RxInformatics.com

poikonen: RT @JFahrni: RT @ismp1: Adverse Drug Events with HYDROmorphone: How Preventable are They? http://tinyurl.com/2co6ozx

Current Issue Comparing the Effectiveness of Computerized Adverse Drug Event Monitoring Systems to Enhance Clinical Decision Support for Hospitalized Patients Journal:Applied Clinical InformaticsISSN:1869-0327DOI:10.4338/ACI-2009-11-RA-0009Issue:Vol. 1: Issue 3 2010Pages:293-303
Journal Issue Article
Comparing the Effectiveness of Computerized Adverse Drug Event Monitoring Systems to Enhance Clinical Decision Support for Hospitalized Patients

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

Summary

Objective: 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...

poikonen: RT @rxinformatics Don’t dismiss the value of an operationally sound pharmacist | RxInformatics.com http://bit.ly/chh329

poikonen: RT @JoeLassiter: U.S. Court of Appeals upheld a decision concluding no evidence to support claims of a vaccine-autism link. http://goo.g ...

poikonen: Jail time for human error in medicine? http://bit.ly/bs41LX @ISMP1 is right on. @ASHPOfficial position is misguided.

poikonen: The iPad vs. The Tablet PCs in Healthcare - Power of Data Visualization http://post.ly/uazK http://RxInformatics.com

poikonen: @jfahrni @psweetman Prescribing w/o CDS is like being in a boat w/o a life jacket. except MD is not in the boat, the patient is!

Obstetrics & Gynecology: September 2010 - Volume 116 - Issue 3 - pp 633-640 doi: 10.1097/AOG.0b013e3181eb6b0f Original Research Using Daily Text-Message Reminders to Improve Adherence With Oral Contraceptives: A Randomized Controlled Trial Hou, Melody Y. MD, MPH; Hurwitz, Shelley PhD; Kavanagh, Erin MPP; Fortin, Jennifer MPH; Goldberg, Alisa B. MD, MPH Abstract

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...

poikonen: It is more important to have social scientists (human factors) than programmers in building apps. per This Week in Google twit.tv

HIStalk reader and clinical informaticist Lincoln Farnum sent over his exclusive article, Common Knowledge: Clinical Decision Support in the Era of Meaningful Use, a CDS Toolkit. I’ve posted it on Drop.io, hopefully free of the sneaky and unwelcome Facebook tie-ins that keep biting me in the rear when I post files for download. It’s a good overview of CDS, the ethics involved in deploying it, the problems with trying to measure its impact on patient outcomes, usability issues, and best practices in CDS deployment. Give it a look.

poikonen: Potential quarterly source of Adverse Drug Event Surveillance rules from fda http://bit.ly/dAGPMN #ADE

use for ADE Rules????

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010

 

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 Information
(as of July 15, 2010)

Clindamycin 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.<...

poikonen: Great for CDS, better than Beers? RT @ortegame Medications That Put Elderly Patients At Risk: The PRISCUS List http://bit.ly/bJf0n9

poikonen: RT @PharmacistScott: Surprise, surprise. Dr. Bob is wrong http://is.gd/eHtlZ #pertussis #vaccines