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.

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.

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:

• Imjudo (tremelimumab) FDA approved
• Tecvayli (teclistamab-cqyv) FDA approved
• Cancer incidence up, mortality down
• Pharmacies administered >50% of COVID vaccines
• AGA Obesity Treatment Guidelines

Connect with us!

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

References:

1. Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. AstraZeneca. https://bit.ly/3NevJKX. Published October 24, 2022. Accessed October 27, 2022.
2. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab Plus durvalumab in unresectable hepatocellular carcinoma. NEJM Evidence. 2022;1(8). doi:10.1056/evidoa2100070
3. Center for Drug Evaluation and Research. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. U.S. Food and Drug Administration. https://bit.ly/3zqMixF. Accessed October 27, 2022.
4. Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. October 2022. doi:10.1002/cncr.34479
5. Hunter E. Overall cancer death rates have declined, but rates among racial/ethnic minorities have not followed suit. Pharmacy Times. https://bit.ly/3gPg4G0.  Published October 27, 2022. Accessed October 27, 2022.
6. Grabenstein JD. Essential services: Quantifying the contributions of America’s pharmacists in COVID-19 clinical interventions. Journal of the American Pharmacists Association. 2022. doi:10.1016/j.japh.2022.08.010
7. @JAPhAJournal. IN PRESS: Pharmacists delivered over 350 million clinical interventions during COVID pandemic. #TwitteRx #pharmacists #COVID19. Posted October 25, 2022. Accessed October 27, 2022. https://bit.ly/3U1xn4N.
8. Grunvald E, Shah R, Hernaez R, et al. AGA clinical practice guideline on pharmacological interventions for adults with obesity. Gastroenterology. 2022;163(5):1198-1225. doi:10.1053/j.gastro.2022.08.045

This week on Pharm5:

• Eliquis v. Xarelto for AFib
• Improve M&M by quickly titrating HFrEF treatments
• National Adderall shortage
• Novavax ok’d as booster
• Student loan forgiveness application

Connect with us!

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

References:

1. Dawwas GK, Cuker A, Barnes GD, Lewis JD, Hennessy S. Apixaban versus rivaroxaban in patients with atrial fibrillation and valvular heart disease. Annals of Internal Medicine. October 2022. doi:10.7326/m22-0318
2. Strong-HF study in patients admitted for acute heart failure (HF) terminated early for superior efficacy. STRONG-HF study in patients admitted for acute heart failure (HF) terminated early for superior efficacy. https://prn.to/3sbDrMv. Published October 13, 2022. Accessed October 14, 2022.
3. Safety, tolerability, and efficacy of rapid optimization, helped by NT-probnp testing, of heart failure therapies - full text view. Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies - Full Text View - ClinicalTrials.gov. https://bit.ly/3MQktVd. Accessed October 14, 2022.
4. Brooks M. FDA confirms nationwide Adderall shortage. Medscape. https://wb.md/3DfXS0O. Published October 14, 2022. Accessed October 14, 2022.
   FDA drug shortages. FDA. https://bit.ly/3yZiAzG. Accessed October 14, 2022.
5. CDC allows Novavax monovalent COVID-19 boosters for adults ages 18 and older. Centers for Disease Control and Prevention. https://bit.ly/3VM10J9. Published October 19, 2022. Accessed October 20, 2022.
6. Center for Biologics Evaluation and Research. Novavax COVID-19 vaccine. U.S. Food and Drug Administration. https://bit.ly/3eMcbkC. Accessed October 20, 2022.
7. Federal Student Aid. https://bit.ly/3ToNLwC. Accessed October 20, 2022.
8. Duster C. How to qualify for Biden's new student loan forgiveness plan. CNN Politics. https://cnn.it/3ALjKjF. Published Wednesday August 24, 2022. Accessed August 24, 2022.
9. Occupational Employment and Wages, May 2021 - Pharmacists. U.S. Bureau of Labor Statistics. https://bit.ly/3PObHXm.  Published March 31, 2022. Accessed August 24, 2022.
10. Smoot C. What is the average pharmacy school debt in 2022? SuperMoney. https://bit.ly/3PHqZNK. Published April 26, 2022. Accessed August 24, 2022.

This week on Pharm5:

• Pharmacy Technician Day
• Boostrix during pregnancy
• AMA reviews PBMs
• COVID boosters for kids
• ISMP guidance for pharmacists in codes

Connect with us!

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

References:

1. Pharmacy technician day. ASHP. https://bit.ly/3exFuaj. Accessed October 13, 2022.
2. 29-2052 pharmacy technicians. U.S. Bureau of Labor Statistics. https://bit.ly/3VuX0wr. Published March 31, 2022. Accessed October 13, 2022.
3. Resume CV development. ASHP. https://bit.ly/3EGX2LY. Accessed October 13, 2022.
4. FDA approves vaccine for use during third trimester of pregnancy to prevent whooping cough in infants younger than two months of age. U.S. Food and Drug Administration. https://bit.ly/3CAlc82. Accessed October 13, 2022.
5. New AMA report calls for state regulation of drug price middlemen. Yahoo! Finance. https://yhoo.it/3rWe0hQ. Accessed October 13, 2022.
6. Guardado JR. AMA. Competition in Commercial PBM Markets and Vertical Integration of Health Insurers with PBMs. https://bit.ly/3MwDSdx. Accessed October 13, 2022.
7. Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups. U.S. Food and Drug
8. Administration. https://bit.ly/3TiXjZA. Accessed October 13, 2022.
9. CDC Covid Data tracker. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed October 13, 2022.
10. Survey results from pharmacists provide support to enhance the organizational response to codes. Institute For Safe Medication Practices. https://bit.ly/3gaqejW. Published October 6, 2022. Accessed October 13, 2022.

This week on Pharm5:

• ProAir HFA discontinued
• New MPJE blueprint
• PREP Act Expansion
• Ebola outbreak in Uganda
• American Pharmacists Month

Connect with us!

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

References

1. ProAir HFA®. Albuterol Inhalers. https://bit.ly/3CfEpvB. Accessed October 6, 2022.
2. ProAir manufacturer discontinuation. NC Medicaid. https://bit.ly/3Vm54Qn. Accessed October 6, 2022.
3. Home Page: Department of Vermont health access. Home Page | Department of Vermont Health Access. https://bit.ly/3Mayn45. Accessed October 6, 2022.
4. Multistate Pharmacy Jurisprudence Examination (MPJE): NABP. National Association of Boards of Pharmacy. https://bit.ly/3RJpYWz. Published October 6, 2022. Accessed October 6, 2022.
5. HHS amends prep act declaration increasing workforce authorized to administer monkeypox vaccines. https://bit.ly/3MbuX0V. Accessed October 6, 2022.
6. JYNNEOS vaccine fact sheet - EZIZ. https://bit.ly/3V8zvJx. Accessed October 7, 2022.
7. Daniel R. Lucey MD. Uganda ebola outbreak grows to more than 60 cases, 882 contacts and a fourth district. IDSA Home. https://bit.ly/3RXIavL. Accessed October 6, 2022.
8. Ebola virus disease. World Health Organization. https://bit.ly/3T68x3d. Accessed October 6, 2022.
9. American Pharmacists Month. APhM. https://bit.ly/3CEncNK. Accessed October 6, 2022.
10. Pharmacy technician day. ASHP. https://bit.ly/3rCTN0f. Accessed October 6, 2022.

This week on Pharm5:

• LDL <70 on statin + ezetimibe reduces stroke risk
• Monkeypox indications expand, & just 1 dose is helpful
• On-X aortic valve needs warfarin
• Relyvrio FDA approved for ALS
• Emergency refills in Hurricane Ian

Connect with us!

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

References

1. Amarenco P, Kim JS, Labreuche J, et al. Yield of dual therapy with statin and Ezetimibe in the treat stroke to target trial. Stroke. September 2022. doi:10.1161/strokeaha.122.039728
2. Monkeypox Vaccination Basics. Centers for Disease Control and Prevention. https://bit.ly/3UOhwb0. Published September 28, 2022. Accessed September 29, 2022.
3. Monkeypox cases by age and gender, race/ethnicity, and symptoms. Centers for Disease Control and Prevention. https://bit.ly/3SpTphr. Published August 22, 2022. Accessed September 29, 2022.
4. Weiland N. C.D.C. says early data offers positive signs about monkeypox vaccine. The New York Times. https://nyti.ms/3SKc0o5. Published September 28, 2022. Accessed September 29, 2022.
5. Artivion I. Artivion follows recommendation to stop proact xa clinical trial. Artivion Follows Recommendation to Stop PROACT Xa Clinical Trial. https://prn.to/3BVSiip. Published September 23, 2022. Accessed September 29, 2022.
6. Kido K, Ball J. Optimal intensity of warfarin therapy in patients with mechanical aortic valves. Journal of Pharmacy Practice. 2017;32(1):93-98. doi:10.1177/0897190017734765
7. FDA approves new treatment option for patients with ALS. U.S. Food and Drug Administration. https://bit.ly/3e0eT5n. Accessed September 29, 2022.
8. ALS drug gets FDA panel thumbs up after Rare second look. Medscape. https://wb.md/3y3XAHn. Published September 29, 2022. Accessed September 29, 2022.
9. Governor DeSantis declares state of emergency for Hurricane Ian. Florida Board of Pharmacy. https://bit.ly/3E5XFyq. Accessed September 29, 2022.
10. South Carolina Board of Pharmacy. SCLLR. https://bit.ly/3LT1M2q. Accessed September 29, 2022.

This week on Pharm5:

• Terlivaz (terlipressin) for hepatorenal syndrome
• Pfizer’s mRNA flu vaccine (enroll here: https://bit.ly/3DMRO0r)
• Potential triple-action drug for diabetes or weight loss
• Warfarin use in AFib with rheumatic heart disease
• CVS and Walmart settle; Walgreens heads to court

References

1. Terlivaz. Package Insert. Mallinckrodt Pharmaceuticals; 2022.
2. Pharmacypracticenews.com. https://bit.ly/3xHxgTm. Published September 15, 2022. Accessed September 22, 2022.
3. Biggins SW, Angeli P, Garcia‐Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and Hepatorenal Syndrome: 2021 practice guidance by the American Association for the study of liver diseases. Hepatology. 2021;74(2):1014-1048. doi:10.1002/hep.31884
4. Pfizer initiates phase 3 study of mrna-based influenza vaccine. Pfizer. https://bit.ly/3dBgvCx. Published September 14, 2022. Accessed September 22, 2022.
5. Mitchel L. Zoler PD. Triple threat: Novel agent shows potent T2D Weight Loss. Medscape. https://wb.md/3SmPWzK. Published September 22, 2022. Accessed September 22, 2022.
6. A1C and weight change results: Mounjaro™ (tirzepatide). Mounjaro. https://bit.ly/3DNdutI. Accessed September 22, 2022.
7. Connolly SJ, Karthikeyan G, Ntsekhe M, et al. Rivaroxaban in rheumatic heart disease–associated atrial fibrillation. New England Journal of Medicine. 2022;387(11):978-988. doi:10.1056/nejmoa2209051
8. Knauth D. CVS, Walmart reach $147.5 million opioid settlement with West Virginia. Medscape. https://wb.md/3BGNWeK. Published September 22, 2022. Accessed September 22, 2022.

This week on Pharm5 with special guests Karl Meyer and Shana Morrison:

• OTC oral contraceptive
• Post-surgical VTE prophylaxis with apixaban
• WHO fighting to end bacterial meningitis
• FDA approvals: Sotyktu, Rolvedon
• COVID vaccine decreases MIS-C risk

Connect with us!

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

References

1. Park B. FDA panel meeting scheduled to discuss RX-to-OTC switch of oral contraceptive opill. MPR. https://bit.ly/3BnOTZm. Published September 13, 2022. Accessed September 15, 2022.
2. ASHP Policy week 2022. ASHP. https://bit.ly/3SbbeA2.  Accessed September 15, 2022.
3. Pharmacist-prescribed contraceptives. Guttmacher Institute. https://bit.ly/3Bn44Cg.  Published August 24, 2022. Accessed September 15, 2022.
4. Westerman ME, Bree KK, Msaouel P, et al. Apixaban vs enoxaparin for post-surgical extended-duration venous thromboembolic event prophylaxis: A prospective quality improvement study. Journal of Urology. 2022;208(4):886-895. doi:10.1097/ju.0000000000002788
5. Henderson Rby E. Oral anticoagulant drug may be safe, effective in preventing blood clots after Urologic Cancer surgery. News. https://bit.ly/3BJFlcA. Published September 13, 2022. Accessed September 15, 2022.
6. Mutsaka F. Who launches drive to fight bacterial meningitis in Africa. AP NEWS. https://bit.ly/3BJETLl. Published September 8, 2022. Accessed September 14, 2022.
7. Uhl R, Riga T. Spectrum Pharmaceuticals receives FDA approval for Rolvedon™ (eflapegrastim-xnst) injection. Spectrum Pharmaceuticals, Inc. https://bit.ly/3BiRowg. Published September 9, 2022. Accessed September 14, 2022.
8. Dykes L. Deucravacitinib receives FDA approval for moderate-to-severe plaque psoriasis. Rheumatology Network. https://bit.ly/3eRss7m. Published September 10, 2022. Accessed September 14, 2022.
9. Zambrano LD, Newhams MM, Olson SM, et al. BNT162B2 mrna vaccination against COVID-19 is associated with a decreased likelihood of multisystem inflammatory syndrome in children aged 5–18 years—United States, July 2021 – April 2022. Clinical Infectious Diseases. 2022. doi:10.1093/cid/ciac637

This week on Pharm5:

• NM vs. Purdue Pharma, et al.
• Antibiotic timing in bloodstream infections
• Spevigo for pustular psoriasis flares
• Annual COVID-19 boosters
• Dolutegravir for pregnant patients living with HIV1

Connect with us!

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

References

1. Siegel D. Three major pharmacy operators begin latest opioid trial in New Mexico, watch online via CVN. CVN News. https://bit.ly/3RtFcQ9. Published September 7, 2022. Accessed September 8, 2022.
2. Pierson B. Pharmacy Operators Walmart, Walgreens, Kroger begin opioid trial in New Mexico. Reuters. https://reut.rs/3Rwi43e. Published September 6, 2022. Accessed September 8, 2022.
3. Van Heuverswyn J, Valik JK, van der Werff SD, Hedberg P, Giske C, Nauclér P. Association between time to appropriate antimicrobial treatment and 30-day mortality in patients with bloodstream infections: A retrospective cohort study. Clinical Infectious Diseases. September 2022. doi:10.1093/cid/ciac727
4. Boehringer. https://bit.ly/3x7N1mi. Published September 1, 2022. Accessed September 8, 2022.
5. Spevigo. Package Insert. Boehringer Ingelheim Pharmaceuticals, Inc; 2022.
6. Bendix A. Covid vaccines will likely become annual like flu shots, health officials say. NBCNews.com. https://nbcnews.to/3cWpcXU. Published September 6, 2022. Accessed September 8, 2022.
7. Statement by President Biden on FDA and CDC authorizing updated COVID-19 vaccines. The White House. https://bit.ly/3KYpABy. Published September 6, 2022. Accessed September 8, 2022.
8. Patel K, Huo Y, Jao J, et al. Dolutegravir in pregnancy as compared with current HIV regimens in the United States. New England Journal of Medicine. 2022;387(9):799-809. doi:10.1056/nejmoa2200600

This week on Pharm5:

• Farxiga (dapagliflozin) for HFpEF
• Updated boosters for COVID-19
• Xenpozyme (olipudase alfa) for rare ASMD
• New York Times on “growing chains, falling wages”
• Phase III olokizumab vs. adalimumab for RA

Connect with us!

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

References

1. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. New England Journal of Medicine. August 2022. doi:10.1056/nejmoa2206286
2. FDA Approves Treatment for Wider Range of Patients with Heart Failure https://bit.ly/3B20I8N.  Published February 24, 2022. Accessed February 24, 2022.
3. Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose. U.S. Food and Drug Administration. https://bit.ly/3cDuyHd. Accessed August 31, 2022.
4. Scheiber N. How pharmacy work stopped being so great. The New York Times. https://www.nytimes.com/2022/08/20/business/economy/pharmacists-job-inflation.html. Published August 20, 2022. Accessed September 1, 2022.
5. FDA approves first treatment for acid sphingomyelinase deficiency, a rare genetic disease. U.S. Food and Drug Administration. https://bit.ly/3AziPS5. Accessed August 31, 2022.
6. Dunleavy K. Sanofi's rare disease drug XENPOZYME scores FDA approval after nods in Japan and Europe. Fierce Pharma. https://bit.ly/3B3kz7F. Published August 31, 2022. Accessed August 31, 2022.
7. Smolen JS, Feist E, Fatenejad S, et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. New England Journal of Medicine. 2022;387(8):715-726. doi:10.1056/nejmoa2201302

This week on Pharm5:

• Rapid-acting Auvelity (bupropion/dextromethorphan) for MDD
• USPSTF’s updated statin recommendations
• Post flu vaccination hyperglycemia in type 2 diabetes
• Twice annual HIV treatment lenacapavir approved in Europe; awaiting FDA approval
• Student loan forgiveness

Connect with us!

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

References:

1. Saro Arakelians PD. Daily medication pearl: Dextromethorphan and bupropion (Auvelity). Pharmacy Times. https://bit.ly/3QPIRY8. Published August 24, 2022. Accessed August 24, 2022.
2. Auvelity (dextromethorphan and bupropion). Package insert. Axsome Therapeutics, Inc; 2022.
3. @DrWestling15. “FDA just approved Auvelity (Dextromethorphan-Bupropion) for Major Depressive Disorder! What should a pharmacist know about this?” https://bit.ly/3R4WKkX. Published August 22, 2022. Accessed August 24, 2022.
4. Mangione CM, Barry MJ, Nicholson WK, et al. Statin use for the primary prevention of cardiovascular disease in adults. JAMA. 2022;328(8):746. doi:10.1001/jama.2022.13044.
5. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11). doi:10.1161/cir.0000000000000678
6. Blood sugars higher for flu vaccine recipients with diabetes. U.S. Pharmacist – The Leading Journal in Pharmacy. https://bit.ly/3PKbDrH. Published August 24, 2022. Accessed August 24, 2022.
7. Hulsizer AL, Witte AP, Attridge RL, Urteaga EM. Hyperglycemia Post-Influenza vaccine in patients with diabetes. Annals of Pharmacotherapy. June 2022:106002802210981. doi:10.1177/10600280221098101
8. Kansteiner F. Gilead HIV prospect escapes FDA hold after glass compatibility glitch triggered regulatory setbacks. Fierce Pharma. https://bit.ly/3R3h3yY. Published May 17, 2022. Accessed August 24, 2022.
9. Gilead announces first global regulatory approval of Sunlenca® (Lenacapavir), the only twice-yearly HIV treatment option. Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option. https://bit.ly/3dXZd2t. Accessed August 24, 2022.
10. Duster C. How to qualify for Biden's new student loan forgiveness plan. CNN Politics. https://cnn.it/3ALjKjF. Published Wednesday August 24, 2022. Accessed August 24, 2022.
11. Occupational Employment and Wages, May 2021 - Pharmacists. U.S. Bureau of Labor Statistics. https://bit.ly/3PObHXm.  Published March 31, 2022. Accessed August 24, 2022.
12. Smoot C. What is the average pharmacy school debt in 2022? SuperMoney. https://bit.ly/3PHqZNK. Published April 26, 2022. Accessed August 24, 2022.

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:

• What most pharmacists need to know about the newest CHEST Guidelines for Perioperative Management of Antithrombotic Therapy!

Connect with us!

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

References:

1. Douketis JD, Spyropoulos AC, Murad MH, et al. Perioperative management of antithrombotic therapy: An american college of chest physicians clinical practice guideline. Chest. August 2022. doi:10.1016/j.chest.2022.07.025
2. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy. Chest. 2012;141(2). doi:10.1378/chest.11-2298

This week on Pharm5:

• Inflation Reduction Act’s impact on Medicare Part D
• Monkeypox and Jynneos vaccine updates
• Tennessee sues Walgreens for opioid over-distribution
• FDA declines Nuplazid’s indication for Alzheimer’s psychosis
• Two BP readings better predicts ASCVD risk

References:

1. Statement by president Biden on Senate Passage of the inflation reduction act. The White House. https://bit.ly/3dcWRfs. Published August 7, 2022. Accessed August 11, 2022.
2. Part D Senior Savings Model (insulin savings) common questions & answers. https://go.cms.gov/3SGrKcx.  Accessed August 11, 2022.
3. JYNNEOS vaccine. Centers for Disease Control and Prevention. https://bit.ly/3STVq6e. Published August 10, 2022. Accessed August 11, 2022.
4. FDA authorizes intradermal use of Jynneos vaccine for Monkeypox. Medscape. https://wb.md/3C2K9ua.  Published August 9, 2022. Accessed August 11, 2022.
5. Assistant Secretary for Public Affairs (ASPA). Biden-Harris Administration Bolsters Monkeypox Response; HHS secretary Becerra declares public health emergency. HHS.gov. https://bit.ly/3pabFhK. Published August 5, 2022. Accessed August 11, 2022.
6. Williams J. Judge says Walgreens contributed to San Francisco's opioid crisis. PBS. https://to.pbs.org/3zMFH04. Published August 10, 2022. Accessed August 11, 2022.
7. Gorman S. Tennessee sues Walgreens Pharmacy chain over Opioid Distribution. Medscape. https://wb.md/3Qk2VkW. Published August 5, 2022. Accessed August 11, 2022.
8. Staff R. FDA declines to approve expanded use of antipsychotic drug. Medscape. https://wb.md/3bIlSz2. Published August 5, 2022. Accessed August 11, 2022.
9. Clark CE, Warren FC, Boddy K, et al. Higher arm versus lower arm systolic blood pressure and cardiovascular outcomes: A meta-analysis of individual participant data from the Interpress-IPD Collaboration. Hypertension. August 2022. doi:10.1161/hypertensionaha.121.18921.
10. Whelton P, Carey R, Aronow W, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. J Am Coll Cardiol. 2018 May, 71 (19) e127–e248. https://doi.org/10.1016/j.jacc.2017.11.006.

This week on Pharm5:

• Pfizer’s Phase 2 trials for revamped COVID vaccine
• Monkeypox updates: vaccines and treatment options
• Treating animal infections with OTC topical medications
• Uninsured rates hit historic US low
• ASHP’s guidance to prevent controlled substance diversion

References:

1. Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate based on enhanced spike protein design. Pfizer. https://bit.ly/3OVxagF.  Published July 27, 2022. Accessed August 4, 2022.
2. FDA Briefing Document Vaccines and Related Biological Products Advisory Committee Meeting. https://bit.ly/3I1wZhY. Published June 28, 2022. Accessed June 30, 2022.
3. JYNNEOS monkeypox vaccine distribution by jurisdiction. https://bit.ly/3vBs0zt. Accessed August 4, 2022.
4. FDA provides update on agency response to Monkeypox Outbreak. U.S. Food and Drug Administration. https://bit.ly/3bw93rj. Published July 29, 2022. Accessed August 4, 2022.
5. Lundberg A, Koch SN, Bierbrier L, Slater M. Treating common skin conditions of cats and dogs in a community setting. Today's Veterinary Practice. 2022:100-106. Accessed August 4, 2022.
6. Spitnagel MB, Hillier A, Gober M, Carlson MD. Treatment complexity and caregiver burden are linked in owners of dogs with allergic/atopic dermatitis. Vet Dematol. 2021;32(2):192-e50. Accessed August 4, 2022.
7. Assistant Secretary for Public Affairs (ASPA). New HHS report shows national uninsured rate reached all-time low in 2022. HHS.gov. https://bit.ly/3zwU48y Published August 2, 2022. Accessed August 4, 2022.
8. Number of retail prescription drugs filled at pharmacies by payer. KFF. https://bit.ly/3QmntJ8 Published March 5, 2020. Accessed August 4, 2022.
9. ASHP releases revised guidelines on preventing diversion of controlled substances. ASHP. https://bit.ly/3d5XZ4F. Published August 2, 2022. Accessed August 4, 2022.

This week on Pharm5:

• Polio in the US
• COVID vaccines linked to fewer CV events
• Vancomycin AUC vs. target troughs
• CMS Star Ratings 2022
• Payment model is needed for Paxlovid prescribing

Use APhA’s pre-written, editable letter to advocate for pharmacist reimbursement for Paxlovid prescribing: https://bit.ly/3cKwm0O

References:

1. Meko H. First polio case in nearly a decade is detected in New York State. The New York Times. https://nyti.ms/3JbGLid. Published July 21, 2022. Accessed July 28, 2022.
2. Polio vaccine effectiveness and duration of protection. Centers for Disease Control and Prevention. https://bit.ly/3JhiIyy. Published May 4, 2018. Accessed July 28, 2022.
3. Kim Y-E, Huh K, Park Y-J, Peck KR, Jung J. Association between vaccination and acute myocardial infarction and ischemic stroke after COVID-19 infection. JAMA. July 2022. doi:10.1001/jama.2022.12992
4. Abdelmessih E, Patel N, Vekaria J, et al. Vancomycin area under the curve versus trough only guided dosing and the risk of acute kidney injury: Systematic Review and meta‐analysis. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. July 2022. doi:10.1002/phar.2722
5. Chung D, Efta J, Brunsman A, et al. Evaluation of pharmacist time dedicated to vancomycin dosing in adult patients using a 24-hour AUC nomogram or Trough Monitoring Approach: A time motion study. American Journal of Health-System Pharmacy. 2022;79(14):1173-1179. doi:10.1093/ajhp/zxac094
6. Press release CMS releases 2022 Medicare Advantage and Part D star ratings to help Medicare beneficiaries compare plans. CMS. https://go.cms.gov/3oEzpKM. Accessed July 28, 2022.
7. Emergency action is necessary to provide payment for pharmacist prescribing of Paxlovid. OneClickPolitics. https://bit.ly/3cKwm0O. Accessed July 28, 2022.

This week on Pharm5:

• Concerns with HHS guidance to retail pharmacies
• Drug overdose disparities
• Antimicrobial resistance after COVID-19
• Colloid v. crystalloid during cardiac surgery
• Novavax endorsed by CDC

References:

1. Christensen J. Biden administration says pharmacies can't turn away people who have a prescription for a drug that may end a pregnancy. CNN. https://cnn.it/3olj1id. Published July 13, 2022. Accessed July 14, 2022.
2. ASHP response and advocacy related to recent federal guidance to "retail pharmacies" on access to Reproductive Health. ASHP. https://bit.ly/3RQHusT. Accessed July 21, 2022.
3. Drug overdose deaths rise, Disparities Widen. Centers for Disease Control and Prevention. https://bit.ly/3PNKSTP. Accessed July 21, 2022.
4. U.S. must curb rising rate of resistance to antimicrobials. IDSA Home. https://bit.ly/3PKz5FS.  Accessed July 21, 2022.
5. Covid-19: U.S. impact on Antimicrobial Resistance, Special Report 2022. June 2022. doi:10.15620/cdc:117915
6. Pesonen E, Vlasov H, Suojaranta R, et al. Effect of 4% albumin solution vs Ringer acetate on major adverse events in patients undergoing cardiac surgery with cardiopulmonary bypass. JAMA. 2022;328(3):251. doi:10.1001/jama.2022.10461
7. CDC recommends Novavax's COVID-19 vaccine for adults. Centers for Disease Control and Prevention. https://bit.ly/3zm4Tv4. Published July 19, 2022. Accessed July 21, 2022.

This week on Pharm5:

• Pharmacists not required to turn away teratogenic prescriptions
• New, protein-based COVID-19 vaccine receives EUA
• Monkeypox update
• Delaware HB399 for Pharmacists Test and Treat
• BPS scores released

References:

1. Christensen J. Biden administration says pharmacies can't turn away people who have a prescription for a drug that may end a pregnancy. CNN. https://cnn.it/3olj1id. Published July 13, 2022. Accessed July 14, 2022.
2. Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 vaccine, adjuvanted. U.S. Food and Drug Administration. https://bit.ly/3B5SNb5. Accessed July 14, 2022.
3. 2022 U.S. Map & Case count. Centers for Disease Control and Prevention. https://bit.ly/3aG6h2i.  Published July 13, 2022. Accessed July 14, 2022.
4. Fact sheet: Biden-Harris Administration's Monkeypox Outbreak response. The White House. https://bit.ly/3o2hYTX.  Published June 29, 2022. Accessed July 14, 2022.
5. Dem, D. House passes pharmacist test to treat bill. Blue Delaware. https://bit.ly/3uNocLr. Published June 17, 2022. Accessed July 14, 2022.
6. Pharmacist prescribing: "test and treat". NASPA. https://bit.ly/3Rw9e6b. Published July 11, 2022. Accessed July 14, 2022.
7. Board of Pharmacy Specialties (BPS) homepage. Board of Pharmacy Specialties. https://bit.ly/3z4QOC6. Accessed July 14, 2022.

This week on Pharm5:

• Pharmacists prescribing Paxlovid
• New oncology payment model from CMS
• Flu shot updates for ≥65 years old
• Conflicting mortality and morbidity data for LVADs in heart failure
• Cardiometabolic trends in the 2000s

References:

1. Coronavirus (COVID-19) update: FDA authorizes pharmacists to prescribe paxlovid with certain limitations. U.S. Food and Drug Administration. https://bit.ly/3AuDqbB. Published July 6, 2022. Accessed July 7, 2022.
2. Enhancing oncology model: CMS innovation center. Innovation Center. https://bit.ly/3yq4bLD. Published June 27, 2022. Accessed July 7, 2022.
3. CDC director adopts preference for specific flu vaccines for seniors. Centers for Disease Control and Prevention. https://bit.ly/3ynmotw. Published June 30, 2022. Accessed July 7, 2022.
4. https://bit.ly/3yOSrUE
5. Vidula H, Takeda K, Estep JD, et al. Hospitalization patterns and impact of a magnetically-levitated left ventricular assist device in the momentum 3 trial. JACC. https://bit.ly/3yQVY4R. Published July 1, 2022. Accessed July 7, 2022.
6. Cogswell R, Rogers JG, M.R. M, et al. Residual heart failure on mechanically assisted circulation: A call to action. JACC. https://bit.ly/3yOSrUE. Published July 1, 2022. Accessed July 7, 2022.
7. O’Hearn M, Lauren BN, Wong JB, Kim DD, Mozaffarian D. Trends and disparities in cardiometabolic health among U.S. adults, 1999-2018. Journal of the American College of Cardiology. 2022;80(2):138-151. doi:10.1016/j.jacc.2022.04.046

This week on Pharm5:

• Roe v. Wade overturned
• ASHP’s response and conflicts of interest
• Fall 2022 COVID-19 booster update
• USPSTF vitamin recommendation statement
• Qsymia for obesity in youth

References:

1. Supreme Court of the United States. https://bit.ly/3u80DfV. Accessed June 30, 2022.
2. MacNaughton H, Nothnagle M, Early J.
3. Mifepristone and Misoprostol for early pregnancy loss and medication abortion. American Family Physician. https://bit.ly/3I2ASmQ. Published April 15, 2021. Accessed June 29, 2022. ASHP Calls for Patients’ Rights to Access Reproductive Health Services. ASHP. https://bit.ly/3NvI7oz. Accessed June 29, 2022.
4. Legislators We Support. ASHP. https://bit.ly/3I9FN5x. Accessed June 29, 2022.
5. Carter: Life wins! Congressman Buddy Carter. https://bit.ly/3y59mk7. Published June 24, 2022. Accessed June 29, 2022.
6. @SC_PharmD Oh god I already hate it here https://twitter.com/SC_PharmD/status/1542121672546717696. Posted June 29, 2022.
7. FDA Briefing Document Vaccines and Related Biological Products Advisory Committee Meeting. https://bit.ly/3I1wZhY. Accessed June 30, 2022.
8. Lafraniere S, Weiland N. F.D.A. advisers recommend updated boosters targeting forms of Omicron. The New York Times. https://nyti.ms/3I3sljt. Published June 28, 2022. Accessed June 29, 2022.
9. Mangione CM, Barry MJ, Nicholson WK, et al. Vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. JAMA. 2022;327(23):2326. doi:10.1001/jama.2022.8970
10. Childhood Obesity Facts. Centers for Disease Control and Prevention. https://bit.ly/3Ox33gf. Published May 17, 2022. Accessed June 30, 2022.
11. FDA approves Qsymia for treating teens with obesity. Medscape. https://wb.md/3a5ywXY. Published June 28, 2022. Accessed June 30, 2022.
12. Qsymia. Package Insert. Vivus, LLC; 2022.

This week on Pharm 5:

• Medicare Part D overpaying by $3.6B vs. Mark Cuban
• Vaxneuvance Pneumococcal-15 for kids
• Healthcare Implications from Biden’s LGBTQI+ Executive Order
• ANCHOR Study reduces progression to anal cancer by 57% in PLWH and HSIL
• ADVANCE Study enrollment open for MSM interested in donating blood

References:

1. Lalani HS, Kesselheim AS, Rome BN. Potential medicare part D savings on generic drugs from the Mark Cuban Cost Plus Drug Company. Annals of Internal Medicine. 2022. doi:10.7326/m22-0756
2. Merck & Co., Inc. U.S. FDA Approves Merck’s VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children. Merck.com. https://bit.ly/3tXVlDL. Published June 22, 2022. Accessed June 23, 2022.
3. Fact sheet: President Biden to Sign Historic Executive Order advancing LGBTQI+ equality during Pride Month. The White House. https://bit.ly/3yfS6Kf. Published June 15, 2022. Accessed June 23, 2022.
4. Palefsky JM, Lee JY, Jay N, et al. Treatment of anal high-grade squamous intraepithelial lesions to prevent anal cancer. New England Journal of Medicine. 2022;386(24):2273-2282. doi:10.1056/nejmoa2201048
5. Advance study. https://bit.ly/3Nbzu2p. Accessed June 23, 2022.

This week on Pharm5:

• FTC launches investigation into PBMs
• COVID vaccines coming soon for kids <5 years old
• Paxlovid’s efficacy against COVID symptoms and mortality
• C. diff with highly reduced vancomycin susceptibility
• Walmart and Sam’s Club raising wages for pharmacy technicians

References:

1. FTC launches inquiry into prescription drug middlemen industry. Federal Trade Commission. https://bit.ly/3NUjNxA. Published June 7, 2022. Accessed June 16, 2022.
2. Jones A. APHA welcomes FTC study of PBMs' anticompetitive business practices – urges agency to take action. American Pharmacists Association. https://bit.ly/3MVUh9N. Published June 7, 2022. Accessed June 16, 2022.
3. Park A, Ducharme J. Covid-19 vaccines for kids 6 months + up recommended by FDA. Time. https://bit.ly/3zGyUq4. Published June 15, 2022. Accessed June 16, 2022.
4. Sarkissian A. Florida is the only state to skip pre-ordering covid-19 vaccines for kids. POLITICO. https://politi.co/3mTkUlf. Published June 15, 2022. Accessed June 16, 2022.
5. Najjar-Debbiny R, Gronich N, Weber G, et al. Effectiveness of Paxlovid in reducing severe COVID-19 and mortality in high-risk patients. Clinical Infectious Diseases. June 2022. doi:10.1093/cid/ciac443.
6. Person. Pfizer stops enrollment in PAXLOVID trial in standard-risk population. Reuters. https://reut.rs/3MZvmm3. Published June 14, 2022. Accessed June 16, 2022.
7. Greentree DH, Rice LB, Donskey CJ. Houston, we have a problem: Reports of clostridioides difficile isolates with reduced vancomycin susceptibility. Clinical Infectious Diseases. June 2022. doi:10.1093/cid/ciac444.
8. Kelly CR, Fischer M, Allegretti JR, et al. ACG clinical guidelines: Prevention, diagnosis, and treatment of Clostridioides difficile infections. American Journal of Gastroenterology. 2021;116(6):1124-1147. doi:10.14309/ajg.0000000000001278
9. Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on management of clostridioides difficile infection in adults. Clinical Infectious Diseases. 2021;73(5). doi:10.1093/cid/ciab549
10. Host K, Jackson S. Walmart launches new approach to pharmacy tech wages with more frequent raises. Corporate. https://bit.ly/3xAf8da. Published June 16, 2022. Accessed June 16, 2022.

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:

• Novavax protein-based COVID-19 vaccine
• Pneumococcal Vaccine Decision Tree
• Dupixent (dupilumab) for atopic dermatitis in kids 6 months to 5 years
• Dostarlimab 100% effective in Phase II colorectal cancer trial
• CHIP and Medicaid COVID-19 vaccine counseling codes

References:

1. FDA Briefing Document Novavax COVID-19 Vaccine. FDA.gov. https://bit.ly/3tsOBxb. Published June 7, 2022. Accessed June 9, 2022.
2. Haslett C, Carrington AE. ABC News. https://abcn.ws/3O2JtI3. Published June 7, 2022. Accessed June 9, 2022.
3. Protecting adults against pneumococcal disease. National Foundation for Infectious Diseases. https://bit.ly/3aKYXlz. Published June 3, 2022. Accessed June 9, 2022.
4. Brunk D. Dupilumab approved for eczema for children 6 months to 5 years. Medscape. https://wb.md/3QoWAFF. Published June 7, 2022. Accessed June 9, 2022.
5. Cercek A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch repair–deficient, locally advanced rectal cancer. New England Journal of Medicine. 2022. doi:10.1056/nejmoa2201445
6. COVID-19 Stand-alone Vaccine Counseling-specific HCPCS Codes. Federal Policy Guidance | Medicaid.gov. https://bit.ly/3QffkY0. Published June 8, 2022. Accessed June 9, 2022.

This week on Pharm5:

• Monkeypox vaccine for work-related exposure to orthopoxvirus
• Lymphoma drug Ukoniq (umbralisib) loses FDA approval
• Psychedelic, synthetic psylocibin tested for use in severe depression
• Expanding uses for antineoplastic agent azacitidine
• Addendum to the 2022 Standards of Medical Care in Diabetes

References:

1. Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. Centers for Disease Control and Prevention. https://bit.ly/3MkpYtq. Published May 27, 2022. Accessed June 2, 2022.
2. FDA withdraws lymphoma drug approval after investigation. Medscape. https://wb.md/3GJIMRw. Published June 1, 2022. Accessed June 2, 2022.
3. Melville NA. Psilocybin effective up to 12 weeks in severe depression. Medscape. https://wb.md/3xeigg5. Published June 2, 2022. Accessed June 2, 2022.
4. DRUGS@FDA: FDA-approved drugs. accessdata.fda.gov. https://bit.ly/3Mr6kvT. Accessed June 2, 2022.
5. Center for Drug Evaluation and Research. FDA approves azacitidine. U.S. Food and Drug Administration. https://bit.ly/3xdSoRw. Published May 20, 2022. Accessed June 2, 2022.
6. FDA approves Ivosidenib/Azacitidine for certain patients with newly diagnosed AML. The ASCO Post. https://bit.ly/3GHaoGY. Published May 26, 2022. Accessed June 2, 2022.
7. Addendum. 10. cardiovascular disease and risk management: Standards of medical care in diabetes–2022. diabetes care 2022;45(suppl. 1):S144–S174. Diabetes Care. May 2022. doi:10.2337/dc22-ad08
8. Aspirin use to prevent cardiovascular disease: Preventive medication. Recommendation: Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication | United States Preventive Services Taskforce. https://bit.ly/3m93gtn. Published April 26, 2022. Accessed Jun 2, 2022.

This week on Pharm5:

• Rare monkeypox spreading globally
• Metformin not helpful in breast cancer survival
• Novel, nonsteroidal Vtama (tapinarof) for plaque psoriasis
• Short-course antibiotics for P. aeruginosa bacteremia
• COVID-19 vaccine saves lives and money

References:

1. LaMotte S. What is monkeypox, its symptoms and threat to you? CNN. https://www.cnn.com/2022/05/24/health/what-is-monkeypox-virus-explainer-update-wellness/index.html. Published May 26, 2022. Accessed May 26, 2022.
2. Goodwin PJ, Chen BE, Gelmon KA, et al. Effect of Metformin vs Placebo on Invasive Disease–Free Survival in Patients with Breast Cancer. Journal of the American Medical Association. 2022;327(20):1963-1973. doi:10.1001/jama.2022.6147.
3. Kansteiner F. Dermavant looks to dethrone topical steroids with first FDA approval for Vtama in psoriasis. Fierce Pharma. https://www.fiercepharma.com/pharma/dermavant-looks-dethrone-topical-steroids-first-ever-fda-approval-vtama-psoriasis. Published May 24, 2022. Accessed May 26, 2022.
4. Dermavant Sciences. Dermavant FDA Approves Dermavants VTAMA tapinarof cream 1 for the Treatment of Plaque Psoriasis in Adults First Topical Novel Chemical Entity Launched for Psoriasis in the US in 25 Years Comments. https://www.dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/. Accessed May 26, 2022.
5. Babich T, Naucler P, Valik JK, et al. Duration of treatment for pseudomonas aeruginosa bacteremia: A retrospective study. Infectious Diseases and Therapy. 2022. doi:10.1007/s40121-022-00657-1
6. Di Fusco M, Marczell K, Deger KA, et al. Public health impact of the pfizer-biontech COVID-19 vaccine (BNT162B2) in the first year of rollout in the United States. Journal of Medical Economics. 2022;25(1):605-617. doi:10.1080/13696998.2022.2071427.

This week on Pharm5:

• IV contrast shortage
• COVID-19 boosters for kids 5-11 years old
• First-in-class tirzepatide for T2DM
• Oral Radacava ORS for ALS
• COVID-19 vaccines in AAPI patients

References:

1. Shortage of contrast dye forces hospitals to ration CT scans, other procedures. NBCNews.com. https://www.nbcnews.com/news/us-news/shortage-contrast-dye-hospitals-ration-ct-scans-procedures-rcna29379. Published May 18, 2022. Accessed May 19, 2022.
2. Commissioner Oof the. Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer BioNTech COVID-19 vaccine booster dose to children 5 through 11 years. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose. Published May 17, 2022. Accessed May 19, 2022.
3. Children and covid-19 vaccination trends. Home. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Accessed May 19, 2022.
4. Commissioner of the FDA approves novel, dual-targeted treatment for type 2 diabetes. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-dual-targeted-treatment-type-2-diabetes. Published May 13, 2022. Accessed May 19, 2022.
5. Radicava ORS (Edaravone) Patient Brochure. https://www.radicava.com/update/pdfs/radicava-ors-patient-brochure.pdf. Accessed May 19, 2022.
6. 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.
7. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous Tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes. JAMA. 2022;327(6):534. doi:10.1001/jama.2022.0078
8. Bureau USC. Week 45 household pulse survey: April 27 - May 9, 2022. Census.gov. https://www.census.gov/data/tables/2022/demo/hhp/hhp45.html. Published May 18, 2022. Accessed May 19, 2022.
9. Ta Park V, Dougan M, Meyer O, et al. Differences in covid-19 vaccine concerns among Asian Americans and Pacific Islanders: The compass survey. Journal of Racial and Ethnic Health Disparities. 2021;9(3):979-991. doi:10.1007/s40615-021-01037-0

This week on Pharm5:

• Adenovirus 41 infections in kids <5 years old
• Mediterranean diet superior to low-fat diet for CVD prevention in males
• Of hospitalized COVID-19 patients, over half still experience ≥1 symptom after 2 years
• Overdose deaths hit record high in 2021
• Former nurse RaDonda Vaught’s sentencing expected today

References:

1. Rosenthal M. Idse.net. https://www.idse.net/Emerging-Diseases/Article/05-22/Pediatric-Hepatitis-of-Unknown-Origin-Cases-Mounting/66928. Accessed May 12, 2022.
2. Overview: Children with hepatitis of unknown cause. Centers for Disease Control and Prevention. https://www.cdc.gov/ncird/investigation/hepatitis-unknown-cause/overview-what-to-know.html. Published May 6, 2022. Accessed May 12, 2022.
3. Adenovirus vaccine information statement. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/adenovirus.html. Published January 8, 2020. Accessed May 12, 2022.
4. Delgado-Lista J, Alcala-Diaz JF, Torres-Peña JD, et al. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): A randomised controlled trial. The Lancet. 2022. doi:10.1016/s0140-6736(22)00122-2
5. Huang L, Li X, Gu X, et al. Health Outcomes in people 2 years after surviving hospitalisation with covid-19: A longitudinal cohort study. The Lancet Respiratory Medicine. 2022. doi:10.1016/s2213-2600(22)00126-6
6. Naloxone: The opioid reversal drug that saves lives - hhs.gov. https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf. Accessed May 12, 2022.
7. Shaw G. Vaught Verdict a ‘Blow’ To Patient Safety Culture. Pharmacypracticenews.com. https://www.pharmacypracticenews.com/Operations-and-Management/Article/05-22/Vaught-Verdict-a-%E2%80%98Blow%E2%80%99-To-Patient-Safety-Culture/66894. Accessed May 12, 2022.

This week on Pharm5:

• AAPI patients underrepresented in clinical trials
• Camzyos (mavacamten) approved for obstructive HCM
• Voquenza (combination vonoprazan products) approved for H. pylori
• Pharmacy job postings up 18% in 2021
• Implications of potential overturn of Roe v. Wade

References:

1. Asian, Indigenous, Latino patients underrepresented in US clinical trials of Biologics. Healio. https://www.healio.com/news/rheumatology/20211208/asian-indigenous-latino-patients-underrepresented-in-us-clinical-trials-of-biologics#:~:text=Asian%2C%20American%20Indian%2C%20Alaska%20Native,research%20letter%20published%20in%20JAMA. Accessed May 5, 2022.
2. Camzyos Prescribing Information. accessdata.fda.gov. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214998. Accessed May 5, 2022.
3. Cosdon N. FDA approves 2 vonoprazan treatments for helicobacter pylori infection. Contagion Live. https://www.contagionlive.com/view/fda-approves-2-vonoprazan-treatments-for-helicobacter-pylori-infection. Published May 3, 2022. Accessed May 5, 2022.
4. Staff PT. FDA approves pair of Vonoprazan treatments for helicobacter pylori infection. Pharmacy Times. https://www.pharmacytimes.com/view/fda-approves-pair-of-vonoprazan-treatments-for-helicobacter-pylori-infection. Published May 4, 2022. Accessed May 5, 2022.
5. Pharmacy Demand Report (PDR) 2021 Yearly Summary - aacp.org. https://www.aacp.org/sites/default/files/2022-04/pdr-2021-yearly-summary.pdf. Accessed May 5, 2022.
6. Roe v. Wade live updates: Protests rage on over leaked abortion ruling. NBCNews.com. https://www.nbcnews.com/news/us-news/live-blog/roe-v-wade-live-updates-protests-rage-leaked-abortion-ruling-rcna27427. Published May 5, 2022. Accessed May 5, 2022.

This week on Pharm5:

• Vivjoa to prevent recurrent vulvovaginal candidiasis
• USPSTF recommendations for aspirin in primary prevention
• Remdesivir FDA approved in kids ≤12 years old
• Moderna applies for EAU in kids 6 months to 5 years old
• National Prescription Drug Take Back Day tomorrow, April 30th

Connect with us!

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

References:

1. Vivjoa. Package Insert. Mycovia Pharmaceuticals, Inc.; 2022.
2. FDA approves Mycovia Pharmaceuticals' VIVJOA™ (oteseconazole), the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). BioSpace. https://www.biospace.com/article/releases/fda-approves-mycovia-pharmaceuticals-vivjoa-oteseconazole-the-first-and-only-fda-approved-medication-for-recurrent-vulvovaginal-candidiasis-chronic-yeast-infection-/. Published April 28, 2022. Accessed April 28, 2022.
3. Aspirin use to prevent cardiovascular disease: Preventive medication. Recommendation: Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication | United States Preventive Services Taskforce. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/aspirin-to-prevent-cardiovascular-disease-preventive-medication. Published April 26, 2022. Accessed April 28, 2022.
4. Gumbrecht J, Howard J. FDA approves remdesivir to treat young children with covid-19. CNN. https://www.cnn.com/2022/04/25/health/fda-remdesivir-covid-treatment-young-children/index.html.  Published April 25, 2022. Accessed April 28, 2022.
5. Hur K. Pfizer director dr. Scott Gottlieb: Shots for kids under 5 delayed due to low Covid cases in trial. CNBC. https://www.cnbc.com/2022/02/14/pfizer-director-dr-scott-gottlieb-shots-for-kids-under-5-delayed-due-to-low-covid-cases-in-trial.html. Published February 14, 2022. Accessed April 28, 2022.
6. Goodman B. Moderna seeks emergency use authorization for covid-19 vaccine for children ages 6 months through 5 years. CNN. https://www.cnn.com/2022/04/28/health/moderna-vaccine-eua-young-children/index.html?utm_term=link&utm_content=2022-04-28T13%3A49%3A07&utm_source=twCNN&utm_medium=social. Published April 28, 2022. Accessed April 28, 2022.
7. Take back day. DEA. https://www.dea.gov/takebackday. Accessed April 28, 2022.

This week on Pharm5:

• Oral tebipenem noninferior to IV ertapenem for complicated UTIs
• Stelara’s potential biosimilar ustekinumab ABP 654’s promising results
• SODIUM-HF trial finds no benefit to extreme sodium restriction in heart failure
• InspectIR COVID-19 Breathalyzer receives EUA
• Avastin’s third biosimilar bevacizumab-maly (Almsys) approved

Connect with us!

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

References:

1. Eckburg PB, Muir L, Critchley IA, et al. Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection. New England Journal of Medicine. 2022;386(14):1327-1338. doi:10.1056/nejmoa2105462.
2. Amgen announces positive top-line results from phase 3 study of ABP 654, Biosimilar candidate to STELARA® (ustekinumab). Amgen. https://www.amgen.com/newsroom/press-releases/2022/04/amgen-announces-positive-topline-results-from-phase-3-study-of-abp-654-biosimilar-candidate-to-stelara-ustekinumab. Published April 18, 2022. Accessed April 20, 2022.
3. Jeremias S. Amgen releases Positive Phase 3 results for Stelara Biosimilar. The Center For Biosimilars. https://www.centerforbiosimilars.com/view/amgen-releases-positive-phase-3-results-for-stelara-biosimilar. Published April 19, 2022. Accessed April 20, 2022.
4. Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (Sodium-Hf): An international, open-label, randomised, controlled trial. The Lancet. 2022;399(10333):1391-1400. doi:10.1016/s0140-6736(22)00369-5.
5. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure. Journal of the American College of Cardiology. April 2022. doi:10.1016/j.jacc.2021.12.012
6. Commissioner of the Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples. Published April 14, 2022. Accessed April 20, 2022.
7. Pharmacypracticenews.com. https://www.pharmacypracticenews.com/FDA-Approvals/Article/05-22/Third-Biosimilar-to-Bevacizumab-Approved/66766. Published April 19, 2022. Accessed April 21, 2022.

This week on Pharm5:

• FDA and DEA warn of online CII sales
• Ultomiris (ravulizumab) improves ADLs and QOL for up to 60 weeks in patients with myasthenia gravis
• Fidaxomicin’s biomolecular specificity to C. diffunveiled
• Sotrovimab has lost its EUA for treatment of COVID-19
• Results from Phase II of ASHP’s Residency Match

Connect with us!

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

References:

1. McCarthy L-J. FDA and DEA warn online pharmacies illegally selling Adderall to consumers. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-and-dea-warn-online-pharmacies-illegally-selling-adderall-consumers. Published April 12, 2022. Accessed April 12, 2022.
2. Ultomiris® (ravulizumab-CWVZ) demonstrated sustained improvements in functional activities and quality of life in adults with generalized myasthenia gravis through 60 weeks. AstraZeneca US. https://www.astrazeneca-us.com/media/press-releases/2022/ultomiris-demonstrated-sustained-improvements-in-functional-activities-and-quality-of-life-in-adults-with-generalized-myasthenia-gravis-through-60-weeks.html. Published April 6, 2022. Accessed April 14, 2022.
3. Ultomiris (ravulizumab-CWVZ). Package insert. Alexion Pharmaceuticals, Inc; 2018.
4. Cao X, Boyaci H, Chen J, Bao Y, Landick R, Campbell EA. Basis of narrow-spectrum activity of fidaxomicin on Clostridioides difficile. Nature. April 2022. doi:10.1038/s41586-022-04545-z
5. Rockefeller University. How a narrow-spectrum antibiotic takes aim at C. Diff. EurekAlert! https://www.eurekalert.org/news-releases/948950. Published April 6, 2022. Accessed April 14, 2022.
6. Center for Drug Evaluation and Research. FDA updates Sotrovimab Emergency Use Authorization. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization. Published April 5, 2022. Accessed April 14, 2022.
7. Person, Kavya B AM. Worldwide covid cases surpass 500 mln as Omicron variant BA.2 surges. Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/worldwide-covid-cases-surpass-500-mln-omicron-variant-ba2-surges-2022-04-14/. Published April 14, 2022. Accessed April 14, 2022.
8. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published April 13, 2022. Accessed April 14, 2022.
9. ASHP Match Statistics. ASHP Match | Statistics of the Match. https://natmatch.com/ashprmp/stats.html.  Published April 13, 2022. Accessed April 14, 2022.

This week on Pharm5:

What most pharmacists need to know about the 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure!

Connect with us!

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

References:

1. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure. Journal of the American College of Cardiology. April 2022. doi:10.1016/j.jacc.2021.12.012
2. Colvin MM. 2022 AHA/ACC/HFSA Heart Failure Guideline: Key Perspectives. American College of Cardiology. https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2022/03/29/19/53/2022-AHA-ACC-HFSA-Heart-Failure-Guideline-gl-hf. Published April 1, 2022. Accessed April 7, 2022.
3. Guideline hub: Heart failure. American College of Cardiology. https://www.acc.org/guidelines/hubs/heart-failure?utm_medium=social&utm_source=twitter_post&utm_campaign=twitter_post. Published April 1, 2022. Accessed April 7, 2022.

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:

• New COVID booster recommendations
• Transdermal dextroamphetamine for ADHD
• No ivermectin for COVID-19
• North Carolina’s workplace condition complaint form
• ASHP Phase II rank list due Wednesday, April 6th

Connect with us!

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

References:

1. CDC recommends additional boosters for certain individuals. Centers for Disease Control and Prevention. https://www.cdc.gov/media/releases/2022/s0328-covid-19-boosters.html.  Published March 29, 2022. Accessed March 31, 2022.
2. Pfizer and BioNTech submit for U.S. emergency use authorization of an additional booster dose of their COVID-19 vaccine for older adults. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-us-emergency-use-authorization. Published March 15, 2022. Accessed March 16, 2022.
3. FDA Approves Xelstrym. https://www.drugs.com/newdrugs/fda-approves-xelstrym-dextroamphetamine-transdermal-attention-deficit-hyperactivity-disorder-adhd-5805.html.   Published March 23, 2022. Accessed March 23, 2022.
4. Reis G, Silva EASM, Silva DCM, et al. Effect of early treatment with ivermectin among patients with covid-19. New England Journal of Medicine. 2022. doi:10.1056/nejmoa2115869
5. Working Conditions Complaint Form. http://www.ncbop.org/NewsItems/WorkingConditionsComplaintForm.html. Accessed March 31, 2022.
6. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published January 6, 2022. Accessed March 16, 2022.

This week on Pharm5:

• Ztalmy (ganaxolone) for CDKL5-CDD seizure disorder
• Opdualag (nivolumab/relatlimab-rmbw) for metastatic melanoma
• Missouri HB1677 for PBM transparency
• COVID-19 linked with increased risk and burden of T2DM
• APhA elections open until April 18th

Connect with us!

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

References:

1. Ztalmy. Package insert. Marinus Pharmaceuticals, Inc; 2022.
2. Opdualag. Package insert. Bristol-Myers Squibb Company; 2022.
3. Erickson K. Missouri lawmakers seek lower drug prices with plan to regulate pharmacy benefit managers. STLtoday.com. https://www.stltoday.com/news/local/govt-and-politics/missouri-lawmakers-seek-lower-drug-prices-with-plan-to-regulate-pharmacy-benefit-managers/article_c0447e7b-af83-5c53-8dac-bf3eecca0cee.html. Published March 23, 2022. Accessed March 23, 2022.
4. Becker C. State policy options and Pharmacy Benefit Managers (pbms). https://www.ncsl.org/research/health/state-policy-options-and-pharmacy-benefit-managers.aspx#/. Accessed March 23, 2022.
5. Xie Y, Al-Aly Z. Risks and burdens of incident diabetes in long covid: A cohort study. The Lancet Diabetes & Endocrinology. March 2022:1-11. doi:10.1016/s2213-8587(22)00044-4. 
6. Election Information. American Pharmacists Association. https://www.pharmacist.com/apha-elections. Accessed March 24, 2022.

This week on Pharm5:

• ASHP Match Results
• Generic Symbicort Approved
• Lynparza reduces death 32% in HER2-neg, gBRCAm breast cancer
• Congress passes 340B protection
• 4th Pfizer COVID vaccine

Connect with us!

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

References:

1. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published January 6, 2022. Accessed March 16, 2022.
2. Commissioner of the FDA approves first generic of Symbicort to treat asthma and COPD. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd?utm_campaign=%2BFDA%2BApproves%2BFirst%2BGeneric%2Bof%2BSymbicort%2Bto%2BTreat%2BAsthma%2Band%2BCOP&utm_medium=email&utm_source=govdelivery. Accessed March 17, 2022.
3. Lynparza® (OLAPARIB) reduced risk of death by 32% in patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer in phase 3 olympia trial. Merck.com. https://www.merck.com/news/lynparza-olaparib-reduced-risk-of-death-by-32-in-patients-with-germline-brca-mutated-her2-negative-high-risk-early-breast-cancer-in-phase-3-olympia-trial/. Published March 17, 2022. Accessed March 17, 2022.
4. Congress passes omnibus spending bill with 340B DSH protection, telehealth provisions. ASHP. https://www.ashp.org/news/2022/03/11/congress-passes-omnibus-spending-bill-340b-dsh-eligibility?loginreturnUrl=SSOCheckOnly. Published March 11, 2022. Accessed March 16, 2022.
5. Pfizer and BioNTech submit for U.S. emergency use authorization of an additional booster dose of their COVID-19 vaccine for older adults. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-us-emergency-use-authorization. Published March 15, 2022. Accessed March 16, 2022.

This week on Pharm5:

• AMA against pharmacy-based test-to-treat
• Expanding pharmacist roles
• Kaleo’s naloxone auto-injector
• E-cigarettes increase odds of pre-diabetes
• 2 years later, COVID-19 deaths hit 6 million

Connect with us!

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

References:

1. AMA statement on Administration's test-to-treat COVID-19 plan. American Medical Association. https://www.ama-assn.org/press-center/press-releases/ama-statement-administration-s-test-treat-covid-19-plan. Published March 4, 2022. Accessed March 10, 2022.
2. March 9, 2022 president Joseph R. Biden the White House. https://www.ashp.org/-/media/assets/advocacy-issues/docs/GRD-Joint-Pharm-Org-Letter-To-WH-on-Test-to-Treat-2022. Accessed March 10, 2022.
3. Sartain M. CDC makes the case for pharmacists’ reimbursement given expanding roles. American Pharmacists Association. https://www.pharmacist.com/Pharmacy-News/cdc-makes-the-case-for-pharmacists-reimbursement-given-expanding-roles. Published March 7, 2022. Accessed March 10, 2022.
4. Ashley Gallagher AE. FDA approves 10-mg naloxone injection to treat exposure to ultra-potent weaponized opioids. Pharmacy Times. https://www.pharmacytimes.com/view/fda-approves-10-mg-naloxone-injection-to-treat-exposure-to-ultra-potent-weaponized-opioids. Published March 4, 2022. Accessed March 10, 2022.
5. BioSpace. FDA approves Kaléo's 10 mg naloxone auto-injector for the treatment of known or potential exposure to ultra-potent weaponized opioids. BioSpace. https://www.biospace.com/article/releases/fda-approves-kaleo-s-10-mg-naloxone-auto-injector-for-the-treatment-of-known-or-potential-exposure-to-ultra-potent-weaponized-opioids/. Published March 2, 2022. Accessed March 10, 2022.
6. The surprising truth about prediabetes. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/library/features/truth-about-prediabetes.html. Published December 21, 2021. Accessed March 10, 2022.
7. Rizzo S, Nirappil F. Global covid-19 death toll tops 6 million, another grim milestone in the pandemic. The Washington Post. https://www.washingtonpost.com/health/2022/03/07/6-million-covid-deaths/.  Published March 7, 2022. Accessed March 10, 2022.
8. CDC Museum Covid-19 Timeline. Centers for Disease Control and Prevention. https://www.cdc.gov/museum/timeline/covid19.html. Published January 5, 2022. Accessed March 10, 2022.
9. Holder J. Tracking coronavirus vaccinations around the world. The New York Times. https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html.  Published January 29, 2021. Accessed March 10, 2022.