Ibrexafungerp is a triterpenoid antifungal that works by inhibiting the formation of the fungal cell wall. Ibrexafungerp (pronounced eye-BREX-ah-FUN- jerp) is the first approved drug of a novel class of antifungals.

Two randomized placebo-controlled positive for 

. Participants clinical trials evaluated the safety and received two 150-mg tablets (300-mg dose) efficacy of ibrexafungerp. Participants were of ibrexafungerp or placebo 12 hours apart postmenarche, nonpregnant females with VVC. In trials, a diagnosis of VVC is defined as a minimum composite vulvovaginal signs and symptoms (VSS) score greater than or equal to 4 and a minimum of 2 moderate signs or symptoms (score of 2 or greater), positive microscopic examination in a sample demonstrating yeast, and a normal vaginal pH. Signs and symptoms were scored along a scale: 0 (absent) to 3 (severe). Median VSS scores at baseline in trials 1 and 2 were 9 and 10, respectively, at baseline; range, 4 to 18. In both trials, the majority of cultures were in a single day, a total daily dose of 600 mg. Participants were reassessed at a test-of-cure (TOC) visit between days 8 to 14 and a follow-up visit between days 21 to 29. Participants with a positive culture for 

who had at least 1 dose of the study drug were included in a modified intention to treat analysis. Compared with placebo, a greater percentage of participants on ibrexafungerp demonstrated negative cultures at the TOC visit (

< .001) and VSS scores of 0 (ie, complete clinical response) at the TOC (

In trials, a total of 545 participants were exposed to a dose of ibrexafungerp. The most common adverse effects (AEs) noted in participants administered ibrexafungerp are diarrhea (16.7%), nausea (11.9%), abdominal pain (11.4%), dizziness (3.3%), and vomiting (2.0%). For comparison, the most common AE noted in participants administered placebo in trials is abdominal pain (5.1%). Ibrexafungerp is metabolized by cytochrome P450 (CYP3A). Concomitant administration of strong inhibitors or moderate to strong inducers of CYP3A may alter the patient’s exposure to ibrexafungerp. A reduced dose of ibrexafungerp, 150 mg (1 tablet), should be given when concomitantly administered with strong CYP3A inhibitors. Ibrexafungerp is potentially teratogenic. The use of ibrexafungerp is contraindicated in pregnant women. A patient’s pregnancy status should be confirmed prior to use. The manufacturer recommends the use of contraception for 4 days after the last dose of ibrexafungerp for all women of reproductive potential. If a woman is pregnant or pregnancy is detected within 4 days after the last dose of ibrexafungerp, patients should report the pregnancy to the manufacturer to include in an ongoing safety analysis by calling 1-888- 982-7299.

The recommended dosage of ibrexafungerp for treatment of VVC is 300 mg. This dose is provided as two 150-mg tablets. To complete a full course of therapy, patients should take two 150-mg tablets for the first dose and two 150-mg tablets 12 hours later. This medication may be taken with or without food.

1. Brexafemme. Prescribing Information. Scynexis, Inc; 2021. Accessed June 14, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214900s000lbl.pdf

Articles

On June 2,2021, ibrexafungerp (Brexafemme; Scynexis, Inc) was approved by the FDA for vulvovaginal candidiasis (VVC) in adult women and girls who have begun menstruating.




Novel Antifungal Treatment Approved for Vaginal Candidiasis    

The year 1981 was a special one for my wife, Denise, and me. We graduated from the University of Pittsburgh School of Pharmacy in April. We got married on the Fourth of July and took our first jobs as licensed pharmacists in August. Like all new graduates, we were ready to apply our new knowledge and patient counseling skills to help our patients. It didn’t take long to realize that the dream was becoming a nightmare.

After a couple months working with a major chain, I came home one night and told my new wife, “If this is retail pharmacy, I made a serious mistake choosing this profession.” When I begged for more tech help, my district manager said, “I’ve watched you work, Pete, and if you stop talking to those customers, you will have [a lot] of time to get my paperwork done.” As good fortune would have it, we later found 2 great jobs for an independent pharmacy chain. As I always tell my student pharmacists: “Your license hangs on the wall by a nail. If you are unhappy in your current position, find a new nail.” My license hung on that independent pharmacy chain’s nail for 26 years until I realized the chain was going to be sold to a major chain.

I found another great nail at a different independent pharmacy and had 12 great years of community practice there. I staffed the bench, and later on, I staffed a physician’s office 2 days per week. By most pharmacists’ standards, this was a dream job. However, I left that job to fill a position as director of clinical services at Nickman’s Drug store in Lemont Furnace, Pennsylvania. I chose this nail not only because of the owner’s interest in providing clinical services, but most importantly, the nail would be closer to my family. I had landed another dream job.

Did you notice that all 3 times I left a job, money had nothing to do with my career move? It was all about conditions outside the paycheck. The major chains have yet to learn this. Wave the big bucks in front of the newbies and get them signed up. After a short time, the joy of the big paycheck is overshadowed by lack of staffing, unattainable metrics, and long hours. As a result, these experienced pharmacists move on to lower-paying jobs with much more opportunity.

Brenda, a pharmacist who lives just up the lane from us, left her chain job for a pay decrease to be part of the West Virginia University community. She now gets to be a mom as well as a pharmacist. Mike, another neighbor of mine, left his job with a major chain shortly after he got married. He took a job with an insurance company doing medication therapy management for a few years and also became a member of the university community. He is now on the national circuit discussing opioid therapy and pain management. Like Brenda’s, Mike’s career moves involved a salary decrease for better conditions and opportunities.

I often compare the big chains to my beloved Pittsburgh Pirates. The Pirates develop players like Andrew McCutchen, Gerrit Cole, Josh Bell, and Josh Harrison, who move on to bigger and better opportunities. The New York Yankees, Washington Nationals, and Los Angeles Angels are grateful to the Pirates for developing the future stars of our profession. By providing better working conditions, staffing, and opportunities, the chains could keep these future stars for their own benefit.

As I celebrate my 40th year in this amazing profession, I’m sure that nail No. 4 will be my last. My extended family is always asking me, “When are you going to retire?” My answer is simple: “When [I’m] darn good and ready.” I love this profession and get great satisfaction going to work every day. My best advice to students and new pharmacists: “Keep looking for your nail.”

Peter A. Kreckel practices pharmacy in Lemont Furnace, Pennsylvania.

Money isn’t everything in this profession. 


What I Learned From 40 Years in Pharmacy

At one point in our education, we all learned about Watson and Crick discovering the double helix structure of DNA in the 1950s. Although Watson and Crick did not know it at the time, this groundbreaking discovery would be the start of evaluating a patient’s specific DNA for more personalized pharmacological treatment.

After Watson and Crick’s discovery, there was a gold rush for DNA. Many new inventions and discoveries would follow years after. Half a century later, the Human Genome Project was launched in 1990 and completed in 2003.

 The goal of the Human Genome Project was to map and identify all of the human DNA base pairs and genes. Branching from the Human Genome Project is now the newer use of pharmacogenomics for medication therapy.

The first example of using DNA sequencing for disease treatment was the discovery of the human epidermal growth factor receptor 2 (HER2)-positive breast cancer mutation in the 1990s.

 Physicians were now able to screen for this HER2 mutation in patients with breast cancer. If the breast cancer expressed the protein HER2/neu, the patient would be receptive to trastuzumab (Herceptin), and therefore treatment would lead to a much better outcome. This proved to be a lifesaving discovery, and it inspired testing like this to continue.	

Since then, testing for genetic variations has become a standard of practice in several areas of health care, including cancer, cystic fibrosis, and HIV. The cost per human genome continues to decrease with technological advancements and more data. Therefore, conducting this testing has become more standardized and less expensive (see Figure).

Currently, pharmacogenomics testing is used for various pharmacokinetic and pharmacodynamic properties, mainly focused on the metabolism of different medicines. The pharmacogenomic results regarding metabolism express whether a patient will be predisposed to a lack of response due to a lower concentration of medicine, normal response, or toxicities from a higher concentration of medicine.

As developments in pharmacogenomics progressed over the years, several initiatives attempted to standardize pharmacogenomic medication information and guidelines. Because of this demand, the Pharmacogenomics Global Research Network and PharmGKB teamed up to develop a shared project termed the Clinical Pharmacogenetics Implementation Consortium (CPIC).

 CPIC addresses the need for guidelines to instruct clinicians on how to modify drug therapy based on genetic information. CPIC provides information on the proven genetic variations and the variations’ effects on medication therapy in 1 concise, clear guideline. CPIC information should be referred to and used by clinicians when applicable to select appropriate medications and doses for patients with genetic variations. As of this publication, there are over 40 medications with CPIC guidelines.

Through CPIC and other sources of pharmacogenomic data, prescribers can now use this information to optimize medication therapies for patients. Genetic variations can cause a patient to have altered responses to medications. The common area where these genetic variations are seen is in the metabolism of the particular medication. If a patient metabolizes a medication for elimination at a slower rate than expected, the patient can be predisposed to toxic concentrations when given standard doses of the medication. Additionally, if a patient metabolizes a medication for elimination at a faster rate than expected, the patient can be predisposed to a subtherapeutic concentration of the medicine. The opposite of these responses will happen when the medication in question is a prodrug, which is an inactive medication metabolized to an active pharmacologic agent in the body, ie, faster metabolism = toxic concentration; slower metabolism = subtherapeutic concentration.

Medication therapy can be optimized when a patient’s DNA sequence is evaluated for known genetic variations associated with certain medications. Personalizing medication choices and doses to the specific needs of a patient’s genetic results will lead to the correct therapeutic drug concentrations while avoiding toxicities or subtherapeutic concentrations.

Pharmacogenomics can not only optimize therapy through proper dose and drug selection but also lead to optimization in other areas of health care. If a patient experiences toxicities leading to adverse effects (AEs) from a medication, they often have to receive additional care either through emergency services or through additional  medication to control the AEs. If pharmacogenomics is considered at the time of prescribing, the therapy can be optimized from the start and additional treatment can be avoided. This saves time for the patient and saves health care dollars overall.		

The Role of the Pharmacist Across Care Settings

Today, pharmacists are the drug experts within the medical field, with extensive education in medication therapy including a heavy focus on pharmacokinetics and pharmacodynamics. Pharmacists have the knowledge and community presence to counsel patients about their genetic results, as well as educate other health care professionals. Through this education, pharmacists can help physicians make recommendations at the time of prescribing. These recommendations can include genetic testing to be done before new medication orders, as well as adjustments to be made on current medication orders.	

Additionally, pharmacists can help address pharmacogenomic components as the last point of intervention before dispensing the medication to the patient. If a new prescription arrives for a patient with an established AE profile, the pharmacist may be the last person to verify if genetic testing has been done. Detrimental AEs can be avoided through intervention at this point in the prescribing process.

Furthermore, pharmacists can serve as advocates for this area of health care. The only way to collect data on additional genetic variations and their associations with medications is through clinical trials. There is a lack of financial incentive for pharmacogenomic clinical trials to be conducted and many clinicians do not understand the importance of this area of research. Pharmacists can encourage health care professionals to begin trials to expand their knowledge of pharmacogenomics and its application in health care.

Though pharmacogenomics in health care has come a long way from where it started, there is still a great deal of growth in this field and there are many more barriers to be crossed. One barrier in pharmacogenomics is the issue of where to store a patient’s genetic information. With genetic results being protected by the Health Insurance Portability and Accountability Act, it is hard to deter- mine an easily accessible place where genetic information can be seen and used by all parties within the health care system. A potential suggestion some physicians have made is an electronic health record pop-up alert on a patient’s profile at the point of prescribing, but development is still needed in this area.

In addition, there is an ethical component when testing a patient’s genetics. Scientists could come across a mutation the genetic test was not indicated for. This is a gray area to decide whether the patient should be informed of the findings since they did not originally consent to search for that mutation. There is also the question of testing for 1 specific gene variation vs testing a multigene panel on a patient. Once again, this is an area that needs more discussion and development.	

As previously mentioned, clinical trials are imperative to the development and success of using pharmacogenomics in healthcare. There is no other way to get the information than to test a patient’s genes and evaluate them for their medication use. Pharmacists play a key role here in educating for clinical trial needs and advocating for more research. Overall, pharmacogenomics is an exciting and growing area of health care. Through additional research and a commitment to using pharmacogenomic findings, this information can eventually be brought to the bedside of every patient to optimize medication therapies for all.

1. The Human Genome Project. National Human Genome Research Institute. Updated December 22, 2020. Accessed June 3, 2021. 

2. Cornez N, Piccart MJ. Cancer du sein et Herceptin [breast cancer and herceptin]. 

3. DNA sequencing costs: data. National Human Genome Research Institute. Updated December 7, 2020. Accessed June 3, 2021. 

www.genome.gov/about-genomics/fact-sheets/DNA-Sequencing-Costs-Data

4. What is CPIC? Clinical Pharmacogenetics Implementation Consortium. Updated April 21, 2021. Accessed June 3, 2021. https://cpicpgx.org

Pharmacogenomics provides an opportunity for pharmacists to enhance their role in patient care. 


The Evolution of Pharmacogenomics

In 2019, almost 50,000 people in the US died as a result of opioid overdose; this number includes events involving prescription pain medications, heroin, and synthetic opioids like fentanyl.1 The CDC estimates the annual economic burden of prescription opioid misuse at $ 78.5 billion.

 Pharmacists can be a valuable resource to patients and the community as a whole by learning about naloxone and how to treat an opioid overdose, as well as recommending naloxone to patients and counseling on its use.

This article is the first of a 2-part series on naloxone education and patient counseling for pharmacists.

Naloxone is an opioid antagonist. It attaches to opioid receptors, rapidly reversing an opioid overdose. Naloxone quickly restores normal breathing in a patient whose breathing has slowed or stopped because of an opioid over- dose. Naloxone is effective only in opioid overdose due to drugs such as oxycodone, hydrocodone, codeine, heroin, fentanyl, and morphine.

Naloxone does not treat overdoses of nonopioid medications, and it does not have an effect on someone who has not taken opioids.

Although any opioid use can lead to overdose, some factors that may increase overdose risk include:

combining opioids with alcohol or other drugs (such as benzodiazepines);

taking more opioids than prescribed by the physician;

taking illegal opioids that could contain unknown substances;

having impaired hepatic or renal function; and • being older than 65 years.

slowed or shallow breathing (or no breathing);

pinpoint pupils (small, constricted pupils);

In the event of an opioid overdose (or suspected overdose), administer naloxone and call 911. Keep the person awake and talking. Another naloxone dose (or more) may be necessary. Stay with the person until emergency help arrives.


Results of studies show that naloxone distribution programs and naloxone access laws reduce opioid overdose deaths without increasing opioid use. Estimates suggest that when laypersons and emergency personnel have naloxone, 21% of opioid overdose deaths could be avoided.

Although naloxone is a prescription drug, many pharmacies in the United States have naloxone available with- out a prescription through a standing order. Law enforcement or emergency medical services personnel can work with local health departments to access naloxone.


Naloxone is available in 3 FDA-approved forms:


Naloxone nasal spray (Narcan; Sankyo) is sprayed into 1 nostril while the patient lies on their back.

One spray into 1 nostril, and then call 911. If the patient responds and goes back into respiratory depression before help arrives, or if the patient does not respond after 2 to 3 minutes, give another dose in the other nostril using a new naloxone nasal spray. If there is still no response and more doses are available, give additional doses every 2 to 3 minutes using a new naloxone nasal spray with each dose, and alternate nostrils each time, until the EMS arrives.


Naloxone autoinjector (Evzio; Kaleo) is a prefilled autoinjection device that is injected into the thigh muscle. When it is turned on, a recording gives instructions.

Administer 1 intramuscular (IM) or subcutaneous (SQ) injection into the thigh (through clothing if necessary), then call 911. If the patient does not respond and more doses are available, doses may be repeated every 2 to 3 minutes until EMS arrives. If the patient responds and goes back into respiratory depression before EMS arrives, give another dose.


Naloxone injection is given by a health care professional. The route of administration may be intravenous (IV), IM, or SQ. The IV route is preferred because of its faster onset.

Depending on the opioid, dose, and route of administration that caused the overdose, the naloxone dose will vary and may require repeat doses.

Each patient who receives a naloxone product, regardless of whether it is an autoinjector or nasal spray, should receive training, read the instructions, and check the expiration date. These 2 dosage forms were designed to be easy to use by anyone in an emergency situation.

Naloxone may cause withdrawal symptoms. Although uncomfortable, withdrawal symptoms are not life-threatening. They may include headache, blood pressure changes, tachycardia, sweating, nausea, vomiting, tremors, irritability, nervousness, aggressive behavior, body aches, fever, runny nose, and sneezing.

Opioid overdose crisis. National Institute on Drug Abuse. Updated March 11, 2021. Accessed May 23, 2021. 

https://www.drugabuse.gov/drug-topics/opioids/opioid-overdose-crisis

Naloxone. National Institute on Drug Abuse. Updated September 2019. Accessed May 23, 2021. 

https://www.drugabuse.gov/publications/drugfacts/naloxone

Preventing an opioid overdose. Centers for Disease Control and Prevention. Accessed May 23, 2021. 

https://www.cdc.gov/drugoverdose/pdf/patients/preventing-an-opioid-overdose-tip-card-a.pdf

Having naloxone on hand can save a life during an opioid overdose. FDA. Updated December 11, 2019. Accessed May 23, 2021. 

https://www.fda.gov/consumers/consumer-updates/having-naloxone-hand-can-save-life-during-opioid-overdose#:~:text=Everyone%20who%20overdoses%20with%20opioids,by%20anyone%2C%20even%20a%20bystander

Naloxone for opioid overdose: life-saving science. National Institute on Drug Abuse. Updated March 2017. Accessed May 23, 2021. 

https://www.drugabuse.gov/publications/naloxone-opioid-overdose-life-saving-science#ref

Opioid overdose reversal with naloxone (Narcan, Evzio). National Institute on Drug Abuse. Updated February 20, 2020. Accessed May 23, 2021. 

https://www.drugabuse.gov/drug-topics/opioids/opioid-overdose-reversal-naloxone-narcan-evzio

Label: Narcan–naloxone hydrochloride spray. DailyMed. Updated March 25, 2021. Accessed May 23, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=724df050-5332-4d0a-9a5f-17bf08a547e1

Label Evzio: naloxone hydrochloride injection, solution. DailyMed. Updated April 5, 2021. Accessed May 23, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fbe8d17-a72f-406d-a736-48e61620f9d8

Label: Naloxone hydrochloride injection. DailyMed. Updated March 18, 2020. Accessed May 23, 2021. 

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1303f15-c48b-a44d-b28a-72f370094e02

Become an expert in naloxone to help educate patients.

Naloxone: A Primer for Pharmacists

This past year, pharmacists faced unprecedented challenges with the rollout of the COVID-19 vaccines, as tens of millions of Americans fought to be among the first to get their shot. As of June 14, approximately 145 million Americans were fully vaccinated, and pharmacists, for the most part, have been able to standardize their procedures for vaccine distribution. But that wasn’t the case at the beginning of the rollout.

Kevin DeMass, RPh, owner of the Apothecary Shoppe in Salt Lake City, Utah, has more than 30 years of experience in the field. He noted that the important lesson he learned from the vaccine rollout was the need for patience.

“It seems that phase 1 took forever and we were in constant communication with our patients, providers, and even the Department of Health to find out what was going on,” he said. “And it certainly wasn’t a smooth process from the get-go.”

For instance, the state’s website crashed almost daily with patients trying to make appointments, and the vaccine supply ebbed and flowed with no predictability. Plus, he found many of his regular patients didn’t want to go into a mass immunization center and wanted his pharmacy to administer the vaccine.

“They were frustrated with the system, and we were as well,” DeMass said. “In many places in our country, patients were asked to go to a strange place to receive a strange drug that they knew nothing about. We haven’t really done anything like that before. Independent pharmacies have built a relationship and trust with their patients for years, and they relied on us, but we didn’t have anything to give them.”

Although that was frustrating to him, he knew not to let that show, as he didn’t want that frustration to spill over to his patients. He described an encounter with a longtime African American customer who refused to allow anyone but DeMass to administer the vaccine because of uncertainty and fear. DeMass worked with him to make that happen as soon as the pharmacy received doses.

“I did a lot of reading online, looked at journals, called friends in New York and California to see what they were doing…and learned from them,” DeMass said.

DeMass said he also learned not to compare what he was doing to pharmacies in different cities.

“We’re all going at different paces,” DeMass said. “You need to know what you can do with your staff to make the experience as smooth as possible. We took lessons we saw from others and improved efficiencies as we went into phase 2.”

Ghaidaa Najjar, PharmD, PhD, community pharmacist for Rite Aid in Plymouth, Michigan, added that the process was confusing and inefficient at the beginning for both patients and the pharmacy.

“I had elderly patients walking in, thinking they would be automatically signed up for the vaccine,” she said. “They did not have smartphones, they may not have children or grandchildren who can help due to the social distancing and they struggled because of isolation.”

She believes there should have been cohesive alignments in terms of eligibility among federal, state, and county entities when pharmacies had to serve the public based on certain criteria.

“People were confused, because a mile from where you live, your neighbors could be getting vaccine way ahead of you,” Najjar said. “Inequality was manifested by preferring some states to get vaccines before others. The category differences within the same state and local counties were also discriminating people and added more confusion. If we could go back, equitable distribution to all states should be the standard.”

According to Heather Ferrarese, PharmD, owner of Bartle’s Pharmacy in Oxford, New York, no one is ever really prepared for something like a global pandemic, even when they think they are. From her perspective, careful communication and planning are most important in adapting to the unpredictability a public health crisis brings. 

“To anticipate having the vaccine, then to have it delayed time and time again, was definitely something we learned from, especially about how to plan and communicate,” she explained. “Once we did get the vaccine, it was a complete learning curve to pull off vaccinations on such a large scale and figure out where to vaccinate so many people. Those were some of the key takeaways from this experience. Thankfully, most people have been very gracious. They understand this is something none of us have ever been through before.”

For many pharmacies, implementing COVID-19 vaccinations was a significant trial-and-error process that resulted in plenty of mistakes. Pharmacies had to adjust their workflows and services to fit their community’s needs. 

“The 2 biggest areas were workflow improvement in the pharmacy and improving efficiency and capacity during vaccinations,” said Mark McCurdy, RPh, an independent pharmacist from Mark’s Pharmacy in Cambridge, Nebraska.

Being in a rural area, the pharmacy works closely with the local health department. It offered vaccination events in multiple locations in 4 of the 9 counties in its service area.

“The goal was to identify the highest-risk and highest-need patients and provide them easy access to care,” McCurdy said. “So aside from the original crush of patients seeking vaccine, we also were faced with logistics of site coordination, travel, and time on making these events happen. Once supply outpaced demand, the biggest challenge has been maintaining interest in receiving the vaccine and filling available appointments. We have struggled to get information to the right places and reach the right people.”

Jasmine Chan, PharmD, chief operating officer at Central Avenue Pharmacy in Pacific Grove, California, said because her pharmacy was a little late in getting vaccines, she was able to learn from the challenges that others were facing, notably with schedules and communication with patients.

“I got to marinate on how we could do it better,” she said. “Organization was key. I like lists, I [like] Excel sheets, but very quickly we learned we can’t overorganize this. We had to be flexible and roll with it.”

She feels the biggest thing she learned was how to navigate to the need of the individual patient. For example, the pharmacy served a lot of hospice patients, and Chan needed to best figure out appointments, transportation, and all the logistics in getting the vaccine to those patients. 

“There were people with language barriers, those with no legal status in the United States, so we had to change our process for each of those barriers and break them down to make sure everyone was properly serviced,” Chan said. “Many of these people couldn’t leave during their work day, yet many clinics were only open 10 to 4.”

Chan’s pharmacy set up clinics near workplaces, such as golf courses for greenskeepers and even in homes where maids were employed, to help improve access to those patients.

Miscalculating the time needed to process paperwork, distribute vaccine cards to patients, and schedule second appointments proved to be one of the biggest mistakes, according to Ferrarese.

“We have been administering vaccines for many years, so we thought we had that down, but we weren’t prepared for all of the questions that customers had and how much more time that would take,” she said. “We also had concerns about keeping people socially distanced, and at first, we were overly aggressive trying to vaccinate too many people. We learned our staff needed to stay in close communication with each other on how things were going.”

Furthermore, the team needed to securely share patient health information, such as insurance cards, and that proved to be more difficult than originally thought.

“When we got to the point where we couldn’t handle so many people within our pharmacy, we set up a vaccination site at our local fire department,” Ferrarese said. “We used Backline from DrFirst to securely communicate with staff who were on-site at the fire department, and they were able to reach those of us who were at the pharmacy.”

One of the biggest mistakes DeMass made was underestimating the entire process from beginning to end, including time, reporting, record keeping, labor consumption, and more.

“My calculations were based on my previous immunization experience with patients in our database,” he said. “But this threw us a hard curveball. It was a little bit scary. Every day, we were adding new patients into our database. Claim after claim, patient after patient. We didn’t have any existing data so it was a very time-consuming process.”

In the beginning, DeMass was having patients fill out the intake paperwork, a qualifying questionnaire, and billing information right in the pharmacy so he could provide a good experience with hopes of getting some repeat business.

“That was a big mistake and we changed that quickly,” he said. “I pushed all of that to our website. All information, scheduling, [adverse] effect information, and everything else was available on the site, which had been underutilized for months and years, but now patients are using it daily.”

In an effort to adapt to the increasing needs of the public, pharmacists and pharmacy technicians across the country quickly set up off-site clinics and walk-up vaccination locations.

“The pharmacist’s role in health care has been greatly expanded in recent years due to our ability to adapt and seek new ventures, along with the great amount of trust that patients have in their pharmacist,” said Aaron Gilbert, PharmD, a pharmacist in Louisville, Kentucky.

Now, the Apothecary Shoppe has preloaded the vaccine into the pharmacy dispensing system and hard-coded the billing and drug utilization review codes, making the flow much easier and increasing the efficiency in processing claims.

“We also preprinted COVID-19 prescription pads and we had all of the info on there that insurance companies would require,” DeMass said.

He also contacted his landlord about extra space and was able to use 3500 square feet directly above the pharmacy to create a COVID-19 vaccination clinic.

“It took more staff than we could handle, so I begged some of my professors from the University of Utah to come and help us and they have been very gracious volunteering their time,” DeMass said. 

There is still conflicting information on whether the COVID-19 vaccination will need to be administered annually like the flu shot, with most experts believing a booster shot will be necessary, but research is still underway to know exactly when.

“As the need for additional COVID-19 vaccinations is still unknown, there is the possibility that pharmacists will play an increasing role in helping the community protect itself from the deadly virus,” Gilbert said. “But what we have seen once again is that pharmacists are stepping up to the plate and making a difference in patient care.”

DeMass said that although he’s not sure if COVID-19 vaccines will become routine, he knows the experience gained over the last 6 months has positioned pharmacists on the front line and put them in place to be a health and wellness destination.

“Now more than ever, the local pharmacy is a trusted health care provider, and the rollout in any future health crisis will happen much more quickly,” he said. “On the positive side, public awareness has been increased on the vaccine process and its importance.”

The vaccine is free to everyone, but pharmacists still need to be reimbursed for their efforts, as they are spending thousands of hours planning and executing to get the vaccine in the arms of whoever needs it.

“I’m still waiting for approval from [the Department of Health and Human Services] and waiting for a third-party check and Medicaid checks to be cut,” DeMass said. “Many pharmacists are still working for free to care for the most vulnerable, high-risk, and disadvantaged citizens of our community. The public needs to be made aware of that.”

Pharmacists reflect on their takeaways from the experience and how to move forward.

Lessons Learned from the COVID-19 Vaccine Rollout

It’s nearly a year since August 2020, when the US Department of Health & Human Services (HHS) authorized licensed pharmacists throughout the country to provide childhood immunizations to patients aged 3 to 18 years during the public health emergency. This is a significant, albeit temporary, expansion of pharmacist authorization to administer pediatric vaccines in many states. Although about half of states and territories allow pharmacists to administer vaccines to patients of any age, many have age limitations and other restrictions pertaining to specific vaccines.

Yet it seems that most pharmacies nationwide have not gotten involved in pediatric vaccinations. “We’re trying not to bite off more than we can chew,” said Kevin Day, PharmD, president of Day’s Miami Heights Pharmacy in Cincinnati, Ohio.“[COVID-19] testing and vaccines have been plenty.”

Perhaps now that the initial rush of COVID-19 vaccination has subsided, pharmacies should consider establish- ing pediatric vaccination programs, as this is an opportunity that can benefit both individual pharmacists and the profession as a whole.


The HHS authorization was intended to bolster childhood immunization levels after the CDC collected data in May 2020 indicating a significant drop in childhood vaccinations in the early months of the pandemic, raising fears of outbreaks of vaccine-preventable disease.

 Even if vaccination levels now appear to have returned to prepandemic levels, there may remain a backlog of patients who are behind on their immunizations, according to Jeffery Goad, PharmD, professor and chair of the Department of Pharmacy Practice at the Chapman University School of Pharmacy in Irvine, California.

Administering childhood vaccines gives pharmacists the opportunity to practice at the top of their license while improving immunization rates in their communities.“Expanding into pediatric vaccines expands the range of providers that you’re able to network with, and that creates more collaboration among providers that you may not have dealt with,” Goad noted. In addition, he said, a childhood vaccination program helps build parents’ trust in pharmacists.

Although the bulk of pediatric immunizations are given to infants up to 18 months of age, the 3-to-18-years group includes 4 recommended vaccines at ages 4 to 6, 3 at ages 11 to 12, and 1 at age 16 years (see Table).

Goad believes the main benefit of pharmacy childhood vaccination, outside the pandemic, is to close the gap for adolescent vaccinations.“The 3 shots that are given at the preadolescent phase, 11 to 12 years, is an important area for pharmacists to help the community get their vaccination rates up,” he said.


Setting up to provide childhood vaccines should not be a major investment for most pharmacies, Goad said, as the basic infrastructure of an immunization administration area and vendors to order vaccines and supplies are already in place.“ They just need to order the right vaccines,” he said.

What may require more attention is establishing the infrastructure to identify children who need vaccination, document appropriately, and communicate with other health care providers to ensure that children are not being under or overvaccinated. This can be accomplished easily if pharmacists have access to electronic health records or if their state has a comprehensive immunization registry that pharmacists can access (in some cases, directly through their dispensing software). But not all states mandate that all providers document vaccinations in the state registry, resulting in incomplete immunization registries. Pharmacists who cannot access vaccine information electronically must find other ways to communicate with pediatricians to share immunization information (eg, faxing records).

Pharmacists who can check immunization registries while filling prescriptions can identify children who are due or overdue for specific vaccines. In fact, COVID-19 vaccinations for adolescents may provide a key opportunity for pharmacists to identify other vaccines these teens need. Importantly, although previous recommendations were to separate COVID-19 and other vaccines by 14 days, the CDC now allows COVID- 19 and other vaccines to be administered without regard to timing.

 Generally, however, the major source of pediatric vaccine business is from physician referrals, so it is crucial for pharmacists to cultivate relationships with local pediatricians. Before establishing a pediatric vaccine program, pharmacists must perform a needs assessment in their community, Goad said, by reaching out to local pediatricians to find out whether “they are struggling to meet the backlog of vaccines.”

Day said a main reason his pharmacy has not jumped in on childhood vaccines is to respect relationships with pediatricians in his area who, he said, “do an excellent job.” In contrast, Travis Wolff, PharmD, owner of Med-World Pharmacy in Sapulpa, Oklahoma, reported that his local physicians find ordering and storing vaccines to be a huge barrier, so they are happy to refer their patients to the pharmacy for vaccination. Establishing which local physicians this is the case for is important.

Although the American Academy of Pediatrics came out strongly against pharmacists providing childhood vaccines at the time of the HHS announcement, Goad believes the academy’s main concern is communication and the potential for under or overvaccination.“ We have to reassure pediatricians that we are not disrupting [the normal visits pediatricians have], that we are simply acting to help them offload some of the patients where they now are behind.” For example, he said, physicians can send their patients to the pharmacy for later doses of a multidose series of vaccines, and pharmacists should encourage parents to schedule their kids for physicals if they haven’t seen the pediatrician in a while.

Before establishing a pediatric immunization program, pharmacists must ensure they’ll be reimbursed for their services. Medicaid and commercial insurance rules vary by state. “The state of Oklahoma currently does not pay pharmacies through our state Medicaid for immunizations in patients under age 19,” said Wolff. “This has proven to be a huge barrier to vaccinating those that need it most.” And, he noted, many commercial insurers cover pediatric vaccines on the medical but not the pharmacy side.

Pharmacies can apply to participate in their state’s Vaccines for Children Program, which covers vaccine costs for children 18 years and below. For more information, go to https://www. cdc.gov/vaccines/programs/vfc/provid- ers/questions/qa-join.html.

According to Goad, the emergency declaration has shown that you can enact a national standard, rather than what he calls “the patchwork of immunization laws” throughout the country.

“As the only pharmacist serving on our state board of health, I am working to educate and encourage reform in the practice privileges of pharmacists every day,” Wolff said.

“This is a window of opportunity,” Goad concluded.“ Pharmacists need to advocate to their legislators and their stakeholders that this is something they can do and they want to do, so that everyone just thinks that the pharmacy is the place to go to get a vaccine.”

1. Pharmacist administered vaccines. National Alliance of State Pharmacy Associations, American Pharmacists Association. Updated September 18, 2020. Accessed May 27, 2021. 

https://naspa.us/wp-content/uploads/2020/08/IZ-Authority-9_2020.pdf

2. HHS expands access to childhood vaccines during COVID-19 pandemic. News release Department of Health and Human Services. August 19, 2020. Accessed May 27, 2021. 

https://public3.pagefreezer.com/browse/HHS%20–%C2%A0About%20News/20-01-2021T12:29/https:/www.hhs.gov/about/news/2020/08/19/hhs-expands-access-childhood-vaccines-during-covid-19-pandemic.html

3. Recommended child and adolescent immunization schedules for ages 18 years or younger, United States, 2021. CDC. Updated February 12, 2021. Accessed May 27, 2021. 

https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

4. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. CDC. Updated May 14, 2021. Accessed May 27, 2021. 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fclinical-considerations.html

Administering pediatric immunizations can be a window of opportunity for pharmacists to demonstrate their value.

Childhood Vaccines During COVID-19 and Beyond

Irritable bowel syndrome (IBS) is a chronic condition that affects the large intestine and can have an impact on patients’ quality of life.

 Treatment typically consists of dietary changes, pharmacotherapy for constipation (IBS-C) and diarrhea (IBS-D), and abdominal pain management.

 Pharmacists can play an integral role in IBS management through medication and dietary education.


Treatment for IBS includes medications to manage diarrhea such as rifaximin (Xifaxan; Salix Pharmaceuticals) and those for constipation like lubiprostone (Amitiza; Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc).

 Dietary changes (eg, increasing soluble fiber) can help manage IBS symptoms.

 The American College of Gastroenterology (ACG) recently released updated guidelines for IBS that addressed 25 clinically important questions including new treatment recommendations.

 Evidence from a systematic review and meta-analysis reveals that a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) can improve IBS symptoms.

 There- fore, a limited trial of a low FODMAP diet is recommended to improve global IBS symptoms.

 Foods that contain FODMAPs include certain grains, vegetables, fruits, and dairy products that can trigger meal-related symptoms in patients with IBS.

 However, there is still a need for more studies evaluating a low 3 FODMAP diet. 

Pharmacists can educate patients on the 3 phases of the plan 3:

Phase 1: Substitution of foods with low FODMAP choices

Phase 2: Gradual reintroduction of foods into diet while evaluating symptoms

Phase 3:Personalized diet to avoid foods that trigger symptoms

The new ACG guidelines include a strong recommendation for the use of rifaximin to manage IBS-D symptoms based on clinical trials.

 Secretagogues such as plecanatide (Trulance; Synergy Pharmaceuticals) and linaclotide (Linzess; Ironwood and Allergan) now have high rankings in efficacy for IBS-C.

 Plecanatide is a guanylate cyclase-C agonist that was not available several years ago and was not mentioned in the 2018 guideline update.

 Linaclotide and plecanatide are both well tolerated, and the most common adverse effect (AE) is diarrhea.

 The serotonin type 4 (5-HT4) agonist tegaserod (Zelnorm; Sloan Pharmaceuticals) was reintroduced into the market in 2019 for IBS-C after it was voluntarily withdrawn in 2007 because of a safety signal of an increased risk of cardiovascular AEs.

 The ACG guidelines recommend the use of tegaserod in women younger than 65 years with < 1 cardiovascular risk factors who have failed secretagogue treatment.

 The use of tricyclic antidepressants (TCAs) is now also recommended for the treatment of abdominal pain as they work by acting on norepinephrine and dopaminergic receptors.3 Pharmacists can recommend that patients be started on a low dose of a TCA that should be titrated up gradually to achieve the best symptom management with the least amount of AEs.

 AEs associated with TCAs include dry mouth, dry eyes, urinary retention, constipation, and cardiac arrhythmias.

Arena Pharmaceuticals reported topline results from the phase 2b CAPTIVATE clinical trial (NCT04043455) demonstrating that olorinab, a novel full agonist of the cannabinoid receptor 2, did not meet the primary efficacy end point of statistically significant improvement in the overall average abdominal pain score from baseline to week 12 for patients with IBS-C and IBS-D.

 Olorinab did demonstrate efficacy for moderate to severe pain at the higher dose studied. The company will evaluate possible future options for IBS.6 OrphoMed is investigating ORP-101 in a phase 2 clinical trial (NCT04129619) for IBS-D, and topline results are expected in the second half of 2021.

 ORP-101 has been granted fast track designation by the FDA and has passed the second planned interim analysis in the phase 2 trial.

1. Irritable bowel syndrome. Mayo Clinic. Updated October 15, 2020. Accessed May 22, 2021. 

https://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/symptoms-causes/syc-20360016

2. Thong VD, Ngoc Phuc N, Quynh BTH. Effectiveness of educational intervention carried out by clinical pharmacists for the quality of life of patients with irritable bowel syndrome: a randomized controlled trial. 

. 2020; 5(2):242-248. doi:10.1002/jgh3.12477

3. Lacy BE, Pimentel M, Brenner D, et al. ACG clinical guideline: management of irritable bowel syndrome. 

. 2021; 116(1):17-44.doi:10.14309/ajg.0000000000001036

4. Lacy BE. Update on irritable bowel syndrome guidelines. 

. Updated December 2020. Accessed May 22, 2021..

https://www.gastroenterologyandhepatology.net/archives/december-2020/update-on-irritable-bowel-syndrome-guidelines/

5. FDA approves the reintroduction of Zelnorm (tegaserod) for irritable bowel syndrome with constipation (IBS-C) in women under 65. News release. BioSpace. April 1, 2019.Accessed May 22, 2021.

Pharmacists must keep up to date with the latest in irritable bowel
syndrome management.