Pharmacy Times Staff

Pharmacy Times spoke with Josh Benner, pharmacist and CEO/founder of RxAnte, about medication misuse and the future of pharmacy in 2021.

With 25 years in the industry previous to COVID-19, Benner used the example of his own technology and clinical services company to describe how he has seen 2 segments of the population during the pandemic and their handling of medication misuse.

Benner also discussed barriers to medication adherence, how the role of the pharmacist has changed, and the future of pharmacy in 2021. 

Videos

Medication Misuse and The Future of Pharmacy in 2021

A coronavirus disease 2019 (COVID-19) vaccine candidate developed by Moderna was deemed highly effective by the FDA in a 

, which could clear the way for a second COVID-19 vaccine to gain emergency use authorization (EUA) in the United States.

The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to review the safety and efficacy data package on December 17, which could lead to an EUA being issued soon thereafter. On December 11, the 

FDA approved an EUA application for BNT162b2

, jointly developed by Pfizer and BioNTech, which began administration to the first wave of recipients on Monday.

Moderna’s COVID-19 vaccine candidate, mRNA-1273, showed 94.5% efficacy in preventing COVID-19, according to preliminary results from the 

. In data submitted to an independent data and safety monitoring board (DSMB) overseeing the trial, the interim review showed that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults, according to a press release from the National Institutes of Health.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, chief executive officer of Moderna, in a November press release.

, conducted on 196 cases, confirmed the 94.1% efficacy observed in the first interim analysis. This efficacy was consistent across age, race and ethnicity, and gender demographics. The cases included 33 older adults and 42 participants who identified themselves as being from diverse communities (29 Hispanic or Latinx, 6 Black, 4 Asian Americans, and 3 multiracial participants).

The primary endpoint of the COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks after the second dose of the Moderna vaccine. In the primary analysis, 185 cases of COVID-19 were observed in the placebo group compared with 11 cases observed in the group who received the vaccine.

A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases. All 30 occurred in the placebo group and none in the vaccinated group. To date, there has been 1 COVID-19-related death in the study, which occurred in the placebo group.

The interim analysis included 95 cases of symptomatic COVID-19 among volunteers. The DSMB found that the vaccine was safe and well-tolerated with a statistically significant vaccine efficacy rate. Ninety of the cases occurred in the placebo group and 5 occurred in the vaccinated group. Among the 95 total cases, there were 11 cases of severe COVID-19, all of which occurred in the placebo group.

 on Tuesday suggest that Moderna’s vaccine candidate may also prevent the spread of COVID-19, with asymptomatic infection reduced by 63% following administration of the first dose; however, the FDA may require 2 doses of the vaccine for maximum protection.

Articles

The FDA is expected to review the safety and efficacy data package from Moderna's COVID-19 vaccine candidate on December 17, which could lead to an EUA being issued this week.

Moderna COVID-19 Vaccine Shows High Efficacy, Clearing Path for EUA

Officials with the FDA have approved Amphastar Pharmaceuticals’ Abbreviated New Drug Application for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial, the company announced today.

This generic drug product was determined by the FDA to be therapeutically equivalent to Adrenalin

 (Endo International and Par Pharmaceutical) and is indicated for emergency treatment of allergic reactions (Type 1), including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock, according to Amphastar. Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial is indicated for intramuscular, subcutaneous, and intravenous use.

Additionally, Amphastar was granted 180 day exclusivity as the first generic filer, the company reported in a press release. The company intends to launch this its generic drug product within 2-3 months. 

According to IQVIA, market annual sales in the United States for the 12 months ending December 31, 2019 for epinephrine injection, 30mg/30mL (1mg/mL) multiple sose vial was approximately $ 131 million.

Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial [news release]. Rancho Cucamonga, CA; April 27, 2020: Amphastar website. http://ir.amphastar.com/news-releases/news-release-details/amphastar-pharmaceuticals-inc-receives-fda-approval-epinephrine Accessed April 27, 2020.

This generic drug product was determined by the FDA to be therapeutically equivalent to Adrenalin.

New Epinephrine Injection Granted FDA Approval

Ashley M. Rogers, PharmD, BCPS, has been named the 2019 Distinguished Young Pharmacist of the Year in Massachusetts. Sponsored by Pharmacists Mutual Insurance Company, the award was conferred at the recent meeting of the Massachusetts Pharmacists Association (MPhA).

The Distinguished Young Pharmacist of the Year award is presented annually to a pharmacist in each state for individual excellence and outstanding contributions in state pharmacy association activities, community affairs and in professional practice.

 According to MPhA, its recipient must be registered in Massachusetts, be a member of the organization in good standing, and have an entry degree in pharmacy received within the last 9 years. The ideal candidate also participates in a national pharmacy association, professional program, state association activities, and/or community service.

Rogers has been employed by Greater Lawrence Family Health Center for 5 years. The Boston-based pharmacist graduated from Massachusetts College of Pharmacy and Health Sciences University in 2010 with a Doctor of Pharmacy degree.

Massachusetts Distinguished Young Pharmacists [news release]. Algona, Iowa; December 23, 2019: Pharmacists Mutual. [email]. Accessed December 24, 2019.

Massachusetts Pharmacists Association. Distinguished Young Pharmacist. MPhA website. 

https://www.masspharmacists.org/assets/docs/dyp.pdf

Ashley M. Rogers, PharmD, BCPS, has been named the 2019 Distinguished Young Pharmacist of the Year in Massachusetts.