Pharm5 – Détails, épisodes et analyse

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:

• 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.