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Archive for the ‘Health law’


CDC Updated Guideline on Prescribing Opioids for Pain

photo of several pills and 2 opioid prescription bottlesThe Centers for Disease Control and Preventions (CDC) recently published the Clinical Practice Guideline for Prescribing Opioids for Pain, which updates and expands 2016 recommendations “for clinicians providing pain care for adult outpatients with short- and long-term pain.”  The 2022 Clinical Practice Guideline addresses four areas:  “(1) determining whether to initiate opioids for pain, (2) selecting opioids and determining opioid dosages, (3) deciding duration of initial opioid prescription and conducting follow-up, and (4) assessing risk and addressing potential harms of opioid use.”  The voluntary recommendations “do not apply to pain related to sickle cell disease or cancer or to patients receiving palliative or end-of-life care.”  CDC developed the recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system of evaluating intervention recommendations, and gathered input from the National Center for Injury Prevention and Control’s Board of Scientific Counselors, peer reviewers, and the public.  The recommendations “are based on systematic reviews of scientific evidence and reflect considerations of benefits and harms, patient and clinician values and preferences, and resource allocation.”

CDC Advisory Committee Updates Immunization Schedules

CDC LogoThe Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) recently voted to update the 2023 child and adult immunization schedules, including “incorporating additional information for approved or authorized COVID-19 vaccines.”  The ACIP did not make any changes to its COVID-19 vaccine recommendations  – the updates will “simply help streamline clinical guidance for healthcare providers by including all currently licensed, authorized and routinely recommended vaccines in one document.”  The updated immunization schedules and guidance will be published in early 2023.  The ACIP is composed on medical and public health experts who develop recommendations that “stand as public health guidance for safe use of vaccines and related biological products” in the United States.  CDC makes recommendations on vaccine use, but state or local jurisdictions determine school-entry vaccination requirements.  For example, the Ohio Department of Health (ODH) provides guidance on immunizations, including the Ohio Immunization Summary for School Attendance chart and more detailed information in the ODH Director’s Journal Entry on “Approved Means of Immunization Pursuant to Sections 3701.13 and 3313.671 of the Ohio Revised Code.”

FDA & CDC Actions on “Updated Boosters”

image of hand injecting vaccine into covid cellThe U.S. Food and Drug Administration (FDA) recently amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 Vaccines “to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.”  The Bivalent vaccines, also called “updated boosters,” contain two messenger RNA components, “one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”  The FDA authorized the Pfizer-BioNTech Vaccine, Bivalent for individuals 12 years and older, and the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years and older.  The U.S. Centers for Disease Control and Prevention (CDC) Director, Rochelle P. Walensky, MD, MPH, also recently “endorsed the CDC Advisory Committee on Immunization Practices’ recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.”  The updated boosters will help “to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading.”

Anthony Fauci Stepping Down, Not Retiring

photo of Dr. Anthony S. FauciDr. Anthony S. Fauci recently announced that he will be stepping down in December from the positions of Director of the National Institute of Allergy and Infectious Diseases (NIAID), Chief of the NIAID Laboratory of Immunoregulation (where he also serves as Chief of the Immunopathogenesis Section), and Chief Medical Advisor to President Joseph Biden.  First appointed NIAID Director in 1984 by President Ronald Reagan, he has advised seven Presidents, dealing with new and re-emerging infectious disease threats including HIV/AIDS, West Nile Virus, Anthrax attacks, Ebola, Zika Virus, and COVID-19.  During the course of his long career, Fauci developed effective therapies for formerly fatal inflammatory and immune-mediated diseases (eg, polyarteritis nodosa), was a key architect of the President’s Emergency for AIDS Relief, and continues to research “the immunopathogenic mechanisms of HIV infection and the scope of the body’s immune responses to HIV.”  He has authored, coauthored, or edited over 1,400 scientific publications, and serves on the editorial boards of many scientific journals.  He has received over 58 honorary doctoral degrees from universities in the United States and abroad, as well as numerous prestigious awards, including the Presidential Medal of Freedom and National Medal of Science.  Fauci is not retiring.  He wants “to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.”

 

Recent FDA Action & Publication Concerning COVID-19

image of covid-19 virusesThe U.S. Food & Drug Administration (FDA) recently “authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.”  On 7/13/2022, the FDA authorized the emergency use of this vaccine for individuals 18 years of age and older.  FDA’s “rigorous analysis and evaluation of the safety and effectiveness data” led to the new authorization.  See the COVID-19 Vaccines page for information on all the COVID-19 Vaccines authorized for emergency use or FDA-approved.  The FDA also recently published the report FDA’s Work to Combat the COVID-19 Pandemic, which “outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.”  The report covers vaccines; pharmaceuticals; devices, including tests and personal protective equipment; supply chains; advanced manufacturing and innovation; inspections, investigations, imports, and fraud; and crosscutting research.