1.Description of Important Potential Risks of Japanese Risk Management Plan on Each Package Insert
Takashi Tomita ; Yuki Ono ; Kumi Nejihashi ; Takanori Taogoshi ; Hiroaki Matsuo
Japanese Journal of Drug Informatics 2016;18(3):214-217
Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs. One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts. In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert. The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts. Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.
2.Risk Factors for Complications after Reconstructive Surgery for Sternal Wound Infection.
Ichiro HASHIMOTO ; Mitsuru TAKAKU ; Shinji MATSUO ; Yoshiro ABE ; Hiroshi HARADA ; Hiroaki NAGAE ; Yusuke FUJIOKA ; Kuniaki ANRAKU ; Kiichi INAGAWA ; Hideki NAKANISHI
Archives of Plastic Surgery 2014;41(3):253-257
BACKGROUND: Although the utility of flaps for the treatment of sternal wound infections following median sternotomy has been reported for 30 years, there have been few reports on the risk factors for complications after reconstruction. The objective of this investigation was to identify factors related to complications after the reconstruction of sternal wound infections. METHODS: A retrospective analysis of 74 patients with reconstructive surgery after sternal wound infection over a 5-year period was performed. Clinical data including age, sex, body mass index (BMI), comorbidities, bacterial culture, previous cardiac surgery, wound depth, mortality rate, type of reconstructive procedure, and complication rate were collected. RESULTS: The patients' BMI ranged from 15.2 to 33.6 kg/m2 (mean, 23.1+/-3.74 kg/m2). Wound closure complications after reconstructive surgery were observed in 36.5% of the cases. The mortality rate was 2.7%. Diabetes mellitus significantly affected the rate of wound closure complications (P=0.041). A significant difference in the number of complications was seen between Staphylococcus aureus (S. aureus) and coagulase-negative Staphylococci (P=0.011). There was a correlation between harvesting of the internal thoracic artery and postoperative complications (P=0.048). The complication rates of the pectoralis major flap, rectus abdominis flap, omentum flap, a combination of pectoralis major flap and rectus abdominis flap, and direct closure were 23.3%, 33.3%, 100%, 37.5%, and 35.7%, respectively. CONCLUSIONS: Diabetes mellitus, S. aureus, harvesting of the internal thoracic artery, and omentum flap were significant factors for complications after reconstruction. The omentum flap volume may be related to the complications associated with the omentum flap transfer in the present study.
Body Mass Index
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Comorbidity
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Diabetes Mellitus
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Humans
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Mammary Arteries
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Mediastinitis
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Mortality
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Omentum
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Postoperative Complications
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Rectus Abdominis
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Retrospective Studies
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Risk Factors*
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Staphylococcus aureus
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Sternotomy
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Surgical Flaps
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Thoracic Surgery
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Wound Infection*
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Wounds and Injuries