Baltimore-based Passport Health, which specializes in giving immunization shots through its clinics nationwide, has to bear part of the cost of re-administering thousands of hepatitis A vaccinations to patients after the second-largest U.S. drug maker recalled batches of the vaccine worldwide.
Merck & Co. Inc. ordered the recall of its Vaqta vaccine and has offered to credit its customers, including Passport, for returned vaccines and supply free replacement doses. Merck will also pay for blood tests of patients who received the vaccine.
But Passport will have to cover the costs of contacting roughly 2,000 patients in the Baltimore area - perhaps 10,000 nationwide - and scheduling appointments and blood tests, and administering new vaccinations.
The recall is "devastating to us," said Fran Lessans, president of Passport Health. Passport operates six offices in the Baltimore area and a network of franchises in 80 locations nationwide.
Lessans said Passport pays about $45 for a single dose of the Vaqta vaccine and charges patients $70.
Passport spends about $4 million a year to buy the vaccine, and the company had sales of $8 million last year, she said.
Merck, based in White- house Station, N.J., recalled several batches of its Vaqta vaccine Dec. 10 after finding in retests of the vaccine in pre-filled syringes that they had less than the recommended dose.
According to a recall letter written by Dr. Thomas M. Vernon, vice president of policy, public health and medical affairs at Merck, people vaccinated with Vaqta in pre-filled syringes from specified lots "may be insufficiently protected against hepatitis A."
The vaccine for hepatitis A, a liver disease, is commonly given to overseas travelers who expect to spend more than a month where the disease is endemic, said Dr. Robert Edelman, clinic director of the University of Maryland Travelers' Clinic. But the vaccine is increasingly being used to vaccinate children in California and high-risk groups, such as homosexual men and people living on Native American reservations, he said.
A page on the Centers for Disease Control and Prevention's Web site that offers information about the Vaqta recall said, "there is no indication that the recalled vaccine is unsafe."
But the financial implications to Passport Health's business are severe, Lessans said.
In its Baltimore office alone, Lessans said, Passport must search through 6,000 patient charts and compare the recalled-vaccine batches to those that were administered to patients over the past 2 1/2 years. She estimates that it will take about 80 manpower hours to find the affected people.
"I think we'll have over 2,000 people that will have to receive a notice that I really can't afford to send but I have to," Lessans said. "Hopefully, it won't put me out of business."
A spokeswoman for Merck said the company was not offering any other type of reimbursement "at this time."
"I think we're doing it in terms of what we felt was medically and scientifically appropriate," said the spokeswoman, who declined to be named.
The Merck recall is rippling across Passport's franchises. Some are newer than others and don't have as many people who received the vaccine, so the record search won't be as exhaustive, Lessans said.
Merck's recall of the pediatric and adolescent vaccine formulations begins with certain batches distributed after June 16, 1999, and for certain adult formulations after May 29, 2001.
A recall is relatively uncommon, said Sara Radcliffe, research director of biologics and biotechnology for the Pharmaceutical Research and Manufacturers of America, a trade group.
Each company handles the terms and procedures of a recall in a different way, depending on the circumstances, she said.