iPLEDGE one year later

Apr 01, 2007, 4:00am

Washington - One year after iPLEDGE's inception, dermatologists applaud the program's elimination of a 23-day lockout period for male and nonchildbearing female patients who fail to fill isotretinoin prescriptions on time.

They also welcome the system's increased user-friendliness, as reflected in shorter call waiting times and easy online editing capabilities.

But sources say concerns about the mandatory federal registry for pharmacists, prescribers and users of isotretinoin remain. Dermatologists say the 23-day lockout period should be eliminated for all patients, and they point to the possibility of congressional hearings and to insurance issues regarding certain pill sizes.

"Some of the early complications we had to deal with in terms of understaffing and inability to get through on the telephone have been taken care of," Dr. Stone tells Dermatology Times.

Concerns still remain about iPLEDGE

Late last year, Covance (the Princeton, New Jersey-based drug development services company that administers iPLEDGE) eliminated a 23-day lockout period for male patients and females of nonchildbearing potential who failed to fill prescriptions within seven days of issuance.

Previously, those patients couldn't get new prescriptions until the lockout period expired. Now, Dr. Stone says, "If they miss their seven-day window, they can get a new prescription" and go to a pharmacy to have it filled.

Covance also should require that women of childbearing potential have an additional pregnancy test before getting a new prescription, he says.

Covance and the Food and Drug Administration (FDA) are "committed to eliminating the 23-day lockout for females of childbearing potential" in the second half of 2007, says Laurene Isip, Covance spokeswoman.

"The iPLEDGE program has made significant progress since its inception," she adds. At the end of 2006, Ms. Isip says, the system had registered nearly 45,000 pharmacies, 16,000 prescribers and more than 244,000 patients.

Covance also has enhanced iPLEDGE's Web site to make it more user-friendly so that prescribers can now download forms, guides, workbooks, package inserts, patient checklists and program instructions, Ms. Isip says.

"iPLEDGE now allows us to edit patients' demographic information" on the fly, Dr. Stone says. Previously, if he made a mistake, such as sending an incorrect birthdate for a male patient, "I had to go through a whole telephone call to iPLEDGE just to get it straightened out so the patient could be properly registered."

For male patients especially, he says, "There was no reason not to allow the doctor who input the data to edit it. Now they're allowing us to do that. That's going to be a big help."

Computer wrinkles

Robert Silverman, M.D., reports that iPLEDGE doesn't support the Safari (Macintosh) browser his office originally attempted to use, or AOL's browser.