ABSTRACT
<b>Objective: </b>For safe use of drugs, it is indispensable to carry out proper and continuous risk management throughout preclinical to post-marketing phases. In Japan, denosumab, a novel anti-RANKL antibody for treatment of bone metastasis, was approved in April 2012. Since beginning of clinical use, severe hypocalcemia has been reported as adverse drug reactions. In this study, the role of pharmacists in minimization of risks of newly introduced drugs was examined using denosumab as an example.<br><b>Methods: </b>Firstly, the description on prevention of hypocalcemia in approval review report and different versions of drug package inserts of denosumab were compared. Secondly, the differences in ratio of hypocalcemia in patients using denosumab with or without concomitant use of Ca and vitamin D preparations in Kobe City Medical Center General Hospital between April 2012 and July 2013 were examined.<br><b>Results: </b>During the few months after beginning of clinical use of denosumab, many cases on the onset of severe hypocalcemia induced by denosumab had been reported. Therefore, drug package insert was revised to enhance and recommend Ca and vitamin D supplementation. Before the in-house enforcement in our hospital, of 26 patients, 6 patients were administered with denosumab without Ca and vitamin D preparations and 2 of them developed hypocalcemia over Grade 3. After the in-house enforcement, no significant changed in serum Ca level in the 20 patients with Ca and vitamin D preparations were observed.<br><b>Discussion: </b>Severe side effects can be avoided if hospital pharmacists take appropriate measures based on rational evaluation of proper information.<br><b>Conclusions: </b>For risk minimization, pharmacists must evaluate and manage the risks of newly introduced drugs.
ABSTRACT
<b>Object: </b>For cancer chemotherapy with injection, oral agents are also frequently prescribed. In checking injection prescriptions for cancer chemotherapy, mistakes in the prescription of oral agents have been found. In this study, we analyzed inquiries for clarifying questionable points, and confirmed the importance of checking oral agents prescribed in cancer chemotherapy.<br><b>Methods: </b>We investigated the following items between January and December 2006: the number of prescriptions in which the checking system for combined oral agents associated with cancer chemotherapy at the outpatient clinic was required, number of prescription errors regarding injection in which the prescription was changed based on inquiries for clarifying questionable points, and number of prescription errors regarding combined oral agents. Furthermore, we classified precautions necessary for checking these prescriptions.<br><b>Results: </b>From January to December 2006, the number of prescriptions was 5,132. In 2,806 (54.7%) of them, it was necessary to check prescriptions for combined oral agents associated with chemotherapy. The oral prescriptions were classified into 3types: agents described as pretreatment agents for chemotherapy in the package inserts, supportive therapy agents for reducing side effects, and oral anticancer agents. There were 59 errors regarding injection, and 54 errors regarding combined oral agents. Among the 54 errors, supportive therapy agents for reducing side effects comprised the highest percentage.<br><b>Conclusion: </b>It was necessary to check prescriptions for oral agents in more than 50% of patients undergoing cancer chemotherapy at the outpatient clinic. In addition, in cases in which adverse reactions could be avoided based on the inquiries, the percentage of injection errors was similar to that of oral preparation errors, confirming the importance of checking prescriptions for oral agents.