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. 

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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.

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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.

Distinguished Young Pharmacist of the Year is Recognized

Research presented Wednesday at the ASHP (American Society of Health-System Pharmacists) 54th Midyear Clinical Meeting & Exhibition in Las Vegas showed that patients who received focused attention from pharmacists during hospital stays expressed higher satisfaction.

Pharmacists Transitions-of-Care Service Improves HCAHPS Scores and Decreases 30-day Hospital Readmission Rates

— focused on the effect of pharmacists putting emphasis on educating patients about medications as they transitioned out of hospital care. Pharmacists reconciled patients’ medication before discharge, talked with patients about the medication they were taking, and contacted them by phone after discharge to discuss their care, during the study.

In the study, 414 of 1728 patients included received the full transition-of-care education protocol, including a follow-up pharmacist phone call. This group showed a substantial increase of 14.7% in the overall average mean score, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Hospital 30-day readmission rates dropped 5% when a post-discharge phone call was made to patients as a part of this study, as per a post-hoc analysis.

The research study team consisted of Katherine L. March, Pharm.D., BCPS, Clinical Pharmacy Specialist — Methodist University Hospital and Assistant Professor – University of Tennessee College of Pharmacy; Michael Peters, PharmD, BCPS; Christopher Finch, PharmD, FCCM, FCCP; Lauchland Roberts, PharmD; and Jennifer Twilla, PharmD, BCPS, FCCP.

Study finds enhanced role of pharmacists contributes to increase in patient satisfaction [news release]. Las Vegas, NV; December 11, 2019: ASHP website. 

https://midyear.ashp.org/About/For-Media/Study-Finds-Enhanced-Role-of-Pharmacists-Contributes-to-Increase-in-Patient-Satisfaction.

Research presented at the ASHP (American Society of Health-System Pharmacists) 54th Midyear Clinical Meeting & Exhibition in Las Vegas showed that patients who received focused attention from pharmacists during hospital stays expressed higher satisfaction.

Study: Enhanced Role of Pharmacists Contributes to Increase in Patient Satisfaction

The American Society of Health-System Pharmacists (ASHP) awarded its 2019 CEO Award for Staff Excellence during the opening session at the ASHP 54th Midyear Clinical Meeting & Exhibition in Las Vegas, honoring David F. Chen, senior director of the Section of Pharmacy Practice Leaders, and Verna L. Reed, director of Customer Relations and Materials Management. The two award recipients were recognized for their exemplary work within the organization.

Each year, the ASHP 2019 CEO Award for Staff Excellence acknowledges staff members who have performed their job duties with distinction. In addition, recipients must have demonstrated exceptional initiative in contributing to ASHP, and in upholding its staff values: serving members and embodying a spirit of teamwork, respect, and excellence.

Chen joined ASHP in 2004 and has consistently demonstrated his personal and professional investment in the future of ASHP as well as the future of pharmacy, according to the organization. Chen has frequently taken leadership roles in critical strategic initiatives within ASHP, thereby demonstrating a strength in identifying current and emerging issues as well as drawing on his experience to accomplish tasks.

His accomplishments include being a key figure in the successful implementation of ASHP’s newest section, the Section of Specialty Pharmacy Practitioners that launched in 2018. According to the press release, his leadership has helped the Section to grow to exceed 4000 primary members in its first year. 

 serves as the director for the Customer Relations team, consistently going above and beyond to ensure that ASHP is providing experiences that meet and exceed member expectations. Additionally, she has been instrumental in making numerous improvements to the registration process for ASHP’s meetings and conferences, including designing new badges that streamline the registration process and improve the on-site member experience at the organization’s largest events.

Reed has also enhanced customer relations by improving payment card industry compliance and credit card processing, and leading the Customer Relations department’s transition to Interactive Voice Response, in order to further secure private payment information, and to improve the payment process for all transactions received by ASHP.

Most recently, Reed launched a Customer Experience Improvement Project. It connects customer relations analysts with other ASHP departments to apply new information from customer communications, trends, and data analysis to improve the customer experience.

ASHP Staff Members Honored for Excellence [press release]. Las Vegas, NV; December 9, 2019: ASHP website. 

https://www.ashp.org/news/2019/12/09/ashp-staff-members-honored-for-excellence

The award is in recognition of members David F. Chen, senior director of the Section of Pharmacy Practice Leaders, and Verna L. Reed, director of Customer Relations and Materials Management for their exemplary work within the organization.