Top Pharmacy Innovations of 2021

The COVID-19 pandemic has brought many changes to the pharmacy profession. Because pharmacists are one of the most accessible health care professionals, they play an integral role in patient care management. From pediatric COVID-19 vaccines to the first interchangeable biosimilar products, multiple innovations have changed—and advanced—the pharmacy profession this year, and it is critical for pharmacists to stay up-to-date on these developments.

Advances in COVID-19

On August 23, the FDA approved the Pfizer-BioNTech COVID-19 messenger RNA vaccine (Comirnaty) for the prevention of COVID-19 disease in individuals 16 years and older.1 This is the first FDA approved COVID-19 vaccine, with approval based on positive efficacy and safety data in patients 6 months after the administration of a second dose.¹

In another recent milestone, the FDA granted emergency use authorization on October 29 for the Pfizer-BioNTech COVID-19 vaccine in children aged 5 to 11 years, with CDC approval following closely on November 2.2,3 Pharmacists are now playing an integral role in vaccinating children across the country, as well as educating vaccine-hesitant parents in an effort to increase immunization rates.

In addition, the US Department of Health & Human Services announced an amendment to the COVID-19 Public Readiness and Emergency Preparedness (PREP) Act to allow licensed pharmacists, pharmacy technicians, and pharmacy interns to order and administer select COVID-19 therapeutics for subcutaneous, intramuscular, or oral administration.4 As part of the PREP Act amendment, an approved training program for subcutaneous and intramuscular injections should

include hands-on injection technique, clinical evaluation of indications and contraindications of COVID-19 therapeutics, and possible treatment-related adverse reactions.⁴

Interchangeable Biosimilar Products

Two interchangeable biosimilar products received FDA approval in 2021: insulin glargine-yfgn (Semglee) and adalimumab-adbm (Cyltezo).5,6 Interchangeable biosimilars have separate, additional regulatory designations and must undergo additional clinical research to demonstrate that they produce the same clinical result as their reference product. Only then may interchangeable biosimilars be substituted for the reference product at the pharmacy, which can help increase patient access to these medications.

The reference-listed product for insulin glargine-yfgn is insulin glargine injection (Lantus), a long-acting insulin. Insulin glargine-yfgn is approved for the treatment of type 1 diabetes in children and adults and type 2 diabetes in adults.⁵ This interchangeable biosimilar approval will help make insulin more affordable for patients as insulin prices have skyrocketed.

Adalimumab-adbm is the first interchangeable biosimilar to adalimumab (Humira) for the treatment of multiple inflammatory diseases,⁶ including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and chronic plaque psoriasis.

New Naloxone Products

According to the CDC, more than 96,000 drug overdose deaths occurred between March 2020 and March 2021, indicating an increase during the COVID-19 pandemic.7 Pharmacists Play a critical role in ensuring patients have access naloxone for opioid overdose reversal. Two new naloxone products were approved this year. Naloxone HCl (Kloxxado) is a higher-dose naloxone nasal spray that delivers 8 mg of naloxone—twice as much as naloxone HCl (Narcan Nasal Spray)8—and naloxone hydrochloride (Zimhi), administered via a single-dose, prefilled syringe that delivers 5 mg of naloxone as an intramuscular or subcutaneous injection.⁹

These approvals both provide additional options for the treatment of opioid overdoses.

References

1. FDA approves first COVID-19 vaccine. News release. FDA. August 23, 2021. Accessed November 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 
2. FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. News release. FDA. October 29, 2021. Accessed November 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
3. Woodworth KR, Moulia D, Collins JP, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years—United States, November 2021. MMWR Morb Mortal Wkly Rep. Published online November 5, 2021. doi:10.15585/mmwr.mm7045e1 
4. Expanding access to COVID-19 therapeutics. US Department of Health & Human Services. Updated September 21, 2021. Accessed November 7, 2021. https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx 
5. FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. News release. FDA. July 28, 2021. Accessed November 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
6. FDA approves Cyltezo, the first interchangeable biosimilar to Humira. News release. FDA. October 18, 2021. Accessed November 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira
7. Vital statistics rapid release: provisional drug overdose death counts. CDC. Updated November 4, 2021. Accessed November 7, 2021. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
8. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. News release. FDA. April 30, 2021. Accessed November 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose
9. FDA approves naloxone injection to counteract opioid overdoses. FDA. Updated October 18, 2021. Accessed November 8, 2021. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-naloxone-injection-counteract-opioid-overdoses