VACCINE COMPENSATION PROGRAM: PATIENT INFORMATION DRAFT

VACCINE COMPENSATION PROGRAM: PATIENT INFORMATION DRAFT forms will not be published in the Federal Register until mid-January, program coordinator Alan Hinman, MD, reported at an FDLI meeting Nov. 30. Vaccine providers will be required to furnish vaccine recipients with specified risk/benefit information by mid-summer (June 22), six months after the publication deadline in the Federal Register. "The fact of the matter is," Hinman explained, "this will not be accomplished by the 22nd of December this year, the time when this is supposed to be accomplished." Draft versions of the information forms will be published in the Federal Register, "within the next six weeks," Hinman predicted. Furthermore, "there will be a public hearing about midway through the public comment period to obtain further comment," he said. Under the government-sponsored National Vaccine Injury Compensation Program, the Bureau of Health Professions of the Health Resources and Services Administration has received 50 claims to date. The draft forms are modeled after the Maryland diptheria-pertussis-tetanus (DTP) vaccine patient information form. "We have used the Maryland DTP form," Hinman continued, "as a template for developing forms for DTP (and its components)... the second form for MMR (and its components), and the third form for poliovirus vaccine (both live and inactivated)." In order to include all of the required information for each vaccine, Hinman said the forms will have to average 2,500-3,000 words each. Noting that "many people read fewer that 100 words per minute," Hinman said "this raises some worrisome questions about whether the forms will be read," particularly when patients receive multiple vaccines in a single visit. The program coordinator cited congested traffic flow in vaccine provider settings as a related problem which may result in private physicians referring patients to the already over-worked public healthcare sector. Addressing the question of the program's effect on vaccine prices, Hinman remarked that "initial indications are not consistent." In response to the excise tax imposed Jan. 1, DTP manufacturers, for example, cut the $8/dose internal liability surcharge by $2, thus offsetting the overall $4.56 excise tax price increase by $2. On the other hand, MMR prices were raised in addition to the $4.44/dose excise tax, while oral polio vaccine prices remained steady.