Associate Clinical Professor, University of Connecticut School of Pharmacy, Storrs, CT.

On February 26, 2021, melphalan flufenamide (Pepaxto; Oncopeptides AB) in combination with dexamethasone was granted accelerated approval by the FDA for adult patients with relapsed or refractory multiple myeloma.

 Relapsed or refractory multiple myeloma is defined in patients who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody. Melphalan flufenamide, a peptide-drug conjugate, targets aminopeptidases and selectively releases alkylating agents into tumor cells.

 Melphalan flufenamide is taken up by myeloma cells because of its lipophilicity. It is rapidly hydrolyzed by peptidases, and cross-linking of DNA is involved in the antitumor activity. Melphalan flufenamide shows synergistic cytotoxicity with dexamethasone in both melphalan-resistant and nonresistant multiple myeloma cell lines.

Accelerated approval of melphalan flufenamide was based on results of the multicenter, single-arm, phase 2 HORIZON trial (NCT02963493).

 To be eligible for the trial, patients were required to have relapsed or refractory multiple myeloma. They had to have received 2 or more prior lines of therapy and been refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 pomalidomide and/or a CD38-directed antibody. The primary end point was overall response rate (ORR) and the secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety, clinical benefit rate, best response, time to response, time to progression, and time to next treatment.

 The ORR was 29% in the all-treated population (95% CI, 22%-37%), with 26% in the triple-class-refractory population (95% CI, 18%-35%). In the all-treated population, median DOR was 5.5 months (95% CI, 3.9-7.6 months), median PFS was 4.2 months (95% CI, 3.4-4.9 months), and median OS was 11.6 months (95% CI, 9.3-15.4 months) at a median follow-up of 14 months.

The most common adverse effects were fatigue (55%), nausea (32%), diarrhea (27%), pyrexia (24%), and respiratory tract infection (24%). The most common grade 3 or 4 laboratory abnormalities were decreases in leukocytes (88%), platelets (80%), lymphocytes (95%), neutrophils (82%), and hemoglobin (50%).

 Melphalan flufenamide carries warnings for thrombocytopenia, neutropenia, anemia, infections, secondary malignancies, and embryo-fetal toxicity. Additionally, this medication should not be interchanged with regular melphalan hydrochloride, such as when prescribed in high doses for conditioning regimens for hematopoietic stem cell transplantation, as higher-than-recommended doses of melphalan flufenamide may be associated with mortality.

Complete blood counts with differential should occur at baseline, during treatment, and as clinically indicated to monitor for thrombocytopenia, neutropenia, and anemia. Melphalan flufenamide should be withheld if the patient’s platelet count is less than 50 × 109/L or neutrophil count is less than 1 × 109/L. Pharmacists should advise patients to take this medication as prescribed, and patients should be monitored for signs and symptoms of infection while taking this medication. Patients should also be monitored long term for development of secondary malignancies. If applicable, patients should use contraception while on melphalan flufenamide because of the potential embryo-fetal toxicity. For females, contraception should be continued for 6 months after the last dose, and for males, 3 months after the last dose. Although it is unknown if melphalan flufenamide passes into breast milk, patients should be advised to not breastfeed during treatment and for 1 week after the last dose of melphalan flufenamide.

The recommended dosage of melphalan flufenamide is 40 mg intravenously over 30 minutes on day 1 of each 28-day treatment cycle in combination with dexamethasone. A serotonin (5-HT3) receptor antagonist, such as ondansetron, or other antiemetics may be taken to prevent nausea and vomiting.

 If needed because of adverse effects, the first dose reduction would be to 30 mg of melphalan flufenamide and the second dose reduction would be to 20 mg. If the patient cannot tolerate 20 mg, melphalan flufenamide should be permanently discontinued.

Kendall Szulimowski is a 2021 PharmD candidate at the University of Connecticut School of Pharmacy in Storrs.

Samantha Troy is a 2021 PharmD candidate at the University of Connecticut School of Pharmacy in Storrs.

Lisa M. Holle, PharmD, BCOP, FHOPA, FISOPP, is an associate clinical professor at the University of Connecticut School of Pharmacy in Storrs.

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma. FDA. Updated March 1, 2021. Accessed March 18, 2021. 

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple-myeloma

Richardson PG, Oriol A, Larocca A, et al. Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma. 

 2021;39(7):757-767. doi:10.1200/JCO.20.0225

Pepaxto. Prescribing information. Accessed March 18, 2021. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214383s000lbl.pdf

Melphalan flufenamide: drug information. Accessed March 18, 2021. http://

www.uptodate.com/contents/melphalan-flufenamide-drug-information

Articles

Melphalan flufenamide (Pepaxto; Oncopeptides AB) in combination with dexamethasone was granted accelerated approval on February 26, 2021, by the FDA for adult patients with relapsed or refractory multiple myeloma. 

Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma

The FDA has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents 12 through 15 years of age, making it the first COVID-19 vaccine available for use in this age group.

The expanded emergency use authorization (EUA) is based on data from a phase 3 clinical trial, which demonstrated 100% vaccine efficacy in adolescent participants. The vaccine was also well tolerated in the study.

The trial enrolled 2260 adolescents 12 to 15 years of age in the United States. Eighteen cases of COVID-19 were observed in the placebo group versus none in the vaccinated group. Vaccination also demonstrated strong immunogenicity in a subset of adolescents 1 month after the second dose, eliciting antibody geometric mean titers (GMTs) of 1,239.5. According to the data, this was shown to be noninferior to GMTs elicited by participants aged 16 to 25 years old in a previous analysis. Participants of the trial will continue to be monitored for long-term protection and safety for an additional 2 years after the second dose.

Pfizer and BioNTech are also conducting a pediatric study evaluating the safety and efficacy of the vaccine in children aged 6 months to 11.

“Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible,” said Ugur Sahin, MD, CEO and cofounder of BioNTech.

 “Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September.”

The CDC’s Advisory Committee on Immunization Practices will now meet to discuss recommendations for use of the vaccine in adolescents based on the amended EUA.

1. Pfizer and BioNTech Receive First US Authorization for Emergency Use of COVID-19 Vaccine in Adolescents. News Release. Pfizer; May 10, 2021. Accessed May 11, 2021. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-authorization

2. Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. News Release. Pfizer; March 31, 2021. Accessed May 11, 2021. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal

The FDA has expanded the emergency use authorization for the COVID-19 vaccine to include individuals 12 to 15 years of age. 

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Adolescents

’s network of independent community pharmacies, launched a 

, a web-based platform designed to conveniently connect individuals with their local community pharmacy to receive COVID-19 vaccines. The tool becomes available as 

 surpasses 1 million doses allocated through its Federal Retail Pharmacy Program partnership to independent pharmacies nationwide.

With all adults and a portion of adolescents now eligible to receive a COVID-19 vaccine, independent pharmacies are in a unique position to take pressure off of health systems and physicians by administering to their region. The 

 is aimed at promoting equitable vaccine access for all patients, particularly those in under-resourced communities, as the national inoculation movement continues across the country. Upon accessing the tool via the 

, users can enter their zip code and receive details on the community pharmacies in their area that are offering appointments for COVID-19 vaccines.

“We’re seeing massive progress in the distribution and administration of COVID-19 vaccines – and we are so proud to have reached 1,000,000 vaccines allocated to independent pharmacies through our program! However, we know there are still gaps in access for many under-resourced communities throughout the country,” said Brian Nightengale, President of 

 “Independent community pharmacies are a convenient and trusted healthcare destination, and they’ve continued to go above and beyond for patients during the pandemic. We hope this tool enables patients to connect with our fearless pharmacies so we can get more shots in arms as quickly as possible.”

 quickly activated its support for the national vaccination effort as part of the Federal Retail Pharmacy Program and grew that support exponentially in the subsequent weeks. During week one, over 10,000 doses were allocated to 102 pharmacies across four states. Now, AmerisourceBergen and Good Neighbor Pharmacy are serving more than 1,000 pharmacies in 46 states, Puerto Rico and Guam.

“We are incredibly proud of the tremendous growth in our program over the last couple of months as part of the Federal Retail Pharmacy Program,” said Jenni Zilka, Senior Vice President of 

 Field Programs and Services. “We have now activated more than 1,000 independent pharmacies across the U.S. and continue to see the tangible impact that independent community pharmacies are having on this national vaccination movement. The stories from the field are absolutely incredible.”

Notable stories from Good Neighbor Pharmacies in the field include:

Clinical pharmacist and owner of Springfield Pharmacy, Dr. Chichi Ilonzo Momah not only vaccinated pharmacy customers, but has visited homebound patients, hosted clinics in low-income areas throughout her county, addressed vaccine hesitancy at local churches and held mass vaccine clinics at local high schools almost every other day. Chichi has provided more than 10,000 vaccines to patients in her county.

Abby and Chase Rice, owners of Good Neighbor Pharmacies Moffet Drug and Ward Drug in rural Kansas, shared COVID-19 vaccines with a local non-profit to help vaccinate homeless and uninsured communities in the Kansas City metro area. Through this effort, the Rice’s joined pop-up clinics at local churches in underserved areas of Kansas City and drove a mobile clinic around the metro area to reach homeless individuals with vaccines.

Jasmine Chan, pharmacist at CAPrx in Pacific Grove, CA, focused on the pharmacy waitlist and reaching people in the surrounding communities with barriers in scheduling appointments. The pharmacy partnered with local organizations to operate mobile vaccine clinics to vaccinate 1,300 patients. By the end of April 2021, CAPrx administered vaccines at domestic violence shelters, local public schools, homeless encampments, and the homes of homebound seniors.

Apothecary Shoppe in Salt Lake City, UT has spent the last 30 years building a robust clinical services program to support community members with HIV. Owner Kevin DeMass knew that the COVID-19 vaccines were important for his 3,700 immunocompromised patients. Apothecary Shoppe partnered with the local organizations to provide education and communication that the COVID-19 vaccine was available at his store and the Apothecary Shoppe is now routinely hosting clinics to support vulnerable patients living with HIV and AIDS.

 To read more about how independent pharmacies across the nation are stepping up in their communities, check out Good Neighbor Pharmacy’s Fearless Pharmacy page: 

https://www.wearegnp.com/fearless-pharmacy

Good Neighbor Pharmacy, AmerisourceBergen’s network of independent community pharmacies, launched a COVID-19 Vaccines Pharmacy Locator Tool on MyGNP.com.

Good Neighbor Pharmacy Launches COVID-19 Vaccines Locator Tool 

 administered and 578,000 COVID-19–associated deaths in the US as of this article’s press time, keeping up with pandemic news is more important than ever.

In vaccine-related news, the FDA is expected to soon authorize Pfizer-BioNTech’s COVID-19 vaccine for children aged 12 to 15 years. The vaccine is currently authorized only for individuals 16 years of age and older. The decision could come as early as this week.

 to stay informed on the latest coronavirus-related news and research.

 is now available on DrugTopics.com. In this issue, 

 covers the latest in diabetes, vaccines, health systems, and more, and our cover story highlights the emerging roles in mental health care for pharmacists.

Variations in prescription drug prices can be due to a variety of reasons. In an upcoming article on 

®, Zakieh Abuelkhair, RPh, MPBA Candidate, breaks down what influences drug prices and the differences between the United States and United Arab Emirates.

Check back this week to read the article on drugtopics.com.

Total Pharmacy®: Pharmacy owner discusses community initiatives

In an upcoming interview, Dan Singh, owner of Dan’s Wellness Pharmacy in Stafford, Virginia, discusses how his store is giving back to the community amid the COVID-19 pandemic.

In Case You Missed It: FDA OKs Dapagliflozin for Chronic Kidney Disease

Last week, the FDA approved dapagliflozin (Farxiga; AstraZeneca) for use in patients with chronic kidney disease (CKD) at risk of progression.

Read more about the expanded approval here.

Here’s a preview of the featured content to watch for this week on Drug Topics®.

This Week on Drug Topics: May 10 to May 14

Director, International Drug Information Center

Back in December 2020, the FDA issued an emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine, followed by authorization for the Moderna and Janssen (Johnson & Johnson) vaccines. Many Americans have yet to be vac- cinated, with the most common reasons for refusing being fear of potential adverse effects (AEs) and concerns about the rapid vaccine development process.

Pharmacists must be familiar with the safety profiles of the vaccines to assure the public of their safety.

COVID-19 Vaccines Available in the United States

Three vaccines are currently available on the US market. The Pfizer and Moderna vaccines are both messenger RNA (mRNA) vaccines, whereas the Janssen is a viral-vector vaccine.

 All 3 result in the production of SARS-CoV-2 spike proteins, which trigger the development of antibodies. The development of immunity and memory cells typically takes a few weeks and, when complete, these protect the body against COVID-19 infections.

 Although the vaccines stimulate an immune response, they do not cause a full COVID-19 infection.

Before a vaccine receives FDA approval, it undergoes a series of trials during which its efficacy and safety profiles are established. Trials begin in animal models and continue with 3 phases of clinical trials. A vaccine gains FDA approval only if the efficacy and safety data prove that its benefits outweigh the risks. Once a vaccine has been approved and launched, postmarketing surveillance begins. Such surveillance allows for the collection of safety data in a larger and more diverse population.

Postmarketing safety information for COVID-19 vaccines has been gathered in several ways. For all vaccines, the FDA’s Center for Biologics Evaluation and Research monitors vaccine safety through passive and active surveillance.

 Passive surveillance consists of adverse event reports received from the public and health care professionals, which are entered into the Vaccine Adverse Event Reporting System. Active surveillance involves proactively obtaining and analyzing information from large health care data systems to verify safety signals identified through passive surveillance or to detect additional safety signals. If a possible link between a vaccine and an AE is identified, public health officials assess the benefits and risks and determine whether the vaccine can continue to be administered and whether administration guidelines require adjustment.

Reported Adverse Effects Associated With COVID-19 Vaccines

The AEs reported with the COVID-19 vaccines are generally mild and resolve within a few days.

 These effects tend to be more intense after the second dose of the mRNA vaccines and are more likely to occur in younger individuals. Ongoing surveillance has identified additional AEs, but it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure (see 

 This point can be illustrated by the reporting in mid-April 2021 of a few cases of thrombocytopenia with cerebral venous sinus thrombosis in individuals who had received the Janssen COVID-19 vaccine. Although these cases appear to be very rare, as of the time of this writing, the FDA and CDC have recommended a pause in the use of this vaccine until this matter is thoroughly investigated.

The more commonly reported AEs associated with the use of COVID-19 vaccines are usually related to the vaccine’s pharmacology and not considered immune-mediated or allergic reactions.

 Despite that, news reports concerning severe postmarketing reactions including anaphylaxis instilled fear among the public.

Anaphylaxis is a severe acute-onset immunologic reaction, generally immunoglobulin E (IgE) mediated, which typically occurs in response to preformed IgE antibodies.

 Acute-onset immunologically mediated reactions commonly manifest as urticaria, swelling, gastrointestinal upset, respiratory distress, or cardiovascular collapse associated with severe cases of anaphylaxis. The onset of acute allergic reactions generally occurs within 30 minutes of exposure, although a reaction may also develop hours to days later, in which case it usually presents as a cutaneous reaction. Generally, the mRNA, DNA, or other antigen components in vaccines are not the culprits for allergic reactions. Allergic reactions are usually attributed to other product components such as stabilizing agents and adjuvants, and, rarely, to latex in the vial’s rubber stopper. The Pfizer and Moderna COVID-19 vaccines contain mRNA, lipids, polyethylene glycol (PEG) 2000, electrolytes, sucrose, and a saline diluent. Although the etiology of anaphylaxis to the COVID-19 vaccines is not known, PEG and related polysorbates have been associated with cases of anaphylaxis to other agents. Individuals who exhibit signs of allergic reaction after COVID-19 vaccination are advised to avoid new PEG exposure and to undergo further evaluation with a board-certified allergist or immunologist.

Although cases of anaphylaxis were not reported in clinical trials with the mRNA vaccines, 21 incidents of possible anaphylaxis were subsequently reported with the Pfizer vaccine (11.1 cases per million doses), with 70% occurring within 15 minutes of administration.

 Ten cases of possible anaphylaxis were reported after vaccination with the Moderna vaccine (2.5 cases per million doses) and 1 case of anaphylaxis was reported with the Janssen vaccine.

 The less extensive use of the Janssen vaccine to date prohibits a comparative assessment of the overall safety of this vaccine relative to the mRNA vaccines.

The CDC recommends that the COVID-19 vaccines not be administered to individuals who have a history of severe or immediate allergic reaction to any vaccine component (eg, PEG in the case of the mRNA vaccines, polysorbate in the case of the Janssen vaccine).

 Patients who experienced a severe or immediate allergic reaction to a COVID-19 vaccine should not receive subsequent doses.

The CDC recommends a postvaccination observation period of 30 minutes for those at high risk for anaphylactic reactions and 15 minutes for all other individuals.

When providing counseling, it is important to emphasize the vaccine’s efficacy. Individuals receiving the mRNA vaccines also should be counseled on the importance of completing the vaccination series with the same product. They should be counseled on the expected postvaccination symptoms: Of those receiving the mRNA vaccines, local symptoms are experienced by 80% to 89%, and systemic symptoms by 55% to 83%; of those receiving the viral-vector vaccine, local symptoms are experienced by 50%, and systemic symptoms by 55%. Reassure recipients that systemic postvaccination symptoms are generally mild to moderate in severity, occur within the first 3 days of vaccination, and resolve within 3 days of onset. Advise recipients that antipyretic or analgesic medications can be taken for postvaccination local or systemic symptoms.

The available COVID-19 vaccines are effective in reducing the spread of the disease. Serious reactions are rare, and the public should be educated on the overall safety of these vaccines.

1. WHO coronavirus (COVID-19) dashboard. World Health Organization. Updated April 6, 2021. Accessed April 6, 2021. 

2. Nguyen KH, Srivastav A, Razzaghi H. COVID-19 vaccination intent, perceptions, and reasons for not vaccinating among groups prioritized for early vaccination–United States, September and December 2020. 

. 2021;70(6):217-222. doi:10.15585/mmwr.mm7006e3

3. Understanding how COVID-19 vaccines work. CDC. Updated March 9, 2021. Accessed April 1, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html

4. COVID-19 vaccine safety surveillance. Food & Drug Administration. Updated February 9, 2021. Accessed April 1, 2021. 

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance

5. Ensuring the safety of vaccines in the United States. CDC. Updated January 2018. Accessed April 1, 2021

https://www.cdc.gov/vaccines/hcp/conversations/downloads/vacsafe-ensuring-color-office.pdf

6. Possible side effects after getting a COVID-19 vaccine. CDC. Updated March 16, 2021. Accessed April 2, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

7. Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension. DailyMed. Updated February 26, 2021. Accessed April 1, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=908ecbe7-2f1b-42dd-94bf-f917ec3c5af8

8. Moderna COVID-19 Vaccine- cx-024414 injection, suspension. DailyMed. Updated March 29, 2021. Accessed April 1, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0651c7a-2fe2-459d-a766-0d59e919f058

9. Janssen COVID-19 Vaccine- ad26.cov2.s injection, suspension. DailyMed. Updated April 2, 2021. Accessed April 6, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14a822ff-f353-49f9-a7f2-21424b201e3b

10. Recommendation to pause use of Johnson & Johnson’s Janssen COVID-19 vaccine. Centers for Disease Control and Prevention website. Accessed April 15, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html

11. Kuder MM, Lang DM, Patadia DD. Anaphylaxis to vaccinations: a review of the literature and evaluation of the COVID-19 mRNA vaccinations. 

. Published online March 1, 2021. doi:10.3949/ccjm.88a.ccc075

12. Rolla G, Brussino L, Badiu I. Maintaining safety with SARS-CoV-2 vaccines. 

. 2021;384(10):e37. doi:10.1056/NEJMc2100766

13. Information about COVID-19 vaccines for people with allergies. CDC. Updated March 25, 2021. Accessed April 5, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html

14. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. CDC. Last reviewed March 5, 2021. Accessed April 5, 2021. 

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

Ease patients’ concerns by being well versed in the safety profiles of each vaccine.

COVID-19 Vaccines: A Focus on Safety

The CDC is easing up on indoor mask-wearing and social distancing guidance for individuals who are fully vaccinated against COVID-19.

CDC Director Rochelle Walensky, MD, MPH, announced the new recommendations during a White House briefing on Thursday. The new guidance still calls for wearing masks in certain crowded indoor settings, such as planes, buses, hospitals, prisons, and homeless shelters. The ease in restrictions will likely help pave the way for more reopenings – for workplaces, schools, and many other venues.

“Anyone who is fully vaccinated can participate in indoor or outdoor activities–large or small–without wearing a mask or physically distancing,” Walensky said in the briefing. “If you are fully vaccinated, you can start doing the things that you had stopped doing because of the pandemic.”

The agency also no longer recommends that fully vaccinated individuals wear masks in outdoor crowds.

Individuals are considered fully vaccinated once they are 2 weeks past their last required COVID-19 vaccine dose. According to the CDC, there are currently more than 117 million Americans who are fully vaccinated and nearly 154 million who have received at least 1 dose.

Miller Z, Balsamo M. Govt eases up guidance on indoor mask-wearing. 

https://apnews.com/article/coronavirus-masks-cdc-guidelines-9d10c8b5f80a4ac720fa1df2a4fb93e5

COVID Data Tracker. CDC. Updated May 12, 2021. Accessed May 13, 2021. 

https://covid.cdc.gov/covid-data-tracker/#vaccinations

Poll

The CDC today announced an updated guidance on mask wearing and social distancing for individuals fully vaccinated against COVID-19.

CDC Eases Indoor Mask-Wearing Guidance for Fully Vaccinated Individuals

The Pharmacy Quality Alliance (PQA) and the Community Pharmacy Foundation (CPF) announced today the recipients of the 2021 Community Pharmacy Innovation in Quality (CPIQ) Awards. The awards honor an individual and a community pharmacy, whose innovative practices have improved care quality, medication optimization and patient outcomes.

The 2021 CPIQ Award recipient in the individual category is Sharrel Pinto, BSPharm, PhD, FAPhA, department head and the Hoch Endowed Professor for Community Pharmacy Practice at South Dakota State University and Director of the Community Practice Innovation Center. Pinto’s innovative programs involve pharmacies, employer coalitions, health systems, unions and counties in Ohio and other states and have generated returns on investment of $12-18 for every $1 invested in pharmacy services, while improving health outcomes and quality of life.

Pinto’s team collaborates with Integrated Delivery Networks, independent and chain pharmacies, Tribal partners, a state-wide EHR network and others to launch innovative programs and services geared towards diverse populations in South Dakota. Pinto also established the Community Practice Innovation Center, which brings together faculty, students, researchers and practitioners to lead change within community practice through innovative community engagement and partnerships, research, education and training.

The 2021 CPIQ Award recipient in the community pharmacy category is Bell Pharmacy in Camden, N.J. Bell Pharmacy has implemented a practice model making it a leader in New Jersey Governor Phil Murphy’s initiative focused on ending the state’s HIV epidemic by 2025. Through a partnership with the Camden Area Health Education Center, Bell Pharmacy has created a novel, collaborative “Pharmacy Based PrEP Clinic.” The practice provides testing, counseling and treatment for HIV, sexually transmitted infections and hepatitis C, among other conditions, in a single setting. This model removes barriers to access and streamlines delivery of care to those most at risk.

“Congratulations to Dr. Pinto and Bell Pharmacy for their innovative work using pharmacy services to improve health care delivery and the lives of patients,” PQA CEO Micah Cost said. “Dr. Pinto’s collaborative approaches are a model for all health care providers. Bell Pharmacy has shown how pharmacy services can significantly improve care and outcomes for vulnerable populations. Both are exemplary examples of the future of pharmacy.”

Award nominations and their contributions to community pharmacy were evaluated for their innovation, measurable impact, replicability, scalability and reach. Priority areas of focus were practices or programs that addressed vulnerable populations, gaps in quality or patient care and the quadruple aim of healthcare: patient experience, population health, reducing costs and care team well-being.

“These awards celebrate innovation and progressive community pharmacy practice, “said Brian Jensen, a CPF Board member and former PQA Board member. “Bell Pharmacy and Dr. Pinto have developed, implemented and maintained patient-centered approaches to pharmacy services that we hope will spread across our health system and in value-based models that reward innovations that deliver good outcomes.”

The awards honor an individual and community pharmacy for innovative, pioneering practices. 


PQA & CPF Announce 2021 Community Pharmacy Innovation in Quality Awards

One day, my wife Denise and I went to our local bank with a plastic card and put it in the machine. We had the option of withdrawing either $25 or $50 out of our checking account. The money dropped down in an envelope with the cash inside. This was amazing technology for 1981. I then went to work and pulled out the Smith Corona typewriter and started typing prescription labels.

Yesterday, I went to our warehouse club and pulled up to the gas pumps. I took out my phone and waved it at the QR code on the screen. I began pumping my gas without ever getting my wallet out of my pocket. I checked my email and saw I had spent $28.54 on pump #4 at 7:46 am. I went to the pharmacy, fired up the computer, and began my working day.

A new patient needed a shingles vaccine. She handed me her 2 prescription cards. We had to enter all the insurance data by hand, making sure we typed in the right bank identification, processor control, ID, and group numbers. After we submitted the claim, it was denied and we needed to use the Medicare Part D card. Next, we entered the alphanumeric information carefully to make sure all the letters and digits were correct. I got out my cheat sheet to make sure I added 4 additional fields, including administration fee, because this was for a vaccine. Then we went to another website to print out her prescreening form, and logged in the site of administration, lot number, and expiration date of the vaccine.

Two outstanding pharmacists who are working to make massive changes in our profession are Stephanie McGrath, PharmD, and my daughter Gretchen Garofoli, PharmD, BCACP. Both are working tirelessly to have pharmacists get paid for their clinical expertise through CPESN-USA. Their focus is on e-care plans, which enable pharmacists to show what interventions they have made that will produce optimal outcomes for our patients.

The biggest challenge with e-care plans is that the technology is clunky at best. Like anything else in health care, it takes more time to document your actions than to carry them out. I’m familiar with 3 of the major e-care plans and I’m not impressed with any of them. The one I use to bill for services to a provider requires 5 different systematized nomenclature of medicine clinical terms (SNOMED CT) codes to be documented. Whether you are documenting hypertension, chronic obstructive pulmonary disease, or asthma, you should not have to search through layers and layers for the appropriate 5 SNOMED codes.

The very best pharmacy software I was ever exposed to was in the late 1990s. It was built by a couple of pharmacists. To this day, I have yet to see a pharmacy filing system that was more pharmacist friendly than that one. I would love to see more pharmacists on the ground floor of software development. If only our pharmacy software could be as intuitive as the iPhones we all carry with us. When’s the last time you read the user manual for your smartphone?

When I stand in front of my pharmacy computer for 10 hours at a time, I often wonder why this technology seems so far behind the other technology I use daily. If we want to move this profession toward more patient-centric care, we must have the tools to do that. All I ask is that my pharmacy computer have the same technology as my gas pump.

Innovation is everywhere, but cumbersome pharmacy technology remains an issue.  

Technology Advances Are Needed to Advance the Profession 

Shared decision-making (SDM) and patient decision aids (PtDAs) can lower health care costs, lower utilization, and increase prevention-related care; however, these outcomes are not always guaranteed, according to the results of a recent study presented during the 2021 Pharmacy Quality Alliance Annual Meeting.

In the session, which was presented virtually on May 11, Theresa Schmidt, vice president, Discern Health, and Kimberly Westrich, vice president, Health Services Research, National Pharmaceutical Council, discussed the findings from a systematic review assessing the effects of SDM and PtDAs in a broad range of settings.

Prior experience shows that SDM can improve both quality and experience, according to Westrich. This is because SDM has a number of patient-centered benefits, such as increasing patient satisfaction and reducing decisional conflict. Many stakeholders also assume that SDM will reduce health care costs, especially as some interventions may help patients elect more appropriate care and promote treatment adherence.

The systematic review aimed to provide a comprehensive understanding of the existing body of evidence around SDM outcomes.

Schmidt explained how the research team defined both SDM and PtDA in literature selection. SDM is defined as the process by which clinicians work with patients to explore care choices, benefits and risks, goals and preferences, and jointly make informed care decisions. PtDAs are defined as evidence-based tools designed to educate patients; this can include paper handouts, videos, or web-based platforms. Although PtDAs can be used in conjunction with SDM, “on their own they don’t count as SDM,” Schmidt said.

Overall, SDM must include collaboration between the patient and provider to make decisions, she added.

For the review, the investigators searched PubMed for articles relating to SDM and PtDAs that reported on cost and utilization outcomes. They focused on articles published between 2010 and 2019.

Outcomes were classified into 3 main categories:

Cost: Includes component costs and total cost of care

Utilization: Resource-intensive services such as cardiac screening or discharge to high-cost settings

Prevention-related care: Outcomes involving a process that could prevent future adverse outcomes or utilization, such as end-of-life planning/hospice, cancer screening, or mental health-related utilization

According to Schmidt, the majority of the articles showed a favorable decrease in cost and utilization, and increase in prevention-related care. However, there were mixed findings, indicating that SDM and PtDAs do not always lead to these outcomes.

“While the majority of the articles did present favorable outcomes, a greater majority assessed at least 1 relevant outcome where no significant difference was observed,” Schmidt explained. This is likely because articles often included multiple outcomes.

One of the favorable outcomes that appeared to be impacted was medication adherence. Nine of the 12 studies that measured adherence showed outcomes with favorable increases, according to Schmidt. Eight studies showed no significant difference.

“Adoption of [SDM] can lead to a greater potential patient-provider bond,” Schmidt said. She added that informed patients who are engaged in choosing their own treatment are more likely to have a better understanding of what to expect and less surprised by adverse effects, and therefore more likely to adhere to their medications.

In the context of value-based care, Westrich explained that the mixed results suggest that these interventions may be critical for patient-centered care, but will not always lead to reduced care. However, this does not mean that they do not add value, she said. SDM can increase patient satisfaction and knowledge, reduce decisional conflict, and improve overall experience and outcomes.

“Our results reinforce the value of these interventions for improving medication adherence,” Westrich said.

Although SDM may not be a panacea for reducing health care costs, implementing these interventions can provide value in other areas and still have the potential to reduce costs and utilization.

Schmidt T, Westrich K. The impact of shared decision-making on cost and utilization and implications for value-based care. 2021 Pharmacy Quality Alliance Annual Meeting; May 11-17, 2021; virtual. Accessed May 12, 2021.

A session held during the 2021 PQA Annual Meeting explored implications for shared decision-making interventions in value-based care. 

Does Shared Decision-Making Reduce Health Care Costs and Utilization?

Medications used to treat stroke are complex and their preparations are complicated. Pharmacists’ knowledge and familiarity with these brain-saving medications is crucial in the typically narrow time windows to effectively treat stroke patients, according to Deborah Sadowski, RPh, BSPharm, MHA, director of pharmacy services at Deborah Heart and Lung Center in Browns Mills, New Jersey.

“The pharmacist is uniquely positioned to assess the safety and appropriateness of these medications for each patient as well as dose and prepare them in a safe and expedient manner,” Sadowski said.

As a result, including pharmacists in stroke care teams can greatly improve patient outcomes. They can be incorporated into a stroke patient care team in a variety of practice settings, including inpatient units, outpatient clinics, and community pharmacies, in addition to emergency departments.

At Mount Sinai Hospital in New York, New York, clinical pharmacist Nicole Davis, PharmD, BCCCP, an assistant professor in the Department of Pharmacy Practice at Touro College of Pharmacy, also in New York, said the pharmacy team is alerted when a stroke patient arrives in the emergency department. When this occurs, a pharmacist will bring a thrombolytic directly to the bedside to assess eligibility as well as to compound the medication. The patient is then transferred to the neurology intensive care unit (ICU) or to a step-down unit or floor bed depending upon their condition, where they are followed by an ICU-trained pharmacist or inpatient pharmacist.

Kristina Stein, PharmD, a neurology clinical pharmacist at the University of Alabama at Birmingham Hospital, is part of a multidisciplinary team that responds to “code strokes.” She receives an alert when a patient has a neurologic change or event that could be concerning for a stroke. “Pharmacists can identify candidates for thrombolytic therapy and reduce time to thrombolytic therapy,” she said. Furthermore, they can facilitate adjunctive therapy, such as blood pressure control or reversing anticoagulation therapy in the case of hemorrhagic strokes.

Pharmacists can also participate in medication reconciliation, secondary stroke prevention, risk reduction, patient counseling and education, and transitions of care initiatives. Stein attends transition-of-care rounds, where she meets with an interdisciplinary group to review each patient with stroke. She also counsels patients who start oral anticoagulants during their hospitalization or who will start one after discharge, works with providers to choose the best agent for patients, and helps monitor heparin, enoxaparin, and warfarin.

Stein would advise smaller organizations to train some inpatient pharmacists in stroke care. First gauge staff interest, then have that group develop a continuing education presentation or other training session. Choose someone who is interested in this effort to take ownership and be responsible for developing house-wide education. The 2019 update to the 

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

 is a great place to start when developing education.

If an institution is looking for other ways to incorporate pharmacists into stroke care, opportunities exist with developing or reviewing stroke electronic order sets; completing competencies in stroke identification, management, and thrombolytic therapy administration; participating in stroke simulation education experiences; and serving on stroke committees, Stein added.

When looking to make a change, such as adding a pharmacist to a stroke care team, it’s helpful to have a physician promote it. After a pharmacist has joined the team, Alyssa Bernard, PharmD, a patient care pharmacist in the stroke unit and neurosensory ICU at Jefferson Hospital for Neuroscience in Philadelphia, Pennsylvania, recommends a few first steps. To begin with, she said, it’s important to review team- and unit-specific policies and procedures, as well as team- and unit-specific disease states and guidelines.

Bernard’s stroke unit and intermediate neurosensory step-down units are the hospital’s only non-ICU units in which IV push administration of labetalol and hydralazine is permitted. “Having some baseline knowledge about disease states that a pharmacist will focus on and the workings of a new unit will allow a pharmacist to make more targeted and useful recommendations to their team,” she said.

Bernard also advises establishing the best point of contact for recommendations and other messages, as well as obtaining other team members’ communication preferences. Her usual go-to individual is a junior resident, but the entire team should be informed of interventions that involve radically changing a patient’s therapy.

Pharmacists can facilitate appropriate medication use by familiarizing themselves with the latest acute ischemic stroke guidelines from the American Heart Association and American Stroke Association, including secondary prevention strategies (ie, antiplatelets, statin therapy, blood pressure management, glucose control, and vasospasm prevention after subarachnoid hemorrhage). This will enable them to intervene throughout a patient’s hospital stay and encourage optimal pharmacotherapy, according to Doug Humber, PharmD, a health sciences clinical professor and clinical pharmacist specialist at Skaggs School of Pharmacy and Pharmaceutical Sciences Department of Pharmacy at the University of California, San Diego.

Humber also noted that pharmacists can be involved in developing computerized prescriber order sets for alteplase to ensure that appropriate decision pathways are followed and that medication orders are entered and viewed in a timely manner. Moreover, hospitals can incorporate pharmacists into the development of an acute stroke care pathway. This would include all aspects of the alteplase process, such as indications and contraindications for alteplase, dosing and administering alteplase, and monitoring patients after giving alteplase, explained Humber.

Further, Bernard noted there are many ways in which a pharmacist can assist in proper medication usage in an inpatient setting, but one that is often overlooked is route of administration. Many patients with stroke experience difficulty swallowing as one of their major presenting symptoms. These patients require nutritional support and medication administration via tubes. “It is vital, therefore, that a pharmacist know which medications can be crushed and which interact with tube feedings,” she said. This can also extend to which medications can be given rectally or converted to IV formulations if a patient does not yet have other access to their gastrointestinal system.

Pharmacists also need to be aware of the different outcome measures for preventing future strokes. Ensuring that patients have good outpatient poststroke discharge plans is important to make sure they are monitored for high blood pressure, high cholesterol, diabetes management, smoking cessation, and other health maintenance concerns, according to Sarah Clark, PharmD, BCPS, a senior pharmacy manager for neurology, psychiatry, and emergency medicine, at Mayo Clinic in Rochester, Minnesota. Outpatient pharmacists can play a role in the ongoing medication management of these patients.

By working collaboratively with providers, pharmacists can build mutual trust and confidence with them, making providers more open to accepting recommendations from pharmacists on medication use. This partnership will benefit patients and provide them with optimum care through team collaboration, Sadowski said.

Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.

Pharmacist inclusion in stroke interventions improves patient outcomes. 

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Integrating Pharmacists Into Stroke Care Teams