Pharmacovigilance in oncology: evaluation of current practice and future perspectives

Baldo, Paolo; Paoli, Paolo De

doi:10.1111/jep.12184

Cited by 22 publications

(14 citation statements)

References 53 publications

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“…The programme was based on "spontaneous reporting by health professionals" that, according to WHO, represents the "mainstay of pharmacovigilance." [1][2][3][4][5][6][7][8][9][10][11][12][13] In each of these units, a professional specifically dedicated to pharmacovigilance, usually a haematologist or a pharmacist, with the function of "safety monitor," was assigned.…”

Section: Methodsmentioning

confidence: 99%

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

Fracchiolla

Artuso

Cortelezzi

et al. 2017

Hematological Oncology

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Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non-Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. "FarmaREL", the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO "Gold Standard" for pharmacovigilance in Lombardy, Italy.

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Section: Methodsmentioning

confidence: 99%

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

Fracchiolla

Artuso

Cortelezzi

et al. 2017

Hematological Oncology

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“…clinical trials, non-interventional studies, registries, and health institutions). In these cases, whenever an ADR is suspected, a causality assessment is enacted; only when a high causal association between the adverse reaction and the drug is established is a solicited report prepared [ 9 , 10 ].…”

Section: Pharmacovigilance Workflow: Italy and The Eumentioning

confidence: 99%

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

2018

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The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects). Incorrect use of terminology can have negative effects on the reporting of adverse drug reactions and on the interpretation of these reports. To explain the most common terms used in pharmacovigilance, this article first describes the pharmacovigilance workflow process in the European Union and, as an example, in Italy. Then, the article reviews common pharmacovigilance terms.

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“…There is an increasing emphasis on improving the quality of cancer treatment side effects and toxicity management, alongside the need to collect real-world pharmacovigilance data to improve health outcomes and quality of life [1,2]. This can be achieved through systematically collecting and evaluating chemotherapyrelated adverse events from a patient-centered perspective [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Routine Surveillance of Chemotherapy Toxicities in Cancer Patients Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

et al. 2018

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Introduction: Systematic documentation of chemotoxicities in outpatient clinics is challenging. Incorporating patient-reported outcome (PRO) measures in clinical workflows can be an efficient strategy to strengthen the assessment of symptomatic treatment toxicities in oncology clinical practice. We compared the adequateness, feasibility, and acceptability of toxicity documentation using systematic, prospective, application of the PRO Common Toxicity Criteria for Adverse Events (PRO-CTCAE) tool. Methods: At a comprehensive cancer center, data abstraction of electronic health record reviews elucidated current methods and degree of chemotoxicity documentation. Web-based 32-item PRO-CTCAE questionnaires, administered in ambulatory clinics of patients receiving chemotherapy, captured chemotoxicities and respective severities. Patient telephone surveys assessed whether healthcare providers had addressed chemotoxicities to the patients' satisfaction. Results: Over a broad demographic of 497 patients receiving chemotherapy, 90% (95% CI 84-96%) with significant chemotoxicities (n = 107) reported that their providers had discussed toxicities with them; of these, 70% received a therapy management change, while among the rest, 17% desired a change in management. Of patients surveyed, 91% (95% CI 82-99%) were satisfied with their current chemotoxicity management. Clinician chart documentation varied greatly; descriptors rather than numerical grading scales were typically used. Although 93% of patients were willing to complete the PRO survey, only 50% thought that it would be acceptable to complete this survey at routine clinic visits. Conclusion: Use of PRO-CTCAE in routine clinical practice promotes systematic evaluation of symptomatic toxicities and improves the clarity, consistency, and efficiency of clinician documentation; however, methods to improve patient willingness to complete this tool routinely are needed.

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Pharmacovigilance in oncology: evaluation of current practice and future perspectives

Cited by 22 publications

References 53 publications

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

Routine Surveillance of Chemotherapy Toxicities in Cancer Patients Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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