In
March 2013, U.S. District Judge James D. Whittemore sentenced pharmacist Emmanuel
Mekowulu to 10 years (120 months) in federal prison for conspiring with other
persons to knowingly and intentionally distribute and dispense and cause the
distribution and dispensing of oxycodone outside of a legitimate medical
purpose and not in the usual course of professional practice.
The pharmacist
had dispensed over 340 prescriptions from Neurology and Pain Center clinics.
The physician presigned prescriptions for people that were not patients and 60
of the prescriptions were issued in the names of employees of the medical
clinic. The court also ordered the pharmacist to forfeit his professional license
and the pharmacy license he held for the Felky Pharmacy.
How
can pharmacists be charged with distributing oxycodone or other Schedule II
drugs? The
Controlled Substances Act, Title 21, United States Code, Sections 841(a)(1) and
846 make it unlawful for any person knowingly or intentionally to distribute or
dispense a controlled substance or to conspire to do so. Medical professionals,
such as physicians and pharmacists, are excepted from this general prohibition as
long as they comply with the legal requirements of their licenses and DEA registration.
In the cases we have seen, the issues
against pharmacists are based primarily on their “corresponding responsibility”
to determine that a Schedule II prescription is based on a legitimate medical
need and is not outside the usual scope of practice. In the past, pharmacists were not vigilant about confirming medical need
and asking for medical records to satisfy themselves once the determined the
physician wrote the prescription. Now that the pharmacy world knows that some
physicians will write prescriptions to patients or fake patients, it is
dangerous for pharmacists to trust physicians or the patients.
Where the pharmacist did not have
actual knowledge that the physician wrote the prescription for cash payment
without medical necessity, the government uses the theory of “willful blindness”
or “deliberate ignorance” to show that the pharmacist dispensed the
prescriptions without verifying the question or validity of the prescriptions
where there were obvious red flags.
The
juries in these pharmacy cases are allowed to consider model guidelines, federal DEA laws and regulations, state pharmacy laws and regulations, along with all other evidence, when determining whether
or not the pharmacists dispensed controlled
substances other than for a legitimate medical purpose and not in the usual
course of professional practice. Evidence is then presented by experts about
the red flags that appeared in these prescriptions and the fact that no one
followed up on these issues. Deliberate
ignorance is used to show intent to join the conspiracy to distribute
oxycodone.
There is a war on prescription drugs and pharmacists must look at each prescription and create their own protocols and procedures in order to protect themselves from civil and criminal liability in these cases. Pharmacists who dispense Schedule II narcotics should have their practices reviewed by outside counsel or compliance experts and make sure that they comply with their own policies and procedures.
Posted by Tracy Green, Esq.
Green and Associates
213-233-2260
tgreen@greenassoc.com