State board looks at testing drugs for dilution

LAKE OZARK, Mo. -- State pharmacy regulators have begun taking steps toward testing prescription drug compounds such as those mixed by a Kansas City pharmacist who admitted diluting cancer preparations.

At a meeting Friday, members of the state Board of Pharmacy decided to ask the attorney general's office to study the legal aspects of such tests. The board itself will look into how such testing could be done and who might pay for it.

But officials acknowledged that the proposed rules still may not catch pharmacists such as Robert R. Courtney, who has pleaded guilty to misbranding, adulterating and tampering with chemotherapy drugs for profit at his Kansas City pharmacy.

Inspections, which monitor whether pharmacists are complying with minimum standards, are not designed to catch criminal conduct such as Courtney's, regulators said.

"You can't write a regulation that is going to" stop what Courtney did, said Kevin Kinkade, executive director of the state Board of Pharmacy.

Sen. Kit Bond, R-Mo., recently criticized the state's inspection process for failing to uncover Courtney's crimes. Bond asked federal officials to encourage state pharmacy boards to implement random testing of compounded drugs as part of the inspection process.

Large-scale random testing, however, would be extremely expensive and difficult, regulators said.

The pharmacy board's discussion Friday suggested it might allow testing when an inspector suspected a problem. Board president James Gray, who is a St. Louis hospital pharmacist, said those cases would be rare.

Missouri already had been considering requiring pharmacists who mix sterile medications to be responsible for occasionally having those mixtures tested for potency, sterility and other safety-related factors.

Maybe monthly samples

Currently, the board is leaning toward having pharmacies test samples monthly. Some other states require occasional testing, Kinkade said. Many Missouri hospital pharmacies already conduct testing as part of quality-assurance programs, Gray said.

Though Courtney could have avoided discovery by correctly mixing drugs he thought would be tested, such tests would catch math errors, equipment malfunctions or other problems that render medications ineffective or dangerous.

The pharmacy board plans to consider the testing issue and other changes to regulations governing sterile compounding as early as next month. The board also plans to strengthen record-keeping requirements for sterile compounders and add regulatory language that emphasizes accuracy.