By Kaitlyn Dillon and Amir Massenburg
Published: May. 17, 2024 at 10:05 AM EDT
SALEM, Va. (WDBJ) - The Virginia Department of Health Professions (DHP) has fined a Salem CVS Pharmacy $75,000 for its findings in a recent investigation by the Virginia Board of Pharmacy. The pharmacy, located on Chestnut Street, has been placed on a one-year probationary period as of May 2, 2024.
VACCINATIONS:
The DHP says a contract nurse, who was improperly trained in diluting and administering vaccines, gave a 17-year-old girl six doses of the Pfizer COVID-19 vaccine on her first day of the job. The patient later reported side effects including swelling, insomnia, headache, forgetfulness, fatigue, and an increased heart rate.
The nurse claimed she did not know the vaccines needed to be diluted and she had never administered the COVID-19 vaccine. The nurse provided an email to the DHP from the CVS Health district manager stating, “New Colleague training has been cancelled so you will not have to complete that.”
DRUG DIVERSION:
The Salem CVS Pharmacy was found in violation of Virginia Code by failing to maintain safeguards in preventing drug diversion. Diversion is when a prescription is illegally distributed or prescribed for purposes other than the medication’s intended use, according to the National Library of Medicine.
The DHP found thousands of tablets of prescription drugs were diverted, with one pharmacy technician admitting to diverting the following medications between August 2021 and December 2021:
- 60 alprazolam 0.5 mg tablets (used to treat anxiety and panic disorders)
- 30 methylphenidate 36 mg tablets (used to treat attention deficit hyperactivity disorder, also known as ADHD)
- 5 lorazepam 0.5 mg tablets (sedative used to treat anxiety and anxiety-related insomnia)
After initial investigation, the DHP discovered the loss of additional medication. The pharmacy claims the additional missing tablets were caused by the pharmacy technician trainee who previously admitted to diverting prescriptions.
- 405 alprazolam 0.5 mg tablets and 363 1.0 mg tablets
- 664 lorazepam 0.5 mg tablets and 496 1.0 mg tablets
- 430 oxycodone (potent opioid to treat pain) 15 mg tablets, 100 30 mg tablets, 31 15 mg tablets.
- 178 oxycodone/acetaminophen (used to manage pain) 10/325 mg tablets
- 50 hydrocode/acetaminophen (used to manage pain and is the most frequently abused medication) 7.5/325 mg tablets
Additionally, 37 hydromorphone (used to manage pain) 8 mg tablets were discovered missing and considered as an “unusual loss” on December 2, 2021 and confirmed by another pharmacist’s count on January 13, 2022. The DHP says this loss was never reported to the Board.
PRESCRIPTIONS:
February 25 and 26, 2022, the Board’s pharmacy inspector found errors in 61 of the 200 prescriptions reviewed. These errors included incorrect prescriber addresses, incomplete or incorrect directions, and incorrect refills, according to the DHP. The inspector found 11 of the 25 prescriptions reviewed, that were given over the phone, did not list the last name of the agent of the prescriber. CVS says this has since been revised.
The DHP says the pharmacy failed to separate the expired drugs and that approximately 30 out of the 100 of the drugs in stock were expired, which CVS says has since been fixed.
The pharmacy is required to keep a perpetual inventory that includes a reconciliation twice a month of each Schedule II drug with a written explanation between any difference in the theoretical and physical count. A reconciliation is when the pharmacist reviews the patient’s medication history to compare to any other prescription they may be taking. This is done to prevent the pharmacist from prescribing the wrong dosage or prescribing a medicine that may counteract with other medication a person is taking, according to the National Library of Medicine.
The DHP says there was no documentation or explanation for differences in the theoretical and physical count for 31 Schedule II drugs for five days in December 2021. CVS claims the error has since been corrected.
Additionally, pharmacies are required to provide a printout of dispensing data for electronic prescriptions, in which the location was not able to provide a report for prescriptions or a report separating the number of Schedule II prescriptions from the Schedule III and IV prescriptions. The DHP says the pharmacy also did not file reports for partial fills or data within the 48-hour period for records requests of the inspector.
PHARMACY OPERATIONS:
CVS Pharmacy was found to have no pharmacist-in-charge (PIC) for at least one month and failed to notify the Board. According to the pharmacy, the PIC had died on December 16, 2021 and the pharmacy did not notify the DHP until January 14, 2022. DHP states the pharmacy continued to unlawfully operate past the 14-day regulatory deadline.
The pharmacy was found to be using corporate-level policies and practices to override the authority of a PIC or of a pharmacist on duty. The DHP found this controlled all aspects of the pharmacy practice and resulted in “...a danger to the health and welfare of the public.”
DHP discovered the district or regional management overrode the requested number of hours scheduled for pharmacy technicians, resulted in an overworked and understaffed pharmacy with no time for employees to conduct “day to day maintenance.” This resulted in an overall unorganized and unsanitary work environment.
The pharmacy failed to make time for an inspection by the Board for twelve months to analyze dispensing errors for 2021 and failed to include information from June to September. Additionally, the “Virginia Continuous Quality Improvement Program Dispensing Error Logs” were either incomplete or not signed by a pharmacy manager in November and December of 2021.
According to the DHP, the pharmacy did not have a security alarm system, so if a breach of safety occurred in the store, the information would not be relayed to the pharmacy. The pharmacy also did not have any working phone numbers for any pharmacists at the location, but CVS claims the issue has since been corrected
PENALTIES:
The Salem CVS Pharmacy is required to pay the Board $75,000 within 60 days of the order. The pharmacy is on probation for one year and must abide by the following conditions in addition to following Virginia laws and regulations:
- One unannounced inspection by the Department of Health Professions during normal business hours, with the pharmacy being responsible for paying the inspection fees. If the DHP finds that the pharmacy violates any laws or regulations, the are required to appear in an administrative proceeding.
- The pharmacy must submit “Self-Reports” including weekly scheduling hours for pharmacists and pharmacist technicians, weekly prescriptions dispensed and vaccines administered, and the hours of operation. The DHP says the reports will be due on a quarterly basis to the Board, due on the last day of March, June, September, and December until their probation ends.
- The location will not be released from their probation if there is a pending investigation or adjudication by the Board for alleged violations of the law or regulations. In that case, the pharmacy will continue to be in a probationary period until a decision is made by the Board.
- The Executive Director of the Board must issue a letter stating the pharmacy has successfully completed the conditions of the probation or refer the matter to the Special Conference Committee.
CVS Pharmacy is not admitting or denying the Findings of Fact and Conclusions of the Law, according to court documents. CVS Pharmacy Lead Director of External Communication Amy Thibault gave WDBJ7 a statement in response to the investigation:
“We’re pleased to have reached an agreement with the Virginia Board of Pharmacy regarding years-old allegations involving our pharmacies in Salem. We look forward to working with the Board on these matters moving forward and continuing to provide safe, high-quality pharmacy care to our patients.
We’re committed to ensuring there are appropriate levels of staffing and resources at our pharmacies and are making targeted investments, including enabling teams to schedule additional support as needed, enhancing pharmacist and technician recruitment and hiring, and strengthening pharmacy technician training. We’re also making roughly $1 billion in wage increases for pharmacists between 2021 and 2024 and are also awarding roughly $70 million in bonuses to recognize and thank our pharmacists, pharmacy technicians and other frontline colleagues this year.”
The full court documents are listed below:
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