Rebecca W. Chater, RPh, MPH, FAPhA

For decades, community pharmacists have been seeking new models of compensation for clinical services, especially as the training they receive has shifted towards a focus on patient care, and in-depth clinical decision-making. These readily available health care professionals have the potential to play a critical role in the care of the patients they see every month, but widespread change from a focus on dispensing has yet to occur.

The meticulous and time-intensive nature of dispensing a high volume of prescriptions every day takes too much of the pharmacist’s time, yet prescription volume remains the main revenue driver. Further, even if pharmacists had the time, their access to usable patient data is very limited, making it difficult to know which patients to focus on, or how to best care for them. Finally, and most critically, payers and health plans have been traditionally unwilling to pay pharmacists enough to make it a sound business decision for them to spend a significant amount of time caring for patients.

Overall payer hesitation appears unrelated to the need for proof of pharmacists’ value in managing chronic disease. In fact, this body of evidence has grown so large it is hard to refute.

 The main impediment is scalability—if payments for patient care services were implemented at scale, would pharmacists across the country collectively have the ability to change their day-to-day workflow, spend time with patients, and manage medications for populations the way they are trained? While it would be a disruptive change in the United States’ primary care delivery model, there exists enormous potential for pharmacists to mitigate the burden of chronic disease&mdash;the largest driver of morbidity, mortality, and cost in US health care (~96-99% of Medicare spending).

In recent years, there has been significant progress to improve the efficiency of dispensing activities through automation, theoretically giving pharmacists more time to perform clinical activities. The appointment-based model has gained traction as a way for pharmacies to transition their care process to a more proactive approach. There have also been significant grassroots efforts, such as the Community Pharmacy Enhanced Services Network (CPESN), to increase the level of service expected from a community pharmacy, particularly for independents and small chains. With these advancements, in a time where many pharmacies are desperately in search of new revenue channels, due to shrinking dispensing margins, perhaps pharmacies are willing to accept the risk of adopting a new care model in their practices.  

The emergence of a new Medicare Advantage plan, Troy Medicare, offers much needed momentum to drive pharmacists’ services. Troy’s model puts pharmacists in the driver’s seat of chronic care, namely by including per-member-per-month payments of $30-$50 to pharmacies that fill prescriptions and provide pharmacy services for their members. Troy will also provide technology that enables pharmacists to have a clear view into patients’ healthcare history, as well as interoperable communication of pharmacy care plans (eCare Plan) between healthcare settings. Through these solutions and a pharmacy-friendly reimbursement model that uses NADAC pricing, imposes no DIR fees, and provides flat dispensing fees, Troy hopes to increase transparency and support pharmacies as a business. More broadly, this model intends to leverage pharmacists’ expertise as chronic care managers in order to improve seniors’ outcomes and lower total cost of care.

As a first of its kind, Troy Medicare has emerged at an opportune time, offering financial flexibility that pharmacists and pharmacies have been seeking. Service-based revenue will enable more pharmacies to invest in needed technology, and become much more invested in care delivery. Pharmacists’ ability to regularly and meaningfully engage with patients to improve their care is not only more gratifying for pharmacists, it is a lower cost option for high quality chronic disease management.

Nonoptimized medications are an immense driver of avoidable cost in US health care (>$500 billion/year)

, and the pharmacist’s training, knowledge, and skill are precisely oriented to the management of complex medication regimens for patients with chronic disease, more so than any other health care professional, including physicians. Perhaps we are approaching pharmacy’s perfect storm—a convergence of factors that will serve as a catalyst for societal change in the way chronic medication management is delivered.

As outcomes-based payments, and quality measures continue to strongly influence provider reimbursement, community pharmacies positioned as integral members of the health care team will become indispensable. Troy’s model provides an ideal environment for this transition to reach critical mass.

By simply facilitating a model in which pharmacists can focus less on filling prescriptions, and more on filling their intended role, reimbursement models like Troy’s could be the force needed to pull the linchpin in pharmacy’s long-awaited disruption.

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Articles

The emergence of a new Medicare Advantage plan, Troy Medicare, offers much needed momentum to drive pharmacists’ services.

Payment for Pharmacists’ Care: Pulling the Linchpin

Over the past several years, medicinal cannabis has become a focus of research and legislation, specifically regarding cannabidiol (CBD) oils and other CBD products. CBD is one of the most popular types of cannabinoids, and has been shown to reduce inflammation, convulsions, anxiety, and nausea.

Chain pharmacies, including Walgreens and CVS, have decided to sell CBD products in their stores.

 The projected retail sales of CBD products are expected to reach $1.9 billion by 2020.

 Legislation regarding CBD products is evolving slowly, in attempt to catch up to this current movement.

CBD derived from any cannabis source was previously a Schedule I controlled substance; therefore, the current research of CBD was limited due to the Controlled Substances Act (CSA) formally making it illegal to cultivate, possess, sale, and distribute CBD. Under this law, researchers interested in studying CBD were required to register with the DEA and provide additional information, such as their qualifications, research protocol, and the institution where the research will take place.

The 2014 Farm Bill was subsequently signed into law, which differentiated industrial hemp from marijuana, and authorized industrial hemp research by institutions of higher education or departments of agriculture in states where hemp cultivation was legalized.

 Later, the 2018 Farm Bill removed hemp from the CSA, paving the way for the legal cultivation, possession, sale, and distribution of hemp, thus streamlining research on hemp-derivatives, including CBD, and speeding up the development of new drugs.

Hemp is regarded by the federal government as cannabis containing no more than 0.3% THC, which means that federally legal CBD, which must be derived from hemp or other lawful source, shall contain no more than 0.3% THC.

CBD, when derived from marijuana, or “all parts” of the cannabis plant, remains a Schedule I substance.

 The 2018 Farm Bill also explicitly preserved the FDA’s authority to regulate any products containing hemp-derivatives under the U.S. Federal Food, Drug, and Cosmetic Act  (FDCA). FDA has not approved the use of CBD as a dietary supplement or food additive.

Dr. Alex Capano, Chief Science Officer for Ananda, and a doctoral candidate focused on cannabinoid science, believes that CBD has many uses within the medical treatment realm. Among these include adjunctive therapy for patients on opioids to help them titrate down, pain management, and reducing withdrawal symptoms for narcotic users.

 Furthermore, Capano stated that a potential issue with CBD containing 0.3% THC or less includes drug testing for employers.

Some manufacturers are responding to the market demand by producing and marketing CBD that is THC-free. Even in this case, according to Capano, “there is still possibly an issue with drug testing due to CBD reactivity and false-positives. In addition, the THC-free CBD products are believed to have less therapeutic potential.”

With greater patient access to CBD, pharmacists will need to be prepared to address potential drug interactions to help patients use these products safely. The FDA has issued numerous warning letters instructing various manufacturers to halt production of OTC CBD products since 2016, due to significant discrepancies existing between the tested contents of products and strengths listed on the product labels. As some products were found to contain no trace of CBD compounds during quality testing, widespread mislabeling can easily occur in the absence of strict FDA enforcement.

Furthermore, according to Capano, there is no standard production method among CBD manufacturers, which can lead to impurities being introduced into products. Therefore, microbiological, pesticide, and heavy metal contamination can lead to harmful effects. These risks can be mitigated by patients obtaining CBD products from reliable sources, such as pharmacies that have vetted vendors as trusted CBD suppliers.

Regarding interactions, in vitro studies have illustrated multiple potential drug interactions for CBD. The lack of standardized products somewhat limits the ability to make definitive statements from available research, but there is evidence that CBD is an inhibitor of many CYP450 enzymes including 2D6, 3A4, and 3A5, as well as a potent p-glycoprotein (P-gp) inhibitor.

 Since these are common enzymes of drug metabolism, and with the widespread adoption of CBD oil use by chronic pain patients, there exists a high potential for drug-drug interactions and safety concerns.

Research also suggests CBD use enhances the effect of opiates, and exhibits other interactions with barbiturates, fluoxetine, sedatives, and antihistamines, as well as having synergistic effects with alcohol.

Community pharmacists are well-positioned to intervene clinically at the forefront of this health culture trend. While OTC products appear safe to many consumers, FDA warning letters to numerous manufacturers suggest otherwise.

Pharmacists are patient advocates to protect against adverse outcomes. They can assist with advising patients who present with quality concerns to use CBD products that provide certificates of analyses, and catch significant drug interactions before they occur. As such, it is important for pharmacists to stay abreast of ongoing research developments regarding CBD products. Staying current with emerging literature and evidence-based research on this topic is the best way for pharmacists to ensure they are continuing to provide the most competent and comprehensive care for their patients.

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DEA speeds up application process for research on schedule I drugs. DEA. https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs. Published January 18, 2018. Accessed June 12, 2019.

Sec. 7606 of the farm bill authorized hemp research and pilot programs. https://www.votehemp.com/laws-and-legislation/federal-legislation/sec-7606-of-the-farm-bill/. Accessed June 12, 2019.

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Pharmacists can assist with advising patients who present with quality concerns to use CBD products that provide certificates of analyses, and catch significant drug interactions before they occur.

Cannabidiol Products' Impact on Pharmacist-Provided Medication Management

Medication nonadherence is a major cause of morbidity, especially in elderly patients. Approximately 10% of hospitalizations may be a result of medication nonadherence.

It is not only an individual patient’s health problem, but also contributes up to $300 billion of avoidable healthcare costs in the United States (US) and up to 30% of wasteful spending.

By 2030, 20% of the US population will be aged 65 years or older.

 Patients over 60 years of age consume 50% of dispensed prescription drugs.

 As the population continues to age, chronic disease becomes more prevalent. This translates to an increase in the volume and complexity of medication regimens, increasing the risk for nonadherence. Other factors increasing the likelihood of nonadherence in the elderly include adverse drug reactions that come with polypharmacy, decreased visibility and motor dexterity, and decreased autonomy.

A study assessing the link between potentially inappropriate medicines and avoidable adverse drug events in patients 65 years or older found 68.9% of hospital admissions were avoidable or potentially avoidable due to inappropriate medications.

On average, older adults take 6-8 medications, typically due to multiple chronic diseases placing them at increased risk for polypharmacy. One in 5 older adults receives inappropriate medications, while 9% take 2 medications from the same drug class.

 Polypharmacy increases the risk of duplicate therapies, adverse drug reactions, drug-drug interactions, and geriatric 'syndromes,' such as urinary incontinence, falls/fractures, and cognitive impairment, all of which may contribute to and exacerbate poor medication adherence.

Pharmacy labels contain a lot of information, typically in a small font, making them difficult to read for elderly patients with visual impairment. Inability to read the labels and understand how to take their medications can lead to incorrect administration, adverse reactions, and ultimately poor adherence. Additionally, elderly patients may experience difficulty opening pill bottles, even non-childproof ones, due to reduced motor dexterity or chronic conditions like arthritis.

Aging patients may be limited in their ability to move, drive, and get to the pharmacy in time to pick up their refills. This can lead to delayed refills, resulting in nonadherence. Additionally, this may limit their ability to speak with a pharmacist regarding a medication-related problem they are having.

Implementing services in community pharmacies that are tailored to the needs of the older adult population is key to combating nonadherence. As one of the most accessible health care providers and medication experts, pharmacists can optimize a patient’s medication regimen in order to minimize polypharmacy and associated adverse drug reactions. Through medication therapy management (MTM), pharmacists can identify duplicate or unnecessary therapies. They can also identify drug-drug interactions and potential side effects, and advise patients on how to alleviate them. MTM provided by pharmacists significantly improves health outcomes, as shown in the recent STOMPP study of diabetes patients receiving MTM where A1C goals were achieved.

Community pharmacies can provide multimed blister packaging to facilitate medication organization and eliminate the need for pill bottles. This packaging uses symbols or colors to indicate the time of the day for each dose, which can help overcome the decreased visual ability that comes with age. Additionally, using blister packs can combat motor dexterity issues associated with opening vials. In the STOMPP study, patients who received multimed blister cards achieved adherence scores greater than 45% above baseline when compared to pill bottles.

A pharmacy with medication synchronization that follows the appointment-based model (ABM) is optimal for older adults with limited access to transportation and decreased autonomy. This system reduces frequent trips to the pharmacy, providing one monthly appointment, based on the patient’s preference, to pick up all medications and meet with the pharmacist. This increases convenience and coordination, improving adherence. In a recent study by Harvard Medical School, patients enrolled in a medication synchronization program had 9% lower rates of hospitalizations and emergency department visits compared to those not enrolled, likely due to the associated improved adherence.

Patient nonadherence to prescribed medications is associated with poor therapeutic outcomes, progression of disease, increased healthcare utilization, and an estimated burden of billions per year in avoidable direct healthcare costs. Medication nonadherence is especially common in older adults. Pharmacies can help overcome this public health concern by providing MTM, multimed packaging, medication synchronization, and utilizing the ABM.

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Medication nonadherence is a major cause of morbidity, especially in elderly patients.

Medication Nonadherence in Older Adults: Patient Engagement Solutions and Pharmacist Impact

Amazon recently announced its entry into pharmacy through the acquisition of PillPack, a service that delivers medications, presorted in adherence packaging, to a patient’s home. The announcement has the pharmacy profession and the pharmaceutical industry debating several questions around the deal’s impact on local pharmacies and the role of the pharmacist in this process. At last estimate, the burden of nonadherence on our healthcare system exceeded $300 billion in direct and indirect costs, with approximately 50% of patients not taking their medications as prescribed, indicating a clear opportunity to mitigate related barriers to improved adherence.

While convenient access to medications certainly aids adherence, and could be facilitated by the PillPack acquisition, the deal stands to disrupt direct pharmacist-to-patient contact and the essential role of the community-based pharmacist within the healthcare continuum. Convenience of medication delivery is not a panacea for resolution of nonadherence and falls woefully short in addressing other critical aspects of addressing medication-related problems including unanticipated medication interactions, gaps in care, cost challenges, lack of patient education, lifestyle incompatibilities, and others.

Rather than focusing on the PillPack acquisition by Amazon as a threat, pharmacists should consider this as an opportunity to reassess the value that they bring—the existing patient care services, tools, and technology that equip them to deliver patient-centric, personalized care. Whether employing data analytics to more efficiently identify needed interventions, adherence packaging, or medication therapy management, pharmacies can enhance their service offerings to differentiate their practices and keep patients at the center of care.

Pharmacists have long differentiated themselves with patients by stepping up to help with the confusion around managing multiple medications, and monitoring health issues. By using technology to streamline patient communications, and offering adherence tools, such as 

, that can be customized to each patient, pharmacists can ensure they are not edged out by the online retailer.

This is especially true when patients experience care transitions. From one care setting to the next, they need the pharmacist as a local resource to help ensure smooth transition, and guide them on their path to better health outcomes. Research has shown that pharmacists are specially qualified to fulfill this role, helping to address concerns, and reduce medication errors that might not always be evident. The one-size-fits-all approach that Amazon is developing circumvents the role of the local pharmacist, and is not designed to meet the individualized needs of patients with unique health concerns.

Enhancing Pharmacy Care for Better Results

As our nation’s most accessible healthcare professionals, pharmacists serve as touchstones of care in communities all across the country, offering patient-centered, personalized, and coordinated care. Emerging data-driven solutions provide pharmacists with tools they need to increase their value through targeted clinical engagement, enabling them to further improve health outcomes, reduce healthcare costs, while offering a level of patient convenience that rivals Amazon-PillPack.

Centralized, actionable data specific to managing patient engagement is essential to improving care while reducing costs across the care continuum. For this reason, healthcare needs a system that not only provides convenience related to medication access—as this Amazon acquisition aims to do&mdash;but also keeps the pharmacist regularly connected to the patient to evaluate medication-related health needs on an ongoing basis, communicating as needed with patient and prescriber regarding medication adherence, potential medication changes or dosage adjustments, side effects, drug interactions, needed vaccinations, and more.

The coming months will reveal changes that result from the Amazon-PillPack deal. In the meantime, pharmacists should take this as an opportunity to amplify their value to further differentiate their practices, ensuring that their role will not be diminished by this new venture. By staying connected to their patients and implementing tools that help to expand their service offerings and improve patient care, today’s pharmacists will reinforce their own essential role in the care continuum, now and in the future.

While convenient access to medications certainly aids adherence, and could be facilitated by the Amazon's recent acquisition of PillPack, the deal stands to disrupt direct pharmacist-to-patient contact, and the essential role of the community-based pharmacist within the healthcare continuum.