BURROUGHS WELLCOME's DETAILS ON ZOVIRAX PATIENT EDUCATION PROGRAM REQUESTED

BURROUGHS WELLCOME's DETAILS ON ZOVIRAX PATIENT EDUCATION PROGRAM REQUESTED for the upcoming joint meeting of FDA's Antiviral Drugs and Nonprescription Drugs Advisory Committees by OTC committee member Alan Sinaiko, MD, University of Minnesota. At a May 19 joint session of the committees, Sinaiko asked that Burroughs Wellcome present "their plan for [consumer] education" on OTC Zovirax (acyclovir) on July 28, the date tentatively set by FDA for the committees to review the Rx-to-OTC switch of the drug.

At the May 19 meeting, which immediately followed a public hearing on the Zovirax switch, the committee said it considered the establishment of an adequate consumer education program for OTC acyclovir as one of the major issues to be addressed by FDA in reviewing the switch application and in preparing for July meeting. In an earlier presentation during the hearing, a Burroughs Wellcome representative outlined the company's consumer education plans.

Sinaiko suggested that Burroughs Wellcome report on any similar programs the company has conducted and on other companies; experiences with such programs. Sinaiko added that he is "wary of turning [the task of patient education] over to a corporation."

In a similar vein, OTC committee member Maria Chanco Turner, MD, National Institutes of Health, said she would "like to see some assessment of [the] efficacy of educational programs" in the area of sexually transmitted disease prevention. Another OTC committee member, Joseph Veltri, PharmD, University of Utah College of Pharmacy, recommended that the panels and FDA explore ways in which to "measure the effectiveness of our education programs" for the drug.

Committee members discussed assertions made by medical groups during the public hearing that patients may not be as well informed about the drug if they are not required to visit a physician in order to get a prescription.

Antiviral committee member Mark Smith, MD, vice president of the Henry J. Kaiser Foundation, suggested that the information currently available to prescription Zovirax users be considered in deciding whether education programs for OTC acyclovir are adequate.

Smith recommended that FDA examine "some science on what... we know about the capacity of physicians" currently prescribing Zovirax to "educate their patients about indications of the drug, proper dosage of the drug [and] how [it] should be taken." In the "absence of knowing what the baseline is now," he maintained, "all sorts of assertions get made" about whether the state of patient knowledge on the drug will improve or worsen with OTC availability.

Smith also questioned the "assertion that the individual clinical professional interaction is important to the proper administration of the drug." Patients visit doctors now and do not take the drug correctly, he argued, noting that the "question is not 'will they take it right if it's over-the-counter' -- of course they won't. The question is how much wronger will it be than the way it is now."

OTC committee member Elizabeth Connell, MD, Emory University, expressed "a lot of doubts about stressing the major advantages of the care that doctors give and other people can't give." Citing her experience, she suggested that physician care "is not necessarily as much of a plus as some people have said today."

"With a limited amount of time and effort," Connell argued, "we could get a much better idea of [whether OTC availability of Zovirax will] be much different than a doctor writing out a prescription for 12 refills." She called for more comprehensive education of both patients and health care professionals on Zovirax and genital herpes. Antiviral Drugs Advisory Committee Chair Deborah Cotton, MD, Massachusetts General Hospital, agreed that "overall, the level of education about [sexually transmitted diseases] is very poor among the professional community and the ability to detect herpes versus other STDs is quite poor."