A Study on the Effect of Changing the Dose on the Package Insert of Distigmine on Cholinergic Syndrome Onset Using the Japanese Adverse Drug Event Report (JADER) Database / 社会薬学

Distigmine has reversible and persistent cholinesterase (ChE) antagonism, and is used for the dysuria due to low activity bladders such as the neurogenic bladder dysfunction widely postoperatively, but fatal cases were reported by cholinergic syndrome. Therefore a dose was limited to 5mg only for adaptation of “the dysuria due to hypotonic bladder such as after surgery and the neurogenic bladder dysfunction” in March, 2010. In the current study, we examined a ministerial policy in the package insert revision using Japanese Adverse Drug Event Report database (JADER). Using a side effect report registered with JADER from January, 2004 to June, 2016, we calculated Reporting Odds Ratio (ROR) which was the index of the safe signal of the medical supplies adverse event and we compared number of reports and ROR of the cholinergic syndrome by the distigmine in approximately the measure in March, 2010 and evaluated it. The number of reports of the cholinergic syndrome by the distigmine was 138 cases before March 2010 and 65 cases after March 2010. After a measure, the number of reports decreased. The possibility that the package insert revision of the distigmine contributed to a decrease in cholinergic syndrome onset was suggested. Whereas monitoring careful sequentially needs the onset of the cholinergic syndrome in constant frequency to be found.

The Introduction Effect of the Protocol for the Appropriate Use of Distigmine Bromide Tablets / 医薬品情報学

<b>Objective: </b>Distigmine can cause cholinergic crisis as the side effect.  In 2010, the safety information of distigmine was announced and its dosage was changed up to 5 mg per day.  However, the malpractice that a pharmacist dispensed over dose of distigmine caused severe health damages in a community pharmacy.  Therefore, we made the protocol with the urologists for the appropriate use of distigmine, including contents of monitoring the side effects.  The purpose of this study was to measure using the protocol was useful for the propulsion of proper use of distigmine.<br><b>Methods: </b>The protocol was introduced in 10 community pharmacies and 1 hospital pharmacy from December 2013 to April 2014, and the patients and pharmacists were filled out the answer to the questions that we have made.  The protocol consisted of five main checks; the dosage, lower urinary tract symptom, presence of renal disease, combined drugs, and signs of the side effects.  Each patient was filled out the checklist given by the pharmacist to monitor the signs of the side effects for 2 weeks.<br><b>Results: </b>The 3 prescriptions of distigmine (18.8%) were more than 10 mg per day.  Although 2 patients were confirmed diarrhea and sweating etc., they were mild.  The pharmacists significantly more (<I>p</I><0.05) answered that the protocol made their motivation to do the pharmaceutical interventions.  All of the patients answered that the pharmaceutical interventions made them relieved.<br><b>Conclusion: </b>The use of protocol that we made supported pharmacists to do the pharmaceutical interventions and patients welcome them.