This ICR is approved consistent with changes made to supporting statement and instruments. AHRQ confirms that the versions of the instruments and supporting statement being approved are the files titled "FOCUS GROUP GUIDE final.doc" and "Supporting Statement Part A Part B FINAL.doc" and the version of the follow-up survey uploaded on 9/25/07.
Inventory as of this Action
Requested
Previously Approved
10/31/2008
12 Months From Approved
570
0
0
98
0
0
0
0
0
Medication errors are among the most common medical errors, harming at least 1.5 million Americans and costing billions of dollars annually. Adverse drug events (ADEs), defined as any untoward event related to mediation (about 30 percent of which are thought to be preventable) also occur frequently. Studies indicate that 400,000 preventable drug-related mistakes occur each year in hospitals, and 6.5 percent of hospitalized patients have an adverse drug event. However, there is a dearth of information about medication errors and adverse drug events that occur in the ambulatory setting, where most prescribing occurs. Manufacturers are required by regulation to report to the U.S. Food and Drug Administration (FDA) all adverse drug reactions. Reporting of such events by health care professionals through the FDAs MedWatch program is however voluntary, and the relatively small number of such reports filed annually by clinicians indicates that this paper-based system is significantly underutilized. Anecdotal information suggests that busy clinicians in the ambulatory setting find the filing of a paper report to MedWatch time-consuming and thus burdensome to the practice. Clincians may also be concerned about the confidentiality and security of the data being reported.
Chart review is the most commonly used method to ascertain medication-related events among inpatients, but inadequate documentation of outpatient care limits the usefulness of this approach in ambulatory settings. For this reason, attention is being focused on prospective collection of data describing outpatient medication-related events. Prospective data about the frequency, type, severity, and consequences of drug-related events among outpatients could not only increase our understanding of the epidemiology and causes of such events, but could also directly assist clinical practices in identifying strategies to keep them from occurring or to ameliorate any consequences.
Through a contractor (Indiana University), and with the collaboration of the FDA, AHRQ has developed and refined (based on beta-testing in three primary care practices) a new internet-based reporting system called Medication Error and Adverse Drug Event Reporting System (MEADERS) designed for use in ambulatory practices. The system enables clinicians and staff within any practice having high-speed internet access to report information on medication errors and ADEs electronically. It has been designed to be simple to use and to require a minimal amount of time for reporting, thereby imposing little or no burden on the primary care practice. The new reporting tool is accessible for viewing at www.pcrxevents.org.
US Code:
9 USC 580
Name of Law: Healthcare Research and Quality Act of 1999
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 1 Focus Group Guide
RESPONSE TO OMB QUESTIONS OF AUGUST 30.doc
Attachment A -- AHRQ Legislation.pdf
Focus Group Guide