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. 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. 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. Published April 27, 2023. Accessed April 27, 2023.
6. CFTR modulator therapies. Cystic Fibrosis Foundation. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Published April 12, 2023. Accessed April 13, 2023.
12. American Society of Health-System Pharmacists resident matching program. https://bit.ly/3UDaTsG.  Accessed April 13, 2023.
13. ASHP match statistics. ASHP Match | Statistics of the Match. 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. Published March 15, 2023. Accessed April 13, 2023.
15. Schedule of dates. ASHP Match | Schedule. 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. Accessed April 6, 2023.
2. Invokana® (canagliflozin) affordability. Janssen CarePath for Healthcare Professionals. 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. 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. Published April 6, 2023. Accessed April 6, 2023.
6. Drug shortage detail: Tretinoin capsules. ASHP. 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. Accessed April 6, 2023.
8. Cingam SR, Koshy NV. Acute Promyelocytic Leukemia. National Center for Biotechnology Information. 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. Published March 30, 2023. Accessed April 6, 2023.
12. Burwell v. Hobby Lobby and birth control. Planned Parenthood Action Fund. 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. 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. 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. 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. 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. Accessed March 30, 2023.
5. FDA panel votes to modify isotretinoin iPLEDGE REMS. Medscape. http://bit.ly/3FZIU0c. Published March 29, 2023. Accessed March 30, 2023.
6. The iPLEDGE REMS Prescriber Guide. iPLEDGE REMS. 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. 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. 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. 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. Accessed March 30, 2023.

This week on Pharm5

• Humira biosimilars
• Vyvanse, Symbicort, and more losing patents this year
• Rezafungin approval
• Senate Committee meets on drug shortages
• COVID-19 declassified

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Sandoz receives US FDA approval for biosimilar Hyrimoz® (Adalimumab-adaz) high-concentration formulation. Novartis. http://bit.ly/3lBJ1rK. Published March 21, 2023. Accessed March 23, 2023.
2. Humira [package insert].North Chicago, IL: AbbVie Inc. Accessed March 23, 2023.
3. Stonehill M. Humira exclusivity expires in 2023: Will biosimilar boom benefit patients or industry? Healio. http://bit.ly/3lzQrvs. Published January 17, 2023. Accessed March 23, 2023.
4. Amjevita™ (Adalimumab-Atto), first biosimilar to Humira®, now available in the United States. Amgen. http://bit.ly/3Z9gesm. Accessed March 23, 2023.
5. Kansteiner F, Sagonowsky E, Becker Z, Dunleavy K, Liu A. The top 10 drugs losing us exclusivity in 2023. Fierce Pharma. https://bit.ly/3LGsm0N. Published March 13, 2023. Accessed March 23, 2023.
6. FDA drug shortages. FDA Drug Shortages. http://bit.ly/3LLEAoY. Accessed March 23, 2023.
7. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. www.ginasthma.org. Accessed March 23, 2023.
8. Cidara Therapeutics, Inc. Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo™ (rezafungin for injection) for the treatment of Candidemia and invasive candidiasis. GlobeNewswire News Room. http://bit.ly/40utHMl. Published March 22, 2023. Accessed March 23, 2023.
9. Thompson GR, Soriano A, Cornely OA, et al. Rezafungin versus Caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): A multicentre, double-blind, double-dummy, randomised phase 3 trial. The Lancet. 2023;401(10370):49-59. doi:10.1016/s0140-6736(22)02324-8
10. FDA Approves Rezzayo, a Novel Echinocandin. Infectious Disease Special Edition. https://bit.ly/3TAbn2d. Published March 23, 2023. Accessed March 23, 2023.
11. Gauthier T. Rezafungin (Rezzayo). IDStewardship. http://bit.ly/3LHBn9X. Accessed March 23, 2023.
12. O'Mary L. Cases of potentially deadly fungus jump 200%: CDC. Medscape. http://bit.ly/40lSRwC. Published March 22, 2023. Accessed March 23, 2023.
13. Drug shortage health and national security risks: Underlying causes and needed reforms. Committee on Homeland Security & Governmental Affairs. https://bit.ly/3ZdX846. Published March 22, 2023. Accessed March 23, 2023.
14. Biden signs Bill on COVID origins declassification. AP NEWS. http://bit.ly/3JCsOKJ. Published March 20, 2023. Accessed March 23, 2023.
15. Pradhan R. End of Covid emergency will usher in changes across the US Health System. Kaiser Health News. http://bit.ly/40xC0H0. Published March 22, 2023. Accessed March 23, 2023.

This week on Pharm5:

• Novo Nordisk insulin price cuts
• Akorn Pharma closing, potential drug shortages
• Zavzpret (zavegepant) migraine nasal spray
• Daybue (trofinetide) for Rett Syndrome
• 2023 Match Results

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024. Novo Nordisk. http://bit.ly/42hziHz. Accessed March 16, 2023.
2. Lilly cuts insulin prices by 70% and caps patient insulin out-of-pocket costs at $35 per month. Eli Lilly and Company. https://bit.ly/3ZQXVcf. Published March 1, 2023. Accessed March 16, 2023.
3. Murphy T. Novo Nordisk plans price cuts for several insulins. AP NEWS. http://bit.ly/3JNzgjz. Published March 14, 2023. Accessed March 16, 2023.
4. Kekatos M, Bakshi N, Coburn J. Nationwide shortage of asthma medication albuterol could worsen in hospitals. ABC News. https://bit.ly/3JfD1wA. Published March 9, 2023. Accessed March 16, 2023.
5. Supply chain disruption due to manufacturer closure: Akorn Pharmaceuticals ceases operations. End Drug Shortages Alliance. https://bit.ly/3JqLZHi. Published March 7, 2023. Accessed March 16, 2023.
6. Pfizer’s Zavzpret™ (zavegepant) Migraine Nasal Spray Receives FDA Approval. Pfizer. http://bit.ly/42kQJag. Published March 10, 2023. Accessed March 16, 2023.
7. Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. The Lancet Neurology. 2023;22(3):209-217. doi:10.1016/s1474-4422(22)00517-8
8. Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective and well tolerated for the acute treatment of migraine: results of a multicenter study. Neurology. 1995;45(8 Suppl 7):S10-S14.
9. Center for Drug Evaluation and Research. FDA approves first treatment for Rett syndrome. U.S. Food and Drug Administration. http://bit.ly/3TjSD6U. Accessed March 16, 2023.
10. Aislinn Antrim E. FDA approves Trofinetide for treatment of Rett syndrome in adult, pediatric patients. Pharmacy Times. http://bit.ly/40fK3bq. Published March 13, 2023. Accessed March 16, 2023.
11. ASHP match statistics. ASHP Match | Statistics of the Match. http://bit.ly/42e4Ga1. Published March 15, 2023. Accessed March 16, 2023.
12. Schedule of dates. ASHP Match | Schedule. https://bit.ly/3I8MJA7. Published March 15, 2023. Accessed March 16, 2023.

This week on Pharm5:

• Voluntary eyedrop recalls
• Bempedoic acid lowers MACE risk
• LDL <70 vs. high-intensity statin
• Walgreens halting mifepristone
• COVID-19 vaccines in pregnancy

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. O'Mary L. Bacterial outbreak linked to EzriCare eyedrops: CDC. Medscape. http://bit.ly/3l3tOz9. Published February 1, 2023. Accessed February 2, 2023.
2. Update: Multistate Cluster of VIM- and GES-producing Carbapenem resistant Pseudomonas aeruginosa associated with Artificial Tears. https://bit.ly/3DDHrey. Published January 20, 2023. Accessed February 2, 2023.
3. Apotex Corp. issues voluntary nationwide recall of brimonidine tartrate ophthalmic solution, 0.15% due to cracks that have developed in some of the units caps of the bottles. U.S. Food and Drug Administration. http://bit.ly/3ZSoygD. Accessed March 9, 2023.
4. Pharmedica USA LLC issues voluntary worldwide recall of purely soothing 15% MSM drops due to non-sterility. U.S. Food and Drug Administration. http://bit.ly/3ZX4PN5. Accessed March 9, 2023.
5. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. New England Journal of Medicine. March 2023. doi:10.1056/nejmoa2215024
6. Hong SJ;Lee YJ;Lee SJ;Hong BK;Kang WC;Lee JY;Lee JB;Yang TH;Yoon J;Ahn CM;Kim JS;Kim BK;Ko YG;Choi D;Jang Y;Hong MK; Treat-to-target or high-intensity statin in patients with coronary artery disease: A randomized clinical trial. JAMA. https://pubmed.ncbi.nlm.nih.gov/36877807/. Accessed March 9, 2023.
7. Walgreens statement on Mifepristone. Walgreens Newsroom. http://bit.ly/3JqyRmW. Accessed March 9, 2023.
8. Walsh M. Why Walgreens won't dispense abortion pills in Ohio. Fox 8 Cleveland WJW. http://bit.ly/3mEV5Zr. Published March 7, 2023. Accessed March 9, 2023.
9. Citu IM, Citu C, Gorun F, et al. The risk of spontaneous abortion does not increase following first trimester mrna COVID-19 vaccination. Journal of Clinical Medicine. 2022;11(6):1698. doi:10.3390/jcm11061698
10. Covid-19 vaccines while pregnant or breastfeeding. Centers for Disease Control and Prevention. http://bit.ly/3LbAKVC. Accessed March 9, 2023.
11. Episode #41 - vaccines, pregnancy, menstruation, lactation and fertility. World Health Organization. http://bit.ly/3J9rYoy. Accessed March 9, 2023.

This week on Pharm5:

• Detailing Eli Lilly’s insulin pricing
• RSV vaccines on the horizon
• XDR shigellosis health advisory
• OTC Flu+COVID test
• ASHP Match Rankings due 11:59 PM

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Lilly cuts insulin prices by 70% and caps patient insulin out-of-pocket costs at $35 per month. Eli Lilly and Company. http://bit.ly/3ZQXVcf.  Published March 1, 2023. Accessed March 2, 2023.
2. Christensen J, Klein B. Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes. CNN. http://bit.ly/3IHmyAY.  Published March 1, 2023. Accessed March 2, 2023.
3. Jewett C. F.D.A. panel recommends 2 R.S.V. vaccines for older adults. The New York Times. http://bit.ly/3SETqPv. Published March 1, 2023. Accessed March 2, 2023.
4. FDA advisers recommend World's first RSV vaccines, from Pfizer and GSK. NBCNews.com. http://bit.ly/3kNJsP7. Published March 1, 2023. Accessed March 2, 2023.
5. FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses. U.S. Food and Drug Administration. http://bit.ly/3ZB3FXf. Published February 24, 2023. Accessed March 2, 2023.
6. Increase in Extensively Drug-Resistant Shigellosis in the United States. Centers for Disease Control and Prevention. http://bit.ly/3ZBeRD5. Published February 24, 2023. Accessed March 2, 2023.
7. Charles H, Prochazka M, Thorley K, et al. Outbreak of sexually transmitted, extensively drug-resistant Shigella Sonnei in the UK, 2021–22: A descriptive epidemiological study. The Lancet Infectious Diseases. 2022;22(10):1503-1510. doi:10.1016/s1473-3099(22)00370-x
8. Schedule of Dates - The 2023 ASHP Match. ASHP Match | Schedule. https://bit.ly/3I8MJA7.  Published January 19, 2023. Accessed March 2, 2023.

This week on Pharm5:

• Ivermectin fails against COVID-19
• Cabenuva noninferior to Biktarvy
• Syfovre for geographic atrophy
• Aspirin for pre-eclampsia prevention
• TRUNCATE-TB results could shorten TB treatment

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Naggie S, Boulware DR, Lindsell CJ, et al. Effect of higher-dose ivermectin for 6 days vs placebo on time to sustained recovery in outpatients with covid-19. JAMA. February 2023. doi:10.1001/jama.2023.1650.
2. Efficacy: Cabenuva (cabotegravir; Rilpivirine). Efficacy: Every 2 Month | CABENUVA Official HCP Website. http://bit.ly/3kpnkdU. Accessed February 23, 2023.
3. VIIV healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, Rilpivirine) is as effective as daily oral biktarvy (BIC/FTC/TAF) for the treatment of HIV-1. ViiV Healthcare. http://bit.ly/3m14uKy. Accessed February 23, 2023.
4. Low-dose aspirin use for the prevention of preeclampsia and related morbidity and mortality. ACOG. http://bit.ly/3kuekE7. Accessed February 23, 2023.
5. Mendoza M, Bonacina E, Garcia-Manau P. Aspirin discontinuation at 24 to 28 weeks’ gestation in pregnancies a high risk of preterm preeclampsia:
6. a randomized clinical trial. JAMA. February 2023. doi: 10.1001/jama.2023.0691.
7. FDA Oks first drug for geographic atrophy, a major cause of adult blindness. FDA OKs First Drug for Geographic Atrophy, a Major Cause of Adult Blindness. http://bit.ly/3ZgFwoE. Published February 17, 2023. Accessed February 22, 2023.
8. Paton NI, Cousins C, Suresh C, et al. Treatment strategy for rifampin-susceptible tuberculosis. New England Journal of Medicine. 2023. doi:10.1056/nejmoa2212537
9. Treatment for TB disease. Centers for Disease Control and Prevention. http://bit.ly/3Y5HxTW. Published March 7, 2022. Accessed February 23, 2023.

This week on Pharm5:

• Narcan possibly OTC soon
• Dexcom G7 now available
• PBM Transparency Act hearing
• Rocuronium shortage
• Phase I Rankings now open

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Hoffman J. Narcan is safe to sell over the counter, advisers to the F.D.A. conclude. The New York Times. http://bit.ly/3S2btPf. Published February 15, 2023. Accessed February 16, 2023.
2. Person, Bhanvi Satija PJ. U.S. FDA panel backs OTC opioid overdose drug, proposes label changes. Reuters. http://bit.ly/3xrx0r5. Published February 16, 2023. Accessed February 16, 2023.
3. New Dexcom G7 CGM Nick Jonas Super bowl 2023. Dexcom. http://bit.ly/3Is32cU. Accessed February 16, 2023.
4. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed February 16, 2022.
5. Bringing transparency and accountability to Pharmacy Benefit Managers. U.S. Senate Committee on Commerce, Science, & Transportation. http://bit.ly/3YAhjKg. Published February 16, 2023. Accessed February 16, 2023.
6. FDA drug shortages. FDA Drug Shortages. http://bit.ly/3Ir1kZb. Accessed February 16, 2023.
7. Drug shortage detail: Rocuronium injection. ASHP. http://bit.ly/3Kat9q3. Accessed February 16, 2023.
8. Schedule of dates. ASHP Match | Schedule. http://bit.ly/3I8MJA7. Published January 19, 2023. Accessed February 16, 2023.

This week on Pharm5:

• Adult Immunization Schedule 2023
• Pediatric Immunization Schedule 2023
• Rapid acting antidepressant, Zuranolone
• 2022 NAPLEX/MPJE Pass Rates
• State of the Union Address

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Murthy N, Wodi AP, Cineas S, Ault KA. Recommended Adult Immunization Schedule, United States, 2023. https://doi.org/10.7326/M23-0041. Ann Int Med. 2023.
2. The 5 biggest changes in the 2023 adult vaccine schedules. Medscape. http://bit.ly/40WmmX5. Published February 9, 2023. Accessed February 9, 2023.
3. Committee on Infectious Diseases. Recommended Childhood and Adolescent Immunization Schedule: United States, 2023. https://doi.org/10.1542/peds.2022-061029. Pediatrics. 2023.
4. Swift D. AAP approves 2023 Child and adolescent immunization schedule. Medscape. http://bit.ly/3RMFhPD. Published February 9, 2023. Accessed February 9, 2023.
5. Biogen and Sage Therapeutics announce FDA accepts filing of New Drug Application and grants priority review of Zuranolone in the treatment of major depressive disorder and postpartum depression. Biogen. http://bit.ly/3HR6pbB. Accessed February 9, 2023.
6. Data & Research. National Association of Boards of Pharmacy. http://bit.ly/40W5qQv. Accessed February 9, 2023.
7. Aislinn Antrim E. State of the union address focuses on affordable health care, cost of insulin. Pharmacy Times. http://bit.ly/3jPc4qT. Published February 8, 2023. Accessed February 9, 2023.
8. Full 2023 President Biden State of the Union Annotated and fact checked. CNN. http://bit.ly/3YlJs7w. Accessed February 9, 2023.

This week on Pharm5:

• Walmart, CVS Claim Pharmacist Shortage
• Changes to Paxlovid, Lagevrio, and COVID vaccines
• EzriCare eyedrops linked to bacterial outbreak
• New FDA approvals: Jayprica, Orserdu, Jesduvroq
• GoodRx sells health info to advertisers

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Valinsky J. CVS and Walmart Cut Pharmacy Hours, close some locations earlier, citing staffing shortage | CNN business. CNN. http://bit.ly/3RpgS2F. Published January 27, 2023. Accessed February 2, 2023.
2. Keagy J. American Pharmacists Association on move to cut pharmacy hours. American Pharmacists Association. http://bit.ly/3JB0v0Q. Published January 30, 2023. Accessed February 2, 2023.
3. Paxlovid, Lagevrio prescriptions no longer need a positive COVID-19 test. Becker's Hospital Review. http://bit.ly/3DC3Jh3. Published February 1, 2023. Accessed February 2, 2023.
4. Fact sheet for healthcare providers: emergency use authorization for Paxlovid. New York, NY: Pfizer. https://bit.ly/3RvXNvO. Revised February 1, 2023. Accessed February 2, 2023.
5. Fact sheet for healthcare providers: emergency use authorization for Lagevrio (molnupiravir) capsules). Rahway, NJ: Merck & Co. https://bit.ly/3HsLo72. Revised February 1, 2023. Accessed February 2, 2023.
6. Bulloch M. FDA Advisory Committee vote to simplify covid-19 regimen. Pharmacy Times. http://bit.ly/3jweY3t. Published February 1, 2023. Accessed February 2, 2023.
7. O'Mary L. Bacterial outbreak linked to EzriCare eyedrops: CDC. Medscape. http://bit.ly/3l3tOz9. Published February 1, 2023. Accessed February 2, 2023.
8. Update: Multistate Cluster of VIM- and GES-producing Carbapenem resistant Pseudomonas aeruginosa associated with Artificial Tears. https://bit.ly/3DDHrey. Published January 20, 2023. Accessed February 2, 2023.
9. Center for Drug Evaluation and Research. Novel drug approvals for 2023. U.S. Food and Drug Administration. http://bit.ly/3wO6ckC. Accessed February 2, 2023.
10. Pagliarulo N. FDA approves cancer drugs from Lilly, Menarini. BioPharma Dive. http://bit.ly/3DEgnfc. Published January 30, 2023. Accessed February 2, 2023.
11. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. U.S. Food and Drug Administration. http://bit.ly/3RsL64E. Accessed February 2, 2023.
12. FTC enforcement action to Bar Goodrx from sharing consumers' sensitive health info for advertising. Federal Trade Commission. http://bit.ly/3l50F6C. Published February 1, 2023. Accessed February 2, 2023.

This week on Pharm5:

• Amazon’s RxPass Subscription
• Brenzavy (bexagliflozin) for T2DM
• Leqimbi (lecanemab) for mild Alzheimer disease
• Vaccine efficacy for Omicron XBB
• TidePool Loop app cleared by FDA

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Gupta V. Introducing RxPass from Amazon Pharmacy, a $5 prescription subscription that helps prime members who take multiple medications save time and money. US About Amazon. http://bit.ly/3ReGKhE. Published January 24, 2023. Accessed January 26, 2023.
2. All RxPass medications. http://bit.ly/3kN8628. Accessed January 27, 2023.
3. FDA grants accelerated approval for Alzheimer's disease treatment. U.S. Food and Drug Administration. http://bit.ly/3HxSkRI. Accessed January 26, 2023.
4. Lecanemab. Lexi-Drugs. Hudson, OH: Lexicomp, 2015. http://bit.ly/3DeqR4X. Accessed January 26, 2023.
5. Park B. Brenzavvy approved for adults with type 2 diabetes. MPR. http://bit.ly/3DjPME3. Published January 23, 2023. Accessed January 26, 2023.
6. Early estimates of bivalent mrna booster dose vaccine effectiveness in preventing symptomatic SARS-COV-2 infection attributable to omicron ba.5– and XBB/XBB.1.5–related sublineages among immunocompetent adults - increasing community access to testing program, United States, December 2022–January 2023. Centers for Disease Control and Prevention. https://bit.ly/3kRkMos. Published January 25, 2023. Accessed January 26, 2023.
7. NCIRD Surveillance Systems. Centers for Disease Control and Prevention. https://bit.ly/3wzcfti.  Published January 17, 2023. Accessed January 26, 2023.
8. Groundbreaking: Tidepool Loop receives FDA clearance. Tidepool. http://bit.ly/3kFRtoR. Accessed January 26, 2023.
9. Briskin A. Tidepool Loop cleared by FDA. diaTribe. https://bit.ly/3XH2mFL. Published January 26, 2023. Accessed January 26, 2023.

Thanks to members of Phi Delta Chi's Delta Beta Chapter for creating this episode - Angelica Okinda, Nihitha Nukala, Shannyn Gilchrist-Oates, Hunter Kieltyka, Sydney Thompson, Dylan J. McNutt, Kristopher S. Ingram, Rebecca Nelson, and Emmanuel Rodivera!

This week on Pharm5:

• Glaspie v. NABP
• Chlorthalidone not superior to HCTZ
• Krazati (adagrasib) FDA approval
• ASHP reports 20 states prescribing OCP
• Federal COVID-19 vaccine funding ends

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Ludens ZD, Glaspie E. In the United States District Court for the Northern District of Illinois. Class Action. https://bit.ly/3V7VhM5. Published November 19, 2022. Accessed December 15, 2022.
2. @NABP. As you may have heard, 220 candidates who took the NAPLEX between July 30th and October 26th received incorrect exam results. https://bit.ly/3UXHfN3. Posted November 10, 2022. Accessed December 15, 2022.
3. Ishani A, Leatherman SM, Woods P, et al. Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's diuretic comparison project. Contemporary Clinical Trials. 2022;116:106754. doi:10.1016/j.cct.2022.106754
4. Flack JM, Sica DA, Nesbitt S. Chlorthalidone versus hydrochlorothiazide as the preferred diuretic. Hypertension. 2011;57(4):665-666. doi:10.1161/hypertensionaha.110.164566
5. Ishani A, Cushman WC, Leatherman SM, Lew RA, et al. Chlorthalidone vs. Hydrochlorothiazide for Hypertension–Cardiovascular Events. 10.1056/NEJMoa2212270.
6. FDA grants accelerated approval to Adagrasib for Kras-G12C-mutated NSCLC. Pharmacy Times. https://bit.ly/3YvCRI8. Published December 13, 2022. Accessed December 15, 2022.
7. Pharmacists can now prescribe hormonal birth control in 20 states. https://bit.ly/3HGMYUI. Published December 5, 2022. Accessed December 15, 2022.
8. Contraception. Centers for Disease Control and Prevention. https://bit.ly/3BGTRl7. Published November 1, 2022. Accessed December 15, 2022.
9. Pharmacist prescribing: Hormonal contraceptives. https://bit.ly/3hqbHSx. Published December 6, 2022. Accessed December 15, 2022.
10. Stephenson J. US COVID-19 Vaccine Costs Expected to Soar if Funding for Federal Program Ends. JAMA Health Forum. 2022;3(12):e225376. doi:10.1001/jamahealthforum.2022.5376
11. Artiga S, Tolbert J, Kates J, Rudowitz R. Implications of the lapse in federal covid-19 funding on access to covid-19 testing, treatment, and vaccines. KFF. bit.ly/3FWDLpM. Published March 28, 2022. Accessed December 15, 2022.

This week on Pharm5:

• Bivalent booster for kids
• Jynneos protects against monkeypox
• Dexcom G7 approved for diabetes
• Rezlidhia (olutasidenib) approved for AML
• PCAT retirement in 2024

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) covid-19 vaccines for children down to 6 months of age. U.S. Food and Drug Administration. https://bit.ly/3UIOuIP. Accessed December 8, 2022.
2. Webinar November 29, 2022 - flu, RSV, COVID-19 and other respiratory threats this fall and Winter. Centers for Disease Control and Prevention. http://bit.ly/3Bf21AX. Published November 16, 2022. Accessed December 8, 2022.
3. Reduced risk for Mpox after receipt of 1 or 2 doses of JYNNEOS vaccine compared with risk among unvaccinated persons - 43 U.S. jurisdictions, July 31–October 1, 2022. Centers for Disease Control and Prevention. https://bit.ly/3FzvTdL. Published December 8, 2022. Accessed December 8, 2022.
4. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed December 8, 2022.
5. Center for Drug Evaluation and Research. FDA approves Olutasidenib. U.S. Food and Drug Administration. https://bit.ly/3W2vSo5. Accessed December 8, 2022.
6. Pharmcas Community. Retirement of the Pharmacy College Admission Test (PCAT). https://bit.ly/3Y9EomW. Published December 6, 2022. Accessed December 8, 2022.

This week on Pharm5:

• Tamiflu backorder
• ADHD medications & CVD risk
• Paxlovid dispensing guidance
• EUA pulled for last remaining COVID-19 monoclonal antibody
• ASHP Midyear Meeting

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Current drug shortages. ASHP. https://bit.ly/3Fk0Keo. Accessed December 1, 2022.
2. Center for Drug Evaluation and Research. Drug shortages. U.S. Food and Drug Administration. https://bit.ly/3B2DGhC. Accessed December 1, 2022.
3. Weekly U.S. Influenza Surveillance Report. Centers for Disease Control and Prevention. https://bit.ly/3gQ77MW. Published November 28, 2022. Accessed December 1, 2022.
4. Zhang L, Yao H, Li L, et al. Risk of cardiovascular diseases associated with medications used in attention-deficit/hyperactivity disorder. JAMA Network Open. 2022;5(11). doi:10.1001/jamanetworkopen.2022.43597
5. HQ APhA. APhA has created a pharmacist decision-making support tool for paxlovid. use it in your practices to help assess whether a prescription for Paxlovid is appropriate. Twitter. https://bit.ly/3H6F3Q7. Published November 30, 2022. Accessed December 1, 2022.
6. FDA pulls U.S. authorization for Eli Lilly's Covid Drug Bebtelovimab. Reuters. https://bit.ly/3UiQyHa. Published November 30, 2022. Accessed December 1, 2022.
7. Midyear clinical meeting 2022 - ASHP. MCM22. https://bit.ly/3B1dunI. Accessed December 1, 2022.

This week on Pharm5:

• BCEMP starting in 2023
• FDA hints at OTC naloxone
• Elahere for advanced ovarian cancer
• Pharmacogenomics reduces risk of ADRs
• Tzield delays T1DM symptom onset

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. Jean-Baptiste A. First Administration of the emergency medicine pharmacy certification examination announced for 2023. Board of Pharmacy Specialties. http://bit.ly/3EeGIQx.  Published November 10, 2022. Accessed November 17, 2022.
2. The Federal Register. Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments. http://bit.ly/3tGEQLu. Published November 16, 2022. Accessed November 17, 2022.
3. Pharmacy Practice News. http://bit.ly/3EepDq5. Published November 16, 2022. Accessed November 16, 2022.
4. Dunleavy K. Four decades in, immunogen gets landmark green light in Advanced ovarian cancer. Fierce Pharma. http://bit.ly/3Ao8Hw9. Published November 15, 2022. Accessed November 17, 2022.
5. Immunogen announces FDA accelerated approval of ELAHERE™ (Mirvetuximab Soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. ImmunoGen, Inc. http://bit.ly/3gjvHp5.  Accessed November 17, 2022.
6. Robinson J. Adverse drug reactions reduced by nearly one third after genetic testing, major trial results to show. The Pharmaceutical Journal. http://bit.ly/3TQK1TQ. Published November 14, 2022. Accessed November 17, 2022.
7. FDA approves first drug that can delay onset of type 1 diabetes. U.S. Food and Drug Administration. http://bit.ly/3gd9j0G. Published November 17, 2022. Accessed November 17, 2022.

This week on Pharm5:

• CDC Opioid Prescribing and Tapering Guidance
• NAPLEX Scoring Errors from NABP
• Third COVID vax is helpful, fourth is not
• USPSTF Recommendations for Hormone Use
• 2022 Flu Season Hitting Early

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. CDC Clinical Practice Guideline for prescribing opioids for pain - united states, 2022. Centers for Disease Control and Prevention. http://bit.ly/3Ej7Ejv. Published November 3, 2022. Accessed November 9, 2022.
2. Brooks M. New CDC guidance on prescribing opioids for pain. Medscape. http://bit.ly/3EeuLKX.  Published November 4, 2022. Accessed November 9, 2022.
3. @NABP. Posted November 10, 2022. Accessed November 10, 2022. https://twitter.com/nabp/status/1590809815156137995.
4. Canetti M, Barda N, Gilboa M, et al. Six-month follow-up after a fourth BNT162b2 vaccine dose. New England Journal of Medicine. November 2022. doi:10.1056/nejmc2211283
5. Chalkias S, Harper C, Vrbicky K, et al. A bivalent omicron-containing booster vaccine against covid-19. New England Journal of Medicine. 2022;387(14):1279-1291. doi:10.1056/nejmoa2208343
6. Hormone therapy in postmenopausal persons: Primary prevention of chronic conditions. Recommendation: Hormone Therapy in Postmenopausal Persons: Primary Prevention of Chronic Conditions | United States Preventive Services Taskforce. http://bit.ly/3NY7Tnh.  Published November 1, 2022. Accessed November 10, 2022.
7. Weekly U.S. Influenza Surveillance Report. Centers for Disease Control and Prevention. http://bit.ly/3TshBiV. Published November 10, 2022. Accessed November 10, 2022.
8. Influenza activity and composition of the 2022–23 influenza vaccine - United States, 2021–22 season. Centers for Disease Control and Prevention. http://bit.ly/3DWJgTi. Published July 21, 2022. Accessed November 10, 2022.

This week on Pharm5:

• SNPhA x ACCP Residency Showcase
• Amoxicillin suspension shortage
• Psilocybin for episodes of major depression
• RSV vaccine trials
• Walgreens removes speed metrics

Connect with us!

• Listen to our podcast: Pharm5
• Follow us on Twitter: @LizHearnPharmD

References:

1. SNPhA x ACCP Residency and Fellowship Showcase. ACCP. https://bit.ly/3fyqSrQ. Accessed November 3, 2022.
2. Weixel N. FDA reports shortages of amoxicillin. The Hill. https://bit.ly/3fsEODL. Published November 1, 2022. Accessed November 3, 2022.
3. Amoxil. Package Insert. GlaxoSmithKline; 2006.
4. FDA drug shortages. FDA Drug Shortages. https://bit.ly/3UlvAb5. Accessed November 3, 2022.
5. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-dose psilocybin for a treatment-resistant episode of Major Depression. New England Journal of Medicine. 2022;387(18):1637-1648. doi:10.1056/nejmoa2206443
6. RSV vaccine protects babies from severe infections, Pfizer study finds. The Wall Street Journal. https://on.wsj.com/3UgNAna. Published November 1, 2022. Accessed November 3, 2022.
7. Pfizer Announces Positive Top-Line Data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate. https://bit.ly/3FFuh2v. Accessed November 3, 2022.
8. Walgreens sharpens focus on patient care and experience, eliminating task-based metrics for Pharmacy Staff Performance Reviews Chainwide. Walgreens Newsroom. https://bit.ly/3t1TdcU. Accessed November 3, 2022.
9. Walgreens will stop judging its pharmacy staff by how fast they work. NBCNews.com. https://nbcnews.to/3zGXvKA. Published October 28, 2022. Accessed November 3, 2022.