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How should pharmacists react when the Drug Enforcement Administration arrives at their pharmacy, and how can pharmacists protect themselves during a DEA investigation?
How should pharmacists react when the Drug Enforcement Administration (DEA) arrives at their pharmacy, and how can pharmacists protect themselves during a DEA investigation?
These were 2 of the main questions answered during a continuing education (CE) presentation at the National Community Pharmacists Association (NCPA) Annual Convention, which took place October 10-14, 2015.
One of the presenters, Carlos Aquino, compliance consultant and founder of PharmaDiversion LLC, has 24 years of experience with the Philadelphia police, including undercover work with the DEA Task Force.
“I bought and sold more cocaine than some cocaine dealers in the city of Philadelphia, except that I did it on behalf of the US government,” Aquino said by way of introduction.
Another presenter, James Schiffer, RPh, Esq, associate counsel at Allegaert Berger and Vogel LLC, has 42 years of experience as a pharmacist, 28 years as a pharmacy owner, and 11 years of experience as an attorney.
Aquino described Schiffer as someone who has been around the block, as he has been held up at his pharmacy 17 times and was even shot once during a robbery.
“I always define a seasoned pharmacist as someone who has been held up at point of gun,” Aquino said. “If you’ve never been held up, you’re still a rookie pharmacist.”
Some of their tips for pharmacists include:
All Schedule 2 and 3 controlled substances that pharmacists purchase get reported to the DEA via the supplier, so it has an idea of which pharmacies are the biggest purchasers, Schiffer and Aquino said. Those who buy the most CII and CIII drugs are more likely to get a visit from the DEA to determine whether the dispensing is legitimate.
If the DEA does find violations in the pharmacy, these issues can set pharmacists back financially very quickly. Schiffer and Aquino warned that violations such as not having a DEA number on a script are $10,000 per prescription.
Other prescriptions issues for controlled substances include lacking any of the following: patient’s full name and address; drug name; dosage form; quantity prescribed; directions for use; and prescriber’s name, address, and registration number.
Some DEA actions could include criminal investigations, civil action through the US Attorney’s Office, administrative actions, and referrals to the state regulatory agency.
The DEA may also send letters of admonition, a memorandum of understanding, order to show cause, and a revocation of registration.
Aquino advised that pharmacists should never voluntarily surrender their DEA registration. Instead, they should call their attorney and try not to talk further.
Aquino pointed out that agents might threaten arrest, but he said they would have already done so if they wanted to.
“They try to bluff,” Aquino said. “When in doubt, call your attorney.”
The key element of a DEA registration revocation is that the “prescriber and/or pharmacist deliberately closed their eyes to the true nature of the Rx.”
Schiffer told a story about a pharmacist who filled forged prescriptions of oxycodone for a woman. While under the influence of oxycodone, the female patient drove onto a property and killed a woman mowing the lawn.
In this case, the pharmacist was charged as a conspirator to the drug trade. Prosecutors said the pharmacist should have had enough professional sense to know that the prescriptions were illegitimate.
In order to avoid what Aquino called “willful blindness and deliberate ignorance,” there are a few red flags that pharmacists should look for, which include requests for refills for bizarre reasons like “the cat ate my pills,” customers asking for controlled substances who arrive at the pharmacy in groups, and cash prescriptions.
Pharmacists should also be on the alert when they are filling prescriptions for patients who live far away.
“No patient drives a hundred miles because of your service,” Aquino said.
Aquino and Schiffer both emphasized the importance of knowing key aspects about the prescriber, the patient, and the prescribed drug.
For example, Aquino asked NCPA attendees if they would fill a prescription for oxycodone for a 60-year-old patient.
“[The doctor] is practicing out of his field of medicine,” Aquino said. “You have to know who your doctor is.”
One time, Aquino saw a pharmacist who filled an oxycodone prescription written by an OB/GYN for a male patient, and the patient paid with cash.
In general, pharmacists should know prescribers’ medical education, field of medicine, board certification, and whether they have a valid DEA and state license.
In terms of the patient, pharmacists should know the medical purpose for a prescription, determine that the patient is not a drug seeker or doctor shopper, and obtain identification and insurance information.
In terms of the prescribed drug, some aspects to pay attention to include the method of payment, “cocktail” prescriptions, off-label use, similar opioids prescribed for pain, and prescriptions with the same drug and quantity.
Schiffer and Aquino also advised pharmacists to use prescription drug monitoring programs (PDMPs) and sign up all pharmacists and technicians, if allowed.
Schiffer emphasized that pharmacists need to use PDMPs appropriately. He told the story of a pharmacist in New Jersey who was fined after looking up Whitney Houston’s records after the singer died.
“Don’t look up dead movie stars,” Schiffer said.