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 license protection case study, presented by HPSO, involves a licensed pharmacist who worked for a national chain pharmacy and had been practicing as a licensed pharmacist for approximately two years.
Summary
The patient, a woman in her mid-30s, presented to the national chain pharmacy location where the insured pharmacist worked and requested an influenza vaccination. The pharmacy technician on duty processed the patient’s request and payment for the influenza vaccination.
The insured pharmacist prepared and then administered a vaccination to the patient, failing to first verify with the patient the vaccination to be administered. It was only when the pharmacist instructed the patient to return for a booster shot that the error was realized. The pharmacist had administered a COVID-19 vaccination in error. The pharmacist then proceeded to administer the influenza vaccine, as the patient had originally requested.
Records show that three weeks later, the pharmacist provided his employer with a written statement regarding the incident. The documentation failed to describe the patient’s reaction or response to the vaccination error. The pharmacist stated that the pharmacy technician had prepared the syringe containing the vaccine. He stated that the technician then placed the syringe and patient consent form on the counter for the pharmacist to proceed with the procedure.
The pharmacist-in-charge (PIC) for the pharmacy then interviewed the pharmacy technician, who denied drawing up the vaccination. The PIC reviewed the video footage from the day of the incident to determine who prepared the syringe containing the COVID-19 vaccine. The video footage confirmed that the pharmacist had drawn the COVID-19 vaccination before administering it to the patient, rather than the pharmacy technician.
The PIC then filed a complaint regarding the pharmacist’s conduct to the State Board of Pharmacy (“the Board”), asserting that the pharmacist failed to follow the pharmacy’s immunization protocol.
Enforcement Inspection
Board inspectors interviewed the pharmacist, pharmacy technician, and the PIC. Inspectors also reviewed the PIC’s complaint, the pharmacist’s statement, and the PIC’s video footage findings.
The investigators concluded that, in addition to failing to follow immunization protocols, the pharmacist made a false or misleading statement regarding the incident in question when his written statement represented that the pharmacy technician prepared the vaccine. The investigation further revealed that the pharmacist failed to adhere to state statutes for vaccine administration by failing to promptly report the vaccines administered to the patient’s primary care provider, or the state immunization registry, and by failing to complete an incident report as soon as possible following the vaccination error.
Resolution
The investigator submitted his report to the Board, recommending that disciplinary charges be filed against the pharmacist. The Board reviewed the report and determined that the pharmacist’s conduct was contrary to accepted standards of practice.
The pharmacist agreed to a consent agreement, which placed his license on probation for two years and imposed a $2,500 civil penalty. This disciplinary action also was reported to the National Practitioner Data Bank (NPDB).
The matter took more than a year to resolve, and the total incurred expenses to defend the pharmacist in this Board investigation totaled more than $2,200. (Note: Monetary amounts represent the legal expenses paid solely on behalf of the insured pharmacist.)
Risk Control Recommendations for Pharmacists
Below are some proactive concepts and behaviors to include in your practice to help mitigate the risk of Board complaints related to vaccine administration:
- Develop, implement and adhere to standard operating procedures designed to prevent/identify errors prior to vaccine administration.
- Store vaccine formulations apart from one another in separate bins that are accurately labeled with the corresponding age group or booster designation.
- Utilize automated identification systems, such as barcode scanning, to reduce the risk of vaccine and administration errors.
- Prior to preparation, check the patient’s vaccine card/medical record, and the immunization information system.
- Clearly label all syringes. Dispense pharmacy prepared syringes where possible.
- Prior to administration, document vaccine information including the National Drug Code (NDC) number, lot number and expiration date of each vial or prefilled syringe. Document vaccine administration after doing so.
- Only bring the intended and labeled vaccine syringe(s) for one patient into the vaccination area and vaccinate one patient at a time.
- Use a checklist to perform a systematic final check, to confirm the correct vaccine/medication, dose, and patient. Involve the patient or caregiver in verifying the correct vaccine by reading the label to confirm the vaccine, formulation, and dose.
- Review and implement additional recommendations appropriate for your practice according to state/jurisdictional regulations and guidance from appropriate organizations:
- Refer to COVID-19 vaccine information from Moderna at: https://www.fda.gov/media/159306/download and Pfizer-BioNTech at https://webfiles.pfizer.com/formulation-guide for guidance on age-related dosing and vaccination schedules.
- For details on immunization schedules, please review the Centers for Disease Control and Prevention (CDC) resource, COVID-19 Vaccine Interim Immunization Schedule for 6 Months of Age and Older at: https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf
- Immunize.org has compiled a tool that organizes information about US COVID-19 vaccines and provides links to dosing guidance, Fact Sheets, package inserts, storage and handling, and preparation and administration which may be accessed at: https://www.immunize.org/catg.d/p3130.pdf
- The Institute for Safe Medication Practices (ISMP) Resource Library has many free resources developed from ISMP's review of reports through its national error reporting programs, peer-reviewed articles in its publications, and/or consensus gathering summits on topics pertinent to specific errors or hazards at: https://www.ismp.org/resources
- The American Pharmacists Association (APhA) Immunization Training Center at https://www.pharmacist.com/immunization-center, as well as a Pharmacy Based Immunization Delivery Certificate Training Program at: https://www.pharmacist.com/Education/Certificate-Training-Programs/Immunization deliver current resources, tools, information, and education.
References
Disclaimers
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 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. 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.