This case study describes an incident involving a female patient in her late 70s. Although her health was stable, she took many medications daily to help manage several chronic conditions. Her health history included breast cancer (cancer-free for more than 20 years), hypertension, type 2 diabetes, atrial fibrillation and an episode of lower limb venous thrombosis. The patient and her spouse lived in their own home prior to the incident, with the patient performing household duties including cooking, cleaning, management of the couple’s finances and providing support to her husband, who was in his mid-80s and whose health and mobility had recently declined.
The patient and her spouse had been patrons of a local independent pharmacy for many years. A year prior to the incident, the pharmacist owner retired and sold the business. During the first months of ownership, the new pharmacist owner developed plans to update the pharmacy’s business practices and introduce new services to improve the pharmacy’s market position. To assist elderly patients taking multiple medications, the pharmacy introduced a new “adherence packaging” service, providing patients with convenient multi-medication packets for appropriate dosage intervals. After consulting with their adult daughter, who assisted the couple with medical care decision-making, the patient and her spouse requested that the pharmacy begin dispensing their medications in the new packet format.
The adherence packaging significantly simplified management of multiple daily medications taken by the patient and her spouse. Perhaps due to recent adjustments of the patient’s medications for hypertension and atrial fibrillation, or due to the new look and convenience of the modified medication packaging, the patient did not notice that her evening dose packets contained phenytoin. The patient’s spouse had taken phenytoin 300 mg each evening for many years. However, the patient had not been prescribed phenytoin, and 300 mg of the medication (the same dosage prescribed for her husband) was erroneously placed in her evening dose packets.
Two days after they began using the adherence packaging, the patient’s daughter visited with her mother and father. Her mother did not feel well, complaining primarily of dizziness and a lack of energy. The following week these symptoms continued, with the patient noting a lack of energy for her customary daily activities. Before the daughter’s next weekly visit, the patient’s spouse spoke with his daughter and explained that the patient had lost her appetite and seemed to be confused about current events, appointments, and certain family matters. The following morning, the patient suffered a fall at home that required the daughter to drive to her parents’ home to help her from the floor. The daughter scheduled a visit with her mother’s physician for a few days later.
The patient fell again that night, this time striking her head, resulting in a small laceration. An ambulance was called to transport the patient to the emergency department for assessment and treatment. After treating the laceration and ruling out head trauma via CT scan, the hospital released the patient to home and recommended that she follow-up with her physician as scheduled.
Unfortunately, the patient’s condition continued to decline, and she experienced multiple falls, confusion, ataxia, and hallucinations that required multiple hospitalizations. A series of miscommunications between the hospital, the pharmacy, and the daughter delayed discovery of the incident’s root cause. Finally, when the drugstore pharmacist spoke with the daughter to apologize and correct “the problem” with her mother’s medications, the daughter investigated. She discovered that the phenytoin capsules had been erroneously included in her mother’s medication packets. The daughter immediately informed the hospital of the medication error. Test results indicated a phenytoin serum concentration of just over 20 mcg/ml, although the hospital had not administered this medication since the patient’s admission two days prior.
Although phenytoin overdose rarely results in death, this medication has a narrow therapeutic index. Even small changes in dose or blood levels may lead to serious adverse drug reactions. The elderly and infants are at higher risk due to lower protein binding and impaired phenytoin metabolism. [See: Phenytoin Toxicity, StatPearls. updated May 2022.]
The treating hospitalist confirmed with the patient’s daughter that the phenytoin serum level was slightly above the therapeutic range. With no medication for two days, he believed the level would have been in a toxic range of 30 mcg/ml or more, for several days before her recent admission. The patient’s encephalopathy and the observed ataxia, hallucinations and the multiple falls experienced may have been attributable to the abnormal phenytoin serum level.
Although the phenytoin serum levels decreased over the next several days, the patient’s confusion and hallucinations continued. The patient’s condition stabilized during the following week, and she was discharged to her home requiring support of home health nurses and 24-hour supervision by family members. During her hospitalization, the patient had developed congestion in her lungs and required home oxygen therapy with several daily breathing treatments. She also needed assistance with bathing and other activities of daily living. The family was convinced that the patient would not soon return to her pre-incident health and activity level, if ever.
A few months later, the family filed a lawsuit. Although their medical expenses were substantial, the plaintiffs asserted that the primary loss involved the patient’s significant decline in mental and physical capacity and the impact of this life-changing event on all family members. With medical expenses, pain, suffering and loss of consortium, the plaintiffs’ demand exceeded $1.5 million. Since there was no doubt as to the medication error, the claim professional and defense counsel recommended seeking an early settlement, and the pharmacist owner agreed. Due to this plan, specifics regarding the error investigation and details of the patient’s medical care are somewhat limited. However, mediation resulted in limited defense expenses and a settlement amount well below the initial demand.
Greater than $800,000.
(Note: Monetary amount represents the payments made solely on behalf of the insured pharmacist owner.)
Risk Management Comments
The pharmacist owner had prior experience with adherence packaging, and he purchased a packaging machine appropriate for the planned service start-up. This incident occurred within the first 3 months of the new service program. The investigation revealed that the incident occurred on a busy day when the technician primarily responsible for the packaging process was not working. A part-time pharmacist who was working on the day of the incident had received only limited training on the packaging equipment.
Phenytoin was not switched from one family member to the other during the packaging process. Instead, both the patient and her husband received phenytoin 300 mg in their evening medication packets. Although the part-time pharmacist had been working at the store for a few years, he was not familiar with the medication history for the patient and her spouse. Since there was no double check process in place to confirm the prescriptions prior to packaging and delivery, the error went unnoticed until after the patient’s hospitalization.
Risk Management Recommendations
Implementation of adherence packaging may result in benefits for both patients and pharmacists. [See: Impact of medication adherence packaging service in community pharmacy. J of Pharm Education and Practice. 2021 Mar;9(1):11.]
As with all pharmacy services, systems and procedures that are designed to help eliminate human error and mitigate the risk of harm associated with medication errors should be implemented.
Consider the following risk management recommendations and related resources:
- Develop, implement and adhere to standard operating procedures designed to prevent and/or identify medication errors prior to dispensing. To help confirm that effective methods and systems are established and implemented, refer to the ISMP Medication Safety Self Assessment® for Community/Ambulatory Pharmacy.
- Ensure that written repackaging policies, procedures and checklists are established, implemented and readily available to facilitate compliance. Conduct and document all necessary training.
- Designate a repackaging area that is separate from other pharmacy activities and minimize all potential distractions.
- Consider limiting the repackaging process to specific days/times when staffing is sufficient to assign an individual to focus solely on this activity.
- Understand and comply with federal and/or state recommendations or requirements associated with repackaging, multi-medication dispensing, or similar services.
- Implement automated identification systems, such as barcode scanning, to reduce the risk of selection and packaging errors.
- Apply an independent double check process. Consider implementing this step to confirm medication selection before repackaging, and as a final check of adherence packaging before dispensing/delivery.
- Use a checklist to perform a systematic final check, comparing the prescriptions with the repackaged medications.
- Counsel the patient or the family member/caregiver any time there are medication changes, including brand, manufacturer, or other changes that alter medication appearance.
Automation in pharmacy operations may improve efficiency and patient adherence. Although technological advances continue, it is also true that automation and computerization are not a panacea. Errors still occur. Pharmacists and all members of the healthcare team must remain vigilant to ensure that automated systems are integrated in ways that will address and enhance patient safety and minimize errors and unintended consequences.
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.