Fred Gebhart

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. 

. 2021;23(8):1989-1994. doi:10.1111/dom.14439

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

Articles

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

Hacking Diabetes: The DIY Bionic Pancreas Is Here to Stay

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

It’s easy to ask what a drug costs; patients ask every day. It’s tough, though, to give them an accurate answer.

“There is no ‘price’ for a drug in the United States,” said Antonio Ciaccia, Senior Advisor for Disruptive Innovation and Practice Transformation for the American Pharmacists Association (APhA) and President of industry consultant 3 Axis Advisors. “Price varies by time and your place in the distribution chain. Drug prices are hidden, set by contract, and are being manipulated by pharmacy benefit managers.”

Ciaccia attempted to clear some of the smoke, mirrors, and confusion around drug prices during his presentation at the APhA Annual Meeting and Exposition in San Antonio, Texas.

Pharmacy benefit managers (PBMs) began intermediaries and claims processors between insurers and pharmacies. Today, 3 PBMs—CVSCaremark, Express Scripts, and OptumRx—control about 80% of the United States pharmaceutical market with vertically integrated organizations that include insurers, pharmacies, rebate aggregators, and other industry players.

Every organization and level in the distribution chain, from manufacturers to patients, has its own private contracts and rebates, both acknowledged and disguised. The rebates that grease the wheels of the drug distribution chain would be called kickbacks in any other business, Ciaccia continued, but are legal in this particular industry.

“PBMs advertise that they are the only entity working to control prescription drug costs,” he said, “but data show that PBM profits generated off prescription drug transactions heavily distorts their incentives to control drug spending for their clients.” The reality, he continued, is that formulary placement fees and other rebates give PBMs positive incentives to distort prices and increase their own profits. Each PBM promotes utilization of different mixes of drug products for different health plans. Different utilization mixes trigger different mixes of rebates and fees, making it more difficult to compare real costs.

Another problem? The entire drug distribution system is based on fake prices. List prices are artificial, Ciccia explained. So is average wholesale price. The AWP for 20 mg of omeprazole magnesium (Prilosec) in 2021 ranged from $0.30 per unit to nearly $9.

“We need a benchmark that isn’t set by somebody who makes money off those drugs,” he said.

Today’s rigged prices leave cash-pay patients and small employers paying list price or close to it. Large employers pay a bit less, followed by Part D Plan sponsors, Big 4 federal buyers—like Veterans Affairs, the Department of Defense, Public Health Service, and Coast Guard, with Federal Ceiling Price protection—and then Medicaid.

One result: An analysis concluded by 3 Axis Advisors found that a group of small, self-insured employers with combined drug spend of over $110 million in 2018 received about $5 million in rebates. Based on the Federal Supply Schedule, a proxy for the best commercial price, they should have received about $30 million in rebates. PBMs pocketed the difference.

The rebate retention game is played by rebate aggregators owned by, or affiliated with, the three largest PBMs: CVS/Zinc, ESI/Ascent, and Optum/Emisar.

Clients get rebate guarantees off list price on a per claim basis. But rebates are increasingly recategorized as mail-order purchase discounts, market share incentives, promotional allowances, commissions, market share utilization, drug pull-through programs, formulary placement fees, administrative fees, data fees, price concessions, volume-based incentives, and other payments not covered by rebate guarantees.

“The higher list prices rise, the more price concessions a PBM can collect and retain,” Ciaccia said.

In 2018, Ohio State Auditor David Yost reported that PBMs pocketed 31% of the state generic drug spend—$208 million in 1 year. In 2021, David Yost, now Attorney General of Ohio, accepted an apology and a check for $88 million from PBM Centene over alleged drug markups of more than $11 per prescription. The company settled similar claims with Mississippi for $55 million and set aside more than $1.1 billion for other states.

“The books are cooked,” Ciaccia said. “In Florida, about 60% of all calcipotriene spending came from one managed care organization. Its PBM billed as a brand, then classified it as a generic for pharmacies and clawed more than $1000 per claim.”

PBMs are playing similar games with Medicare Part D. In early 2019, the patient price for imatinib mesylate—the generic of Gleevec—ranged from $9.62 per pill to $315.74. A national study of dimethyl fumarate found that the largest insurers and PBMs were steering patients to the branded product at $8,275 per month, instead of toward a generic option available at a cost of $184.

“We need to rein in PBM abuses,” Ciccia said. “Strategies include Medicaid carve-outs or a single PBM; pass-through pricing with full transparency; prohibitions on patient steering; bans on spread pricing, gag clauses, co-pay clawbacks, and co-pay accumulators; pushing rebates through to patients; reverse auctions, and real fiduciary requirements. As list prices for drugs continue to rise, those who can engage in price-setting in the middle, PBMs, can continue to benefit significantly at great cost to drug purchasers.”

Ciaccia A. Unraveling US drug pricing distortions and their impact on pharmacies. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

PBMs use hidden rebates and other strategies to rig drug pricing and sidestep regulatory efforts

US Drug Prices Distorted to Favor Pharmacy Benefit Managers

As a pharmacist, some of your patients are likely using marijuana—be it bud, concentrates, edibles, extracts, tinctures, or topicals. All marijuana formulations have documented interactions with drugs and foods, and none have the kind of randomized controlled trial data that pharmacists usually turn to for counseling.

“We need to open the door for communication about these products with our patients,” said Kam Capoccia, PharmD, BCPS, CDCES, Clinical Professor of Community Care, Western New England University College of Pharmacy and Health Sciences. “Whenever we take a history, we include medical and recreational marijuana along with tobacco, medications, and health history. If you ask, you will learn.”

Capoccia discussed the latest developments in marijuana at this year’s American Pharmacists Association 2022 Annual Meeting & Exposition in San Antonio, Texas.

Legal questions about marijuana use are the easiest to answer, she said. On the federal level, the only legal form of any 

 species is hemp, which must contain ≤0.3% delta 9-tetrahydrocannabinol or THC, the principal psychoactive component.

The tide of CBD products flooding pharmacies and other retail channels are made from hemp, which leaves them legal as supplements under federal regulation. But, Capoccia noted, that’s where the complications begin.

A growing number of states—but not all states—have legalized some form of marijuana, either medical or recreational—or both. Each state has its own rules and regulations on growing, processing, selling, and using marijuana in its different forms. “As a pharmacist, it is important to know the rules for you and your patients in your own state,” Capoccia said.

A 2021 Gallup Poll found that 49% of respondents have tried marijuana, up from 45% in 2017 and 2019. Gallup reported that 1 in 7 Americans use CBD products, primarily for pain (40%), anxiety (20%), sleep (11%), and arthritis (8%).

Smoking is the most common formulation for young adults, but age is no barrier: In 2020, 53% of patients surveyed at a University of California, San Diego Seniors Clinic said they use cannabis regularly. Forty-six percent use CBD-only products for pain/arthritis (73%), sleep disturbance (29%), anxiety (24%, and depression (17%).

“Everyone is using marijuana, you just have to ask to find out,” said Capoccia, “and use is growing. Among older patients at UCSD, more than half said they tried it for the first time after the age of 50.”

Because federal regulation has long criminalized any use of marijuana, there are few large randomized controlled trials, and no standards for purity or composition, Capoccia noted. Labeling can be questionable as well. A 2017 study of 84 CBD products from 31 companies found that just 30.95% of labels were accurate, with 42.85% of products under labeled and 26.19% over labeled. Pharmacists, therefore, should advise patients to use only products with analysis certificates from recognized and reliable laboratories, she cautioned.

Lexicomp and the Natural Medicines Database show multiple drug-drug interactions for marijuana, including protein binding displacement, many CYP450 interactions, and P-glycoprotein substrate binding. There are also multiple food-drug interactions.

“What you have in your stomach matters,” she said. “A fatty meal increases absorption of CBD, which can lead to an unintended overdose.”

The FDA strongly advises against the use of marijuana during pregnancy or while breastfeeding. Marijuana crosses the placenta and has been associated with lower birthweight and increased neonatal ICU admissions, while CBD is fat soluble and lingers in breast milk.

There is conclusive or substantial evidence of effectiveness of marijuana for chronic pain, as an antiemetic in chemotherapy-induced nausea/vomiting, and patient-reported multiple sclerosis spasticity, according to the National Academies of Sciences, Engineering, and Medicine. Systematic reviews and randomized controlled trials found that oral CBD can significantly reduce the use of opioids by patients with neuropathic pain as well as reduce pain compared to placebo. The Arthritis Foundation has also concluded that CBD may help with arthritis pain, Capoccia added; the Foundation identified no major safety issues, while warning that CBD should not be used to replace any disease-modifying drugs. With no established guidelines, the group advised starting with low doses and increasing in small increments.

 concluded that the evidence is too weak to make any cannabinoid-based recommendation for anxiety, post-traumatic stress disorder, depression, insomnia, and other psychiatric disorders.

“Research is expanding,” Capoccia said. “The evidence is not solid and there are no standards, a very uncomfortable space for pharmacists, but CBD demonstrates some benefits. We should be counseling on product selection, safety, efficacy, evidence, and interactions. I advise people to start low, go slow, and to use a journal to track their own dosing and effects. We don’t have any other guidance for now.”

Capoccia K. The many faces of marijuana: Implications for pharmacists. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

Patients should start low, go slow, and track their own dosing and effects

As Use Increases, Understanding Marijuana Is Essential for Pharmacists

elivering clinical services doesn’t start with the patient walking into the pharmacy or talking with the pharmacist. Clinical care begins long before. Existing programs such as medication synchronization and Medicare Part D’s Medication Therapy Management (MTM) can help. Medication synchronization serves 2 purposes. Enrolling 30% to 50% of chronic patients in an appointment-based refill program frees up a significant amount of pharmacist time compared with walk-in refills, according to Cody Clifton, PharmD, director of clinical services at Duvall Family Drugs in Duvall, Washington, and director of practice transformation and clinical programs for Community Pharmacy Enhanced Services Network (CPESN).

Regular, scheduled follow-ups then pave the way for other clinical services. “Reaching out to patients 7 to 10 days in advance of every refill lets you take services to the next level by asking straightforward questions about medication changes, changes in health, vaccinations, testing, and all the other ways we can help,” Clifton said.

Many independent pharmacies use Outcomes MTM’s standalone Part D MTM program. The program boosts nondispensing cash flow and can help identify patients who need more than a compre- hensive medication review (CMR). “We sometimes use that CMR to identify patients [who] could benefit from other services,” said Tripp Logan, PharmD, vice president of SEMO Rx Pharmacies, which has pharmacies across 3 counties in southeast Missouri.“From a value standpoint, we don’t see a ton of clinical value in 1 visit because these patients are complex enough that they need more than 1 intervention a year. That CMR is an identify clinical needs. The payer or network can forward patient contacts or selection criteria directly.

“Our program identifies patients who are part of a certain health plan, have disease states within certain date ranges, or [have] other criteria,” explained Farah Madhat, PharmD, executive vice president at PrescribeWellness.“We try to empower community pharmacies to run their own clinical programs. And once you’ve identified that population through software, you can send out singular communications to only those select patients.”

Other pharmacies use social media to drive demand. Traditional media can also be effective, depending on cost.

“We do a lot of social media and radio advertisements for the pharmacy,” said Martika Martin, PharmD, MBA, director of clinical services at Danhauer Drugs in Owensboro, Kentucky.“We mostly use Facebook, which is hugely successful in our area. Our pharmacy has been here since 1904, so people are used to coming to the pharmacist with questions. And when they’re asking questions, they are asking you to help make their lives better.”

How to follow up on those initial contacts depends as much on the pharmacist as it does on patients. Some pharmacists would rather spend time calling patients directly rather than using robocalls, as some patients dislike prerecorded calls.

However, Madhat said Prescribe-Wellness metrics suggest that phone messages recorded by the local pharmacist with follow-up by text messaging can be highly effective in bringing potential patients into the pharmacy and reminding them of existing appointments. Email is generally less effective.

“We already have the phone number from the health plan, and a voice message really reinforces that connection and drives them to come in,” she said. “We’ve started using texting for intake components, texting them a link to provide some of the information before they ever come in. And in the pharmacy, they can scan a QR code and do some of the preappointment work It saves everyone time.”

Support staff also play key roles in clinical work by identifying patients due for refills, consults, vaccinations, or other services; making phone calls; retrieving patient files; and watching for opportunities.

“If you have good communication with your staff and they have a clear understanding of your clinical vision, they can help,” said Tammy Bullock, PharmD, BCACP, clinical pharmacy coordinator for Osterhaus Pharmacy in Maquoketa, Iowa.“They can spot a MedWise patient or an OutcomesMTM opportunity and alert the pharmacist. A growing number of states allow certain technicians to administer vaccines, a move that accelerated during COVID-19.

“When you get vaccinated in a physician’s office, who provides that vaccine?” asked Josh Howland, PharmD, MBA, vice president of clinical strategy at PioneerRx. “It’s the medical assistant, maybe the nurse.

Providing clinical services takes time, which is why appointment-based sched- uling matters. A scheduled visit gives the pharmacist time to review the patient file, gather any educational materials, and prepare for the encounter. But convincing patients to make and then keep appointments can be challenging.

“[COVID-19] has made that easier. People were asking, ‘Exactly what time do you want me in the pharmacy?’ That experience helped change attitudes about making pharmacy appointments,” Martin said.

It’s crazy to pay your most expensive resource to provide a vaccine. So if your state allows, make sure your techs are certified to administer immunizations and let them do it. Every- one in the pharmacy—you, the techs, other support staff—should be practicing at the very top of their license.”

Providing clinical services takes time, which is why appointment-based scheduling matters. A scheduled visit gives the pharmacist time to review the patient file, gather any educational materials, and prepare for the encounter. But convincing patients to make and then keep appointments can be challenging.

“[COVID-19] has made that easier. People were asking,‘Exactly what time do you want me in the pharmacy?’ That experience helped change attitudes about making pharmacy appointments,” Martin said.

Osterhaus Pharmacy tries to arrange appointments but also builds time into pharmacists’ schedules just in case. “We ask if they have a few minutes to talk, and most of the time, they do,” Bullock said.“If not, we ask about a more convenient time or offer to call them at home at a specific time. Having that flexibility to sit down for 15 minutes is a priority in our workflow and our staffing plans. That’s why MedSync is so important to clinical workflows. If I know this patient is coming in tomorrow, I can prepare my action plan ahead of time.”

COVID-19 has been a stress test for health care, and pharmacy is showing solid results.

“We vaccinated the first health care professionals in our country along with the hospital,” Bullock said.“We talk with physicians on the phone all the time, but they almost never step into the pharmacy. Being on the receiving end of services helped them see why we are so different.”

Kentucky is one of the states requiring pay parity with other providers.

“[COVID-19] was a catalyst for passing provider status in Kentucky,” Martin said. “Commercial insurers are now required to pay the pharmacy the same for services that they would pay any other provider. That’s a real boost for patient care.”

The critical takeaway from COVID-19 is that pharmacists have the flexibility and training to provide direct patient care, track their interventions, and deliver solid clinical outcomes. All they need are regulatory approval and assured reimbursement.

“[COVID-19] blew the door open on clinical services in pharmacy,” Howland said.“Pharmacists showed they are the one provider in the country willing and able to mobilize quickly to provide services at scale. It’s up to pharmacists to walk through that door now before it shuts.”

The final installment of this 3-part series on medication management services delves into the process of providing clinical care in the pharmacy.