Pharmacovigilance in oncology.

Background Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow therapeutic windows, and the high doses and rigid timing of treatment regimens. Aim of the review To identify the main issues in carrying out an effective pharmacovigilance activity in oncology. Method We searched PubMed for articles about pharmacovigilance in relation to chemotherapy, radiotherapy and targeted therapy for cancer, using MeSH terms and text words. We also searched Embase, CINAHL, Scopus, Micromedex, the Cochrane Library, two pharmacovigilance databases and the gray literature for articles published in 2012-2018. Overall, 137 articles were considered potentially relevant and were critically appraised independently by two authors, leading to the inclusion of 44 relevant studies, guidelines and reviews. Another 10 important research reports were included in the review. Results Eight critical issues of pharmacovigilance in oncology were identified. These issues pertain to: terminology; range of side effects; targeted therapy and immunotherapy; chemoradiotherapy; generic drugs and biosimilars; drug interactions, pharmacogenetics and polypharmacy; special patient categories; and under-reporting of ADRs. Conclusion The importance of pharmacovigilance in oncology must be highlighted with every effort, to improve safety and offer cancer patients every possible help to improve their quality of life during such a critical period of their lives.

A pilot project of a cancer patient library in Italy: results of a customer-satisfaction survey and its products.

AIMS: The purpose of this study is to determine the degree of satisfaction of users of the Cancer Information Point section of the Library for Patients (CIP-LP), active since 1998 at the National Cancer Institute of Aviano, Italy. The CIP-LP is based on a skilled intermediary, adequate informative material and a specific location, within the Scientific Library of the Institute. PATIENTS AND METHODS: A survey was developed to assess service functionality and quality from the users' viewpoint. During a 6-month period, a questionnaire was mailed to 194 patients and relatives who previously used the CIP-LP; 113 (58%) were returned and processed. RESULTS: Of the respondents, 91% were pleased with the CIP-LP and 95% would recommend the service to other people. The information obtained contributed to a clearer understanding of the illness and treatment (45% as first answer) and a better control of the situation (33%). Fifty-one per cent evaluated the information received as 'good', 42%'excellent' and 4%'of sufficient quality'. CONCLUSION: This survey shows the appreciation and usefulness in the users' perception of a specific hospital library for cancer patients and their relatives, providing an information service supplementary to doctor-patient communication.