Joan Vos MacDonald is a freelance writer living in upstate New York. 

Joan Vos MacDonald

Although the booming demand can make CBD products a profi table addition to any pharmacy inventory, some questions remain about the legal compliance factors when carrying CBD products in the pharmacy.

CBD oil and CBD-infused products first began to appear on pharmacy shelves after the passage of the federal Agriculture Improvement Act of 2018, also known as the Farm Bill, which declassified hemp as a Schedule I drug under the Controlled Substances Act (CSA). By 2019, both independent pharmacies and pharmacy chains such as CVS and Walgreens were selling a variety of CBD products. However, these products are regulated by a tangle of federal and state regulations that can be challenging to decipher.

“The main thing to know is that the federal 2018 Farm Bill removed hemp (defined as less than or equal to 0.3% THC) from the definition of ‘marijuana’ in the Controlled Substances Act, and hence from the prohibitions of that act,” said Mark K. Osbeck, JD, clinical professor of law, legal practice program, at the University of Michigan in Ann Arbor, and coauthor of 

Although CBD derived from hemp gained a significant measure of legal protection in 2018, hemp-derived products are still subject to active regulation by the US Department of Agriculture and the FDA. The Farm Bill specifically provides that states may pass more restrictive regulations of their own, though they cannot interfere with the flow of interstate commerce in hemp.

“Accordingly, several states have made hemp and CBD illegal, meaning it can pass through the state, but it cannot be sold or grown in that state,” Osbeck said.

So, can you safely carry CBD products in your pharmacy? It depends. According to Kurt Proctor, RPh, senior vice president of strategic initiatives at the National Community Pharmacists Association (NCPA), the legality of CBD products varies according to the composition of the products, the jurisdiction where the products are being sold, and how the products are being marketed.

“Pharmacists are encouraged to confirm with their applicable board of pharmacy, the FDA, and any other governing bodies,” Proctor said.

Although several states have legalized CBD oil for medicinal purposes, and others permit medical and/or recreational use of marijuana (which includes hemp-derived products), states may have different regulations governing sales.

“Every state has an equivalent of a bureau or department of cannabis control, and their websites will answer many of these questions,” said Robert Solomon, JD, clinical professor of law at The University of California, Irvine, School of Law, and cochair of the UCI Center for the Study of Cannabis. 

Research into the therapeutic possibilities of hemp-derived medicine is ongoing, but to date the FDA has approved only 4 hemp-derived treatments for US distribution: nabilone (Cesamet), cannabidiol (Epidiolex), and tetrahydrocannabinol (Marinol and Syndros).

Pharmacists can safely dispense these medications if they comply with the federal and state requirements, such as registering with the Drug Enforcement Administration (DEA).

The approved uses of these hemp-derived treatments—combined with the increasing presence of CBD in OTC products—might suggest that all uses of CBD oil are permitted. Yet under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, the FDA does not permit the addition of CBD to food, beverages, or cosmetics, or allow it to be sold as a dietary supplement. “The Farm Bill did not affect the FDA’s jurisdiction over drugs, supplements, food additives, and cosmetics,” Osbeck said. “According to the FDA, CBD cannot be included legally as a food additive because the FDA has approved Epidiolex, whose active ingredient is CBD, as an approved drug for the treatment of childhood seizure disorder, and food additives may not contain FDA-approved drugs. The FDA has also not approved CBD as a drug. And its position with respect to designation as a supplement is that CBD does not meet the definition of a supplement because it contains an approved drug.”

If CBD oil were an FDA-approved supplement, the required labeling would have to list ingredients and dosage information. To that end, Rep Kurt Schrader of Oregon and Rep Morgan Griffith of Virginia filed H.R. 8179, known as the “Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020,” in the House of Representatives.

 The bill proposes that hemp derivatives be regulated and sold as a dietary supplement, with accurate FDA-required labeling. However, as Osbeck noted, defining CBD as a supplement, when CBD is already an ingredient in an approved drug, may be complicated.

Because CBD products are not regulated, pharmacists must exercise caution when promoting claims about the often-touted, but as yet scientifically unsubstantiated, benefits. CBD oil has been cited as a remedy for a variety of conditions—including anxiety, acne, and arthritis— but until more testing is done, the claims remain anecdotal.

“There are significant risks associated with making claims of medical efficacy with respect to CBD, whether such claims ultimately turn out to be true or not,” Osbeck said. “The FDA regulates as drugs substances about which health claims are made, and therefore such claims are subject to FDA approval following appropriate clinical tests. Thus, any claims about CBD’s efficacy absent such approval are deemed unsubstantiated, and therefore [they] violate FDA regulations.”

What does this mean for pharmacists? To date the FDA has done little to crack down on unsubstantiated claims by pharmacists, but it has issued a number of warning letters to manufacturers and marketers who make some of the boldest claims (for example, that CBD can fight cancer). However, there is no assurance that in the future pharmacists will be safe from the repercussions of making unproven claims.

Any claims regarding CBD products or benefi ts may lead to private lawsuits from consumers or investigations from regulating bodies,” Proctor said.

Safety is always a concern in products not vetted by the FDA. Since CBD oil contains both pharmacodynamic and pharmacokinetic properties, using CBD products can prompt interactions with other common medications, including immunosuppressives, antidepressants, and blood thinners. In some cases, a combination may have adverse effects.

Proctor suggests that pharmacists encourage patients to confi rm any CBD usage with their physicians. “Pharmacists should also inform customers that CBD products are not intended to prevent, diagnose, treat, mitigate, or cure diseases or disorders,” Proctor said.

Because state and national regulations governing hemp-based products don’t necessarily synchronize, pharmacies that stock CBD products can potentially face closer scrutiny from the DEA, which can lead to increased pharmacy audits and inspections. In addition to the usual compliance measures that pharmacies adopt, pharmacies that fill CBD prescriptions, if they are legal under that state’s laws, should adopt measures specific to CBD compliance. Failure to comply with applicable laws can leave pharmacists vulnerable to substantial fines and, potentially, criminal prosecution.

“I think the takeaway is that CBD is sold in most states and is legal, subject to state regulations, under the laws of those states,” Osbeck said. “And while CBD derived from hemp is no longer an illegal substance under federal law, it is still subject to federal regulation. Thus, sellers assume certain risks when they market CBD in violation of these federal regulations, particularly when they make unsubstantiated claims about the safety or efficacy of CBD.” 

If a pharmacy decides to carry CBD products, there are ways to determine the most reliable sources. “Pharmacists should pay attention to enforcement actions taken against companies with misleading or false labels and seek out products that have been independently verified by third party sources,” Proctor said. “Pharmacists can visit ncpacbdsource.com for CBD products that have been independently tested to confirm the accuracy of the labels and ingredients.”

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 Published May 20, 2019. Accessed September 18, 2020. 

https://www.forbes.com/sites/irisdorbian/2019/05/20/cbd-market-could-reach-20-billion-by-2024-says-new-study/#64a1331549d0

2. FDA. FDA and Cannabis: Research and Drug Approval Process. Last updated October 1, 2020. Accessed October 1, 2020. 

https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-proces

3. Hoover A. Despite trends, feds still band CBD in food. These bills seek to change that. NJ.com. Published September 15, 2020. Accessed September 28, 2020. 

https://www.nj.com/marijuana/2020/09/despite-trends-feds-still-ban-cbd-in-food-these-bills-seek-to-change-that.htm

4. Brown JD, Winterstein AG. Potential adverse drug events and drug-drug interactions with medical and consumer cannabidiol (CBD) use. 

 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6678684/

Articles

Although the booming demand can make CBD products a profitable addition to any pharmacy inventory, some questions remain about the legal compliance factors.

CBD: A Look at the Legal Landscape

One in 4 Americans used 3 or more prescription medications during the last 30 days.

 Such medications may have been prescribed by multiple specialists and filled at various pharmacies, combined with supplements or OTC medications, leading to potential adverse effects (AEs) or less than optimal results.

 Such mismanagement—or rather a lack of overall management—leads to 1.5 million preventable adverse events every year.

That’s where medication therapy management (MTM) can help. By incorporating MTM into their practice, independent pharmacists can help patients prevent medication-related problems and optimize their medication use.

When patients are invited to an MTM session for a comprehensive medication review (CMR), they are asked to bring all their medications, including supplements and OTC products.

“Medication therapy management is a very broad term which includes interventions performed by pharmacists like medication reconciliation, medication synchronization, comprehensive medication reviews, therapeutic interchange, identifying drug therapy problems, immunization, and disease state education,” said Dimmy Sokhal, PharmD, chief clinical officer at Hayat Pharmacy. “While we offer comprehensive medication review, the pharmacist reviews the medications for the patients and reconciles the medication based on medication lists received from the patient’s prescribers to ensure accuracy.”

MTM has been shown to prevent AEs in patients, enhance medication use, and reduce hospitalizations. After assessing a patient’s total medication regimen, a pharmacist can provide the information to every member of a patient’s health care team. “Medication therapy management involves an assessment and evaluation of the patient’s complete medication therapy regimen, rather than focusing on an individ- ual medication product,” said Jessica Abraham, PharmD, APh, director of population health for the University of Southern California School of Pharmacy and director of the USC Medication Management Center.“MTM services optimize therapeutic outcomes and reduce the risk of adverse events through improved medication use.”

Providing this service is not only useful to patients and members of the health care team. It can be a good way for independent pharmacies to expand their business, as a variety of payers are prepared to cover the costs of such oversight.

“Since Medicare Part D payers are required to cover MTM services for eligible patients, this is an opportunity for pharmacies to provide a billable service and expand beyond solely dispensing functions, hence further building up their business,” Abraham said. Additionally, some adherence problems are simple to diagnose, and an MTM session can prevent serious problems, and reduce costs for both the patient and health care system over time.

Emlah Tubuo, PharmD, RPh, and owner of Powell Pharmacy, had one patient bring 6 bottles of metformin to an MTM session. When asked why she had so many bottles of her diabetes medication, the patient described her last doctor’s visit, where she was praised for her progress in controlling the disease. After 3 months of taking the medication, she assumed she was cured and had not taken any more of the treatment for 2 months.

“The doctor was encouraging her because she is on a positive path and she thought, I’ve treated my diabetes and I’m good to go,” said Tubuo.“Fortunately, we did CMR on that day and I told her, this is a journey, one step at a time. She had not asked the doctor whether she should stop taking
it. She just assumed. She would have gone back in 3 or 4 months to see the doctor and would have been back to where she started.”

Occasionally, a patient may have 2 prescriptions for the same condition with potentially dangerous consequences.

“We also see people who see multiple doctors for different things, and we start to see duplicates of medication—not even the same meds,” said Brianne L. Porter, PharmD, MS, assistant professor of clinical pharmacy, The Ohio State University, College of Pharmacy. “So, someone goes to a heart doctor and gets a drug for their heart, a β-blocker, and they are out of refills and the doctor is not responding. They might call their general practitioner and their general practitioner says, ‘I don’t want you to run out of it, I’ll refill it just for this month,’ and then the heart doctor restarts it. Then suddenly the patient is on the same kind of med from 2 different doctors, and they don’t know because they are not talking to each other.”

As well as making recommendations for medication safety and efficiency, during a review, a pharmacist 

might also suggest a vaccine. Patients with diabetes might be urged to get a flu vaccine, whereas patients over 50 years of age may be reminded about the shingles vaccine.

“We then send the recommendations to the physician, saying, we saw your patient and these are the things we discussed,” Tubuo said. “Here are our recommendations. Let us know what you think, print it out, sign it and send it back to us. If we have a patient with diabetes, we can ask if they want to add a statin. Sometimes we initiate it, sometimes they make a different decision, ‘no, not at this time.’ We work together as a team to take care of the patient. Don’t look at it as the pharmacist doing the doctor’s job. No one can do it all.”

Nonpharmacological options are also addressed. “You come in and you’re taking
a statin and chances are that you’re looking at what else you can do which will help your cholesterol and lower your chances of having a cardiovascular event,” said Tubuo. “As a pharmacist, we also focus on those non- pharmacological options, optimizing those medication outcomes, because if you look at the guidelines, they always say in addition to lifestyle and diet changes. We forget that. Those are hard. Those are where we need to hold each other’s hands.”

5 Core Elements of Medication Therapy Management

Examine the patient’s personal medication record 

Make necessary interventions and/or referrals 

A pharmacist can help set up a specific plan. “Once the medications are reviewed, pharmacists address barriers to 

compliance, review the patient’s pertinent vitals, lab values and set up clinical goals,” said Sokhal .“Pharmacists also review relevant lifestyle changes and set up SMART goals [specific, measurable, achievable, relevant, time-bound] for the patients. We utilize our dispensing software to document the interventions, action plan, and follow-up plan and also to submit pharmacist eCare plans.”

Vendor-supplied documentation platforms, such as Outcomes and SinfoniaRX, provide centralized information and can make documentation easier.

“When I pull you up, if you filled your prescription at any of the chains, I will see your prescription history for the past 12 months.” Tubuo said.

Many patients are not aware that the MTM service exists or that it is often free.

“Marketing MTM services is important so that members realize they have a service available to them that may improve their therapeutic outcomes while reducing the risk of adverse events,” said Abraham. “It’s also important to emphasize that MTM services are free and may save you money since pharmacists help optimize medication use with cost-effective drug choices.”

There are several ways pharmacies can get paid for this service. “As a new pharmacy wanting to provide MTM services and get paid for it, I would definitely start looking at the American Pharmacists Association’s MTM Resources,” Abraham said. “There are some basic requirements which you probably already have as a pharmacy, such as obtaining a National Provider Identifier number. The easiest way is to consult with all of your contracted payers to determine how MTM services should be billed.”

In some cases, the payer uses its own employee pharmacists to provide MTM and does not contract for the services, but in other cases the payer contracts with pharmacies or

individual pharmacists to provide the services.

“We receive MTM-eligible members from the health plan and then basically provide outreach to them so that we can provide them with their MTM opportunities remotely at their convenience,” said Abraham.

MTM sessions can serve a critical function during the coronavirus disease 2019 (COVID-19) pandemic, which has made it more difficult but even more important for vulnerable patients to manage chronic diseases such as diabetes, hypertension, heart failure, and asthma.

“Patients have decreased access to care and are scared to visit their doc- tors’ offices,” said Abraham. “Many of them have questions about their medications, uncontrolled chronic disease conditions, general health, and nowhere to go. Access to care has dramatically decreased in the COVID era, and the provision of MTM services provides patients increased access to care from their home at their convenience.”

The pandemic has resulted in more remote health care communication. To set up remote MTM meetings, on a basic level, pharmacists need a computer/laptop, phone, and documentation platform to provide MTM services. Technology resources such as Doximity, Microsoft Teams, Zoom, and Cisco Webex, have proven helpful.

Providing MTM services also opens opportunities for other clinical pharmacy services such as comprehensive

medication manage- ment (CMM) services, where pharmacists are able to provide chronic disease state management to patients in partner-

ship with their health plan and primary care providers.

In Tubuo’s experience, when patients find out MTM is a free service, they almost always want to do it. “People feel rushed every time they are around a medical provider. If you go online and look for physician reviews, the best review is, ‘This doctor actually sat down and talked with me. I did not feel like he just wanted to hurry me out of the room.’ People want to be listened to. Typically when you come to the pharmacy, you pick up your prescription, you make a payment and walk out the door. People go home with so many questions.”

CDC. Therapeutic Drug Use. National Center for Health Statistics. Accessed July 23, 2020. Last reviewed April 13, 2020. 

https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

American Pharmacists Association. Advancing the Value of MTM. Accessed July 23, 2020. 

https://portal.pharmacist.com/advancing-value-mtm#:~:text=Medication%2Drelated%20problems%20and%20medication,%24177%20billion%20in%20injury%20%26%20death

  Medication Therapy Management

Why are some individuals prone to developing certain health conditions? Why do some have a more robust immune system than do others? These are only 2 of the many questions that research into the microbiome—the complex community of bacteria, fungi, and viruses that live in and on the human body—may answer.

Microbiome studies, the latest wave of health research, explore the role of the microbiome in a host of chronic conditions and examine how it affects metabolism, regulates the immune system, and protects against pathogens. "Over 2000 years ago, Hippocrates, the father of medicine, said that all disease begins in the gut," said Suzanne Keyes, PharmD, IFMCP, FACA, of Keyes Com-pounding and 180 Wellness in Elk City, Oklahoma. “Now, with advances in med-ical technology, in testing and analysis, we can see that link clearly.”

Currently hundreds of pharmabiotics companies are engaged in more than 650 active research programs. At least 3 companies have microbiome-related treatments in the trial phase. The first microbiome-targeted products likely to win FDA approval are expected to be treatments for skin or gastrointes-tinal (GI) conditions.

“Emerging therapeutics are following the path of least resistance in terms of access to the therapeutic area and the regulatory path,” said Sandrine Miller-Montgomery, PharmD, PhD, executive director of the Center for Microbiome Innovation and professor of practice, bioengineering, at the Jacobs School of Engineering, University of California, San Diego. “In terms of therapeutic areas, skin diseases have quite a significant amount of product in development; the same is true for GI diseases. What will likely lag behind in reaching the market are therapeutics targeting organs. The notable exception will likely be in the cancer field, as it is starting to be well documented that microbes play a significant role in the effectiveness [of and] responsiveness to chemotherapy.” Research suggests that modulating the gut microbiome may help boost the immune system in patients with cancer and also reduce the adverse effects of some cancer treatments.

The balance of the microbiome is vulnerable to a variety of factors, including medication and environmental exposure. One example is overexposure to antibiotics. “According to the latest statistics in 2017, the average 2-year-old has had 3 rounds of antibiotics,” said Keyes. “By the time a child is 17, they’ve had 21 rounds of antibiotics.”

Prolonged or frequent antibiotic use can lead to an increase in the number of antibiotic-resistant microbes. Individuals who frequently take antibiotics for an underlying condition are often prone to recurrent 

infections, which damage the lining of the large intestine, causing diarrhea. Such infections affect half a million Americans every year.

A proposed donor stool therapeutic uses microbes to help restore a healthy microbiome balance, enabling the gut to fight the infection. Ferring Pharmaceuticals’ nonantibiotic therapeutic RBX2660 is currently in phase 3 clinical development for the prevention of recurrent 

 infections. Fecal transplants may one day also play a role in correcting the microbiome imbalance, which has been suggested as a possible link to obesity and diabetes.

Although patients may ask pharmacists to recommend a probiotic supplement, it’s not a 1-size-fits-all remedy. Probiotic products sold as dietary supplements don’t require FDA approval, so quality may vary. Products also contain different strains, the most common being Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, Escherichia, and Bacillus.

“Make sure to stock probiotics that you trust are stable and have data to show that they are still active once they get to the small intestine and the colon,” said Melody Hartzler, PharmD, PhD associate professor of pharmacy practice at Cedarville University School of Pharmacy in Ohio.

“There are some commercial products that have been shown in multiple clinical trials to have benefits. Find those products that you know are backed by good research and are strain specific to conditions you would recommend them for.

“The other thing you need to think about when you talk about probiotics is prebiotics. Prebiotics are the food that grows the good bacteria, so if we take probiotics and we don’t eat any fiber, it’s not going to be as helpful to our microbiome as [also] eating prebiotic fibers in our diet. People who don’t get enough in their diet...may need a prebiotic supplement. Some probiotics are mixed with prebiotics.” However, the effects of probiotics are usually not permanent. “When you take a probiotic, you take them every day,” said Suzanne Keyes, of Keyes Compounding and 180 Wellness. “The growth that is happening is very short lived.”

Studies investigating soil microbes suggest the effect of these microbes may last longer, said Hartzler. The effects of fecal microbe transplants may also be permanent. “Fecal transplants are definitely a big area of research, but there are 2...high-dose probiotics that are already available for doctors to prescribe: VSL#3 and Visbiome,” said Hartzler.

Although pharmacists may not yet encounter a slew of mi- crobiota-targeted medications, they can help patients achieve and maintain a healthier microbiome by exercising antibiotic stewardship, recommending probiotics, and encouraging a healthier lifestyle.

“Diversity of your microbiome is key, and commercially available probiotics usually [comprise] only a few strains,” said Sandrine Miller-Montgomery, of the Center for Microbiome Innovation. “So it will always remain crucial to eat a diverse diet and include a large variety of fermented food as well. Although pharmacists—and I am one by training—are always looking forward to providing a miracle pill to their patients, they need to keep in mind that having a healthy microbiome at the individual level starts with advising patients to have a good quality of life: a diverse and nutritious diet, quality sleep, appropriate amount of exercise, and a stress reduction practice.”

In the past 2 decades, microbiome research has accelerated thanks to less invasive sampling techniques and more efficient means of analysis. But development of microbiome-based treatments remains complicated. Not only is an individual’s microbiome unique, but it also features trillions of organisms, making the determination of cause-and-effect relationships difficult. Sequencing an individual’s microbiome as a diagnostic tool has become increasingly popular, but it may not always provide useful information.

“Although there are some companies that have taken advantage of this market need, they are still not off ering true insights, as we are still in the observation phase when it comes to understanding the microbiome,” said Miller-Montgomery. “Sure, we have made humongous leaps in better understanding at the population scale the diversity of a microbiome profile, but translating this into something that works at the individual level despite the claims of some service providers—we are surely not there yet.”

1. Gosálbez L. The microbiome biotech landscape: an analysis of the pharmaceutical pipeline. Microbiome Times. March 26, 2020. Accessed May 17, 2020. 

https://www.microbiometimes.com/the-microbiome-biotech-landscape-an-analysis-of-the-pharmaceutical-pipeline/

2. Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A

, Wargo JA. The influence of the gut microbiome on cancer, immunity, and cancer immunotherapy. 

. 2018;33(4):570‐580. doi:10.1016/j.ccell.2018.03.015

3. Institute of Medicine (US) Food Forum. 

4. Haiser HJ, Gootenberg DB, Chatman K, Sirasani G, Balskus EP, Turnbaugh PJ

. Predicting and manipulating cardiac drug inactivation by the human gut bacterium 

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5. National Institutes of Health. Probiotics: fact sheet for health professionals. Updated June 3, 2020. Accessed May 18, 2020. 

https://ods.od.nih.gov/factsheets/Probiotics-HealthProfessional/

Prepare to counsel patients on microbiome-related products.

Microbiome Research Calls  for Due Diligence in Pharmacy

Digital health technology is transforming every aspect of pharmacy practice, whether it deploys robotics to fill prescriptions, uses analytics to track medication data, or offers access to digital therapy. Pharmacists in both the hospital and retail settings are using recently developed technology to prevent adverse drug effects, monitor the use of antibiotics, modify unhealthy behavior, and promote medication adherence.

Not only can technology make a pharmacist’s day more efficient by automating repetitive tasks, but new digital health products are providing more insight into data and the opportunity for real-time patient interaction.

One type of digital health technology that helps pharmacists monitor adherence is an at-home medication dispenser that lets them know, in real time, whether the patient is actually taking the medication.

Developed by Catalyst Healthcare and a feature of the Pack4U connected care system, spencer is a dispenser and monitor that not only reminds patients when it’s time to take medication but offers them a way to communicate concerns remotely with a pharmacist, who can then troubleshoot any required solutions. The integrated system offers several advantages in treating high-risk patients, who are often on multiple medications.

“The pharmacy in our model is usually responsible for delivering a specially packaged cartridge to the patient, and then at the patient level, we have the device that sits on the patient’s countertop, called spencer,” said Shane Bishop, founder and CEO of Catalyst Healthcare and Pack4U. “The patient can slip the cartridge into the device. We check and make sure the right patient gets the right cartridge for the right device, and then the pharmacy is connected in real time with the device on the countertop.”

When the patient takes out the medication, a question may pop up on the screen, such as “How are you?” Or the question can be customized to the particular medication or condition.

Prescriptions are packed centrally, then shipped back to pharmacies. Each step of the process is tracked, including who sent the order, where the order is, who received it, and even expiry dates. Spencer also notes adherence problems, while collecting data on medication use, that can prove valuable to research.

“You get the responses back in real time,”said Bishop.“So now you can turn that data into being proactive for that patient and even triage that information for clinicians and physicians, as well as making pharmacy very relevant in the care of the patient, because pharmacists can get access to data faster than anyone else involved in care.”

Telehealth solutions have been invaluable during the quarantine prompted by the coronavirus disease 2019 (COVID-19) epidemic, providing a link to housebound patients who require ongoing care for chronic conditions.

“Our adherence rates run at 98%, and that’s actual medication in the patient’s hand at the time they are supposed to take it,” said Bishop. “It keeps the patient safe at home and lowers the total cost of care.”

Although the system primarily works with retail pharmacies, hospitals can discharge patients with the device so a pharmacist network can remotely monitor the patient. One advantage to this technology, according to Bishop, is that pharmacists have more time to focus on patients.

“I believe there is a lot of capacity in pharmacy to do much more than they’ve been tasked with,” he said.

When it comes to behavior modification therapy, there’s now an app for that-an app that requires a prescription.

Technology-based therapy, known as digiceuticals, uses FDA-approved apps on smartphones, tablets, and other mobile devices to gather data and provide patients with real-time guidance.

Digiceuticals can be used as monotherapy or in addition to medication. Pear Therapeutics created reSET, which can be used as an adjunct to a contingency management system, to treat some forms of substance abuse. The company’s reSET-O targets opioid addiction as part of a treatment plan that also includes medication. Somryst, the company’s newest product, provides cognitive behavioral therapy for chronic insomnia.

“As these products become more and more sophisticated in relation to [their] use in conjunction with other medications, the role of the pharmacist is going to be how to use them in terms of the patient’s overall medication,” said Yuri Maricich, MD, MBA, chief medical officer and head of development at Pear Therapeutics.

A code is required to access these apps. Before dispensing the code, pharmacists need to review the patient’s profile. “With all of these [apps], the way they are dispensed is [by] the prescription [being] sent to a specialty pharmacy where a pharmacist reviews the information,” said Maricich. “A pharmacist reviews every script. If everything looks copacetic, they actually dispense and fill, providing patients with a prescription access code. The patient then goes to Google Play or the Apple apps store. They download the software, input their prescription access code from the pharmacy, and get access to that treatment for the prescription duration. If the patient wants a renewal or a refill, that can be done."

According to Maricich, the difference between digiceuticals and biologic medicine will eventually fade away until it will all simply be described as medicine. “This is something that can be prescribed through a telemedicine visit and filled and used MBA without ever having to physically go to a clinic,” said Maricich. “In an era where we’re moving into virtual care, it will fit more and more into models outside traditional brick-and-mortar care delivery.”

According to the CDC, between 2013 and 2016, almost half of all Americans took at least 1 prescription drug in the prior 30 days, 24% took 3 or more, and 12.6% took 5 or more, raising the risk for adverse effects (AEs). To assess risks in patients taking multiple medications, The Tabula Rasa HealthCare (TRHC) MedWise Risk Score (MRS) employs technology that identifies and aggregates markers of AEs.

“These risk factors are considered in an algorithmic approach, designed using millions of patients’ data, which creates the MedWise Risk Score,” said Robert L. Alesiani, PharmD, chief pharmacotherapy officer at TRHC. “Each patient has a dynamic risk score that changes with modification in medication therapy. We can pinpoint and act upon medication risks identified using the risk score. We also can predicate the impact of MRS, including changes in total medical spend. The MedWise system is built by pharmacists for pharmacists, incorporating the array of science we learned in pharmacy school-pharmacodynamics, pharmacokinetics, pharmacogenomics, pharmacology, and chronopharmacology.”

Rather than depend on a series of 1-to-1 drug interactions for each patient’s drug profile, the system performs a simultaneous aggregate drug interaction check that can help identify high-risk and unsafe medication regimens, overprescribing, inappropriate prescribing, overutilization, improper or suboptimal administration schedules, and drug-gene and drug-drug- gene interactions. By reducing the AE risk, the analysis also lowers the medical costs associated with treating potential health problems.

“Without a complete medication reconciliation, profile omissions represent interactions missed, increased risks of oversedation, symptoms of delirium [and] confusion, impaired gait leading to falls with injury, irregular heart rates, and, at worst, sudden death,” said Alesiani. “When a patient is taking an enzyme-inhibiting medication, it can affect so many other medications on the profile. If we don’t know about that drug, our recommendations could be useless.”

Technology can help pharmacists stay up-to-date on interactions. “When patients are on 2, 3, or more medications that are metabolized through the same drug-metabolizing enzyme, these drugs compete for the metabolism,” said Alesiani. “Pharmacists learned all about this in school, but there’s no way to memorize metabolic pathways for every drug on the market and then efficiently apply that knowledge in daily pharmacy practice.”

According to the CDC’s 2019 AR Threats Report, antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and 35,000 deaths in the United States each year. To track and better steward antibiotic use, Becton, Dickinson and Company (BD) integrated new analytics into the company’s connected medication management platform. These analytics provide near real-time alerts when an inappropriate and potentially ineffective antibiotic has been prescribed.

“You have all these players–physicians, pharmacists, and nurses–trying to make sure that the right medication gets to the right patient at the right time at the right dose,” said Clint Pridgen, platform leader, MedMined Surveillance Services at BD. “It seems like that would be a pretty simple process, but every player has a different piece of information and because everyone is moving so fast, that information doesn’t always translate from person to person to person.”

Members of a health care team can receive alerts on lab results and changes in a patient’s condition, which may prompt a timely reassessment of the medication regimen. The results from the latest lab tests might, for example, suggest that a drug that was appropriate from an antimicrobial stewardship perspective when it was prescribed may no longer be the best medication.

Health systems have more data than ever before. Although useful, data can take time to process. A pharmacist who is responsible for 30 to 40 patients each day may receive a constant influx of information, which needs to be organized and prioritized. The COVID-19 pandemic clearly illustrates the need for the efficient collection and organization of data.

“Blending in technology that closes in the gaps in visibility enables you to identify patients that are infected or identify resistant organisms or to identify trends that allow health systems to get in front of pandemics and epidemics as quickly as possible,” said Pridgen.

Digital health care technology makes it easier to derive insight from an over-abundance of information.

“Technology is going to continue to be a driver,” said Pridgen. “But the key is that it’s got to provide actual intelligence. One of the real challenges is visibility because there is so much information, but it’s so hard to pull all those pieces together in an effective mechanism. What you’re going to find with technology solutions is a desire for a mechanism to close the gaps and connect the dots.”

Pharmacy practice will continue to evolve along with the latest technology, which may help pharmacists spend more time interacting with patients.

“I think that pharmacists have al- ways wanted to participate more clinically and drive patient outcomes,” said Pridgen. “I think the technology that’s available now allows for pharmacies to do that.”

New digital health products are providing more insight into data and the opportunity for real-time patient interaction.