42 Questions
What is typically characteristic of a mandatory reporting system?
Run by state or federal regulatory programs with authority to investigate
What is the primary purpose of error reporting?
To hold providers accountable for performance
Which of the following is an example of a voluntary reporting system in aviation?
Near miss reporting through the confidential Aviation Safety Reporting System
What kind of errors are typically reported in a voluntary reporting system?
Errors that result in minimal injury or no harm
What is the primary function of FDA MedWatch?
To receive reports from the public and publish safety alerts for FDA-regulated products
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
What type of products does the FDA regulate, besides medical devices and combination products?
Food, dietary supplements, and special nutritional products
What should be reported to MedWatch, according to the FDA?
Unexpected side effects, product quality problems, and medication errors
What is the primary purpose of the Vaccine Adverse Event Reporting System (VAERS)?
To detect potential safety problems in U.S.-licensed vaccines
Who is required to report pre-specified reportable events for various vaccinations to VAERS?
Only healthcare professionals
What is a limitation of the VAERS system?
Limited ability to determine cause-and-effect
What is the Medication Errors Reporting Program (MERP) used for?
To learn the underlying causes of reported medication errors or hazards
Who can report to the Medication Errors Reporting Program (MERP)?
Both healthcare professionals and consumers
What is the purpose of the Institute for Safe Medication Practices (ISMP)?
To learn the underlying causes of reported medication errors or hazards
What is a type of product that is regulated by the FDA?
All of the above
What is the purpose of the FDA's MedWatch program?
To collect information on adverse events and product problems
What is the purpose of the ISMP MERP form?
To report medication errors and near misses
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
What is the primary goal of Patient Safety Organizations (PSOs)?
To analyze data and provide feedback to promote learning and minimize patient risk
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
What is the focus of the PSO Common Formats?
Diagnostic safety
What is the primary goal of The Joint Commission's National Patient Safety Goals?
To improve patient safety in healthcare organizations
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
What is the purpose of reporting sentinel events to The Joint Commission?
To identify potential system failures and improve patient safety
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
What is the primary benefit of working with a Patient Safety Organization (PSO)?
Legal protections for reported patient safety information
What percentage of pharmacists did not receive any education on how to use an error reporting system?
25%
What percentage of pharmacists reported being directly involved in a medication error?
87.7%
What is a major barrier to error reporting, according to the Arizona Pharmacists Error Reporting system?
Time constraints
What is a limitation of error reporting systems, according to the literature?
Variable levels of detail provided in each report
What percentage of reports come from nursing staff, according to the literature?
50-80%
What is the estimated percentage of errors that are actually captured by voluntary reporting systems?
A very small number
What is the primary function of Veterans Health Administration State Reporting Systems?
To promote accountability and learning
How many states and Washington, DC require adverse event reporting, according to 2015 data?
27 states and Washington, DC
Which state is the only one that requires healthcare facilities to report all incidents of harm or potential for harm?
Pennsylvania
What is a limitation of state reporting systems?
Limited evidence that mandatory reporting leads to actual changes in healthcare organizations
What is often bypassed in internal incident reporting programs?
Internal system
What is a resource needed for internal error reporting?
Time, data entry, data analysis, and expertise
Where were errors most frequently reported in community pharmacy settings?
Pharmacy-specific error reporting system and ISMP MERP
What is the most common type of error reported in community pharmacy settings?
Wrong directions
What percentage of pharmacies reported 'near misses' in community pharmacy settings?
26%
What is the objective of the Arizona Pharmacists Error Reporting survey study?
To explore error reporting behaviors and barriers
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
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.
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