[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35485-35487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Health Care Research and Quality, Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare and Research and Quality (AHRQ) to request that the Office 
of Management and Budget (OMB) allow the proposed information 
collection project: ``Development of an Electronic System for Reporting 
Medication Errors and Adverse Drug Events in Primary Care Practice 
(MEADERS).'' In accordance with the Paperwork Reduction Act of 1995, 
Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to 
comment on this proposed information collection.
    An earlier version of this proposed information collection notice 
was previously published in the Federal Register and a period of 90 
days was allowed for public comment. At the request of OMB, AHRQ is 
publishing this notice to allow an additional 30 days for public 
comment. The original

[[Page 35486]]

30 day notice is available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-574.pdf .

DATES: Comments on this notice must be received by July 30, 2007.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036, 
Rockville, MD 20850, or by e-mail at [email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from AHRQ's Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports 
Clearance Officer, (301) 427-1477.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Development of an Electronic system for Reporting Medication Errors 
and Adverse Drug Events in Primary Care Practice (MEADERS)''

    AHRQ will develop and pilot test an electronic system for reporting 
medication errors and adverse drug events that occur in outpatient 
physician practices. The reporting system, MEADERS, is being developed 
in collaboration with the Food and Drug Administration (FDA) and data 
collected will closely mirror information included in paper-based 
physician reports to MedWatch. While the major purpose of this project 
is to determine the ability and willingness of busy clinicians to use 
the electronic reporting system and to investigate barriers and 
facilitators to its actual use in practice, the data collected on 
medication errors and adverse drug events will be reported back to 
practices for their use in improving the quality of care provided. The 
landmark Harvard Medical Practice Study, published in 1991, stated that 
98,000 Americans die each year from medical errors. (Ref: Brennan TA, 
Leape LL, Laird NM, et al. Incidence of Adverse events and negligence 
in hospitalized patients: Results of the Harvard Medical Practice 
Study. N Engl J Med 1991; 324:370-376.)
    Although the exact figure has been disputed, no one disputes the 
fact that too many Americans are injured unnecessarily by medical 
mistakes that could be avoided. (Ref: McDonald CJ, Weiner J, Hui SL. 
Deaths due to medical errors are exaggerated in the Institute of 
Medicine Report. JAMA. 2000; 284:93-95 and Leape LL. Institute of 
Medicine medical error figures are not exaggerated. JAMA. 2000; 28:95-
97). Another study performed by the Department of Veterans Affairs 
suggests that in one out of every 10,000 hospitalizations, a patient 
dies due directly to a medical error. (Ref: Hayward RA, Hofer TP. 
Estimating hospital deaths due to medical errors: Preventability is in 
the eye of the reviewer. JAMA. 2001; 286:415-420).
    In response to the growing concern over medical errors, the Agency 
for Healthcare Research and Quality (AHRQ) has published three 
important monographs outlining the problem of errors, (Ref: Institute 
of Medicine. To Err Is Human: Building a Safer Health System. 
Washington, DC: National Academy Press, 2000), their effects on the 
quality of care, (Ref: Institute of Medicine. Crossing the Quality 
Chasm: A New System for the 21st Century. Washington, DC: National 
Academy Press, 2001), and offering suggestions on improving patient 
safety. (Ref: Institute of Medicine. Patient Safety: Achieving a New 
Standard for Care. Washington, DC: National Academy Press, 2004). The 
first recommendation of this third monograph was to ``capture 
information on patient safety--including both adverse events and near 
misses--as a byproduct of care, and use this information to design even 
safer care delivery systems.'' One central theme to each of these 
monographs is that there simply is too much chaotic information flowing 
in the medical environment for a single provider to handle effectively. 
Therefore, solutions to the problem of medical errors should include 
some combination of health information technology and redesign of 
health care systems to enhance the prevalence of appropriate decisons 
(i.e., avoiding errors of omission) and reduce the occurrence of 
avoidable mistakes (i.e., avoiding errors of commission).
    A recent conference sponsored by AHRQ highlighted interventions to 
improve medical decision-making and reduce medical errors. (Ref: http://www.blsmeetings.net/PatientSafetyandHIT/ (Accessed August 11, 2005)). 
Most of the interventions presented were based in hospitals, where the 
most intensive and immediately life-threatening events occur. Yet the 
majority of medical decisions are made in outpatient practices and 
offices where there has been little error-reduction research performed. 
Further, most outpatient studies have been performed in academic 
medical centers which have capabilities, providers, and patients that 
may not typify the average U.S. medical practice. (Ref: Green LA, Fryer 
GE, Yawn BP, Lanier D, Dovey SM: The ecology of medical care revisited. 
N Engl J Med 2001; 344:2021-2025).
    With the recent passing of the Patient Safety and Quality 
Improvement Act of 2005, 42 U.S.C. 299b-21-b-26, now is an opportune 
time to evaluate a primary care error reporting system. In most primary 
care practices there is no mechanism in place to report medication 
errors as they occur, and adverse drug events observed in the primary 
care setting are currently under-reported to the FDA. (Ref: Uribe CL, 
Schweikhart SB, Pathak DS, Dow M, Marsh GB. Perceived barriers to 
medical-error reporting: An exploratory investigation. J Healthcare 
Management. 2002;47(4):263-79). We propose to develop and pilot test a 
computer-based error reporting system to better understand the ability 
of physicians to identify their own medication errors as well as 
adverse drug events, and their willingness to report them 
electronically. The fundamental objectives are to (1) evaluate the 
usefulness, ease of use, and actual use of the system in everyday 
clinical practices, and (2) identify provider and practice 
characteristics that predict uptake and use of this system in 
participating primary care practices. The data collected on medication 
errors and adverse drug events will be aggregated by practice and fed 
back to the practice for its use in improving the quailty of care 
provided.

Methods of Collection

    A total of 45 physicians and their practice staff will participate 
in the pilot test of the reporting system in addition to completing 
baseline surveys of their practice and reporting on use and 
satisfaction with the reporting system. The reporting system will 
request information about the patient involved (to be encrypted), 
category of event (error, adverse drug event, drug-drug interaction), 
timing of event, specific medications involved, type of event (e.g., 
wrong drug prescribed, wrong dose, wrong patient), contributing 
factors, and evidence of patient harm. The surveys will capture data 
describing the practice and the patients it serves, the extent of the 
error reporting system's use, and an assessment of the users' overall 
satisfaction with the system. Practice and provider information will be 
collected at baseline along with characteristics that could be 
facilitators (such as an electronic medical record system) or barriers 
(such as lack of time and resources needed to report information) to 
implementation of the MEADERS system. Data collected on the system's 
use will include the number of clinicians who have used MEADERS at

[[Page 35487]]

least once, the number of times used overall, the time it takes to 
enter data into the electronic MEADERS, and the types of medication 
errors and adverse drug events that are being reported. A follow-up 
assessment will include clinicians' and managers' satisfaction with the 
system (e.g., ease of use, usefulness of the generated reports and 
individual feedback) and whether they intend to continue its use after 
the study period has concluded.
    Although any clinician in the practice will be able to use the 
system, physicians are likely to be the primary users of the system. We 
estimate that physicians will account for about 80% of MEADERS use and 
Nurse Practitioners, Physician Assistants and Medical Assistants will 
make up the remainder (see Exhibit 1). The time for entering an event 
into the system is estimated to require no more than 8 minutes of a 
clinician's time.

Estimated Annual Respondent Burden

                               Exhibit 1.--Estimate of Cost Burden to Respondents
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                                                     Estimated                                       Estimated
                                     Number of       time per        Estimated        Average       annual cost
     Data collection effort         responses *   respondent  in   total burden     hourly wage      burden to
                                                       hours           hours          rate **       respondents
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Office Manager Baseline survey..              45           0.25            11.25          $34.67         $390.04
Physician baseline survey.......              45           0.25            11.25           57.90          651.38
Physician opinion survey of                   45           0.25            11.25           57.90          651.38
 system.........................
Physician entry of medication                216           0.134           28.94           57.90         1675.63
 error..........................
Nurse opinion survey of system..              45           0.25            11.25           27.35          307.69
Nurse entry of medication error.              18           0.134            2.4            27.35           65.64
PA/NP opinion survey of system..              45           0.25            11.25           34.17          384.41
PA/NP entry of medication error.              18           0.134            2.4            34.17           82.00
Medical assistant survey of                   45           0.25            11.25           12.58          141.53
 system.........................
Medical assistant entry of                    18           0.134            2.4            12.58           30.19
 medication error...............
Office Manager opinion-survey of              45           0.25            11.25           34.67          390.04
 system.........................
                                 ----------------                ----------------                ---------------
    Total.......................             585  ..............          114.89  ..............         4769.93
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* Based on a six month trial period of MEADER reporting system.
** Based upon the mean of the average wages, National Compensation Survey: Occupation wages in the United States
  2004, ``U.S. Department of Labor, Bureau of Labor Statistics.''

    This information collection will not impose a cost burden on the 
respondent beyond that associated with their time to provide the 
required data. There will be no additional costs for capital equipment, 
software, computer services, etc.

Estimated Costs to the Federal Government

    The total cost to the government for this activity is estimated to 
be $640,000.00.

Request for Comments

    In accordance with the above-cited legislation, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of health care research and 
information dissemination functions of AHRQ, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: June 21, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-3159 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-90-M