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State: Pharmacy sold fake meds

The business mixed compounds sold as brand-name drugs to respiratory patients, an investigator says.

By RICHARD DANIELSON
Published April 9, 2005

OLDSMAR - A pharmacy based in Oldsmar mixed its own medical compounds for patients, including children with cystic fibrosis, instead of the brand-name drugs that doctors prescribed and then billed Medicaid for the more expensive drugs, state investigators said this week.

The owners of the Rapha Associates, Patricia and Roderick Hauser of Tampa, were charged this week with organized fraud, counterfeiting drugs and illegally compounding medications.

In sworn criminal affidavits, an investigator with a state's Medicaid fraud control unit estimated that the Hausers received Medicaid overpayments of more than $146,000.

"It's unconscionable that somebody would do what these people are alleged to have done," Florida Attorney General Charlie Crist said Friday. "The sheer greed factor here is just astounding."

State officials accuse the Hausers, neither of whom is a pharmacist nor a pharmacy technician, of selling medical compounds mixed at their business as three brand-name drugs for patients with respiratory conditions: TOBI, Albuterol and Pulmicort.

Investigators began looking into Rapha Associates after a nurse who adopted two children with cystic fibrosis noticed that Rapha Associates had sent her a bottle that looked different from the packages she had received before.

The U.S. Food and Drug Administration tested several samples of medicines from Rapha, and one vial tested positive for bacteria. The medicines were sent to patients with cystic fibrosis and other serious conditions, state officials say.

"My understanding is that (the number of patients who received the unauthorized compounds) was more than 100, and the good news is that at least, as far as we're aware, none of them has been hurt," Crist said.

Most of the patients were believed to be from the Tampa Bay area, Crist said.

The Hausers were booked into the Pinellas County Jail early Thursday, and each was released after posting $5,000 bail later that day. Neither they nor their attorney, Denise Bartilucci of Tampa, returned calls from the Times on Friday.

Patricia Hauser, 50, is the president of Rapha Associates. Roderick Hauser, 37, is the company's vice president.

The door was locked and no one answered the door or the telephone at Rapha's offices in a small industrial park on Dunbar Avenue in Oldsmar on Friday afternoon. Signs on two delivery vans parked in front of the business said Rapha specialized in home IV therapy, prescription drugs, wound care, respiratory drugs and nutritional services. The company's Web site said Rapha also sells office furniture, janitorial supplies, church pews, robes and linens.

Along with filing criminal charges, state officials said they are suing the Hausers in civil court, seeking to recover damages and civil penalties of at least $245,625.

The fraud took place from October 2003 through July 2004, according to state officials.

State Medicaid fraud investigator Thomas Watterson interviewed doctors who wrote prescriptions, nurses, parents of patients and pharmacists who previously worked at Rapha. None of the doctors said they authorized compounded medicines for their patients instead of the brand names.

Moreover, there are no commercially available or FDA-approved generic substitutes for TOBI, Watterson said in a sworn statement.

Former employees told Watterson that they watched Roderick Hauser prepare compound medications and that Patricia Hauser asked them to help prepare the compounds. When shown their signatures on batch sheets for compounded medicines, the pharmacists told Watterson that the signatures had been forged, according to court records.

While the compound medications were mislabeled as the brand-name drugs, the claims that the Hausers submitted to Medicaid were for the more expensive drugs, officials said.

When the nurse who adopted the children with cystic fibrosis called Rapha to question the medication she had received, Patricia Hauser told her that the company "had recently purchased the equipment to compound their own TOBI and it would be exactly the same as what she had received before," Watterson said.

A doctor with the manufacturer for TOBI said the medicine that the mother received from Rapha was chemically different from TOBI, according to the state's investigation. And a random sample of a key ingredient in the pharmacy's compound for TOBI tested positive for bacteria, officials said.

A medical compound that is not created with commercial-grade products, in sterile environments and according to exacting techniques "absolutely puts the patient at risk," said Dr. Daniel Buffington, a clinical pharmacologist who teaches at the University of South Florida College of Medicine.

"Clearly," he said, "there is an area where the preparation techniques can make all the difference."

[Last modified April 9, 2005, 07:10:29]

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