Physician assistant Laura Bush called the help center 22 times after she suddenly couldn’t access the account she regularly uses to prescribe acne medication to her patients.
But the helpline for the iPLEDGE program – the platform providers and patients must use to get the drug commonly known as Accutane – did not pick up. She lost access the same day iPLEDGE underwent a system update.
“We’ve been locked out for days and some people for weeks,” said Bush, who is also secretary and treasurer of the Society of Dermatology Physician Assistants. However, access to the system is critical for a drug whose effectiveness depends on continuous and uninterrupted use over several months.
Bush, who says his access has been restored, is just one of many influencers frustrated with connection issues and longer-than-average wait times on the platform’s helpline since the rolling out system updates on December 13, 2021. The Food and Drug Administration said on January 14 that “the majority of iPLEDGE users now have access to their accounts”, but that “a significant amount of work remains to do” to restore full access.
Continued access to acne medication is essential because it can take prescribers several months to work patients up to a dosage level that works best for them, healthcare providers say. The longer severe cystic acne patients go without treatment, the more likely they are to end up with permanent scarring, said Ilona Frieden, chair of the American Academy of Dermatology Association’s iPLEDGE task force.
“An urgent solution is needed,” Frieden said. “Every day that this problem persists, patients lose access to needed treatments.”
More than 2 million people have taken the drug to date according to the American Osteopathic College of Dermatology. Medical providers and pharmacy groups say access to iPLEDGE is gradually improving, but a more permanent solution is needed to ensure the platform works for everyone as intended.
The Isotretinoin Products Manufacturers Group (IPMG), which is responsible for managing the iPLEDGE system, said in an emailed statement Jan. 18 that it is “working — together with the FDA and stakeholders contributing to solutions – to help resolve the current situation, such as As soon as possible.”
The iPLEDGE program, an FDA risk assessment and mitigation strategy, is made up of companies approved to produce and market isotretinoin — often referred to by its former brand name Accutane — including Teva Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries Ltd. REMS programs are put in place for drugs with potentially serious side effects to ensure that the benefits of the drug outweigh the risks.
The purpose of the iPLEDGE system is to prevent serious birth defects that can occur when isotretinoin is used in pregnant women. The platform requires that before pharmacies can dispense it, medical providers confirm a patient’s pregnancy test results and inform a patient of the risks of taking the drug during gestation.
In December, the system’s sponsors moved to a new platform that, among other things, removed gender-specific categories and separated patients based solely on their ability to get pregnant.
But problems merging user data from the old system into the new one has prevented many users from logging into their iPLEDGE accounts, leading to treatment disruptions for patients across the country.
Bush learned in mid-January that some patients and pharmacies were still unable to access their accounts, either because they did not have the necessary login information or because their accounts were not immediately registered in the new system.
Sara Wilchowski, a dermatology assistant in Michigan, said she initially had to have some isotretinoin prescriptions filled and shipped through a Florida pharmacy because “it was the only pharmacy that could access the iPLEDGE system” after the upgrade. software update.
Pharmacies, like prescribers and patients, have also reported long wait times when trying to get in touch with the iPLEDGE call center. Bush said that one day she was left on hold for eight hours straight.
Being “on hold for hours at a stretch and not reaching someone to resolve this access issue” can “definitely be a challenge on the pharmacist side,” said Brigid Groves, senior practice and business manager. professionals at the American Pharmacists Association. Pharmacies across the country are already overwhelmed with Covid-19 tests, vaccinations and other care during the pandemic.
“Discouraging” and “frustrating”
Prescribers and pharmacies say patients suffer the most from access issues.
Cystic acne has “a lot of negative connotations, psychosocial impact, and it’s serious,” Bush said. “It’s a condition that already causes a lot of stress and anxiety for the patient,” so having new barriers to accessing isotretinoin “was pretty important.”
The delayed access has been “so discouraging and so frustrating on so many levels,” Wilchowski said. She noted that “taking this drug can take six to nine months of treatment to get ‘patients’ on a specific dose to make sure the drug was effective.”
Disruptions can also be time-consuming for patients, Bush said, particularly because patients capable of becoming pregnant must take a pregnancy test within a certain time frame before starting isotretinoin therapy.
“When they couldn’t get their medicine, then they had to take another pregnancy test,” Bush said. “They had to miss work or school to do this. We had to make another visit.
Disrupted access to refills for patients already on isotretinoin may also affect “effectiveness of the drug,” Frieden said.
“The success of isotretinoin is based on a continuous full and uninterrupted course, so we don’t fully know the impact this will have on patients,” she said. “Since there is no equivalent drug to treat severe acne, patients will end up with substandard therapies, including prolonged oral antibiotics.”
Preparation is key
The FDA told Bloomberg Law that it does not administer REMS programs but “stands ready to exercise regulatory flexibility on a temporary basis as needed with respect to certain requirements of the REMS iPLEDGE, provided the IPMG offers a workable solution that also ensures the necessary safety conditions of use are maintained.
IPMG said in a statement that “while work is underway, we have taken several immediate steps to mitigate technical issues, manage call volumes and reduce wait times.” The group said it has added staff to the contact center and added features to address login issues, including the ability for prescribers to send patient links to their accounts if they are still having trouble logging in. by themselves.
The most recent fix was “a necessary system update”, but it “is a short-term workaround and further highlights issues with the call center, as the load falls on the prescribers to ensure functionality,” Bruce Brod, chair of AADA’s council on government affairs and health policy, said Jan. 21.
“In many cases, the call center acts as a triage of issues and must always escalate issues to a higher level for resolution,” he said.
Groves said manufacturers could have prepared for potential problems with the system before launch by developing a “workaround” for prescribers to send information to pharmacies without needing to go through the iPLEDGE system.
“Being more proactive and having that foresight and a plan in place ahead of time about what alternative options may be to get that patient the medication they need at that time is definitely, I think, something we need to take into account when converting any technological elements,” said Groves.
Wilchowski said that while IPMG’s new temporary fix “will be helpful,” dermatology providers and other stakeholders should be included in the development of any future updates so that these access issues and access delayed isotretinoin patients no longer recur.
“These frustrations for thousands of patients and prescribers across the country, truth be told, could all have been avoided if the rollout had been done better,” she said.