The 2017-2018 flu season-one of most severe in recent U.S. history-drove home the need for increased vaccinations and for current data on the illness and its spread. Fortunately, the CDC, Walgreens, and other entities track the areas of the country where influenza is most severe and hospitalizations and mortalities attributed to the flu, and also provide updates on the effectiveness of anti-influenza drugs against the circulating influenza strains.

Using weekly retail prescription data for antiviral flu drugs across Walgreens and Duane Reade stores nationwide, Walgreens Flu Index ranks the top 10 states as well as the top 10 designated market areas (DMAs) with flu activity by those experiencing the greatest gains in activity week-over-week.

“The Walgreens Flu Index can help pharmacists educate patients on the prevalence of flu activity in their communities, stressing the importance of getting the flu shot to help protect your- self and others from influenza,” Dorothy Loy, PharmD, director of immunizations at Walgreens, tells Drug Topics.

The data for the index, which was launched in December 2014, is analyzed at state and geographic market levels to measure absolute impact and incremental change of antiviral medications on a per store average basis, Loy says.

Walgreens updates the index each week during the flu season, with the turnaround time in data at just a few days, according to Loy.

Weekly U.S. Influenza Surveillance Report

The CDC’s Weekly U.S. Influenza Surveillance Report tracks influenza activity across all 50 states, and reveals the prevalence of flu strains by influenza A subtype (H1 or H3) and influenza B.

Especially helpful for pharmacists is the CDC’s antiviral resistance monitoring within the report. “All viruses tested since late May show susceptibility to the antiviral drugs oseltamivir [Tamiflu], zanamivir [Relenza], and peramivir [Rapivab],” CDC wrote in its November 24 report. Xofluza (baloxavirmarboxil) will also be available this flu season.

Data for CDC’s weekly surveillance report comes from WHO and National Respiratory and Enteric Virus Surveil- lance System (NREVSS) collaborating laboratories (which include both pub- lic health and clinical labs).

The labs, located in all 50 states, Puerto Rico, Guam, and the District of Columbia, report the total number of respiratory specimens tested for influenza and the number positive for influenza by virus type, CDC explains on its web site.

The Epidemiology and Prevention Branch in the Influenza Division at the CDC then collects and compiles the data and produces FluView, a weekly influenza surveillance report, and FluView Interactive, which allows for more in-depth exploration of influenza surveillance data-such as flu activity during past seasons.

The information allows CDC to track influenza-related illness, find out when and where flu activity is occurring, determine which viruses are circulating, detect changes in viruses, and measure the impact influenza is having on hospitalizations and deaths, Kristen Nordlund, a CDC spokesperson, tells Drug Topics.

There is a two-week lag time in the weekly influenza surveillance reports, Nordlund says. Influenza surveillance data collection is based on a reporting week that starts on Sunday and ends the following Saturday of each week. Participants summarize weekly data and submit it to CDC by Tuesday after- noon of the following week.

Other organizations and companies provide influenza prevalence reports. In partnership with the Weather Channel, U.S. Theraflu’s Cold and Flu Tracker aggregates social media mentions and community crowdsourcing to develop its “Sickscore,” an “easy-to-understand, real-time threat level of contagious cold and flu activity near you,” according to the web site.

Another influenza tracking resource is Flu Near You, created by Harvard, Boston Children’s Hospital, and the Skoll Global Threats Fund. Using crowd-sourced data from thousands of participants across the nation, the site lists flu activity for the past 7 days by state. Site visitors can also view the CDC’s weekly influenza data across the United States.

Articles

Tracking the disease from 2010 to the end of 2018.

Influenza Update

It was twenty years ago this summer, in 1998, that my wife and I attended a drug company-sponsored event in State College, PA, and were delighted to run into two of our classmates from the class of 1981. One is a well-known clinical pharmacist for a health system about one hour from our home. He is an outstanding pharmacist, mentor, and teacher. His skill set is acute care, and he’s an expert with respect to acid-base balance in the intensive care unit.

The other classmate is the director of pharmacy of an area hospital. Both guys are top-flight pharmacists. The conversation quickly changed to community pharmacy. Both were insistent that by 2008, there would be no such thing as a retail pharmacy. “By then there will be kiosks setting around, and the patient will walk up insert a card and their meds will drop out, just like buying a soda from a vending machine.” 

I asked, “So how will these prescriptions get into the machine?”  Their answer “Robots-by 2008 this profession will be so automated, there will be no reason to have a human involved.”

I must say these two guys really got my attention. I think of our conversation frequently, and just shake my head. We are 10 years past that prediction of what was to occur in 2008, and our patients in the community setting are needier than ever. My patients can’t (or won’t) use the Interactive Voice Response system to order their refills. They simply press “0” to talk to someone, and then frequently say “Just get everything ready.” The patients don’t have prescriptions numbers, or even drug names. We won’t even mention insurance card issues, prior authorizations, adherence, or even the refill status of their prescription. Our patients simply can’t navigate the ever-complicated healthcare system.

I do see the frustration of my fellow pharmacists practicing in the community setting. Low reimbursements, overwhelming workloads, reduction in staffing and long hours make many pharmacists less than satisfied with their career choice. I keep my sanity by thinking of all the patients I help with effective patient counseling and with the wonderful relationships I’ve developed with both the local physicians and patients.

I make every attempt to practice “at the top of my license,” by always networking with other professionals, learning the latest information, and teaching future pharmacists and physician assistants, all for the benefit of my patients. If I don’t, I could easily be disgruntled with the numerous shortcomings of this profession. I often tell my student pharmacists that the attractive salary or “golden handcuffs” is one of the biggest challenges of this profession. Because of the salaries this profession commands, we seem to put up with understaffing, lack of lunch breaks, and even the day-to-day hassles from physicians, patients, and management just because of what is printed on our W-2 form at the end of the year.

I don’t see my patients as interruptions to what I am doing. I see my patients as what I am supposed to be doing. They are my reason for going to work. They are why I put on a clean ironed shirt (thanks to my attentive wife, Denise), wrap a Pancaldi tie around my neck (thanks to a pharmacist friend Jerry), put on my white lab coat, and open the drug store.
	When 9 a.m. strikes, the phone rings off the wall, patients have tons of questions, lots of interventions, and patient interactions remind me that I won’t be replaced by a robot any time soon. Throw in a couple of immunizations, and I quickly realize how much my patients need my level of expertise. No doubt in the next 10 years that none of my brothers or sisters in the community pharmacy will be replaced by a vending machine!

The key to job satisfaction lies in your perspective.

Opinion: Job Satisfaction is a Choice

In September, the FDA approved dacomitinib (Vizimpro, Pfizer), a second-generation selective nonreversible inhibitor of epidermal growth factor receptor (EGFR), as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutation detected by an FDA-approved test.


	EGFR is a transmembrane protein growth-signaling receptor. It’s over expression has been implicated in numerous human cancers with most prominence in lung, head and neck, and glioblastomas.

Approval of dacomitinib was based on a randomized controlled multicenter open-label clinical trial enrolling 452 patients with unresectable stage IIIB/IV EGFR-positive NSCLC (ARCHER 1050).

 The ARCHER trial consisted of two arms comparing safety and efficacy of dacomitinib versus gefitinib, a previous first-line therapy option for EGFR-positive NSCLC.

Patients in the dacomitinib arm received 45 mg by mouth daily, while gefitinib was dosed at 250 mg by mouth daily. The primary outcome measure was progression-free survival (PFS) as determined by blinded Independent radiological central review panel

To be enrolled in the trial, patients had to have an Eastern Cooperative Oncology Group performance status score of 0 or 1. They also had to have no prior therapy for metastatic disease or be at least 12 months without recurrent disease.

The trial showed improvement in median PFS at 14.7 months (95% confidence interval [CI], 11.1-16.6) in the dacomitinib arm and 9.2 months (95% CI, 9.1-11.0) in the gefitinib arm (hazard ratio [HR], 0.59, 95% CI, 0·47-0·74; p<0·0001). Median duration of follow-up for progression-free survival was 22.1 months (95% CI, 20.3-23.9).

Overall survival was also improved, with a median overall survival time of 34.1 months with dacomitinib compared with 26.8 months with gefitinib (HR, 0.76; 95% CI, 0.582-0.993, p=0.44).

Of the 227 patients who received dacomitinib, 27% experienced serious adverse reactions. The most common adverse events reported included diarrhea (87%), paronychia (61%), acneiform rash (49%), stomatitis (44%), decreased appetite (31%), dry skin (27%), decreased weight (25%), alopecia (24%), cough (21%), and pruritus (20%).

 Interstitial lung disease (ILD,  0.4%) and grade 3 diarrhea (8%) were the two side effects that most frequently resulted in discontinuation of the study drug.

For patients developing respiratory symptoms (cough, shortness of breath) indicative of possible ILD, dacomitinib should be held.

 If these symptoms worsen (exertional dyspnea, fever) or ILD is confirmed, treatment should be permanently discontinued.

Patients who develop grade 3 to 4 diarrhea should have their medication held until symptoms resolve and then should be restarted at the same or lower dose. Diarrhea should be treated at the onset with antidiarrheals (loperamide or diphenoxylate hydrochloride/ atropine sulfate).

Dacomitinib exhibits a drug-drug interaction with proton pump inhibitors, which should be discontinued; histamine-2 receptor antagonists and antacids are permitted. Medications that are cytochrome P450 (CYP)2D6 substrates also exhibit interactions with dacomitinib and should be avoided as concomitant usage can cause elevated medication levels.

Females with childbearing potential should be advised to use effective contraception while taking, and for at least 17 days after discontinuing, dacomitinib.

Recommended dosing for dacomitinib is 45 mg daily by mouth, with or without food. If a dose is missed, or vomiting occurs shortly after taking, another dose should not be taken. Patients should resume with the next scheduled dose of the medication.

This medication is available in 15-mg, 30-mg, and 45-mg formulations.

Matthew J. Hadfield, DO is an intern in internal medicine at UConn Health.

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

1. Center for Drug Evaluation and Research. (2018, September 28). Approved Drugs - FDA approves dacomitinib for metastatic non-small cell lung cancer. Retrieved Oct. 30, 2018, from https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm621967.htm.

2. Harari PM. Epidermal growth factor receptor inhibition strategies in oncology. Endocrine-related cancer 11.4 (2004): 689-708.

3. Wu YL et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol 18.11 (2017): 1454-1466.

4. Mok TS, Cheng Y, Zhoe X, et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR activating mutations. J Clin Oncol. 36 (2018): 2244-2250.

5. Package Insert. Vizimpro.  November 2018.Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf. Accessed on Nov. 13, 2018.

Approved by the FDA in September, this new drug serves as a first-line therapy for patients with particular metastatic non-small lung cancer.

Dacomitinib Approved for Non-Small Cell Lung Cancer

Within the next five years, people with diabetes will wear sensors that will alert them to healthy food choices when they arrive at a restaurant, predicts David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center in San Mateo, CA.

The GPS-based technology, says Klonoff, will be preprogrammed with dietary preference information based on a sound diet that is less likely to raise blood glucose levels and leads to slightly lower A1c levels and complications.

Klonoff also projects more widespread use of continuous glucose monitors (CGMs) that include alarms with personalized notifications. The alarms signal for very low or very high glucose levels before they become dangerous and, as a result, reduce the incidence of hospital admissions for hypoglycemia. Eventually, CGMs also will decrease the rates of admission for chronic complications of diabetes related to high glucose levels, such as heart attack and kidney failure, he says.

CGM technology will also become more portable, accurate, last longer, require less calibration, and yield more decision support, according to Klonoff. “The technology will gradually push self-monitoring of blood glucose out of the marketplace for about half of patients who currently use it.”

Michael LeMay, MD, an endocrinologist at Hartford Hospital in Hartford, CT, agrees that CGM devices will continue to evolve and improve. Already, the latest CGMs are more portable and powerful than first-generation models, he says. They’re also easier to use and the science behind them is exponentially more accurate

In addition to an alarm that alerts users to high or low glucose levels, he says CGMs may include features such as:

The ability to record (based on user input) meals, physical activity, and medicines;

The ability to download data to a computer or smart device so trends can be monitored more easily; and

The ability to immediately transmit information to the smartphone of a parent, partner, or caregiver.

One study of women with type 1 diabetes found that the use of a CGM during pregnancy results in healthier moms and babies. The study showed that using a CGM during and prior to pregnancy improves health outcomes because women who used a CGM spent 100 extra minutes per day with blood sugars in a healthy range. That results in their babies being less likely to have hypoglycemia postpartum.
	The study appeared in The Lancet in 2017.

According a survey of 339 patients and healthcare providers that appeared in Diabetes in Control in March, 39% of patients with type 1 diabetes are using CGMs and healthcare providers see a steady upward trend in their adoption, In fact, providers who took the survey estimate that 77% of their type 1 patients will be using CGM five years from now.

Practitioners believe CGM usage in patients with type 2 diabetes will soar in the next five years. Currently, they estimate 11% of these patients are using CGMs; in five years, they expect that will increase to 46%.

But according to Schafer Boeder, MD, Division of Endocrinology, at the University of California, San Diego, only about 15% to 20% of patients with type 1 diabetes-and a much smaller percentage of patients with type 2 diabetes-in the United States, are believed to be using a CGM.

“Cost is a major barrier, though lack of familiarity by both patients and providers is also an issue,” he says.

Although LeMay encourages patients to use CGMs, issues like insurance coverage prohibit some from doing so. “I’ll give a patient a sample sensor, which they get used to and love, but when they try to put in a prescription for it, they find it’s too expensive. Sometimes, insurance companies lag behind.”

Chuck Green has covered healthcare for more than 10 years.

Up Next: 'The Artifical Pancreas' by Karen Appold 

Medtronic released its MiniMed 670G automated insulin delivery pump in 2017, a major step toward a fully automated insulin delivery system (also known as an artificial pancreas), for type 1 diabetes patients. “This is the first commercially available device to use continuous glucose monitoring information to adjust insulin doses,” says Anders L. Carlson, MD, medical director, International Diabetes Center. “Using an algorithm inside the insulin pump, the system adjusts insulin doses up or down accordingly to target a healthy glucose level.”

Data show improved average diabetes control, more time spent in a more ideal blood glucose range, and fewer blood glucose readings in the low range. “This is important because both high and low glucoses are associated with significant complications and costs,” Carlson says. Hypoglycemia hospital admissions from the emergency department, for instance, cost an average of $1.2 billion per year, so any technology that prevents levels from going too low is a major advancement.

Carlson says the next step would be to create a fully “closed loop” device, rather than a “hybrid closed loop” device, which will be smart enough to give a quick burst of insulin when the patient eats without having to tell the device that they are going to eat something. Currently, patients must enter their blood glucose and amount of carbohydrates they estimate are in a meal. Then, based on programed settings, the pump delivers an appropriate burst of insulin. To close the loop, the device would need to be able to handle that rapid increase in blood glucose following a meal or snack. Several groups are working on this, and newer systems may involve other hormones in addition to insulin being placed in the insulin pump.

David Klonoff, MD, of the Diabetes Research Institute, Mills–Peninsula Medical Center, San Mateo, CA, expects hospitalized people with diabetes to be treated with a combination of hardware and software advances that are uncommon in hospitals today. Patients will be fitted with a rapidly equilibrating CGM device, and insulin doses will be ordered by software programmed with their outpatient daily insulin dose, insulin sensitivity factor, and carbohydrate-to-insulin ratio, he says. This process will culminate in tighter mean glycemic control with less hypoglycemia, and translate into lower costs, as well as a reduced length of hospitalization.
	Schafer Boeder, MD, Division of Endocrinology, at the University of California, San Diego says use of CGM in hospitals-even for those not on CGM as outpatients-is an area of active research. If CGMs can reduce inpatient hypoglycemia events, decrease complications, shorten hospital stays, and/or reduce readmissions, it may become a standard technology in the hospital.

GPS-based dietary prompts, continuous glucose monitors among the devices poised to revolutionize diabetes treatment and patient management. 

The Smart Technology That Will Change Diabetes Care

In Western North Dakota, Jody Doe, RPh, has spent the past 23 years operating the Killdeer Drug Store in the small town of Killdeer, population under 1,000.

“This is the only pharmacy in the whole county-it’s more than an hour away from the next one-and it’s a service that’s needed here,” Doe says. “I enjoy providing the service and helping people out. I’m here every day so I know what’s going on and I can provide a personal touch that those in other areas of the country can’t.”

After pharmacy school, Doe worked as a pharmacist in bustling Portland, OR, but returned to rural North Dakota because he missed the small-town atmosphere he was raised in.
	Independent pharmacists in rural America like Doe are vital to the residents who live in these small communities. But they are becoming increasingly rare, as challenges force them to shut down.

The RUPRI Center for Rural Health Policy Analysis at the University of Iowa released a policy brief this year that revealed more than 16% of the independently owned rural pharmacies in the United States closed between March 2003 and March 2018, lowering the number to just 6,393.

Among the worrisome findings of the report was the disappearance of retail pharmacies in some rural communities altogether, with the data showing that 630 rural communities that had at least one retail pharmacy in March of 2003 no longer had one in March of 2018.

Recent analysis by the National Council for Prescription Drug Programs revealed that independent pharmacies, which represent 52% of all rural retail pharmacies, are often the only operating pharmacy in a community, with the data showing that more than 1,800 independent community pharmacies are the lone source in a particular rural area. And because 1,231 independently owned rural pharmacies have closed over the last 16 years, this is alarming.

And it’s not just the independent rural pharmacies suffering. Many rural hospitals and chains are finding it hard to find staff pharmacists willing to live in rural areas.

Rural pharmacies are forced to shut their doors for many reasons. Keith Mueller, PhD, director of the RUPRI Center for Rural Health Policy and principal investigator in rural pharmacy closures, says for one, the costs they pay to drug manufacturers per prescription are higher than their urban counterparts. This is because they purchase less at a time, and since they tend to sell less volume as well, their profits tend to be smaller. Plus, with increasing competition from internet suppliers, where prices are lower because they deal in bulk supplies, many are not getting the customer base needed to survive, he says.

Mike Swanoski, PharmD, BCGP, FASCP, associate professor of pharmacy practice and pharmaceutical sciences, University of Minnesota College of Pharmacy, says the decline in rural pharmacies is primarily due to declining reimbursements for medications dispensed as reimbursement rates are often barely enough to cover the cost of the medication.

Still, he says, the rural pharmacy is a lifeblood of small-town America.

“The pharmacists practicing in rural pharmacies serve an important role in assuring that not only their patients’ medication needs are met, but also in providing important information regarding health conditions that can be appropriately treated with OTC treatments and when patients should be referred to their medical provider,” Swanoski says.

Mueller agrees that reimbursement is a problem, both for community pharmacies and rural hospitals.

Maintaining in-stock medications, when the costs to the pharmacy are rising faster than changes in reimbursement based on average wholesale prices, is challenging, he says, adding that weak negotiation position with insurance plans, including those participating in Medicare Part D, is also a factor. 

Jennifer Laws, BSPS, CPhT, is supervisor of the pharmacy department at Scotland County Hospital in Memphis, MO, a city with a population of 1,822.

“The main challenge is the lack of pharmacists willing to move to rural areas,” she says. “Unless they have a tie to the specific rural area, most pharmacists will take higher paying jobs in metropolitan areas,” she says. “Rural pharmacies also struggle with declining reimbursement amounts from PBMs, which is another detriment.”

Nicholas Herrmann, PharmD, pharmacist in charge at Memphis Community Pharmacy in Memphis, MO, agrees staffing is a huge challenge. 

“It is even more difficult to find part time or per diem staff,” he says. “If a position doesn’t offer enough guaranteed hours, sometimes the closest people you can find are from more metropolitan areas, which means paying higher rates for things like drive time and hotel accommodations.”

Reimbursement and staffing aren’t the only challenges rural pharmacists face. Many feel isolated because they are often the lone person working, and there are rarely colleagues nearby to share information and talk about what’s happening in the pharmacy industry, according to Mueller.

He adds it’s also harder to get time off to go to a conference or attend advanced educational classes with fellow pharmacists because there’s no one to cover the time away and the venues are usually too far for a quick trip anyway.

On Page 2: Overcoming Barriers & the Draw to Rural Pharmacy...

Herrmann notes there are some benefits to pharmacists who work in these areas.

“It allows the pharmacist to take a more prominent place in the community as a whole,” he says. “Also, it makes knowing your patients that much easier and more important.”

As for the financial challenges, Swanoski says pharmacists in these areas should consider expanding the scope of healthcare provided at their pharmacies to include: comprehensive medication management, which is a covered service under Part D Medicare, immunizations, and medical supplies.

“They should explore opportunities for providing medications to patients residing in assisted living or skilled nursing facilities,” he says. 

Pharmacists in rural areas might also consider how to expand their offerings by using technology. When telepharmacy became legal in North Dakota, Doe opened two remote locations there: one, 56 miles away in the city of Beach and the other, 95 miles away in the city of New England.

Thanks to his live video sessions, Doe can have face-to-face interactions with customers and monitor and supervise an onsite pharmacy technician at each location who is tasked with counting and distributing the medications.
	“It’s been a good thing, and people support it well,” he says. “It’s like I’m virtually there, and it’s a service that was desperately needed.” 

Jennifer Laws, BSPS, CPhT, grew up in a town of 1,822 people and started volunteering in a rural hospital pharmacy in high school. Although she headed to Kansas City to begin her career, she always knew she wanted to come home and work in a friendlier, more deep-rooted community.

“I worked in the Kansas City area for 11 years before moving back to my hometown and am currently working in a neighboring critical access hospital,” she says. “The benefits of rural areas are getting to know more about your customers and having a presence in the community. The biggest con is the lack of coverage for days off and vacations, so it becomes a 24/7 job.”
	When Laws does need time away, a pharmacist in the general vicinity covers her shifts.

The career of Mike Swanoski, PharmD, BCGP,  FASCP,  includes more than 20 years of practicing in a small town or neighborhood pharmacy.

The biggest payoff, he says, was getting to know his customers extremely well. “The trust and confidence my patients placed in me as their pharmacist was the highest honor I could ever hope to achieve and one that I was professional obligated to continually and consistently earn,” he says. “I was fortunate to practice in a setting in which I was able to spend the necessary time with each patient to assure their needs were met and there questions answered.”

Keith Loria has been writing for major newspapers and magazines for nearly 20 years.

Telepharmacy and expanded services may stem the tide of rural pharmacy closures, but more purchasing power is critical.

Finding Ways to Save Rural Pharmacies 

Each year, approximately 200,000 children ages 17 years and younger land in emergency departments (EDs) from adverse drug events (ADEs). Children younger than 5 years of age are most likely to visit the ED for ADEs, according to the CDC. 

Adverse drug events (ADEs) are a leading cause of injuries and death in children in the United States, and psychotherapeutic agents such as antidepressants and central nervous system (CNS) stimulants have been implicated in rare, but serious, side effects such as suicide, serotonin syndrome, and death. Pediatric CNS stimulant prescriptions have skyrocketed 483% from 1990 to 2015, according to an October 2016 New York Times article. The increasing number of prescriptions is raising concerns regarding the potential overprescribing and unnecessary prescribing of stimulants and other psychotropic medications in children.

Pharmacists who are involved in patient care, including community pharmacists, have unique opportunities to manage patients and help improve safety outcomes. 

“Pharmacists play a critical role in ensuring evidence-based prescribing of psychotropic medications, identification, and management of drug interactions, and monitoring of side effects,” says Danielle Stutzman, PharmD, BCPP, a psychiatric pharmacist at Children’s Hospital Colorado in Aurora. 

Part of psychotropic medication management includes limiting the effects of psychotropic polypharmacy, defined as taking more than one psychotropic medication that offers the same therapeutic effect. Stutzman says several factors contribute to polypharmacy in pediatric populations taking these medications. They include:

Misconceptions regarding the onset of clinical effect such as in the case of antidepressants that take several weeks to see their full effect.

Poor understanding of specific symptoms clinicians hope will improve after initiating psychotropic therapy.

Inadequate knowledge of side effects associated with these medications. Stutzman says this is especially problematic in certain subpopulations, such as children diagnosed with autism spectrum disorder who are less likely to tolerate antidepressants and may actually have worsening mood and increased irritability.

Many psychotropic medications have not been approved by the FDA for use in children, but they are still frequently prescribed for them. Pharmacists should be aware of this trend as well as how these medications behave differently in children than adults.

“An important piece to remember is that we cannot necessarily apply pharmacologic treatment principles in psychiatry to pediatric patients,” cautions Stutzman. She adds that off-label prescribing also increases’ children risk for polypharmacy because psychotropic medications can have different responses in children than in adults.

Equally as important is that pharmacists recognize that certain populations-such as foster children and children from lower-income families-are at greater risk for polypharmacy than others. Evidence-based medicine offers the best weapon to counter this challenge, but pediatric studies are insufficient, says Takesha Cooper, MD, MS, assistant professor of psychiatry at the UC Riverside School of Medicine.

“The lack of pediatric studies is a plug for the need to do more pediatric research,” says Cooper.

Pharmacists can help combat polypharmacy by identifying a single psychotropic medication indicated for several psychiatric conditions, Stutzman says. They can also use established state guidelines to help develop and implement protocols for prescribing psychotropic medications and monitoring their levels, labs (for example, lipid panels and A1c), and assessing extrapyramidal effects. 

Charles Caley, PharmD, BCPP, clinical professor and chair of pharmacy practice at Western New England University College of Pharmacy and Health Sciences in Springfield, MA, says pharmacists can leverage their specialized knowledge of pharmacokinetics to improve patient safety when evaluating the potential for pharmacokinetic interactions-especially for children who may have psychiatric illness such as bipolar disorder, ADHD, and anxiety.

For example, a pharmacist’s understanding that antidepressants such as fluoxetine, bupropion, and paroxetine inhibit the CYP2D6 pathway is helpful when a child taking any of these drugs receives a new prescription for Adderall. Since Adderall is metabolized via the CYP2D6 pathway, medications that inhibit this pathway would increase potential Adderall-related drug side effects such as hypertension, increased heart rate, tic-like movements, and seizures. In this situation, Caley recommends reducing a child’s Adderall dose by 50%.

Keenly aware of public concerns regarding over- and inappropriate prescribing, Cooper points out that medication is not the only first-line treatment, but that medication is necessary for some children depending on their manifestations.

Older evidence suggests that some children with behavioral health issues may actually be undertreated. According to a 2014 post by former director Thomas Insel at the National Institute of Mental Health, 4.2% of the 7.5 % of children taking prescription medications are taking psychostimulants, but 11% of children have received a diagnosis of ADHD. This statistic suggests some children may not be receiving pharmacological treatment for psychiatric disorders. While psychotropic medications can serve as first-line, concomitant, or second-line treatment, pharmacists should also recognize that nonpharmacological management such as psychotherapy also plays a significant role in improving symptoms in patients. Psychotherapy includes weekly talk therapy, skill-building, cognitive ability, and helping children think through situations-such as strategies for coping with urges for self-injury.

“The pill doesn’t teach the child anything, but it can help reduce symptoms so that children are better able to benefit from psychotherapy,” says Cooper. “It’s really the psychotherapy that teaches the child skill to cope, and it’s also important to work with therapists to make sure children’s needs are being met.” 

Negative perceptions also contribute to medication-related challenges in behavioral health and create additional barriers to patient treatment and recovery while diminishing the quality of physical care patients with psychiatric conditions receive, according to a 2013 JAMA Pediatrics article, “Medication Use in US Youth with Mental Disorders.”

Caley emphasizes that negative mindsets can have exceptionally deleterious impacts in community pharmacy because of its degree of patient accessibility. “Pharmacists need to be reflective and feel confident about addressing psychotropic medications,” he says. “It’s important to acknowledge that there’s a stigma or unwillingness to address mental illness in children and other populations among community pharmacists because there’s a lack of comfort in discussing this topic.”

Pharmacists should acknowledge their discomfort in discussing behavioral health issues with patients and parents of children with these challenges, Caley says. They should seek additional education and training to become more comfortable with their roles in addressing psychotropic challenges in children. The American Academy of Child and Adult Psychiatry offers a prescribing guide and other resources.
	“Psychotropic illnesses are brain illnesses which are influenced by many other things-the environment, perceived stress, genetics,” says Caley. Pharmacists need to have more than a casual familiarity with these medications.”  

Frieda Wiley, PharmD, BCGP, is a regular contributor. She writes for several medical magazines and serves on the American Medical Writers Assn. National Communications Committee.

Each year, approximately 200,000 children ages 17 years and younger land in emergency departments (EDs) from adverse drug events (ADEs). Children younger than 5 years of age are most likely to visit the ED for ADEs, according to the CDC.

Psychotropic Drugs in Pediatrics: Looking at the Whole Child

More than 900 public and private accountable care organizations (ACOs) in the United States manage the healthcare costs of around 32 million Americans, according to healthcare consultancy Leavitt Partners. As that number grows, so does the number of pharmacists these organizations employ to optimize medication use.

ACOs are a reimbursement model where healthcare organizations strive to meet cost and quality targets. If successful, they receive higher reimbursement.

“While underutilized in early ACO models, pharmacists today are playing an increasingly important role in the success of these organizations, and more and more pharmacists are being hired on staff to oversee medication management and optimization,” says Susan A. Cantrell, RPh, CAE, CEO of the Academy of Managed Care Pharmacy (AMCP). 

Half of all Americans take at least one prescription drug per-month, whereas almost a quarter take at least three prescription drugs per-month, according to the CDC. Without managing medication costs, which are expected to rise faster than any other medical expenses, ACOs will find it increasingly difficult to deliver cost-effective quality healthcare.

According to a recent study in the ACMP’s Journal of Managed Care and Specialty Pharmacy, ACOs that employ or contract pharmacists are better at managing medication costs while delivering value.

“That’s because pharmacists are uniquely positioned to help optimize appropriate medication use, reduce medication-related problems, and improve health outcomes,” Cantrell says. “As a clinical expert working as part of an interdisciplinary team, pharmacists can assess whether medication use is contributing to unwanted effects and can help achieve desired outcomes from medication use.”

A key aspect of a pharmacist’s work in an ACO is counseling patients. Pharmacists counsel them in drug therapy management clinics, such as anticoagulation clinics; transplant programs; and HIV, hepatitis C, psychiatric and lipid management clinics, to ensure that patients take their medications correctly and that drug-related problems are identified and managed.

They also play a key role in transitional care: counseling post-discharge patients on the proper use of any medications prescribed during their hospital stay. Not taking medications properly and/or not recognizing a side effect or symptom can land the newly discharged patient back in the hospital.

“ACOs currently working with pharmacists have seen positive results in reducing hospital readmission and ER utilization, particularly when they integrate pharmacists in their transitions of care teams,” says Stephanie Gernant, PharmD, MS, assistant professor at the University of Connecticut School of Pharmacy in Storrs.

“I think we’re going to see a greater surge of pharmacist integration in outpatient and primary care settings in the upcoming years. No matter your political ideology, payment based on value is never going away-the cat is out of the bag,” she says.

Currently, the percentage of ACOs working with pharmacists is 63% and that is likely to grow, says Gernant.

“An ounce of prevention is worth a pound of cure, and ACOs working with pharmacists-especially in primary care, preventative care, and risk management settings-see the return. For every adverse drug reaction a pharmacist discovers, for every omission of care she/he corrects, there’s a downstream positive patient outcome, and for ACOs that means dollars.”

Pharmacists can help identify gaps in medication use or red flags that may not be as readily apparent to other providers, says Cantrell. “A pharmacist engaged in therapeutic drug monitoring knows if a patient is not filling a prescription or is taking multiple medications that have been prescribed by different doctors.”

Pharmacists can offer solutions to some of the challenges that patients face in taking medication. They can inform patients about what to expect during treatment, what side effects are common, or how long it might take for a medication to work. They can also help with the challenge of prohibitive costs by suggesting less costly generic alternatives.

Interdisciplinary care in ACOs is growing because not only are today’s healthcare professionals being trained this way, but government organizations like the Agency for Healthcare Research and Quality (AHRQ) is investing in tools that maximize the role of each team-member, like its TeamSTEPPS, says Gernant. This program is a teamwork system developed jointly by the Department of Defense and AHRQ to improve institutional collaboration and communication relating to patient safety.

College pharmacy courses are also providing skills that enable ACOs to make the most of future pharmacists as team members. “Students within the PharmD curriculum are introduced to managing costs throughout their coursework, both while in class and on experiential rotations,” says Alexandra Watson, PharmD, BCACP, assistant professor at Albany College of Pharmacy and Health Sciences. “Students are required to take Pharmacy Administration and Pharmacoeconomics during their professional coursework.” They learn about the healthcare system as well as techniques to assess economic outcomes, including cost-benefit analysis and cost minimization. In other courses, they have opportunities to apply cost management within real world scenarios and discuss ethical questions surrounding access to medication.

Students are given patient cases in which pharmacoeconomic barriers are addressed and resources including lower cost alternatives, coupons, or patient assistance programs are reviewed. They also conduct mock pharmacy and therapeutic meetings to reduce costs through appropriate deprescribing or determining lower cost alternative therapies.

Training in pharmacology, pharmacokinetics, and pharmacoeconomics enables pharmacists to assess medication use in ways other healthcare practitioners might not be prepared to.

“Since healthcare is moving away from fee-for-service and toward value-based care payment structures, pharmacists now have opportunities to further assist the team by helping meet quality markers,” says Watson.

One reason pharmacists will play a larger future role in ACOs is the growing number of specialty pharmacy products on the market-medications that are often prohibitively expensive, need special administration, or require extensive monitoring to manage side effects.

“Patterns of care are shifting specifically to focus more on overall drug management due to more specialty pharmaceutical products becoming available in the market,” says Jane Lutz, executive director of the Pharmacy Benefit Management Institute (PBMI).  “As a result, the clinical expertise of a pharmacist becomes more and more critical.”

Pharmacists can assist in managing costs in all settings, from managing formularies in the hospital to creating criteria for the use of new biologic agents in managed care, says Watson.

“Community pharmacists are often on the front line and can offer opportunities for interchange or decrease barriers to adherence concerns due to costs,” she says. “Within the ambulatory care setting, pharmacists are becoming integrated both at the patient care and administrative levels to combat rising prescription costs.” 

Joan Vos MacDonald is a healthcare journalist and a regular contributing editor.

How pharmacists are becoming key members of the ACO model.

ACO Hospitals Increasingly Seek Help from Pharmacists

I wish I could say I envision a bright tomorrow for pharmacist compensation. I want that, but these four things must happen first.

We must come together and speak with a unified voice on basic ideals such as public health, patient support, and the proper place of pharmacists as valued members of the healthcare team. And I am convinced we must gain the support of government to radically overhaul the profit-oriented system to one that is evidence based, that eliminates insurance companies, managed care organizations, and pharmacy benefit managers.
	We need to change to a system that benefits the patient, such as a single-payer-type system like Kaiser.

A review of how pharmacies are owned and operated in Europe reveals a much higher appreciation for the pharmacist’s role in healthcare. Some European countries regulate pharmacy and pharmacist density to ensure the appropriate number of professionals per capita for their citizens. Pharmacists are organized into a union or guild to negotiate with governments on reimbursement. Many of these countries, such as Denmark, Sweden, and Norway, ban chains and insist that the majority of pharmacies are owned and operated by pharmacists.
	The Pharmaceutical Group of the European Union wanted to know whether weaker government regulation and the proliferation of chain pharmacies would result in better access to pharmaceutical care and lower drug prices. The study the group commissioned by the independent German firm OBIG examined practices in six European countries.
	The European study found: “Assuming increasing competition and cost-containment as the two key aims of deregulation, the research undertaken in this study could not provide any evidence that these goals have been achieved through deregulation of community pharmacies.” On the contrary, it found that prices did not go down, competition did not increase, and service was less personal with chains.

We Must Strengthen the Pharmacist’s Role

The CDC has shown that in 2017, 42% of all flu vaccines were administered in pharmacy outlets in the United States, saving thousands of lives. This was accomplished by better reimbursement and increasing pharmacy profits as a result of state legislation under provider-status contracts instituted by more than 20 states. This needs to be done at the national level by Congress.
	Unless regulation strengthens the pharmacist’s role, we will continue to have overworked, underpaid pharmacists and technicians forced to work under impossible circumstances, making grievous mistakes that result in injury and death. We will go right on being paid inadequate salaries to fill, count, pour, and type unreasonable numbers of prescriptions, with little or no opportunity to add life-saving value through counseling and consulting.

We can only achieve a desperately needed regulatory support by advocating for it with a compelling, unified voice. My colleague Dan Hussar writes frequently about the need for pharmacists to unionize under the employee chain pharmacists’ banner, and to correct the oversupply of schools of pharmacy. Pharmacy professionals must organize with new leaderships, legislation, and regulation.
	If we as a profession want to improve our own careers, and the health of our communities and our country, we had better focus forward and work toward these radical changes to save our profession. It’s time for a revolution.

4 things that need to happen before pharmacists can expect improvements in compensation. 

Opinion: Only a Healthcare Revolution Can Change Compensation Trends 

As drug costs continue to increase at an unsustainable rate, many industry insiders believe the current trajectory of pharmaceutical expenses will eventually bankrupt the U.S. healthcare system.

Girish Dighe, PharmD, MS, director of pharmacy, business services, at OhioHealth, a not-for-profit system of hospitals and healthcare providers in Columbus, notes that there are fundamental flaws within the healthcare system that cause vastly complex challenges to drug pricing.

“The multitude of stakeholders involved in the drug channels for bringing patients access to medications (manufacturers, insurers, pharmacy benefit managers [PBMs], providers, retail pharmacies, wholesalers) revolves around financial incentives driving each stakeholder,” Dighe says. “The growing spread between pharmaceutical list price and net price negotiated by drug channel stakeholders has negatively impacted patients’ out-of-pocket costs.”

According to a recent survey from NORC at the University of Chicago and the West Health Institute, 75% of Americans believe prescription drug prices are unreasonably high. 
	President Donald Trump took a big stand against rising drug prices early in his tenure, and since then some drug companies-Pfizer, Novartis, Sanofi, Roche, and Merck among them-have announced that they’re freezing or even lowering drug costs. Although those pledges seem to be short-lived.

Alex Azar, HHS secretary, recently announced that the administration is also working to stop drug rebates to PBMs.

The Pharmaceutical Care Management Association (PCMA), which represents PBMs, issued a report recently blaming high drug prices on drug makers, not PBMs.

In the report, Mark Merritt, PCMA’s president and CEO, said the findings supported the belief that drug makers set and raise prices unrelated to the rebates they negotiate with PBMs.

“Drug companies keep raising prices even when rebates go down,” he says. “Simply eliminating plans’ ability to negotiate price concessions would enrich drug makers at the expense of patients, who would not only face higher prices, but also higher premiums and out-of-pocket costs.”

Amy Beatty, PharmD, BCPS, OhioHealth’s clinical director of pharmacy services, says medication shortages are to blame for some drug price escalations. 

“When lower-cost generic medications enter shortage status, providers are faced with selecting more expensive alternatives,” she says. “This pattern of drug shortages has continued to the point where many organizations are now funding positions and teams to manage the fragile supply chain.”

As drug costs continue to escalate, many hospitals worry about access to important medications because they cannot always get what they need when they need it. That’s why many hospitals, such as OhioHealth, have begun rationing drugs in certain situations, and some larger healthcare systems have even started a company, Civica Rx, to produce their own medications to address both cost and supply concerns.

Earnest Alexander, PharmD, assistant director, clinical pharmacy services, Tampa General Hospital, a teaching hospital for the USF Health Morsani College of Medicine, notes that hospitals and pharmacy departments work closely with group purchasing organizations, which negotiate lower drug prices for member organizations, to monitor and attempt to predict inflation trends. This isn’t an exact science and can vary based on several factors, such as changes in formulary and clinical practice, drug shortages, and alterations in competition in the marketplace for drugs.

For example, a decade ago, yearly inflation would range 3% to 5%, Alexander says. In the last five years, this has more than doubled to 8% to 12% increases in cost yearly.

“Interestingly, the number of drug shortages has skyrocketed in the past five to 10 years, resulting in decreased supply and sharply climbing costs for the remaining drugs available for patient care,” Alexander says. “Challenges exist because there is a constantly shrinking margin, which poses operational issues for facilities.” 

John M. Allen, PharmD, clinical assistant professor, College of Pharmacy, University of Florida, says rising drug costs are certainly not a new phenomenon; however, the price has risen recently for several medications that have few alternatives and that are commonly used in the care of critically ill patients, including epinephrine, vasopressin, and calcitonin. Historically, these agents had relatively low prices and minimal cost increases year after year.

“Hospital pharmacies routinely monitor for changes in drug pricing and evaluate different ways to mitigate the impact of increasing drug prices without sacrificing patient care,” he says. “Some strategies may include establishing criteria for using more expensive drugs, development of order sets to drive appropriate use, and prospective drug audits.”

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When price simply cannot be negotiated, appropriate use of drugs is the only pathway to manage escalating drug costs, says Linda Huang, PharmD, OhioHealth’s medication utilization coordinator for pharmacy services.

“First, the [pharmacy and therapeutics] committee must agree upon what appropriate use is,” she says. “The classic use strategies for formulary management are either to deny the drug, deny the drug and use an alternative that provides similar outcomes at a lower cost, or to add the drug but apply restrictions for use around the type of ordering provider, indication, dosing, site of care, and/or other qualifiers in order to guide appropriate use.”

Still, guaranteeing the success of use restrictions can be difficult and labor intensive. It requires a willingness from the providers to agree with these restrictions as well as vigilance from front-line pharmacy staff to uphold restrictions and/or be comfortable with making judgments around use if a scenario occurs outside of the restrictions.

“We have been most successful with use strategies when we can build logic into our EHR to naturally guide physicians toward appropriate use; when we have partnered with our ordering providers to develop accepted restrictions; and when there is transparency and accountability around appropriate use,” Huang says. “Traditionally, monitoring use to ensure a strategy is successful has been a very manual process, but data-management tools can help make this process more automated.”

Sentara Healthcare, based in Virginia, saw a significant potential opportunity to increase revenue and streamline services and costs to make high-cost drugs more accessible to patients. It decided to retain specialty pharmacy revenue and margins within the Sentara Healthcare system by creating Proprium Pharmacy, its own specialty in-house pharmacy.

“The program was successfully implemented with an impact of $10.7 million annualized,” says Chris Tagliente, PharmD, system director of pharmacy clinical programs at Sentara. “During this implementation, they met all operational timelines and kept clinical patient support and customer satisfaction levels high. They were also able to successfully integrate and train an entirely new set of staff, overcome space availability obstacles, and navigate through several internal transitions and changes in pharmacy state licensure.”

As a result of internally distributing these specialty medications, Proprium Pharmacy has successfully and drastically increased revenue, managed costs, and made these drugs more accessible to patients, he says.

“The Proprium Pharmacy has optimized the patient experience through the integration of clinical activities to help create a better patient experience and reduce overall costs for both the hospital and patient,” Tagliente says. Proprium Pharmacy has also helped to sustain customer satisfaction of greater than 97% with virtually no customer complaints, and improved medication adherence to an overall rate of 93.7%.

Houda Hachad, PharmD, chief science officer at Translational Software Inc., which provides recommendations based on genetic data to more than 20,000 clinicians, says DNA-guided prescribing/pharmacogenomics (PGx) is a great way to improve treatment efficacy and costs.

“We now have data that shows if you implement pharmacogenetic approaches in different specialties, they result in optimizing different metrics that can be used to assess medication optimization,” Hachad says. “These include fewer emergency room visits and fewer hospitalizations, and some of them have shown reduction in total costs compared to standard approaches.”

She explains that using genetic tests can help healthcare workers ascertain the best medication and appropriate dosage based on a patient’s DNA before prescribing, which not only improves the effectiveness of treatment, but lowers drug costs by identifying the medication that works best for each patient.

Hachad codeveloped a PGx knowledgebase and a drug interaction database that are used by pharmaceutical companies, regulatory agencies, commercial laboratories, and academic healthcare organizations.

Analytics can help healthcare systems monitor drug costs and find opportunities to reduce spending without reducing quality of care. Western Maryland Health Systems (WMHS), which offers healthcare services in Allegany and Garrett counties in Maryland and surrounding counties in West Virginia and Pennsylvania, presents an excellent example.

It began using Dimensional Insight’s Diver platform after the cost of the IV form of acetaminophen jumped 250%, to $35 per vial, says George Dealy, vice president of healthcare applications at the analytics company. It used the platform to examine whether the IV drug actually produced better outcomes than the oral version, justifying the increased cost.

After examining various surgical procedures, patient lengths of stay, and number of opiates given, WMHS found no significant difference in patient outcomes with IV acetaminophen, says Dealy. As a result, the health system sharply decreased the amount of the drug it purchased, reducing its spending by 78% over two years, from nearly $250,000 in FY2015 to just over $55,000 in FY2017.

Alexander says the most critical step to dealing with escalating drug costs is a proactive review of the spend/cost data that can aid in spotting issues and altering purchasing on an ongoing basis.

Hospital pharmacies are exploring various avenues to mediate the threat of bankruptcy as a result of unsustainable drug costs.

Drug Topics December 2018

Influenza Update

Opinion: Job Satisfaction is a Choice

Dacomitinib Approved for Non-Small Cell Lung Cancer

The Smart Technology That Will Change Diabetes Care

Finding Ways to Save Rural Pharmacies

Psychotropic Drugs in Pediatrics: Looking at the Whole Child

ACO Hospitals Increasingly Seek Help from Pharmacists

Opinion: Only a Healthcare Revolution Can Change Compensation Trends

9 Ways to Deal with Escalating Drug Costs

Annual Salary Survey Results: Money Isn't Enough

Small Doses: December News

Specialty Pharma to be Half of Total Drug Spend in a Few Years

How Pharmacists Can Initiate Changes with ACOs