Pharmacists Medical Malpractice Case Study with Risk Management Strategies
Presented by HPSO and CNA
According to HPSO and CNA’s most recent Pharmacist Liability Claim Report
, although the combined percentage of pharmacist professional liability claims associated with “wrong drug” and “wrong dose” declined by more 23 percent*, these two issues continue to represent the most common allegations in pharmacist professional liability .
Note: This case involves a 78-year-old male patient with multiple health conditions. At the time of the alleged incident, the patient was receiving treatment from his primary care physician and several specialists for hypertension, degenerative arthritis, Type II diabetes and angina pectoris. The patient’s significant medical history also included surgical removal and radiation therapy for squamous cell carcinoma of the lower lip vermilion border. The patient’s recent 5-year follow-up examination revealed that he continued to be cancer-free. However, the patient experienced oral discomfort and problems with denture retention and stability from xerostomia, secondary to radiation therapy. He also required the use of a walker due to periodic lightheadedness and instability, which had resulted in falls with associated soft tissue injuries.
After his spouse passed away, and nearly five years before the alleged incident, the patient had moved to his current independent living apartment in a continuing care retirement community. He routinely ordered 10 to 12 prescription medications from the defendant’s community pharmacy, which were delivered to the patient’s apartment.
Several years prior to the alleged incident, on two separate occasions, the patient received methotrexate for several months to provide relief from increasing arthritis pain. When his arthritis pain again became more severe and unmanageable, the patient returned to his rheumatologist for an evaluation. The doctor prescribed methotrexate 2.5 mg (#24), with directions to take three tablets by mouth every seven days. The physician’s office communicated this order to the defendant’s pharmacy, and the patient received the medication by delivery the following day.
Ten days after receiving the prescription, the patient was seen in a nearby hospital emergency department (ED) due to a fall. In addition to pain from the fall, the patient complained of severe mouth discomfort. The patient’s dentist had prescribed nystatin a few days prior for thrush, but symptoms and discomfort had worsened. The patient reported that he was unable to wear his dentures and had not been eating well. Considering his complex medical history, the ED physician recommended hospital admission and further testing. Severe oral and esophageal candidiasis was diagnosed and treated with IV fluconazole therapy. Laboratory studies also revealed pancytopenia, which was inconsistent with testing performed a few weeks earlier during the patient’s 5-year cancer follow-up assessment.
Upon admission to the hospital, the patient’s current medications were reviewed. During this evaluation, it was discovered that the recently prescribed methotrexate was not taken weekly as intended but had been taken daily instead. The prescription bottle was erroneously labeled, resulting in the patient taking a significantly higher than prescribed dose of methotrexate.
While hospitalized, a percutaneous endoscopic gastrostomy (PEG) tube was placed due to the patient’s dysphagia and failure to thrive. He remained hospitalized for more than two weeks to treat dehydration, the candida infection, and to stabilize his overall medical condition. He was discharged to a skilled nursing facility and moved to an assisted living facility two months later. His overall health had degraded significantly over this time, and it seemed unlikely that he would be able to return to independent living in the near future, if at all.
Soon after discharge from the skilled nursing facility, the patient and family filed suit against the pharmacist. The suit alleged that the pharmacy technician mislabeled the medication with instructions to take three tablets daily for seven days, rather than three tablets every seven days. The complaint asserted that the defendant pharmacist did not exercise due care, by failing to confirm the medication labeling with respect to the prescription and also ignoring the high dosage warning generated by the pharmacy’s electronic system. The filed complaint further asserted that this breach of care resulted in permanent bodily injury, pain and suffering, disability and loss of capacity, requiring the patient to need ongoing assistance with activities of daily living. The complaint also asserted that the patient’s degraded health condition resulted in significant financial loss, including expenses for the recent hospitalization and rehabilitation, as well as for required ongoing medical expenses.
Many of the patient’s ongoing symptoms were consistent with his pre-existing medical conditions. However, after case review, it was apparent that the duty owed to the patient had indeed been breached. On advice of counsel, the defendant pharmacist agreed to seek settlement in this case. Although the negotiation and settlement process proved to be difficult and costly, the defense was pleased that the case settled well below the initial plaintiff demand.
Total Incurred: $515,000
Risk Management Comments
The process of dispensing medication requires a number of tasks. These tasks may include, but are not limited to, transcription of a telephone order, prescription review/interpretation, medication selection, generation of prescription labeling and packaging, oversight and review of co-worker actions. Each task has the potential for human error that may lead to patient harm. General error prevention methods, such as ensuring that personnel are well-trained, understand their roles and responsibilities and that they comply with pharmacy standard operating procedures, are critical to error prevention. In this case scenario, standard operating procedures designed to prevent or detect such errors prior to dispensing were in place and should have prevented the incident. Failure to adhere to procedures related to professional oversight, electronic system warnings, high-alert medications, and specific high-alert recommendations for methotrexate all contributed to this scenario.
Risk Management Recommendations
- Confirm that the medication, dose, patient instructions and other information on the label are consistent with the original prescription.
- Utilize systems to identify and prevent drug dosage errors, interactions and/or contraindications.
- For nononcologic use of methotrexate:
* Pharmacist Liability Claim Report: 2nd Edition.
Wrong drug and wrong dose continue to be the most common allegation, accounting for 52.1% of all pharmacist malpractice claims, a decrease from 75.3% in the 2013 report.
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.