Pharm5

We’ll be taking a break in May, June, and July while our host is on maternity leave. See you again in August!   This week on Pharm5: * Vowst (SER-109) for recurrent C Diff * Trikafta for CF in 2+ years * Mounjaro for weight loss in diabetes * Qalsody accelerated approval for ALS * J&J talc baby powder settlement   Connect with us! * Listen to our podcast: Pharm5 * Follow us on Twitter: @LizHearnPharmD   References: 1. FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile infection. U.S. Food and Drug Administration. https://bit.ly/3Li7Cue [https://bit.ly/3Li7Cue]. Published April 26, 2023. Accessed April 27, 2023. 2. Feuerstadt P, Louie TJ, Lashner B, et al. Ser-109, an oral microbiome therapy for recurrent clostridioides difficile infection. New England Journal of Medicine. 2022;386(3):220-229. doi:10.1056/nejmoa2106516 3. Vowst [package insert]. Cambridge, MA: Seres Therapeutics, Inc.; 2023. 4. FDA approves Trikafta for children ages 2 through 5 years with certain CF mutations. Cystic Fibrosis Foundation. https://bit.ly/44dP3QD [https://bit.ly/44dP3QD]. Published April 26, 2023. Accessed April 27, 2023. 5. Lobo A. FDA expands its approval of Trikafta to cover younger children. Cystic Fibrosis News Today. https://bit.ly/3oSuhG0 [https://bit.ly/3oSuhG0]. Published April 27, 2023. Accessed April 27, 2023. 6. CFTR modulator therapies. Cystic Fibrosis Foundation. https://bit.ly/3Az4epZ [https://bit.ly/3Az4epZ]. Accessed April 27, 2023. 7. Lilly's tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and type 2 diabetes in surmount-2. Eli Lilly and Company. https://bit.ly/3VkD9AE [https://bit.ly/3VkD9AE]. Published April 27, 2023. Accessed April 27, 2023. 8. Galvez-Jiminez N, Goyal NA, Cudkowicz ME. Disease-modifying treatment of amyotrophic lateral sclerosis. UpToDate. http://www.utdol.com [http://www.utdol.com]. Updated May 17, 2022. Accessed May 19, 2022. 9. Liu A. FDA awards Biogen's ALS Drug Qalsody an accelerated approval, following its experts' feedback this time. Fierce Pharma. https://bit.ly/3VaVwrC [https://bit.ly/3VaVwrC]. Published April 25, 2023. Accessed April 27, 2023. 10. FDA approves Qalsody™ (Tofersen) as the first treatment targeting a genetic cause of ALS. PR Newswire: press release distribution, targeting, monitoring, and marketing. https://bit.ly/3ADSe6N [https://bit.ly/3ADSe6N]. Published April 25, 2023. Accessed April 27, 2023. 11. Qalsody [package insert]. Cambridge, MA: Biogen, Inc.; 2023. 12. J&J to retain all talc-related liabilities from litigation in US, Canada. Reuters. https://bit.ly/3HjTS10 [https://bit.ly/3HjTS10]. Published April 27, 2023. Accessed April 27, 2023. 13. Spector M, Knauth D. J&J unit files for second bankruptcy to pursue $8.9 billion talc settlement. Reuters. https://bit.ly/426xfoY [https://bit.ly/426xfoY]. Published April 5, 2023. Accessed April 27, 2023.

This week on Pharm5: * PREP act extended to December 2024 * Doxy-PEP for MSM * Medicare expands CGM coverage * COVID vaccine changes * DEA Drug Take Back Day   Connect with us! * Listen to our podcast: Pharm5 * Follow us on Twitter: @LizHearnPharmD   References: 1. Fact sheet: HHS announces intent to amend the declaration under the PREP Act for medical countermeasures against COVID-19. HHS.gov. https://bit.ly/3osEGZ4. Published April 14, 2023. Accessed April 20, 2023. 2. HHS extends PREP act for certain pharmacist and technician services. ASHP. https://bit.ly/3ovmq19. Accessed April 20, 2023. 3. Luetkemeyer AF, Donnell D, Dombrowski JC, et al. Postexposure doxycycline to prevent bacterial sexually transmitted infections. New England Journal of Medicine. 2023;388(14):1296-1306. doi:10.1056/nejmoa2211934 4. NIH-funded study finds doxycycline reduces sexually transmitted infections by two-thirds. National Institutes of Health. https://bit.ly/3H2jtvr. Published April 6, 2023. Accessed April 20, 2023. 5. Glucose Monitor - Policy Article. CMS.gov Centers for Medicare & Medicaid Services. https://bit.ly/3owSyl2. Accessed April 20, 2023. 6. Tucker ME. Medicare expands CGM coverage to more with type 2 diabetes. Medscape. https://bit.ly/3KR9eet. Published April 17, 2023. Accessed April 20, 2023. 7. Chen S. Medicare expands CGM coverage for people with type 2 diabetes. diaTribe. https://bit.ly/3AgHLxV. Published April 17, 2023. Accessed April 20, 2023. 8. Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. U.S. Food and Drug Administration. https://bit.ly/41HrXQr. Accessed April 20, 2023. 9. CDC simplifies COVID-19 vaccine recommendations, allows older adults and immunocompromised adults to get second dose of the updated vaccine. Centers for Disease Control and Prevention. https://bit.ly/3V0dxsE. Published April 20, 2023. Accessed April 20, 2023. 10. Take back day. DEA. https://bit.ly/41IEgfb. Accessed April 20, 2023.

This week on Pharm5: * Mifepristone’s FDA approval up in the air * Statins for primary prevention in PLWH * Xylazine sedative found in illicit fentanyl * Death by H3N8 avian flu * Phase II Match Day In in honor of National Minority Health Month, this week's episode was fully written, developed, and recorded by members of the Student National Pharmaceutical Association (SNPhA) at the HSC College of Pharmacy. Thank you to SNPhA members Hillary Matthews, Alyssa Ching, Jalyn Vance, Brizeek Martin, Lauren Robertson, ChiChi Opara, Jared Mitchell, Jasmine Hill, and Alexis Zamora for your contributions!                                                                                           Connect with us! * Listen to our podcast: Pharm5 * Follow us on Twitter: @LizHearnPharmD References: 1. Perrone M, Weber PJ. Access to abortion pill in limbo after competing rulings. AP NEWS. http://bit.ly/3KDc9qU [http://bit.ly/3KDc9qU]. Published April 8, 2023. Accessed April 13, 2023. 2. Bose N. White House plans support for drugstores, pharma in Abortion Pill Battle. Reuters. http://bit.ly/3o9pekg [http://bit.ly/3o9pekg]. Published April 10, 2023. Accessed April 13, 2023.  3. Stein P, Marimow AE, Masih N. Appeals Court temporarily keeps abortion pill available but limits access. The Washington Post. http://bit.ly/41mQIRO [http://bit.ly/41mQIRO]. Published April 13, 2023. Accessed April 13, 2023.  4. Daily statin reduces the risk of cardiovascular disease in people living with HIV, large NIH study finds. National Institutes of Health. http://bit.ly/41rv7aR [http://bit.ly/41rv7aR]. Published April 11, 2023. Accessed April 13, 2023. 5. Triant VA. Cardiovascular disease and HIV infection. Curr HIV/AIDS Rep. 2013;10(3):199-206. doi:10.1007/s11904-013-0168-6 6. Nakagomi A, Shibui T, Kohashi K, et al. Differential Effects of Atorvastatin and Pitavastatin on Inflammation, Insulin Resistance, and the Carotid Intima-Media Thickness in Patients with Dyslipidemia. J Atheroscler Thromb. 2015;22(11):1158-1171. doi:10.5551/jat.29520 7. Hoffman J. White House designates animal sedative as an 'emerging drug threat'. The New York Times. http://bit.ly/3o07pE7 [http://bit.ly/3o07pE7]. Published April 12, 2023. Accessed April 13, 2023.  8. Biden-Harris Administration designates fentanyl combined with xylazine as an emerging threat to the United States. The White House. http://bit.ly/3GFiIbr [http://bit.ly/3GFiIbr]. Published April 12, 2023. Accessed April 13, 2023.  9. China reports first human death from H3N8 bird flu: Who – DW – 04/12/2023. dw.com. http://bit.ly/3o1LWuw [http://bit.ly/3o1LWuw]. Published April 12, 2023. Accessed April 13, 2023. 10. Baz M, Paskel M, Matsuoka Y, et al. A single dose of an avian H3N8 influenza virus vaccine is highly immunogenic and efficacious against a recently emerged seal influenza virus in mice and ferrets. Journal of Virology. 2015;89(13):6907-6917. doi:10.1128/jvi.00280-15 11. China Records World's first human death from H3N8 bird flu, WHO says. Reuters. https://bit.ly/3KxAJcR [https://bit.ly/3KxAJcR]. Published April 12, 2023. Accessed April 13, 2023. 12. American Society of Health-System Pharmacists resident matching program. https://bit.ly/3UDaTsG [https://bit.ly/3UDaTsG].  Accessed April 13, 2023. 13. ASHP match statistics. ASHP Match | Statistics of the Match. https://bit.ly/42e4Ga1 [https://bit.ly/42e4Ga1]. Published March 15, 2023. Accessed April 13, 2023. 14. Overview of the match. ASHP Match | Overview of the Match. http://bit.ly/3MGOV67 [http://bit.ly/3MGOV67]. Published March 15, 2023. Accessed April 13, 2023. 15. Schedule of dates. ASHP Match | Schedule. https://bit.ly/3I8MJA7 [https://bit.ly/3I8MJA7]. Published March 15, 2023. Accessed April 13, 2023.

This week on Pharm5: * Cost Plus Drug Co. adds Invokana products * Gohibic (vilobelimab) EUA for COVID-19 * Makena (hydroxyprogesterone caproate injection) withdrawn from market * APL treatment oral tretinoin shortage * Federal judge strikes down ACA’s OCP and PrEP coverage     Connect with us! * Listen to our podcast: Pharm5 * Follow us on Twitter: @LizHearnPharmD   References: 1. Mark Cuban CostPlus Drug Company - Medications. http://bit.ly/3KjKYS5 [http://bit.ly/3KjKYS5]. Accessed April 6, 2023. 2. Invokana® (canagliflozin) affordability. Janssen CarePath for Healthcare Professionals. http://bit.ly/3nWANLm [http://bit.ly/3nWANLm]. Published October 18, 2022. Accessed April 6, 2023. 3. Center for Drug Evaluation and Research. FDA authorizes Gohibic (vilobelimab) injection. U.S. Food and Drug Administration. http://bit.ly/3nWDsVm [http://bit.ly/3nWDsVm]. Published April 4, 2023. Accessed April 6, 2023. 4. Gohibic [highlights of emergency use authorization]. Jena, Germany: InflaRx GmbH. Published April 2023. Accessed April 6, 2023. 5. FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena. U.S. Food and Drug Administration. http://bit.ly/3ZMOY35 [http://bit.ly/3ZMOY35]. Published April 6, 2023. Accessed April 6, 2023. 6. Drug shortage detail: Tretinoin capsules. ASHP. https://bit.ly/3KhQ2pT [https://bit.ly/3KhQ2pT]. Published March 20, 2023. Accessed April 6, 2023. 7. Treatment of acute promyelocytic leukemia (APL). American Cancer Society. http://bit.ly/3mb3Nif [http://bit.ly/3mb3Nif]. Accessed April 6, 2023. 8. Cingam SR, Koshy NV. Acute Promyelocytic Leukemia. National Center for Biotechnology Information. http://bit.ly/3nGw5RV [http://bit.ly/3nGw5RV]. Accessed April 6, 2023. 9. Phillips C. Help Desk for Oncologists Treating People with a Rare Leukemia Pays Big Dividends. National Cancer Institute. http://bit.ly/40EtxT3. Published February 2, 2023. Accessed April 6, 2023. 10. Braidwood Management, Inc., et al. v. Xavier Becerra, et al. Civil Action No. 4:20-cv-00283-O. Supreme Court of Texas, 2022. Accessed April 6, 2023. 11. Judge strikes down Obamacare provisions requiring insurers cover some preventive care services. NBCNews.com. https://bit.ly/3MncZKV [https://bit.ly/3MncZKV]. Published March 30, 2023. Accessed April 6, 2023. 12. Burwell v. Hobby Lobby and birth control. Planned Parenthood Action Fund. http://bit.ly/419fPaq [http://bit.ly/419fPaq]. Accessed April 6, 2023. 13. Stolberg SG, Abelson R. Federal judge strikes down Obamacare requirement for free preventive care. The New York Times. http://bit.ly/3nSSAU1 [http://bit.ly/3nSSAU1]. Published March 30, 2023. Accessed April 6, 2023.

This week on Pharm5: * OTC Narcan (naloxone) * Higher dose Rybelsus (semaglutide) * iPLEDGE REMS in discussion * WHO COVID-19 guidance for healthy kids * Pradaxa (dabigatran) recall   Connect with us! * Listen to our podcast: Pharm5 * Follow us on Twitter: @LizHearnPharmD   References: 1. FDA approves first over-the-counter naloxone nasal spray. U.S. Food and Drug Administration. http://bit.ly/42O0I8a [http://bit.ly/42O0I8a]. Accessed March 29, 2023. 2. Hoffman J. Over-the-counter Narcan could save more lives. but price and stigma are obstacles. The New York Times. http://bit.ly/3lWSrhF [http://bit.ly/3lWSrhF]. Published March 28, 2023. Accessed March 30, 2023. 3. Oral semaglutide 25 mg and 50 mg demonstrate superior reductions in HbA1c and body weight versus 14 mg in people with type 2 diabetes in the PIONEER PLUS phase 3 trial. Novo Nordisk. http://bit.ly/3nBDJNG [http://bit.ly/3nBDJNG]. Published March 24, 2023. Accessed March 30, 2023. 4. Ozempic® (semaglutide) injection-A1C control within your control for a range of T2D patient Needs1,2,4,5. novoMEDLINK. http://bit.ly/40ISVHv [http://bit.ly/40ISVHv]. Accessed March 30, 2023. 5. FDA panel votes to modify isotretinoin iPLEDGE REMS. Medscape. http://bit.ly/3FZIU0c [http://bit.ly/3FZIU0c]. Published March 29, 2023. Accessed March 30, 2023. 6. The iPLEDGE REMS Prescriber Guide. iPLEDGE REMS. http://bit.ly/3lU85ue [http://bit.ly/3lU85ue]. Published October 2021. Accessed March 30, 2023. 7. Hassan C, Regan H. Who experts revise covid-19 vaccine advice, say Healthy Kids and teens low risk. CNN. http://bit.ly/3KlyOJt [http://bit.ly/3KlyOJt]. Published March 29, 2023. Accessed March 30, 2023. 8. Mueller B, Hoffman J. Routine childhood vaccinations in the U.S. slipped during the pandemic. The New York Times. http://bit.ly/3ziptMc [http://bit.ly/3ziptMc]. Published April 21, 2022. Accessed March 30, 2023. 9. Birth-18 years immunization schedule – healthcare providers. Centers for Disease Control and Prevention. http://bit.ly/3JXI3y7 [http://bit.ly/3JXI3y7]. Published February 10, 2023. Accessed March 30, 2023. 10. Ascend Laboratories LLC. issues voluntary nationwide recall of dabigatran etexilate capsules, USP 75 mg and 150 mg, due to the detection of N-Nitroso-Dabigatran (NDAB) impurity. U.S. Food and Drug Administration. http://bit.ly/3TUrGXN [http://bit.ly/3TUrGXN]. Accessed March 30, 2023.