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Pharmacists License Defense Case Scenario with Risk Management Strategies

Case Study: Wrong dose dispensed; failure to consult with prescribing practitioner; misconduct; incompetent practice

Total Incurred: Greater than $5,700
(Monetary amounts represent only the legal expenses paid on behalf of the insured pharmacist.)

Summary

An 88-year-old female patient was transferred to a skilled nursing facility after a hospital stay. The patient’s diagnoses included acute myocardial infarction and left femoral artery occlusion with left foot gangrene. The patient was terminal and was placed on hospice on comfort measures only. She had orders to be medicated with morphine sulfate oral solution 2 mg – 4 mg every 4 hours as needed.

Several weeks after her admission to  the  skilled  nursing facility, the patient’s physician wrote a new order for morphine sulfate 4 mg sublingual every 6 hours, with specific orders to hold the medication if the patient’s respiratory rate fell below 8 breaths per minute. The physician also wrote an order for one fentanyl 12.5 mcg transdermal patch every 72 hours to the patient’s chest.

The insured pharmacist received the faxed medication order from the skilled nursing facility for the patient.The medication order was not on a controlled substance prescription form pursuant to state health and safety code requirements. It also did not include the prescriber’s address and telephone number, nor the address of the patient for whom the controlled substance was prescribed, among other state health and safety code requirements.

The pharmacist dispensed five fentanyl 75 mcg patches and five fentanyl 50 mcg patches, totaling five doses of fentanyl 125 mcg patches for the patient instead of five fentanyl 12.5 mcg patches as prescribed. The dose for the patient should not have exceeded 25 mcg of fentanyl.

Following what was dispensed by the pharmacy, the patient was administered one fentanyl 75 mcg patch and one fentanyl 50 mcg patch at 9:00am. The patient’s respiratory rate began to fall, until she eventually stopped breathing. She was pronounced dead at 2:25pm.

Risk Management Comments

The State Board of Pharmacy opined that the pharmacy should have been licensed as a closed-door pharmacy, as opposed to a retail pharmacy, as it did not operate as a retail pharmacy.

Furthermore, as the pharmacist-in-charge, the insured had submitted a pharmacy self-inspection report to the state declaring that the “facility is not affiliated with and does not dispense prescription medications for internet pharmacy sites or third-party processors.” This made it difficult to defend the pharmacist’s actions.

Additionally, the agreements that the pharmacist, as owner and operator of the pharmacy, entered into with the prescription processing companies required that  the  pharmacist  hold all licenses or  permits  required  to  dispense  medications to residents of the state(s) where medications were being delivered, and that the pharmacist would comply with all applicable state laws and regulations.

State Board of Pharmacy investigators purported that the pharmacist failed to note the irregularity of a medication order for fentanyl 125 mcg patches, given  that  fentanyl patches come in doses of 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, and 100 mcg per patch. According to the pharmacist, a pharmacy technician at the pharmacy contacted a nurse at the skilled nursing facility and verified the order, however there was no documentation to support her assertion. The skilled nursing facility also had no documentation of a call from the pharmacist, or anyone else at the pharmacy, to clarify the medication order. In the absence of documentation to support the pharmacist’s claim, the Board investigators concluded that the pharmacist failed to contact the prescriber to validate the prescription prior to dispensing the fentanyl to the patient.

Furthermore, the pharmacist dispensed the fentanyl, which is a Schedule II controlled substance, pursuant to a prescription that failed to comply with state health and safety code requirements, making the pharmacist’s actions even more difficult to defend.

Resolution

After initial review of the complaint, the State Board of Pharmacy revoked the pharmacist’s license. However, the revocation was deferred, and the pharmacist’s  license was placed on probation for two years barring successful completion of probationary terms, which included:

  • Submit an appropriate program of 12 hours of in- person continuing education related to opioids within 90 days to the Board.
  • Report quarterly to the Board during the probationary period.
  • During the probationary period, the pharmacist is required to notify employers and prospective employers of the Board’s decision.
  • Reimburse the Board for the costs of the investigation, which exceeded $7,600.

Risk Control Recommendations

  • Prepare and dispense medications pursuant to a legal prescription from a licensed practitioner as defined and regulated by the state.
  • Contactthe prescribing practitioner for any questionsrelated to the safety or efficacy of the prescription and speak directly to him/her. Prescription verification by a member of the practitioner’s staff is not sufficiently reliable and may not absolve the pharmacist of liability in the event of an error.
  • If the prescription is unclear or questionable, and the prescribing practitioner is not available, inform the patient of the problem and explain that, for reasons of safety, the prescription cannot be filled until the question/issue is resolved. If a delay in initiating drug therapy could pose a hazard to the patient, consider recommending that the patient seek emergency medical care.
  • Document all discussions with prescribing practitioners,patients, parents/guardians, or other parties, including any questions as well as the resulting response, and ensure that this documentation is included in both patient and pharmacy records.
  • Reviewstate specific regulations regarding the scopeof practice for pharmacists at least annually, to ensure understanding and compliance with the legal scope of practice and standards of care for pharmacists.
  • Complywith state requirements regarding other regulatorybodies, such as the board of medicine (if applicable).
  • Atleast annually, complete education on avoiding errors with High –Alert Medications, narrow therapeutics index medications, and other error-prone medications or devices.

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