Drug diluting in Kansas City: A pharmacist's crime shakes a community

Physicians are left scanning medical records, notifying some patients and reassuring others. Rebuilding trust will likely be as complex as sorting everything out legally.

By Victoria Stagg Elliott, amednews staff. May 20, 2002.

Last month, Audrey Kunin, MD, a dermatologist in Kansas City, Mo., received two letters. One was from the local health department informing her that a drug she ordered to treat a patient's skin disorder may have been diluted by the local pharmacist who filled the prescription. The other told her that her own medication -- a blood thinner she took to prevent a second stroke -- was not necessarily what the doctor ordered.

"I could have died. The good news is I'm fine, but I'm very angry," said Dr. Kunin, president of DermaDoctor.com Inc., who also used to be in private practice. "It's a huge betrayal. Everybody who was doing their best to give quality medical care was screwed."

10 years of broken trust
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Region: Midwest

The Kansas City area medical community is reeling from the revelation that Robert Courtney, owner and operator of two local pharmacies, may have diluted tens of thousands of injectable and infused medications during the past decade. His goal: to make more money.

Courtney's wrongdoing began to unravel last year after suspicions raised by a drug company marketing representative led to oncologist Verda Hunter, MD, ordering lab testing of a drug sample. Ultimately, the pharmacist was convicted of 20 counts of drug tampering. Dr. Hunter received the FBI's 2001 Director's Community Leadership award but is not commenting on the case.

After the evidence came to light, Courtney admitted to diluting anti-cancer drugs for 34 patients treated by one physician from November 2000 to May 2001. But even then, there were suspicions the betrayal had gone further.

Physicians talked of AIDS patients who didn't do as well as expected and women who didn't get pregnant despite the best fertility drugs. Oncologists who are usually pleased when a patient tolerates brutal chemotherapy were questioning why some didn't lose their hair.

A Kansas City pharmacist confessed to diluting 98,000 prescriptions since 1992.

And then in April, the worst fears were confirmed. As part of his plea agreement, Courtney confessed to actions well beyond the charges -- including diluting 98,000 prescriptions written by 400 physicians since 1992.

These numbers have not been independently verified, and a full accounting may never be possible. But area physicians are now left wondering how to clean up the mess. How can they track down patients who may have moved several times? If a patient has died, what should the doctor tell the family? What do they tell patients who are healthy?

"I have one patient who I will have to contact," said Dr. Kunin. "I'm going to say, 'You responded to your treatment. You're fine. This was three or four years ago, and I just felt you needed to know.' But I almost feel like I'm going to open up a bigger can of worms. He's fine."

Letters from the state and local health departments and the local medical society have been sent to the 400 doctors who may have been affected, telling them to review their medical records -- focusing on the most recent ones -- to determine whether any treatment plans need to be changed.

Most on the list have no more than one or two patients who may have been directly affected. But many physicians are still having to deal with a deluge of patient concerns and their own soul-searching. Should they have considered the unthinkable when some drugs did not work as expected?

"If the drug doesn't have side effects, should you be grateful that [the patient is] not sick or should you be worried that they're not getting the drug?" said Ann Romaker, MD, a pulmonologist in Kansas City. "Usually, your first assumption is not that someone is diluting the drugs. You think it's great that you've got a patient who tolerates the drug well."

There's no way to know who got the diluted drugs.

For many patients, however, particularly those treated more than a couple of years ago, it's unlikely that they will be prescribed new drugs or have their medication changed. If an antibiotic, for example, didn't work -- whether it was diluted or not -- another one was probably tried until the infection was eradicated. In addition, Courtney's tampering was intermittent. It's likely that many patients got what they were prescribed.

"For most patients, the disposition has been determined, and for any patient treated more than a year ago, there's probably not a lot that we would do differently for them," said Vickie Massey, MD, a radiation oncologist with the Kansas City Cancer Center. "If someone is cured, they're probably cured, and if they were not, then you would have probably switched to something else."

But it's the intermittent nature of Robert Courtney's actions that also makes this case so trying for many physicians. There's no way to accurately quantify the harm done, because there's no way to know who got the diluted drugs.

"It's the most frustrating, horrible, sad, terrible feeling," said Dr. Massey, who is also president of the Metropolitan Medical Society of Greater Kansas City. "Based on what he's said, we don't suspect that every patient has been affected, but frankly we don't know."

Also, patients do die even if treatment is textbook-perfect. Maybe the drugs were diluted. Maybe they weren't. But Courtney didn't keep those kinds of records.

Doing the unthinkable

It is clear, though, that Courtney destroyed, at least temporarily, the trust that exists between physicians and allied health professionals and between doctors and patients. Everyone's index of suspicion has been raised.

"I have patients who come in and ask: 'Is this the right dose?' What patients want right now is to be reassured that it's OK," said Dr. Massey.

There has been talk of new safeguards or laws to prevent this from happening again, although the Courtney case is one that pharmacy experts describe as rare. They say Courtney was a fluke -- a solo operator who, unlike most pharmacists, had little supervision or other safeguards.

"Usually there are multiple people doing things and there are multiple checks," said Frank Ascione, PharmD, PhD, associate dean for academic affairs at the University of Michigan College of Pharmacy. "In the 37 years I have been a pharmacist, I have never heard of a case like this."

Courtney has been sentenced to 17 to 30 years in jail and faces fines up to $15 million. He is also the defendant in more than 300 civil suits filed by patients and Kansas City Internal Medicine, the practice most affected by his actions. The drug companies Eli Lilly and Bristol-Myers Squibb have also been named as defendants, but have denied all wrongdoing.

"We are horrified that Robert Courtney adulterated this product," said Judy Kay Moore, spokeswoman for Eli Lilly.

"We all depend on licensed professionals to do their jobs. In this case, a licensed, trained professional violated his professional code of conduct and any sense of humanity."

ADDITIONAL INFORMATION:

10 years of broken trust

1992 Pharmacist Robert Courtney begins diluting injectable and infused medications.
May 15, 2001 An Eli Lilly sales representative alerts Verda Hunter, MD, to a discrepancy between the chemotherapy drugs Courtney ordered and the amount for which he billed.
May 17, 2001 Dr. Hunter sends a drug sample to a lab for testing.
July 27, 2001 Federal investigation begins.
Aug. 15, 2001 Courtney surrenders to the FBI.
Aug. 22, 2001 Judge orders Courtney to give up pharmacist licenses and close pharmacies.
Feb. 26, 2002 Courtney pleads guilty to 20 counts of tampering with chemotherapy drugs.
Mid-March 2002 As part of his plea agreement, Courtney confesses to diluting thousands of drugs since 1992.
April 17, 2002 State agencies begin to notify 400 physicians who prescribed drugs that may have been diluted.