SALEM, Va. (WSET) — The Virginia Board of Pharmacy has revealed a list of shocking health and safety violations from a CVS in Salem.
CVS/Pharmacy #3794, located at 11 Chestnut Street, was ordered to pay $75,000 for violations, including improper COVID-19 vaccine administration by an inadequately trained nurse and the theft of substantial amounts of pharmaceutical drugs by a pharmacy technician trainee.
Improper Vaccines Administration
According to a Consent Order from the Virginia Board of Pharmacy, on October 5, 2021, the pharmacy delegated the administration of COVID-19 vaccines to a contract nurse who had been inadequately trained in diluting and administering vaccines.
On the first day of her job, the contract nurse gave a 17-year-old girl six undiluted doses of the Pfizer COVID-19 vaccine, according to the report, and the girl reported suffering from arm swelling, insomnia, headache, forgetfulness, fatigue, and increased heart rate.
The Consent Order states that the nurse said after the incident that she did not know the vial containing the vaccine required dilution, nor did she have any prior experience administering the COVID-19 vaccine. The nurse also provided a copy of an email from a district manager at CVS Health that said the "New Colleague Training class has been canceled so you will not have to complete that."
Controlled Substance Safeguards
The Consent Order also details several other violations, including the theft of pharmaceutical drugs. The report states that a pharmacy technician trainee admitted to the theft of the following drugs between August 2021 and December 2021:
- 60 alprazolam 0.5mg tablets
- 30 methylphenidate 36mg tablets
- 5 lorazepam 0.5mg tablets
Following an internal investigation into the theft of those medications, CVS found thousands more in losses attributed to the same trainee. Those losses include:
- 405 alprazolam 0.5mg tablets
- 664 lorazepam 0.5mg tablets
- 363 alprazolam 1.0mg tablets
- 496 lorazepam 1.0mg tablets
- 430 oxycodone (c-ii) hcl 15mg tablets
- 100 oxycodone 30mg tablets
- 31 oxycodone hcl ir 15mg tablets
- 178 oxy/acetaminophen 10/325mg tablets
- 50 hydro/acetaminophen 7.5/325 mg tablets
Corporate Override of Management
The CVS broke several Virginia laws and regulations by implementing corporate policies that took control away from the pharmacist-in-charge (PIC) and other pharmacists on duty, compromising the safety and management of the pharmacy.
- Scheduling Control: Corporate policies allowed district or regional managers to override the number of hours pharmacy technicians were scheduled, limiting the control of the PIC or other pharmacists over staffing, which could negatively impact pharmacy safety.
- Understaffing Issues: Multiple pharmacists and pharmacy technicians reported to a Virginia Department of Health Professions (DHP) inspector that CVS's policy on scheduling led to chronic understaffing. The PIC and other staff indicated that understaffing prevented them from completing daily maintenance tasks and created a stressful and unsafe work environment.
- Prescription Errors: An inspection on February 24-25, 2022, revealed 61 errors in 200 reviewed prescriptions, including incorrect prescriber addresses, incomplete or incorrect instructions, and incorrect refills.
Various Compliance Failures
On January 13, 2022, a DHP Inspector conducted a routine inspection of the CVS and found the following deficiencies:
- Lack of PIC: The pharmacy did not immediately inform the Board or appoint a new PIC after the previous PIC died on December 16, 2021. They submitted a new PIC application on January 14, 2022, missing the 14-day deadline. This left the pharmacy without a PIC for about a month, violating Virginia laws.
- Security Alarm System: The pharmacy failed to maintain an alarm system that could notify the PIC or an on-duty pharmacist of any breaches. The security center had no contact numbers for the current pharmacists, which has since been corrected.
- Inventory Management: The pharmacy did not properly keep track of Schedule II drugs, failing to reconcile monthly counts and document discrepancies. No records explained differences in physical versus theoretical counts for 31 drugs identified in December 2021. This issue has been corrected.
- Reporting Losses: The pharmacy did not report the loss of thirty-seven 8mg hydromorphone tablets discovered on December 2, 2021. A later count confirmed the loss, but it was not reported to the Board.
- Electronic Prescription Records: The pharmacy couldn't provide a printout of electronic prescription data during the inspection or within 48 hours of the request. They also failed to provide records for partial prescription fills. These issues have been corrected.
- Expired Drugs: The pharmacy had expired drugs mixed with the active stock. About thirty out of one hundred drug bottles were expired. This issue has been corrected.
- Cleanliness and Organization: The pharmacy was found dirty and disorganized, with drugs and boxes scattered around. The patient restroom was also closed due to a clog. These issues have been corrected.
- Oral Prescription Records: Eleven out of twenty-five oral prescriptions reviewed did not include the full name of the prescribing agent. This issue has been corrected.
- Dispensing Error Records: The pharmacy failed to maintain records of dispensing errors for twelve months. Records for June to September 2021 were missing, and logs for November and December 2021 were incomplete or unsigned. These issues have been corrected.
- District Leader's Statement: During the interview, the district leader stated that he was not licensed in Virginia and was not accountable to the Virginia Board of Pharmacy.
Penalties
Based on their findings, the Virginia Board of Pharmacy ordered CVS to pay a $75,000 fine and adhere to the conditions of a one-year probation, which began on April 30. Under the probation terms, the pharmacy will be subject to one unannounced inspection within the year and will be responsible for the inspection fees.
CVS is also required to submit quarterly self-reports on staff, prescriptions dispensed, and weekly number of vaccines administered.
The pharmacy was ordered to follow all pharmacy laws and regulations in Virginia, and violation of these terms or pharmacy laws may lead to more disciplinary actions.
The Executive Director of the Board also has the power to issue a letter confirming the completion of these conditions or refer the matter for further review of compliance.
In signing the Consent Order, CVS neither admits nor denies the findings.
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