Pharmacy Error Reporting Systems

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Questions and Answers

What is typically characteristic of a mandatory reporting system?

Run by state or federal regulatory programs with authority to investigate (correct)

Practitioners are encouraged to report voluntarily

Reports are submitted anonymously and/or confidentially

Errors associated with serious injuries or death

What is the primary purpose of error reporting?

To identify and punish individuals who make errors

To provide information that leads to improved safety

To track the number of errors made by healthcare providers

To hold providers accountable for performance (correct)

Which of the following is an example of a voluntary reporting system in aviation?

Reporting serious passenger injury or substantial aircraft damage

Near miss reporting through the confidential Aviation Safety Reporting System (correct)

Reporting pilot errors to the Federal Aviation Administration

Reporting aircraft maintenance issues

What kind of errors are typically reported in a voluntary reporting system?

Errors that result in minimal injury or no harm Signup and view all the answers

What is the primary function of FDA MedWatch?

To receive reports from the public and publish safety alerts for FDA-regulated products Signup and view all the answers

What is the purpose of the Institute for Safe Medication Practices (ISMP) Medication Error Reporting System (MERP)?

To provide a confidential reporting system for medication errors Signup and view all the answers

What type of products does the FDA regulate, besides medical devices and combination products?

Food, dietary supplements, and special nutritional products Signup and view all the answers

What should be reported to MedWatch, according to the FDA?

Unexpected side effects, product quality problems, and medication errors Signup and view all the answers

What is the primary purpose of the Vaccine Adverse Event Reporting System (VAERS)?

To detect potential safety problems in U.S.-licensed vaccines Signup and view all the answers

Who is required to report pre-specified reportable events for various vaccinations to VAERS?

Only healthcare professionals Signup and view all the answers

What is a limitation of the VAERS system?

Limited ability to determine cause-and-effect Signup and view all the answers

What is the Medication Errors Reporting Program (MERP) used for?

To learn the underlying causes of reported medication errors or hazards Signup and view all the answers

Who can report to the Medication Errors Reporting Program (MERP)?

Both healthcare professionals and consumers Signup and view all the answers

What is the purpose of the Institute for Safe Medication Practices (ISMP)?

To learn the underlying causes of reported medication errors or hazards Signup and view all the answers

What is a type of product that is regulated by the FDA?

All of the above Signup and view all the answers

What is the purpose of the FDA's MedWatch program?

To collect information on adverse events and product problems Signup and view all the answers

What is the purpose of the ISMP MERP form?

To report medication errors and near misses Signup and view all the answers

What is the issue with the McKesson-packaged levetiracetam 250 mg unit dose blister packages?

The barcode scans as naproxen 500 mg on one side Signup and view all the answers

What is the primary goal of Patient Safety Organizations (PSOs)?

To analyze data and provide feedback to promote learning and minimize patient risk Signup and view all the answers

What is the purpose of Patient Safety Work Product (PSWP) privilege and confidentiality protections?

To prevent the use of PSWP in criminal, civil, administrative, or disciplinary proceedings Signup and view all the answers

What is the focus of the PSO Common Formats?

Diagnostic safety Signup and view all the answers

What is the primary goal of The Joint Commission's National Patient Safety Goals?

To improve patient safety in healthcare organizations Signup and view all the answers

What is a sentinel event, according to The Joint Commission?

An error that reaches a patient and results in severe temporary harm and intervention required to sustain life Signup and view all the answers

What is the purpose of reporting sentinel events to The Joint Commission?

To identify potential system failures and improve patient safety Signup and view all the answers

What is the main difference between reporting patient safety incidents to a PSO and to a regulatory agency?

The legal protections provided for the reported information Signup and view all the answers

What is the primary benefit of working with a Patient Safety Organization (PSO)?

Legal protections for reported patient safety information Signup and view all the answers

What percentage of pharmacists did not receive any education on how to use an error reporting system?

25% Signup and view all the answers

What percentage of pharmacists reported being directly involved in a medication error?

87.7% Signup and view all the answers

What is a major barrier to error reporting, according to the Arizona Pharmacists Error Reporting system?

Time constraints Signup and view all the answers

What is a limitation of error reporting systems, according to the literature?

Variable levels of detail provided in each report Signup and view all the answers

What percentage of reports come from nursing staff, according to the literature?

50-80% Signup and view all the answers

What is the estimated percentage of errors that are actually captured by voluntary reporting systems?

A very small number Signup and view all the answers

What is the primary function of Veterans Health Administration State Reporting Systems?

To promote accountability and learning Signup and view all the answers

How many states and Washington, DC require adverse event reporting, according to 2015 data?

27 states and Washington, DC Signup and view all the answers

Which state is the only one that requires healthcare facilities to report all incidents of harm or potential for harm?

Pennsylvania Signup and view all the answers

What is a limitation of state reporting systems?

Limited evidence that mandatory reporting leads to actual changes in healthcare organizations Signup and view all the answers

What is often bypassed in internal incident reporting programs?

Internal system Signup and view all the answers

What is a resource needed for internal error reporting?

Time, data entry, data analysis, and expertise Signup and view all the answers

Where were errors most frequently reported in community pharmacy settings?

Pharmacy-specific error reporting system and ISMP MERP Signup and view all the answers

What is the most common type of error reported in community pharmacy settings?

Wrong directions Signup and view all the answers

What percentage of pharmacies reported 'near misses' in community pharmacy settings?

26% Signup and view all the answers

What is the objective of the Arizona Pharmacists Error Reporting survey study?

To explore error reporting behaviors and barriers Signup and view all the answers

Study Notes

Error Reporting Systems

Purpose of error reporting systems:
- Hold providers accountable for performance
- Provide information to improve safety
Characteristics of mandatory and voluntary reporting systems:
- Mandatory: errors associated with serious injuries or death, run by state or federal regulatory programs
- Voluntary: minimal injury or no harm, reports are submitted anonymously and/or confidentially to an external group
Examples of reporting systems:
- Aviation: mandatory reporting of serious passenger injury or substantial aircraft damage, voluntary near miss reporting
- Healthcare: reporting of medical errors, near misses, and adverse events

Impact of Reporting Systems

Impact on patient safety:
- Reporting systems can lead to improved safety by identifying and addressing system weaknesses
- Data from reports can be used to develop strategies for improvement
Barriers to error reporting:
- Time
- Fear of punishment or litigation
- Uncertainty about what to report
- Doubts about the effectiveness of reporting

Examples of Reporting Systems

FDA MedWatch:
- Medical product safety reporting program for healthcare professionals, patients, and consumers
- Reports are used to publish safety alerts for FDA-regulated products
ISMP Medication Error Reporting Program (MERP):
- Reports of medication errors and hazards are analyzed to identify causes and develop prevention strategies
- Reports are submitted voluntarily by healthcare professionals and consumers
Patient Safety Organizations (PSOs):
- Established to analyze voluntarily reported data and provide feedback to healthcare providers
- PSOs provide legal protections for reported information

Types of Reporting Systems

Employment-based vs. public reporting systems:
- Employment-based: internal reporting systems within healthcare organizations
- Public: reporting systems open to the general public, such as FDA MedWatch
Mandatory vs. voluntary reporting systems:
- Mandatory: reporting is required by law or regulation
- Voluntary: reporting is optional and often anonymous

Limitations of Reporting Systems

Limitations of VAERS:
- Passive reporting system
- Limited ability to determine cause-and-effect
- Reports often lack details and may contain errors
Limitations of state reporting systems:
- Lack of standardization
- Variable levels of detail provided in each report
- Duplicative reporting
Limitations of internal error reporting systems:
- Limited resources (time, data entry, analysis, expertise)
- Need for buy-in, implementation, and evaluation of changes

Resources Needed for Error Reporting

Time
Data entry
Data analysis
Expertise
Identification of improvement opportunities
Buy-in and implementation of changes
Commitment to continuous improvement
Evaluation of changes on desired outcomes

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Description

Test your knowledge of pharmacy error reporting systems, including the primary purposes of error reporting, types of reporting systems, and characteristics of mandatory and voluntary systems. Learn about the differences between employment-based and public reporting systems, and how they impact patient safety.