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

Joan Vos MacDonald

When patients first experience asthma symptoms, their first instinct may be to try an over-the-counter (OTC) bronchodilator. That these remedies are sold OTC may lead patients to believe that there are no contraindications—but that’s far from the case.

Asthma is a chronic disease in which lung airways become inflamed and narrow, making it difficult for the patient to breathe. Asthma symptoms include shortness of breath, chest tightness or pain, wheezing, and coughing. While OTC products may temporarily alleviate some symptoms, the inflammation associated with repeated asthma attacks can permanently scar airways. Patients need to relieve symptoms, but they also need a way to prevent future attacks. For that reason, asthma is best treated under medical supervision, and getting a professional diagnosis is an important first step.

“There are other diseases with similar symptoms,” said Melanie Carver, chief mission officer, Asthma and Allergy Foundation of America (AAFA). “People with asthma strongly benefit from having an accurate diagnosis and a tailored treatment approach from an allergist, pulmonologist, or primary care provider. The National Institute of Health’s Guidelines for the Diagnosis and Management of Asthma

 recommend the use of control medicines to reduce airway swelling and inflammation and quick-relief medicines to open the airways. These asthma guidelines do not recommend the use of [OTC] products.”

Asthma medications relax the muscles around the airways while reducing swelling and mucus inside. Approved treatment regimens

 can include a combination of short- and long-term bronchodilators, as well as oral medications, to prevent and treat asthma symptoms. While some OTC products are promoted as useful for mild, intermittent asthma, that recommendation is not necessarily echoed by medical professionals.

“According to the national guidelines that were updated in December 2020, patients with very mild asthma would be on a short-acting bronchodilator,” said Rachel L. Miller MD, FAAAAI, system division chief, Division of Clinical Immunology, Icahn School of Medicine at Mount Sinai. “No [OTC] asthma medications are recommended for patients without evaluation by a physician.”

Two OTC products currently sold to treat asthma are Primatene Mist HFA, an inhaler containing epinephrine, and Asthmanefrin, a bronchodilator that contains racepinephrine. Primatene Mist HFA is the only nonprescription inhaler approved by the FDA,

 but that approval comes with certain conditions.

“The FDA recommends that [OTC] products for asthma…only be used by people with a prior diagnosis of mild intermittent asthma,” Carver explained, adding that regular use of these products may lead to medication overuse because underlying lung inflammation is not being treated. “The medication should not be used by patients who have heart disease, high blood pressure, diabetes, thyroid disease, seizures, benign prostatic hyperplasia, or glaucoma,” Carver added.

Primatene Mist HFA was removed from pharmacy shelves in 2011 because it used chlorofluorocarbons (CFCs), a propellant banned by the EPA. The inhaler returned to the market in 2019 after CFCs were replaced with hydrofluoroalkane (HFA). However, medical professionals and health organizations like the AAFA, the American Thoracic Society,

 and the American Association for Respiratory Care

 expressed concerns about the decision to return Primatene to the shelves, citing the potential for misuse and the lack of efficacy. Epinephrine can overstimulate the heart and studies have found it less effective than albuterol, found in prescription medications such as Ventolin HFA.

“These OTC products also have side effects to be aware of such as increased blood pressure or heart rate,” Carver said. “Patients should not stop or switch their prescribed asthma medicines to take [OTC] options instead. If someone is experiencing asthma symptoms 2 or more times per week, they need medical care to assess their asthma severity and control.”

Tommy Thompson, RPh, owner of Mechanicsville Drug Store in Mechanicsville, Virginia, believes OTC medications like Primatene have their place.

“They’re not widely used in my pharmacy because most of my customers have some kind of relationship with a physician,” Thompson said. “The albuterol inhalers are effective, and most people have insurance that covers them.”

Thompson notes that most patients who buy these OTC products have already seen a physician, but occasionally people will buy OTC medications because they are waiting to see their physician or cannot afford the visit. Keeping these medications behind the counter gives Thompson a chance to ask patients about their symptoms and discuss treatment options.

“If someone is taking it for the wrong reasons, we are going to suggest that it won’t help,” said Thompson. “That’s why we keep it behind the counter—not because it’s being abused a lot where we are, but more so that we can counsel patients about why they are using it.”

View the rest of our February 2022 issue here.

2020 focused updates to the asthma management guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. National Institutes of Health. December 2020. Accessed January 4, 2022. 

https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/2020-focused-updates-asthma-management-guidelines

Understand your asthma medication. American Lung Association. Updated June 23, 2020. Accessed January 4, 2022. 

https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/living-with-asthma/managing-asthma/understand-your-medication

FDA statement on approval of OTC Primatene Mist to treat mild asthma. News release. FDA. November 8, 2018. Accessed January 4, 2022. 

https://www.fda.gov/news-events/press-announcements/fda-statement-approval-otc-primatene-mist-treat-mild-asthma

Sadreameli SC, Brigham EP, Patel A. The surprising reintroduction of Primatene Mist in the United States. 

2019;16(10):1234-1236. doi:10.1513/AnnalsATS.201902-164HP

Willden H. FDA announces new OTC option, AARC raises concerns. American Association for Respiratory Care. November 9, 2018. Accessed January 4, 2022. 

https://www.aarc.org/fda-announces-new-otc-option-aarc-raises-concerns/

Articles

Patients seeking OTC remedies for asthma should be counseled on the risks associated with OTC asthma products. 

OTC Update: Asthma Medications 

According to a 2019 Gallup poll,1 14% of Americans use cannabidiol (CBD) products, which makes the hemp derivative a potentially profitable addition to pharmacy shelves. However, the lack of a regulatory standard for selling CBD has created a gray area for pharmacists.

“What really makes that difficult is that as pharmacists we’re not comfortable operating in a gray area,” said Tim Gregorius, RPh, vice president of operations for PRS Pharmacy Services in Latrobe, Pennsylvania, and chief adviser for the National Community Pharmacist Association CBD resource page. “Our line of work is usually very cut and dried. You want to know how many you can sell and the exact strength and how to report it.”

In February 2021 the bipartisan bill HR 8412 proposed classifying and regulating CBD as a supplement. However, legislators await FDA input. Two years ago, the FDA promised a statement on CBD’s potential uses but research continues. The FDA has not issued a conclusion. HR 841, also known as the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, is identical to HR 8179,3 which was proposed in 2020. Both bills urge the regulatory agency to approve CBD for use in dietary supplements. 

Before the Farm Act4 legalized hemp and hemp products in 2018, many individuals were already buying unregulated CBD products online. After the Farm Act passed, CBD products proliferated in retail markets while pharmacies faced a confusing patchwork of federal and local laws governing CBD sales.

“Pharmacy came to the game late, in 2018 and 2019,” said Gregorius. “We got there and said, ‘This is safe, there’s no THC [tetrahydrocannabinol], we’re going to sell this,’ and that’s where it got really sticky because a lot of state boards said, ‘No, you don’t.’ And in a few states, agencies such as the department of agriculture or the department of transportation had an issue. Nebraska had an issue where it was not the state Board of Pharmacy but it was the state Department of Agriculture that said, ‘CBD comes from marijuana and marijuana is illegal. Therefore, don’t bring it into our state.’”

Despite the growing number of states legalizing marijuana for medical and/or regulatory use, it remains illegal at the federal level. However, CBD has less than 0.3% THC, the compound responsible for the marijuana high, and the hemp product falls under the Farm Act. So far, the FDA has only approved5 1 CBD product, a prescription drug that treats seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

The FDA has not approved any other therapeutic use for CBD. It cannot be used as a dietary supplement or added to a food product. Some state pharmacy boards have prohibited selling CBD, whereas others told pharmacists to follow existing FDA guidelines.

“Those are the only things the FDA has been clear about,” said Gregorius. “And the state boards of pharmacy said, ‘We are not going to stop you from selling it because it is not illegal. It doesn’t have THC.’ If the FDA says, ‘If you’re going to sell it, we’re going to look the other way’—which is effectively what their enforcement discretion says—then sure, go and sell it. Just make sure you do it under FDA guidelines. And that’s where we are now.”

In March 2021, the FDA issued warning letters6 to 4 companies for selling CBD products, citing a violation of the Federal Food, Drug, and Cosmetic Act. Although these letters raise the possibility of seizing CBD products, they are targeted at manufacturers who do not meet the requirements to legally market their products. Pharmacists need not worry if they follow the existing guidelines.

“What we’re telling pharmacies and what the state boards of pharmacy are telling pharmacists is just don’t make those claims,” said Gregorius. “The manufacturers who are making those claims on their packaging and in their marketing are the ones that are the target of the FDA.”

Brenan M. 14% of Americans say they use CBD products. Gallup. August 7, 2019. Accessed July 30, 2021. 

https://news.gallup.com/poll/263147/americans-say-cbd-products.aspx 

Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, HR 841, 117th Cong (2021). Accessed July 30, 2021. 

https://www.congress.gov/bill/117th-congress/house-bill/841/all-actions?r=24&overview=closed&s=2#tabs

Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020, HR 8179, 116th Cong (2019-2020). Accessed July 30, 2021. 

https://www.congress.gov/bill/116th-congress/house-bill/8179

Hemp Production and the 2018 Farm Bill; testimony before the Senate Committee on Agriculture, Nutrition, and Forestry (testimony of Amy Abernathy, MD, PhD, principal deputy commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health and Human Services). FDA. July 25, 2019. Accessed July 30, 2021. 

https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019

FDA regulation of cannabis and cannabis-derived products, including cannabidiol (CBD). FDA. Updated January 22, 2021. Accessed July 30, 2021. 

https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

Warning letters and test results for cannabidiol-related products. FDA. Updated March 22, 2021. Accessed July 30, 2021. 

https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products

Selling CBD can be profitable for pharmacies, if they follow regulatory guidelines. 

CBD Legislation Remains in Limbo

Nearly 1 in 5 US adults lives with a mental health disorder.

 Many are currently being treated with medication regimens that benefit from pharmacist oversight.

As the antipsychotic medication landscape evolves, more roles are emerging for pharmacists to fine-tune their patients’ regimens and serve as important access points for individuals experiencing mental health crises.

Psychiatric Pharmacy: A Career Path in Mental Health

For a growing number of pharmacists, an interest in providing mental health care leads to a specialization in psychiatric pharmacy, also known as mental health pharmacy. Currently, there are over 1300 board certified psychiatric pharmacists in the United States and that number is expected to grow, said Charles F. Caley, PharmD, BCPP, chair and professor of pharmacy practice, department of pharmacy practice, at Western New England University College of Pharmacy and Health Sciences in Springfield, Massachusetts.

“The vast majority of psychiatric pharmacists are going to be working in inpatient psychiatric hospitals or in ambulatory or outpatient clinics,” said Caley. “Depending on where you live in the country, they could be state-run facilities or federally run facilities or county-run facilities. For example, in California, the counties govern and dictate and deliver behavioral health care, but in Connecticut that is not the case. It’s the state. So wherever public health care can be delivered, there’s the potential for pharmacists to be involved.”

Medication therapy that is managed by pharmacists has been shown to improve patient adherence while cutting costs for the care provider.

“Many patients are on many, many drugs because it is much easier for someone to add a medication than it is to take one away,” said Stephen R. Saklad, PharmD, BCCP, director of the Psychiatric Pharmacy Program at the University of Texas at Austin College of Pharmacy and a founding member of the College of Psychiatric and Neurologic Pharmacists.“Every time they change providers someone layers on another drug. They may or may not get their prescriptions from the same pharmacies, so many pharmacies may not see the composite picture of what they’re taking. It’s an opportunity for pharmacists to be able to reach in and clean up their meds, make the patient better, and decrease costs. Also, there’s a number of opportunities in giving long-acting antipsychotics or monitoring [patients taking] clozapine. Those are 2 areas where pharmacists have really stepped up.”

To provide and monitor long-acting injectable drugs, such as clozapine, pharmacists must first set up a protocol with the prescriber. They can then monitor treatment and, after getting lab results, adjust doses in collaboration with the prescriber.

“The protocol will differ depending on the state you are in,” said Saklad. “It’s not really very difficult or tedious but requires a few hurdles to jump over depending on [your] state…. There’s a really big opportunity for ambulatory care in community pharmacy and this is being done in a number of states around the country.”

As an associate professor at Pacific University in Forest Grove, Oregon, Bridget Bradley, PharmD, RPh, BCPP, educates future pharmacists about potential roles in mental health care. She also works as a psychiatric pharmacist at Virginia Garcia Memorial Health Center, a federally qualified health center.

“I truly love everything about my job,” said Bradley. “I get to work side by side with physicians, [physician assistants], NPs [nurse practitioners], nurses, [medical assistants], behavioral health providers, mental health providers, and the amazing support staff. In Oregon, pharmacists have the opportunity to practice at the top of their license. I get to provide medication management for patients with depression [and] anxiety, and support providers with managing many different psychiatric medications.”

Choosing psychiatric pharmacy as a career gives pharmacists an opportunity to improve lives and fight the stigma associated with mental health.

“Being knowledgeable about the medications [gives you] the opportunity to connect with a patient and help them with their medication use,” said Bradley. “Psychiatric pharmacists have the opportunity to help patients understand their medications.”

For More Information on Mental Health Care

The College of Psychiatric and Neurologic Pharmacists

 offers information on careers and training in psychiatric and neurologic pharmacy at 

The National Community Pharmacists Association

 offers mental health first aid training (virtual during COVID-19) at 

The National Council for Behavioral Health

 provides information on mental health services and mental health first aid at 

According to Saklad, about a third of all psychiatric patients in the United States are cared for at a family practice. A family practice provider might prescribe a selective serotonin reuptake inhibitor (SSRI) or other antidepressant and schedule a standard 3-month follow-up.

“They might make 1 dose adjustment and if that does not work, send the patient to a psychiatrist,” said Saklad. “Well, there’s not enough psychiatrists. Three months is too long. If you have a psychiatric pharmacist in your practice, patients are sent to them for a more appropriate monitoring adjustment. You have them come back in 1 to 2 weeks to see how they are doing and maybe then make an adjustment.”

Taking advantage of pharmacists’ expertise can do more than ease the burden on family practice physicians and NPs. With the shortage of psychiatrists expected to reach 25% of need by 2025, psychiatric pharmacists will be more essential than ever.

The medication intervention and management performed by a pharmacist is also valuable during telehealth consultations. A 2020 study followed the pharmacist-led telemental health transitions conducted by a care clinic at a Veterans Affairs medical center. The aim was to improve continuity of psychiatric medication therapy following discharge from an acute psychiatric hospitalization. The study results showed that the pharmacist-led telemental health transitions improved the likelihood of patients adhering to antidepressant medication after their leaving the hospital.

Becoming a board certified psychiatric pharmacist requires specialized training. After graduating from a doctor of pharmacy program accredited by the Accreditation Council for Pharmacy Education, pharmacists can specialize in psychiatric pharmacy by acquiring postgraduate residency training, clinical experience, or a combination of the 2.

 Although all pharmacy students learn about common mental health conditions and medications, specialization in psychiatric pharmacy involves rotations in a mental health setting.

“You need experience talking with these folks, talking about the illness, learning how they live and what they struggle with in order to shape how you approach them, so you are of the most benefit to them,” said Caley.

Continuing mental health education, whether that involves focusing on psychiatric pharmacy or taking a mental health first aid course, makes it easier for pharmacists to approach the topic.

“A lot of pharmacists want to be able to do the right thing but they’re not sure what the right thing is,” said Caley. “They also think that talking with someone who has a mental health condition might take too much time, so they don’t. Given how common depression is, you could make the argument that pharmacists should be as well versed in depression as in diabetes, high blood pressure, and other common conditions. If you’re not interested in psychiatry and you don’t do a residency, then it’s up to individual pharmacists to pursue continuing education in areas that are focused on mental illness.”

Opportunities Exist in Community Pharmacy

Pharmacists working in the community setting can also play an important role in mental health care. According to the National Community Pharmacists Association (NCPA), pharmacists are more likely to encounter a patient having a mental health crisis than a patient requiring basic life support or cardiopulmonary resuscitation (CPR). By offering mental health first aid,

 a pharmacist can provide essential support during a crisis and then refer the patient to the appropriate medical professional. 

NCPA offers a course for community pharmacists about common mental health disorders and how to deal with a crisis. The training recommends that a pharmacist who notices a patient acting differently—sadder, more anxious, or perhaps more manic—might suggest a simple mental health screening. Such screenings only take a few minutes.

“It really is like CPR—where it stops short of someone providing sutures if you slice a finger,” said Hannah Fish, PharmD, NCPA’s associate director of strategic initiatives. “You’re there to understand. You need to provide some sort of compression to stop the bleeding, but then you call 911 and they’re on their way. It’s the same thing with mental health first aid, where you’re able to figure out what the issue may be or where someone might need some extra support and then extend that support to the person who needs it.”

One way to start the conversation is to post a sign letting patients know that you offer mental health screenings. It’s not unlike putting up a sign that says you offer influenza shots.

“You can say, ‘Hey, how are you doing, are you interested in a screening today?’ We’re here to talk and to help,” said Fish.

The screening is more effective if a patient receives a questionnaire during a 1-on-1 interaction with a pharmacist. A 2019 study

 explored whether distributing the standard Patient Health Questionnaire‐9 (PHQ‐9) for depression screening was more effective when added to a prescription pick-up bag or when patients had a 1‐on‐1 conversation with the pharmacist at prescription pick‐up or during a previously scheduled medication therapy management appointment. The highest participation rate occurred during a 1-on-1 interaction between pharmacist and patient, according to the results.

To provide timely referrals, pharmacists need an up-to-date list of accessible mental health professionals, clinics, and services. At Saklad’s Forty Acres Pharmacy in Austin, Texas, that list is updated on a monthly basis.

“Referring someone to a dead end is a bad, potentially lethal thing to do,” said Saklad. “We also check back with all the people we refer in 2 weeks to make sure they made contact and make sure they are okay. If they didn’t make contact we give them another referral and we may basically contact that referral while they are on the phone and get them an appointment. You have to lean in.”

A mental health crisis can happen to anyone—even to those who do not normally suffer from an ongoing mental health disorder.

“A significant portion of adults will go through some kind of mental health crisis at some point in life,” said Fish. “It’s not always permanent. Someone can have a panic attack without having a panic disorder, someone can go through a depressive period and not necessarily be clinically diagnosed with depression.”

Given the isolation prompted by a year of COVID-19 lockdowns, some individuals may be more likely to experience bouts of anxiety and depression.

“There’s a real opportunity for pharmacists to make the outreach, to just do a wellness check with folks and to normalize the mental health conversation,” said Fish.

Mental illness. National Institute of Mental Health. Updated January 2021. Accessed March 2, 2021. 

https://www.nimh.nih.gov/health/statistics/mental-illness.shtml#:~:text=Mental%20illnesses%20are%20common%20in,(51.5%20million%20in%202019)

Lebovitz L, Eddington ND. Trends in the pharmacist workforce and pharmacy education. 

Barrett M, Ward S, Colvard M. Pharmacist-led telemental health transitions of care clinic improves antidepressant medication continuity posthospitalization. 

 2020;10(6):381-384. doi:10.9740/mhc.2020.11.381

Becoming a psychiatric pharmacist. College of Psychiatric and Neurologic Pharmacists. Accessed March 19, 2021. https://cpnp.org/career/training

Mental health first aid. National Community Pharmacists Association.

 Accessed March 3, 2021. https://ncpa.org/mental-health-first-aid

Ballou JM, Chapman AR, Roark AM, Hule CH, McKee J, Marciniak MW. Conducting depression screenings in a community pharmacy: a pilot comparison of methods. 

More opportunities are emerging for pharmacists to fine-tune their patients’ regimens and serve as important access points for individuals experiencing mental health crises. 

Emerging Roles in Mental Health Care for Pharmacists

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.”

1. Dorbian I. CBD Market Could Reach $20 Billion By 2024, Says News Study. 

 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/

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.

Prepare to counsel patients on microbiome-related products.