The Coronavirus resource center provides clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.

Visit Our Coronavirus Resource Center

 One of the things I’ve been working on a lot is how to leverage the EMR [electronic medical record] data and dispensing data. It’s important that we look at dispensing data when we’re identifying patients, because we’re filling for them. A lot of times we have a slightly more intimate feel with them because we control when they get that refill, and we know what their proportion of days covered is like. But at the same time, how do we interface that with the electronic medical record so that we’re looking at patients who we’re not always filling for but we’re aware have been started on therapy and when their follow-up visit is coming?

One of the biggest opportunities as we leverage EMR data is matching up ICD-10 [International Classification of Diseases, 10th Revision] codes and dispensing data so that when I’m in the clinic, I’m not only looking at the patient and saying, “We started this patient with MPN [myeloproliferative neoplasm] on this therapy. How are they doing? Have they called in with any adverse effects?” But when we have a medically integrated specialty pharmacy or pharmacy, we can say, “We know that their proportion of days covered is out of range. They’re not at 100%. How do we do some follow-up?” Or, “We saw this patient called who had an issue with some type of skin adverse effect. How do we make sure they have that supportive care medication earlier so that they’re less likely to abandon therapy and be more compliant?” I’d like to see how we can leverage the EMR and dispense data moving forward.

Many of us, myself included, have external third-party software that we use to manage patients. We do an initial assessment of that patient, part of your accreditation or quality improvement initiatives, and then we see when their next refill is coming. We’ve got to make sure we check in with them and see if they have any adverse effects. “How are things going?” It’s good to have that process in place. It’s important as part of the patient care journey.

But how do we make sure there’s transparency with those data? How do we make sure the care team providers also see that and can act on that information so it’s not just pharmacy, it’s key stakeholders, the provider, the advanced practice practitioner, and the pharmacy working together to improve those outcomes. When you can leverage that integration of data from the clinic to the individuals calling, whether it be the pharmacy technicians or the pharmacist, and even the pharmacy that’s dispensing, then you have coordination of care and everyone is playing off that same sheet of music. I feel like that’s the future in terms of where we’re going.

Improving that is looking at how people integrate their dispensing systems into the EMR. Then you have everyone going to 1 source of information. When you run reports, instead of having to use VLOOKUP to match up those data, which I often do because I’m a data-driven individual, it creates more seamless integration. That’s sometimes where I look at the future of leveraging EMR data in addition to dispense data to make sure all patients are taken care of and not just the ones we dispense for.

Jeff, I don’t know if you have experience [with this]. I’m imagining you’re doing a lot of these quality improvement projects trying to leverage both. What has been your experience leveraging EMR data? Do you look at fill data separately from EMR? Do you try to integrate them? How do you see it moving forward?

 Going back to the pharmacy technician comment, I can’t say enough good things about our technicians. They keep the clinic running. They leverage EHR [electronic health record] data in terms of signing patients up for patient assistance and co-pay assistance programs and keeping patients on schedule, renewed year after year, without a break in therapy. That’s important, especially with MPNs where a break in therapy can be really detrimental to the patient’s health. Come January, we all sweat a little more in signing everyone up and hoping all the patient assistance programs are renewed on time. That’s one way we’ve leveraged EHR data.

In terms of dispensing and adherence, when we’re able to fill in-house at our own specialty pharmacy, it makes it very easy, like you’re saying. There’s a central location that we can go to. We can easily see exactly when the prescription was sent, when it was filled, and when it was dispensed. That takes some of the guesswork out of following up to ensure adherence with that patient.

 I have a comment I want to add, too. The biggest thing we’ve noticed with utilizing our EMR is to develop activities that will go directly into the EMR. At our practice, the nurses are dropping down the flow sheet or that treatment plan, and from there, we’re putting our data directly into the EMR. If we do our initial education with the patient, we’re dropping it down where it’s an activity, so that way I’m able to run reports in our EMR to determine if there are certain patterns that I need to look for if I need to run a report on a specific patient to see what our previous drug utilization reviews have been for these particular patients. So we actually form an activity.

By placing these data in the EMR, we notice that we receive fewer questions from the nursing staff. Everyone has a central place they can go to in order to see what’s going on with our patients. We even get calls from staff within the clinic, and they’re like, “I was looking at this note, and we noticed that this was going on with the patient.” And, “Thank you, this is how we’re going to move forward.” It’s very exciting to see that happening and to have these conversations.

It’s key that if you’re going to put information into the EMR, to go ahead and develop that activity so that you have a way of collecting these data. We’re able to look at adherence because each month we’re dropping this activity into the patient’s chart and it shows up on the patient’s flow sheet. I can see that if I called this patient on February 15th, I know that we call the patients about 7 days ahead of time. If they tell me they have 20 days of medication remaining, I’m going to say, “What’s going on? It’s not lining up with what’s in our EMR, what we’ve been doing for you over time.” It also allows us to put notes in, like if a patient is on hold because they were having an adverse reaction. We’re able to see the patient over time and calculate these values based on adherence that we’re looking for with our patients. We’re putting activities in the EMRs for these different phone calls that we’re doing for our patients.

 I like how much you’re leveraging the EMR, because I feel like that’s the right thing to do for patient care. Like you said, it puts it out front for all practitioners to see, and people can act on those data.

Videos

Dr Haumschild leads a discussion about maximizing the impact of care through electronic medical record (EMR) utilization.

Practice Pearls

Clinical

Quality Initiatives in MPNs: Electronic Medical Records and Clinical Pathways

Health care facilities can significantly reduce the incidence of hospital-onset 

 (HO-CDI) by establishing interprofessional teams to implement evidence-based, selected infection-prevention intervention, according to the results of a study published in the 

“Our project showed that interprofessional collaboration and continuous improvement can profoundly impact HO-CDI incidence and sustain reductions over years,” Cherith Walter, MSN, RN, from Emory St. Joseph’s Hospital, said in a statement. “We hope our findings will help other health care teams struggling with this incredibly challenging health care-associated infection to improve patient safety and reduce associated costs.”

Walter and other investigators creased an interprofessional team to address the HO-CDI incidence at their 410-bed community hospital, which was consistently about the national CMS benchmark of 

 The interprofessional team comprised an antimicrobial stewardship pharmacist, a clinical microbiologist, a clinical nurse specialist, an environmental service representative, a hospital epidemiologist, an infection preventionist, a physician champion and unit nurse champions.

The team revived the HO-CDI events at their facility between 2014 and 2016 to determine causative factors.

Additionally, they identified appropriate, evidence-based infection prevention interventions, which comprising diagnosis stewardship, including the development of a Diarrhea Decision Tree (DDT) testing algorithm with a nurse-driven ordering protocol; education and accountability, focusing on encouraging compliance with the DDT algorithm; and enhanced environmental cleaning, antimicrobial stewardship, including a system-wide electronic medical record intervention to reduce fluoroquinolone use.

After the first year, the investigators recorded a 63% decrease in HO-CDIs compared with the 2 years prior, which amounted to about 4.72 per 10,000 patient days and 12 per 10,000 days, respectively.

Additionally, the number improved further, showing 2.8 per 10,000 days after 3 years of implementation of the selected interventions, which was a 77% decrease from the baseline.

The investigators also saw a decrease in the facilities standardized HO-CDI infection ratio, which is the total number of infections divided by the National Health Safety Network’s risk-adjusted predicted number of infections. That decreased to 0.43 in 2020 from 1.11 in 2015.

The interventions also improved CDI testing practices, increased testing for appropriate patients within the first 3 days of hospital admission to 81.1% in late 2019 from 54% in 2014 to support prompt treatment of individuals who are infected.

The practice also helped identify and differentiate cases of community-acquired CDI from HO-CDI, which reduced the financial impact of HO-CDIs on the facility after 2016.

Finally, investigators successfully increased compliance with the algorithm from 50% in mid-2018 to 80% in mid-2020, which they said happened because of empowering nurses to hold physicians accountable for judicious test ordering and creating a system of accountability notices that alerted nurses and physicians to DDT algorithm deviations.

“These study findings are exciting, because they suggest that professional collaboration to consistently apply known, evidence-based practices can significantly reduce the incidence of HO-CDI,” Linda Dickey, RN, MPH, CIC, FAPIC, and 2022 president of Association for Professionals in Infection Control and Epidemiology, said in the statement. “They are also the first findings demonstrating the impact of education and accountability interventions in reducing HO-CDI incidence and improving compliance with standards of practice.”.

Interprofessional collaboration leads to significant and sustained reduction in hospital-onset 

 infections. EurekAlert. News release. May 12, 2022. Accessed May 12, 2022. https://www.eurekalert.org/news-releases/952143

Articles

Infections at community hospitals fell by 63% after 1 year and 77% after 3 years, new data show.

News

C. difficile

 Resource Center is a comprehensive resource for clinical news and expert insights on issues related to 

, a bacteria that causes colitis, a serious inflammation of the colon

Infectious Disease

® Infectious Disease Resource Center is a comprehensive resource for clinical news and expert insights on a group of disorders caused by organisms, such as bacteria, viruses, fungi, or parasites.

Hospital

® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to hospital and health-system pharmacists.

Study: Interprofessional Collaboration Reduces Incidence of Hospital-Onset C. Difficile 

Half of individuals who were admitted to the hospital with a 

 infection still have at least 1 symptom after 2 years, according to results of the longest follow-up study to date.

, included 1192 individuals in China who were infected with SARS-CoV-2 during the first phase of the pandemic in 2020.

The analysis suggested that individuals who had COVID-19 still tend to have poorer health and quality-of-life outcomes than the general population, especially for those who have long COVID, which was classified as still having at least 1 symptoms 2 years after initial infection.

“Our findings indicate that for a certain proportion of hospitalized COVID-19 survivors, while they may have cleared the initial infection, more than 2 years is needed to recover fully from COVID-19,” Bin Cao, MD, of the China-Japan Friendship Hospital in China, said in a statement.

“Ongoing follow-up of COVID-19 survivors, particularly those with symptoms of long COVID, is essential to understand the longer course of the illness, as is further exploration of the benefits of rehabilitation programs for recovery.”

The investigators of the study sought to analyze the long-term health outcomes of individuals who were hospitalized with COVID-19, as well as the implications of long COVID. They evaluated the health of 1192 individuals with acute COVID-19, who were treated at Jin Yin-tan Hospital in Wuhan, China, between January 7 and May 29, 2020. They evaluated the individuals at 6 months, 12 months, and 2 years.

The assessment involved laboratory tests, questionnaires, and a 6-minute walking test, looking at health care use after discharge, health-related quality of life, mental health, and whether they had returned to work.

The negative effects of long COVID, pertaining to exercise capacity, health care use, mental health, and quality of life, were determined by comparing individuals who did not have and had long COVID.

Health outcomes at 2 years were determined using age, comorbidities, and sex that were matched to a control group of individuals with no history of COVID-19 infection.

At 6 months after initial COVID-19 infection, approximately 68% of individuals reported at least 1 long COVID symptom. By 2 years, the reports of symptoms had fallen to approximately 55%. Fatigue or muscle weakness were the most reported symptoms and fell from 52% at 6 months to approximately 30% at 2 years.

Regardless of severity of their initial infection, 89% of individuals had returned to their original work at 2 years.

At 2 years after initial infection, individuals with COVID-19 reported generally poorer health, with 31% reporting fatigue or muscle weakness and 31% reporting sleep difficulties. The percentage of individuals who did not have a COVID-19 infection reported these symptoms at 5% and 14%, respectively.

Additionally, those with COVID-19 were more likely to report other symptoms, including dizziness, headaches, joint pain, and palpitations. In the questionnaires, approximately 12% of individuals with COVID-19 reported anxiety and depression and 23% of reported discomfort or pain compared with 5% and 5%, respectively, for individuals who did not have a COVID-19 infection.

Furthermore, approximately half of study participants had symptoms of long COVID at 2 years and reported lower quality of life than those who did not have long COVID. In the questionnaires, approximately 19% of individuals reported anxiety or depression, and 35% reported discomfort or pain, while those who did not experience long COVID reported these symptoms at 4% and 10%, respectively.

Additionally, 5% of individuals who had long COVID also experienced problems with their activity level at 4% and mobility at 5% compared with 2% and 1%, respectively, for those who did not experience long COVID.

The mental health assessment found that individuals with long COVID displayed symptoms of anxiety at 13% and symptoms of depression at 11% compared with those without long COVID at 3% and 1%, respectively.

Furthermore, those with long COVID used health care services more often at discharge, with 26% reporting an outpatient clinic visit compared with 11% of those without long COVID. Hospitalization was reported at 17% for those with long COVID and 10% for those without long COVID.

Investigators said their study had limitations, including lacking a control group of individuals who were in the hospital unrelated to a COVID-19 infection, which made it hard to determine whether observed abnormalities were specific to COVID-19.

: Two years after infection, half of people hospitalized with COVID-19 have at least one symptom, follow-up study suggests. EurekAlert. News release. May 11, 2022. Accessed May 12, 2022. https://www.eurekalert.org/news-releases/952229

Individuals who have recovered from the initial disease are in generally poorer health later on compared with the general population, the analysis shows.

Retail

® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to retail, community, and independent pharmacists.

Coronavirus

® Coronavirus Disease Resource Center is a comprehensive resource for clinical news and expert insights on COVID-19, an infectious disease caused by the SARS-CoV-2 virus, including vaccine information and treatments for the disease.

Study: Half of Patients Hospitalized With COVID-19 Have at Least 1 Symptom 2 Years Later

 spoke to Melissa Castora Binkley, PQA Senior Director of Research, about different research projects using PQA's methods.

 A quantitative research project that we're doing right now is looking at how medication adherence is related to outcomes. This is an area where there's actually a lot of research and a lot of evidence that suggests that adherence is associated with outcomes. But we're going to dive a little bit deeper into the disparities and how there's disparities in terms of outcomes related to adherence. For qualitative research, we have a really cool project where we're interviewing patients to find out more about their experience with comprehensive medication reviews. So it's really important to make sure we understand the patient experience and there are calls for more measures related to patient experience and patient reported outcomes. But sometimes you have to take a step back and start with the evidence and sometimes you find out that there's not enough evidence to support a measure. So right now we're building that evidence base by talking to patients understanding their experiences, and eventually creating a conceptual framework which will lead us to a tool to actually measure patient experience related to comprehensive medication reviews.

One of PQA's quantitative research projects that they are working on now is looking at how medication adherence is related to outcomes.

Conference

Using Different Research Methods for Medication Adherence

Asundexian (BAY2433334) is an investigational, orally administered coagulation factor XIa (FXIa) inhibitor. In contrast to available anticoagulants, research shows that FXIa inhibitors, through selective inhibition of the intrinsic coagulation cascade, can reduce the occurrence of thrombosis without increasing bleeding risk.

In February 2022, Bayer announced that the FDA granted asundexian Fast Track Designation based on the preliminary findings of PACIFIC-STROKE (NCT04304508), a phase 2 study evaluating asundexian’s safety and efficacy when combined with antiplatelet therapy in patients following an acute, non-cardioembolic ischemic stroke.

A 3-part study of more than 4000 patients world-wide, the PACIFIC (Phase 2 Program of Anticoagulation via Inhibition of FXIa by the Oral Compound BAY2433334) program is also exploring the role of asundexian (vs apixaban) in stroke prevention in patients with non-valvular atrial fibrillation (PACIFIC-AF, NCT04218266) and as secondary prevention (vs placebo) in combination with antiplatelet therapy following acute myocardial infarction (MI) (PACIFIC-AMI, NCT044303434).

A phase 1 study (NCT04510987) to evaluate asundexian’s pharmacokinetics, pharmacodynamics, and safety in subjects with varying degrees of renal compromise (including dialysis-dependence) is ongoing.

Asundexian is a chemically synthesized, small molecule that binds to and inhibits the activity of the active, catalytic site of FXIa. Through selective inhibition of the intrinsic coagulation pathway, asundexian may prevent pathological clot formation (thrombosis) without hindering hemostasis (clotting that occurs in response to injury).

For the secondary prevention of non-cardioembolic stroke or MI, phase 2 PACIFIC program participants receive investigational doses of 10 mg, 20 mg, or 50 mg.

 For the prevention of stroke in non-valvular atrial fibrillation, phase 2 PACIFIC program participants receive investigational doses of 20 mg or 50 mg.

A phase 1 dose-escalation and food interaction study has shown asundexian may be taken without regard to meals. Of note, asundexian does not appear to have any clinically meaningful effect on CYP3A4 activity.

Asundexian has been well tolerated in phase 1 studies. In a phase 1 dose-escalation and food interaction study, researchers screened 86 healthy men for treatment-emergent AEs (TEAEs), including treatment-related bleeding, hepatobiliary dysfunction, and pancreatic disorders.

The reported TEAEs attributed to the study drug in 8.6% of 70 subjects in the dose escalation study included dysgeusia (n=4), nausea (n=1) and ventricular ectopic beats (n=1). In the food-interaction portion of the study (n=16), 2 subjects experienced a TEAE attributed to asundexian.

The first subject reported palpitations, vertigo, and sensation of a foreign body. The second subject reported paresthesia, xerostomia, and feeling cold. No clinically significant electrocardiogram, physical examination, or laboratory findings were observed in any subject.

In a separate phase 1 dose-escalation study of 48 healthy men, headache was the most common TEAE, followed by nasopharyngitis. All events were considered mild and no clinically significant electrocardiogram, physical examination, or laboratory findings were observed in any subject.

Asundexian appears to be well tolerated based on phase 1 studies, however these studies were performed using small groups of healthy subjects.

Results of larger phase 2 studies are yet to be reported and phase 3 studies have not yet begun.

Asundexian has not been studied in pregnant women. It is unknown whether the drug is passed into breast milk.

Allison T. Rhoads, PharmD, is a clinical pharmacist at an outpatient oncology center in Tallahassee, Florida.

Thomas D, Kanefendt F, Schwers S, Unger S, Yassen A, Boxnick S. First evaluation of the safety, pharmacokinetics, and pharmacodynamics of BAY 243334, a small molecule targeting coagulation factor XIa. 

 2021;19(10):2407-2416. doi:10.1111/jth.15439

Fredenburgh JC, Weitz JI. New anticoagulants: Moving beyond the direct oral anticoagulants. 

J. Kakkar A, Weitz J, Büller H, Connors J. Factor XI inhibition: The holy grail of haemostasis-sparing anticoagulation. Presented at: 

International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

https://www.emjreviews.com/hematology/symposium/factor-xi-inhibition-the-holy-grail-of-haemostasis-sparing-anticoagulation-j190421/

Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding phase 2 study to evaluate efficacy and safety of BAY2433334 in patients following an acute non-cardioembolic ischemic stroke. ClinicalTrials.gov identifier: NCT04304508. Updated February 9, 2022. Accessed March 9, 2022. 

https://clinicaltrials.gov/ct2/show/NCT04304508

Bayer Receives U.S. FDA Fast Track Designation for asundexian Stroke Program. News release. Bayer Communications. February 10, 2022. Accessed March 9, 2022. 

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-Receives-US-FDA-Fast-Track-Designation-for-asundexian-Stroke-Program?Open&parent=news-overview-category-search-en&ccm=020

Investigation of pharmacokinetics, pharmacodynamics, safety, and tolerability of a single oral dose of 25 mg BAY 2433334 in male and female participants with different stages of renal impairment (including on dialysis), as compared to age, gender and weight matched participants in a single-center, non-randomized, non-controlled, non-blinded, group stratification design study. ClinicalTrials.gov identifier: NCT04510987. Updated December 22, 2021. Accessed March 10, 2022. 

https://clinicaltrials.gov/ct2/show/NCT04510987

Kubitza D, Heckmann M, Distler J, Koechel A, Schwers S, Kanefendt F. Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study. 

Published online January 10, 2022. doi:10.1111/bcp.15230

Asundexian was granted FDA Fast Track Designation based on a phase 2 study evaluating its safety and efficacy combined with antiplatelet therapy in patients following an acute, non-cardioembolic ischemic stroke.

Cardiovascular Health

® Cardiovascular Health Resource Center is a comprehensive resource for clinical news and expert insights on the health of the heart and blood vessels, including coronary heart disease, stroke, heart failure, heart arrhythmias, and heart valve issues.

Clinical Overview: Asundexian for Secondary Prevention in Patients With Non-Cardioembolic Ischemic Stroke

Pharmacistsa are a viral part of the health care ecosystem, relied on by patients to help them navigate an evermore-complex health care system.

Their first-hand knowledge about the challenges patients face at the pharmacy counter is vital to the conversation about how the ecosystem is or is not serving patients.

When I was in pharmacy school, I thought the relationship between drug company, patient, payer, and pharmacy was straightforward: Drug companies make drugs and ship them to pharmacies; patients buy health insurance from payers, who pay pharmacies for the drugs; patients obtain their drugs from the pharmacy and go home happy (Figure 1).

As any pharmacist can attest, that is not how the system works. Medications and the payments for them do not travel on a superhighway connecting the laboratory bench to the insurance company and the patient at the pharmacy counter. The system is opaque, chock-full of confusing road signs, detours, and traffic lights.

Typically, those detours do not proceed in a smooth, far less affordable, manner that would allow patients to benefit from the immense value pharmaceutical innovations provide (Figure 2). The complicated rules that govern this system have an enormous impact on patients. At present, patients often struggle to navigate this complex and costly system because not all the parts of the supply chain work together smoothly.

Pharmacists, with their patient-centered role in the ecosystem, are uniquely positioned to observe how the system affects patients.

They can help patients better navigate the complexities and costs they face by deepening their own understanding of how all the system parts interact.

I was honored to share this message with faculty members and pharmacists in training at the University of Mississippi School of Pharmacy (Ole Miss School of Pharmacy in March 2022, when I visited the campus to deliver the annual Charles W. Hartman Memorial Lecture. In conversations with faculty members and students during my visit, it became clear that understanding how drugs are paid for would make them better pharmacists and better serve patients, even though pharmacists do not go to school to learn about reimbursement policy. Some of the conversations at Ole Miss School of Pharmacy that excited me the most highlighted the unique perspective that pharmacy school training gives pharmacists setting them up to make key contributions to ongoing conversations about how to help this system work better for patients.

Navigating Insurance Plan Drug Benefit Designs

Understanding insurance plan drug benefit designs is increasingly important for pharmacists, so they can help patients. When people talk about the high price of a medication, they are talking about the price they paid at the pharmacy counter. The biggest influence on that out-of-pocket cost? The rules of the patient’s insurance plan.

Pharmacists across the country are already working every day to help patients navigate what are often inadequate and usually confusing drug benefits that can vary greatly. But understanding the plan rules is important for helping patients stay healthy, because navigating co-pay accumulator adjustment programs or step therapy can be detrimental to a patient’s health.

The co-pay programs can be a particular roadblock for patients to get the medicines they need. Research results have shown that patients who find out that their health insurance plans will not apply coupons to their deductibles often stop filling their prescriptions.

Of course, many individuals have the opportunity to select a new health plan at least once a year. But the unfortunate reality is that in some cases, there is not enough transparency about the drug benefit design for many patients to know for sure whether a medication they need will be covered by insurance.

Recognizing the Flaws of the Rebate System

Another part of the system that is wholly

lacking in transparency concerns rebates.

Despite the rhetoric surrounding intermediaries, such as pharmacy benefit managers (PBMs) as cost savers, data show that the fees, rebates, and other perverse incentives do not save money but add to costs. IQVIA research results showed they pushed up US payer drug costs by 19%, or $135 billion, in 2020. These increases come as STAT reported that the 5 largest PBMs are handling a massive sum of gross drug revenue, up 56% since 2015.

 These increases are felt by patients at the pharmacy counter. Other IQVIA findings showed 33% of drug spending in 2020 went to an entity other than the drug company that made the medicine but not to the patient.

The impact this has on patients at the pharmacy counter is why we are glad to see the Federal Trade Commission examining the role of PBMs and what impact their fees and rebates have on net drug prices, formularies, and patient access.

The shadowy system of hidden fees and rebates is also driving up costs for the government and, in some cases, driving pharmacies out of business.

For example, take direct and indirect remuneration fees: Findings in a recent report sponsored by the American Pharmacists Association showed that by narrowing the gap between gross and net prices, Medicare Part D could save more than $18 billion annually.

Following the Evidence to Help Patients at the Pharmacy Counter

The conversations I had at Ole Miss School of Pharmacy caused me to reflect on my journey from pharmacy school to the National Pharmaceutical Council (NPC) and how the patient-centered perspective of pharmacists is important in conversations on making the system work better for patients. At NPC, we will continue our mission to provide high-quality data on the value that medicines deliver to patients and society and how proposed policy solutions can affect patient access and affordability.

Frustratingly, policy conversations focus too little on the impact a policy might have on patients and more on Capitol Hill insider baseball. Take the recent conversations about proposals to allow the government to set prices for drugs: The Congressional Budget Office has continued to write in its reports that government price setting will lead to fewer drugs coming to market. It is impossible to predict which drugs would not be available and for which conditions. That would have a negative effect on patients.

Further, it is unclear that patients would save money at the pharmacy counter from these price controls.

NPC’s research with Xcenda showed that just 1 in 4 health plan decision-makers surveyed would pass savings from lower-priced drugs along to patients at the pharmacy counter.

 A patient-centered view would say that making policy decisions on sound data and research is essential to helping the parts of the system work better together on behalf of patients.

It is a critical time for this work, and we need more people to join us. I have been fortunate in my career to have met mentors who helped me see the impact pharmacists could have by working at the intersection of pharmacy, research, and policy. NPC welcomes the chance to speak with pharmacists who find themselves at the intersection of their formal education and the broader health care policy conversation, and we invite pharmacists to connect with us and talk to us when planning research.

 The profession would benefit if more decision-makers adopted the patient-centric mentality of pharmacists. Keeping the North Star of that patient at the pharmacy counter in sight can help us arrive at solutions that help the health system work for patients.

is president and CEO of the National Pharmaceutical Council.

1. Starner CI, Alexander GC, Bowen K, Qiu Y, Wickersham PJ, Gleason PP. Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums. Health Aff (Millwood). 2014;33(10):1761-1769. doi:10.1377/hlthaff.2014.0497

2. Herman B. The biggest PBMs are handling more and more of the country’s drug price negotiations. STAT. March 22, 2022. Accessed April 14, 2022. https://www.statnews.com/2022/03/22/pharmacy-benefit-managers-revenue-contracts/

3. The use of medicines in the US: spending and usage trends and outlook to 2025. IQVIA. May 27, 2021. Accessed April 14, 2022. https://www.iqvia.com/insights/the-iqvia-institute/reports/the-use-of-medicines-in-the-us

4. Deserving of better: how American seniors are paying for misaligned incentives within Medicare Part D. 3 Axis Advisors. March 7, 2022. Accessed April 14, 2022. https://www.3axisadvisors.com/projects/2022/3/7/deserving-of-better-how-americanseniors-are-paying-for-misaligned-incentives-within-medicare-part-d-3aa

5. Affordability is about more than drug prices. National Pharmaceutical Council. July 21, 2021. Accessed April 14, 2022. https://www.npcnow.org/resources/affordability-about-more-drug-prices

6. Submit a research proposal. National Pharmaceutical Council. Accessed April 14, 2022. https://www.npcnow.org/get-involved/submit-research-proposal

Health care policy decisions based on sound data and research are essential for addressing the challenges.

Improve the Pharmaceutical Ecosystem for Patients

, recognizing a disease that can be both acute or chronic as well as infectious and non-infectious.

Hepatitis can have a widespread impact on the health

 and pharmaceutical needs of patients. It also carries a stigma that may make patients hesitant to seek treatment or disclose their condition.

As a result, providers may not be aware of unique pharmacotherapy requirements these patients may have. Prevention, optimal disease state management, and appropriate pharmacokinetic and therapeutic attention are all part of the holistic approach to hepatitis care.

Many of patients with hepatitis that pharmacists encounter have viral hepatitis, which can be easily remembered as the ABCs of hepatitis. Starting with the A for hepatitis A virus (HAV), the Centers for Disease Control and Prevention’s Division of Viral Hepatitis has noted an increasing number of HAV cases since March 2017.

This is thought to be linked to imported foods that had been contaminated, causing primary infection continuing to spread from person-to-person. HAV infection can be prevented through a vaccine, good hygiene, and patients decreasing their risk factors.

Promoting the HAV vaccine to patients, especially those at high risk of HAV infection, can be arguably the best preventative measure to ensure a patient’s safety, as HAV can result in cholestatic hepatitis, relapsing hepatitis, autoimmune hepatitis or even liver disease. Just one dose of inactivated HAV vaccine can provide protection from HAV for up to 11 years.

Risk factors for contracting HAV include illicit drug use, sexual contact with a person infected with HAV, contact with a person infected with HAV, homelessness, and travel to countries where HAV is prevalent including, Saudi Arabia, Syria, Turkey, and Eygpt.

 The spread of HAV can be reduced through good hand hygiene after using the restroom following contact with body fluids or stool, and through avoiding unsanitary food and water sources.

The role of the pharmacist has been highlighted in various HAV outbreaks across the United States. Once such pharmacist, Dr. Monica Payne, a pharmacist from Section, Alabama, was on the front lines of fighting HAV in her community during an outbreak in 2019.

“The hepatitis A outbreak in 2019 was a trying time for our community, but it was also an excellent opportunity for pharmacists to show what we can do as the most accessible healthcare providers,” Payne said

In late 2018, North Alabama, including Jackson County and Section, saw the start point of an outbreak that eventually made its way through the entire state by the end of 2020.

 Payne’s community pharmacy, Section Pharmacy, worked with the Alabama Department of Public Health to provide vaccine clinics in rural areas near Section where many patients did not have adequate transportation to a pharmacy or prescriber's clinic.

“We vaccinated hundreds of individuals across Jackson County to help control the outbreak, and we were proud to do our part in protecting the health of our community,” Payne said.

In contrast to HAV, there has been a steady decrease in hepatitis B virus (HBV) cases over the past 10 years. HBV prevalence has decreased in correlation with an increased vaccine prevalence. From 1999 to 2018, infection rates decreased from 5.7% to 4.3% with higher rates in men and non-Hispanic, Asian adults.

HBV can be contracted through sexual contact, contaminated blood, or be passed from mother to newborn. Due to this, vaccination was advocated for newborns and is correlated with today's decreased past and current cases of HBV.

It is important to continue to advocate for the HBV vaccine to all patients as severe complications can lead to cirrhosis, liver failure or kidney disease. During the years of 2015-2018, 25.2% of adults over 18 years of age had been vaccinated for HBV.

 Women had a higher prevalence of vaccination history, which would correlate with women having a lower prevalence for being infected.

These numbers and correlations of infections to vaccinations clearly depict a linear relationship of vaccinations lowering the number of infections and is why pharmacists should advocate for all patients to be fully vaccinated.

 A study published in 2020 showed clinically significant data that clinical pharmacists improved the attitude of patients living with HBV toward their infection and increased their knowledge about HBV through interviews.

During these interviews the pharmacists elicited what the patient currently knew about the disease, corrected any misinformation, and then further educated them about HBV. After the interviews, patients indicated that their attitudes toward HBV had improved now that they had gained more knowledge about the disease.

Also, as a rule, the better educated a patient is about their condition, the more likely they are to be adherent to their medication and non-pharmacological recommendations, improving patient outcomes.

Unlike HAV and HBV, hepatitis C virus (HCV) is more common in the United States. An estimated 2.4 million Americans are currently living with HCV.

In 2018, a conservative estimate of 14,242 deaths in the United States were reported as a result of chronic HCV.

Although this number continues to decline each year, pharmacists still need to promote the importance of risk reduction and frequent testing of those at high risk because complications of HCV can result in cirrhosis or liver cancer.

HCV is spread through contact with blood from an infected person and no vaccine is currently available for prevention. Pharmacists should encourage patients to get tested for HCV, because it often has no signs or symptoms and can lead to liver cancer if left untreated.

One population of high risk that pharmacists should recommend screening for are those born between the years 1946-1964, also known as the Baby Boomers. Risk reduction and early diagnosis are the best ways to increase the patient’s chances of a positive prognosis.

Talk with your peers about their comfortability level of performing point-of-care testing and providing basic education about HCV. A survey in 2019 was sent out to pharmacists in community settings that inquired about their comfortability level of performing point of care testing and patient education for HCV.

This survey concluded that the pharmacists surveyed were in support of the implementation of HCV point of care testing and that they would be willing to provide basic patient education.

 Having community pharmacists available for HCV testing could open the door for many patients who may feel more comfortable not going to a physician’s office and feel more comfortable with their pharmacist.

In the same mindset, National Hepatitis Testing Day is May 19. Use this day as an opportunity to discuss the importance of testing with patients to help protect themselves and others around them.

One study illustrated the impact clinical pharmacists have on the outcomes of patients with HCV and HIV coinfections. The most notable roles the pharmacist played within the study included HCV medication adherence counseling, HCV drug-drug interaction counseling and screening, HCV medication counseling regarding common adverse events (AEs), HCV counseling regarding HCV treatment outcomes and risk of reinfection, ordering laboratory tests, and interpreting the HCV laboratory values.

The study was conducted to compare AEs and outcomes between groups of patients who had contact with a clinical pharmacist versus those who did not. The results were in favor of a clinical pharmacist’s expertise as part of a multidisciplinary care team to decrease AEs, increase favorable outcomes, and have better drug management for patients living with HCV/HIV coinfections.

Studies such as these show the importance of pharmacists caring for patients with special pharmacokinetic indications, like hepatitis.

In addition to HAV, HBV, and HCV, there is also acute non-viral hepatitis. Acute non-viral hepatitis can stem from exposure to some medications, illegal drugs, alcohol overuse, and toxins.

Some autoimmune diseases can also lead to acute hepatitis, especially when they go uncontrolled for a prolonged period of time.

 These autoimmune diseases include thyroiditis, type 1 diabetes, hemolytic anemia, and celiac disease.

This illness results in inflammation of the liver that could progress to liver disease. In 2021, cases of acute non-viral hepatitis with unknown etiologies were suspected to have been derived from “Real Water” alkaline water, a brand that was recalled due to lack of compliance with the FDA.

Pharmacists can counsel patients to not consume products not approved by the FDA, help control any other comorbid conditions patients have, and to watch for signs and symptoms, such as fatigue, fever, abdominal pain, and joint pain.

Take time to educate patients on all-things hepatitis during the month of May. Educate patients on available vaccines, regular testing, and risk factors for contracting HAV, HBV, and HCV, as well as non-viral hepatitis.

Promote patient testing and immunizations, educate yourself on ways to promote hepatitis awareness, new testing procedures, and new treatment methods when available. Aside from educating patients, take the time to educate other health care professionals around you about the importance of hepatic dose adjustments for patients who have liver diseases.

It is instinct for many providers to double-check renal dose adjustments, but many may be unaware of the need for modifying the dose of drugs that are hepatic cleared to keep the patient safe and the drug at therapeutic concentrations. Overall, pharmacists hold a unique role in fighting hepatitis because of their extensive knowledge of pharmacokinetics and pharmacodynamics when treating hepatitis and preventing further liver damage.

Pharmacists are also the most easily accessible health care provider and can provide a safe and convenient space for patients to get tested and vaccinated against hepatitis.

“Widespread Outbreaks of Hepatitis A Across the U.S.” 

Centers for Disease Control and Prevention

, 2 May 2022, https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm.

Ott JJ, Wiersma ST. Single-dose administration of inactivated hepatitis A vaccination in the context of hepatitis A vaccine recommendations.

2013 Nov;17(11):e939-44. doi: 10.1016/j.ijid.2013.04.012. Epub 2013 Jun 21. PMID: 23791857.

McMahon BJ, Beller M, Williams J, Schloss M, Tanttila H, Bulkow L. A program to control an outbreak of hepatitis A in Alaska by using an inactivated hepatitis A vaccine. 

 Med. 1996 Jul;150(7):733-9. PubMed PMID: 8673200.

Ghasemian A. Prevalence of hepatitis A across various countries in the Middle East, African and Eastern European countries. 

Centers for Disease Control and Prevention. (2022, March 30). 

Many of patients with hepatitis that pharmacists encounter have viral hepatitis, which can be easily remembered as the ABCs of hepatitis.

Latest Clinical News