The FDA will require the iPLEDGE Isotretinoin Product Manufacturers Group (IPMG) to implement the following changes to the iPLEDGE REMS:
Remove the waiting period requirement (also referred to as the “19-day lockout”) for patients if they do not obtain isotretinoin within the first 7-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting (as described above) without any required waiting period.
Revise the pregnancy registry requirement to remove the objective to document pregnancy and fetal outcomes (and associated data collection) for each pregnancy.
Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.
Remove the requirement that pregnancy tests must be performed in a CLIA-certified laboratory; however, all pregnancy testing before isotretinoin treatment initiation must be completed in a medical setting (e.g., prescriber’s office, clinic laboratory). Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. As of Nov. 7, 2023, all pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory).
These changes may take up to a year or more to be implemented fully. The AADA has already requested to participate in the next phase of this process.
DermWorld Insights and Inquiries: Aquagenic pruritus and polycythemia vera: Still valid (and mysterious) after all these years
It was thrilling to deliver the introductory dermatology lecture to our first-year medical students this year because most of the class was in person and fully engaged with the material. I am approaching the half-century mark when I was in their place — I recall so many ingrained dictums that affected my practice (whether valid or not). One caveat that has stood the test of time is to “think of polycythemia vera (PV) if your patient complains of itching after bathing.” It is difficult to ascertain the origin of that axiom, however the term “aquagenic pruritus” (AP) is attributed to Walter Shelley in a question-and-answer column from JAMA in 1970, responding to a query as to why a 17-year-old male developed pruritus after his skin became wet and then dried, without any apparent skin lesions. Keep reading!
Treatment access burdens for comorbidities related to atopic dermatitis
The National Eczema Association published new research in the Annals of Allergy, Asthma, and Immunology that elucidates the burden patients with atopic dermatitis (AD) face when using, accessing, and paying for prescription treatments to manage comorbid conditions. Findings from the study revealed that AD patients were using, on average, nearly six prescriptions in the past year to manage their AD and associated conditions, and over one in four had challenges obtaining medications for their comorbid conditions. Most patients who faced an insurance coverage issue for a comorbid condition also faced at least one coverage issue for an AD prescription in the same 12-month period.
The authors note that some treatments may not only improve AD symptoms but alleviate atopic comorbidities as well. Conversely, some newer treatments may increase the risk of infections and ocular conditions. Future research should focus on the impact AD treatments may have on comorbidities, which could lower the need for additional prescription treatments and mitigate the substantial treatment cost and access burdens faced by patients, the authors conclude.
Risk of malignancies in psoriasis patients treated with IL-17, IL-23 inhibitors
A global cohort study published in the Journal of the European Academy of Dermatology and Venereology assessed the risk of cancer in patients with psoriasis treated with IL-23 inhibitors (IL-23i) and IL-17 inhibitors (IL-17i) versus those treated with tumor necrosis factor inhibitors (TNFi) within the first five years after treatment initiation. IL-17i use was associated with reduced risks of non-Hodgkin lymphoma, colorectal cancer, hepatobiliary cancer, ovarian cancer, melanoma, and basal cell carcinoma. IL-23i use was associated with reduced risks of non-Hodgkin lymphoma, hepatobiliary cancer, and basal cell carcinoma. Both IL-17i and IL-23i were linked to lower cancer risks in a sensitivity analysis comparing the outcomes of patients receiving IL-17i and IL-23i with those of biologic-naïve patients.
A JAAD research letter evaluated the safety and efficacy of using the JAK1 oral inhibitor upadacitinib to treat patients with alopecia areata. All 25 patients were started on 15 mg per day, with three (12%) patients being increased to the 30 mg dose after four weeks of therapy. No adjunctive therapy (minoxidil, intralesional triamcinolone) was used during the first 24 weeks of therapy. The median absolute Severity of Alopecia Tool scores reduced from 50 to 25 after 12 weeks of therapy, reducing further to a median of 5. Dermatology Quality of Life Index scores demonstrated a similar decline, from a median of 15 to 8 at week 12, further reducing to 2 at week 24. Eyelash and eyebrow hair regrowth of >50% was also observed. The authors noted that patients on upadacitinib saw rapid regrowth of hair and significant improvement in quality of life.
A guide to transitioning to JAK inhibitors for AD patients. Read more.
Reducing documentation burden: Pilot program for AI voice assistant seeks participants
EHR documentation alone adds an additional six hours to a dermatologist’s work week. Join the no-cost pilot project with Suki, an AI voice assistant aiming to reduce clinical documentation burden. The AAD and Suki are launching a 45-day project, incorporating Suki’s ambient feature which allows dermatologists to continue to engage in their current documentation practices while Suki runs in the background. For details and ideal candidate criteria, review the FAQs. To participate, email practicecenter@aad.org by Dec. 20, 2023.
FDA evaluates plastic syringes made in China
The U.S. FDA has issued a safety communication to consumers, physicians, and other health care professionals to inform them that the FDA is evaluating the potential for device failures, including leaks, breaks, and other problems, with plastic syringes manufactured in China. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
The FDA received information about quality issues associated with several Chinese manufacturers of syringes and is concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance. As the FDA continues its evaluation, it is recommended to avoid using plastic syringes manufactured in China.
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