Certifying specialty pharmacy care

BY Gary Rice, MS, MBA

Countless industries are continuously updating and retooling their approaches to production, organization, communication, training and other systemic procedures to keep up with ever-changing landscapes. The specialty pharmacy industry is no different and, in fact, has reached a critical point when it comes to training, qualifying and educating the growing number of pharmacists practicing in this complex area.

To treat such chronic diseases as cancer, multiple sclerosis and rheumatoid arthritis, specialty drugs can require special handling, distribution and administration.

Specialty drugs require special handling, distribution and administration to treat such diseases as cancer, multiple sclerosis and rheumatoid arthritis. Due largely to a robust pipeline of new biologics, additional indications on existing medications and innovative drug therapies for medical conditions previously untreated, specialty pharmacy has rapidly become one of the fastest-growing segments in pharmacy. And its projected growth is staggering. U.S. spending on specialty prescription drugs is projected to increase 67% by the end of 2015, according to Express Scripts. Prescription drug spending on eight of the top 10 specialty therapy classes will continue to increase over the next three years, and what was a $90 billion market in 2012 is projected to grow to more than $100 billion in 2013. While these dollars are spent in about 3% to 5% of the population, they will account for more than 55% of total pharmacy costs, according to CuraScript.

These statistics are expected to rise along with the aging population and increases in such age-related diseases as Alzheimer’s disease, cancer and cardiovascular diseases. This tremendous growth signals that the specialty pharmacy industry must make available to its pharmacists and to important stakeholders — including patients — a standardized, uniform tool for ensuring highly qualified, highly trained professionals: professional certification. It’s essential to public health, to the growth of the industry and its partner industries, and to general healthcare resource management that specialty pharmacists become as knowledgeable and competent as possible within the space of high-cost, highly managed drugs — and that they learn to keep the pace with the ever-evolving technology.

Certification programs ensure specialty pharmacists possess the most up-to-date skills — something that benefits all sectors of the industry, as well as public health. To the individual pharmacist, certification provides the opportunity to sharpen existing skills and prove to employers a dedication to their craft, to patients and to the evolving industry. On the flip side, those who choose to forgo certification — and the education and training associated with the certification criteria and process — may not be able to withstand the demands of innovation and risk being under-qualified for such expectations. To those who employ specialty pharmacists, certification offers a systematic procedure for proving competency — ensuring continued confidence from healthcare institutions — and processes for developing and securing top talent within the industry. Industrywide, certification helps create standards to enhance quality and establishes new benchmarks that elevate patient care and safety, reinforcing confidence in where the industry is headed.

And the certification ball is moving. Already we are seeing the demand for certification-like programs, largely from payers who are eager to work with accredited pharmacies employing only cutting-edge technologies and the highest-trained staff. Universities also are seeking training programs to help prepare aspiring pharmacists in the area of high-cost, complex pharmaceuticals. Indeed, certification will become an important benchmark as this rising industry continues to evolve and become more relevant, providing an important educational point of reference and a track record of competent experienced staff.

To fill these growing demands, the specialty pharmacy industry is working diligently to make available certification opportunities. One such opportunity is the Certified Specialty Pharmacist. Available through the Specialty Pharmacy Certification Board, the certification program provides verifiable evidence of proficiency in all aspects of specialty pharmacy practice. Administered twice yearly in April and October, CSP was created by industry experts using a nationally recognized certification program and examination development process, providing an objective method for measuring the knowledge and ability of specialty pharmacists.

Such credentials as the CSP are a key indicator to employers, manufacturers, patients, payers, other healthcare providers and the general public that a professional is an expert in specialty pharmaceuticals and demonstrates proficiency in specialty pharmacy management duties in a variety of practice settings. It’s critical that individual specialty pharmacists and the industry as a whole embrace certification to help ensure a dedicated work force is keeping pace with inevitable growth and the technological and scientific advancements that come with it. With the continued expansion in the marketplace and the demand placed on high-cost, complex pharmaceuticals, those involved with specialty pharmacy must commit to bettering their careers and their skills sets by investigating and completing certification. If you’re connected in any way to specialty pharmacy, or wish to be, it’s that important.

Gary Rice, RPh, holds a Master of Science degree and MBA, and serves as both board president of the Specialty Pharmacy Certification Board and VP of clinical services at Diplomat Specialty Pharmacy.



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Which area of the industry do you think Amazon's entry would shake up the most?

Screening for risks

The healthcare industry has been laser-focused on prevention since it became obvious that stemming the tide of disease in our country required an upstream solution. From tackling prediabetes in adults to preventing childhood disease with infant immunizations, health professionals are onboard — with most finding a way to incorporate disease prevention into everyday practice.   

But one area of preventive care is often overlooked. According to the Centers for Disease Control, a full 75% of the morbidity and mortality in adolescents is a direct result of preventable risk behaviors.1 Such organizations as the American Medical Association, American Academy of Pediatrics and American Academy of Family Physicians all recommend annual screening of adolescent risk behaviors. But despite these statistics and evidence-based recommendations from leading organizations, teens have been overlooked in standards of care to date. A survey of AAP’s fellows revealed that fewer than 25% of providers regularly screen teens for risk behaviors.2  

Rapid Assessment for Adolescent Preventative Services, or RAAPS, is an adolescent risk-screening tool that was born out of research and a practical need to overcome some of the most common barriers to adolescent risk screening: time, provider confidence, lack of counseling tools and resources, and teen engagement.  

RAAPS was designed to be quick and effective for ease-of-use in a retail setting, and screening teens in this setting is especially important. Because teens utilize health care less than any other segment of the population, a visit with them may be the only health care they receive for that year — or longer.

Despite the need to screen for risky behaviors, it can be a struggle to connect with teens using a traditional interview style or incorporate long surveys into the practice workflow. Prior to RAAPS, a 72-question survey — known as Guidelines for Adolescent Preventive Services, or GAPS — was the best option for providers, but this survey took nearly 30 minutes for teens to complete and was not a good fit in a clinic environment.  

Rapid Assessment for Adolescent Preventative Services, or RAAPS, is an adolescent risk-screening tool used to overcome some of the most common barriers to adolescent risk screening, including time, provider confidence, lack of counseling tools and resources, and teen engagement.

RAAPS was developed to fit easily into the workflow. The team of industry leaders and academic experts at the University of Michigan incorporated evidence-based literature and completed a validation study to ensure identification of the top contributors of morbidity and mortality in adolescents.
Equally important as the science that went into the survey was the group of consulting experts: teens themselves. The team had strong teen involvement in every aspect of development to make the survey more engaging and to help teens feel more comfortable answering sensitive questions. This collaborative development process led to some innovative features that increase both engagement and effectiveness in the teen population.  

For example, the RAAPS survey can be completed on any device with Internet access — such as an iPad, Kindle or Android-powered tablet — which provides the mobility and flexibility for the survey to be used in almost any care setting, as well as minimizes “shoulder surfing” by both casual observers and protective moms. Audio and multilingual options help improve health literacy, which is especially important among underserved populations. The short, 21-question format decreases survey fatigue, and the technology interface provides better quality data. As research shows, teens are more likely to provide honest answers with technology than with face-to-face or paper surveys.3

Because adults aren’t the only ones who forget half of what they hear in an appointment, teens can choose to e-mail themselves the individualized health messages they receive from the RAAPS system that are specific to their identified risk behaviors following completion of the survey questions. These messages can serve as reminders of what was discussed and as a resource that can be referred to at a later time, increasing their exposure to the messages and increasing the chance that they will make positive behavior changes.

The team also added innovative features just for health professionals. Risk assessment can uncover a broad range of risk behaviors, and clinicians have indicated that they have significant experience talking with teens about some topics, but not others, particularly sex and mental health.  

Evidence-based talking points were developed for each question to help professionals in their discussions with teens across all of the potential risk behaviors. Health messages appear for professionals as a PDF document linked directly to each teen’s completed survey. These health messages focus on what has been proven to be most effective in messaging to teens: providing ideas for changing behaviors, rather than focusing on why they should change, and including such self-efficacy messages as, “You can make a difference in your life and the lives of your friends by making safe driving choices.”  Each message includes national or government websites specifically for teens, as well as hotline numbers where applicable. Since 2001, there has been a massive growth in teens using the Internet to seek health information, yet few take steps to ensure the credibility of the online sources they are finding.  RAAPS is giving them reputable resources.  

RAAPS users report that these messages have helped them increase the effectiveness of their counseling sessions and, most importantly, build trust and rapport to support ongoing discussions, not just one-time encounters.

Another useful feature is access to risk data. Prior to having an online system, clinicians would have to counsel hundreds of teens with paper surveys and had no way of easily tracking individual outcomes or reviewing all of the risk data that had been collected, outside of time-intensive chart reviews full of human error. So, when building the reporting features, the RAAPS team asked clinicians what questions they had about their teen populations and created reports that responded to such questions as:  

  • What is the effectiveness of the risk counseling I am providing?
  • What are the greatest risks in my teen population?
  • Are my programs and services focused on the greatest risks?

Teen risks change over time, and having accessible data that reveals changing trends is critical for professionals serving adolescent populations. For example, a review of RAAPS 2012 data shows a significant increase in mental health risks among teens, even surpassing the usual issues of teen drinking, drugs and unprotected sex.

Used in care settings ranging from hospital outpatient clinics to school-based health centers, and with a benchmark database of more than 33,000 completed surveys, RAAPS’ innovative approach has engaged teens and improved the effectiveness of both the identification and reduction of risk behaviors. And the data from RAAPS has been used to change service at all levels.

Consider a case study in Michigan, which began as a pilot and rapidly expanded across the state. The data from this initiative has been collected and analyzed at the state level and used to inform changes in Medicaid programming. Increased awareness from this project of the unique needs in teen populations also spurred adoption of an adolescent risk assessment guideline for Michigan.

Despite these successes, risk screening is not yet a standard practice among care providers serving the adolescent population. With 75% of all illness and death in the teen population attributable to preventable risk behaviors, and more than 75% of providers failing to routinely screen adolescents for these behaviors, the issue cannot be ignored. To learn more about RAAPS, visit

Jennifer Salerno is a nurse practitioner and former director of the University of Michigan Regional Alliance for Healthy Schools (RAHS) school-based health center program and the UM Adolescent Health Initiative, where she developed the RAAPS screening tool. Salerno is currently a consultant to the Michigan Department of Community Health, overseeing grant funding for the transformation of adolescent healthcare delivery in Michigan. She serves as a board member and adviser on many state and national organizations focused on adolescent health.


1 Centers for Disease Control and Prevention [CDC]. (2012). The youth risk behavior surveillance system – United States 2011. MMWR  61(4). Retrieved from
2 American Academy of Pediatrics (AAP) Periodic Survey of Fellows #71, conducted in 2008.
3 Paperny, D. M., Aono, J. Y., Lehman, R. M., Hammar, S. L., & Risser, J. (1990). Computer-assisted detection and intervention in adolescent high-risk health behaviors. The Journal of Pediatrics, 116(3), 456-462.


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Which area of the industry do you think Amazon's entry would shake up the most?

Cast in a new light

BY Jim Frederick

As the pharmacy profession marks American Pharmacists Month in October, its drive to achieve full recognition and status for pharmacists as health providers continues to gain momentum.

The campaign for provider status and full integration in a collaborative healthcare system enlists the lobbying efforts of virtually all the nation’s top pharmacy organizations and dozens of state-based pharmacy groups. It also goes to the heart of pharmacy’s future, defining the industry’s struggle to evolve beyond the confines of the old prescription-dispensing model and to secure a full stake in the integrated healthcare model now taking shape across the United States.

Specifically, the effort aims to “pursue legislative and regulatory changes to the Medicare program and relevant sections of the Social Security Act … to recognize the direct patient care services of qualified clinical pharmacists as a covered benefit under the Medicare program, regardless of the settings in which they practice,” noted the American College of Clinical Pharmacy. The target is “more patient-centered, team-based and quality-focused care” that provides recognition and a fair reimbursement for pharmacists engaged in that care model, ACCP reported.

The effort is critical to pharmacy’s future. Noting that “a dichotomy exists between what many pharmacists do and what they’ve been trained to do,” the American Pharmacists Association casts the issue as a “paradox in pharmacy between the vision of patient care and the reality of community pharmacy practice.” The gap between that vision and reality for community pharmacy continues to stymie efforts by pharmacists to gain elevated stature as fully engaged members of the health provider network in America — or to gain the recognition and reimbursement that pharmacists need to fully develop the kinds of collaborative practice models needed to transform the fractured, overly expensive U.S. health system.

This, despite the fact that “when pharmacists get involved, overall healthcare costs go down and quality and patient safety improve,” APhA asserted. The group has joined with other pharmacy organizations — including the National Association of Chain Drug Stores; the National Community Pharmacists Association; the American Society of Health-System Pharmacists, or ASHP; the Academy of Managed Care Pharmacy, or AMCP; the American Association of Colleges of Pharmacy; the ACCP; and a number of pharmacy retailers — in a major push to generate support among congressional lawmakers and federal health officials for a change in federal health regulations that would designate pharmacists as recognized healthcare providers.
The focus of that effort is convincing lawmakers to insert new language in the Social Security Act that would define pharmacists as patient care providers who qualify as such for payments under Medicare. “We need the recognition as providers so the healthcare system supports us financially,” noted ASHP CEO Paul Abramowitz at the group’s summer meeting in June.

Also backing “the recognition of pharmacists as non-physician providers under the Social Security Act” is the Academy of Managed Care Pharmacy. Provider status, AMCP stated, would “allow pharmacists to be reimbursed directly from Medicare Part B for providing cognitive services to patients covered under the program.”

“Although current Medicare Part D law reimburses pharmacies for pharmacists providing some cognitive services, including medication therapy management to a select subset of patients, the program is restrictive and encompasses only a small set of the services pharmacists are capable of undertaking,” the group asserted in a position statement. “Most states permit pharmacists to enter into collaborative practice agreements with prescribers, which grant pharmacists authority to manage a patient’s drug therapy.”

“A large body of published literature provides significant evidence of the benefits gained by allowing pharmacists to more fully utilize their expertise within clinical settings as part of the healthcare team,” added the statement. “AMCP strongly believes the inclusion of pharmacists as healthcare providers will enhance their ability to work as part of healthcare teams to address primary healthcare needs and increase the potential of pharmacists to provide these services with fewer barriers.”

NCPA calls the change “long overdue,” and noted, “with this federally recognized designation, pharmacists could finally be recognized for the valuable work they do and for their dedication to their patients.”

APhA agreed. “Provider listing in the Social Security Act is an important component in the ultimate goal of providing consumers and other healthcare providers with access to our services,” noted the pharmacy organization. “For patients to achieve the full benefit of their medications, pharmacists must be part of the team.”

To drive progress on the move to boost pharmacists’ provider status, APhA allocated $1.5 million to “a multifaceted initiative by the profession to gain recognition for pharmacists as healthcare providers.” The effort, said the group, seeks to ensure that:

  • Payers and policy-makers give patients access to pharmacists’ clinical services and recognize pharmacists as healthcare providers who improve access, quality and value to health care;
  • Patients have access to pharmacists’ clinical services through Medicare/Medicaid, other federal and state health benefit programs, integrated care delivery models and/or private payers by listing pharmacists as providers and/or properly valuing these services in payment models; and
  • Every patient’s health benefit plan package includes pharmacists’ clinical services as a core component.

The drive for provider status isn’t limited to big organizations and retail pharmacy chains. Individual pharmacists, including Sandra Leal, a PharmD and certified diabetic educator, and even student pharmacist Steve Soman have launched petition drives to convince President Barack Obama, the U.S. Congress and health policy-makers to support provider status and adequate clinical care compensation for pharmacists.

Meanwhile, pressure is building at the state level for legislation granting pharmacists professional provider status. In California, for instance, the California Medical Association in August agreed to drop its opposition to a bill in the state legislature that would expand the role of pharmacists after negotiations with the California Pharmacists Association, or CPhA. If enacted, the bill would boost pharmacists’ authority to order and interpret some tests of patients’ drug therapies and initiate routine vaccinations, among other duties.

“This exciting development reflects the recognition in the provider community of pharmacists’ high level of training and expertise, and of the contributions that pharmacists can make to patient care,” CPhA stated.

Pharmacy gained a powerful ally in the drive for provider status when the U.S. Public Health Service, or USPHS, and U.S. Surgeon General Dr. Regina Benjamin went on record urging policy-makers and health regulators “to support and implement existing, evidence-based and cost-effective pharmacist-delivered patient care models as the demands within our healthcare system escalate.”

Importantly, USPHS also noted that adequate reimbursement for this higher level of pharmacy practice was essential to making it work. “For pharmacists to continue to improve patient and healthcare system outcomes, as well as sustain various roles in the delivery of care, recognition as healthcare providers and compensation models reflective of the range of care provided are needed,” noted the agency, which is part of the Department of Health and Human Services.

In June, Rear Admiral Scott Giberson, chief professional officer for USPHS pharmacists, reiterated that support for provider status for pharmacists in a speech to the ASHP in Minneapolis. “Pharmacists are the second-most highly trained health professional … based on years of formal education,” Giberson noted, and are “a primary key to cost containment,” with a demonstrated “average return on investment of $4-to-$1 over the last two decades.”
Giberson added: “Pharmacists are likely the most underutilized healthcare provider in the nation. We may be missing an opportunity to address health system burdens with one of the nation’s most capable providers.”



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Which area of the industry do you think Amazon's entry would shake up the most?