Pharmacy Error Likely Caused Hepatitis C Outbreak, Report Says

Cheryl A. Thompson

The Maryland health department has concluded that cross-contamination at a nuclear pharmacy most likely caused the fall 2004 outbreak of hepatitis C in suburban Baltimore, according to the summary report of the investigation.

Although the report referred to the facility as Pharmacy A, the March 28 news release from the health department identified the site as the Cardinal Health nuclear pharmacy in Timonium.

Cardinal publicly acknowledged early in the investigation that the Timonium pharmacy had prepared the 16 doses of radioactive tracer suspected of transmitting hepatitis C virus.

One of the people who contracted the disease died on Dec. 25, about 10 weeks after he received a dose of radioactive tracer prepared by the pharmacy for a stress test, area newspapers reported in early January.

Another man, Ronald Hughes Jr., has filed a lawsuit against Cardinal and the cardiovascular testing facility where he received the allegedly tainted radiopharmaceutical.

According to the Associated Press, Hughes seeks $5 million for "negligence, liability, and breach of implied warranties." Additionally, Hughes and his wife seek $1 million for "loss of consortium," a legal term for the inability of spouses to engage in sexual intercourse.

Hepatitis C virus infection can spread through sexual intercourse. A 2003 brochure from the Centers for Disease Control and Prevention (CDC) states that the agency does not know the effectiveness of latex condoms in preventing transmission of the virus.

Investigators reported in late March that the "only apparent common source" of the hepatitis C virus infections in the 14 men and two women was technetium Tc-99m sestamibi lot number 04289140 prepared by the pharmacy on Oct. 15, 2004, and administered during stress tests later that day.

Tests conducted at CDC found "a high degree of genetic similarity" between the viruses infecting the 16 patients and the hepatitis C virus carried by a patient whose blood was processed at the pharmacy on Oct. 14.

The investigation did not begin until Nov. 12 when a hospital reported a case of acute hepatitis C to the Anne Arundel County health department. By that time, the pharmacy had disposed of the infected blood specimen and all supplies used in radiolabeling it and preparing the doses of technetium Tc-99m sestamibi.

According to the summary report, investigators' interviews with pharmacy staff members indicated that cross-contamination could have occurred at the facility. The infected blood specimen could have been in the same work area in which the stress-test material was prepared hours later. Also, the same equipment or disposable materials could have been used during those maneuvers.

The state health department advised the pharmacy to follow all the directions and recommendations of the Maryland Board of Pharmacy, which assisted in the investigation. In addition, the pharmacy must eliminate "any ongoing potential" for cross-contamination between unscreened blood or blood components at the facility and other injectable products.

Investigators who visited the Timonium facility and another Cardinal nuclear pharmacy in Maryland viewed the latter's physical setup as superior. Specifically, the investigators liked that the workflow paths and equipment used in processing blood-derived material at the second facility were clearly separated from its paths and equipment for preparing radiopharmaceutical doses not derived from blood.

Cardinal had announced Jan. 31 that it would review the physical layout of each of the company's nuclear pharmacies, particularly their areas for aseptic processing and sterile compounding, and take additional actions.

According to the summary report, the person identified as the index case for the outbreak had previously tested positive for hepatitis B virus, hepatitis C virus, and HIV. During the state's investigation, none of the 16 patients tested positive for HIV infection. The one patient who tested positive for hepatitis B virus had been previously infected.

Cardinal said its Timonium facility ceased operations immediately after being told by the health department that the site was the primary focus of the investigation.