The implementation of the iPLEDGE program for isotretinoin prescribing has been delayed by 1 month for pharmacies and by 2 months for physicians and patients, the Food and Drug Administration announced last month.
Pharmacies must now register by Dec. 30 to receive new supplies of isotretinoin or see supplies pulled back by the manufacturers starting Dec. 31.
Physicians now must be registered and activated by March 1, 2006, for a prescription written by them to be dispensed to a patient, who must also be registered and activated by that date.
In the meantime, prescriptions written using the yellow stickers of the expiring SMART program, and the analogous programs of the other isotretinoin products, will be dispensed by pharmacies through February 2006.
The delay of iPLEDGE was necessary largely because not enough pharmacies had signed up yet, sources said in an interview.
Implementation of the iPLEDGE program was only publicly announced by FDA in August (FAMILY PRACTICE NEWS, Sept. 15, 2005, p. 8).
“We needed time to iron things out—it's a very complicated task,” said a source at FDA. “We've all been having daily meetings on this for months.”
By mid-October, only about 15,000 of 55,000 retail pharmacies in the United States had registered with Covance Inc., the company running the iPLEDGE registration system, according to Douglas Hoey, R.Ph., a senior vice president with the National Community Pharmacists Association.
The association was one of several organizations, including the American Academy of Dermatology, that had begun lobbying the FDA for the delay, Mr. Hoey said.
“We wanted to make sure that as many pharmacists as possible were ready to serve patients,” he said.
It is expected that most pharmacies will sign up and that physicians who prescribe isotretinoin will not have trouble finding a dispensing pharmacy in their area, Mr. Hoey said. The problem was in the timing, getting the word out, and getting pharmacists informed and up to speed, he added.
The delay comes at a time, however, isotretinoin prescribers are expressing increased irritation about the restrictions being placed on isotretinoin prescribing (FAMILY PRACTICE NEWS, Nov. 1, 2005, p. 33).
And, sources said in an interview that physician registration to date in the iPLEDGE program has not been exceptionally brisk.
The number of isotretinoin prescriptions dropped significantly in the year after the implementation of the SMART program.
Alan Shalita, M.D., said he was somewhat relieved to learn of the program implementation delay, adding that he was not worried about being able to prescribe isotretinoin when the time came. He had registered with the iPLEDGE program soon after it came online and by November had still not received his patient materials from the program.
“I think it was an intelligent move to put implementation off,” said Dr. Shalita, chair of dermatology at the State University of New York Downstate Medical Center in Brooklyn.