first-line therapies in advanced nonsmall-cell lung cancer harboring EGFR-activating mutations Introduction: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) afatinib, erlotinib, and gefitinib are an established treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Objectives: Consistent with published meta-analyses, this study compares the cost of management of the adverse events (AEs) associated with these three drugs from the perspective of the Italian National Health System (NHS). Methods: The frequency of AEs was established based on a recently published meta-analysis. Only the costs of management of the AEs were considered. Resource utilization in the management of the AEs was estimated by a panel of Italian oncologists and based on previously published studies. Results: The mean cost per patient treated with afatinib, erlotinib, and gefitinib was €141.03, €90.74 and 121.87, respectively. With afatinib, the cost per patient and per AE of grades ≤2 and ≥3 was €36.70 and €104.33. With erlotinib, the cost per patient and per AE of grades ≤2 and ≥3 was €46.99 and €40.75, whereas the cost with gefitinib was €34.76 and €87.11, respectively. Conclusion: In advanced EGFR mutation-positive NSCLC patients, first-line treatment with erlotinib could reduce the cost of management of the AEs for the NHS. Keywords: Adverse e...

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“…26,29 Recent studies have uncovered numerous genetic linkages with drug-induced toxicity and/or side effects, where knowledge of the individual genetic profile can indicate the likelihood of an undesirable outcome and direct the physician towards alternative medications if necessary and available. Abacavir and carbamazepine are two prime examples, especially as patients who do not carry the HLA-B*57:01 and HLA-B*15:02 alleles, respectively, for the two drugs will almost never experience abacavir-induced hypersensitivity or carbamazepine-induced Stevens-Johnson syndrome.…”

Section: Strengths Of Pharmacogenomics In Clinical Medicinementioning

confidence: 99%

Role of pharmacogenetics in public health and clinical health care: a SWOT analysis

2016

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Pharmacogenomics has been lauded as an important innovation in clinical medicine as a result of advances in genomic science. As one of the cornerstones in precision medicine, the vision to determine the right medication in the right dosage for the right treatment with the use of genetic information has not exactly materialised, and few genetic tests have been implemented as the standard of care in health systems worldwide. Here we review the findings from a SWOT analysis to examine the strengths, weaknesses, opportunities and threats around the role of pharmacogenetics in public health and clinical health care, at the micro, meso and macro levels corresponding to the perspectives of the individuals (scientists, patients and physicians), the health-care institutions and the health systems, respectively.

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Clinical and economic burden of adverse drug reactions

Cited by 419 publications

References 64 publications

Drug Safety Surveillance: Modern Trends and Industrial Action

Drug Safety Surveillance: Modern Trends and Industrial Action

Il Costo Degli Eventi Avversi Associati ad Afatinib, Erlotinib e Gefitinib Nel Trattamento del Tumore del Polmone non a Piccole Cellule con Mutazione EGFR

Role of pharmacogenetics in public health and clinical health care: a SWOT analysis

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