G. N. Petratos (1), Y. Kim (2), R. S. Evans (3, 4), S. D. Williams (5), R. M. Gardner (3, 4)
(1) Hoffmann-La Roche, Inc.; (2) Seoul National Medical University; (3) University of Utah; (4) Intermountain Health Care; (5) Utah Department of Health
SummaryObjective: Performance of computerized adverse drug event (ADE) monitoring of electronic health records through a prospective ADE Monitor and ICD9-coded clinical text review operating independently and simultaneously on the same patient population for a 10-year period are compared. Requirements are compiled for clinical decision support in pharmacy systems to enhance ADE detection. Methods: A large tertiary care facility in Utah, with a history of quality improvement using its advanced hospital information system, was leveraged in this study. ICD9-based review of clinical charts (ICD9 System) was compared quantitatively and qualitatively to computer-assisted pharmacist-verified ADEs (ADE Monitor). The capture-recapture statistical method was applied to the data to determine an estimated prevalence of ADEs. Results: A total estimated ADE prevalence of 5.53% (13,420/242,599) was calculated, with the ICD9 system identifying 2,604 or 19.4%, and the ADE monitor 3,386 or 25.2% of all estimated ADEs. Both methods commonly identified 4.9% of all estimate...
OBJECTIVE: To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders.
METHODS: This randomized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users. Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection. During the study period, participants assigned the intervention received a daily reminder text message. Eighty-two women were assigned randomly to detect a 1.6±2.0 pill difference (90% power, 5% α, 15% dropout).
RESULTS: Participants were 79% white, non-Hispanic, 99% high school graduates, and 99% nulliparous with a mean age of 22 years. Most reported condom use with past coital activity, and more than half reported prior emergency contraception use. The mean number of missed pills per cycle did not differ significantly between the groups: 4.9±3.0 for the text-message group and 4.6±3.5 for the control group (P=.60). The number of missed pills per cycle increased over the course of the study, but this pattern did not increase differentially between the groups. Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries. Despite poor pill-taking, there were no pregnancies.
CONCLUSION: Daily text-message reminders did not improve oral contraceptive pill adherence. Although the lack of benefit may be attribu...
The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period April - June 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) April - June 2010
Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional InformationClindamycin injection (Cleocin)
Overdose due to labeling confusion/medication errors
FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Dronedarone hydrochloride
(Multaq)
Torsade de Pointes
FDA is continuing to evaluate this issue to determine the need for any regulatory action.<...