Summary
The contracted pharmacy received the patient’s new prescription order by fax. Pharmacy personnel proceeded to process and then deliver the order to the ALF later that day. Individuals involved included a pharmacy technician, a pharmacy student intern and the pharmacist preceptor on duty. Staff with the facility integrated the new medication into the patient’s administration schedule the following morning, and she continued to receive the medication for ten days. During this time, the patient began to feel ill and became increasingly weak. Complaints of GI distress, nausea, vomiting, and, later, GI bleeding followed. Commencing at approximately day five of the ten-day period, the patient’s COPD symptoms worsened.
ALF staff were concerned with the patient’s new and increasingly severe symptoms. They notified the patient’s primary care physician and transported her to the hospital emergency department (ED) for assessment. In the ED, the patient’s condition deteriorated rapidly, resulting in her admission to the intensive care unit. Due to her medical history and pulmonary symptoms, hospital staff suspected pneumonia. A pneumonia diagnosis was confirmed, but blood tests also revealed the presence of severe pancytopenia. After reviewing the patient’s existing medications, the hospitalist contacted the ALF personnel and then the pharmacy. This review led to the discovery of the wrong drug error. The pharmacy confirmed metolazone 2.5 mg—one tablet daily— had been prescribed for the patient. However, pharmacy records indicated that the dispensed prescription medication was labeled as, and contained, methotrexate 2.5 mg, one tablet daily. Despite the efforts of hospital personnel over several days, the patient’s condition continued to decline. Less than a week following hospital admission, she expired from respiratory system complications and sepsis.
Resolution
Approximately six months after the patient’s death, the family filed a professional liability civil lawsuit naming the prescribing physician, the ALF, the pharmacy, the pharmacist, and the pharmacy intern (who was insured by the university). The physician and pharmacy intern were later dropped from the suit. With respect to the physician being dropped from the suit, the written prescription for metolazone was found to be without error. The investigation revealed that the pharmacy intern’s actions contributed to the medication error. Nevertheless, according to state administrative rules, the pharmacist preceptor is “responsible for the intern’s actions” related to the practice of pharmacy.
The plaintiff asserted that the pharmacist preceptor and the pharmacy were negligent, resulting in the medication error. This negligence caused, or significantly contributed to, the patient’s death. Clearly, a medication error occurred, and that error resulted from the actions and/or inactions of pharmacy personnel, facilitated by inadequate safety systems and procedures. The plaintiff also asserted negligence on the part of the ALF, since the facility and its personnel were responsible for administering the medication. The facility should have had established appropriate protocols to confirm that the administered medication was consistent with the written prescription order.
After investigating the events leading to the prescription error, the pharmacy defense team recommended pursuing settlement. The defense team’s expert opinions were split on whether methotrexate was the primary cause of the patient’s death. Although it may have been possible to convince a jury that the medication error was not the primary cause of death, it was probable that the jury would decide that methotrexate significantly contributed to the outcome. The initial demand of the plaintiff exceeded policy limits. However, the evidence compiled, as well as defense expert opinions related to causation, aided negotiations, resulting in a policy limit settlement.
The co-defendant ALF did not agree to participate in settlement negotiations. The ALF asserted that the pharmacy was solely responsible for the medication error and that their personnel simply administered the dispensed medication. The labeled medication, methotrexate 2.5 mg, was consistent with the updated medication administration record provided by the pharmacy. The outcome of the plaintiff’s action against the ALF is unknown.
Total Incurred: Greater than $1,000,000
(Note: Monetary amount represents the legal defense expense payments made solely on behalf of the insured pharmacy.)
Risk Management Comments
The investigation revealed that the error began immediately after receipt of the prescription by fax. The pharmacy technician entered “met” into the medication database, and then selected methotrexate 2.5 mg rather than metolazone 2.5 mg. The error was not discovered by the pharmacy intern’s check step, and the prescription was filled as methotrexate 2.5 mg, one tablet daily. Moreover, the pharmacist preceptor failed to perform a final check before completion and delivery of the order. Defense experts agreed that failure to do so breached the standard of care. Further action by the state board of pharmacy ensued, resulting in significant disciplinary action against the pharmacist, including license probation, a fine and required continuing education.
Risk Management Recommendations
Errors associated with high-alert medications continue to result in significant patient injuries and professional liability claims. The recently published resource, ISMP Targeted Medication Safety Best Practices for Community Pharmacy (ISMP; 2023) expressly identifies the need to prevent “inadvertent daily dosing of methotrexate for non-cancer indications”. Review the Best Practices and download the available Excel worksheet to assist with assessing and improving medication safety efforts in the community pharmacy setting.
Initially published in 2008, the most recent list of High-Alert Medications in Community/Ambulatory Care Settings (ISMP; 2021) includes medications that bear a heightened risk of significant patient harm in the event of a medication error. High-alert medications include anticoagulants, insulins, opioids, sedation agents, immunosuppressant agents, sulfonylurea agents and others. All pharmacy professionals will benefit by remaining current on this information, which is developed from error reports, professional literature, safety and clinical experts, as well as input from pharmacy practitioners.
In addition to the current listing of high-alert medications, refer to the ISMP’s web site to access the High-Alert Medication Learning Guides for Consumers, in order to help counsel and educate patients on this important topic. The article High-Alert Medication List-Relatively Useless Without Associated Risk-Reductions Strategies primarily focuses on the hospital setting. Much of the information also is relevant to other pharmacy practitioners.
Following are several actions to consider in the prevention of high-alert medication errors. However, readers are strongly encouraged to explore the linked resources above for additional details and mitigation strategies.
Methotrexate-specific:
- Set a weekly dose regimen as the electronic system default for oral methotrexate prescription orders.
- Require a system hard-stop verification or clarify/confirm all daily methotrexate prescription orders before dispensing if there is no documented oncologic diagnosis.
- Provide patient or caregiver with counseling on oral methotrexate and confirm understanding of the dose schedule and medication risks. Refer patients or caregivers to ISMP’s methotrexate consumer information leaflet.
General actions:
- Consider a secondary labeling system and unique automated warnings for high-alert medications.
- Enter a minimum of five letters into the pharmacy medication electronic database to mitigate the risk of selection errors.
- If possible, include both the brand and generic names in electronic database selection menus and search options as another strategy to reduce the chance of a selection error.
- Limit access to high-alert medications to appropriately trained staff as much as possible.
- Use electronic hard stops at the point of sale to require patient counseling and education before dispensing high-alert medications, or when dispensing to high-risk patient populations.
- Ensure that pharmacy computer systems incorporate critical alerts for narrow therapeutic index and high-alert medications. Establish a protocol to confirm routine system updates.
- Utilize pharmacy computer systems that are designed to perform dose range checks, and that warn staff regarding potentially dangerous doses (overdose or sub-therapeutic) for narrow therapeutic index and high-alert medications.
- At a minimum, provide annual education to pharmacy staff on strategies to avoid errors with high-alert medications, narrow therapeutic index medications, and other error-prone medications or devices.
- Incorporate medication safety discussions into regular team meetings. Review near misses, successful safety process improvements and corrective actions, as well as medication safety resources.
Disclaimer
These are illustrations of actual claims that were managed by the CNA insurance companies. However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice, or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws, and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information.