PERALTA – A pharmacy in Valencia County can no longer fill prescriptions after inspections found more than 20,000 doses of opioids unaccounted for.
The state Board of Pharmacy reached an agreement with Joe’s Pharmacy, owner Michael Leon Otero and pharmacist-in-charge Shirley Jojola on May 26. The settlement comes after federal Drug Enforcement Agency inspections in 2018 and 2019 found “substantial deficiencies” in the pharmacy’s operations, including the unaccounted for doses of various opioids.
The state pharmacy licensing board accepted the surrender of Otero’s board-issued licenses last month.
The settlement agreement required Otero to surrender his licenses after the completion of the proper disposition of all “dangerous drugs and prescription products” at the pharmacy. Otero’s licensure as a pharmacy technician was used for the 30 days the board gave the pharmacy for disposal of prescription products in its possession.
The pharmacy has 45 days to complete a full audit of “dangerous drugs and prescription products from the date of acceptance of the settlement to two years prior, and within 60 days of the board’s approval of the agreement, Joe’s Pharmacy shall surrender its board-issued license.
The settlement terms conclude that Otero shall “never again engage in activity requiring licensure” from the board or apply for approval to do so.
Otero, who is also a Peralta town councilor, declined to comment on last month’s Board of Pharmacy settlement, or the events leading to the settlement.
According to state law, “Whenever an applicable law, rule or regulation requires or prohibits action by a pharmacy, responsibility for the violation shall be that of the owner and the pharmacist in charge.”
As part of the settlement, Jojola agreed to transfer her PIC duties to another licensed and qualified pharmacist when the board accepted the agreement last month.
She is never again allowed to work as pharmacist-in-charge or consulting pharmacist in the state, and will serve a five-year probationary period on her pharmacist’s license. Both Otero and Jojola signed the settlement May 25.
The settlement with the board came after a state drug inspector investigated two DEA audits in August 2018 and February 2019 found “substantial deficiencies” after looking at 10 different medications dispensed by Otero’s pharmacy.
According to an investigative report completed by Board of Pharmacy investigators in March 2019, the DEA audit found a “shortage of approximately 4,000 tablets … for oxycodone 15mg, a shortage of approximately 1,000 tablets of clonazepam 1mg and an approximate shortage of 450 films of Suboxone 8/2mg sublingual,” all of which are highly regulated opioids.
Otero voluntarily surrendered his DEA registration, which is required to operate a retail pharmacy in the United States, on March 12, 2019. He surrendered his New Mexico Board of Pharmacy controlled substances registration two days later.
An inspection conducted by an investigator working for the New Mexico Board of Pharmacy beginning in April 2019 found Joe’s Pharmacy had a shortage of eight of the 10 controlled substances previously audited by the DEA – carisoprodol, clonazepam, diazepam, hydrocodone, oxycodone 15mg, oxycodone 30mg, suboxone and zolpidem. The shortage amounts to about 22,000 doses from May 1, 2017, to March 12, 2019.
The audit also reported an overage of both alprazolam and morphine.
In addition to shortages and overages of controlled substances, the 2019 on-site inspection by the Board of Pharmacy reported that a pharmacy technician was using another technician’s credentials to log in to the reporting system.
“Otero indicated that non-licensed/non-staff family members had access to the front area of the store after hours, but the pharmacy is not secured separately from the front area,” the inspection report indicated.
Several of the inspector’s findings carried over from the last NMBOP state inspection in August 2017, which reported food, some growing mold, stored in the same fridge as medications, expired medications stored alongside in-date medications, negative amounts of medication entered into the pharmacy operating system and improper disposal of personal health information.
“This was presumably occurring because prescriptions were processed as ‘dispensed’ prior to having the medication in-stock,” the investigator wrote in the report to NMBOP.
According to the Joe’s Pharmacy Facebook page, although the pharmacy is closed, the front of the store will remain open for the time being.
Joe’s Pharmacy was established in 1967 by Jose Otero, Leon Otero’s father. Jose Otero sold the business in the 1980s.