Dear
Editors:
We would like to submit the enclosed manuscript entitled“Profile of adverse drug events in depressed inpatients
in China and associated risk factors: a retrospective review using the
Global Trigger Tool” , which we wish to be considered for publication
in British Journal of Clinical Pharmacology . The work
described was original research that has not been published elsewhere
and not been submitted simultaneously for publication elsewhere. All
authors have contributed to the paper significantly, and all authors are
aware of the submission and agree with it.
Antidepressant (AD) is one of the elementary treatments for depression.
The number of people using ADs worldwide has increasing significantly in
recent years. The increasing use of ADs has aroused concerns on the
adverse drug events (ADEs) monitoring in clinical practice.
Traditional methods to detect ADEs are mainly passive monitoring by
spontaneous reporting, which accounting for only 10-20% of the total
ADEs. The Global Trigger Tool (GTT) developed by the Institute for
Healthcare Improvement (IHI) is a retrospective review of a random
sample of inpatient hospital records using “trigger” to identify
possible ADEs, and appears to increase the rate of ADE detection 50-fold
from traditional reporting methods.
Different triggers have been established for different clinical
department. Nevertheless, no trigger was specifically designed for a
certain disease previously. In this study, trigger items suitable for
depression were established for active monitoring of ADEs in inpatients,
and the feasibility and potential of the Global Trigger Tool (GTT) were
evaluated.
To our knowledge, this was the first study to investigate ADEs of
medicines for a certain disease using global trigger tools. It was found
that GTT was an effective method for identifying ADEs in depressed
inpatient with a relatively high positive predictive value (42.59%),
and the incidence of adverse reactions detected by GTT was much higher
than that of spontaneous report. Constipation, hypokalemia, tachycardia
and hypertension were the most common adverse reactions in hospitalized
patients taking antidepressants. Number of ADs and concomitant
medications were shown to be the risk factors for the occurrence of ADEs
of antidepressants during hospitalization.
We deeply appreciate your consideration of our manuscript, and we look
forward to receiving comments from the reviewers. If you have any
queries, please don’t hesitate to contact me at the address below.
Thank you and best regards.