Role of Pharmacists in Introduction of New Drugs for the Minimization of Risk
10.11256/jjdi.16.28
- VernacularTitle:新規医薬品導入時における リスク最小化活動のための留意点と薬剤師の役割
- Author:
Haruna Yamamoto
;
Noriaki Kitada
;
Naoki Shibatani
;
Masaki Hirabatake
;
Tohru Hashida
- Publication Type:Journal Article
- Keywords:
denosumab;
hypocalcemia;
risk management plan
- From:Japanese Journal of Drug Informatics
2014;16(1):28-32
- CountryJapan
- Language:English
-
Abstract:
Objective: 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.
Methods: 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.
Results: 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.
Discussion: Severe side effects can be avoided if hospital pharmacists take appropriate measures based on rational evaluation of proper information.
Conclusions: For risk minimization, pharmacists must evaluate and manage the risks of newly introduced drugs.
