Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance.

Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance. Setting CRO Aviano, Italian National Cancer Institute. Method From February 2013 to April 2015, we conducted an observational study enrolling 154 patients (≥ 18 years) undergoing treatment with at least one of ten targeted-therapies included in the study. Main outcome ADR reporting in the real-world setting. Patient satisfaction with clinical pharmacist support. Results Reported ADRs in the real setting do not always correspond with data described in the respective SPCs. Unknown ADRs were also identified such as hyperglycaemia with lenalidomide and sorafenib; and hypomagnesaemia with bevacizumab. We also observed a 124.3% increase in spontaneous reports. Conclusion This study shows the high value of active pharmacovigilance programs, and our results might be a starting point for developing a randomised trial which should aim to demonstrate the impact of the pharmacist on improving patient's adherence and in measuring the difference in ADRs reports in the different arms followed or not by the pharmacist.

Use of oxycodone controlled-release immediately after NSAIDs: a new approach to obtain good pain control.

INTRODUCTION: Opioids are recommended as appropriate therapy for the treatment of cancer pain and chronic non-malignant pain. Oxycodone is an alternative agent to its parent compound, morphine, and is available in a controlled-release (CR) formulation that allows convenient twice-daily dosing. The aim of this study was to evaluate the efficacy and tolerability of oxycodone CR as first-line therapy in patients with chronic cancer or non-cancer pain that was not relieved by non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: This was a prospective, open-label, multicentre trial carried out in 8 pain and oncology centres in Italy. Patients (n = 309) with NSAID-refractory chronic cancer (55.7%), noncancer (39.4%) or mixed (4.9%) pain (rating of 4-10 on a numerical rating scale [NRS] from 0-10) were enrolled. Patients were treated with oral oxycodone CR twice daily for at least 28 days. Dosage was individualized for each patient and up-titrated over the first week of treatment. The primary endpoint was reduction in NRS score for pain. Secondary endpoints were tolerability, quality of life and patient assessment of treatment efficacy. RESULTS: A significant decrease (57%) in pain intensity was recorded during the first week of therapy (decrease in NRS score from 7.85 +/- 1.4 to 3.35 +/- 1.8; p < 0.00001). Overall, there was a 72.3% reduction in NRS pain score from baseline at the end of the study. Quality of life significantly (p < 0.005) improved during oxycodone therapy, and 91% of patients rated treatment as "effective" or "very effective". Five patients stopped oxycodone CR treatment because of adverse events, and one stopped treatment because of dysphagia. CONCLUSIONS: The results of this study demonstrate the efficacy and tolerability of oxycodone CR in patients with moderate-to-severe pain of a variety of aetiologies and confirm the feasibility and effectiveness of moving directly from step I to step III on the WHO analgesic treatment ladder.