Pharmacists and Medical Malpractice Case Study with Risk Management Strategies
Presented by HPSO and CNA
Medical malpractice claims may be asserted against any healthcare provider, including pharmacists. This case study involves a licensed pharmacist, working in a community pharmacy.
Note: This case involves a 54-year-old female patient with a complex medical history. At the time of the incident, the patient was on full disability related to back and neck injuries suffered in a single-car automobile accident several years prior, with associated chronic pain. In addition to physical disability, the patient received medical care for asthma, hypertension and depression.
The patient and her spouse presented prescriptions at their community pharmacy for promethazine tablets, 12.5 mg, and fentanyl transdermal patch (72 hour), 12.5 mcg/hour. Although this was the patient’s first prescription for a transdermal analgesic patch, her medication history included other dosage forms of opioid medications. The spouse returned in the evening to collect the medications, which were later confirmed to have been erroneously filled with promethazine 25 mg tablets and fentanyl patch (72 hour), 75 mcg/hour
. The pharmacist provided appropriate verbal and written drug information to the patient’s spouse but did not catch the medication dispensing errors while reviewing the drug information with the patient’s spouse.
The same evening, the patient applied one fentanyl 75 mcg/hour patch and took one promethazine 25 mg tablet. The following day, the patient’s spouse left for work at 7:30 AM. His workplace was in close proximity to their home, and he often returned home for lunch. When he arrived home that day, he found his wife unresponsive on the couch. He immediately called 911 for assistance. Upon arrival, emergency personnel quickly assessed the patient’s condition and learned that she had just started two new medications. They rapidly removed the transdermal fentanyl patch and administered naloxone to reverse the respiratory depression. The patient’s condition improved, although she did not regain consciousness during emergency medical transport. The patient experienced seizures after arrival at the hospital and she was admitted to the intensive care unit. The patient was comatose for ten days and remained in the hospital for almost four weeks before beginning rehabilitation for the alleged anoxic brain injury.
Risk Management Comments
Approximately two years after the incident, the plaintiff filed suit, asserting damages related to the error made in filling the prescriptions. Although there was no doubt that the medications the patient received were dispensed in error, the defense strongly disputed that the alleged injury and damages were a direct result of the incident.
Several of the plaintiff’s expert witnesses, including a pharmacologist, the prescribing physician and an anesthesiologist opined that the patient’s respiratory depression directly resulted from the higher than intended fentanyl and promethazine doses. The plaintiff’s expert witnesses noted that opioid analgesics may cause respiratory depression, which could be exacerbated when used in combination with other medications, such as promethazine. Medical test results supporting or refuting the plaintiff’s claims were unavailable. The unavailability of this information was due, in part, to the patient’s history of chronic pain therapy and two previous hospital stays for opioid-related medication misuse, which contributed to a delay in confirming the dispensing error.
After reviewing the patient’s comprehensive medical history, defense expert witnesses in pharmacology, neurology and pulmonology concluded that although the dosages of fentanyl and promethazine were higher than prescribed, other factors may have contributed to the adverse outcome. Based upon the patient’s history of chronic pain therapy, as well as the medications and dosages prescribed prior to the incident, the defense experts opined that the patient would not have experienced severe respiratory depression unless she had taken other prescription medications or non-prescribed substances at the same time. Medical records indicated that the patient had been hospitalized in the past for drinking alcohol while taking prescribed opioids, as well as another instance in which she had combined two opioid medications (one not prescribed).
The defendant pharmacist had practiced for more than 10 years without experiencing any professional liability incidents. Although he stated that he had followed proper procedures to review the original prescriptions against the medications to be dispensed, the patient received the wrong dosage for both fentanyl and promethazine. The pharmacist could not ascertain how the incident occurred and considered leaving the profession as a result of the incident before eventually deciding to continue pharmacy practice.
While the plaintiff’s case and expert opinions had weaknesses, the trial venue and the relatively poor deposition of the defendant pharmacist were concerning. The pharmacist and his employer sought to settle the case. The defense experts provided comprehensive reviews and presented well at deposition, leading both parties to agree to a settlement. While the total incurred amount for the professional liability claim was greater than $1 million, the final settlement amount was well below the plaintiff’s original demand.
(Note: Monetary amounts represent only the payments made solely on behalf of the insured pharmacist.
Risk Management Recommendations
Everyone, pharmacists and all other healthcare providers alike, are subject to human error and may make mistakes. Therefore, it is essential to first develop and implement systems and methods to reduce the potential for errors and related adverse outcomes. Adherence to prevention methods, including a commitment to continuous improvements, will help pharmacists adhere to the standard of care and lead to improved patient safety. Consider the following risk management recommendations, among others:
- Promote and maintain a professional atmosphere and process while performing all prescription/dispensing related duties. Minimize all potential distractions.
- Keep all patient history and drug information up-to-date and investigate any inconsistencies.
- Confirm that the medication, dose, patient instructions and other information on the label are consistent with the original prescription.
- Verify that the medication in the package or container to be dispensed is the correct medication and dosage prescribed.
- Provide required patient information leaflets and written instructions.
- Comply with all controlled substance requirements, including those pertaining to the applicable state prescription drug monitoring program (PDMP).
- Counsel patients and/or patient representatives to ensure understanding and promote adherence.
- Encourage and respond to drug information questions or concerns.
- Follow all pharmacy/employer policies and procedures.
- Utilize systems to identify relevant drug interactions and contraindications.