Eighteen months into implementation of the isotretinoin risk management program, iPLEDGE, whose rocky rollout sparked a veritable firestorm last spring, most dermatologists who continue to prescribe the acne drug appear to be coping reasonably well with iPLEDGE’s complex requirements and associated practice burdens.
The program’s operator, Covance, has resolved many of the initial technical snafus and iPLEDGE call-center overload issues that plagued dermatology practices in the early weeks. The Isotretinoin Product Manufacturers Group (IPMG), in concert with the U.S. Food & Drug Administration, last fall lifted certain of the particularly onerous requirements for male patients and females of non-child-bearing potential (FNCBP) — most notably the elimination of 23-day lockout period that prevented patients from receiving a new Accutane prescription if the initial one wasn’t filled within 7 days. Computer- and telephone-system glitches that caused users to get “locked out” and made remote call-in particularly difficult for dermatologists also have been largely resolved, and the iPLEDGE Web site has been streamlined to allow for easier interaction.
In addition, both dermatologists and patients apparently have become more adept at maneuvering within the iPLEDGE system. That’s evidenced by the fact that the initial barrage of calls to the American Academy of Dermatology (AAD) has slowed to a trickle in recent months, according to AAD officials.
Some Recent Improvements and Others That Are Expected
That is not the say that iPLEDGE is smooth sailing now or that dermatologists, overall, are pleased with the program, but rather that those most affected by the program intended to prevent fetal exposure to the teratogenic agent are simply making do with its hassle factor.
“The things that bothered us the most have been addressed, so some of our dreams are coming true,” says Hilary Baldwin, M.D., President of the American Acne & Rosacea Society, in reference to the 23-day lockout-period amendment and phone-system modifications. “Call-response times are way down, partly because we all know what we’re doing now, and people aren’t finding the program particularly onerous anymore.”
Two other hoped-for amendments are expected by year’s end, Dr. Baldwin notes. These include:
• eliminating the 23-day lockout for females of child-bearing potential (FCBP) provided they obtain another pregnancy test before the prescription is reissued
• changing pregnancy-testing timing requirements to alleviate the logistical burden on prescribers’ practices.
“Within what the system is, I think that the changes that have been made and the ones that are coming … are about the most we can expect,” says Dr. Baldwin, Vice Chair of the Department of Dermatology at the State University of New York-Downstate in Brooklyn.
She also cited other helpful minor modifications made to iPLEDGE in recent months. For one, “delegates” and “designees” have been combined for the purposes of delegating patient management duties to another prescriber or allowing access to the system to update patient data, which has reduced some of the associated confusion, Dr. Baldwin notes.
In addition, the participation requirements have been modified slightly to allow practices to download program materials as needed, rather than storing cumbersome iPLEDGE binders in the office.
“Many of these are minor changes, but they’ve been helpful,” Dr. Baldwin says.
On the downside, prescribers and patients who use Apple computers continue to experience sometimes significant problems interacting with the iPLEDGE program, according to AAD officials, presumably because the system was designed for Windows-based computers.
Burdensome Issues Remain
Although the changes made to date have been welcomed, dermatologists would like to see further modification to the more burdensome aspects of iPLEDGE, said American Academy of Dermatology Association President Diane R. Baker, M.D.
“Some program features have improved over the past 18 months . . . however, making the program more workable and less burdensome for patients and prescribers is still an issue,” says Dr. Baker, a Portland, OR, dermatologist in private practice. “Streamlining the program for female patients of childbearing potential is essential. Also critical is ensuring both that confidential patient information is not shared with third parties.”
The AAD is also pushing for modifications that would make iPLEDGE fully accessible and usable by all computer operating systems, she explained, and also is pressing the IPMG to renew the free medication program for indigent patients that was available prior to iPLEDGE.
Attempts to “Game the System” Bring New Risks
As is likely to occur with any initiative that has the breadth and reach of the iPLEDGE program, unexpected post-implementation issues have surfaced. Some are mere nuisances. However, others are potentially significant, according to Stephen Stone, M.D., the AAD’s Immediate Past President and current Chair of the Academy’ Isotretinoin Task Force.
On the minor end of the scale, dermatologists in academic practice are finding that they cannot readily cover for one another’s iPLEDGE-enrolled patients because of the program’s requirements regarding assigning delegates. “One of the residents might be OK-ed to sign off on a patient [entry], for example, but I might not be able to do that for another doctor in our practice,” explained Dr. Stone, a Professor of Dermatology at Southern Illinois University in Springfield. That could be remedied, he suggests, by restructuring iPLEDGE so that all dermatologists in a formal group or faculty practice, for example, could be deemed authorized delegates for one another.
A more problematic issue that has emerged in the wake of iPLEDGE is how to deal with off-label uses of the drug, Dr. Stone maintains, when patients are prescribed atypical doses for conditions other than the indicated acne vulgaris.
“A number of doctors are using isotretinoin for Darier’s disease, or for uncommon conditions like lichen planus,” he says. “So we have to enroll them anyway in iPLEDGE, even if they only take the drug for a few months — but then the patients are considered lost to follow-up. It would be helpful if we could bring in other diagnoses [besides just acne] under the program.” The off-label use issue is actually more problematic with patients “who will be on very long-term drug,” he adds.
A far bigger issue, in the realm of unintended consequences, is that some patients enrolled in iPLEDGE are reportedly taking their prescriptions and having them filled online, to avoid remaining in the program. That not only increases risk to patients, but it also puts iPLEDGE participating prescribers in a bad spot ethically, Dr. Baldwin notes, especially when patients divulge their plans.
“This is a problem, and one of the issues is that there are physicians out there who are either condoning it or not attempting to interfere with the process,” Dr. Baldwin says. “So we’re part of the problem.” The AAD has indicated that some members have cited such concerns and sought guidance on handling the issue. It’s apparently becoming prevalent enough that the FDA has stepped in. The agency recently issued a warning notice on its Web site (and which pops up frequently when Internet surfers enter Accutane on search engines) alerting patients to the potential dangers of purchasing the drug online.
For her part, Dr. Baldwin thinks that dermatologists can nip the problem in the bud by taking a hard line with patients who indicate that might go outside official channels to obtain the drug. “I know that some people would disagree with me, but I think dermatologists should say, ‘if you’re going to the Internet to get your drug, you’re no longer my patient,’” she says.
The FDA has indicated, indirectly so far, that iPLEDGE is achieving the intended objective of reducing pregnancies in women taking isotretinoin. Although the agency hasn’t publicly released data on the number of pregnancies since the program’s implementation, officials have indicated that during the program’s first year, the number of pregnancies occurring at the initiation of therapy is “trending toward zero.” (Some studies have found fetal-exposure rates as high as one per 300 to 400 isotretinoin courses in the predecessor sticker-based SMART isotretinoin risk-management program.)
“If it is indeed zero, that’s a good thing — not only because we avoided those pregnancies but because that [zero] is really the number the FDA is looking at,” Dr. Baldwin says. “They recognize that we can’t be in the bedroom with the patients, making sure they’re not getting pregnant. But they do make us [dermatologists] personally responsible for ensuring that no one starts the drug while pregnant.”
Despite the hassles that complying with iPLEDGE entails, Dr. Baldwin urges her colleagues — most of whom are “pretty much on board now,” she notes — to try to focus more on the risk management program’s ultimate goal than on its problematic aspects.
Keeping the End Goal in Mind
“People who are really using the system and not just griping about it realize that if we have stopped a couple of pregnancies, it’s all worthwhile,” she says. “And unless we keep our eye on that, which is the most important thing, all of this bellyaching isn’t going to do us any good.”
Dr. Stone concurs with Dr. Baldwin’s view, for the most part. Still, he points to the AAD survey last summer that found that about 5% of dermatologists who once prescribed isotretinoin stopped doing so after iPLEDGE was implemented. He also cites continuing anecdotal reports about dermatologists who are simply deciding not to prescribe isotretinoin.
“Even if we cut the pregnancy rate in half, iPLEDGE is worthwhile. But we know that some doctors are just getting out of the Accutane business altogether,” he says, because they’re just “not willing to deal with” the program. That, ultimately, could reduce access to a valuable drug, he says. “And that’s not a good thing.” n
Eighteen months into implementation of the isotretinoin risk management program, iPLEDGE, whose rocky rollout sparked a veritable firestorm last spring, most dermatologists who continue to prescribe the acne drug appear to be coping reasonably well with iPLEDGE’s complex requirements and associated practice burdens.
The program’s operator, Covance, has resolved many of the initial technical snafus and iPLEDGE call-center overload issues that plagued dermatology practices in the early weeks. The Isotretinoin Product Manufacturers Group (IPMG), in concert with the U.S. Food & Drug Administration, last fall lifted certain of the particularly onerous requirements for male patients and females of non-child-bearing potential (FNCBP) — most notably the elimination of 23-day lockout period that prevented patients from receiving a new Accutane prescription if the initial one wasn’t filled within 7 days. Computer- and telephone-system glitches that caused users to get “locked out” and made remote call-in particularly difficult for dermatologists also have been largely resolved, and the iPLEDGE Web site has been streamlined to allow for easier interaction.
In addition, both dermatologists and patients apparently have become more adept at maneuvering within the iPLEDGE system. That’s evidenced by the fact that the initial barrage of calls to the American Academy of Dermatology (AAD) has slowed to a trickle in recent months, according to AAD officials.
Some Recent Improvements and Others That Are Expected
That is not the say that iPLEDGE is smooth sailing now or that dermatologists, overall, are pleased with the program, but rather that those most affected by the program intended to prevent fetal exposure to the teratogenic agent are simply making do with its hassle factor.
“The things that bothered us the most have been addressed, so some of our dreams are coming true,” says Hilary Baldwin, M.D., President of the American Acne & Rosacea Society, in reference to the 23-day lockout-period amendment and phone-system modifications. “Call-response times are way down, partly because we all know what we’re doing now, and people aren’t finding the program particularly onerous anymore.”
Two other hoped-for amendments are expected by year’s end, Dr. Baldwin notes. These include:
• eliminating the 23-day lockout for females of child-bearing potential (FCBP) provided they obtain another pregnancy test before the prescription is reissued
• changing pregnancy-testing timing requirements to alleviate the logistical burden on prescribers’ practices.
“Within what the system is, I think that the changes that have been made and the ones that are coming … are about the most we can expect,” says Dr. Baldwin, Vice Chair of the Department of Dermatology at the State University of New York-Downstate in Brooklyn.
She also cited other helpful minor modifications made to iPLEDGE in recent months. For one, “delegates” and “designees” have been combined for the purposes of delegating patient management duties to another prescriber or allowing access to the system to update patient data, which has reduced some of the associated confusion, Dr. Baldwin notes.
In addition, the participation requirements have been modified slightly to allow practices to download program materials as needed, rather than storing cumbersome iPLEDGE binders in the office.
“Many of these are minor changes, but they’ve been helpful,” Dr. Baldwin says.
On the downside, prescribers and patients who use Apple computers continue to experience sometimes significant problems interacting with the iPLEDGE program, according to AAD officials, presumably because the system was designed for Windows-based computers.
Burdensome Issues Remain
Although the changes made to date have been welcomed, dermatologists would like to see further modification to the more burdensome aspects of iPLEDGE, said American Academy of Dermatology Association President Diane R. Baker, M.D.
“Some program features have improved over the past 18 months . . . however, making the program more workable and less burdensome for patients and prescribers is still an issue,” says Dr. Baker, a Portland, OR, dermatologist in private practice. “Streamlining the program for female patients of childbearing potential is essential. Also critical is ensuring both that confidential patient information is not shared with third parties.”
The AAD is also pushing for modifications that would make iPLEDGE fully accessible and usable by all computer operating systems, she explained, and also is pressing the IPMG to renew the free medication program for indigent patients that was available prior to iPLEDGE.
Attempts to “Game the System” Bring New Risks
As is likely to occur with any initiative that has the breadth and reach of the iPLEDGE program, unexpected post-implementation issues have surfaced. Some are mere nuisances. However, others are potentially significant, according to Stephen Stone, M.D., the AAD’s Immediate Past President and current Chair of the Academy’ Isotretinoin Task Force.
On the minor end of the scale, dermatologists in academic practice are finding that they cannot readily cover for one another’s iPLEDGE-enrolled patients because of the program’s requirements regarding assigning delegates. “One of the residents might be OK-ed to sign off on a patient [entry], for example, but I might not be able to do that for another doctor in our practice,” explained Dr. Stone, a Professor of Dermatology at Southern Illinois University in Springfield. That could be remedied, he suggests, by restructuring iPLEDGE so that all dermatologists in a formal group or faculty practice, for example, could be deemed authorized delegates for one another.
A more problematic issue that has emerged in the wake of iPLEDGE is how to deal with off-label uses of the drug, Dr. Stone maintains, when patients are prescribed atypical doses for conditions other than the indicated acne vulgaris.
“A number of doctors are using isotretinoin for Darier’s disease, or for uncommon conditions like lichen planus,” he says. “So we have to enroll them anyway in iPLEDGE, even if they only take the drug for a few months — but then the patients are considered lost to follow-up. It would be helpful if we could bring in other diagnoses [besides just acne] under the program.” The off-label use issue is actually more problematic with patients “who will be on very long-term drug,” he adds.
A far bigger issue, in the realm of unintended consequences, is that some patients enrolled in iPLEDGE are reportedly taking their prescriptions and having them filled online, to avoid remaining in the program. That not only increases risk to patients, but it also puts iPLEDGE participating prescribers in a bad spot ethically, Dr. Baldwin notes, especially when patients divulge their plans.
“This is a problem, and one of the issues is that there are physicians out there who are either condoning it or not attempting to interfere with the process,” Dr. Baldwin says. “So we’re part of the problem.” The AAD has indicated that some members have cited such concerns and sought guidance on handling the issue. It’s apparently becoming prevalent enough that the FDA has stepped in. The agency recently issued a warning notice on its Web site (and which pops up frequently when Internet surfers enter Accutane on search engines) alerting patients to the potential dangers of purchasing the drug online.
For her part, Dr. Baldwin thinks that dermatologists can nip the problem in the bud by taking a hard line with patients who indicate that might go outside official channels to obtain the drug. “I know that some people would disagree with me, but I think dermatologists should say, ‘if you’re going to the Internet to get your drug, you’re no longer my patient,’” she says.
The FDA has indicated, indirectly so far, that iPLEDGE is achieving the intended objective of reducing pregnancies in women taking isotretinoin. Although the agency hasn’t publicly released data on the number of pregnancies since the program’s implementation, officials have indicated that during the program’s first year, the number of pregnancies occurring at the initiation of therapy is “trending toward zero.” (Some studies have found fetal-exposure rates as high as one per 300 to 400 isotretinoin courses in the predecessor sticker-based SMART isotretinoin risk-management program.)
“If it is indeed zero, that’s a good thing — not only because we avoided those pregnancies but because that [zero] is really the number the FDA is looking at,” Dr. Baldwin says. “They recognize that we can’t be in the bedroom with the patients, making sure they’re not getting pregnant. But they do make us [dermatologists] personally responsible for ensuring that no one starts the drug while pregnant.”
Despite the hassles that complying with iPLEDGE entails, Dr. Baldwin urges her colleagues — most of whom are “pretty much on board now,” she notes — to try to focus more on the risk management program’s ultimate goal than on its problematic aspects.
Keeping the End Goal in Mind
“People who are really using the system and not just griping about it realize that if we have stopped a couple of pregnancies, it’s all worthwhile,” she says. “And unless we keep our eye on that, which is the most important thing, all of this bellyaching isn’t going to do us any good.”
Dr. Stone concurs with Dr. Baldwin’s view, for the most part. Still, he points to the AAD survey last summer that found that about 5% of dermatologists who once prescribed isotretinoin stopped doing so after iPLEDGE was implemented. He also cites continuing anecdotal reports about dermatologists who are simply deciding not to prescribe isotretinoin.
“Even if we cut the pregnancy rate in half, iPLEDGE is worthwhile. But we know that some doctors are just getting out of the Accutane business altogether,” he says, because they’re just “not willing to deal with” the program. That, ultimately, could reduce access to a valuable drug, he says. “And that’s not a good thing.” n
Eighteen months into implementation of the isotretinoin risk management program, iPLEDGE, whose rocky rollout sparked a veritable firestorm last spring, most dermatologists who continue to prescribe the acne drug appear to be coping reasonably well with iPLEDGE’s complex requirements and associated practice burdens.
The program’s operator, Covance, has resolved many of the initial technical snafus and iPLEDGE call-center overload issues that plagued dermatology practices in the early weeks. The Isotretinoin Product Manufacturers Group (IPMG), in concert with the U.S. Food & Drug Administration, last fall lifted certain of the particularly onerous requirements for male patients and females of non-child-bearing potential (FNCBP) — most notably the elimination of 23-day lockout period that prevented patients from receiving a new Accutane prescription if the initial one wasn’t filled within 7 days. Computer- and telephone-system glitches that caused users to get “locked out” and made remote call-in particularly difficult for dermatologists also have been largely resolved, and the iPLEDGE Web site has been streamlined to allow for easier interaction.
In addition, both dermatologists and patients apparently have become more adept at maneuvering within the iPLEDGE system. That’s evidenced by the fact that the initial barrage of calls to the American Academy of Dermatology (AAD) has slowed to a trickle in recent months, according to AAD officials.
Some Recent Improvements and Others That Are Expected
That is not the say that iPLEDGE is smooth sailing now or that dermatologists, overall, are pleased with the program, but rather that those most affected by the program intended to prevent fetal exposure to the teratogenic agent are simply making do with its hassle factor.
“The things that bothered us the most have been addressed, so some of our dreams are coming true,” says Hilary Baldwin, M.D., President of the American Acne & Rosacea Society, in reference to the 23-day lockout-period amendment and phone-system modifications. “Call-response times are way down, partly because we all know what we’re doing now, and people aren’t finding the program particularly onerous anymore.”
Two other hoped-for amendments are expected by year’s end, Dr. Baldwin notes. These include:
• eliminating the 23-day lockout for females of child-bearing potential (FCBP) provided they obtain another pregnancy test before the prescription is reissued
• changing pregnancy-testing timing requirements to alleviate the logistical burden on prescribers’ practices.
“Within what the system is, I think that the changes that have been made and the ones that are coming … are about the most we can expect,” says Dr. Baldwin, Vice Chair of the Department of Dermatology at the State University of New York-Downstate in Brooklyn.
She also cited other helpful minor modifications made to iPLEDGE in recent months. For one, “delegates” and “designees” have been combined for the purposes of delegating patient management duties to another prescriber or allowing access to the system to update patient data, which has reduced some of the associated confusion, Dr. Baldwin notes.
In addition, the participation requirements have been modified slightly to allow practices to download program materials as needed, rather than storing cumbersome iPLEDGE binders in the office.
“Many of these are minor changes, but they’ve been helpful,” Dr. Baldwin says.
On the downside, prescribers and patients who use Apple computers continue to experience sometimes significant problems interacting with the iPLEDGE program, according to AAD officials, presumably because the system was designed for Windows-based computers.
Burdensome Issues Remain
Although the changes made to date have been welcomed, dermatologists would like to see further modification to the more burdensome aspects of iPLEDGE, said American Academy of Dermatology Association President Diane R. Baker, M.D.
“Some program features have improved over the past 18 months . . . however, making the program more workable and less burdensome for patients and prescribers is still an issue,” says Dr. Baker, a Portland, OR, dermatologist in private practice. “Streamlining the program for female patients of childbearing potential is essential. Also critical is ensuring both that confidential patient information is not shared with third parties.”
The AAD is also pushing for modifications that would make iPLEDGE fully accessible and usable by all computer operating systems, she explained, and also is pressing the IPMG to renew the free medication program for indigent patients that was available prior to iPLEDGE.
Attempts to “Game the System” Bring New Risks
As is likely to occur with any initiative that has the breadth and reach of the iPLEDGE program, unexpected post-implementation issues have surfaced. Some are mere nuisances. However, others are potentially significant, according to Stephen Stone, M.D., the AAD’s Immediate Past President and current Chair of the Academy’ Isotretinoin Task Force.
On the minor end of the scale, dermatologists in academic practice are finding that they cannot readily cover for one another’s iPLEDGE-enrolled patients because of the program’s requirements regarding assigning delegates. “One of the residents might be OK-ed to sign off on a patient [entry], for example, but I might not be able to do that for another doctor in our practice,” explained Dr. Stone, a Professor of Dermatology at Southern Illinois University in Springfield. That could be remedied, he suggests, by restructuring iPLEDGE so that all dermatologists in a formal group or faculty practice, for example, could be deemed authorized delegates for one another.
A more problematic issue that has emerged in the wake of iPLEDGE is how to deal with off-label uses of the drug, Dr. Stone maintains, when patients are prescribed atypical doses for conditions other than the indicated acne vulgaris.
“A number of doctors are using isotretinoin for Darier’s disease, or for uncommon conditions like lichen planus,” he says. “So we have to enroll them anyway in iPLEDGE, even if they only take the drug for a few months — but then the patients are considered lost to follow-up. It would be helpful if we could bring in other diagnoses [besides just acne] under the program.” The off-label use issue is actually more problematic with patients “who will be on very long-term drug,” he adds.
A far bigger issue, in the realm of unintended consequences, is that some patients enrolled in iPLEDGE are reportedly taking their prescriptions and having them filled online, to avoid remaining in the program. That not only increases risk to patients, but it also puts iPLEDGE participating prescribers in a bad spot ethically, Dr. Baldwin notes, especially when patients divulge their plans.
“This is a problem, and one of the issues is that there are physicians out there who are either condoning it or not attempting to interfere with the process,” Dr. Baldwin says. “So we’re part of the problem.” The AAD has indicated that some members have cited such concerns and sought guidance on handling the issue. It’s apparently becoming prevalent enough that the FDA has stepped in. The agency recently issued a warning notice on its Web site (and which pops up frequently when Internet surfers enter Accutane on search engines) alerting patients to the potential dangers of purchasing the drug online.
For her part, Dr. Baldwin thinks that dermatologists can nip the problem in the bud by taking a hard line with patients who indicate that might go outside official channels to obtain the drug. “I know that some people would disagree with me, but I think dermatologists should say, ‘if you’re going to the Internet to get your drug, you’re no longer my patient,’” she says.
The FDA has indicated, indirectly so far, that iPLEDGE is achieving the intended objective of reducing pregnancies in women taking isotretinoin. Although the agency hasn’t publicly released data on the number of pregnancies since the program’s implementation, officials have indicated that during the program’s first year, the number of pregnancies occurring at the initiation of therapy is “trending toward zero.” (Some studies have found fetal-exposure rates as high as one per 300 to 400 isotretinoin courses in the predecessor sticker-based SMART isotretinoin risk-management program.)
“If it is indeed zero, that’s a good thing — not only because we avoided those pregnancies but because that [zero] is really the number the FDA is looking at,” Dr. Baldwin says. “They recognize that we can’t be in the bedroom with the patients, making sure they’re not getting pregnant. But they do make us [dermatologists] personally responsible for ensuring that no one starts the drug while pregnant.”
Despite the hassles that complying with iPLEDGE entails, Dr. Baldwin urges her colleagues — most of whom are “pretty much on board now,” she notes — to try to focus more on the risk management program’s ultimate goal than on its problematic aspects.
Keeping the End Goal in Mind
“People who are really using the system and not just griping about it realize that if we have stopped a couple of pregnancies, it’s all worthwhile,” she says. “And unless we keep our eye on that, which is the most important thing, all of this bellyaching isn’t going to do us any good.”
Dr. Stone concurs with Dr. Baldwin’s view, for the most part. Still, he points to the AAD survey last summer that found that about 5% of dermatologists who once prescribed isotretinoin stopped doing so after iPLEDGE was implemented. He also cites continuing anecdotal reports about dermatologists who are simply deciding not to prescribe isotretinoin.
“Even if we cut the pregnancy rate in half, iPLEDGE is worthwhile. But we know that some doctors are just getting out of the Accutane business altogether,” he says, because they’re just “not willing to deal with” the program. That, ultimately, could reduce access to a valuable drug, he says. “And that’s not a good thing.” n
