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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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




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 Start Printed Page 3548630 day notice is available at​7/​257/​2422/​01jan20071800/​​2007/​pdf/​07-574.pdf .


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


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

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.

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Doris Lefkowitz, AHRQ, Reports Clearance Officer, (301) 427-1477.

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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:​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 Start Printed Page 35487least 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

Data collection effortNumber of responses *Estimated time per respondent in hoursEstimated total burden hoursAverage hourly wage rate **Estimated annual cost burden to respondents
Office Manager Baseline survey450.2511.25$34.67$390.04
Physician baseline survey450.2511.2557.90651.38
Physician opinion survey of system450.2511.2557.90651.38
Physician entry of medication error2160.13428.9457.901675.63
Nurse opinion survey of system450.2511.2527.35307.69
Nurse entry of medication error180.1342.427.3565.64
PA/NP opinion survey of system450.2511.2534.17384.41
PA/NP entry of medication error180.1342.434.1782.00
Medical assistant survey of system450.2511.2512.58141.53
Medical assistant entry of medication error180.1342.412.5830.19
Office Manager opinion-survey of system450.2511.2534.67390.04
* 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.

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Dated: June 21, 2007.

Carolyn M. Clancy,


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[FR Doc. 07-3159 Filed 6-27-07; 8:45 am]