Denial Is Not the Best Policy

The Institute for Safe Medication Practices (ISMP) regularly receives reports of medication errors directly from patients. Often these reports describe errors that occurred in community pharmacies. Although they are concerned about the errors, the patients reporting them are usually more upset about the response, or lack of, from the pharmacist or pharmacy management team. Below is an actual case reported to the ISMP Consumer Medication Errors Reporting Program:

I picked up a prescription for temazepam to help me sleep. The pills didn’t work, and I felt worse taking them. Over the course of 4 days, I only slept about 5 hours total. I had heart palpitations, chest tightness, and feelings of panic and agitation. Concerned, I brought the medication back to the pharmacy, and the pharmacist identified the pills as Adderall, not temazepam. The pharmacist immediately became defensive and refused to answer questions about what I should do. He just told me I need to switch pharmacies.

When medication errors happen, especially those that result in serious patient harm, practitioners can experience extreme anxiety and stress. Fear of litigation may cause health care organizations and practitioners to view the patient as an adversary or threat.

When this happens, the organization’s or practitioner’s first inclination may be to deny and defend. Unfortunately, this approach can alienate patients and close the organization’s eyes to the risks that contributed to the event and patient response.

Instead, responding to victims of errors with honesty and transparency puts the patients’ interests and safety first. It encourages open communication about errors and supports system improvements. Most importantly, it is the right thing to do.

How to Respond

Every pharmacy should have written policies and procedures for handling medication errors. Discuss and review these procedures with the pharmacy team, including float, newly hired, and part-time staff members, so that the process is clearly understood. Regularly review the procedures for appropriateness and update them to reflect changes in technology and workflow. The policies and procedures should contain specific guidance about what to do and say, what not to do or say, who should be contacted, particularly when all the facts of the case may not be immediately known, and who will follow up.

General principles include the following:

• Create a written policy on disclosure and apology to caregivers, patients, and others, as necessary, that is agreed upon and followed by management and staff.
• Decide how to report the event (eg, using the pharmacy’s internal reporting system) and when to notify regulatory bodies as required, risk management employees, supervisors, and upper management.
• Define management and staff roles in response to an actual or possible medication error.
• Document the event and response, and include the date, details, and time of the event. Make a note in the patient’s profile, so that other staff members are aware.
• Establish a continuous quality-improvement program to detect, document, and assess errors to determine the causes, develop an appropriate response, and implement risk-reduction strategies.
• Outline a process to follow up with patients and staff to provide investigation results.
• Practice and role-play possible scenarios with all staff members using established guidelines and procedures.
• Report the event confidentially to the ISMP (ismp.org/report-medication-error), when appropriate, to help others prevent similar errors.
• Respond immediately with compassion and empathy. Be direct and open with the patient reporting the error. The goal is to correct the error and minimize any harm or negative impact to the patient.
• Share and discuss events, prevention strategies, and procedural changes with staff members.
• Support staff members who are involved in the incident by consoling them and offering those involved with the error access to employee assistance programs if necessary.

CANDOR Toolkit

To help health care organizations and practitioners avoid adversarial responses to harmful events, the Agency for Healthcare Research and Quality has published the Communication and Optimal Resolution (CANDOR) toolkit (ahrq.gov/patient-safety/capacity/candor/index.html). The CANDOR process is designed to help organizations and practitioners respond to harmful events in a just and thorough manner, emphasizing transparent disclosure of adverse events and a more proactive method to achieve a fair resolution for the organization, patients, and practitioners. The process is also designed to support organizations’ efforts to fully investigate and analyze harmful events, improve quality of care and safety, and prevent patient harm. The toolkit includes multiple modules, including a disclosure checklist to help guide organizational discussion and implementation of the CANDOR process.

Conclusion

Practitioners should approach all patients reporting actual or potential medication errors with empathy and transparency. Keep in mind that attention and concern demonstrated to the patient and family members through admission of and apology for an error as well as follow-up discussion of what will be done to prevent future occurrences can help achieve an amicable, fair resolution for all involved.

Michael J. Gaunt, PharmD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care newsletter at the Institute for Safe Medication Practices in Horsham, Pennsylvania.

REFERENCE

Excuse me, I think there is an error with my prescription: practitioners should respond with empathy and honesty. Institute for Safe Medication Practices. February 27, 2021. Accessed April 16, 2021. https://www.ismp.org/resources/excuse-me-i-think-there-error-my-prescription-practitioners-should-respond-empathy-and