Fred Gebhart

At best, the regulation of cannabidiol (CBD) in the United States can be described as patchwork. On a federal level, any part or constituent of 

 plants, more commonly known as cannabis or marijuana, is a Schedule I controlled substance. Hemp—defined as 

 containing less than 0.3% Δ-9-tetrahydrocannabinol (THC) and the basis for CBD product—was exempted from this scheduling by the Agriculture Improvement Act of 2018 (Farm Bill).

Enactment of the Farm Bill removed hemp from Schedule I of the Controlled Substances Act and launched a surge in hemp growing and a boom in the production of CBD products derived from now-legal hemp—and created confusion for regulators and pharmacists.

“I checked the landscape legally before I got involved,” said Tim Kotschwar, PharmD, owner of Alliance Community Pharmacy in Alliance, Nebraska. “I talked with the local police chief, the state patrol, our prosecuting attorney, even a local judge. I was basically told it’s not officially legal in Nebraska, but you can buy CBD in Bed, Bath & Beyond or just about any gas station.

“I was still nervous, so I talked with the state board of pharmacy and the Nebraska Pharmacists Association. They all said it’s not officially legal yet, but it belongs in the pharmacy. That guy in the gas station isn’t going to be able to talk about the long list of CBD-drug interactions or [adverse] effect profiles,” Kotschwar continued. “The FDA says we can’t call OTC CBD a drug, but pharmacists are the people trained to...counsel buyers about the drug-like qualities of CBD.”

The text of the Farm Bill set the upper allowable limit of THC in hemp as less than 0.3% by dry weight of plant material but said nothing about THC or other constituents in products derived from hemp products, including CBD. The bill also underlined the authority of the FDA to regulate hemp, said Al Carter, PharmD, MS, RPh, executive director and secretary of the National Association of Boards of Pharmacy. The problem, he explained, is that the FDA is largely avoiding CBD regulation outside the 2018 approval of cannabidiol (Epidiolex) for certain seizures.

The agency bans CBD claims for the diagnosis, cure, mitigation, treatment, or prevention of any disease, as well as adding CBD to human or animal food products—although use in cosmetics is specifically allowed.

“CBD was approved as an active pharmaceutical ingredient in a drug product; therefore, CBD is excluded from the definition of a dietary supplement,” Carter explained. “The law similarly does not allow sildenafil or gabapentin to be added to foods or supplements after being marketed as prescription-only drugs. A product can make the regulatory jump from being a food [or] supplement to also becoming a drug, like [omega-3-acid ethyl esters (Lovaza)], but there is no clear path to go the other way from drug to food [or] supplement.”

However, Carter added, the FDA is not entirely silent on CBD. Since 2018, the agency has issued more than 60 warning letters to companies selling CBD in violation of existing prohibitions against medical claims or additions to food or beverage products. But the agency has not acted on requests to reconsider regulations of nonprescription CBD.

“States got tired of waiting [for the FDA] and acted on their own,” said Tim Gregorius, RPh, vice president of operations for PRS Pharmacy Services in Latrobe, Pennsylvania. “Two years ago, there were maybe 20 states where CBD was still a bad word and 3 states where it was flat-out illegal. That is no longer the case.”

But individual states have taken different paths toward CBD regulation. Idaho appears to be the most restrictive, Carter said. There, CBD remans a banned, controlled substance unless it contains 0.0% THC and is derived from mature stalks, oil, or cake made from seeds or achene, or sterilized seed.

 Nebraska, like many states, allows up to 0.3% total THC as measured by dry weight of hemp, but it does not address products derived from hemp.

Most states require retailers to obtain a license or registration to sell CBD products, Gregorius said, but these requirements vary widely. Some states focus on product content, certificates of analysis, and allowing/disallowing products from specific vendors. Other states focus on labeling with batch/lot identification, expiration dates, and QR codes linked to certificates of analysis. Ultimately, selecting and carrying products that meet these requirements are the pharmacist’s responsibility.

When—or if—federal regulation of CBD will happen is still unknown. The secretary of the US Department of Health & Human Services has the authority to bypass the usual exclusion of prescription-first products from OTC or dietary supplement regulation and initiate CBD rulemaking, explained Jane M. Wilson, director of program development for the American Herbal Products Association, but no secretary has acted.

“We see hemp as another botanical with robust regulatory frameworks at the federal level as dietary supplements and foods that can be used as the basis for regulating CBD products,” she said. “We and other industry groups have been advocating with the FDA to consider these CBD products as distinct from the pharmaceutical that has been approved.”

The absence of FDA regulation has helped spur the introduction of at least 5 bills to regulate CBD products in the US House of Representatives and Senate this year, Wilson said. One bill, HR 3617, the Marijuana Opportunity Reinvestment and Expungement Act, passed on a largely party-line vote in April 2022. Wilson and Gregorius agreed that stand-alone federal CBD legislation is unlikely to pass this year.

“We would encourage pharmacists to only stock products that comply with applicable law and recommend products based on their professional judgment,” Carter said. “This analysis should include weighing the risk vs benefits of the therapy, which is somewhat unusual for pharmacists, and needs to factor in the quality of the product and the possibility of undeclared THC or inaccurate labeling.”

There is no single information source for cannabidiol (CBD) regulation. The Agriculture Improvement Act of 2018

 regulates hemp but not finished CBD products, and the FDA has steered clear of nonprescription CBD,

 leaving regulation to the 50 states and resulting in 50 different approaches. Neither the American Pharmacists Association nor the National Association of Boards of Pharmacy track CBD regulation by state.

The National Community Pharmacists Association has information on CBD science, pharmacy-focused education, and marketing at ncpacbdsource.com, but it provides no regulatory guidance.

State pharmacy associations are the most reliable starting points for local regulation and requirements. Some state boards of pharmacy play active roles in CBD regulation while other boards are silent on CBD, leaving regulations to other agencies. Ultimately, there may be inconsistencies between state statutes, board of pharmacy rulings, federal laws or regulations, and local law enforcement priorities.

“The standing joke for years was that you could walk down the street in a certain major state smoking a joint and nobody would blink an eye, but you couldn’t buy CBD in a pharmacy, just in gas stations and grocery stores,” said Tim Gregorius, RPh, vice president of operations for PRS Pharmacy Services in Latrobe, Pennsylvania.

Some states may require—or prohibit—specific language such as “Δ-9-tetrahydrocannabinol (THC)-free” or “low THC.” These requirements, however, may not match the diverse terminology used in the description, marketing, and labeling of CBD products as understood by consumers, retail channels, or pharmacy.

Potency, for example, is a measure of biological activity in pharmacy and federal drug regulation but is often used in CBD labeling describe the amount of CBD or some other constituent(s), an attribute pharmacists know as strength. The American Herbal Products Association’s Hemp Lexicon

 is a useful guide to current industry terminology.

1. Agriculture Improvement Act of 2018, PubL115-335 (Farm Bill). Accessed August 18, 2022. 

https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf

2. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. News release. FDA. June 25, 2018. Accessed August 15, 2022. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

3. FDA regulation of cannabis and cannabis-derived products, including cannabidiol (CBD). Updated January 22, 2021. Accessed August 15, 2022. 

https://www.fda.gov/newsevents/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-productsincluding-cannabidiol-cbd#dietarysupplements

4. Cannabidiol(CBD). Idaho Office of Drug Policy. Accessed August 15, 2022. 

5. Nebraska Hemp Farming Act, Laws 2019, LB657, §1. Accessed August 15, 2022. 

https://nebraskalegislature.gov/laws/display_html.php?begin_section=2-501&end_section=2-519

6. American Herbal Products Association. Hemplexicon. Updated May 2021. Accessed August 15, 2022. 

https://www.ahpa.org/Files/Document%20Library/AHPA%20Guidance%20Documents/HempLexicon/AHPA_HempLexicon_Final.pdf

Articles

No federal agency has taken charge of regulating cannabidiol products, leaving decisions up to the individual states.

The Evolution of the CBD Regulatory Landscape

Selling cannabidiol (CBD) products in the pharmacy can be tough, and not just because of misinformation or retail competition. Due to a lack of regulation, undeclared tetrahydrocannabinol (THC) is common in topical and oral CBD products, including products claiming to be THC-free.

Pharmacists recognize the potential for positive drug tests for those using CBD products.

“Anybody who has a Commercial Driver License—a truck driver—I basically refuse to sell CBD to them, because they can lose their livelihood from a positive THC test,” said Cory G. Garvin, PharmD, president and owner of Wester Drug in Muscatine, Iowa.

A study published in June 20201 found widespread mislabeling across 105 topical CBD products purchased from brick-and- mortar retail outlets and online. THC was detected in 27 (35%) of the products, including 4 products (11%) labeled as THC-free. Most of the THC-containing products did not reference THC on the label.

“We know from research in my lab that pure CBD products— oral or vaped—do not trigger positive drug tests for cannabis,” explained Tory R. Spindle, PhD, assistant professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine Behavioral Pharmacology Research Unit. “However, products that contain even trace amounts of THC, within legal limits to be considered hemp, can produce positive tests, especially with regular use.”

 found greater mislabeling. Of 80 CBD products purchased from physical and online retailers, 52 (65%) contained THC in amounts ranging from 0.008 mg/mL to 2.071 ng/mL. Of the 21 products labeled THC-free, 5 (23.8%) contained between 0.015 mg/mL and 0.656 mg/mL THC. Epidiolex (cannabidiol), the sole FDA-approved CBD formulation, contained 0.022 ng/mL THC.

“Consumers who are interested in taking CBD are at a complete loss,” said senior author Shanna Babalonis, PhD, assistant professor of behavioral science, University of Kentucky College of Medicine Center on Drug and Alcohol Research. “They don’t know what is in their products, they can’t trust the labels, and they can’t trust certificates of analysis if there is one. If you test positive, there is no way to distinguish this THC contamination from smoking a joint or using any other marijuana product.”

Tim Gregorius, RPh, vice president of operations for PRS Pharmacy Services suggested stocking only THC-free products. PRS and a few other manufacturers use QR codes on product labels to link each container to a certified certificate of analysis. Iowa requires QR codes linking to certificates of analysis on all CBD labels; Garvin said he goes 1 step further and checks each batch to match certificate, batch, expiration, and product analysis.

The problem stems from the federal classification of marijuana, or 

, as a Schedule I controlled substance. The 2018 Farm Bill

 exempted hemp containing less than 0.3% delta-9 THC by dry weight from the Controlled Substances Act, but that exemption specifies hemp as an agricultural product. Nothing in the Farm Bill defines allowable THC levels in finished hemp products such as salves, oils, tinctures, capsules, gummies, or other edibles after the plant biomass has been removed, Babalonis explained. Regulation is up to individual states, all of which have taken different approaches. The CBD industry uses a 0.3% THC cutoff for convenience and marketing.

Federal regulations assess THC levels in people, not products. The Department of Transportation (DOT) has an initial urine-based testing cutoff of 50 ng/mL for marijuana metabolites and a confirmatory cutoff of 15 ng/mL, Garvin explained. Private employers can set their own cutoff levels.

DOT covers what are known as safety-sensitive employees: pilots, school bus drivers, truck drivers, train engineers, transport vehicle operators, aircraft maintenance personnel, fire-armed transit security personnel, ship captains, and pipeline emergency response personnel, among others. “Since the use of CBD products could lead to a positive drug test result,” the agency cautioned in 2020, “Department of Transportation–regulated safety-sensitive employees should exercise caution when considering whether to use CBD products.

Enforcement of state DUI laws is another potential hazard. Some field tests are quantitative, Garvin said, and some are qualitative. Some are specific for THC and some test for any cannabinoid. “I spend a lot of time educating my patients to make sure they understand potential testing issues,” Garvin said. “My advice is to talk with their employer or whoever is doing the testing to find out the kind of tests being used, the cutoffs, and whether CBD products are allowed. I try to minimize risks to the patient and in doing so, I also minimize my own liability.”

1. Spindle TR, Sholler DJ, Cone EJ, et. al. 

Cannabinoid content and label accuracy of hemp-derived topical products available online and at national retail stores.

JAMA Netw Open. 2022;5(7):e2223019. doi:10.1001/jamanetworkopen.2022.23019

2. Johnson E, Kilgore M, Babalonis B. Cannabidiol (CBD) product contamination: Quantitativeanalysis of Δ9-tetrahydrocannabinol (Δ9-THC) concentrations found in commercially available CBD products. Drug Alcohol Depend.2022;237:109522. doi:10.1016/j.drugalcdep.2022.109522. doi:10.1016/j.drugalcdep.2022.1095522

3. The Agriculture Improvement Act of 2018, Pub.L. 115-334 (Farm Bill); p. 420, Subtitle G—Hemp Production. 

4. U.S. Department of Transportation, DOT “CBD” Notice. February 18, 2020. Accessed August 11, 2022.

https://www.transportation.gov/odapc/cbd-notice

Even “THC-free” cannabidiol products may contain trace amounts of THC.

Drug Testing Challenges Emerge With CBD Product Use

Opioid use disorder (OUD) and overdose deaths are an epidemic. During the COVID-19 pandemic, opioid overdose deaths in the United States soared by 45%—up to 107,622 drug overdose deaths in 2021, according to the CDC.

 Despite these high numbers, when individuals with OUD or their caregivers ask their pharmacist for help, the answer all too often is “I can’t.”

“The barriers to patient access to medication for opioid use disorder [MOUD] are decades old, entrenched in our clinics, our regulations, and our attitudes that stigmatize OUD and [individuals] who have OUD,” said Anna Legreid Dopp, PharmD, CPHQ, senior director of clinical guidelines and quality improvement at American Society of Health-System Pharmacists in Washington, DC. “But the evidence is there that MOUD reduces mortality and facilitates recovery, and we are seeing change.”

There are decades of data supporting the effectiveness of naltrexone, buprenorphine, and methadone to treat OUD, and nearly as many decades of legal and regulatory restrictions on their use. Naloxone—used to reverse acute opioid overdose— is the 1 clear success in the continuing battle against opioid fatalities, said Anne Burns, RPh, vice president of professional affairs for the Ameri- can Pharmacists Association in Washington, DC. Although naloxone saves lives, it does not treat OUD.

Naltrexone, a complete opioid blocker, is most commonly formulated as an injectable and is seldom used for MOUD due to inconvenience of routine injections and unwelcome adverse effects, including headache, fatigue, joint and muscle pain, loss of appetite, and vomiting. Methadone is a complete opioid agonist dispensed in pharmacies for analgesia but can be used for MOUD only in federally approved opioid treatment programs.

Buprenorphine, a partial opioid blocker, is also dispensed for analgesia. As a schedule III narcotic, it can be prescribed and titrated by pharmacists if the state practice act allows. However, prescribing or titrating the same buprenorphine for MOUD is restricted to clinicians who hold a waiver under the Drug Addiction Treatment Act of 2000 (DATA 2000).

These waivers, sometimes called X waivers, were originally restricted to physicians meeting specific training requirements. Subsequent legislation extended waivers to physician assistants and nurse practitioners—but not to pharmacists.

“Regulations that would allow for patients to receive the appropriate level of care where and when they need it, so [patients] could potentially receive methadone and buprenorphine in community pharmacies— and having pharmacists be able to prescribe or order these medications where it is part of their scope of practice— could go a long way to expanding access,” said Bethany DiPaula, PharmD, BCPP, FASHP, who is part of a primary care practice focused on substance use disorders in Baltimore, Maryland. She is also a professor and the director of the PGY2 Psychiatric Pharmacy Residency Program at the University of Maryland School of Pharmacy.

“I can enter buprenorphine prescriptions in our electronic order entry system, but they are actually prescribed by a practice physician, not by me,” she said. “That’s an extra step, an additional barrier, to providing treatment that works. Internationally, pharmacists provide MOUD in the community pharmacy setting, and there have been studies about expanding MOUD in community pharmacies in this country. DATA 2000 is the big hang-up.”

However, that could change. A coalition of pharmacy, medical, and other groups have been pushing both to expand DATA 2000 waivers to pharmacists and eliminate waiver requirements altogether. In June, the United States House of Representatives passed HR 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022. The bill would eliminate the need for pharmacists and other clinicians to obtain a DATA 2000 waiver to administer MOUD but would continue current training requirements.

“Patients in need must have access, but this well-established solution is hindered by unnecessary and unproven bureaucratic processes,” said Timothy D. Fensky, RPh, DPh, president of the National Association of Boards of Pharmacy in 2021 in Suffolk County, Massachusetts. “Pharmacists are well positioned to help eliminate barriers and allow more patients with OUD to access the treatment they need.”

Only approximately 20% of individuals who could benefit from MOUD actually get it, Burns noted. Stigma in the community, from law enforcement, government, and the health care industry, gets in the way.

“There are pharmacists who feel that if they dispense buprenorphine, [they are] trading one addiction for another,” Burns said. “Some addiction specialists say it is being diverted onto the street, which is probably a good thing. If someone uses buprenorphine vs heroin or fentanyl, it is very unlikely they are going to overdose. MOUD requires a different mindset.”

Of this mindset, some in law enforcement are taking note. “The chief barriers to expanding MOUD access...are often based on misguided stereotypes and stigmas about the treatment and diversion concerns,” wrote Assistant United States Attorneys David Sinkman, of the Eastern District of Louisiana, and Gregory Dorchak, of the District of Massachusetts in the 

Department of Justice Journal of Federal Law and Practice

 “Equating the prescription use of MOUD with addiction overlooks the fact that most chronic diseases require long-term use of medication. [Although] those with high blood pressure are dependent on their β-blocker medication, they are not addicted. The same holds true for MOUD.”

Buprenorphine has low potential for abuse because it blocks opioid euphoria and other positive reinforcement. Its appeal on the street is that it also blocks opioid craving. “I’ve had new patients who can tell me what dose of buprenorphine they need because they’ve been using it on the street to treat themselves,” DiPaula said. “There is good data showing that a subset of diversion is associated with self-medication.”

But unfortunately, pharmacists are no less likely to stigmatize OUD than other providers. “The long-term data show medication helps prevent relapses and helps [individuals] to be opioid-free, productive members of their community,” said Grace Allen, RPh, chief operating officer of Pursue-Care, a telehealth startup specializing in mental health and substance use disorder treatment in Huntington, West Virginia. “It’s like the difficulties getting oral contraceptives when they first came out. The stigma and judgement that any woman trying to get that prescription filled at the pharmacy [faced] was almost overwhelming. It’s the same kind of situation for patients [with substance use disorder] trying to get their medications.”

It’s not just individual pharmacists prejudging patients, Allen noted that some pharmacy chains discourage out- lets from accepting patients who need MOUD or from filling MOUD prescriptions. “Wholesalers have certain controlled substance dispensing patterns they expect to see, and chains don’t want to lose their ability to purchase,” she said. “It’s terrifying to think you could be cut off from ordering medications because you don’t fit an algorithm that doesn’t take substance use disorder medications into account.”

In turn, wholesalers are trying to avoid attention from the Drug Enforcement Administration (DEA), which has cracked down on opioid sales in recent years. It is unclear how the DEA views MOUD dispensing. The agency touted steps taken to expand access to MOUD in a March 2022 press release, a list that includes “engaging in regular outreach with pharmacists and practitioners to express support for the use of medication-assisted treatment for those suffering from substance use disorder.”

But what that outreach has accomplished is unclear. “DEA is hearing from a lot of advocacy groups, including ASHP,” Dopp said. “There is positive momentum with other stakeholder groups to try to educate and advocate within the DEA to create change.” Ongoing discussions with the agency have brought no discernable changes in policy or enforcement, she added.

“It’s a tangled web of barriers for pharmacists who want to take care of patients,” said Hannah Fish, PharmD, CPHQ, director of strategic initiatives for the National Community Pharmacists Association in East Greenwich, Rhode Island. “All these regulations effectively limit access to care rather expanding access.”

On top of navigating these barriers, MOUD can also be a financial strain, as it is a time-intensive, high-touch practice. Few payers adequately reimburse pharmacists for the time involved. “[When] treating [patients with] substance use disorder, you have to think back on why you got into pharmacy,” Allen said. “When you see in real life how these people have turned their lives around with good care and the right medication at a pharmacy that doesn’t give them a hard time about filling their prescriptions, it reminds you why you got into this practice in the first place.”

Atkins J, Dopp AL, Temaner EB. Combatting the stigma of addiction—the need for a comprehensive health system approach. 

. 2020;2020:10:31478/202011d. doi:10.31478/202011d

Sinkman DH, Dorchak G. Using the Americans With Disabilities Act to reduce overdose deaths. 

Ending the stigma of addiction. Shatterproof. Accessed July 13, 2022. 

https://www.shatterproof.org/our-work/ending-addiction-stigma

. 2020;77(14):1158-1165. doi:10.1093/ajhp/zxaa117

Opioid use disorders. College of Psychiatric and Neurologic Pharmacists. Accessed July 13, 2022. 

Learning tools. ONE (Opioid and Naloxone Education). Accessed July 13, 2022. 

Action collaborative on countering the U.S. opioid epidemic. National Academy of Medicine. Accessed July 13, 2022. 

https://nam.edu/programs/action-collaborative-on-countering-the-u-s-opioid-epidemic/

Training and webinars. American Pharmacists Association. Accessed July 13, 2022. 

Patient-Care-Services/Opioid-Use-Misuse/Opioid-Training-and-Webinars

Buprenorphine can only be prescribed by pharmacists with waivers, limiting access to this necessary treatment for communities.

Pharmacists Fight to Take on Opioid Use Disorder

Telepharmacy is on a roll. In 2001, when North Dakota became the first state to enact regulations allowing the practice.

 By early 2023, 28 states will allow some form of telepharmacy, and Kansas is poised to finalize regulations later this year, according to telepharmacy services provider TelePharm. Approval is advancing in other jurisdictions as well.

“Through the pandemic, there has been a drastic uptake in technology, especially remote technology,” said Brett H. Barker, PharmD, vice president of operations for NuCara Pharmacy, which operates physical stores and telepharmacies in Illinois, Iowa, Minnesota, North Dakota, and Texas. “I think we jumped forward a decade in about 2 weeks back in March 2021 with [individuals’] comfort levels, uptake, and acceptance of remote care. Telepharmacy is good for patients, good for communities, and good for pharmacists.”

Telepharmacy is also a challenge. Roughly 40% of states do not allow telepharmacy, cautioned Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists. Among states allowing telepharmacy, no two have adopted the same practice regulations.

Payers take similarly diverse approaches. Washington and some other states require commercial insurers to reimburse pharmacists on the same basis as physicians, nurse practitioners, and other health care providers. However, most states are silent on payment parity and most commercial payers still balk at paying for nondispensing services, although that could change as the profession continues to push for provider status at state and federal levels.

Medicare does not recognize pharmacists as providers, Kliethermes noted, although the program does reimburse pharmacists up to $150 per month for complex chronic care management. Medicaid reimbursement for pharmacists varies by state.

The biggest financial difference between a traditional pharmacy and a telepharmacy is the cost structure. The return on investment for a traditional pharmacy depends largely on prescription volume, front-end sales, and pharmacist costs. Telepharmacy lowers the financial bar by sharing pharmacist time across multiple dispensing locations.

According to Barker, reimbursement for remote dispensing is similar to conventional in-person dispensing. The current telepharmacy break-even point is around 70 to 80 prescriptions daily, he said, but the number varies by patient population, prescription mix, payer mix, and other familiar factors.

On the cost side, telepharmacy requires more video hardware than conventional pharmacy to facilitate real-time pharmacist monitoring and conversations, but the cost of off-the-shelf hardware is low—and falling. But best practices, and in many cases state regulations, call for off-site storage of all video and still images from both the remote telepharmacy site and the supervising pharmacist, which increases cloud storage costs.

Telepharmacy software providers typically charge an activation fee and monthly use fees, Barker added. The total cost is roughly equivalent to having a pharmacist on site 1 day per week. Telepharmacy providers should expect to pay for the best technicians available.

The 3 T's: Telemedicine, Telehealth, or Telepharmacy?

“You absolutely need rock star pharmacy technicians because they have a higher level of responsibility and visibility in telepharmacy,” Barker said. “You need good problem solvers who can think on their feet and you need a high level of trust. When you have a telepharmacy, the technician is the public face of the pharmacy.”

Getting paid for virtual clinical services can be as challenging as payment for face-to-face clinical services, Kliethermes said. Medicare reimburses pharmacists for telehealth complex chronic care management. One pharmacy provider, Tabula Rasa HealthCare, is being reimbursed under PACE, the federal Program of All-Inclusive Care for the Elderly, which covers frail older adults who are often eligible for Medicare and Medicaid. However, Medicare payments to pharmacists are more the exception than the rule.

“Because Medicare does not recognize pharmacists as providers, it limits reimbursement regardless of the applicable practice act,” she said. “That makes reimbursement challenging because not all of the Medicare telehealth codes are applicable to pharmacists.”

Technicians are also part of the clinical service and revenue mix. A growing number of states allow pharmacy technicians to administer point-of-care tests, immunizations, specimen collection, and other clinical services under pharmacist supervision, Barker noted.

“All of those clinical services can happen safely and effectively through the telepharmacy model,” he said. “At this point, the model is proven and works well. Telepharmacy is letting us extend the reach of our pharmacists and their clinical services. Pharmacists are delivering the same care they provide in a traditional community pharmacy; they’re just delivering it in a different model.”

Tzanetakos G, Ullrich F, Meuller K. Telepharmacy rules and statutes: a 50-state survey. 

Telehealth in your pharmacy practice. American Pharmacists Association. June 1, 2020. Accessed February 23, 2022. 

https://aphanet.pharmacist.com/sites/default/files/audience/APhACOVID-19Telehealth0620_web.pdf

Telehealth. American Pharmacists Association. Accessed February 23, 2022. 

https://pharmacist.com/Practice/Practice-Resources/Telehealth

Before the pandemic, telepharmacy and telehealth were nice ideas. Today, they’re crucial to delivering personalized care with limited in-person contact.

Telepharmacy Rising: Challenges Accompany the Growth of Telepharmacy Use

New career paths are appearing in pharmacy, and these career paths are digital ones. The FDA is approving growing numbers of digital products to monitor and treat patients, building on a growing acceptance of wearable products to monitor health, health apps to guide daily activities, smart pill dispensers to monitor and improve adherence, and much more.

“Technology is changing the patient journey,” said Timothy Aungst, PharmD, Associate Professor of Pharmacy Practice at the Massachusetts College of Pharmacy and Health Sciences. “Digital health is mainstream, accelerated by the COVID-19 pandemic and telehealth. We need to catch up with digital resources, not stay tied to legacy approaches. Digital health needs digital pharmacists.”

Aungst explored ways pharmacists can move practice into the digital world during his presentation at the American Pharmacists Association (APhA) 2022 Annual Meeting & Exposition, held in San Antonio, Texas.

Digital health is hardly a new concept, he explained. Digital monitoring and mechanical health alerts have long been standard for cars and trucks in the United States. In humans, though, digital health includes a growing variety of sensors, mobile apps, telehealth applications, artificial intelligence, voice assistances, robotics, and automation. Most patients—80%, Aungst noted—already use the Internet to search for health information, and 42% of adults use digital health tracking devices. The first smart toilets, to monitor urine and feces for glucose, blood, and other biomarkers, are poised to enter the market soon.

“Patients have become consumers of health and the home is becoming the center of care,” Aungst said. “We need to move away from a product-based model towards a focus on services empowered by digital technology, meeting patients where they are, and adopting a consumer-first mentality. This is the future of how we will deliver care for patients.”

The broad umbrella of digital health includes multiple overlapping technologies, approaches, audiences, and uses:

platforms for healthcare systems, clinics, and other enterprise settings, including pharmacy

technology platforms and support systems for clinicians and support staff

patient-facing products that capture, store, or transmit health data

products to diagnose, guide diagnosis, or monitor patients directly

products that deliver medical interventions and therapies

When it comes to regulatory oversight, guidance varies. Most digital health platforms and products don’t require clinical evidence or regulatory oversight. Digital medicine, evidence-based software and/or hardware that measure or intervene in human health, may require regulatory oversight, and digital therapeutics (DTx) that deliver evidence-based therapeutic interventions do require regulatory oversight based on product claims of risk, efficacy, and intended use.

“The goal of all this technology is to have it work in the background of our lives and only intervene when needed,” Aungst said. “We have more in our toolkit to help patients. It’s not just medications anymore.”

For example, EndeavorRx, the first FDA-cleared game, treats ADHD as an adjunct to therapy, medications, and or education programs. RESET and RESET-O, the first FDA-approved DTx platform, is used with pharmacologic therapy for substance use disorder and opioid use disorder. “There are other DTx products in chronic disease management, oncology, ophthalmology, and [women’s] health,” Aungst said. “We need to incorporate all of these developments into patient care within the pharmacy space.”

That means rethinking pharmacy services. Current health monitoring is intermittent, when the patient visits the pharmacy for a refill and maybe a blood pressure check. Data collection is spotty and can be subjective. Digital health integrates real-time patient monitoring to detect and treat problems at an earlier stage to improve outcomes. Data collection is continuous and objective.

Most asthma patients do not use inhalers correctly, Aungst noted. Apps can provide real-time technique feedback to improve drug delivery and outcomes. Diabetes is similarly poised for digitally guided outcomes.

“We have the tools today and more are coming,” he said. “Digital health guided medication management is what we need to latch onto for better medication management and better outcomes.”

Just as consumers expect retail sellers to offer digital access, pharmacy patients expect a digital front door into health-related services, medications, and interactions. The pharmacy may no longer be the sole source of medications, Aungst cautioned—but pharmacy can expand as the hub of medication management and related services. Payers are already moving to digital, and pharmacists have a clear role for medication optimization.

“It’s time for us to meet patients where they are and adopt a consumer-first mentality,” Aungst concluded. “And we need to show payers that we can do this, otherwise we’re not going to get paid. We need data showing not just clinical impact but data that shows economic impact as well.”

Aungst T. Digital health 101. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX.

What is digital health? FDA. Updated September 22, 2020. Accessed April 4, 2022. 

https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health

Mobile health apps interactive tool. Federal Trade Commission. April 2016. Accessed April 4, 2022. 

https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool

Patients need digital pharmacists to monitor the growing armamentarium of digital therapeutics and the flood of patient-specific data

The Future of Pharmacy is Digital

Ask any patient with type 1 diabetes (T1D) about disease management, and you’ll likely hear stories of meticulous monitoring, hardware challenges, and more. So it’s no surprise that enterprising patients and caregivers have begun to hack their insulin pumps and continuous glucose monitors (CGMs) to create hybrid, closed-loop automated insulin delivery (AID) systems using off- the-shelf hardware and do-it-yourself (DIY), open-source smartphone apps to build their own bionic pancreas.

Aaron J. Kowalski, PhD, CEO of the Juvenile Diabetes Research Foundation (JDRF), received a diagnosis of T1D at age 13. When he learned about the DIY closed-loop AID system called Loop,

 he jumped right in. “I was a very early adopter because my first responsibility is to my health and my family. I had worked in the science for many years, and I felt that the risk was worth taking,” Kowalski said.

Kowalski isn’t alone. Many JDRF staffers have T1D, and they often use open-source DIY AID systems. The same is true at Integrated Diabetes Services. Owner and clinical director Gary Scheiner, MS, CDCES, and many of his staff clinicians use open- source AID.

“I wouldn’t consider myself tech savvy; I’m tech comfortable,” Scheiner said. “DIY is not much different conceptually from what’s available commercially today, but DIY systems like Loop are more flexible [and] more customizable. Commercially available systems have serious guardrails [and] very few variables that the user can adjust, which limits functionality. With something like Loop, you can achieve higher time in range, tighter averages, and lower [hemoglobin A levels] than with commercially available systems because you can adjust to your daily needs more easily.”

Insulin pumps and CGMs have been a staple in T1D care since the 1980s and early 2000s, respectively. But for a time, the 2 devices could not communicate, as no feedback loop existed between CGMs and insulin pumps to automatically regulate insulin dosing and blood glucose levels.

In 2014, some insulin pump users realized that a security flaw in the now-discontinued Medtronic pump models let them hack their pumps. Anyone with the right tech savvy could create their own algorithm, load it on a smartphone, and use real-time CGM data to calculate insulin dosing and control their pump. And thus looping—closing the CGM-insulin pump loop using DIY, open-source soft- ware—was born.

Many early adopters were parents of children with T1D who wanted to be able to remotely monitor their child’s serum glucose and adjust insulin dosing as needed, Kowalski explained. Under the banner #WeAreNotWaiting, parents formed an online community, Nightscout,

 an “open-source DIY project that allows real time access to CGM data,” he said. In its first iteration, Nightscout was specifically made to remotely monitor Dexcom G4 CGM data. Eager users shared Open Artificial Pancreas System (OpenAPS)

 documentation, including open-source reference designs, safety information, and step-by-step implementation instructions. Everything was designed touse existing FDA-approved devices, commodity hardware, and open- source software. As the information spread, AndroidAPS (for Android devices) and Loop (for iPhones and later iOS devices) focused on users in device-specific communities.

By 2016, OpenAPS users were presenting data at scientific gatherings sponsored by the American Diabetes Association

 and other medical organizations focused on diabetes research and care. Tidepool added Loop data in 2018

 and began developing a commercial algorithm with financial support from JDRF and other sources. In 2021, Tidepool completed the first open-source AID algorithm 510(k) application to the FDA.

Tidepool forked the original DIY Loop to create a more efficient, easier to use, and better documented app for the FDA submission, said Christopher Snider, Tidepool’s community and clinic success manager. DIY loopers have incorporated some of the updates, but Tidepool remains a dis- tinct algorithm.

“We put a tight code base on the app and used human factors approaches to increase the safety and efficacy of the algorithm and improve the overall user experience,” Snider said. “When Tidepool becomes commercially available, we will have a support team in place to work with [individuals] directly, just as you would expect with any other insulin delivery system. Support is a little more nebulous in the DIY space where you go to Facebook or Twitter with questions.”

In the medical device world, customer support is generally device specific; every pump, CGM, and hybrid closed- loop system has its own support team. Open source, though, lets users mix and match pumps and CGMs from different manufacturers, creating more flexibility and more choices in features.

“Insulin is prescribed as usual and the health care team still needs to figure out how much insulin the patient is using,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, endocrine clinical pharmacy specialist and remote monitoring program coordinator at the Cleveland Clinic Endocrinology and Metabolism Institute in Ohio. “With systems like Tidepool and Nightscout, we can view all the user data to figure insulin needs.”

She added, “I can’t configure a DIY system because it’s not FDA approved. But what I can do as a pharmacist is review patients’ data and advise them on ways to remain safe. We have a professional responsibility to support our patients and keep them safe.”

Although Isaacs sees open-source AID due to her location and her high visibility within the diabetes com- munity, data published in a recent international consensus statement in 

 estimated that approximately 10,000 individuals with diabetes are using DIY AID—a miniscule figure considering the 9 million individuals world- wide who have T1D.

John Beckner, RPh, senior director of strategic initiatives at the National Community Pharmacy Association, said that for now DIY is “just not that prevalent. And as technology continues to advance, there isn’t going to be much need to do it.”

The future of DIY will depend largely on industry. Dexcom, Medtronic, Tandem, Insulet, and other manufacturers regularly iterate existing products, bringing new systems online. And for now these products remain a closed ecosystem. “The tendency in industry is to want it all under your own shop,” Kowalski said. “If we fast forward 5 years, it would be shocking to me if we are not plugging and playing most of these com- ponents. We don’t have plug-and-play systems in the United States but we do in Europe.”

European regulators approved CamAPS FX, an Android app created by CamDiab, a JDRF-funded project at Cambridge University, in 2020. The app, which links pumps and CGMs across manufacturers, is approved for systems used by patients 1 year and older.

Kowalski predicted a future with fully interoperable closed-loop systems that combine pump X, sensor Y, and app Z. If industry doesn’t do it, DIYers will do it for them. “I was just talking with some of our team about when the Omnipod system is going to launch,” he said. “They’ve been saying publicly this fall, but in the meantime, there are a lot of [individuals] doing Omnipod DIY. If there is a tool to help diabetes be easier to manage with better numbers, that’s a first consideration.”

Patients with T1D can spend hours managing their condition. This month, 

® sat down with Kate,* a New York City resident who received her T1D diagnosis at age 10, to share her perspective on the current state of diabetes technology.

Q: You’re in the process of making the change to an APS. What do you hope will change?

Kate: I’ve read online that the open-source algorithm designed by Open APS [Artificial Pancreas System] can control blood sugars a lot better than the algorithms currently in use.

I remember reading one testimonial from a teenage boy that the [Open APS] algorithm works so well, [he] doesn’t even tell the pump when he eats, and still keeps his blood sugars in relatively good range.

I’m hoping that once I am able to get all the necessary hardware for Open APS, I’ll have better managed blood sugars, especially after eating meals; that my blood sugars will be better managed when unexpected factors affect my blood sugars (such as stress); and that I will get better sleep.

Q: What do you want your health care providers to know about why you’re making this change?

One of the most frustrating things is knowing how much red tape is out there in terms of insurance coverage and companies being unwilling to work with the Open APS community to create the best product. I’m sure the commercial pump algorithms could work a lot better if they collaborated with the people working on this open- source algorithm.

T1D is a strange condition because it is so finicky and involves so much data management. If I didn’t have educated parents who were knowledgeable about medicine and technology to help me learn how to manage this condition, I would probably be in a much worse state than I am now. The best physicians I have had take the time to educate themselves and keep up to date on pump and sensor technology so they can advise me on what to get. I also think it’s important for diabetics to talk to an experienced diabetes educator regularly for help understanding patterns in their data. I love my endocrinologist, but she just doesn’t have time during appointments to go over that in detail.

Limits on insurance coverage are also problematic; some patents are restricted in terms of what’s covered and what’s compatible with Open APS. I’ve waited years for my insurance to approve an insulin pump from a different company that I think will likely work much better for me. But without insurance, insulin and supplies would be outrageously expensive. I have been scared to leave jobs, or even take a leap to start my own business, because I worry about insurance coverage for T1D. Health care providers are likely just as frustrated by these things as I am; it’s one of the most challenging aspects of managing diabetes in this country.

2. The Nightscout Foundation. Accessed May 20, 2022. https://www.nightscoutfoundation.org/

4. Lewis D. Real-world use of Open Source Artificial Pancreas Systems—poster presented at American Diabetes Association Scientific Sessions. OpenAPS.org. Published June 11, 2016. Accessed May 20, 2022.

6. Tidepool completes FDA 510(k) submission of Tidepool Loop. News release. Tidepool. January 7, 2021. Accessed May 20, 2022. 

https://www.businesswire.com/news/home/20210107005324/en/Tidepool-Completes-FDA-510-k-Submission-of-Tidepool-Loop

7. Look H. 99 years closer: About our FDA submission of Tidepool Loop. Tidepool. Published January 11, 2021. Accessed May 20, 2022. 

https://www.tidepool.org/blog/99-years-closer-about-our-fda-submission-of-tidepool-loop

8. Braune K, Lal RA, Petruzelkova L, et al; for the OPEN International Healthcare Professional Network and OPEN Legal Advisory Group. Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

. 2022;10(1):58-74. doi:10.1016/S2213-8587(21)00267-9

9. Jeyaventhan R, Gallen G, Choudhary P, Hussain S. A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G. 

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10. CamAPS® FX. CamDiab. Accessed May 20, 2022. 

A do-it-yourself option to replace traditional diabetes management technology is growing in popularity. 