Levodopa/carbidopa is currently the gold standard for controlling motor symptoms associated with Parkinson disease. For patients taking this medication, symptoms such as tremor, difficulty walking, and initiating movement can return throughout the day as the levodopa wears off. On April 24, 2020, the FDA approved opicapone (Ongentys; Neurocrine Biosciences) as an adjunctive treatment for patients with Parkinson disease who experience these “off” episodes.

Levodopa is peripherally metabolized by catechol-O-methyl- transferase (COMT). Opicapone, a selective and reversible COMT inhibitor, aims to prevent this metabolism in the blood and increase the duration of levodopa activity by allowing greater availability across the blood-brain barrier. Evidence suggests that levodopa shortens these episodes compared with entacapone, a treatment already available on the market, with no new safety concerns observed.

Two randomized, multicenter, double-blind, 12-week trials were conducted in 522 patients taking levodopa/carbidopa who had inadequate control of their symptoms. Trial 1 took place at 104 sites in European countries; trial 2, at 69 sites across Europe and Asia. Opicapone 50 mg was given
to 265 patients, and the remaining 275 received a placebo. The primary end point was the change in mean absolute off-time. The secondary end point was on-time without troublesome dyskinesia. Patients kept 24-hour diaries, and efficacy was measured by recorded change in hours from baseline off-time.

Patients who were treated with opicapone demonstrated a significant decrease in mean off-time compared with those who received placebo. Of note, most patients were white; therefore, efficacy among different races cannot be determined.

The most reported adverse effect (AE) of opicapone was dyskinesia, which occurred in 20% of patients receiving treatment. This was the most comment reason for discontinuation of therapy. Other common AEs defined as at least 4% incidence and greater than placebo include constipation, increased blood creatinine levels, syncope, and weight loss.

 Serious AEs may include decreased blood pressure and fainting, somnolence during normal activity, uncontrolled movements, abnormalities in impulse control, and changes in heart rate and blood pressure when taken with nonselective monoamine oxidase (MAO) 3 inhibitors. The occurrence of AEs wassimilar between men and women, as well as between patients above and below age 65 years.

Opicapone is available as hard gelatin capsules in 25-mg and 50-mg doses. The current dosing recommendation is one 50-mg oral capsule taken every 24 hours, at bedtime, in addition to levodopa/carbidopa. If a dose is missed, the subsequent dose should be taken at the scheduled time the following day. Do not double doses. For patients with moderate hepatic impairment (Child-Pugh class B), the recommended dose is 25 mg at bedtime. Patients with severe hepatic impairment (class C) should avoid use because there are no studies evaluating this population. Use with nonselective MAO inhibitors is contraindicated.

Patients should be informed not to eat at least 1 hour prior and 1 hour after taking opicapone, because food decreases the mean peak plasma concentration by 62% and mean overall plasma exposure by 31%.

Neurocrine Biosciences announces FDA approval of once-daily Ongentys (opicapone) as an add-on treatment for patients with Parkinson’s disease experiencing “off” episodes. News release. Neurocrine Biosciences, Inc. April 27, 2020. Accessed June 30, 2020. 

https://ongentyshcp.com/assets/pdf/Neurocrine-Biosciences-Announces-FDA-Approval-of-Once-Daily-ONGENTYS-opicapone.pdf

Ferreira JJ, Lees AJ, Poewe W, et al. Effectiveness of opicapone and switching from entacapone in fluctuating Parkinson disease. 

. 2018;90(21):e1849-e1857. doi:10.1212/WNL.0000000000005557

Opicapone (Ongentys). Package insert. Neurocrine Biosciences, Inc; 2020. Accessed June 30, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf

Drug trials snapshots: Ongentys. FDA. Updated May 8, 2020. Accessed June 30, 2020. 

www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ongentys

Articles

Levodopa/carbidopa is currently the gold standard for controlling motor symptoms associated with Parkinson disease. 

Opicapone Can Help Treat Patients Experiencing “Off” Episodes With Parkinson Disease

After logging over 166,000 miles on her 2011 Toyota RAV4, my wife, Denise, decided she needed a new car. All 3 kids are out of college and have their own homes, so we decided it was time for her to treat herself. She settled on a bright blue 2020 Honda CR-V. Despite being a Japanese model, the 2020 Honda CR-V is also manufactured in North American plants, in Marysville and East Liberty, Ohio; Greensburg, Indiana; and Ontario, Canada. I wish we could say the same about the drugs we dispense in our pharmacies; instead of a foreign brand made in America, we have American brands made in foreign countries.

A lot of noise has been made the past 6 months about buying our medical supplies; namely, personal protective equipment and pharmaceuticals. So much of our drug supply—especially generics, which account for the majority of what we community pharmacists dispense daily—is manufactured in foreign countries. Since the 1990s, US companies have increasingly imported pharmaceutical products from India and China, where ingredients are cheaper and manufacturing is subject to fewer regulations and significantly less FDA oversight. Because of this, the United States relies heavily on India and China for our generics, which I routinely dispense.

“Buy American” is shouted from the rooftops. I’m all for it too; however, the question becomes “Why do we pharmacists buy generics from these manufacturers?” The answer is pure and simple: It is the cost. There are no reasonably priced alternatives, given the ridiculously low level of payment from many of the insur- ance companies and managed care organizations (MCOs).

Recently, while working “on the bench,” I paid particular attention to the reimbursement levels for very common drugs. One MCO reimbursed 79 cents for a 30-day prescription of lisinopril 20 mg. According to the 2020 Cost of Dispensing Study, it costs $12.40 for a pharmacist to dispense a prescription.

 How much longer can independent pharmacists sustain such reimbursements? That is why we dispense generics that originate from China and India.

In Blair County, Pennsylvania, where I have spent my professional career, we’ve seen 14 independent pharmacies close in the past 10 years. As I said in a column in September 2019, quoting Dr Martin Luther King Jr, “We must learn to live together as brothers or perish together as fools.” The demise of the independent pharmacies is the canary in the coal mine, warning that more and more job opportunities for pharmacists are at risk.

I am all for buying American and bringing as much manufacturing of the medical necessities as possible to our shores so that we are no longer at the mercy of the overseas governments. We have the ability to manufacture all our medical supplies, including generic drugs. For that to become a reality, the government, which spent $325 billion in 2015 on drugs, must ensure proper reimbursement for these American-made generic drugs. Pharmacists need to be reimbursed adequately for every prescription dispensed with a reasonable fee for service.

Direct and indirect remuneration fees need to go away immediately. The pricing schemes of average wholesale price, wholesale acquisition cost, national average drug acquisition cost, and Affordable Care Act–weighted-average manufacturer price must fall into line to reflect exactly what pharmacies pay for these drugs. Because we are getting poorly reimbursed for the cheap overseas generics, we need reassurance that when we are mandated to buy American generics, which I’m sure will be slightly more expensive, we will not take any more of a financial hit.

Denise loves her new car, and the Honda dealer does not have to worry about clawing back on the check we wrote. Isn’t that supposed to be how a business transaction works?

Why do we pharmacists buy generics from foreign manufacturers? The answer is pure and simple: the cost. 

 To “Buy American” Generic Drugs, Pharmacists Must Be Adequately Reimbursed

Attention-deficit/hyperactivity disorder (ADHD) treatment options for children continue to evolve. This year, however, caregivers may face a new challenge: finding the best treatment strategy for their child during a pandemic.

“It’s pretty clear that the pandemic has created unprecedented challenges at every level of society, particularly health care,” said John Beckner, RPh, senior director of strategic initiatives at the National Community Pharmacists Association (NCPA).

The coronavirus disease 2019 (COVID-19) pandemic has created significant challenges for all children and their families, but those obstacles may be “considerably greater” for those with ADHD, Beckner said, with some students facing virtual classrooms or less access to their regular physicians.

Lea S. Eiland, PharmD, BCPS, BCPPS, FASHP, FPPA, a clinical professor and associate department head of the Department of Pharmacy Practice at Auburn University Harrison School of Pharmacy in Alabama, said parents and health care providers need to consider the child’s unique needs and struggles when determining the best care plan.

The good news, she said, is that the ADHD drug market provides multiple options in type of medication, dosageformulation, and dosage requirements. As the market grows, pharmacists can help patients get optimal results from customized regimens.

Drug treatment options for ADHD fall into 2 categories: stimulants and nonstimulants.

According to Eiland, stimulants continue to be the first-line drug class recommended for both adults and children with ADHD.

With this drug class, which includes amphetamines and methylphenidates, pharmacokinetics and dosage formulations greatly affect the medication’s distribution in the body and its efficacy, according to Eiland. “You’re seeing, I would say even in the last several years, additional products that are marketed that have longer efficacy with a 1-time dose, and we’re still continuing to see that,” she said.

Most ADHD medications require dosing in the morning, but in 2019, Jornay PM arrived on the market, signaling the first FDA-approved stimulant designed for evening dosing. The methylphenidate product is taken at night but isn’t released in the body until morning, which helps reduce the severity of symptoms early in the day.

Earlier this year, it seemed another drug to treat ADHD could soon enter the market, but in May, Sunovion Pharmaceuticals Inc announced it was withdrawing its new drug application for dasotraline, a dopamine and norepinephrine reuptake inhibitor. The drug had also been studied for treating binge eating disorder (BED).

“[Although] Sunovion considers dasotraline to be a promising, novel treatment for BED and ADHD, we believe that further clinical studies would be needed to support a regulatory approval for dasotraline in these indications,” the drugmaker said in a statement announcing the decision. The company said it did not plan to pursue further development of the drug at this time.

Sunovion seems to have hit the brakes on dasotraline, but Vallon Pharmaceuticals Inc recently announced positive data from a pilot study of Abuse Deterrent Amphetamine Immediate Release (ADAIR).

 “Results from this pilot study suggest that Vallon’s investigational immediate-release stimulant, ADAIR, may demonstrate less abuse potential than standard dextroamphetamine when manipu- lated and misused intranasally,” Timothy Whitaker, MD, a board-certified psychiatrist and Vallon’s chief medical officer, said in a statement.

If the drug continues to jump approval hurdles, it would be the first intranasal product for ADHD, Eiland said. Overall, most of the chemical entities in clinical trials focus on the adult ADHD population rather than the pediatric setting. However, in some pediatric studies, investigators are looking into the neurobehavioral effect of drug holidays—stopping medication for a brief period of time, such as during summer break or weekends—or examining the effects of certain behavioral therapy interventions, Eiland said.

As more drug formulations and options enter the market, Eiland said, the key to determining the best strategy often requires looking at the child’s own needs.

“Do they wake up with symptoms? Do they wake up and it’s hard to get them dressed, get them to school, get them to day care? Or is it that you can get them up, but they have a harder time focusing during school, during the lunch hour, afternoon hours or evenings when they come home? And so we can actually select a stimulant product that works best based on when the child needs the most control for symptoms,” she said.

Pharmacists on a health care team can talk with physicians about individual drug options, the medications’ release in the body, and even the “vast pharmacokinetic difference” between a tablet, capsule, and liquid suspension form of the drug, Eiland said.

Community pharmacists can also play a valuable role by counseling a patient or caregiver on how to administer the medication and what adverse events to watch out for, Eiland said. Pharmacists should also alert the patient’s physician if a patient is struggling with a particular dosage form or there might be an adherence concern.

As a result of the ongoing global pandemic, visits to primary care physicians and specialists are down, Beckner said, which suggests that children with ADHD and parents may not get the 1-on-1 time with the physician they had in the past.

As more accessible health care providers, pharmacists can lend a hand by answering patient questions, counseling patients and their caregivers even during refills to identify possible concerns, and helping parents navigate dosage timing.

Children adjusting to new daily schedules may be spending much more time at home than they did in the past. “Behavioral parenting strategies are taking on an even greater role as a supplement to medications,” Beckner said. Some children may head back to the classroom; others may continue with virtual learning. Parents will need to consider individual needs to decide whether a new schedule requires changes to dosage timing or when a child learning from home seems to struggle the most with symptoms.

“There are some students that thrive in the virtual setting, and there are some students that struggle in the virtual setting, and we’re just learning that. That’s going to be something to try to figure out,” Eiland said.

Parents who opt for a medication holiday during summer break may also need to decide whether they want their child to resume medication dur- ing virtual learning.

In each case, experts say, pharmacists can help caregivers and children navigate the possible changes ahead. “It’s just talking with them, inquiring...checking on adherence, checking on administration, and checking on [adverse drug reactions],” Eiland said.

Sunovion discontinues dasotraline program. News release. Sunovion Pharmaceuticals Inc. May 13, 2020. Accessed July 14, 2020. 

https://news.sunovion.com/press-releases/press-releases-details/2020/Sunovion-Discontinues-Dasotraline-Program/default.aspx

Vallon Pharmaceuticals presents positive data from pilot intranasal human abuse study of its investigational abuse deterrent stimulant, ADAIR, at the American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting. News release. Vallon Pharmaceuticals Inc. January 21, 2020. 

https://www.vallon-pharma.com/press-release-index/vallon-pharmaceuticals-presents-positive-data-from-pilot-intranasal-human-abuse-study

FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD. News release. FDA. June 15, 2020. Accessed July 14, 2020. 

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd

Caregivers of children with ADHD can choose from an increasing number of treatments that can be customized.

Pandemic Presents Unique Challenges for ADHD Management

“Pharmacy compounding is the best option for many of our patients who have conditions or needs that are not met with manufactured medication and, in 2020, even more important,” said Almaz Dawit, PharmD, founder of CortexRx Compounding Pharmacy in La Jolla, California. “Compounding pharmacies have stepped up and provided much-needed sanitizer and other supplies that fell short due to COVID-19, highlighting the need for their existence even more.”

Although compounding has experienced a severe and drop in coverage by shortsighted payers

, the events surrounding the COVID-19 pandemic have demonstrated the worth of having ready and capable compounding pharmacies,

 according to Jesse C. Dresser, Esq, partner at Frier Levitt, a pharmacy law group in New York. “From mixing hand sanitizer to ensuring a steady supply of [drugs] for patients in dire need, compounding pharmacies have more than proved their worth in the midst of this crisis,” he said. “But ultimately, the value and importance of pharmacy compounding in 2020 go far beyond safeguarding against medication shortages and continue to play a vital role in fulfilling unmet medication needs for individual patients and health systems alike.”

From nonsterile to sterile compounding, there has never been a greater need for flexibility while maintaining the highest safety standard, with the most robust policies and standard operating procedures to back it up, said AJ Rivosecchi, PharmD, director of clinical solutions at Kit Check.

“The situation pharmacies find themselves in with unpredictable, ongoing, and pervasive shortages has in many cases taken what may have been a decision on buying finished goods versus compounding based on ability and economics and made it a necessary reality of daily life to maintain standards of care,” Rivosecchi said. “Coupling this increased need with the rising regulatory bandwidth being paid to sterile, nonsterile, and hazardous compounding makes pharmacy compounding a top priority in terms of importance for pharmacies around the country.”

From FDA-enforced current good manufacturing practices at the manufacturer level down to individual state boards, there is no dearth of regulations in the compounding space.

P [United States Pharmacopoeial Convention] chapters 795, 797, and 800 are forefront on the minds of pharmacy leaders,” Rivosecchi said. “[USP general chapter

] 795 covers nonsterile compounding, 797 covers sterile compounding, and 800 covers hazardous drug handling. This trio of regulations, when taken together, has had the biggest impact on the industry.”

Pending revisions to chapters 795 (last updated in 2014) and 797 (last updated in 2008), as well as the official adoption of chapter 800 on December 1, 2019, have guided decisions in the compounding space for the past decade. 

Between the proposed revisions and the official version of USP 800, the industry has never before had so much guidance for ensuring both patient and employee safety. Rivosecchi calls that a “real win” for the industry because it will help standardize best practices and prevent bad actors from skirting more lax regulations. However, these mandates are largely unfunded, and good actors, who aim for compliance and maintenance of best practices, may not have adequate capital to invest to meet new regulations.

“The USP, along with state agencies, regulators, and oversight organizations, [all affect] the industry; the difficulty for pharmacies is that there is no firm consensus of exactly what or when ultimate requirements will be stipulated and/or exactly how they will be enforced,” Rivosecchi said. “There is often significant capital expenditure, in excess of $500,000 even for a midsize hospital pharmacy, which accounts for millions within a health system, that is invested to meet requirements that do not yet exist.”

The biggest challenge the regulations pose to the industry is lack of clarity. For example, although traditional compounding pharmacies are directly regulated by state boards of pharmacy, which inspect, license, and discipline according to state police powers, the FDA retains jurisdiction to regulate the manufacture of new drugs.

“In examining whether a compounding pharmacy is engaged in the improper manufacture of drugs, the FDA’s authority and jurisdiction are often ill defined, and if the FDA determines, in its discretion, that the pharmacy is acting outside the scope of a traditional pharmacy, it may seek to apply higher standards more normally associated with drug manufacturing,” Dresser said. “This could, in turn, lead to additional and unforeseen disciplinary action being taken against the pharmacy.”

In lieu of promulgating formal regulations, the FDA has opted to issue industry guidance on intended regulatory enforcement. It has taken the FDA several years to “finalize” much of this guidance, Dresser said; at press time, the memorandum of understanding addressing the interstate distribution of compounded medications has not yet been finalized and adopted by states and the FDA.

Industry insiders noted that success in compounding involves understanding the landscape and asking key questions: “What does the market need? Where does it need it? How do I meet that need efficiently to allow me to comply with all relevant regulations?”

“To answer those questions, you must consider what’s already commercially available; what the FDA has deemed appropriate for compounding due to shortages; what is the cost of your materials, labor, and maintaining compliance; and, ultimately, where is the balance that makes all these things an attractive target and leads to success,” Rivosecchi said. “The demand is clearly there, so that much is known—the true key to being successful in this space, whether in a hospital or in a commercial application, is identifying what demand you can meet safely and efficiently.”

According to Dawit, success lies in the ability to meet the specific needs of patients who can pay cash for tailored medications and in being innovative and targeted when selecting products. She also noted the importance of visibility to practitioners who support patients whose needs are not met by typical retail pharmacy.

Dresser listed 3 crucial steps toward success: (1) Institute robust procedures that ensure compliance with all applicable forms of regulation. (2) Identify a workable business model in the wake of coverage restrictions. (3) Avoid common legal and regulatory pitfalls.

Pharmacists who want to get involved in compounding should learn from their peers, according to Rivosecchi. “Whatever your focus will be—sterile, nonsterile, or hazardous—go find people who are doing it well and leverage their best practices and learnings,” he said. “No one will have a turnkey solution for you, but everyone in the field is doing something well, and being a true student of the competition can help you identify how to effectively enter this field in a manner that works for your focus.”

Dresser agrees: “There are many experienced consultants—clinical, business, and legal—who can help guide new pharmacies through this industry,” he said. “Taking proactive steps can help mitigate some of the known challenges, such as aggressive and heavy-handed [pharmacy benefit manager] and payer audits.”

Eager pharmacists need to study demographics and be able to educate local practitioners on what compounding involves

, noted Dawit. “Compounding pharmacy allows me to help patients who have specific needs and are overall wanting to improve their health, not just treat a condition,” she said. “I like spending time getting to know my patients, and [it is] rewarding to be able to solve problems that are not addressed by big-box pharmacies. Independent ownership is difficult in this time but also has its advantages for those who want to think outside the box.”

In the era of coronavirus disease 2019 (COVID-19), pharmaceutical compounding is as vital as ever. 

Health Crisis Highlights Value of Pharmacy Compounding

High workloads for pharmacists increase the potential for medication errors, and during the current coronavirus disease 2019 (COVID- 19) pandemic, the pressures are greater than ever. Unions are taking unprecedented steps to protect pharmacists and their patients. Their focus over the next year will be on making significant and lasting changes to prevent the growing number of obstacles that distract pharmacists from safely dispensing drugs.

In Chicago, permanent changes are occurring. Several years ago, a 

investigation revealed that 52% of 255 Chicago-area pharmacies had failed to warn patients about drug combinations that could cause harm or death.

 Since then, Teamsters Local 727 has worked with the Illinois legislature to update the state’s pharmacy act to better reflect the issues of working in a retail pharmacy. The union is pushing for mandatory, uninterrupted breaks for pharmacists.

In 2020, Teamsters Local 727 aims to raise standards, improve working conditions, and lift the collective voice of pharmacists and members of Teamsters Local 727. In an email, Teamsters Local 727 told 

 that the union is advocating for further reforms to the Illinois Pharmacy Practice Act, and, through its 2 seats on the Illinois Pharmaceutical Task Force, this fall it will give recommendations to the state legislature regarding further reforms.

The union supports additional policy reforms, including limiting retail pharmacists’ workdays to 8 hours, requiring that at least 1 pharmacy technician be on duty at all times when a pharmacist is scheduled, and requiring a separate break room to guarantee uninterrupted breaks. In addition, Teamsters Local 727 is asking for a triple-pay penalty for days when a retail employer fails to give a pharmacist the opportunity for an uninterrupted break.

“Retail chains should be held responsible for any failure to allow pharmacists to take uninterrupted breaks. When pharmacists are unable to take breaks, it’s usually due to understaffing in the pharmacy while the duties for pharmacists continue to grow,” Teamsters Local 727 said in the email.

Protecting Pharmacists and Their Patients

Ilisa Bernstein, PharmD, JD, senior vice president for pharmacy practice and government affairs at the American Pharmacists Association in Washington, DC, said several states have rules governing pharmacist breaks, including the minimum number, based on hours worked, and where they can be taken. “In addition, some employers have begun providing breaks for pharmacists,” Bernstein told 

® in an email. “Whether by law or policy, employers should provide pharmacists with mandatory, scheduled, uninterrupted meal breaks away from the pharmacy workflow to promote pharmacist well-being and improve patient safety.”

The COVID-19 pandemic has created significant disruptions in pharmacy operations and raised pharmacist safety concerns, according to Bernstein. “Access to appropriate [personal protective equipment (PPE)] and barriers in accordance with CDC guidance, distancing issues, personnel shortages, drug supply disruptions, and more have left pharmacists in a constant state of uncertainty, and they are taking extraordinary measures to ensure consistent delivery of quality patient care,” she said.

States, federal agencies, and employers have taken steps to improve conditions, she said, but as the pandemic evolves, so do pharmacist issues and concerns. For example, she said, although pharmacists welcome the ability to provide COVID-19 testing and a potential vaccine, employers and employees need to collaborate in the workplace to mitigate pharmacy operation and safety concerns.

Veronica Bandy, PharmD, MS, past president of the California Pharmacists Association in Sacramento, said that state laws regarding staff breaks vary. “Breaks for pharmacy personnel are needed to prevent fatigue and allow for time to use the facilities. Adequate staffing, breaks, and safety would be beneficial to be addressed to ensure the ability for pharmacists to provide health care at its highest level,” Bandy told 

The pandemic has changed the practice of pharmacy. Some pharmacies have placed protective partitions between patients and personnel. Individuals are encouraged to use drive-through or other social distancing methods for prescription pickup. In addition, masks need to be worn, and PPE use and social distancing between staff members must increase.“The California Pharmacists Association has been instrumental in advocating that pharmacists as health care providers have access to face masks and other [PPE]. As with many areas of health care, the practice of pharmacy is adapting on a daily basis as more scientific information becomes available,” Bandy said.

James Broughel, a senior research fellow at the Mercatus Center at George Mason University in Arlington, Virginia, said that in response to the pandemic, many governors expanded pharmacists’ prescribing authority or made it easier for medical professionals licensed in another state to practice. Many states have drive-through COVID-19 testing sites at pharmacy locations; although the extent of these operations varies significantly across states, pharmacists already play a significant role, which is likely to grow over time. "Unions should anticipate that pharmacists are going to be doing a lot of COVID-19 testing and ensure that adequate precautions are taken to ensure the safety of pharmacy staff, as well as customers,” Broughel told 

Study results published in 2007 in the journal Medical Care found that high workloads for pharmacists increase the potential for medication errors.

In a retrospective study, investigators reviewed data submitted to insurance companies by 672 pharmacies in 18 metropolitan regions. The pharmacies filled an average of 17,948 prescriptions from January to March 2003. The investigators found that factors significantly related to an increased risk of dispensing prescriptions with potential drug-drug interactions included pharmacist workload (odds ratio [OR], 1.03), pharmacy staffing (OR, 1.10), and various technologies, such as sophisticated telephone systems, internet receipt of orders, and refill requests.

The pharmacies employed an average of 1.2 pharmacists for each hour the store was open, and each pharmacist filled an average of 14.1 prescriptions per hour. The risk of dispensing potentially harmful drug combinations increased by 3% for each additional prescription filled per hour. There has been little improvement since the research was done, said study investigator Dan Malone, PhD, RPh, a professor at the University of Utah College of Pharmacy in Salt Lake City. “Working conditions are worse,” Malone told 

 in an email. “I would suggest that not much has changed.” 

Mike DeAngelis, senior director of corporate communications for CVS Health in Woonsocket, Rhode Island, said the company has policies and protocols to help ensure that stores are safe for both employees and patients during the current pandemic. All employees have received protective masks, gloves, hand sanitizer, and cleaning supplies and are required to wear a company-issued mask, their own mask, or a cloth face covering. “We have installed protective panels at our pharmacy counters and front-store checkout stations in all stores. We have hourly protocols in place for cleaning hard surfaces and more frequent cleaning of commonly handled items,” DeAngelis said in an email.

B. Douglas Hoey, MBA, RPh, CEO of the National Community Pharmacists Association in Alexandria, Virginia, said community pharmacies are the safety nets helping their communities during both times of crisis and normal times. In addition, pharmacists now are on the front line in America’s fight against COVID-19, ordering and administering tests. “With testing now and immunizations once a vaccine becomes available, community pharmacists could be the centerpiece for helping the country get back to normalcy,” Hoey told 

® in an email. How smoothly that goes will depend on the rights and protections afforded pharmacists in retail stores across the nation.

Roe S, Long R, King K. Pharmacies miss half of dangerous drug combinations. 

 December 16, 2016. Accessed July 1, 2020. https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Malone DC, Abarca J, Skrepnek GH, et al. Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions. 

 2007;45(5):456-462. doi:10.1097/01.mlr.0000257839.83765.07

Workplace conditions can affect both pharmacist and patient safety.

Pharmacy Unions Push for Improvements

The term vasculitis refers to a rare and complex family of diseases that can cause inflammation of the aorta and other arteries, veins, and blood vessels. Vasculitis manifests in many forms, involving different parts of the body and presenting with a diverse range of severity and duration.

Kawasaki disease (KD),a form of vasculitis that is exclusive to children,is known to inflame blood vessels throughout the body, especially those feeding the heart. Currently, the CDC is investigating reports of multisystem inflammatory syndrome associated with coronavirus disease 2019 (COVID-19) in children, which may present with KD-like features.

Recent studies suggest that, although rare, KD may be triggered by underlying infections such as COVID-19 or flu.

 KD produces clinical signs such as prolonged fever; swollen lymph nodes; bloodshot eyes sans drainage; rash; red, cracked lips and tongue; swollen lymph nodes on 1 side of the neck; and a fever of 100.4 °F or more that persists for 5 days or longer. KD typically occurs in children under 5 years of age but can also affect older children.

The coronavirus family has been suspected of playing a role in the onset of KD for the past 2 decades. In a 2005 study, a group of researchers in Connecticut, identified a novel strain of the disease, human coronavirus New Haven, in the respiratory secretions of 8 of 11 children who had KD versus 1 out of 22 controls.

COVID-19 was initially pegged as a disease that primarily affects the respiratory system. However, that changed with news of potential cutaneous involvement in certain populations in Italy in spring 2020, following reports of strange lesions on children’s skin. The results were published in The Lancet in May 2020. The Italian province of Bergamo, which had the highest number of COVID-19 infections and deaths in the Mediterranean country, experienced a 30-fold increase in incidence compared with the monthly incidences recorded during the previous 5 years.

During the month of April, investigators observed an increased incidence of what they referred to as “Kawasaki-like disease.” Between February 18 and April 20, 2020, 10 children (aged 7.5 years [SD, 3.5]) received diagnoses of KD. Children were admitted to the hospital and, on average, presented with fever on day 6 (range, 4 to 8). Half the patients presented with typical manifestations of KD, including cutaneous involvement such as polymorphic rash; hand and feet anomalies such as firm induration, erythema, or both; and nonexudative conjunctivitis. Investigators observed altered appearance of the lips and/or oral cavities of 80% of patients. The remaining 5 patients presented with incomplete forms of KD.

However, truly discerning the connection between COVID-19 or other members of the coronavirus family requires additional study.

KD manifestations often resolve on their own, and many children recover fully. However, children who fail to receive appropriate medical evaluation and treatment face heart damage and other complications. Because no specific test can diagnose KD, a fever lasting for more than 5 days is often used as an indicator of potential disease. To help determine whether a patient has KD, a physician might run blood and urine tests, an electrocardiogram, and an echocardiogram.

KD has 2 primary treatments: prolonged aspirin therapy, initiated every 6 hours and then decreased to once-daily dosing, and intravenous immunoglobulin to curtail swelling in blood vessels.

Vasculitis. American College of Rheumatology. Updated March 

https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Vasculitis

Kawasaki disease (KD). American College of Rheumatology. March 2019. Accessed May 28, 2020. 

https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Kawasaki-Disease-KD

Verdoni L, Mazza A, Gervasoni A, et al. An outbreak of severe Kawasaki-like disease at the Italian epicenter of the SARS-CoV-2 epidemic: an observational cohort study. 

 2020;395(10239):1771-1778. doi:10.1016/S0140-6736(20)31103-X

A Kawasaki-like inflammatory disease has affected children who have coronavirus disease 2019.

Investigators Find COVID-19 Connection in Vasculitis

With more work being done online, cyber protection in pharmacies is more crucial than ever. Pharmacies bear the responsibility to safeguard both provider- and patient- level information in their workflow, which can be especially challenging with enrollment in patient portals.

“Until recently, the concept of cyber protection has largely taken a back seat to general business operation,” said Chase Kassel, govern- ment relations manager for Acronis, a Tempe, Arizona–based cloud security provider. “Malicious actors have increasingly been turning their attention to the health care industry, [and] new threats to data security have been emerging.”

The internet and use of computer technology are the backbone of pharmacy operations, supporting the role of providing drug therapy oversight to patients, according to Barbara Giacomelli, PharmD, area vice president at McKesson Pharmacy Optimization in Vineland, New Jersey. Safeguarding against cyberattacks is critical to maintaining a secure drug database, financial transactions, and protecting confidential patient information, she said.

“A cybersecurity attack not only disrupts pharmacy services [but also] has the potential to [affect] patient care, increase liability, and [have] a negative financial impact,” Giacomelli added.“ Cybercrime continues to advance tactics to breach computer systems. It is important to stay ahead of cybercriminals by having the latest computer security software, maintaining backup, and considering regular security scans.”

Pharmacy personnel also need to be educated on the importance of cybersecurity and phishing risks. Many techniques can be applied to fortify against cyberattacks and protect customers’ data.

“You not only want to keep your customers’ trust but you [also] want to ensure that they feel safe leaving their details with you,” said Heather Paunet, senior vice president of product and marketing at Untangle, a leader in com- prehensive network security for small- to-medium businesses. “Since most pharmacies take customer details in order to help with prescriptions, there is a risk for those details to be hacked. Implementing the right security within your pharmacy will ensure that all that data are safe, keeping your customers safe and keeping your business safe from further damage.”

In this time of change and uncertainty, best practices can still be adopted to help protect pharmacies against breaches and other cyber threats. Giacomelli’s top recommendations include giving employees access only to information required to do their jobs, with individual sign-ons and passwords, and running regular system security scans.

One of the biggest threats to pharmacies involves phishing, a type of online scam in which hackers send an email that appears to be legitimate and asks for sensitive information, usually to be provided via a link. The information goes straight to the crooks behind these clever fakes.

Many small businesses, including pharmacies, have seen a huge increase in phishing scams related to coronavirus disease 2019 (COVID-19), mostly through emails that claim to have updates concerning the virus. Employees need to be trained to spot phishing attempts, and use phishing filters with any email service.

Pharmacies also must look out for ransomware attacks. These involve a form of malware that encrypts a victim’s files, and then the attacker demands a ransom to restore access to the data.

“Ransomware is a major threat we’ve seen in recent years, which also often results in a data breach,” Kassel said.“ Any unnecessary PHI [protected health information] or PII [personally identifiable information] should not be retained, and what must be held on to should be encrypted and not accessible to any internet-facing location.” 

Herb Brychta, security risk services manager at AE Works, noted that staff awareness and training are key to mitigating risk. “Even before COVID-19, human beings were vulnerable,” he said. “So many viruses happen because people click on a link
in their email, which deploys a virus. As we’ve transitioned to an environment where people are working from home where they are most comfortable, their awareness is not as heightened, and everyone is more susceptible when comfortable.”

Proper backups and an effective ransomware protection solution are also critical for both protection and continuity of operations. In addition, keep all software updated to help eliminate vulnerabilities, and run antimalware software to protect against other types of malware.

“[Internet of Things (IOT)] devices are another major concern in today’s world,” Kassel said. “These can be personal devices, like cell phones and smart speakers, or internet-connected equipment to improve efficiency with specific job functions.” He recommends keeping personal devices off any networks with any business systems and separating systems containing PII and PHI from any necessary IOT devices that are incorporated into the business operations.

To guard against e-commerce dangers, invest in and use antivirus software; run scans frequently and at the end of the day, Brychta suggested. Virus scans should filter out known hazards, especially for pharmacists who receive attachments such as order forms. Keep operating systems updated. “These help safeguard against risks. Having an up-to-date computer best protects you,” he said.

“If you can, I highly suggest using a separate computer to receive orders and using different one to do banking and books. If the order-taking computer gets infected, there is less risk because you aren’t logged into any secure sites like banking. While you’re at it, have separate email addresses for orders and administration.”

When COVID-19 hit, everyone rushed into working remotely. New tools were pushed, with little training, onto employees, and skipping critical steps to ensure correct operation introduced security risks.

“The most common mistake for virtual meetings is not protecting access with a password,” said Nick Santora, CEO of Curricula. "When you’re scheduling a virtual meeting, you can check a box requiring a password. Always make sure that box is checked. If you invite someone to a meeting with that link directly from the platform, it should automatically populate for a URL with the password to be included in the calendar invitation.”

Most companies with a proprietary code base, such as Skype, WhatsApp, and Slack, tend to be vague about how they manage or store customers’ data. Using those platforms means taking many risks, such as the data being routed out of the country and, in turn, not following data privacy laws such as General Data Protection Regulation, Health Insurance Portability and Accountability Act (HIPAA), and California Consumer Privacy Act.

By integrating patient linking and matching technology and adding the right layers of verification and authentication across workflow and platforms, pharmacies can remain HIPAA compliant and protect critical data such as patient names, birth dates, and prescription information, according to Mark Barwig, executive vice president of Epic Pharmacies, Inc, a network of independently owned pharmacies.

“Multifactor approach [MFA] to security and identity management extensively assesses the risk of both physical and digital identity attributes to enable accurate and timely risk detection and identity decisions,” Barwig said. “The MFA uses at least 2 independent elements, or factors, such as identity document authentication, knowledge-based questions, 1-time passwords, email verification, facial recognition, device analytics, or voice biometrics, to verify patients based on the criticality of transactions.”

As cybercrooks evolve with technology, so should pharmacies and staff. A service that receives regular updates and security fixes can help. “Familiarize yourself with the available features of the service of your choice,” Santora said. “Subscribe to newsletters, use available training and documentation material, and share it with all users. Audit the effectiveness of your selected safety measures regularly, and take action if things are not working the way they should.”

Focus on best practices and implement new technology to safeguard
against security breaches.

Protect Your Pharmacy’s Online Presence

An estimated 80% of Americans will be infected with human papillomavirus (HPV) at some point. For many people, the infection will clear on its own without causing symptoms; for others, it can cause cancer later in life.

Pharmacists are highly trained and conveniently positioned to advocate for and administer vaccines. “As highly accessible healthcare professionals, pharmacists are equipped to identify patients who should receive the HPV vaccine and increase vaccination rates to assist with disease prevention,” said Katelyn Johnson, PharmD, MS, BCACP, assistant professor of pharmacy practice and community pharmacist at University of Cincinnati James L. Winkle College of Pharmacy and Kroger Health in Cincinnati, Ohio.

Community pharmacists are among the most accessible health care professionals; more than 90% of Americans live within 5 miles of a pharmacy, noted Deanna Tran, PharmD, BCACP, an assistant professor of pharmacy practice and science at the University of Maryland School of Pharmacy in Baltimore. These providers interact with customers who are picking up their medications, getting an OTC recommendation, or just passing by while buying something else. “Through these regular interactions, pharmacists are uniquely positioned to provide education on HPV and HPV vaccines, debunk myths associated with the vaccine, and administer the vaccine at the pharmacy,” she said.

Furthermore, young adults, including those in the age group indicated for the vaccine, often seek out convenient health care. Community pharmacists can provide that convenience, Tran said. Pharmacies may be open later than a traditional medical office or clinic practice, and pharmacists can administer vaccines with minimal wait times or without appointments. Community pharmacists can also play a vital role in rural or underserved areas, where a primary care provider may not be as easily visited.

Pharmacists who work in an ambulatory care clinic or in a hospital also can help boost vaccination rates. As medication experts, they often review medications and screen patients for necessary vaccinations, Tran said.

HPV vaccination helps prevent new HPV infections. It does not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease.

The Advisory Committee on Immunization Practice (ACIP) recommends that the HPV vaccination series be started at age 11 or 12 years, although it can be initiated as early as age 9. Catch-up is recommended for all individuals through age 26 who weren’t adequately vaccinated previously.

For unvaccinated patients aged 27 to 45 years, vaccination can be considered based on shared clinical decision-making between the provider and patient. “Although transmission is most likely to occur in adolescents and young adults, some people may have specific behavioral or medical risk factors that increase their risk of HPV infection,” said Danielle C. Mayer, PharmD, BCACP, an assistant professor in the Department of Pharmacy Practice at Thomas Jefferson University’s Jefferson College of Pharmacy in Philadelphia, Pennsylvania. Currently, HPV vaccines aren’t licensed for use in adults older than 45.

“Vaccine effectiveness is lower in this older age group because these individuals may already be exposed to HPV, so a discussion with a provider would be beneficial,” Tran added.

The vaccine is not recommended for pregnant women. If a woman has not been fully vaccinated for HPV, Mayer recommends starting or finishing the series in the postpartum period. The vaccine can be administered to a woman who is breastfeeding.

Gardasil 9 is the only HPV vaccine currently distributed in the United States. For patients aged 9 through 14 years, Gardasil 9 can be administered using a 2- or 3-dose schedule. For the 2-dose schedule, the second dose should be given 6 to 12 months after the first dose. If the second dose is administered less than 5 months after the first, a third dose should be given at least 4 months later. For the 3-dose schedule, Gardasil 9 should be administered 2 and 6 months after the first dose. Study results have shown that in patients aged 9 through 14 years, the 2-dose schedule, with at least 6 months between doses, provided an antibody response as good as or better than that of the 3-dose schedule.

For patients aged 15 through 45 years and for immunocompromised patients, including those with HIV infection, Gardasil 9 should be administered using a 3-dose schedule at 0, 2, and 6 months.

Existing vaccines cover only a limited number of the more than 100 HPV types, according to Zvi Loewy, PhD, professor of pharmaceutical and biomedical sciences, associate dean of research, and immediate past dean at Touro College of Pharmacy in New York, New York. The Merck vaccine covers high-risk HPV types (16 and 18) and those that cause genital warts (6 and 11). A vaccine made by GlaxoSmithKline covers oncogenic, or high-risk, types (16 and 18) exclusively. Another vaccine in development covers 9 types of HPV.

State laws differ regarding a pharmacist’s ability to give the vaccine. Of 50 states and the District of Columbia, 40 have laws expressly granting pharmacists the authority to administer the HPV vaccine, Loewy said; 22 have laws that authorize pharmacists to vaccinate preadolescents aged 11 or 12 years, the age group recommended by the CDC. Pharmacists have prescriptive authority in just 5 states.

More than 12 years of monitoring data and research demonstrate that the HPV vaccine is very safe, Tran said. Similar to other vaccines, the HPV vaccine can cause injection site reactions such as pain, redness, or swelling, as well as nausea and headache.

Fainting after receiving any vaccine is more common among adolescents, and dizziness or fainting may be more common with the HPV vaccine. Johnson suggests having patients sit or lie down for 15 minutes of observation after getting the vaccine. Patients may minimize potential pain by relaxing their arm during administration and moving their arm around afterward.

Ask the experts: human papillomavirus. Immunization Action Coalition. October 10, 2018. Updated March 1, 2020. Accessed June 29, 2020. 

www.immunize.org/askexperts/experts_hpv.asp

Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. 

Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination - updated recommendations of the Advisory Committee on Immunization Practices. 

CDC recommendations for patients 9-26 years of age. Merck Vaccines. June 2020. Accessed June 29, 2020. 

https://www.merckvaccines.com/gardasil9/cdc-recommendations-hpv-vaccination/

Pharmacists should counsel patients on how taking steps now can prevent certain cancers later.

Communicating Facts Can Help Boost HPV Vaccination Rates

With influenza season approaching, it is critical to be prepared, because coronavirus disease 2019 (COVID-19) will likely still be circulating throughout the United States. Pharmacists serving on the front lines amid the pandemic also will play an important role in flu vaccine administration and education.

The CDC estimates that from October 1, 2019, to April 4, 2020, there have been 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths related to influenza in the United States.

 Influenza vaccine efficacy varies and was 39% effective overall during the 2019-2020 season.

 A total of 185 influenza-associated pediatric deaths were reported to the CDC; generally, approximately 80% occur in those who were not fully vaccinated.

Promoting flu vaccines is critical to easing the influenza hospital burden, especially because COVID-19 will likely coincide with the upcoming season.

 Everyone 6 months and older should receive the current influenza vaccine, which offers the best way to prevent flu and serious complications, including hospitalization and death.

Even though the influenza vaccine does not protect against COVID-19, it can help keep patients healthy and prevent hospitalizations during the pandemic.

Both influenza and COVID-19 are infectious respiratory illnesses, but there are differences between the viruses (

. Flu symptoms typically include fever, cough, body aches, and fatigue, and patients may also experience vomiting and diarrhea.

Influenza Vaccines Available for Upcoming Season

Vaccine options are similar to the 2019-2020 flu season and include standard-dose quadrivalent, quadrivalent cell-based, and recombinant quadrivalent shots (

The live attenuated influenza vaccine nasal spray is also an option.

 For adults 65 years and older, 2 new vaccines are available for the 2020-2021 flu season. These include a quadrivalent high-dose vaccine (Fluzone High-Dose Quadrivalent), replacing the trivalent high-dose vaccine, and a quadrivalent adjuvanted vaccine (Fluad Quadrivalent), which is similar to the previous trivalent, with 1 additional influenza B component.

 Pharmacists should educate patients to get vaccinated before the end of October to ensure optimal protection and remind them that it takes about 2 weeks after administration for the flu vaccine to become fully effective.

Additionally, universal influenza vaccines are being investigated to provide long-lasting protection against most or all flu strains. There are currently 2 universal flu vaccines in the pipeline: FLU-v and M-001 (

Families should be counseled that children 6 months to 8 years of age require 2 doses of the flu vaccine separated by at least 4 weeks if they are receiving it for the first time or previously received just 1 dose.

 Families should ensure that they begin the vaccine process early for their children, especially those being vaccinated for the first time, because full efficacy occurs 2 weeks after administration of the second shot.

The World Health Organization named vaccine hesitancy as one of the 10 threats to global health in 2019.

According to a recent survey, approximately 25.8% of parents are hesitant for their children to receive the influenza vaccine.

Keep up-to-date on flu vaccine options and counseling considerations, especially as coronavirus disease 2019 continues to strike.

Drug Topics August 2020