Keith Loria is a contributing writer to Medical Economics.

Keith Loria

Advancements in pharmacy management systems and increased usage of electronic medical records (EHRs) allow community and independent pharmacists to practice more clinically— beyond just dispensing medications.

Pharmacists already store information such as drug-dispensing histories that may not be available to other health care professionals. By making this information securely available to other health care providers through the EHR, pharmacists can contribute to a comprehensive overview of a patient’s medicine use, including medication adherence and persistence inferred from the frequency of dispensing.

Access to dispensing records and other drug-related histories also may facilitate effective and efficient medication reconciliation at transitions of care, such as admission to and discharge from the hospital.

Early pharmacy management systems essentially were designed for gathering lists of the prescriptions patients received. The systems didn’t connect with insurance companies, and there were few drug interaction checks.

“Today, a wide array of features within pharmacy management systems help pharmacists provide advanced clinical care, including diabetes management, weight management, and smoking cessation,” said Heidi Polek, RPh, a pharmacist and strategic program manager for DrFirst, a provider of innovative technology solutions that works with 67,000 pharmacies nationwide. “Pharmacy management systems also help pharmacists create electronic care plans that can be shared with patients and providers.”

For instance, a pharmacist looking at a patient’s profile will be reminded if they need immunizations. And when patients share important information such as blood pressure or cho- lesterol levels, pharmacy management systems now provide areas to save this information, allowing pharmacists to more completely assess a patient’s medication and health history. Ultimately, this enables more collaborative care between a pharmacist and a provider.

“Although e-prescribing is widely available, pharmacists still contend with the need to manually correct free text found in patient directions [known as sigs] for 84% of new prescriptions, which can lead to errors, take time away from patients, and slow down pharmacy productivity,” Polek said.

DrFirst is bringing technology driven by artificial intelligence to community pharmacies across the nation to help address this issue, which will improve safety and give pharmacists more time for patient counseling. SmartSig, which accurately translates 93% of patient directions, interprets electronic prescriptions as they enter a pharmacy system and fills in the information pharmacists typically type, minimizing the occurrence of misinterpretation or incorrect entry errors.

DrFirst works with multiple pharmacy system providers—including BestRx, Rx30, Computer-Rx, QS/1, and Speed Script—to enhance the clinical information gathered from patients and improve communication with health care teams, bridging gaps to help EHRs and pharmacy management systems “talk” with each other and enhance patient care.

Richard Scholz, RPh, chief strategy officer of ERxDirect, a platform of Health in Motion Network that offers the first fully virtually enabled independent pharmacy group in the United States, noted that community pharmacy has been a leader in adopting electronic pharmacy profiles dating back to the 1980s.

“The pharmacist utilizes the patient’s electronic pharmacy record to manage [adherence], check for drug-drug interactions, prevent duplicate or overlapping drug regimens, and check for drug-disease contraindications,” he said. “This clinical functionality is built into most pharmacy management software solutions to facilitate the pharmacist making clinical decisions.”

Unfortunately, community pharmacy has had limited visibility of 

the patient’s clinical EHR originating from the treating practitioners’ EHR system.

“The community pharmacist’s role has evolved through the addition of expanded clinical services, compounding, and specialty pharmacy clinical support,” Scholz said. “Each of these expanded clinical services is supported by the pharmacies’ [EHR]. The new opportunity is for patients to be capable of sharing any of their medical records within their care management team to improve coordination of care and optimize outcomes.”

ERxDirect provides a platform for member practitioners, pharmacists, and patients to securely communicate and seamlessly share medical records through the patient’s utilization of Health in Motion Network’s Total Health Engagement application.

“Physician group practice and health system EHR technology is evolving in a siloed, proprietary manner,” Scholz said. “Empowering patients to have access to those proprietary EHR-generated medical records and be capable of sharing the medical records with other members of the patient’s health care team is a valuable tool to expand patient understanding of their health challenges and treatment opportunities.”

Luis Rodriguez, president of Keycentrix, a pharmacy software and technology company, noted that the pressures of data collection, tracking performance metrics, direct and indirect remuneration, modern systems security, and shifting generational demographics are shaping demand and pushing pharmacies to further infuse technology into their operations.

“Pharmacies are leveraging mobile communications and tools to influence adherence, coordinate delivery, navigate a complex universe of benefits, and tie in the providers,” he said. “As this continues to evolve and sophisticate, expect to see major shifts in tried-and-true pharmacy operational models.”

Ketan Mehta, CEO of Micro Merchant Systems, said the company has several tools to help a pharmacist provide the best patient care possible.

“We have 2-way texting that gives the pharmacist a way to continue chatting with a patient and let them know when it’s time to take medication, and the system will automatically send a reminder to the patients,” Mehta said.

“There will also be reminders for refills and helping them through the automated refill process.”

The company also offers PrimeRxPAY, which allows a pharmacy to send a text message to the patient, then the patient pays for his or her copay remotely and in a secure manner, and the funds get deposited by the credit card processor, allowing the pharmacy to collect prescription copays from patients.

Once the credentials are provided to the pharmacy, they will be able to log on and view a patient by name or date of birth, and view the prescription profile. By default, PrimeRx pulls up the prescriptions filled in the last 30 days.

“Some of the newer technologies we are focused on are related to patient engagement,” Mehta said. “We are able to create a clinical assessment or questionnaire for the patient in the pharmacy system and then push it out to the patient. They provide feedback about their health and medications they are taking, allowing the pharmacist to focus on the clinical component and keep helping the patient to have better outcomes.”

One of the biggest barriers in adoption of newer EHR technology or any management system in the community pharmacy setting is a resistance to change.

“During the pandemic, however, pharmacists have had to change what has traditionally been a face-to-face model to keep their staff and patients safe,” Polek said.

Other barriers for community pharmacists to fully participate in expanded patient care management may be payer related, such as pharmacists being recognized as a provider by CMS, or financial constraints posed by transitioning resources to pharmacy care management.

According to Mehta, the new-age pharmacies opening up today understand the importance of synergy between these systems. However, many long-time pharmacists remain stuck in their ways.

“That model has to change,” he said. “On top of everything the pharmacists do, the mindset of moving along with technology can be challenging. Slowly, things are changing, but it’s important to utilize these tools for better health outcomes.”

Articles

A look at how community pharmacies use EHRs and management systems.

Understanding Pharmacy Management Tech Solutions

has announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).

, the center will be an important step in furthering the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device (SaMD), wearables used with medical devices, and technology used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.”

The FDA aims to continue building and formalizing the coordinating structure and operation of the center as part of an its effort to modernize policies and regulations, as well as providing efficient access to specialized expertise, knowledge, and tools in accelerated access to digital health technology, the release says.

Continue reading this article on Medical Economics

The new center aims to advance digital health technology. 

FDA Launches Digital Health Center of Excellence

The generic pipeline continues to provide significant value to payers and patients as key products in top therapeutic classes lose patent protection.

Matt Gibbs, PharmD, president of commercial markets for Capital Rx, Inc, said although the second generic wave peaked in 2018, many impactful generics entered the market over the past 12 months—most notably, the launch of multiple generics for pregabalin (Lyrica; Pfizer) in July 2019.

“Because there wasn’t a single generic with a 180-day exclusivity period, it resulted in an immediate significant price drop for payers and patients,” he said. “Fourth quarter 2019 also saw the first generic for popular contraceptive NuvaRing enter the market, providing patients who prefer a nonsystemic contraceptive a generic option. This will also benefit payers providing $0 contraceptive coverage to their members under the Affordable Care Act, as brand NuvaRing is a key driver of plan spend in the contraceptive category.”

Early 2020 saw the return of generics to the market for albuterol rescue inhalers ProAir HFA and Ventolin HFA. Generic albuterol inhalers utilizing chlorofluorocarbon propellants existed in the market by the late ’90s, but the requirement to change to alternate propellants shifted these products back to brands.

“The availability of generics in the class will benefit both patients and plans in mitigating spend in the asthma category,” Gibbs said.

He feels the biggest notable generic coming in 2020 is the availability of generic emtricitabine/tenofovir (Tru

vada; Gilead) for use in HIV preexposure prophylaxis (PrEP).

“As plans begin to implement $0 ACA coverage for PrEP, the availability of generic Truvada will significantly decrease overall cost to plans as we see awareness of and access to PrEP improve across the US,” Gibbs said. “This improved awareness and focus on access to PrEP is one step in the global and US goals of getting to zero new HIV transmissions by 2030.”

Ryan Schmidt, associate director of formulary services for Madison, Wisconsin–based Navitus Health Solutions, says that overall, the generic market this past year has been relatively slow.

“There haven’t been many blockbuster generic releases, and the ones that hit the news are generally ‘authorized generics,’ where the manufacturer of the generic product either has an agreement with the brand manufacturer, or in some instances is the brand manufacturer,” he said. “The other thing that limits impact of these releases is a lot of them have come from classes with multiple alternative generic options already, meaning the amount of use in the brand space has been limited.”

Ross Goetz, PharmD, director of business development and national pharmacy compliance administrator for Healthwarehouse.com, noted that digital companies with direct-to-consumer models have increased access to generic medications at an affordable price, making generic drugs more desirable to the consumers opting to manage their own cost portfolio.

Still, when referring to abbreviated new drug application (ANDA) approvals,or first-time approvals of generic drugs, he calls 2020 “a weak year,” citing a few HIV therapies pending generic launch, and the generic for varenicline (Chantix; Pfizer), which has been delayed since the initial date. At press time, the FDA has so far approved 35 first-time generics.

 In 2019, the FDA approved 107 first generic drugs out of a total of 1014 approved or tentatively approved ANDAs, according to the 2019 Office of Generic Drugs annual report.

Shashank Upadhye, JD, a pharmaceutical patent attorney with Chicago, Illinois-based Upadhye Cwik LLP, who has practiced in generic drug law for more than 20 years, said it’s been a tough year for companies that are in just traditional, simple solid oral dosage forms.

An exception, he noted, is Mylan, which obtained recent approval for its biosimilar for insulin glargine— called Semglee, which is a biosimilar to Sanofi’s Lantus insulin.

“Mylan had won some patent litigation and thus had removed the patent obstacle. But it finally won FDA approval for its pen and vial product,” he said. “Mylan [and its production partner Biocon] had some troubles getting approval. It is a complex product, and thus it was not a question of simply copying the Lantus product. Now patients have new options, with hopefully better pricing, now that the FDA has approved more insulins.”

The most notable generic products, Schmidt shared, have not had the major financial impact one would typically expect over the last year.

“Generic insulin products offer significant price decreases for those 

patients without insurance, reducing prices to where they were back in 2012,” he explained. “However, rebates offered on the original brand products still make the brand medications less expensive to plans in most situations, meaning we haven’t seen these have impact on overall spend.”

Similarly, a number of generic inhalers have come to market for common products such as Advair, Symbicort, Proair, and Ventolin. Although the increased competition has had some impact on overall spending, major savings opportunities haven’t risen yet, as the complexity of these devices have prevented a scenario where multiple low-cost generic products are available.

Experts agree that there is an unmet need for more less expensive, generic versions of complex medications in the market.

“Significant savings to payers and the federal government from approving more generic versions of complex medication could be realized,” Bob Lobo, PharmD, director of clinical programs at Vanderbilt University Medical Center, Nashville, Tennessee, told 

 He cited a recent study on the economic burden associated with extended-release (ER) versus immediate-release (IR) formulation among Medicare and Medicaid beneficiaries, in which the findings showed a potential annual cost savings of $2.6 billion by switching certain ER drugs to comparable generic IR formulations.

 The study looked at only 20 ER oral medications, but it suggests that the annual savings from greater access to generic medications are quite significant.

According to Schmidt, the drug with one of the largest effects on spending in the past 12 months has been pregabalin, the generic equivalent to Lyrica.

“There were multiple manufacturers ready to go at launch, meaning costs for the generics were significantly lower than the brand at launch,” he said. “This is important as it helps drive down patient cost, regardless of copay or coinsurance, helping to facili

tate conversion to the generic product, saving both the patient and the plan money right away.”

Conversely, ramelteon, Rozerem’s equivalent, was first released at a similar time, but due to lack of competition in the market, has retained a higher cost relative to other generic medications in the class.

“Pregabalin has dropped in price by over 95% compared with brand Lyrica, [which also took an approximately 5% price increase on January 1, 2020,] and is covered nearly universally,” Schmidt said. “Ramelteon, on the other hand, still costs close to $100 per month.”

Goetz agreed that pregabalin has been the most significant generic over the past year.

“When you look into medications for nerve pain, there is not a great depth of options. Outside of narcotic pain medications, gabapentin stood as the most cost-effective option,” he said. “Although gabapentin comes tied with challenges like a notable [adverse effect] profile, it is often the drug of choice on insurance formularies. For those who rely on their insurance coverage to afford medications, paying for brand name Lyrica was simply not an option. Now available as generic pregabalin, patients can more comfortably elect to switch away from gabapentin without a major cost burden, if any.”

Due to the coronavirus disease 2019 (COVID-19), the FDA has stopped conducting foreign inspections. Given that more than 80% of the generic drugs sold in the United States are made outside the country, the lack of inspections has resulted in delayed or aborted new generic drug launches.

Upadhye said COVID-19 has caused several problems, including decreased profitability for existing generic companies’ products; increased price pressures by the buyers who them- selves are facing business pressures; pressures on existing patent litigation to either do very little to advance the case or to settle the case quickly on whatever terms being offered; and the FDA’s refusal to conduct foreign 

inspections, resulting in delayed or aborted new generic drug product launches or delays in relaunches.

It’s not a surprise that the pandemic is affecting the generic drug market, as when the disease was spreading rapidly in March, there was a major rush to refill medications, leading to a large increase in claims and even shortages. This was immediately followed by a drop-off in overall claims volume, which is now returning closer to normal.

“One major shift is from 30-day claims to more patients getting 90-day supplies via delivery or mail order,” Schmidt said.“The interesting component of this is that maintenance medications seem to have rebounded well, whereas acute medications aren’t rebounding quite as quickly. This isn’t as surprising, as many elective clinical visits are being delayed, and general improved health precautions are likely leading to less non-COVID infections.”

From a new product perspective, the FDA is still in full swing, and the industry has continued to see new approvals of both brand and generic products. The impact of these new releases may be seen a couple of years down the road as some clinical trials have gone on hold or been delayed due to COVID-19.

Goetz believes the market is shifting heavily toward convenience and safety over price alone.

“Utilization of telehealth services reached an all-time high in April 2020, while ambulatory prescriber practices were down roughly 60% in office visits,” he said. “Now that patients are more aware of the options available, it can be expected that they will consider the financial and personal impact of each option as they weigh their plans for their future. As we have seen with many areas of modern commerce, the power is no longer with the large chains with storefronts in every area; it falls with the companies who can provide a service at a fair price, with a larger focus on convenience than ever before.”

1. FDA. First generic drug approvals. Updated July 14, 2020. Accessed August 12, 2020. 

https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals

2. FDA. 2019 Office of Generic Drugs annual report. February 2020. Accessed August 12, 2020. 

https://www.fda.gov/media/135329/download

3. Schieszer J. Barriers coming down for complex generic drug products. 

®. April 14, 2020. Accessed August 12, 2020. 

https://www.drugtopics.com/view/barriers-coming-down-complex-generic-drug-products 

4. Sumarsono A, Sumarsono N, Das SR, et al. ​Economic burden associated with extended-release vs immediate-release drug formulations among Medicare Part D and Medicaid beneficiaries. 

2020;3(2):e200181. doi:10.1001/jamanetworkopen.2020.0181

A Look at the Year in Generics

Awareness of artificial intelligence (AI) is increasing throughout health care. Relative to pharmacy, the American Society of Health-Systems Pharmacists Foundation’s “Pharmacy Forecast 2020: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems” specifically lists the emergence of AI in its report, inspiring industry discussion and guiding the strategic planning processes of health system pharmacy leadership across the country.

For pharmacy, AI provides information on drug interactions, drug therapy monitoring, formulary selection, costs, usage trends, and more.

“AI is already transforming health care but will become increasingly valuable as investments in systems that can capture and manage data are made and clinical informatics entities work more collaboratively to address current data shortfalls,” said Doug Zurawski, PharmD, senior vice president of clinical strategy at Kit Check, Inc, maker of radio frequency identification (RFID)/AI technology for hospital pharmacies to help with medication management. “It is incumbent upon us, in this industry and in this field, to take the lead and learn more, invest in systems that support AI and machine learning, and prepare for the future with access to artificial intelligence.”

Deborah Sadowski, MHA, RPh, director of pharmacy services at Deborah Heart and Lung Center in Browns Mills, New Jersey, said IBM estimated back in 2011 that there were over 161 billion gigabytes of data in the entire health care arena, which she projects has easily doubled by now.

“We are seeing more and more pharmaceutical companies looking to leverage AI and machine learning solutions to translate their data into therapies that have a better chance of benefiting patients.” 

“It is impossible to manage that much information safely and efficiently with the human mind, so it is essential that we incorporate AI as a tool to help us better care for patients—be it preventing medication errors, managing pharmacogenomics applications for better medication choices, or doing prospective cost analysis for treatment choices—all by processing billions of bits of information efficiently and quickly,” she said. “It is key to remember however that AI is a tool to supplement knowledge and should be used in conjunction with, not a replacement for, the clinical judgment and human experience that the pharmacist or other health care provider brings to the table.”

Vin Singh, MBA, MS, the CEO of Gaithersburg, Maryland–based BullFrog AI Holdings, Inc, a precision pharmaceutical company built around an AI platform, noted that pharmaceutical companies have been plagued for years with vast amounts of data, but most do not have the proper technologies to analyze it all.

“We are seeing more and more pharmaceutical companies looking to leverage AI and machine learning solutions to translate their data into therapies that have a better chance of benefiting patients,” he said. “By combining experts in machine learning and AI with subject matter experts in pharmaceutical and health industries, we can approach it with an open mind and share strategies from a multifunctional perspective.”

Wolf Ruzicka, MBA, chairman and IT innovator for Washington, DC–based EastBanc Technologies, said AI can be used to search for similar chemical molecules to already known drugs in huge existing databases.

A new application is to use AI technologies to analyze large clinical trial data sets to link certain responses and adverse effects to individual genetic markers.

“The goal is to find new drugs with similar treatment properties but less expensive or with less [adverse effects],” he said. “As a result, we can determine which patients could be treated successfully, in some cases lifesaving, while for other patients the drug may not be useful.”

AI represents an innovative way in which entrepreneurs and health care professionals are reinventing the US health care system to better serve patients, which is why many in the pharmacy industry are embracing AI offerings today.

Health care technology company DrFirst recently released its next-generation, patented SmartSig AI technology to improve the quality of patient medication history when it is imported into hospitals’ and health systems’ electronic health records (EHRs).

SmartSig 2.0 accurately translates nearly 93% of incoming prescription information, saving up to 30 seconds of work for each drug entered during the medication reconciliation process.

Rebecca Sulfridge, PharmD, an emergency medicine clinical specialist with Covenant HealthCare in Saginaw, Michigan, credits the new technology with helping to minimize additional patient risks and protecting staff from unnecessary face-to-face exposure during the influx of patients with coronavirus disease 2019 (COVID-19) over the past few months.

“We are spending less time reconciling medication histories manually, and in the first month of use, we recaptured an additional 15% productivity per shift, which represents approximately $650,000 per month, while also improving patient safety and outcomes,” she said. 

Tom Knight, MBA, MS, the CEO of Invistics Corp, a Peachtree Corners, Georgia–based software company working with AI, explained that machine learning is being used to create drug diversion prevention software solutions that are self-learning.

“The goal is to prevent diversion from happening at all, and employing AI-powered technology is a huge step toward this goal—it can catch policy violations and program loopholes before a diversion even occurs.” 

“This is very important to pharmacies and health care facilities as they work to detect and prevent employees from stealing medications, also known as drug diversion,” he said. “Machine learning allows solutions to learn from past diversion incidents, so they become better and better at detecting potential diversion incidents.”

For example, machine learning technology can pick up on isolated incidents that are aligned with known patterns of diversion, such as if a pharmacist is filling prescriptions for oxycodone 3 times more frequently than their colleagues, and synthesize that information with other data, such as reports of suspicious activities from pharmaceutical technicians, and create alerts for managers, or drug diversion specialists. Therefore, drug diversion incidents that might have taken weeks to discover before can be found in hours.

Kara Earle, MBA, MS, senior drug diversion specialist at FairWarning, which works with hospital pharmacies on their drug diversion programs by using AI to help prevent new diversion cases, says she’s seeing a strong push from pharmacies looking to replace older technologies that require manual processes with new, AI-powered technology to streamline workflows.

For example, Mount Sinai in New York, New York, employs FairWarning’s Drug Diversion Intelligence to monitor all daily transactions and detect irregular behavior such as unusual access of controlled substances, medication access after termination, and inventory discrepancies.

“AI has the ability to handle large quantities of data and cross-reference data from multiple systems, so it helps to automate manual steps and increase visibility into the movement of medications to create a broader monitoring picture,” Earle said. “These benefits are big drivers in why today’s pharmacy should be investing in AI-powered technology like drug diversion monitoring.”

Although the impact of AI is growing, Zurawski noted that a lack of standardization in EHRs and regulatory hurdles sometimes hinder access to sufficient volumes of reliable data to effectively inform advanced computing applications.

In the years ahead, he believes clinical informatics, vendor cooperation, and collaboration will help address some of the gaps in data access.

Earle noted AI will continue to evolve, and models will become more effective at identifying diversion before major problems arise.

“The goal is to prevent diversion from happening at all, and employing AI-powered technology is a huge step toward this goal—it can catch policy violations and program loopholes before a diversion even occurs,” she said. “For instance, incorrectly provisioned security settings on dispensing cabinets, users not following proper wasting 

procedures, or nurse managers failing to follow up on open discrepancies are all typical policy violations that may indicate diversion. Identifying those policy gaps early can prevent diversion and save lives.”

During the coronavirus disease 2019 (COVID-19) pandemic, it is very likely that decisions are being driven by vast amounts of data being accessed from around the world. Health care AI gives providers, administrators and others access to data sets of information (eg, patient demographics, length of stay, treatments and outcomes, costs, geography, survival rates).

“Because AI can identify and analyze trends from data and predict, via machine learning from vast amounts of data, it is highly plausible that AI is already being used to strategically plan for redeployment of resources and space—an application of AI extremely useful during crises like the COVID-19 pandemic,” Zurawski said.

Singh noted that the pandemic requires quick solutions that only AI can bring. “AI can help speed up the drug development process without jeopardizing safety and accuracy,” he said. “The benefits that AI can bring to help tackle the COVID pandemic have yet to be fully realized, and it has the potential to serve as a valuable and irreplaceable tool. Global infectious disease challenges will continue to spawn, and having AI tools that can prevent or minimize the damage to public health is essential.”

Additionally, the change in workflows during COVID-19, such as staff assignments and the addition of contract, travel, and float nurses, have made manual monitoring methods almost obsolete.

“Pharmacies need the ability to track medication usage across departments, and even system-wide and near to real time as possible, which AI is capable of accomplishing,” Earle said. “One of our Drug Diversion Intelligence customers was able to identify diversion and medication tampering by a travel nurse who was hired during COVID-19 within 10 days. This allowed the hospital to minimize any impact to patients and fully investigate and remediate the incident in a fraction of the time it would have taken them with manual processes.”

Vermeulen LC, Swarthout MD, Alexander GC, et al. ASHP Foundation Pharmacy Forecast 2020: strategic planning advice for pharmacy departments in hospitals and health systems. 

. 2020;77(2):84-112.doi:10.1093/ajhp/zxz283

An examination of how this innovation is affecting pharmacy.