The American Academy of Dermatology Association (AADA) has been working closely with the U.S. Food and Drug Administration (FDA) to make the iPLEDGE program less burdensome for patients who cannot become pregnant. The Academy’s first request — to reclassify patients who cannot become pregnant — has been granted and is underway. iPLEDGE program sponsors are in the process of updating the program so that patients will be classified as “patients who can become pregnant” or “patients who cannot become pregnant.” The modification is expected to take effect later this year.
The AADA’s second request is to reduce attestation frequency for patients who cannot become pregnant. The FDA informed the iPLEDGE sponsors that it is willing to review a proposal to reduce the attestation policy. The sponsors would like to meet with the AADA in early 2022 to discuss the proposal in further detail.
DermWorld Insights and Inquiries: Getting to the heart of neonatal lupus erythematosus
I have found that rendering the diagnosis of neonatal lupus erythematosus (NLE) is fraught with emotional challenges. Not only are mothers concerned for their children, frequently they are unaware of the fact that they are also at risk for potential complications of autoimmune disease.
It has been more than 60 years since NLE has been recognized. The incidence is approximately 1 in 12,500 to 20,000 live births, being slightly higher in girls and premature newborns. Approximately 40-60% of mothers are asymptomatic when NLE is diagnosed. Some mothers may have systemic lupus erythematosus, Sjögren syndrome, rheumatoid arthritis, or another undifferentiated autoimmune disease. Keep reading!
DermWorld Young Physician Focus: Advancing the cause
As I sit typing at my computer, I am mentally fast-forwarding to next week when I’ll be enjoying some time away from work. My resolution for this summer is to unplug and enjoy the great outdoors and simple pleasures with my family. Although modern technology affords us many luxuries, it is surely a love-hate relationship as we have become servants to our devices.
I recently read (on my Kindle, of course) an interesting excerpt from a book about our post-pandemic world, noting that the COVID-19 crisis has served as an accelerant, propelling us at warp speed into the future by forcing rapid changes in many economic sectors. We all lived through a prime example of this in our own offices, with the rapid uptake of telemedicine services during the start of the pandemic. Keep reading from DermWorld Young Physician Advisor Jenna O’Neill, MD.
Cutaneous reactions after mRNA COVID-19 vaccines
In a study published inJAMA Dermatology, nearly 50,000 employees at Mass General Brigham received an mRNA COVID-19 vaccine and then completed a daily symptom survey for three days following vaccination. More than 4% of respondents reported a cutaneous reaction with rash and itching (not at the injection site) as the most commonly reported reaction. Other cutaneous reactions reported include hives/urticaria and swelling of the lips, tongue, eyes, or face.
[Read about the risk of allergic reaction to COVID-19 vaccine among patients with allergic skin diseases inDermWorld Weekly.]
Overall, 95% of respondents who experienced cutaneous reactions following the first dose went on to receive the second dose. Most of the patients (83%) did not experience a recurrent reaction. Of those with no cutaneous reaction to the first dose, 2.3% reported cutaneous reactions after the second dose.
Effective July, 20, HHS Secretary Xavier Becerra issued the latest renewal of the COVID-19 public health emergency (PHE). The declaration is effective for 90 days, and can be renewed.
AMA House of Delegates adopts two resolutions: Non-physician titles, information-blocking rules
The American Medical Association (AMA) held its Virtual Annual Special Meeting of the House of Delegates (HOD) on June 11-16. The Dermatology Section Council (DSC) testified on resolutions that addressed scope of practice, gender-affirming care, telehealth post-pandemic, diversity in medicine, sharing COVID-19 resources, and rural health needs. The DSC authored two resolutions: One on information blocking regulations and the other on non-physician title misappropriation. Both resolutions were adopted.
Resolution 233 – Non-Physician Title Misappropriation: Almost immediately after the American Academy of Physician Assistants’ (AAPA) House of Delegates (HOD) voted to change the title of their profession from physician assistant to physician associate, the DSC authored a resolution to oppose the AAPA name change. The DSC believes this is the latest effort by non-physician organizations to expand their scope of practice and mislead the public concerning their education and training. The overwhelming majority of the AMA HOD agreed with the DSC and voted to direct the AMA to actively oppose the AAPA name change and advocate that the stand-alone title ‘physician’ be used only to refer to doctors of allopathic medicine (MDs) and doctors of osteopathic medicine (DOs), and not be used in ways that have the potential to mislead patients about the level of training and credentials of non-physician health care workers.
Resolution 206 – Redefining the Definition of Harm / Resolution 212– ONC’s Information Blocking Regulations: The DSC sought to immediately request delay for compliance and clarification regarding information-blocking provisions in the recently implemented 21st Century Cures Act. The information-blocking rules impose burdens on physician practices already affected by financial and other strains caused by the current COVID-19 public health emergency. The new federal regulations also require physicians to release health information, even when doing so could potentially emotionally or psychologically harm the patient. Delegates called for the AMA to advocate to the Office for Civil Rights (OCR) to revise the definition of harm to include mental and emotional distress and urge the Office of the National Coordinator for Health Information Technology (ONC) to consult with relevant stakeholders about unintended or unforeseen consequences that may arise from the information-blocking regulations.
Adam Rubin, MD, FAAD, was appointed to the Specialty and Service Society (SSS) Governing Council.
Jessica Krant, MD, FAAD, was nominated to the Surgical Caucus Executive Committee. She also serves on the AMA Special Committee/Election Task Force.
George Hruza, MD, MBA, FAAD, served on Reference Committee B: Legislation.
Hillary Johnson-Jahangir, MD, PhD, FAAD, served on the Public Health Reference Committee and the SSS Nominating Committee. She is also a 2021 AMA appointee to the two-year Women’s Leadership Program.
Daniel Bennett, MD, FAAD, was awarded the “Distinguished Residency Teaching Award” by the University of Wisconsin, Madison, Department of Dermatology.
Marta Van Beek, MD, MPH, FAAD, serves on the Council of Legislation to the AMA leadership roles of dermatologists.
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