The escalation in health care costs, the growing complexity of drug therapies, the shortage of primary care physicians, the demand for improved medical outcomes, and the heightened role of the pharmacist in the patient care team are just a few of the catalysts demanding a gravitation of the pharmacy profession towards specialization.  
 
As knowledge and technology has advanced the profession, pharmacy has followed the precedent set by other arms of the health care industry in the development of areas of distinct expertise and subsequent accreditation.1 Just as practitioners have developed specialties in areas such as ophthalmology and cardiology, pharmacy has begun to offer distinct services to complex disease states, such as HIV, hemophilia, and oncology.
 
Currently, the specialty pharmacy market, which represented a $98.3 billion industry in 2015,2 is dominated by 4 major players – CVS Health, Express Scripts, Walgreens, and OptumRx. Collectively, these companies held 65% of the specialty pharmacy market share in 2015.3 

However, the explosive growth in specialty pharmacy, which is currently the fastest growing sector of the US drug market,4 is attracting a multitude of players. Today the revenue generated by specialty drugs is shared amongst retail, mail, and specialty pharmacies, as currently any pharmacy can designate itself a “specialty pharmacy.”
 
Competition in an area that was once just on the periphery of the pharmacy industry is increasing exponentially, as the number and types of pharmacies providing specialty products and services continues to grow.
 
As a result, the value-added services range broadly from one specialty pharmacy to another. Typically, these services include supportive clinical and educational services, drug utilization and adherence monitoring, outcomes documentation from a clinical and economic perspective, and reimbursement assistance. 
 
The development of accreditation standards through third party organizations, such as the Utilization Review Accreditation Commission (URAC), the Accreditation Commission for Health Care (ACHC), and the Center for Pharmacy Practice Accreditation (CPPA) are standardizing the services provided by specialty pharmacies, and providing greater consistency in care. While accreditation is not mandatory, it is becoming more of a standard than an option.
 
As the demand for improved health care outcomes and cost containment intensifies, manufacturers and payers are drifting towards the employment of restricted specialty pharmacy networks to ensure their patients are receiving reliable, high-quality care that will ultimately lead to improved therapeutic outcomes and cost-savings. 
 
By adopting the practice of contracting with a limited number of pharmacies, manufacturers and payers are able to partner with specialty pharmacies that present themselves as strong strategic partners in obtaining these goals. In order to participate in these restricted networks, pharmacies seeking to enter distribution contracts for specialty pharmaceuticals are being called to validate their capabilities in providing quality-focused services.  
 
Pharmacy benefit managers (PBMs) have taken the lead in driving the trend towards increasing accreditation. In 2015, Catamaran, one of the largest managers of prescription drug benefits in the nation, demanded that pharmacies dispensing specialty medications to any of its patients go through an accreditation process to remain within their network. 
 
Without accreditation, pharmacies were forced to transfer prescriptions to BriovaRx, its specialty pharmacy, or another accredited pharmacy. This served a dual purpose for the large PBM. 
First, it ensured its patients were receiving consistent quality-focused specialty care, but secondly, it drove more claims to Catamaran’s specialty network. The increase in claim count gives Catamaran leverage in negotiating reimbursement and rebate contracts with pharmaceutical manufacturers. 
 
The latter effect is sure to urge other PBMs, seeking to leverage economies of scale in negotiations, to follow in Catamaran’s footsteps. Specialty pharmacies, although not required, are proactively seeking accreditation as a means to differentiate their service model, authenticate their services, and protect their contracts with PBMs.5
 
ACHC and URAC are the 2 major specialty pharmacy accrediting organizations. ACHC accredited its first specialty pharmacy in 2000; however, URAC emerged as the gold standard in specialty pharmacy accreditation, following its establishment in 2008. 
 
The number of companies achieving URAC accreditation has grown at an astonishing rate since this time. In 2008, only 6 pharmacy locations representing 2 companies achieved full accreditation; however, by 2015 the number of unique pharmacy locations holding URAC accreditation reached 250.2,3
 
Although the process can be costly and tedious, with most timelines lasting close to a year from application to accreditation, third party organizations administering the accreditation process provide assistance throughout the timeline in the form of corrective action plans. Guidance through the initial accreditation is typical; however, the onus of achieving re-accreditation, which is required at various time points depending on the accrediting body and comes with another price tag, lies heavily on the specialty pharmacy.
 
The increased competition and trend towards restricted networks will shrink the market share of unaccredited and undifferentiated pharmacies. Dual accreditation is a strategy increasingly employed by specialty pharmacies as single accreditation is no longer a differentiator. Recently, there has been an increase in the number of accreditation organizations to answer this trend. 
 
CPPA, for example, grew out of a collaboration between the American Pharmacy Association (APhA), the National Association of Boards of Pharmacy (NABP) and the American Society of Health-System Pharmacists (ASHP) in 2012, and published its list of standards last year in 2015. It offers another means for pharmacy practices to raise the level of pharmacy-delivered patient care services. 

Secondary accreditation can also be obtained from organizations, such as the Joint Commission or a pharmacy can obtain a state level, NABP-affiliated accreditation as a Verified Pharmacy Practice (VPP). Third party accreditation serves as a means to develop, measure, and validate the capabilities and performance of a specialty pharmacy. 
 
Each independent accrediting organization publishes a list of standards by which specialty pharmacies are able to be measured against. Although not identical, these standards typically address a pharmacy’s organizational infrastructure, patient access in accordance to manufacturer requirements, clinical management of patients, and subsequent quality outcomes and improvements.2 
 
By abiding to these standards, a specialty pharmacy demonstrates its proficiency in the management of specialty pharmaceuticals, and the clinical management of the nation’s sickest patients with the intent to achieve desired therapeutic and economic outcomes. Accreditation provides consistency to the practice of specialty pharmacy, verifies quality of services offered and overall value to the marketplace for all stakeholders – manufacturers, payers, plan sponsors, practitioners, and, most importantly, patients. 
 
The overarching goal of accreditation is to serve as a mechanism to drive best practices, which is inevitably going to be at the forefront of the health care evolution as the industry continues to focus on value-based care.
 
About the Author
Heather Brand earned her B.A. in Chemistry and PharmD from the University at Buffalo, SUNY. She worked for an oncology based pharmacy for six years prior to transitioning to a consultant role for a benefits management firm. She is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.  

 
References
  1. Meade, V.  Specialization in Pharmacy. American Pharmacy. January 1991. Vol NS31(1):24.
  2. The Specialty Pharmacy Accreditation Boom Continues. Adam Fein thurday march 10, 2016.  Drugchannels.net (accessed 6 July 2016)
  3. The Top 10 Specialty Pharmacies of 2015.  Adam Fein Thursday march 8 2016 drugchannels.net (accessed 6 July 2016).
  4. IMS Institute for Healthcare Informatics.  Medicines Use and Spending in the U.S.  A Review of 2015 and Outlook to 2020.  http://www.imshealth.com/en/thought-leadership/ims-institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2015-and-outlook-to-2020#form (accessed 2016 July 6).
  5. Manning, M.  Pharmacy Accreditation: Establishing Discipline and Consistency.  Inside Pharmacy.  March 2015:3(3).  Insidepatientcare.com (accessed 2016 July 6).