Part 2 of “The Pharmacist and the Doctor“
“We can tell you that the Controlled Substances Act was enacted in 1970 and has been in effect continuously since then. Under the Act, for a controlled substance prescription to be lawful, it must be issued for a legitimate medical purpose by a DEA-registered practitioner acting the usual course of his/her professional practice. 21 CFR 1306.04(a). This requirement was reaffirmed by the U.S. Supreme Court in United States v. Moore, 423 U.S. 122 (1975). The issuance of a prescription outside of the usual course of professional practice is an unlawful distribution under 21 USC 841(a)(1), and a pharmacist who knowingly fills such a prescription also engages in an unlawful distribution of a controlled substances under section 841(a)(1). 21 CFR 1306.04(a).” [DEA, via e-mail]
Pharmacist Jack Kirsch filled a lot of prescriptions for Dr. Nichopoulos (written out to Elvis), and for that he paid a price. Why? Because when a pharmacist fills a prescription he should be aware of the frequency and quantity of the prescriptions, especially for Schedule II drugs, and he should be able to assess as an objective outside party whether the prescriptions are necessary for legitimate medical treatment. No one can read through the list of prescriptions written for Elvis by Dr. Nichopoulos and filled by Kirsch over a 19-month span and objectively conclude that there was any sort of curative treatment involved in this “care.”
So when the doctor writes the prescription, the pharmacist should be part of the first line of defense…someone to keep an eye on the prescriptions and examine whether the prescriptions are truly needed. This is basic stuff…Pharmacy 101. In the case of Nichopoulos, he wrote the prescriptions, and Kirsch filled them, but Kirsch filled them for Nichopoulos, meaning he provided the drugs to Nichopoulos to manage/dispense as he saw fit. This is not the way prescriptions are handled.
[NOTE: A doctor writing a prescription in a patient’s name and then retaining that medication is a violation of the Controlled Substances Act of 1970.]
What we are looking at is a doctor writing prescriptions for dangerous drugs for a singular patient, the pharmacist dutifully filling the prescriptions day after day, month after month, and the cycle ending only because the patient dies. But if the pharmacist provides the drugs back to the doctor, as opposed to filling the prescription for the patient directly, how does he know the drugs are being properly managed and dispensed? He doesn’t. He has to trust the doctor. And he has to trust anyone the doctor trusts (assuming he knows who else is handling the drugs, which would not be likely). When Kirsch handed a bottle of Quaalude to Nichopoulos, then, a prescription intended for Elvis and written in his name, Kirsch was apparently working under the assumption that Nichopoulos was managing the dispensing of the drug to Elvis, even if this arrangement was not legal. But, at this point, there’s a far more important question, so let’s remove Kirsch from the discussion.
Nichopoulos leaves the Prescription House with a bottle of Quaalude, a prescription he wrote for Elvis in Elvis’s name. How does he get the drugs to Elvis, at least part of the time? He assigns an employee of the Medical Group, a nurse, to handle the drugs, and this nurse lives on the Graceland property (and is beholden to some extent to Elvis for her residence, and her husband is employed by Elvis). How does this nurse manage the drugs, and get them to Elvis? Let’s check the records she kept:
[She kept no records.]
Damn. That’s weird. Dangerous prescription drugs and no records? OK, let’s check the records Dr. Nichopoulos kept then:
[Dr. Nichopoulos kept no records.]
[NOTE: Failure to maintain complete and accurate inventories and records of all transactions involving controlled substances is a violation of the Controlled Substances Act of 1970.]
Great, no records from the doctor, either, how very convenient. Let’s bring Jack Kirsch back in then and take a look at a portion of what he was charged with, and let’s see if Dr. Nichopoulos and his staff fall under the same umbrella:
Quick question: What is the key phrase in this paragraph?
Answer: “…should have known…”
So here’s how this works: Nichopoulos writes a prescription in Elvis’s name and gives it to Kirsch. Kirsch fills the prescription and gives the medication to Nichopoulos. Nichopoulos, then, not Elvis, possesses the medication. After doing this a number of times the quantity of pills steadily increases and eventually amounts to the “medicine chest” mentioned in Count II above. (Nichopoulos actually wrote many of the prescriptions at the same time, but we’ll stick to the theory.) The next step is for Dr. Nichopoulos to distribute/provide these pills to Elvis, but since he doesn’t live on the Graceland property he sends these “medicine chest” prescriptions over to Nurse Tish Henley to keep in her trailer. It is Henley, then, who manages the “medicine chest.”
[NOTE: Stockpiling medications for a patient is a violation of the Controlled Substances Act of 1970.]
The question now arises as to which party is responsible for these drugs. Nichopoulos wrote the prescriptions, and either he keeps them in his possession, or the drugs are in the possession of his direct employee, Henley. Nichopoulos was charged with over-prescribing and though he was acquitted at his first trial in the early 1980s, he lost his medical license for these same charges in 1995. Jack Kirsch lost his pharmacist’s license in 1980 but it was reinstated a mere 18 months later due to his having attended a course in pharmacy law. Kirsch requested reinstatement because of Dr. Nichopoulos’s acquittal, arguing that, “if the doctor wasn’t guilty, I don’t guess the prescriptions I filled would be illegal, either.” (We’ll discuss this one another time.) So the doctor and the pharmacist both ran into quite a bit of trouble due to the prescriptions written to, and filled for, Elvis, and yet there was at least one person who was left out of this disciplinary effort.
The key phrase I mentioned above, “should have known,” is instructive here. When a doctor writes these types of prescriptions for dangerous medications, as Nichopoulos did for Elvis, there are several tests that must be applied. Is the medication necessary? Is the medication being prescribed for a legitimate course of curative treatment? Is the dosage of the medication appropriate for the patient within the curative protocol? And while these questions are asked of the doctor, they are also asked of the pharmacist. If a doctor “should have known” the prescriptions he was writing were dangerous, then a pharmacist “should have known” the exact same thing: that the prescriptions were dangerous. If the doctor continues to write prescriptions in this manner, it is incumbent upon the pharmacist to take some sort of action to break the cycle. Again, the key phrase is, “should have known.” Not “did know,” but “should have known.” This is a very critical distinction which prevents the doctor from later defending himself by saying, “I didn’t know,” when the threshold is actually, “you should have known.”
Now look at the wording from Count II:
“…delivered to Dr. Nichopoulos personally or his employees…”
Key point: “…or his employees.”
Or the singular: delivered to…his employee.
If a doctor “should have known” better, and a pharmacist “should have known” better, isn’t it reasonable to say that a nurse…the medically-trained employee working under and on behalf of the doctor…also “should have known” better? When the nurse takes dangerous, excessively-prescribed pills out of the “medicine chest,” sorry, “overnight bag,” for a patient, shouldn’t she have “known better”? Did these drugs not give her pause? No alarm bells? Nothing? In the case of Nurse Henley, she was delivering C-II narcotics to Elvis without any semblance of a treatment protocol. And no record of what she was dispensing. And who was often delivering these drugs to Elvis on Henley’s behalf? Any number of people, including at least two known drug abusers. (We’ll get to this later, as well.)
Why were the pharmacist and the doctor facing charges in the early 1980s, but not the nurse, who was the employee of the doctor, and who played a direct role in this over-prescribing situation, and in the dangerous operation of the Backyard Pharmacy®? They all worked towards the same end.
Nichopoulos > Kirsch > Nichopoulos > ? > Elvis. Who was the missing link here?
They all knew (or, at the very absolute least, “should have known”) that the patient in question had a serious prescription drug addiction, and yet:
- Nichopoulos kept writing the prescriptions. He faced serious consequences.
- Kirsch kept filling the prescriptions. He faced serious consequences.
- Henley kept passing on the medications to Elvis. She faced no consequences.
Not one of these three people broke the cycle, and yet they all knew what was going on. Two faced legal trouble. One did not. Not one of these three people raised a red flag, or refused to continue playing a role in this arrangement. Not one of these three people found his/her conscience and said, “Enough is enough.”
One event, and one event only, ended this arrangement: the death of the patient.
When Nichopoulos and Henley were questioned by the MPD detective and by the ME Investigator on the afternoon of August 16, neither of them mentioned anything about this arrangement.
“I hope to God he had a heart attack.”