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