The patient took multiple medications to manage these medical issues. His daughter helped him with the medication orders and refills. He resided in the independent living area of a continuing care community, and he filled his prescriptions at a local community pharmacy.
The alleged incident involved the patient’s gout treatment medication, allopurinol. His latest three-month refill was the last one authorized on the prescription from the treating rheumatologist. The pharmacy contacted the physician’s office on multiple occasions to determine if the medication would be continued. Notwithstanding the well-documented attempts to communicate with the provider, the pharmacy did not receive authorization to refill the allopurinol.
When the patient’s daughter picked up his prescription refills, the allopurinol was not included. Neither the patient nor his daughter contacted the pharmacy at any time about the lack of allopurinol or about any of the patient’s other medications.
A few weeks after receiving the medication refills, the patient was hospitalized for a urinary tract infection and sepsis. Exam findings were also consistent with a slight worsening of the patient’s congestive heart failure (CHF), and his diuretic was changed to furosemide from hydrochlorothiazide. During the hospital stay, the patient did not complain of any joint pain, and there were no exam findings consistent with an exacerbation of gout. After administration of antibiotics, his infection was successfully treated during the 7-day hospital stay. Due to his weakened status, the patient was discharged to a rehabilitation facility prior to a planned return to independent living.
Near the end of the patient’s rehabilitation stay, he began experiencing joint pain. The facility sought a rheumatology consultation. The new rheumatologist was concerned that the patient had not received allopurinol since before his hospitalization. He also expressed concern that other drug regimen changes during hospitalization and rehab may have caused a cascade of unintended consequences in an otherwise stable, albeit unhealthy, elderly individual. The physician prescribed allopurinol for the patient, and, with the patient’s agreement, he continued to manage his rheumatology care. The following day, the patient was discharged from rehab to the assisted living level of care, as his condition had not improved sufficiently for independent living.
The patient’s daughter later stated that her father never fully recovered following hospitalization and rehab. His condition deteriorated in assisted living, and, within six weeks, he was moved to the continuing care community’s skilled care unit. Following this move, his health continued to decline. Approximately two months later, he passed away, with a documented cause of death of CHF.
Approximately five months after her father’s death, his daughter filed a $1.5 million lawsuit alleging negligence and wrongful death, naming the pharmacy, as well as co-defendants - the hospital and the rehabilitation facility -involved in the patient’s care. The plaintiff’s case asserted that failure to receive allopurinol as previously prescribed contributed to the patient’s hospitalization. Moreover, changes to the patient’s drug regimen during hospitalization and rehab allegedly led to the patient’s continuing health decline and eventually, to his death.
For unknown reasons, the plaintiff’s counsel failed to respond in a timely manner to discovery requests. Confirmation of plaintiff experts, response to interrogatories, production of records and other discovery activities were routinely delayed. When ultimately received, inadequate or incomplete information had been supplied. The defense was concerned that the Court tolerated and approved multiple plaintiff delays. Juries in the venue also tended to sympathize with plaintiffs, with judgments for the defense occurring infrequently.
Over the next several months, two dismissal requests were denied. The defense team for the pharmacy diligently pursued discovery to support the insured, in the event that the case proceeded to trial. Defense experts strongly supported the view that the pharmacy met the standard of care in its attempts to seek refill authorization for allopurinol. Not only did the pharmacy contact the rheumatologist multiple times, but, when contacts were unsuccessful, the pharmacy also contacted the patient’s internist to obtain authorization for the medication. However, the internist refused to prescribe the medication. Telephone records obtained by the defense team were consistent with the pharmacy’s comprehensive documentation and communication efforts, reinforcing the strength of the defensibility of the lawsuit.
All defendants agreed that mediation might be the best course of action in this case. The plaintiff agreed to pursue this course, and mediation was scheduled. Given the strength of expert opinion and pharmacy records, the insured pharmacy defense strategy was to educate the plaintiff of its position during mediation, seek dismissal of all claims against the pharmacy and have the plaintiff focus its pursuit against the co-defendants. Following several hours of negotiations, this strategy proved to be successful and all claims against the insured pharmacy were dismissed.
Total Incurred: Greater than $80,000.
(Note: Monetary amount represents the legal defense expense payments made solely on behalf of the insured pharmacy.)
Risk Management Comments
Malpractice lawsuits often involve multiple defendants, as in this case. More than one provider and/or facility may fail to provide appropriate care, resulting in harm and professional negligence. However, in this case, the defense was able to strongly assert that the pharmacy fulfilled its professional duty. If any negligence occurred, it happened during the patient’s hospitalization and rehabilitation and was not due to the pharmacy’s actions or failure to act.
One potential issue raised by the defense expert was that the pharmacy failed to communicate directly with the patient or his daughter to advise that efforts to obtain authorization to refill allopurinol were unsuccessful. However, in the state where the suit was filed, contributory negligence is a valid legal theory. Consequently, even if the pharmacy was found to be negligent, the patient and/or daughter may be found to have been contributorily negligent for failing to pursue a refill or new allopurinol prescription. The prescription label indicated “no refills” and no allopurinol was dispensed with the patient’s other prescriptions. Neither the patient nor the daughter contacted the pharmacy or the prescriber about the medication. A strong case for contributory negligence could have been made if the allegations against the pharmacy had not been dropped.
Risk Management Considerations
The pharmacy’s process and procedures to pursue a medication refill or new prescription for the patient and its associated documentation were integral to this successful outcome. In the absence of these protocols and documentation, the plaintiff would have probably continued to pursue the pharmacy. If the litigation against the pharmacy had proceeded, it would have been required to participate in settlement negotiations at mediation, or risk going to trial in a plaintiff-oriented venue. Instead, competent defense counsel and qualified experts were able to build a strong defense refuting the plaintiff’s allegations of medical malpractice.
In view of this case, reflect on the following risk management considerations:
- Document all discussions with patients, parents/guardians, prescribing practitioners, managers, or other parties. Also document all counseling sessions and/or refusals of counseling in the patient’s pharmacy record. This brief article provides additional documentation recommendations to consider. [https://www.drugtopics.com/view/documentation-pays-off-in-more-than-way-than-one]
- Counsel the patient or the family member/caregiver any time there are medication changes, including brand, manufacturer or other changes that alter medication appearance. Patients have a responsibility for their own healthcare. However, this additional action probably would have averted allegations against the pharmacy in this case study.
- Obtain complete patient information and update at each patient/caregiver encounter. Such documentation includes complete name, address, telephone (home/cell), email address, date of birth and any known allergies. Also obtain and update a current medication list (Rx and OTC).
- Obtain and update essential information about chronic/comorbid conditions such as hypertension, diabetes, coronary artery disease, heart failure.
- Provide space in the pharmacy for confidential patient/caregiver education and counseling activities, and ensure that staffing/schedules allow for this important activity.
- Ensure that all patients/caregivers are offered the opportunity for counseling, including information about medication changes, how to take/administer medications, possible side effects, medication interactions and other information as appropriate.
- Instruct patients to contact the pharmacy regarding any concerns or questions about medication therapy.
- If an individual other than the patient or caregiver picks up the prescription, make a reasonable effort to contact the patient directly to offer medication counseling (e.g., telephone call to patient or a note in the prescription bag to call the pharmacy for counseling).
- Implement written pharmacy policies for such matters as assessment and clarification of unusual medications or doses prior to dispensing and methods to resolve conflicts with prescribers regarding pharmacist concerns.
- Consider conducting a comprehensive self-assessment as part of ongoing pharmacy and pharmacist quality improvement activities. Such a questionnaire is available from the Institute for Safe Medication Practices (ISMP). [https://www.ismp.org/sites/default/files/attachments/2018-01/ISMP117C-Pharma%20SA-FINAL%20020317.pdf]
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.