	It is not news that the specialty pharmaceutical market is growing at a rapid pace. Spending continues to shift from traditional to specialty medications and utilization of specialty drugs to treat patients with complex conditions in the areas of oncology, rheumatology, and endocrinology is rapidly increasing. According to the National Center for Biotechnology Information, specialty drugs account for 67% of the total drug spend—and that number continues to rise.

	What is new is that specialty pharmacies and health care providers now have to figure out how to operate within the value-based care (VBC) environment. VBC programs, such as the oncology care model (OCM), are focused on improving access to care, driving better outcomes, and appropriate spending. VBC programs measure value by focusing on improving quality, as defined by achieving better outcomes, improving patient satisfaction, and lowering costs by decreasing the total cost of care and avoidable medical spending.

	Speaking on this topic at the recent National Association of Specialty Pharmacy Annual Meeting and Educational Conference, I realized that there is a great deal of uncertainty regarding the impact of VBC. This article will focus on what you need to know about starting a specialty pharmacy or refining your existing operations to be competitive in this evolving environment.

	The shift to value-based reimbursement models will have a significant impact on nearly all stakeholders. For patients, it means safe, appropriate, and effective care with enduring results at a reasonable cost. Providers must employ&ensp;»  evidence-based medicine as well as proven treatments and techniques that take into account patient wishes and preferences. Manufacturers will succeed by moving beyond simply marketing an effective drug and focusing on cost-effective outcomes.

	Within this environment, there is great opportunity for specialty pharmacies to help support this new payer transformation. Specialty pharmacies have the clinical knowledge and expertise in access and patient support that can help practices deliver on the promise of value. If you are looking to open your own specialty pharmacy to take advantage of this opportunity, there are a number of requirements you need to consider, including:

	With the tremendous growth of specialty drugs over the past several years, there are clear revenue opportunities for a competitive specialty pharmacy that can prove value to patients and providers. Because this is a high-reward, high-risk business venture, the best way to mitigate that risk is through the development of a comprehensive business plan, evaluating your ability to capture market share and generating recurring revenue.

	In economics, the minimum efficient scale is the lowest amount of production a company can achieve to minimize long-term total average costs while still taking full advantage of economies of scale. In terms of starting or operating a specialty pharmacy, what level of efficiency is required to achieve the scale needed to offset the ongoing depression of reimbursement? What capital investment is needed to reach and maintain that scale and support the delivery of enhanced patient services?

	Unlike a traditional retail pharmacy, the potential volume for a specialty pharmacy is less about location than it is about venue. Can you meet scale with a contract with a single large oncology group or health system? Would the business be big enough to support your minimum volume or do you need to work with multiple health systems? Do you need to work with 10, 25, or 50 health systems to aggregate enough volume?

	The choice of therapeutic focus areas is also important in terms of defining your market. Can you meet volume by trying to capture a percentage of business across many therapeutic areas or is it better to focus on oncology in general or even a few specific disease states? Once you build your financial case, then you can focus on how to showcase your clinical expertise and ability to improve patient care.

	With the complexity of specialty pharmaceuticals, patient onboarding, prior authorizations, and other administrative tasks are important to ensure patients have timely access to needed treatments and the practice is paid properly. However, these tasks are a significant burden for oncology practices. This is a competitive advantage for specialty pharmacy partners that can provide comprehensive practice management resources that help practices run more efficiently. This is about showcasing your expertise and being able to do it with scale and efficiency.

	When we look at the level of care coordination and the flow of data required to process a referral, you can begin to see that the specialty pharmacy workflow is much more than prescription fulfillment (

). Specialty pharmacy dispensers require heavy interaction with patients, providers, manufacturers, and payers paired with the knowledge and resources to navigate patient access.

	Community practices want a specialty pharmacy partner with extensive therapeutic expertise and experience in oncology that will support their treatment plans and alleviate their administrative burden so they can focus on treating patients. They want a pharmacy provider with the skill, expertise, and resources to understand and help manage the clinical, financial, and emotional complexities associated with cancer treatment.

	Gaining access to treatment is just the first step. Ongoing education and patient-centric support is critical to maintain adherence and improve patient outcomes. Practices must own the primary responsibility for patient care; however, specialty pharmacies can help manage clinical complexities, such as educating patients on how to properly take their medications, controlling adverse effects, helping patients deal with late-stage therapies, and other intricacies that affect this niche patient population (

	Several of the enhanced care requirements are historical core services that specialty pharmacies provide today. Financial counseling, symptom management, and increased surveillance through behavioral-trained contact center agents are things that specialty pharmacies do well today. Specialty pharmacy partnerships can help oncology practices effectively and efficiently manage critical patient needs with a high-touch, high-care multidisciplinary operating model.

Value-Based Care and Quality Data Reporting

	The Center for Medicare and Medicaid Innovation’s OCM is an alternative payment model designed to test whether specific changes in cancer care delivery can result in “better care, smarter spending, and healthier people.” Practices that participate in the OCM are now required to provide care with a focus on outcomes and affordability.

	Although these new requirements are expected to help improve access and patient care, implementing them is a challenge for community practices not used to tracking and reporting quality data. This provides a great opportunity for specialty pharmacies to help practices meet many of these new quality and reporting requirements.

	The ability to capture, track, and report accurate and timely data is very valuable to oncology practices as more payers base payments on outcomes. With the increasing need to describe the patient experience, specialty pharmacies provide critical data on important factors such as adverse events, patient-reported outcomes, compliance measures, and patient durability. These data not only translate into actionable insight to improve operational and clinical efficiencies that support high-quality care, but they also provide critical visibility for billing and reimbursement.

	While the ownership and arbitration of the data and analysis of value-based contract metrics is up for debate, specialty pharmacy is well suited for that role, given its interaction with multiple payers and pharmacologic expertise that helps reduce medication abandonment and improve adherence.

	Specialty pharmacies have the expertise in reimbursement, access, and patient support that provides value to both patients and practices. As the industry continues to shift toward value-based care payment models, there is tremendous opportunity for specialty pharmacies to succeed and grow. Optimize your success through careful business planning and implementation of patient-centric clinical services and capabilities that help practices deliver cost-effective care and improved outcomes.

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Within the evolving value-based care environment, there is great opportunity for specialty pharmacies to help support this new payer transformation.

Value-Based Care Requires Specialty Pharmacy Scale With Broad Capabilities to Deliver Enhanced Patient Services

	The transformative health care events of the past year were incredibly diverse, as 2017 was truly a year of firsts. These significant changes include the first medicine approved with a digital ingestion tracking system, creating an exciting new possibility for the management of drug adherence. The first chimeric antigen receptor T-cell therapies entered the market, too, bringing great promise for improved outcomes for patients with cancer. The precision medicine movement continued with the first approval of a cancer drug based on the presence of a gene mutation, irrespective of the origin of the tumor within the body, which creates new implications for how cancers will be diagnosed and treated in the future. 

	At the same time, the industry continued to wrestle with such challenging issues as rising drug costs, value-based reimbursement, the growing opioid crisis, and strategies for bringing medical advances to the market faster. This article will delve into how these trends will evolve in the immediate future, as well as what new developments will have the biggest impact on the specialty industry.

	Although quality payment programs, such as a merit-based incentive payment system (MIPS) and alternative payment models (APMs), technically started several years ago, 2018 may be the year when these programs start to have a tangible impact on patient care. For the nearly 200 oncology practices participating in the oncology care model (the largest APM model in the industry), this is the year in which provider incentives change from a reward for participation and reporting to having a portion of their payments at risk based on how their performance compares with that of other practices. As a result, poorly performing practices are likely to take steps to lower their costs. One of the key ways in which they can impact costs involves changing their prescribing behavior. Tracking prescribing trends in oncology over the next few years will be telling. Will physicians shift toward prescribing lower-priced products to achieve cost savings? Or will the influx of innovative new therapies lead providers to choose higher-cost treatments with an expectation of improved patient outcomes?

	Another trend to watch is how independent physician practices will respond to growing pressures associated with quality payment programs. Although the Trump administration has taken some steps to soften the impact of MIPS by exempting low-volume Medicare practices from the system, this change has had a minimal impact on specialty physicians, such as oncologists with predominantly older patients. 

	For those who have no option but to participate in CMS quality payment programs, research conducted by Cardinal Health Specialty Solutions in 2017 shows that 27% of oncologists are unsure of the steps they need to take to comply with the Medicare Access and CHIP Reauthorization Act. With the penalty phase for MIPS beginning in 2019, it is likely that more independent specialty physicians, particularly those 65 years and older, may take steps to sell or merge their practices rather than make the changes necessary to operate under a value-based reimbursement model.

	Last year saw the most new drug approvals in 21 years. It also marked a watershed year for cellular and genomic therapies, which reflect the movement toward precision medicine. In addition to the approvals discussed above, the FDA approved targeted drugs for acute myeloid leukemia and bladder, ovarian, and lung cancers.

	Gene therapies, in which the patient’s cells are removed, genetically reengineered, and then returned to their bodies, has emerged from the pages of science fiction to become science fact. Today, there are more than 7000 inheritable genetic disorders. Treatment for many of these diseases may dramatically improve in the coming years as a result of precision medicine research. Luxturna (voretigene neparvovec-rzyl), a gene therapy for a rare form of blindness, is the first treatment approved for an inherited disease, but many more are in the pipeline. We will likely see cures for debilitating inherited diseases, such as sickle cell anemia and hemophilia, over the next few years. 

	Although these innovative therapies are delivering hope for patients and health care providers, they also are bringing complex challenges. Most of these products will be very expensive and stakeholders will undoubtedly engage in an intense debate regarding how to calculate their value, which patients should receive them, and how to pay for them. We will likely see new payment models emerge in which payments for drugs are stretched out over several years, as well as increased use of rebates if patients fail to meet certain therapeutic thresholds. 

	Another implication of the precision drug movement is increased specialization. As we shift from an era in which 10 drugs treated 100 diseases to an era in which there are 100 drugs to treat 10 diseases, the management of care will become far more complicated. Providers will inevitably need to rely on tools when making care decisions. This is where we may see the growing use of artificial intelligence (AI) in practices. Providers will feed clinical, demographic, and genetic testing data into an AI program, which will then provide a recommended treatment plan. Increased specialization may also change the role of allied health professionals, such as pharmacists, who may take on greater responsibilities for managing patient care and prescribing.

	At the end of 2017, 9 biosimilars had been approved in the United States and dozens more were in the late-stage pipeline. More biosimilars are anticipated to be approved in 2018, and access will improve as some of the products that were approved last year reach the supply chain. Although research shows that specialty physicians are open to prescribing biosimilars in place of their reference biologics, there is also an expectation that biosimilars will deliver significant cost savings. In a research study of oncologists conducted by Cardinal Health, 66% of physicians said it was extremely or very important to save costs when prescribing biosimilars. However, the cost difference between biosimilars and reference drugs is less than 20% today, and several of the reference brands are aggressively defending their position in the market through negotiated rebates. Therefore, providers and payers are not seeing the desired savings yet.

	In the year ahead, we will likely see prescribers “testing the waters” when it comes to biosimilars, rather than a dramatic pendulum shift. Our research further suggests that physicians are likely to prescribe biosimilars for some of their patients’ newly diagnosed disease states but may not move existing patients off of reference brands in the near term. At the same time, legal battles between biosimilar and reference brands are likely to continue. Biosimilar players may become more aggressive in negotiating with payers and reaching out directly to providers and patients to share their value proposition. For specialty pharmacies and hub service providers, greater adoption of biosimilars may lead to broader opportunities to deliver patient support services, while biosimilar manufacturers look to put themselves on par with reference brands. 

	When the 21st Century Cures Act was passed in December 2016, it called for the increased use of real-world evidence (RWE) to help speed FDA approval of certain drugs and medical devices. FDA Commissioner Scott Gottlieb, MD, reinforced that point in 2017, when he announced that the agency would allow drug developers to use RWE to support new uses of approved drugs under a forthcoming policy. Dr. Gottlieb said that RWE will ultimately help achieve better outcomes and safer, more efficient use of technology. The use of RWE has been quietly gaining steam over the past few years, but now with prominent support from officials such as Dr. Gottlieb, there is growing momentum to adopt RWE more broadly into both clinical development and postapproval commercialization efforts.

	Up to this time, one of the barriers to wider use of RWE has been that most real-world studies were sponsored by pharmaceutical manufacturers. Although not inherently bad, this has led to a somewhat limited perspective. Payers have historically not sponsored RWE studies, which is perplexing given they have a vested interest in understanding how drug therapies compare in terms of both economic and clinical outcomes. This paradigm may begin to shift now that RWE has been endorsed by Dr. Gottlieb and other policy leaders. As a result, we may see broader sponsorship of RWE studies among various health care stakeholders, as well as wider use of these data in everything from phase 4 studies to reimbursement strategies and marketing campaigns.

	For years, the industry has been buzzing about the concept of patient centricity, but 2018 might be the year that the patient truly becomes the center of care. Signs of this trend are everywhere. Physicians who are participating in value-based reimbursement programs are finding that a portion of their payment will be based on the patient experience. Hospital systems, which are increasingly competing for patients in complex specialty areas, such as oncology and neurology, are investing in improving the patient experience in the hopes of becoming a treatment center of choice. Pharma manufacturers are delivering more robust patient support services, including treatment education programs, on-call nurses who can counsel patients about adverse effects, financial assistance programs, and psychosocial support programs, to help ease the burdens of managing a chronic disease. 

	We’ve also seen a call for increased use of patient-reported outcomes data in clinical research, a sign that patients’ experiences of using a drug may soon be given as much consideration as efficacy and safety data. Adherence and patient education programs delivered by specialty pharmacies and hub service providers are also expanding as a result of a growing acceptance of the role that education and support services play in helping to drive cost efficiencies and better outcomes.

	This is an exciting time for those who have a role in the specialty health care industry, whether they be physicians, pharmacists, payers, drug manufacturers, policy makers, or patients. Scientific breakthroughs are delivering advancements in specialty treatment that might have seemed like science fiction just a decade ago. Along with these new possibilities, the industry is facing more confounding challenges around costs, reimbursement, and quality of care. Collaboration and communication among stakeholders are desperately needed to ensure that innovative therapies are made available to the patients who can benefit from them.

Current developments and innovations that will shape the future of specialty pharmacy.

Trends That Will Affect Specialty Health Care Into the FutureÂ 

	In a recent survey of hospital pharmacy executives, 78% of respondents answered yes when asked, “Are you aware the federal DEA agency has created a task force seeking to identify diversion fraud in hospitals today…and there are penalties in the millions of dollars as well as prison sentences for potential violators?” Additionally, 56% said yes when asked, “Would knowing about the DEA Drug Diversion Task Force affect your opinion about the importance of analytics to identify diversion in your system?”

	The Drug Enforcement Administration’s (DEA) Diversion Control Division web page (deadiversion.usdoj.gov/) states that challenges related to drug abuse stem from legitimately made controlled substances that are diverted via illicit drug traffic. The mission statement further notes that this division of the DEA seeks “to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.”

	This description likely calls to mind what the media and medical community are now referring to as the opioid crisis in the United States. According to the National Institutes of Health, more than 90 Americans die from opioid overdose every day. The CDC estimates that the economic burden associated with the opioid epidemic, including the cost of care, addiction treatment, and involvement in the criminal justice system, totals $78.5 billion per year.

	Unfortunately for stakeholders, the focus on pain medications is only part of the problem because expensive specialty drugs are a growing concern that is traditionally overlooked in drug diversion efforts.

	Specialty drugs are often used to treat conditions such as cancer, HIV, hemophilia, and multiple sclerosis. Because these are chronic conditions, drug therapies are often required for the duration of a patient’s life and are commonly more expensive than other medications. According to a report from IMS Health, specialty drug spending grew more than 15% from 2014 to 2015, contributing $150.8 billion to total US drug spending in 2015.

	Drug diversion in hospitals occurs in many forms, some intentional and some accidental. It can often be a case of medications not being tracked or followed correctly or completely along the journey of care. With the increasing use of specialty drugs across disease indications, hospital leaders must develop solid protocols for these medications, just as they do for narcotics.

	Looking at the standard operating procedures and challenges around maintaining records and preventing drug diversion with opioids and narcotics gives us a good idea of what the obstacles will be in terms of managing specialty drugs. It’s common enough to track inventory. What’s more complicated is comparing purchasing data to the actual use of the medication. Optimally, we also want to track which physicians prescribe which medications the most often as well as dosage, disease indications, and whether the amount purchased matches what is received. It’s these types of gaps in data, along with how the data are managed and tracked, that leave a health system open to drug diversion risks.

Checks and Balances: Using Analytics to Stay on Track

	As hospitals and health systems contemplate which protocols need to be in place to mitigate the risk of drug diversion and maintain accurate records on their specialty medications, several angles should be considered.

	First, it’s vital to identify the right personnel. Who is involved with mitigating drug diversion largely depends on the size of the organization and the resources available. Ideally, staff members from different departments should be involved in data tracking, logging, analysis, etc, with an eye out for drug diversion. This should include team members from the pharmacy department, both pharmacists and technicians, as well as risk or compliance representatives within the hospital system but outside the pharmacy. It’s about covering all bases. The more people included in this process, the less likely that any single person is able to intentionally manipulate the system or make an inadvertent data tracking or processing error.

	Next, drug storage and utilization protocols should be reviewed. It’s likely that most hospitals have a strong system already in place based on their experience with handling narcotics. Hospital leaders should evaluate where they keep high-cost specialty drugs and how they manage and track usage on a daily, monthly, quarterly, and annual basis.

	Overall, a successful drug diversion mitigation strategy is all about having checks and balances in place—different people on different levels responsible for various parts of the puzzle. A solid compliance solution coupled with robust analytics tools is necessary to effectively identify and manage drug diversion activity within an organization. Many issues must be considered, such as: 

		Can your system follow a high-cost drug from purchase to the patient?

		Are your processes manual or electronic?

		Do you have access to a longitudinal patient database, to compare costs and utilization patterns, that includes National Drug Code data and prescribing information?

		Can you efficiently sift through your data to look for patterns and outliers?

		Will your system spot a potential drug diversion problem before it spirals or will you only know about the issue once it is too late?

	The risk that hospitals run in not having a strong strategic plan in place for drug diversion is high. These risks include compromising patient safety, developing a negative reputation that can hurt business in the long term, lost revenue in high-cost narcotics, specialty drugs that do not make it to the patients who need them, and legal and financial fallout should the DEA become involved. 

	Profit margins for hospitals across the country are already thin and continue to diminish, particularly in rural areas where prescription drug abuse is especially high. A report from the Chartis Center for Rural Health notes that 80 rural hospitals across the United States have closed since 2010 and many are struggling to remain open, with 41% of rural hospitals operating at a negative margin.

	It’s possible that the financial picture could get worse before it gets better, according to another report from the American Society of Hospital Pharmacists (ASHP). For the report, the ASHP surveyed 165 experts in multiple areas of pharmacy practice, including chief pharmacy officers and directors of pharmacy from teaching hospitals, nonteaching hospitals, and academia. These experts work in multiple settings, including home health care, specialty pharmacy, and ambulatory, pediatric, and hospice care. 

	In the ASHP survey, 61% of respondents said they felt it was “very likely” or “somewhat likely” that the annual number of hospital and health-system bankruptcies will increase by at least 25% over the next 5 years. In response to this prediction, the ASHP report recommended that health systems “be prepared for significant reductions in revenue by ensuring good stewardship of your organization’s financial resources,” focusing on areas that include “optimal inventory management.”

	With reports and projections such as these, drug diversion is a risk the industry simply cannot afford to take. What’s your strategy?

https://www.sentryds.com/more-than-half-of-hospital-executives-recognize-analytics-as-crucial-to-mitigating-drug-diversion-risks/

https://www.deadiversion.usdoj.gov/prog_dscrpt/

https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

https://morningconsult.com/wp-content/uploads/2016/04/IMS-Institute-US-Drug-Spending-2015.pdf

https://www.chartisforum.com/wp-content/uploads/2017/05/The-Rural-Relevance-Study_2017.pdf

http://www.vshp.org/uploads/6/3/6/0/6360223/williams-forecast_1_per_page.pdf

Expensive specialty drugs are a growing concern that are traditionally overlooked in drug diversion efforts.

Mitigating Drug Diversion Risk: More Than Just Narcotics, Specialty Needs to Look at This Growing Problem

	Upon successfully earning an RPh or a PharmD degree, many newly minted pharmacists likely exhale deeply, with the belief that the education requirements for a successful career have finally been satisfied. Most students believe that becoming a licensed pharmacist will distinguish them from the pack—allowing them to select their career path at will after paying their dues in an entry-level role. However, several years of practice in a traditional setting can foster malcontent even in the most dedicated pharmacist and may not provide advancement opportunities as anticipated. 

	Although there is no correct answer to address this dissatisfaction, many pharmacists who find themselves in this predicament see value in further professional differentiation. However, even after deciding to seek additional credentials, navigating the maze of options and the value they add is nothing short of overwhelming. Because the myriad choices yield distinctly different opportunities, each individual should evaluate every path before pursuing the best match for their goals. 

	The section header is slightly misleading, as the various certificate programs are far from a walk in the park, but the Jackson 5 declined to record any iconic tunes about challenging yet obtainable goals. Although not intellectually easy, obtaining a certification has distinct advantages over other more labor-intensive means of differentiation. The crux of obtaining a certificate hinges on successfully completing an exam that bestows the sought-after credentials upon the candidate. 

	Rather than rejoining the ranks of collegiate students, pursuing a certificate program allows for self-study at the discretion of the candidate. Additionally, the examination fees are generally less than $1000 compared with tens of thousands of dollars for tuition. The credentials obtained are certainly less impactful than an additional degree, but the flexibility afforded by the process can certainly justify the effort expended by the certificate holder. A brief discussion of certifications that can be valuable to a specialty pharmacist is found below.&ensp;»

	A division of the American Pharmacists Association, BPS offers certifications in 

 of pharmacy practice. Eligibility requirements vary from exam to exam, each of which is designed to assure adequate experience to maintain quality applicants. Although any of these certifications would be beneficial for a pharmacist, the Board Certified Oncology Pharmacist (BCOP) best aligns with the specialty pharmacy space. 

, candidates must meet the baseline eligibility requirements. In addition to graduating from an accredited pharmacy school and maintaining an active pharmacist license, experience as an oncology pharmacist must be documented. This requirement can be satisfied by:

		Completion of 4 years of practice experience (postpharmacist licensure), with at least 50% of time spent in oncology pharmacy activities.

		Completion of a postgraduate year 1 residency plus 2 additional years of practice (postpharmacist licensure) with at least 50% of time spent in oncology pharmacy activities.

		Completion of a specialty post-graduate year 2 residency in oncology pharmacy.1

	Once these requirements have been satisfied, an examination covering content from 4 domains—patient management and therapeutics, research and education, practice administration and development, public health and advocacy&mdash;must be completed with a passing grade.

	This path is far from easy, but it can distinguish a successful applicant in their career path. According to the 2015 BPS Annual Report, only 1990 pharmacists actively hold BCOP certification.

	More specific to the specialty space, the Specialty Pharmacy Certification Board (SPCB) offers the CSP designation to help distinguish more seasoned practitioners. In addition to a pharmacy degree and an active license, individuals wishing to achieve the CSP designation must complete 30 hours of specialty continuing education and log at least 3000 hours of specialty pharmacy practice.3 Once these requirements are satisfied, the candidate must successfully complete a comprehensive exam.

 containing information that outlines all facets of the qualification and examination process. As a newer certification, the CSP designation is currently held by only 168 pharmacists.4 Such finite numbers, in conjunction with payers investigating whether to require a specialty pharmacy provider to employ a CSP, suggest that obtaining this certification could serve as a differentiating characteristic for a specialty pharmacist.

School’s Out for Summer, School’s [Not] Out Forever

	For the pharmacist seeking a more dynamic change to their career path, a degree in any of several complementary disciplines may be the answer. It would not be feasible to provide an in-depth discussion of the multitude of options, including research, public health, law, information systems, and data analytics, among countless others. However, the veritable explosion and proliferation of the specialty channel has created a climate rife with opportunities for the business-minded pharmacist.

	Although success in the business world can come without any additional formal education—CVS CEO Larry Merlo has led the company to uncharted prosperity without a formal business degree&mdash;obtaining a master of business administration degree (MBA) can distinguish a pharmacist from their counterparts who lack similar credentials. However, not all MBA programs are created equally, and evaluating the merits of the multitude of options is an arduous undertaking. Below is a high-level overview of some of the options discussed in brief.

	For pharmacists working full time, an online program appears to offer the best opportunity, at first glance. A program delivered via the internet provides students with the flexibility to learn at their discretion and develop an understanding of marketing, finance, and accounting—the cornerstones of any MBA program; however, the flexibility provided is a double-edged sword. Although online programs alleviate some of the time demand compared with a traditional program, the advantage comes at the sacrifice of countless networking opportunities with fellow classmates and instructors.

	The adage that suggests whom you know is more important than what you know is somewhat true in the business world. The ability to increase your professional network, as well as nurture the ability to interact with that network, is as much a part of the curriculum of a traditional MBA program as finance or marketing. Indeed, knowledge of the basics of accounting are critical, but the ability to function on a multidisciplinary team is paramount to functioning in a business role.

	Understanding the challenges facing a student working full-time, many business schools offer a litany of choices regarding the speed of the program. From full-time programs to part-time programs that take several years to complete, a traditional MBA is obtainable under myriad, distinct conditions.

	Although both online and traditional MBAs provide training and insight into the business world at-large, a specialized MBA may be considered the best option to the pharmacist striving to influence the business of pharmacy.

	The master of science in pharmacy business administration (MSPBA), offered for the first time at the University of Pittsburgh in 2016, is a novel option that provides guidance into the unique dynamics of the pharmaceutical industry. A hybrid degree from the School of Pharmacy and Joseph M. Katz Graduate School of Business, the 12-month program is the first of its kind nationwide. 

	In the interest of transparency, I will break the fourth wall and acknowledge my participation in the inaugural MSPBA cohort. Although I lack any experience with other MBA programs, I confidently champion my experience in the MSPBA program. My pursuit of this degree has exceeded my wildest expectations regarding the acquisition of knowledge, expansion of my professional network, and access to opportunities for career advancement.

[Trying to Avoid Being Just] Another Brick in the Wall

	Regardless of the path, pursuing additional certifications and education can position a pharmacist to advance beyond a traditional role. Pharmacists tend to be dedicated, hardworking, caring, and trustworthy. These traits, among many others, enable most pharmacists to provide a high level of care to their patients. Although the role of a bench pharmacist is more than satisfactory to a great number of practitioners, many find themselves seeking more: more opportunities, more diversity, more challenges. 

	For those who find themselves questioning their career trajectory, certification and additional education may help to answer that question. Pharmacists can distinguish themselves and advance to leadership positions that wield greater influence on decisions that affect greater numbers of patients. In this way, these ambitious persons will act as stewards for patient care—which will always be the epicenter of pharmacy services.

http://www.bpsweb.org/bps-specialties/oncology-pharmacy/

http://board-of-pharmacy-specialties.epaperflip.com/v/2015-Annual-Report#?page=16

http://www.spcboard.org/certification/eligibility-requirements/

http://www.spcboard.org/news-resources/frequently-asked-questions/

Navigating the maze of professional pharmacy credentialing options and the value they add is nothing short of overwhelming.

We Donâ€™t Need No Education: Postâ€“Pharmacy School OptionsÂ 

	The practice of specialty pharmacy is among the most high-touch processes in the outpatient pharmacy space. Efficient patient care coordination is necessary to ensure a continuous prescription journey, from concept to administration. However, lost within the fast-paced specialty pharmacy environment are updates to pharmacy software systems that can accommodate the ever-growing needs of patients. 

	Although some tools are found in bits and pieces among available prescription processing software, an all-encompassing suite remains elusive. These features should match or exceed standards set by accrediting bodies, such as URAC and the Accreditation Commission for Health Care (ACHC). 

	Below are some challenges that need to be addressed to improve patient management and overall prescription processing efficiency, along with potential solutions for how to accomplish this:

Lack of technologic solutions to overcome gaps in therapy

	The high-touch nature of specialty medication prescription management yields a greater risk of human error, a risk that may lead to unwarranted gaps in therapy. As such, many specialty pharmacies look for creative technological approaches to patient management; however, they often utilize expensive, clunky software systems, or even Microsoft Office products, to track patients. Thus, without the ability to develop proprietary software, pharmacists and care coordinators alike are left longing for some sort of task-generating automated program that can direct focus toward the journey of the prescription and away from time-consuming ancillary processes. If thought is taken out of certain challenges, such as the ones listed below, both pharmacists and care coordinators can alleviate the worry of missing a step in the process and focus more on patient care.

	Examples of processes that could be beneficial to automate would be:

		Prescription refill calls to patients, in which priority is assigned to care coordinators by chronology and driven by days’ supply remaining

		Assignment of prior authorization follow-up calls with the provider’s office

		Assignment of patient follow-up calls if demographic or insurance information is missing

		Automated faxes resent to end user if clinical or demographic information is missing

		Automated status updates faxed or securely e-mailed to the prescriber to notify of changes in prescription status

Difficulty tailoring patient experience based on disease state

	A lack of automation couples with an inability to monitor patients without assistance from external software and personnel involvement. Specialty patients are named as such not just because the medications are expensive and should be handled carefully but because each disease state is complex and requires a unique approach to patient monitoring. To offer a truly tailored experience to patients, software companies should enable customizable patient tracks. This would allow clinical staff to develop monitoring and follow-up checkpoints for both the patient and the prescriber, organized by disease state.

	As such, once a patient is entered into a disease state track, the pharmacy software system should be able to utilize some of the task-centric automation concepts listed above to carry the patient along the disease state track timeline. Monitoring parameters, refill calls, outcome monitoring, etc, should be generated as scripted tasks that, upon completion by the pharmacist or care coordinator, move the patient along to the next phase of the monitoring timeline. 

	Therefore, at any point in time, a patient may be assessed by their place in the monitoring timeline, and all information should be readily available for review in a concise summary. Additionally, both negative and positive patient outcomes of drug therapy and disease state management could be recorded within each track and addressed appropriately. The ability to perform a snapshot view of each patient poses a potential benefit for prescribers who show interest in cultivating strong care coordination with the pharmacy. 

The need to utilize several platforms to maintain the status quo with prescription management

	A common theme in most specialty pharmacies is the use of multiple platforms to support an appropriate level of patient management, more so to maintain the path of the prescription itself. This involves using a combination of prescription processing software, an external patient management application, and shared documents with manual dictation of prescription status. 

	In a setting such as this, the risk for human error is high and accountability is low. Pharmacies seeking strong quality assurance programs that match expectations for URAC and ACHC accreditation must ensure their employees maintain a high level of awareness when traversing patient management platforms. Missing information could be damning, not only for pharmacy relationships with provider offices but also for the patient.

	Without the ability to utilize some of the above solutions in unison, specialty pharmacies must ensure staff are properly trained at a high level. These ideas are not meant to replace human involvement, but to divert attention away from extraneous and unnecessary tasks toward an approach more focused on patient care. Although there are prescription processing platforms available today that contain some of the ideas discussed in this article, there will likely be a continued push to include this level of attention to the prescription process. Time-wasting procedures are costly. 

	With wasted employee effort, poor reimbursement for independent specialty pharmacies, and the daunting possibility of retroactive direct and indirect remuneration fees, pharmacies should embrace any technological efficiencies available to advance the capability of patient care.

Lost within the fast-paced specialty pharmacy environment are updates to pharmacy software systems that can accommodate the ever-growing needs of patients.

Current Tech Hurdles in Specialty Pharmacy Lead to a Decrease in Effective Care

	Hemophilia is a genetic bleeding disorder caused by a deficiency or absence of a clotting factor protein. Treatment is often an infusion of the missing clotting protein (factor). Considerable clinical evidence has shown that prophylaxis treatment (replacement of clotting factor) from an early age prevents bleeding, allowing those living with hemophilia to lead a fuller life with minimal restrictions. Yet, despite medical recommendations, many patients do not consistently remain adherent to their prophylactic schedule.

	Lack of adherence isn’t limited to maintaining a prophylaxis regimen; it also extends to appropriate treatment recording keeping. As stated in Managing Hemophilia: The Role of Mobile Technology, “Good record keeping is an essential component of home-based hemophilia care. Well-kept treatment diaries can help healthcare professionals to ensure optimal factor use, adherence with treatment regimens, and timely infusion practices.”

	The advent of mobile health (mHealth) apps provides a new alternative to managing bleeding disorders. Individuals can set reminders and track their treatment, record information related to bleeds, generate logs, access additional resources, and locate a hemophilia treatment center (HTC) while traveling. Despite the potential benefits mHealth offers, however, many people have not embraced this new technology.

	BioMatrix SpRx, a corporate governance agency for a family of specialty pharmacies, conducted a study investigating the use of hemophilia mobile apps. The purpose of the study was to provide insight into the current use of mHealth by patients with hemophilia to increase awareness of potential benefits and to provide recommendations to increase usage, with the goal of improving health outcomes for people living with bleeding disorders. A cross-sectional survey was conducted with patients with severe hemophilia. This was followed by a systematic evaluation of current hemophilia mobile apps within focus group meetings.

High Access to Mobile Technology and Moderate Experience With mHealth

	Most survey respondents had access to mobile technology and were quite familiar with mobile apps. Ninety-three percent used a smartphone and 65% used a tablet or other portable personal computing device with a touchscreen interface; only 5% did not use apps. Furthermore, 90% of respondents used mobile apps daily, with a majority using between 1 and 5 apps per day with social media, photo/video, and music/games/entertainment being the most frequently used app types. A little more than half (56%) had experience with mHealth, but only 14.5% regularly used hemophilia mobile apps.

Narrow Awareness and Limited Use of Hemophilia Mobile Apps

		The majority of survey respondents (68%) were not aware of the scope of hemophilia mobile apps currently available.

		There were widespread opinions regarding the benefits of using hemophilia mHealth; 32% saw no benefit.

		66% indicated use of an app was never recommended by their doctor or HTC.

		45% had downloaded a hemophilia mobile app.

	From the 45% who downloaded a hemophilia mobile app:

		Approximately one-third discontinued using the app.

		Approximately one-third used the app on a regular basis (a few times a week).

		Approximately one-third were limited users (once a month or only for the alert feature).

Hemophilia Mobile Apps Improve Adherence to Treatment

	Fifty-eight percent of individuals reported some degree of nonadherence to treatment, defined as missing a regular, scheduled infusion over a period of 1 month. Within this group, 89% missed between 1 and 3 infusions per month and 11% missed 4 or more per month. Regarding adherence to record keeping, our survey responses were more positive than expected given that research findings indicate “compliance with record keeping is notoriously poor.”

		11% keep “prophylaxis-only” or “bleed-only” records

		48% keep a record of both regular prophylaxis treatment and bleeds

Adherence to record keeping was lowest in the age 18-to-24 category and highest among those 60 years and older. Although we were unable to draw statistically significant conclusions from this study regarding the relationship between adherence to a treatment regimen and good record keeping, those who kept some sort of a log seemed less likely to miss scheduled treatments. Additionally, those who used a hemophilia mobile app appeared more likely to remain adherent to treatment. Open-ended responses to survey questions highlighted the value of an “alert feature,” serving as a reminder to infuse and supporting adherence to a treatment regimen. 

	One parent commented, “When my first son went to college, he did not use a hemophilia mobile app or keep a log. As a result, he experienced many bleeds (including 2 kidney bleeds) due to missing treatment. When my second son went to college, he used a hemophilia mobile app just for the alert feature (he did not log treatments). However, he remained 100% adherent to his treatment and didn’t experience a single bleed during his first year of college.”

Consumers Provide Insight into Valuable Features

	Seventy-four percent of survey respondents indicated bar scanning technology to automate the logging of dosage information was the most wished-for feature that would encourage use of a hemophilia mobile app. Other noteworthy desired features included the ability to locate an HTC when traveling (45%), the ability to share information with a personal HTC or doctor (44%), and the ability to use voice command to enter data (42%). Other recommended features included sending alerts for treatment, reordering factor and supplies from a pharmacy, recalling product information, printing graphs from logs, tracking inventory, and customizing and capturing data to accommodate inhibitor patients.

Nonuse and Discontinued Use of a Hemophilia Mobile App

	For those who had never downloaded a hemophilia mobile app, the most common reasons included “I don’t keep a log,” “I’m not familiar with hemophilia apps,” “They are too complicated or too much of a hassle to use,” and “I prefer to use paper logs or a spreadsheet.” 

	A lack of interest in an app and a lack of trust in the protection of personal data were also noted concerns. Common reasons for discontinuing the use of a hemophilia mobile app included failure of an app to allow for multiple patient profiles, accommodate a respondent’s current factor product, meet the needs of patients with inhibitors, provide an easy-to-use interface, and work without malfunction.

Implications to Consider Voice-Activated Technology and Other Devices in Managing Hemophilia

 While only 10% of those surveyed reported using voice-activated technology in the home, such as Alexa or Google Home, 55% reported an interest in voice-activated technology. Those who had downloaded a hemophilia mobile app tended to be universally interested in using voice-activated technology, whereas those who had never downloaded an app were equally divided.

 Approximately one-third of respondents expressed interest in linking a fitness tracker, such as a Fitbit or Garmin, to a hemophilia mobile app.

Experience With Hemophilia mHealth Influences Perceived Impact

	The perceived impact varied based upon previous experience with hemophilia mHealth. The majority of respondents (90%) who had downloaded a hemophilia mobile app (not necessarily current users) believed that use of the app would improve their health care. Opinions were equally divided among those with no previous experience with hemophilia mHealth.

		Although the sample size was too small to determine a statistically significant relationship, the study findings are consistent with earlier research findings that show that hemophilia mHealth improves adherence to a treatment regimen.

		Access to mobile technology (smartphones and tablets) is high.

		Respondents generally embraced technology and were quite supportive of technological solutions to improve health care.

		Many respondents were receptive to solutions beyond hemophilia mHealth, including the use of voice-activated technology.

		Respondents were generally aware of the benefits of hemophilia mHealth and its likelihood of improving adherence.

		Despite access to technology, a willingness to employ the technology toward managing their health care, and an understanding of the benefits of using hemophilia mHealth to improve adherence, adoption rates of hemophilia mHealth remain quite low.

		Several factors seem to be driving low adoption rates of mHealth: a lack of awareness of hemophilia mHealth options, app complexity, burdensome data entry, concerns with the protection of health information, and inflexible app features (eg, unable to use with an individual’s factor product, cannot be customized to accommodate inhibitor patients, etc).

	Several hemophilia mobile apps were reviewed and evaluated by focus groups. These were their conclusions:

		Problems exist in identifying a hemophilia mobile app that best meets consumer needs.

		Many focus group participants expressed little interest in using hemophilia mHealth due to a lack of interest in record keeping and a lack of time.

		Protection of health information within a hemophilia mobile app and the transmission of treatment logs through a nonsecure method were major concerns.

		Although several hemophilia mobile apps required users to create a username and password for exploration, focus group participants favored an app that allowed users to investigate the product without the prerequisite of registering.

		Hemophilia mobile apps that had too many menus or features prevented clear navigation and were perceived as complex and frustrating.

		Opinions varied between digital natives and non-natives regarding hemophilia mobile app layout, graphics, and visual appeal.

		Most focus group participants were frustrated by a hemophilia mobile app’s inability to submit a bleed or infusion record without providing 100% of the requested data.

		The most valued features included treatment alerts and the ability to log an infusion by responding to a hemophilia mobile app alert.

		The evaluation process served as a beneficial educational opportunity for all group participants.

		Many participants who didn’t use a hemophilia mobile app are now using an app to manage their bleeding disorder.

Despite medical recommendations, many patients do not consistently remain adherent to their prophylactic schedule.

Exposing Benefits and Barriers: mHealth Use in Managing Hemophilia 

	The increasing cost of health care is a major concern for health systems, patients, and insurance providers nationwide. The Centers for Medicare & Medicaid Services projects that health spending will grow an average of 5.8% per year over the next 20 years.

 Prescription expenses in 2015 alone rose overall by 11.7%, with the greatest increase being in health maintenance organizations, at 25.3%.

 There is a constant balancing act for health care systems to provide the newest and most up-to-date care for patients while being financially responsible. The results of a recent study show that for the top 20 cancer drugs, up to 37% of the leftover drug in the vial is discarded.

 Wasting even a small portion of expensive antineoplastic drugs can translate to significantly increased costs. 

	For many years, the United States Pharmacopoeial Convention (USP) Chapter <797> has directed pharmacies on safe compounding techniques to minimize microbial growth. USP <797> states that a single-dose sterile product must be used within 6 hours of being breached if opened and stored in an International Standards Organization (ISO) Class 5 environment and within 1 hour if opened and stored in worse than an ISO 5 environment. The 6-hour rule is based on very specific and strict testing described in USP <71>.

 This rule, while in place to protect patients from infection, can lead to pharmacies wasting significant amounts of expensive medications that might still be stable, safe, and active for several days or weeks. 

	USP recently published a new chapter, USP <800>, which will require hospitals to implement new processes to help protect patients, health care providers, and the environment from hazardous drugs (HDs). Anyone compounding substances that are listed on the National Institute for Occupational Safety and Health (NIOSH) HD list will have to adhere to the strict regulations laid out by USP <800>.

 For hospitals, this means implementation of additional protection levels, including closed-system transfer devices (CSTDs). These devices are designed to contain HD drips, sprays, and vapors that occur during compounding and administration.

 There are several CSTDs available for HD compounding and administration. The most common brands are PhaSeal, Spiros, ChemoClave, and OnGuard.

	The FDA recently gave approval to a CSTD to extend the beyond-use dating (BUD) of opened vials from 6 hours to 7 days, with up to 10 reconnections of components.

 Equashield has been found to prevent the release of vapors into the environment and has fewer leakage issues than other CSTDs.

 Some also consider Equashield easier to use than other available products. A study conducted by The University of New Mexico Hospital found that both pharmacy departments and nursing staff preferred Equashield over 2 other products tested. The study was a 4-step process that included a survey of the health care personnel who would be using the CSTDs. At the end of study, the consensus was that the Equashield components simplified the entire drug compounding and administration processes.

	Nelson Laboratories performed a test with extreme-use conditions to assess the ability of Equashield to prevent the transfer of microbial contaminants into drug vials. The double-membrane design of Equashield is thought to prevent the ingress of bacteria by protecting the coring-free needles from contamination by environmental microbes. Nelson Laboratories used 4 groups of vials that contained growth media. These groups were accessed by 770 Equashield syringes, for 5, 7, or 10 times—depending on the group&mdash;over a 7-day period. The surfaces of the access membranes were inoculated with either gram-positive or gram-negative bacteria for 30 minutes and then disinfected with a 70% isopropyl alcohol pad before media was withdrawn from the vial. To replicate standard hospital compounding, ISO 5 environmental conditions were used throughout. As an additional extreme measure, one-third of the Equashield syringes and vial adapters were products that had expired. After 7 days of being accessed, the vials were incubated for 2 days at 30° C to 35°C, for a total of 9 days of testing. There was no growth in any of the media-filled vials at the end of the study. Nelson concluded that the double-membrane needleless design of the device is essential for the prevention of the ingress of environmental contaminants into the vial and HD substances from egressing.

The results of the Nelson Laboratories study were validated by a similar study done by the University of Toronto. This study included a control group of vials that were not accessed during the study, as well as control groups that contained microbial contamination. There were 32 vials per study group, for a total of 288 vials. The vials were incubated for 14 days, after which none that had been accessed using Equashield had microbial growth. All positive controls demonstrated growth within 48 hours of inoculation and all negative controls showed no growth for the duration of the study. This study concluded that Equashield can maintain the sterility of single-use vials in ISO Class 5 environments and conditions poorer than ISO 5.

	With FDA approval to extend the microbial stability of the drugs by 7 days, there are theoretical cost savings available to organizations that use CSTDs with this change in practice. Some of the savings may cover the cost of implementing a CSTD. Mount Sinai Hospital recently assessed the cost savings realized through the Equashield system for 1 month, when it used the CSTD to extend the BUD of expensive chemotherapy and biotherapy agents. The hospital did a prospective economic analysis for 28 of the agents in single-dose vials it uses by documenting wasted amounts of the agents on a daily basis and estimating the potential waste if the vials had been thrown out on the same day rather than 7 days later. Although the researchers found a cost savings for just 6 agents, the sum of these 6 was enough to offset the cost of using Equashield to be compliant with USP <800> and extend the BUD by 7 days.

	Despite several CSTDs being FDA-approved for extended BUD, The Joint Commission (TJC) and the USP do not universally recognize the extended BUD results from published studies. TJC states that in order to take advantage of prolonged BUD, each facility must conduct, at a minimum, its own sterility testing for each agent not simply use data from other studies.

	Bronson Battle Creek (BBC) is a community hospital with an integrated comprehensive cancer center. The infusion area of the BBC Cancer Care Center (CCC) has its own dedicated chemotherapy compounding area that is fully compliant with the current USP regulations for mixing HDs; it compounds nearly 300 HD preparations per month. The annual drug spend for the hospital is about $15 million, with approximately $11 million coming from the CCC. Any cost saving in the CCC would be beneficial to the hospital. 

	The main purpose of this study was to determine whether the BUD extension with the use of a CSTD had a financial benefit from decreasing waste that would offset the cost of implementation of the CSTD at a comprehensive CCC. Secondary objectives included a count of the number of parenteral antineoplastic and biologic agents compounded in the CCC, measured employee exposure to HDs, determined cost savings from being able to use larger bulk vials of products, and a survey of the use of CSTDs in other Michigan hospitals.

	All of the antineoplastic agents and biologic agents were prepared in the BBC outpatient care center area, which uses a Class 2, Type A2 biological safety cabinet with an ISO Class 5 environment. Personnel trained in the CCC compounding area observe current USP <800> rules and regulations for preparation and handling of HDs in anticipation of the July 2018 enactment. The stability of medications used in the CCC was gathered from manufacturer recommendations (Table 1

). For billing and insurance purposes, the current protocol at BBC for opened vials is to discard them after each patient. BBC is a qualified 340B facility and is able to purchase appropriate outpatient medications, such as those used in the CCC at 340B pricing; however, for the purposes of this study, the group purchasing organization cost was used as the basis for the calculations. 

	The 20 most commonly used antineoplastic and biologic agents administered in the BBC CCC from June 2015 to June 2016 were included in this study. All patients older than 18 years who received their antineoplastic or biologic agent in the CCC were included. Methotrexate doses compounded in the CCC for use in the obstetric unit were excluded from the study. For the primary outcome, a Microsoft Excel spreadsheet was used to record the data and perform the calculations. The calculation performed was:

	[(The price of the drug saved by using extended BUD + the price of the CSTDs not used on the vials that were saved with extended BUD) — The price of the CSTDs that would have been used = The cost of implementing a CSTD]. 

	A wipe study by ChemoGLO was done as directed by USP <800> pre-implementation of a CSTD to assess for employee &ensp;» exposure to HDs in the pharmacy, nursing, and patient areas. Six areas were tested for 5 HDs. Of these 5 HDs, 4 were commonly compounded in the CCC. One HD that was tested acted as a control because it was not dispensed in the CCC. The site tested was considered contaminated if there was more than 10 ng/ft2 of drug present. 

There is a constant balancing act for health care systems to provide the newest and most up-to-date care for patients while being financially responsible.

March/April

Value-Based Care Requires Specialty Pharmacy Scale With Broad Capabilities to Deliver Enhanced Patient Services

Trends That Will Affect Specialty Health Care Into the FutureÂ

Mitigating Drug Diversion Risk: More Than Just Narcotics, Specialty Needs to Look at This Growing Problem

We Donâ€™t Need No Education: Postâ€“Pharmacy School OptionsÂ

Current Tech Hurdles in Specialty Pharmacy Lead to a Decrease in Effective Care

Exposing Benefits and Barriers: mHealth Use in Managing Hemophilia

Outpatient Cancer Center Cost Evaluation of Extended Beyond-Use Dating with a Closed-System Transfer Device

Asembiaâ€™s 2018 Summit Continues to Enhance the Growth of Specialty Pharmacy

Convergence: Is Bigger Better?

Update on Rheumatoid Arthritis

Letter to the Editor

In Memoriam: Specialty Pharmacy TimesÂ® Editorial Director Kirk McKay