Sentencing not end of Courtney case’s impact

? As Robert Courtney begins serving his 30-year term prison term for diluting drugs, the pharmacy industry and politicians are weighing the fallout from a crime that shook the public’s confidence in those who mix and dispense drugs.

Pharmacy organizations say the national attention the case received has already prompted some changes, with more possible as they try to prevent a similar case from ever happening again.

Courtney was sentenced Thursday after pleading guilty in February to diluting 158 chemotherapy doses for 34 patients from March 2001 through June 2001. But he admitted that greed drove him to dilute drugs since 1992, affecting as many as 4,200 patients, 400 doctors and 98,000 prescriptions.

When sentencing Courtney, U.S. District Judge Ortrie Smith said his crimes had shocked the conscience of the nation.

“You alone have changed the way a nation thinks,” Smith told Courtney. “The way a nation thinks about pharmacists. The way a nation thinks about prescription medication. The way a nation thinks about those institutions that we trusted blindly.”

Pharmacists across the country have reported that patients are questioning them about the Courtney case and about their prescriptions, said Susan Winkler, vice president for policy and communications for the American Pharmaceutical Assn.

“It is driving pharmacists to look at their practice and their commitment to patient care,” Winkler said. “It also is a call for consumers to look at their pharmacists as an important health care provider, even to just know who their pharmacist is. While arising from a tragic situation, both things are positive.”

Sen. Kit Bond, R-Mo., has called for Senate hearings to study ways to more strictly regulate compounded medications, which are usually mixed by independent pharmacists who are not subject to the regulations imposed on drug companies.

“The Courtney case really underscored the concern that many people have in regard to the adequacy of regulatory oversight of the practice of compounding pharmacies,” said Bond’s spokesman, Ernie Blazar. “Those are the questions we are raising at all levels and will continue to pursue as a way to restore confidence in the industry.”

Blazar acknowledged that finding the right regulations will be difficult.

“This is a relatively new practice and as such there has not been much study of proper regulations,” he said. “Nobody has even raised these questions before. We are into new territory here.”

Pharmacists consider Courtney an appalling aberration in their profession, and Winkler says everyone wants to find ways to stop anyone who might commit a similar crime. But she urged caution in creating regulations that may damage trustworthy pharmacists.

“Really what we are trying to find is a balance,” she said. “What steps can we take to make sure there are not more people like him out there? But at the same time, making sure that we don’t put in new checks and balances that are going to hurt good people.”

For example, Winkler said, if a board of pharmacy could suddenly revoke the license of a pharmacist who made an honest mistake, pharmacists would be less likely to report those mistakes.

“One of the most difficult aspects of error prevention is being able to talk openly about those errors,” she said. “If there is the possibility of a serious sanction, people may hide honest errors. We have to be able to talk about how to prevent them.”

Bond has also suggested that states randomly test drugs after they have been mixed by pharmacists. In Missouri, the state Board of Pharmacy has asked the legislature for $157,000 to randomly test compounded medications.

The request is one of several initiatives the board is pursuing. Another would allow a pharmacist’s license to be removed or suspended more quickly. The board had been considering such initiatives before the Courtney case but it has had an impact, said executive director Kevin Kinkade.

Kansas, which is one of about a dozen states that has no regulations governing pharmacy compounding, is reviewing other states’ laws on the issue, said Susan Linn, executive director of the Kansas Board of Pharmacy.

The board has asked the state for money to hire another person to help inspect the state’s pharmacies, she said.

“We would have done that anyway,” Linn said. “We have just had a huge increase in the number of pharmacies and we are stretched thin with only three inspectors. The Courtney case might help us get the Legislature to approve the money.”

Linn and others said the most important legacy of the Courtney case should be an increased awareness from patients about monitoring their prescription drugs.

“You shouldn’t really blindly trust anyone in the medical profession,” she said. “Part of getting a prescription is being aware that mistakes can happen.”