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GRP-004 A New Strategy For Monitoring and Identification of Adverse Drug Reactions in Oncology Patients
  1. E Cini1,
  2. MC Leo1,
  3. M Cecchi1,
  4. E Agostino1,
  5. A Pugi2,
  6. AI Rispoli3,
  7. R Banfi1
  1. 1Careggi University Hospital, Pharmacy, Florence, Italy
  2. 2University of Florence, Centre of Pharmacovigilance Department of Pharmacology, Florence, Italy
  3. 3Careggi University Hospital, Oncology, Florence, Italy


Background Drug safety is an important issue in clinical practise because Adverse Drug Reactions (ADRs) are frequent and potentially life-threatening complications in patients undergoing cancer treatment.

Purpose This study had two main purposes: firstly, to monitor the safety of oncology patients in chemotherapy treatments and to identify and describe the toxicity of drugs; secondly, to compare the incidence and frequency of ADRs in approved experimental chemotherapy protocols compared to the ADRs in common clinical practise.

Materials and Methods From September to December 2012, all prescriptions reducing the normal dosage by at least 25% were examined to evaluate whether or not the reduction or withdrawal were related to ADRs. During these analyses pharmacists supported oncologists in completing ADR spontaneous report forms.

Results To date, eighty-two patients with dose reductions have been screened in the database. Seventeen patients (20.7%) experienced an ADR and the reports were recorded in the Italian Pharmacovigilance Database. Of the 17 patients, 12 were female and the median age was 62 years. All the observed ADRs are known and described in the summary of product characteristics. The drugs mainly responsible for the reactions were 5-fluorouracil, platinum-based agents, bevacizumab and cetuximab. Eight ADRs were graded as serious and required hospitalisation. Reducing the dose or withdrawing the drug after the onset of reactions led to a complete recovery in the majority of the patients. In 1 patient the ADRs caused treatment failure.

Conclusions Our exploratory survey demonstrates a clear and consistent underreporting in this patient setting. Management and understanding of ADRs in the course of drug treatment in cancer patients is important for improving the response to, and tolerability of, the treatment. Collaboration between different professionals is needed to improve the clinical efficacy and safety of care for patients.

No conflict of interest.

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