Radiopharmacy infects cardiac patients with hepatitis C virus in Maryland

A contaminated radioisotope used in cardiac stress tests caused 16 cases of hepatitis C infection, according to officials in the Maryland Department of Health and Mental Hygiene.

A report prepared by MDHMH and released March 28 states that the patients were exposed to hepatitis C virus Oct. 15, 2004, when each was given technetium-99m-labeled sestamibi. By December, all 16 patients had developed clinical or laboratory evidence of hepatitis C.

The radioisotope was prepared by a nuclear pharmacy owned by Cardinal Health in the central Maryland city of Timonium. Cardinal Health shut down the pharmacy in November, after being notified of the contamination. It remains closed. The company plans to build a new pharmacy in the Baltimore area, incorporating the latest design standards, according to spokesperson Jim Mazzola.

Although 16 patients were contaminated, the MDHMH report lists follow-up data on only 15. This supports speculation that one person may have died from the infection, although Maryland authorities and Cardinal Health refused to confirm or deny the possibility.

The MDHMH probe was conducted a month after the Oct. 15 contamination date and did not draw a firm conclusion as to the mechanism of contamination. There may, however, be a connection between a blood-labeling procedure and preparation of the contaminated doses of radioisotope.

A patient whose labeled leukocytes were prepared at the pharmacy on Oct. 14 had been diagnosed previously with the hepatitis B and C viruses, as well as HIV. Staff at the pharmacy told Maryland health investigators that at certain points in the preparation procedure, this patient's blood or blood components could have been processed in the same work area or with the same equipment used hours later to prepare the radiolabeled product.

MDHMH officials said an inspection of the pharmacy indicated hurried and sloppy work. Their report quoted the pharmacist as saying a rapid work pace was required to prepare a large number of doses with short expiration periods. This was exacerbated by the need to get the doses to clinics quickly.

The report noted several potentially serious shortcomings at the preparation site:

• poorly defined work areas in the pharmacy

• no policy for cleaning containers used to transport doses to clinics and to return the empty syringes to the pharmacy

• syringes scattered about the counters and sitting in cups

The investigation began when Maryland health officials were notified Nov. 12 about a case of acute hepatitis C. The patient mentioned knowing someone similarly diagnosed at a different hospital.

Examination of clinic records revealed a third person whose hepatitis C was reported on Nov. 11. Further scrutiny of records showed that the three patients with confirmed hepatitis, as well as five others tested at the clinic on Oct. 15, had been injected with doses of Tc-99m-labeled sestamibi prepared at the same pharmacy.

MDHMH sent statewide alerts, requesting prompt entry of cases into Maryland's electronic reporting and surveillance system, but no other cases turned up. The MDHMH and the Centers for Disease Control and Prevention also tested employees at the clinic and the pharmacy, but all were negative.

Local and state officials expanded their investigation to other clinics that had received doses of the radionuclide drawn from the same lot number, uncovering the remaining cases spread over three counties.

Although the Maryland health investigation indicated that the contamination was an isolated incident, Cardinal Health will reevaluate the physical layout of its pharmacies, paying special attention to the proximity of the aseptic processing to the sterile compounding, Mazzola said. The company also is reevaluating and strengthening its training protocols.