COMMUNITY PRACTICE

R.Ph.s oppose testing compounded Rxs

Having state pharmacy boards randomly test compounded drugs is an idea whose time has not come, according to the overwhelming majority of pharmacists who responded to an informal on-line Drug Topics survey.

Out of 1,383 votes cast, 66% turned thumbs down to such random testing, compared with 32% who liked the idea, and 29% who weren't sure. The computer program that operates the poll on the Drug Topics Web site accepts only one vote per visitor regardless of how many times a visitor tries to vote, so one person can't skew the survey results by voting repeatedly.

The issue of random testing by pharmacy boards was put on the policy table in July by Sen. Kit Bond (R, Mo.). Upset by the case of the Kansas City pharmacist who admitted diluting chemotherapy drugs to boost profits, he called on the Health & Human Services Department to consider mandating random testing of compounded drugs.

The Senator's plan butts heads with the reality of the cost of such random testing, the lack of trained pharmacy board personnel to conduct testing, and the slim odds of actually uncovering problems, according to respondents pointing out the downsides of randomly checking compounded Rxs.

"Pharmacy boards do not have the expertise to test or evaluate a compounded prescription," said Mike Anderson, Triad Pharmacy, San Antonio. "Second, if they are going to test compounded drugs, they need to test all compounded drugs, including intravenous admixtures prepared by hospitals and home infusion."

Bob Davidson, who has spent 42 years compounding scripts at Frisco Pharmacy in Joplin, Mo., said, "I would respond not just 'No' but 'Hell, No.' It's just another case of Uncle Sam or whoever looking over our shoulder. I take great pride and joy as a compounding pharmacist in solving problems for my patients. To those who would propose such an absurd program I would say, 'Deposit this idea in the same File 13 as HIPAA.'"

On the other side, a strong Yes vote came from David Nation, a compounding pharmacist at PRN Compounders in Owensboro, Ky. "Test away," he commented. "Why should I care if my compounds are tested? If I were doing something wrong, I would want to know. But I feel assured that anything we compound would stand up to analysis. I would like to see unqualified, untrained, and unethical compounders shut down. They do patients a disservice, and they hurt all of us."

Tony Park's first reaction was negative, but he said he had an attitude adjustment as he was "filter sterilizing hyaluronidase 150 U/ml solution," at his Park Compounding Pharmacy in Westlake Village, Calif. He decided he'd rather have the state pharmacy board do random sampling than have a Food & Drug Administration team "swarm my practice and rear its big, fat, ugly head." He added that in light of the deaths from contaminated injectables in California and the chemotherapy dilution case, "I think that anything we can do to boost confidence in pharmacists in general can yield only good things for our profession in the future."

The question of who would pay for testing bothers Phyllis Wene, a pharmacist investigator with the Washington State Board of Pharmacy. "The pharmacy community as a whole should not have to pay for testing for the pharmacies that wish to compound," she said. "This is what would happen if the pharmacy boards did the testing. A better approach would be for the state laws or regulations to require the compounding pharmacies to show proof of testing of a reasonable sample of their compounded medications."

More emphasis on quality may be needed, but costly random testing is not the answer, according to Dan Herbert, a prominent pharmacist who is president of Richmond Apothecaries in Richmond, Va. "Product testing could be done when there is some probable cause to think an individual practitioner is doing something improper," he said. "I oppose fishing expeditions ... trying to stumble on something wrong. If boards need to do anything, they should require the implementation of quality control procedures in the pharmacy with documentation and some testing results. Periodic testing does give the honest compounder information to modify compounding procedures."

Carol Ukens

Carol Ukens. R.Ph.s oppose testing compounded Rxs.

Drug Topics

2002;19:35.