Keith Loria is a contributing writer to Medical Economics.

Keith Loria

As the United States surpasses 26 million COVID-19 infections, immunization against the disease is critical. President Biden has pledged to increase the vaccine supply so that 100 million doses can be distributed during his first 100 days in office, and that means that community pharmacies should prepare to do their share.

But pharmacists still need to oer other immunizations as well, so the addition of these expected COVID-19 vaccinations will only add to the pharmacy’s workload. That’s why pharmacists need to think about how to improve workflow eciencies and create a stronger system management. Technology is often the answer.

Technology allows for faster counting and better record keeping, and for those pharmacies that can invest in automation, the impact can be exponential in improving eciencies, both in vial dispensing and in medication adherence packaging.

Peter Saad, PharmD, MBA, director of product strategy at pharmacy automation company Parata Systems, noted that the COVID-19 vaccine efforts will be new waters for retail pharmacy, as much of the process will be dierent, including, but not limited to, billing and tracking.

“Technology and automation will be key in streamlining processes for these pharmacies by freeing up time for pharmacists and technicians to focus on the clinical initiative of vaccine efforts and understanding the new waters,” Saad said.

More than ever, pharmacists are seen as frontline medical providers for the vaccine, and as such, they need to be front of house counseling patients. That’s why we are seeing retail pharmacies invest in technology, whether new to automation, or scaling their existing automation.

“Tactically, there are a variety of ways pharmacists can rely on technology for workflow and system management,” Saad said.

These include syncing patient medication regimens to monthly cycles to limit time to dispense/sell in the pharmacy, allowing more time for vaccine discussion and distribution; using Health Insurance Portability and Accountability Act compliant online form submission and preemptively inputting patients before arrival to streamline the vaccination process; and automating the filling process or hiring an additional pharmacy technician, as at least 1 technician will likely be occupied with receiving and inputting patient and vaccine information.

“If possible, have all refills filled via central fill, which allows for the ability to fill prescriptions quickly without using new resources, as this supports the bottom line and returns pharmacists and techs to activities that support patient care,” Saad said.

Jason Turner, PharmD, owner of Moundsville Pharmacy in Moundsville, West Virginia, said a great way to create a strong foundation of efficiencies in a pharmacy is to initiate a medication synchronization program.

“Medication synchronization changes your workflow from being ‘on demand’ workflow, meaning when the patient calls in the prescription, you begin to work on it in a way where your pharmacy team is in control of when you process a large percentage of your prescription volume,” he said.

For example, there are 1800 patients enrolled in Moundsville Pharmacy’s SyncRx program—73% of monthly prescription volume.

“We are able to schedule the work with a strategy to be most efficient in our prescription processing and most available to our patients for clinical services, such as immunization,” Turner said.

Jason Ausili, PharmD, chief clinical officer for FDS, a provider of pharmacy technology solutions for independent pharmacists, noted that tech can help drive immunization efficiencies in numerous ways.

“It can be used for billing the medical benefit for vaccine and/or administration fees in a way that is streamlined with workflow, provide automated reporting to state registries for reportable vaccine events, and allow a pharmacist to query state registries for vaccine eligibility at the patient level,” Ausili said. “Tech makes clinical documentation easy and efficient and makes the patient scheduling process a more automated and organized experience.”

At Moundsville Pharmacy, there are 2 Kirby Lester units, a ScriptPro SP 200, and a Parata PASS 300VP to increase efficiencies in the sta, workflow, and programs.

Turner recommends using dierent colored paper for each immunization record, which allows the staff to access and recognize vaccines in the workflow quickly, from billing to vaccinating, documenting, and record storage.

“For larger pharmacy teams, I would create a workflow for your immunization prescriptions,” he said. “This way, if a patient comes in and requests a vaccine, everyone knows how that clipboard is to flow to maximize your eciency and not disrupt existing workflow.”

Because vaccine billing can be challenging, Turner suggests directing vaccine billing to 1 or 2 vaccine specialists to make sure they are processed timely and identify quickly if you are unable to bill a payer through your pharmacy management system.

Maximizing the features of pharmacy software is no longer an option, as many pharmacies continue to use their software the way they did 5 or even 10 years ago, either not detecting the upgrades in their pharmacy management systems or not knowing how to incorporate them into their workflow.

Too often pharmacies invest in automation, counting technology, or a fancy new bell or whistle for their pharmacy management system, only to find that it doesn’t change the outcome.

“Over the years, in working with and training pharmacy owners in medication synchronization, it has become clear that the physical workflow of the pharmacy—how the prescription moves about the pharmacy—and the processes that support pharmacy workflow really dictate the eciency of a pharmacy,” Turner said.

The expense of automation technology and lack of cash flow for retail pharmacies are no question the largest barriers for adoption. But Saad said the best way to increase efficiencies with existing staff is by incorporating automation.

“Not only will it allow pharmacists to move to the front of the pharmacy and practice at the top of their license, but it will allow for value-adding activities for patients, all the while technology is handling routine prescription fills quietly in the back of the pharmacy,” he said. “When pharmacies start to hit 200 scripts a day, there will already be ROI from the technology, helping to fix that cash flow problem and making the cost worth it almost instantaneously.”


In 2021, there will be a lot of buzz around the approved COVID-19 vaccines and their availability, and although these vaccines have given pharmacists opportunities, they also have added pressure.

“The most important first step is to train your staff in how to respond to calls and inquiries about the vaccine,” Turner said. “This will help to keep inquiries consistent, concise, and informative for the patient. Utilize your automated attendant to record a manager’s message at the beginning of every received call and your on-hold system to provide additional information.”

The pharmacy management system will be able to record and bill immunizations. However, understanding what insurance you can and cannot bill will be important, keeping in mind that, even if you cannot bill the insurance, you cannot deny the patient the vaccine.

Additionally, when the vaccine supply increases, retail pharmacies will be busier than ever, which means long lines made even longer with social distancing efforts.

Saad said that although billing will be unified, normal business activities, in combination with vaccine efforts, will be hard to manage without relying on assistance, including technology and automation.

“After the pandemic passes, retail pharmacies need to accept what they have known for a decade: Fee for service is no longer viable,” he said. “If they don’t pivot their pharmacist role to one that is more collaborative and clinical in nature, they will be out of business in the next decade. Free up pharmacist time using automation, work to identify clinical services, and start providing."

Articles

Pharmacies can leverage technology for their workflow and system management. Here’s how.

Improve Immunization Efficiencies With Automation

Last year, California Gov Gavin Newsom announced the state would transition the pharmacy benefit for Medi-Cal beneficiaries from managed care plans to a fee-for-service (FFS) program, bringing approximately 13 million Medi-Cal beneficiaries to a new pharmacy program by January 2021.

Because of the ongoing challenges and evolving health care landscape associated with the coronavirus disease 2019 (COVID-19) pandemic, the Department of Health Care Services (DHCS) has delayed implementation until April 1, 2021.

This change was implemented pursuant to an executive order, as opposed to legislative efforts. It reflects patient dissatisfaction with the performance of the Medi-Cal managed care organizations when it comes to pharmacy services and medication access, as well as state concerns about a system that was failing to control prices.

Ken Thai, PharmD, CEO of 986 Degrees Corporation, said the extension to April was welcomed because some details of the rollout needed to be finalized. He noted that during the last few months of 2020, more pharmacists voiced concerns that reimbursements were going from bad to worse—and independent pharmacies were hit especially hard.

“I think there’s optimism that this Medi-Cal FFS program changing back to the state will be very positive for the most part; however, there are concerns about the transition,” Thai said. “With 13 million lives being taken back on, there are some hiccups expected.”

Other concerns he’s heard involve how this structure will apply to higher-cost drugs such as HIV or mental health medications. “I do expect this to be easier for patients who didn’t really understand how the Medi-Cal system worked previously,” Thai said.

Lucas W. Morgan, an attorney in Frier Levitt’s life sciences department

, explained that DHCS will reimburse pharmacies based on a combination of their actual drug acquisition cost and preestablished fees (eg, dispensing fees).

Magellan Medicaid Administration, Inc will be the sole pharmacy benefit manager (PBM) responsible for administering the program and was awarded a 5-year contract on December 12

, 2019 with 5 optional 1-year extension periods.

The executive order states that California’s “spending on prescription drugs has increased at an unsustainable rate, including hikes of approximately 20% per year since 2012, constituting a substantial fiscal drain.”

“The stated goal of the executive order is to achieve cost savings for California’s spending on prescription drugs,” Morgan said. “A relatively small subset of high-cost drugs accounts for a disproportionate amount of spending, with the 25 most expensive drugs accounting for approximately half of the state prescription drug expenditures.”

The executive order states that a major cause of skyrocketing prescription drug prices is unequal bargaining power, by which the pharmaceutical industry—often wielding monopoly power—is left unchecked in the absence of a strong counterparty at the bargaining table.

“The language of the executive order and other related commentary suggests that this unequal bargaining power is related to drug manufacturers,” Morgan said. “While manufacturers certainly play a role in this, it is important to note the critical role PBMs have played in the rising costs of prescription drug prices.”

Sidebar. Medi-Cal Rx Transition to Fee-For-Service Objectives

California Governor Newsom’s executive order to transition all Medi-Cal pharmacy services from managed care to fee-for-service (FFS) seeks to

Marshal public and private entities to counterbalance corporate bargaining power to address rising prescription drug prices and promote broader access to affordable health care for Californians

Establish a single-purchaser for the highest-cost prescription drugs

Standardize the California Medicaid pharmacy benefit

The Department of Health Care Services (DHCS) noted that transitioning pharmacy services from managed care to FFS will better standardize the Medi-Cal pharmacy benefit statewide and will improve access to pharmacy services with a pharmacy network that includes approximately 94% of the state’s pharmacies, while strengthening California’s ability to negotiate state supplemental drug rebates with drug manufacturers.

Furthermore, DHCS explains that expenditures for medical care and services administered to Medi-Cal certified eligibles can take many forms, including capitation payments to managed care health plans, Medicare premiums for low-income dual eligibles, and federal disproportionate share hospital payments to safety-net public hospitals.

Harry Nelson, JD, managing partner of Nelson Hardiman, a health care law firm in Los Angeles, said this change will expand dramatically the number of pharmacies able to participate in dispensing outpatient prescription medications to the 14 million Medi-Cal members in California without the challenge of being part of the Medi-Cal managed care networks, which had been a barrier to patient access and a regulatory burden for pharmacies.

“Instead, pharmacies can directly enroll in Medi-Cal with DHCS and bill claims, which will be managed by a single, centralized pharmacy benefit manager,” he said. “My sense is that the majority of pharmacies see this as a positive change, particularly given that Medi-Cal has become the single biggest payer in the state, with almost 36% of state residents and growing.”

Because there will be a single payer for California’s pharmacy benefit, Morgan said this is in stark contrast to previous arrangements in which multiple PBMs managed the pharmacy benefit with varying reimbursement benchmarks.

“The FFS model will likely eliminate PBM spread pricing in California Medicaid, which is a widespread PBM practice where the PBM charges a plan sponsor a higher price for a medication but then reimburses the pharmacy a lower amount and retains the difference,” he said.

Many states have investigated the practice of PBM spread pricing within in-state Medicaid programs and found prominent use of such practices in Medicaid.

“Pharmacy reimbursement being based on pharmacies’ actual drug acquisition cost combined with predetermined fees should result in more reasonable [and] sustainable reimbursement for pharmacies, at least in Medicaid, especially independent pharmacies,” Morgan said. “This could be especially pronounced in reimbursement for generic drugs, which comprise that vast majority of the prescription drugs prescribed and dispensed throughout the country annually.”

Morgan further explained that with in-state Medicaid programs relying on multiple PBMs to manage the pharmacy benefit on behalf of various plans, generic drug reimbursement is often made under a Maximum Allowable Cost (MAC) framework 

created solely by that particular PBM. However, PBM MAC reimbursement is often inconsistent among the various PBMs and often occurs at levels that are so low, pharmacies are losing substantial amounts of money.

“MAC reimbursement is also one of the primary ways in which PBM spread pricing is implemented by PBMs at their sole discretion,” he said. “In addition, because PBM MAC lists are deemed by the PBM to be confidential and proprietary, they are not subject to public scrutiny, which enables the PBM to set arbitrary and unreasonable MAC reimbursement that is not subject to any meaningful challenges.” Therefore, more pharmacies will likely be able to participate in California Medicaid.

One of the primary benefits of the new program will be increased access and freedom for patients to choose pharmacy providers because there likely will be more pharmacies able to participate in California Medicaid.

According to DHCS, “the vast majority of the state’s pharmacies” will be included in California Medicaid’s pharmacy network—citing 94% at last report.

“Patients were restricted to a relatively smaller number of pharmacies that contracted with the 2 dozen or so Medi-Cal managed care organizations,” Nelson said. “After the carve-out, patients will be able to obtain their medications through most pharmacies that will participate in ‘straight’ Medi-Cal [without the managed care organizations]. This is likely to benefit pharmacies focused on Medi-Cal populations, including pharmacies contracted to support federally qualified health centers through the 340B program.”

Once enacted, this will be good for all parties going forward, he said.

“The big attraction for Medi-Cal patients is the ability to go to almost any pharmacy in the state and have instantaneous processing thanks to the technology that allows PBMs to provide convenience for patients with private insurance,” he said. “For the state, centralizing drug rebates and having a single PBM utilizing a cost-based model holds out the potential for savings that did not materialize” in the current managed care organization-negotiated model.

Medi-Cal Rx: transition. Department of Health Care Services. Updated December 21, 2020. Accessed January 12, 2020. 

https://www.dhcs.ca.gov/provgovpart/pharmacy/Pages/Medi-CalRX.aspx

Executive order N-01-19. Executive Department, State of California. January 7, 2019. Accessed January 12, 2020. 

https://www.gov.ca.gov/wp-content/uploads/2019/01/EO-N-01-19-Attested-01.07.19.pdf

Medi-Cal and fee-for-service expenditures. Department of Health Care Services. Updated October 7, 2020. Accessed January 12, 2020. https://www.dhcs.ca.gov/dataandstats/statistics/Pages/Medi-Cal_Fee-for-Service_Expenditures.aspx

What pharmacy needs to know about the transition to the new fee-for-service program in California for Medi-Cal 

Pharmacy Benefit Changes Are Coming for Medi-Cal Beneficiaries 

At the end of 2020, the biggest buzz in pharmacy—and the world—were the Pfizer and Moderna coronavirus disease 2019 (COVID-19) vaccines. At press time, both vaccines have received emergency use authorizations by the FDA and began shipping in the US. 

Tom So, PharmD, clinical pharmacist/manager of the Meducation Group at First Databank, which provides drug and medical device databases that help health care professionals make precise decisions, noted that these vaccines will present challenges to pharmacies due to the special storage requirements and handling issues with ultracold freezing needed for the Pfizer vaccine (–80 degrees °C to –60 degrees °C). Additionally, these vaccines are 2-dose regimens, so medication adherence will be crucially important to their effectiveness.

Another challenge will be vaccine hesitancy as a result of the rhetoric that surrounds the vaccines and their rapid development to date. Will patients trust the safety of these rapidly developed vaccines? 

“All of this remains to be seen, but it’s certainly an area where pharmacists can make a big impact,” So said. “Pharmacists are one of the professions that patients truly trust. As pharmacists, we should follow the science and convey this information to patients in language they can understand, to boost the number of Americans that get vaccinated, in an effort to hopefully help end this pandemic.”

Calvin Knowlton, PhD, MDiv, BScPharm, CEO of Tabula Rasa Healthcare and former president of the American Pharmacists Association, believes one of the biggest trends in 2021 will be a focus on the safe use of medications. 

“We have been talking about this for more than 5 decades, but it seems that this will become the future of the pharmacy practice,” he said. 

Reasons for this shift are many. For one, dispensing margins continue to shrink, which will reduce a pharmacist’s involvement and increase the responsibilities of pharmacy technicians. Additionally, society, via government mandates, is moving the industry to value-based payment versus fee-for-service health care models.

In Knowlton’s opinion, pharmacists are uniquely suited for identifying and mitigating adverse drug effects. “Pharmacists fully understand and have been educated on the sciences underlying drug disposition,” he said. “If one compares the curriculum of pharmacy school education to medical school education, pharmacy education focuses on pharmacokinetics, pharmacogenomics, pharmacodynamics, etc, and medical education focuses on patho-physiology of organ systems and differential diagnoses.”

Among the trends to keep an eye on for 2021, said George E. MacKinnon III, PhD, MS, RPh, FASHP, FNAP, who is founding dean and professor of the Medical College of Wisconsin School of Pharmacy, are continued adoption of virtual, telehealth, and digital health services and the electronic health record (EHR) becoming more accessible digitally to pharmacies, nontraditional sites, and patients.

“Additionally, the ongoing shortage of primary care physicians and the fact that many patients have not been seen by providers due to COVID-19 for their chronic medical conditions that most often require medications and dosage adjustment to achieve goals, presents a unique opportunity for pharmacists to be reimagined as the ‘Front Door to Health Care,’” he said. “Bidirectional access to the EHR is critical.”

So noted a key priority for pharmacists will include helping patients with medication adherence. Because comorbidities are risk factors for COVID-19, it is important that patients be adherent to their medications, especially for chronic conditions such as heart disease, diabetes, and COPD. Other priorities will include pharmacists taking on more responsibilities such as ordering and administering COVID-19 vaccines, making medication therapy recommendations to optimize patients’ drug regimens, and making drug substitutions when drug shortages occur.

Giuseppe Aragona, MD, general practitioner and medical advisor at Prescription Doctor, sees more pharmacies turning over to a more advanced click and collect system in 2021, where patients will book in to collect medicine at specific time slots, rather than just show up.

“This is likely to stop masses of people arriving at the same time, helping to keep a more controlled environment for prescription pick-ups,” he said. “Secondly, and slightly more difficult, will be a more common move towards delivery. Dealing with prescription drugs is a lot more sensitive than delivering somebody’s meal, so whether this could feasibly be done on a larger scale, with privacy and safety front and center, will be a big part of whether we see this happen more commonly.”

The COVID-19 pandemic of 2020 has brought forward the challenges of an overwhelmed health care system and a need to embrace all essential health care providers, and that embrace needs to include pharmacists. The pandemic has changed society and the way that individuals go about their daily lives. 

“For the major pharmacy retailers and even independent pharmacies, making home delivery an option may cut down on in-store purchases, but it could retain existing business and bring in new sales by alleviating concerns from patients who are seeking ways to limit their potential exposure to the virus through similar options such as grocery deliveries,” So said. 

With the pandemic, many patients were directed to stay at home or shelter-in-place, severely disrupting the previous paradigm of in-person receipt of care. “Perhaps the greatest fundamental shift was the acceleration in the acceptance of telemedicine,” said Jesse C. Dresser, Esq, a partner and head of the pharmacy group at law firm Frier Levitt. 

“Previously viewed with skepticism by regulators and payers alike, telemedicine prescribing has become a central aspect of care delivery, and will remain in 2021.”

With President-Elect Joe Biden set to take office on January 20, 2021, pharmacists should see some impact going forward.

“We may see legislation that could result in pharmacists being granted widespread provider status that may enable them to gain reimbursement for specific services such as pharmacogenomic testing evaluation and drug therapy recommendations,” So said. “However, gridlock on Capitol Hill could stall these changes.”

Although the Trump Administration has long been pushing to remove manufacturer rebates in the Medicare Part D space, this does not appear to be a high priority on President-Elect Biden’s agenda. “Instead, Biden has emphasized that his administration will reduce drug prices through various avenues including, without limitation, repealing laws that prevent Medicare from negotiating lower drug prices with drug companies, setting reasonable prices for new drugs that don’t face competition, prohibiting companies with ‘abusively priced generic drugs’ from raising their prices and impos-ing tax penalties on these companies, allowing people to buy safe prescription drugs from other countries, improving generic drug supplies, and eliminating tax breaks for drug company ads,” Dresser said.

Biden has hinted at revoking the non-interference clause, the Medicare Part D provision that has long prevented the government from taking a direct role in negotiating drug prices.

Kok-Hong Tan, BSPharm, a pharmacist at EHR Pharmacy, an independent community pharmacy in Fort Worth, Texas, said the pharmacist profession and practice will continue to evolve in 2021, driven by the changing needs of society, pharmaceutical markets, advancements in treatment, government regulations, and so on. 

As the pharmacy landscape evolves, health care technology standardization and advancement will also need to progress. 

“When one of these factors above creates a ripple, the pharmacy practice landscape will be affected in a different magnitude,” Tan said. “Pharmacist-provided patient care will be the future of pharmacy services, as the pharmacist profession slowly gains full provider status in the health care world.”

So noted that Amazon’s entry into the pharmacy services space will have a potentially big impact on the market in 2021. “They will offer direct competition to major pharmacy retail chains,” he said. “People are so used to using their Amazon app to purchase other essentials, whether it is household products, face masks, clothing, or electronics—it will be interesting to see if they will also use the service to order prescription drugs.”

And although there’s no question that COVID-19 has altered pharmacy, Knowlton argues that Amazon and its subsidiary, Pillpack, will have larger lasting effects on the pharmacy landscape in the future. “This is all the more reason that community pharmacists must position themselves as the medication regimen quarterback or coach, and charge for it as a concierge pharmacist,” he said. “To move from the 50-year-old, 1-drug to 1-drug interaction construct that is based on what has been reported in the literature, to a multidrug simultaneous drug interaction system based on pharmacotherapy science, with COVID-19 drugs or without, is the future for the profession.”

In 2021, Knowlton encourages fellow pharmacists to use their pharmacokinetics, pharmacogenomics, and pharmacodynamics background and put it to use.

“This is our real value proposition as pharmacists,” he said. Pharmacists assist in management of chronic conditions through comprehensive medication management services in community pharmacies. Yet, reimbursement models from many commercial insurers and government (Medicaid and Medicare) have not caught on to fairly compensating pharmacists. 

MacKinnon feels the pharmacy profession in conjunction with medicine, needs to step forward to accept this challenge and make changes for patient and provider benefits alike. 

“Keeping a patient on their medication and out of the ER/hospital saves money,” he said. 

Looking ahead, MacKinnon would like to see more emphasis on pharmacy partnering with medicine. “The explosion of high-cost specialty pharmaceuticals and growing use of biomarkers with the soon-to-be future of precision medicine at our doorstep, as deployed via pharmacogenomics, it only makes sense that pharmacists emerge with a more appreciated and expanded role,” he said. 

“Frankly, the addition of a pharmacist to most physician group practices will be clinically and financially prudent if not essential in time.”

How will a change in administration, a vaccine for COVID-19, and other factors change the industry in the year ahead?

Pharmacy in 2021: Trends to Transform an Evolving Profession

Coronavirus disease 2019 (COVID-19) news may have dominated headlines for most of the year, but there were plenty of other noteworthy drug and product launches in 2020 that pharmacists were excited about.

As of late October 2020, First Databank (FDB) has added 75 new drug applications (NDAs), 223 abbreviated new drug applications (ANDAs), and 27 biologics license application (BLA) approval numbers to its MedKnowledge drug database. At press time, the FDA has approved 42 novel drugs, 62 first-time generics, and 45 medical devices in 2020.

Hussam Hamoush, PharmD, pharmacy manager and owner of Stonebriar Pharmacy in Frisco, Texas, called clascoterone (Winlevi; Cassiopea) cream 1% a huge breakthrough in acne treatment because it is the first medicine offering a nonantibiotic approach. The FDA approved clascoterone on August 27 and Cassiopea expects the drug to launch in early 2021.

“The [fewer] antibiotics that we use, the less chances [there are] of more drug-resistant bacteria,” Hamoush said. “This is a whole new approach in treating acne using a different mechanism of action. This will be huge for people that have had a lot of trouble with acne in the past.”

He also noted that rimegepant (Nurtec ODT; Biohaven Pharmaceuticals), which was approved on February 27, is a great drug for patients with migraine, as it only needs to be taken once to resolve migraine attacks in less than 1 hour.

“It’s a quick-dissolve tablet and with just 1 dose, it can prevent migraines for up to 48 hours,” Hamoush said.

In addition to rimegepant, lasmiditan (Reyvow; Eli Lilly and Company) and ubrogepant (Ubrelvy; Allergan
USA) have also been impactful for migraines this past year, as there have been no therapies with a novel mechanism of action for acute migraine treatment since triptans were first approved over 20 years ago. Julie Suko, PharmD, vice president of editorial content at FDB, noted that one of the most effective drugs in 2020 was naloxone, which, if administered quickly, can reverse opioid overdose effects within minutes.

“It’s available in several dose forms, but as a nasal spray can be used by untrained persons in case of accidental ingestion of opioids or suspected overdose,” she said.“While it’s not a new drug approval in 2020, the FDA announced new requirements in July to increase naloxone accessibility as an in-home antidote to tackle the opioid crisis head-on. Although different states have varying regulations, most allow naloxone to be furnished directly by the pharmacist, meaning that many more patients can gain access to this important and potentially life-saving treatment at the pharmacy counter when they are prescribed opioids.”

Another important new drug is peanut allergen powder-dnfp (Palfor- zia; Aimmune Therapeutics), which is used as oral immunotherapy to mitigate reactions, including anaphylaxis, caused by accidental peanut exposure in pediatric patients aged 4 to 17 years with confirmed peanut allergy. “This peanut allergen powder is the first drug to be approved in the United States for this indication,” Suko said. “Palforzia requires 3 phases of dosing––initial dosing, up-dosing, and maintenance––and therefore requires a commitment to frequent office visits.”

Another new drug is fostemsavir (Rukobia; ViiV Healthcare), an HIV-1 drug approved for use in combination with other antiretrovirals to treat adults with multidrug-resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

“This oral extended-release tablet requires baseline and ongoing lab monitoring, including ongoing liver function testing,”Suko said. “It cannot be prescribed in patients with hepatitisBorC.”

Jamie Bearse, CEO and president of ZERO – The End of Prostate Cancer, noted that for the many men across the United States facing advanced prostate cancer, the approvals of olaparib (Lyn- parza; AstraZeneca Pharmaceuticals) and rucaparib (Rubraca; Clovis Oncology) signify resounding hope and new tools to help them fight for their lives.

“These drugs are the first [poly ADP-ribose polymerase (PARP)] inhibitors approved for use in prostate cancer, allowing prostate cancer to join the ranks of other cancers tied to the BRCA gene, such as breast and ovarian cancers, in being able to benefit from precision medicine,” he said.

According to Ryan Schmidt, PharmD, the associate director of formulary services at Navitus Health Solutions, in 2020 there was a trend of approvals primarily in the specialty space. Most of these products, particularly in the oncology segment, end up being clinically meaningful for the populations they target, but those are often quite small. However, the approval of elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta; Vertex Pharmaceuticals Incorporated) for cystic fibrosis (CF), albeit at the end of 2019, has had a major impact in 2020 for most patients with CF.

“In trials, it showed not only an improvement over existing treatment options, but also efficacy in patient populations for whom treatments had not been available,” Schmidt said. “This has led to a major shift in utilization. Approximately two-thirds of our patients using CFTR-modulating treatments have already switched to Trikafta.”

Another medication that aroused interest upon approval was bempedoic acid (Nexletol; Esperion Therapeutics), designed to lower low-density lipoprotein (LDL) cholesterol.

“As guidelines continue to push for lower goal levels of LDL to help prevent atherosclerotic cardiovascular disease, this potentially adds another option for treatment,” Schmidt said. “However, unlike products such as statins or PCSK-9 inhibitors, trial data regarding the impact of Nexletol on cardiovascular morbidity and mortality are not yet available. When [they are] available, we can expect a higher uptake in the use of this agent.”

One of the areas that generated increased interest among health care providers in 2020 was digital therapeutics (DTx).

“DTx products deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease,” Suko said. “DTx products, typically reviewed or cleared by the FDA as software or as a medical device, are an important area to watch. Increasingly, DTx are being prescribed either to augment medication therapy or even as a companion therapy.”

Clinicians use these products in therapeutic areas such as behavioral health, as well as for chronic pain, attention deficit hyperactivity disorder, and heart failure.

DTx are a way to leverage technology to collect active and passive data in between face-to-face appointments. Monitoring takes place via patient-facing apps and sometimes remotely through wearables to evaluate how a patient is doing on a specific medication.

“That feedback can tell a clinician if they need to intervene or change a treatment plan, especially as it relates to changes that may need to be made to a medication or dosage to ensure therapeutically effective therapy,” Suko said. “DTx also can monitor if patients are adhering to their medications, so a clinician can contact the patient if there’s an issue so it can be corrected.”

In the targeted immunomodulatory space, 2 products approved last year— upadacitinib (Rinvoq; AbbVie) and risankizumab-rzaa (Skyrizi; AbbVie)— have had a big push in 2020.

“Although both of these products are joining existing classes, the marketing efforts are definitely noticeable in the uptake with these agents,” Schmidt said.“Another agent that is starting to pick up more utilization this year, which came out in late 2019, was Rybelsus (semaglutide), the first oral GLP-1 receptor agonist. This unique oral formulation provides an alternative for patients who may have trouble with or dislike injections, making it a very popular option for diabetes treatment.”

As the calendar turns to 2021, pharmacists envision another year full of important drug discoveries and innovative products.

“Fueled by the need for widespread influenza and eventually COVID-19 vaccinations, [there will be] more
and more pharmacists administering vaccines, educating people on vaccines and potential [adverse] effects, tracking vaccines via CVX and MVX codes, and much more,” Suko said. “We’ll also be watching for more biosimilar product approvals, which will increase competition and potentially offer cost savings to patients.”

Schmidt indicated that there are other areas on the horizon that should see some additional treatments over the next few years, although the pandemic has definitely created some questions around when approvals may actually happen.

“Although not new medications, ...SGLT2 inhibitors in heart failure could be significant and really expand product use from where it is today,” he said.“Interesting new approaches to HIV also lie ahead, including long-acting preventive medications and new mechanisms of action, which could lead to further advances in this space.

A look back at the most impressive drug approvals and product launches of the year.