Medication Errors
The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.”1
Although reporting medication errors to the FDA’s Adverse Event Reporting System or the Institute for Safe Medication Practices is voluntary in the United States, the FDA encourages health care providers, patients, consumers, and manufacturers to report all medication errors.2
About the Author
Kathleen Kenny, PharmD, RPh, earned her doctoral degree from the University of Colorado Health Sciences Center. She has more than 30 years’ experience as a community pharmacist and works as a clinical medical writer based in Homosassa, Florida.
Pharmacists are considered medication experts due to their extensive education and training, but they are human. That human element means that mistakes can and will occur. Consistently recording all errors and near misses indicates that the pharmacy is aware of incidents and can then institute proactive improvements to limit the risk of recurrence.
Unfortunately, when errors are discovered, there is a tendency to blame the professional involved in the incident. Formal punishment from one’s employer may occur. Unless the incident is due to blatant neglect, errors should not result in punitive measures. The question of who was involved in the incident is far less important than how and why the system failed. Essential components of any incident report are included in the Table.
Benefits of Reporting
There are many benefits to timely and complete incident reporting, including the following:
- Improved safety: Incident reporting can help identify risks to patients and pharmacists and help reduce medical errors.
- Enhanced compliance: Incident reporting can help pharmacies comply with regulations and policies and avoid fines and penalties.
- Optimal communication: Incident reporting can help streamline communication and task assignment within the pharmacy team.
- Superior resource utilization: Incident reporting can help identify and fix inefficiencies, leading to better resource utilization and a more productive work environment.
- Better learning: Incident reports can be used as case studies or in staff training to help prepare staff for real-life situations.
- Enhanced culture: Incident reporting can help create a culture of trust and transparency among staff and improve employee engagement.
- Improved risk management: Incident reporting can help pharmacies measure their risk management performance against their peers.
Writing an incident report should follow specific steps and best practices. First, gather information about the incident, including the who, what, when, where, and how. Employers should have an incident report form available. Second, provide a clear and objective description of the incident. Avoid speculating, assigning blame, or assuming liability, and instead focus on the factual details that can be verified. Keep in mind the report may be made available to the patient. If applicable, include witness statements to provide additional perspectives on the incident. Ensure any accounts are recorded accurately and objectively.
Identifying the root cause and outlining corrective actions may be the 2 most important steps. Conduct a thorough investigation to identify the incident’s root cause, looking beyond immediate causes to understand the underlying factors. Finally, detail the corrective actions taken to address the incident and prevent recurrence. This may involve procedure changes, additional compliance training, or other measures to enhance safety and compliance.
After submitting an incident report, expect a thorough investigation to identify or verify the root cause of the incident, receive feedback on the report, and potentially be involved in discussions about corrective actions to prevent similar occurrences. This may include notifying relevant stakeholders, providing support to those involved, and implementing changes to policies or procedures based on the findings of the investigation.
REFERENCES
1. About medication errors. National Coordinating Council for Medication Error Reporting and Prevention. Accessed October 8, 2024. https://www.nccmerp.org/about-medication-errors
2. Medication errors related to CDER-regulated drug products. FDA. Updated January 11, 2024. Accessed October 8, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/medication-errorsrelated-cder-regulated-drug-products