A regulatory board complaint may be filed against a pharmacist by a patient, colleague, employer, and/or a regulatory agency, such as the State Department of Health. Complaints are subsequently investigated by the Board of Pharmacy in order to ensure that licensed pharmacists are practicing safely, professionally, and ethically. Board of Pharmacy investigations may lead to outcomes ranging from no action against the pharmacist to revocation of the pharmacist’s license to practice. This case study involves a licensed pharmacist who had been practicing for approximately twelve years and worked as a staff pharmacist at a large, urban medical center.
Summary
On Thursday morning, a physician ordered 5 mg of spironolactone to be dispensed every 12 hours to a critically ill infant patient in the neonatal intensive care unit (NICU). At the time the physician ordered the spironolactone, the patient’s potassium level was 3.9 mmol/L, which was within the normal range. The pharmacist dispensed 5 mg spironolactone suspension. However, instead of labeling the syringe correctly with 5 mg/mL concentration, she labeled it with 1 mg/mL concentration. As a result, the patient received the incorrect dosage of spironolactone. Specifically, the patient received 25 mg, five times the prescribed dose, on three separate occasions over the course of 36 hours.
On Friday evening, a pharmacy intern discovered the error and notified the pharmacist that the concentration of spironolactone suspension and prescription label were not the same. The medical center’s medication error reporting policy stated that immediately upon discovery of a potential or actual medication error, the error must be reported to the prescriber and to the patient or the patient’s parent/agent. However, instead of informing the NICU physician or the pharmacist-in-charge (PIC) of the medication error, the pharmacist went to the NICU and retrieved the syringes containing the wrong concentration of spironolactone, discarded them, and replaced them with syringes containing the correct concentration. After the pharmacist corrected the medication error, she then changed the concentration from 1 mg/mL to 5 mg/mL in the pharmacy’s computer.
Thereafter, the pharmacist began secretly monitoring the patient’s potassium levels. On Saturday, the patient’s potassium level increased to 5.9 mmol/L, which NICU providers flagged as high. Then on Sunday, the patient’s potassium level increased to 6.2 mmol/L, which NICU providers flagged as critical. The pharmacist failed to alert the appropriate parties about the dosage error, despite knowing that the overdosing of spironolactone most likely caused, or at a minimum contributed to the increase in the patient’s potassium level.
Finally, on Monday, the pharmacist disclosed the medication error to the PIC. The PIC immediately informed the patient’s NICU physician so that the error could be addressed. The PIC also filed a complaint with the Board of Pharmacy (“the Board”) concerning the pharmacist’s medication error and her three-day delay in reporting.
Enforcement Inspection
Board inspectors interviewed the pharmacist, who explained that the working environment in the medical center’s pharmacy was very busy. When she received the order for the prescription of spironolactone 5 mg, she processed the order in the pharmacy’s computer, which presented a drop-down menu of concentrations. The pharmacist erroneously selected the concentration of 1 mg/mL, as opposed to 5 mg/mL, from the drop-down menu. The pharmacist explained that for at least the last ten years that she had worked at the medical center, the master spironolactone formulation was a 1 mg concentration. The pharmacist testified that she had not realized that the master spironolactone formulation had been changed six months prior to a 5 mg concentration.
The pharmacist further testified that when the intern notified her about the medication error on Friday evening, the pharmacist did not immediately report the error to the PIC because he had just left work for the weekend. The pharmacist opined that she was “afraid” of the PIC’s potential reaction if she contacted him about the error while he was off duty. The pharmacist said that she found the PIC to be intimidating, and she believed that the PIC had anger management issues due to his history of retaliation against subordinate pharmacy staff members when he was irritated. In addition, the pharmacist did not report the error to the prescribing NICU physician due to prior negative experiences with the physician, who routinely yelled at pharmacists when they called him to ask a question or clarify a prescription.
The pharmacist explained that she was also personally humiliated about the error. She testified that when she learned about the error, she was in shock, upset that the patient had received the wrong dosage for at least one day. The pharmacist stated that her primary concern was the infant’s health. She was afraid that the patient would continue to receive incorrect doses without immediate action, which is why she went to the NICU and replaced the syringes containing the wrong concentration of spironolactone with syringes containing the correct concentration. Although the pharmacist testified that she was not aware of any law or hospital policy concerning medication error reporting requirements, the pharmacist acknowledged that she had, at least, a moral obligation to report the error. She expressed great remorse, and elaborated that since the incident, she had been steadfast in her medication safety efforts and remained committed to reporting any medication errors or near misses immediately should precautions fail.
The pharmacist’s defense attorney engaged with a pharmacy expert witness to provide expert testimony on behalf of the pharmacist in this Board matter. The defense expert reviewed the accusation, the pharmacist’s testimony, and other documents, and prepared an opinion letter. The expert concluded that the pharmacist demonstrated great remorse, and he stated that he believed the pharmacist would never again handle a medication error in the same manner. The expert further stated that the medical center and PIC were responsible for several pharmacy system failures, which contributed to this error, including failing to alert pharmacy staff to the change in the master spironolactone formulation. The expert explained that these system failures were exacerbated by the medical center’s lack of a “just culture” safety science framework pertaining to error reporting. The intimidation the pharmacist had experienced from the NICU physician and PIC further reinforced the issues associated with the cultural deficiencies of the medical center. However, the expert conceded that the pharmacist nevertheless had a duty to immediately report the medication error upon discovery.
Resolution
After reviewing the evidence, including the pharmacist’s testimony, the defense expert’s opinion letter, and letters of reference/support submitted by the pharmacist’s colleagues on her behalf, the Board inspectors recommended that disciplinary charges be filed against the pharmacist. The Board reviewed the inspectors’ report and determined that, although this was an isolated incident of misconduct in the pharmacist’s career, her conduct was egregious. The Board opined that the pharmacist’s intentional concealment of the medication error was selfish and reckless, and risked the patient’s life, exposing the patient to a potential heart attack.
Given the isolated nature of the incident and the pharmacist’s expression of great remorse, the Board decided against revoking her license. The Board placed the pharmacist’s license on probation for five years and imposed a $17,000 civil monetary penalty. The disciplinary action also was reported to the National Practitioner Data Bank.
Total Incurred: This Board matter took over four years to resolve, and the total incurred expenses to defend the pharmacist in this investigation totaled
$25,000.
(Note: Monetary amounts represent the legal expenses paid solely on behalf of the insured pharmacist.)
Risk Control Recommendations for Pharmacists
- Complete regular training and continuing education to serve pediatric patients, especially pharmacists who work in settings that serve both adult and pediatric patients, and maintain awareness of and access to organizational/facility pediatric protocols and guidance. Refer to resources such as those on the Pediatric Pharmacy Association website, and pediatric topics posted on the Medication Safety Officers Society website.
- Utilize standard intravenous drug concentrations as much as possible to avoid confusion. The number of concentrations should be minimized.
- Ensure that accurate doses are prescribed, dispensed, and documented. Be aware of the potential for error due to different concentrations of medications available in the organization’s formulary.
- Ensure that all prescriptions are checked against the original order prior to dispensing, preferably by a second pharmacist, for additional safety. In a single-pharmacist setting, the pharmacist must:
- Check each prescription against the original order;
- Verify that the proper drug, dosage, and quantity are dispensed;
- Ensure that the medication and doses ordered are the correct therapy for the patient, based upon the patient’s current state of health;
- Confirm that the label, patient instructions, and any warnings are correct.
- Evaluate whether workplace practices or conditions represent an unacceptable risk for dispensing errors and take appropriate corrective actions.
- Share hazardous conditions, close calls, and errors that have occurred according to organizational/facility policies and procedures to help prevent the same or similar incidents from occurring in the future.
- Maintain files that can be helpful with respect to your character in the event that your ability to practice safely and competently is subject to review. Retain copies of documents, such as letters of recommendation, performance evaluations, thank-you letters from patients, awards, volunteer records, and CE certificates.
- Never testify in a deposition without first consulting your insurer or legal counsel. Contact your attorney or designated professional before responding to calls, emails, or requests for documents from any other party.
Risk Control Recommendations for Pharmacies
According to the Institute for Safe Medication Practices (ISMP), wrong dose dispensing errors related to a medication’s concentration are more prevalent when pharmacies switch to an alternative product with a different concentration. ISMP recommends that pharmacies should consider the following risk control practices, among others, to help prevent medication errors such as the one described in this case study:
- Proactively establish a comprehensive concentration change plan to prevent adverse events during and following the conversion. Determine a go-live date in advance and establish a staff communication and education plan to alert all affected staff regarding the concentration change and go-live date.
- Involve frontline staff to identify the systems that will be impacted by the concentration change and anticipate the necessary modifications.
- Determine any necessary modifications that need to be made to reference/education materials, including standard concentration references, related policies and procedures, conversion charts, master formulation records for extemporaneously compounded products, and patient teaching materials.
- Evaluate areas and technologies in the pharmacy where the concentration will need to be modified, including inventory system software, prescribing systems/EHRs, medication administration records, smart infusion pump drug libraries, and automated compounding devices.
- For concentration changes involving stock medications or infusions, establish a plan for eliminating and replacing the old stock. Consider where the current supply of the old concentration is stored, how all of the stock will be removed, how to validate that all stock of the old concentration has been removed, and where the new concentration should be placed.
- Engage in safety walkarounds in the pharmacy and all affected patient care units to answer questions and troubleshoot any issues, both during and following the concentration change.
- Encourage staff to share hazardous conditions, close calls, and errors that have occurred. Consider conducting retrospective reviews with staff to discuss what went well and what could be improved upon. Create action plans and engage staff in steps the organization is taking to help prevent the same or similar incidents from occurring in the future.
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Disclaimers
These case scenarios 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 and regulations, 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. This material is for illustrative purposes and is not intended to constitute a contract. 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.
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