The administrative burden of prescribing isotretinoin
A research letter published in JAAD aimed to quantify the workload required to manage patients on isotretinoin for acne treatment. The study included 144 patients all under the age of 21 years who received both isotretinoin and non-isotretinoin medications for acne. A total of 1,500 communications occurred during isotretinoin treatment — 40.8% were with patients, 24.3% with pharmacies, and 13.1% with insurance companies.
During non-isotretinoin treatment, 252 communications occurred. On average, 10.70 ± 8.54 communications/patient occurred during isotretinoin treatment versus 1.72 ± 2.66 communications/patient during non-isotretinoin treatment. Further, 1.61 ± 1.40 communications were required to process one prescription of isotretinoin versus 0.38 ± 0.85 communications to process a non-isotretinoin prescription. The cost to process one isotretinoin prescription could range from $6.15-$147.80 (5-120 minutes). The findings likely underestimate the actual administrative burden as non-phone communications and time spent on documentation, iPLEDGE portal activities, and electronic prior authorization submissions were not included.
DermWorld Insights and Inquiries: Sweating over acquired idiopathic generalized anhidrosis
Rising temperatures mean outdoor exercise and sweat. For those with anhidrosis, spring and summer are potentially life-threatening.
Generalized anhidrosis may be seen in patients with ectodermal dysplasias, Fabry disease, Sjögren syndrome, dermatoses that plug eccrine glands (severe atopic dermatitis, ichthyosis, or psoriasis), neurologic disorders with autonomic dysfunction (multiple sclerosis), peripheral neuropathies (diabetes, Guillain-Barré syndrome), or drugs (anticholinergics). Anhidrosis may also be idiopathic — this commentary focuses on acquired idiopathic generalized anhidrosis (AIGA). It is essential that the causes of generalized anhidrosis be ruled out before rendering the diagnosis of AIGA. Keep reading!
AADA counters IPMG objections to iPLEDGE improvements
On June 3, 2022, AADA Government Affairs and Health Policy Council Chair Bruce Brod, MD, FAAD, sent a letter to the Isotretinoin Product Manufacturer Group (IPMG) to address IPMG’s reservations with AADA’s recommendations for improvements to iPLEDGE that were shared during a May 18 meeting between the AADA, IPMG, and FDA.
As previously reported, IPMG shared plans to address some of the AADA’s concerns, including reinstating the calendar functionality, an enhanced enrollment process, and general prescriber and designee updates, but was unable to provide a timeline for implementation, stating such improvements could take up to six months due to FDA review. In his letter, Dr. Brod again urged the IPMG to make these changes as quickly as possible and questioned the need for FDA review since these features previously existed but disappeared when the program migrated to the new platform.
During the meeting, AADA again urged IPMG to:
Remove the monthly physician attestation requirements for patients who cannot become pregnant.
Remove the 19-day “lockout” period if a patient misses an initial window period.
The IPMG shared its concerns that removing the monthly physician attestation requirements for patients who cannot become pregnant would increase the potential for drug diversion and additional changes would further upset users. In his letter, Dr. Brod responded that there is no evidence supporting these concerns and offered additional suggestions and comments.
The IPMG expressed reservations with AADA’s recommendation to remove the 19-day “lockout” period when patients miss the initial window period to pick up the medication. They shared that the rationale for the 19-day “lockout” policy is based on a standardized 28-day ovulation cycle and the need to avoid starting the drug in the “fertile period” in the second month. The AADA argued that such concerns are also unfounded and provided alternatives that would more effectively achieve the appropriate balance of avoiding fetal exposure to isotretinoin and ensuring patients have safe access to the medication.
Dr. Brod again called on IPMG to increase transparency and facilitate multi-stakeholder meetings between prescribers, IPMG, and the FDA.
Actinic keratosis guidelines updated to reflect tirbanibulin research
The guideline update, published in the Journal of the American Academy of Dermatology, focuses on the strongly recommended use of tirbanibulin, a first-in-class microtubule inhibitor recently approved by the U.S. Food and Drug Administration to treat actinic keratoses. This is the AAD’s first focused update to a guideline and represents a novel guidance development process for the AAD focused on producing timely updates to current AAD guidance in light of new, potentially practice-changing evidence. The guidance issued in the focused update is intended to update the existing, recently published AAD Guidelines of Care for the Management of Actinic Keratosis.
For the focused update, the guideline workgroup performed a systematic review of data on the use of tirbanibulin for the treatment of AKs, identifying two relevant studies. Analysis of the evidence resulted in a strong recommendation for the use of topical tirbanibulin as field therapy for AKs.
FDA updates recommendations for the use of Renuvion/J-Plasma device
In March, the FDA warned consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for aesthetic procedures intended to improve the appearance of the skin through dermal resurfacing or skin contraction.
The FDA has updated its safety communication to inform health care providers and consumers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be used for certain aesthetic skin procedures. On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece to be used with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick Skin Types I, II or III. This is separate from existing Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during surgical procedures.
The FDA continues to warn against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through skin contraction.
Topical treatment improves hyperpigmentation in skin of color
According to research published in the Journal of Drugs in Dermatology, a topical brightener and antioxidant combination improved the appearance of hyperpigmentation among individuals with skin of color. The researchers examined the combination of LYT2, a comprehensive HQ-free, retinol-free cosmetic topical brightener that has previously been shown to improve hyperpigmentation in a variety of skin tones, and LVS, a dual serum that includes antioxidants and supports skin repair. The study included 13 participants comprised of 23% Asian individuals, 38.5% African American individuals, and 38.5% Hispanic individuals. Subjects applied LYT2 and LVS daily, in addition to a basic skincare regimen, for 12 weeks.
After 12 weeks, treatment with combination LYT2 and LVS resulted in significant improvements in all efficacy assessments compared with baseline, including a 23% improvement in overall hyperpigmentation, along with skin tone evenness (33%) and radiance (51%). At the end of the study, all patients noted at least a slight improvement in skin condition, and 70% reported good or excellent satisfaction.
Dermatologists discuss new understandings of the pathogenesis of melasma and emerging treatments inDermWorld.
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