INCREASE OF REPORTS OF SUSPECTED ADVERSE DRUG REACTIONS IN ONCOLOGY
Keywords:
Chemotherapy, Adverse drug reactions, PharmacovigilanceAbstract
Objective: The information of safety of antineoplastic agents derives solely from clinical studies that have a number of limitations, such as the number of patients enrolled, selected case studies, follow-up of short duration; therefore, it is not possible to identify the complete profile of safety and possible side effects of the drugs under study. ADRs monitoring and reporting programmes aim to identifying and quantifying the risks associated with the use of drugs provided in a hospital setting. The main objectives of this study were to evaluate the ADRs that occurred during hospitalization for chemotherapy in 7 cancer centers, and to facilitate the development of a monitoring system of pharmacovigilance.
Methods: An observational study was conducted in 7 cancer centers in the Emilia Romagna region over a period of 2 years, from January 2012 to January 2014. This study was based on an analysis of ADRs reported. Several parameters were utilised in the data evaluation, including drug and reaction characteristics.
Results: From January 2012 to January 2014 No. 884 ADRs were included in National Network of pharmacovigilance. The highest ADR rate (57.4%) was found in the adult females with a mean age of 62. The oncology drug most frequently reported were taxanes and platinum derivates.
Conclusion: The results obtained will contribute to the development of strategies for the pharmacovigilance service in 7 cancer centers, which will improve the quality of ADR reporting and ensure safer oncology drug use.
Downloads
References
World Health Organization. Technical report series no. 425. Geneva, Switzerland: World Health Organization. International drug monitoring: the role of the hospital;1966. p. 1–24.
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146607.pdf.
Van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004;3:457–64.
Leape L, Reporting of adverse events. N Engl J Med 2002;347:1633–8.
Magalhães SMS, Carvalho WS. Ciências Farmacêuticas. Uma Abordagem em Farmácia Hospitalar. São Paulo: Atheneu, Reações Adversas a Medicamentos; 2001. p. 125–46.
Passarelli MCG. Reações adversas a medicamentos em uma população idosa hospitalizada. PhD thesis. Universidade de São Paulo: Faculdade de Medicina;2005.
[7]Rozenfeld S. Agravos provocados por medicamentos em hospitais do Estado do Rio de Janeiro. Rev Saude Publica 2006;41:1–8.
Gomes AP. Incidência de reações adversas a medicamentos em Hospital de Ensino do Nordeste do Brasil. MSc thesis. Universidade Federal do Ceará, Faculdade de Ciências Farmacêuticas; 2004.
Pfaffenbach G, Carvalho OM, Bergsten-Mendes G. Reações adversas a medicamentos como determinantes da admissão hospitalar. Rev Assoc Med Bras 2002;48:237–41.