A brief overview of specialty pharmacy, specialty drugs, eligibility for specialty pharmacy
Specialty pharmacy focuses on handling the complexities in interactions between drugs, cost, and FDA breakthroughs. Every year in the United States, the Centers for Medicaid and Medicare Services (CMS) determines the cost thresholds as a major complexity.

The examination of prescription drug event data for the prior year reveals the percentage of monthly fills that exceed the stated limit. The lower threshold for the year 2020 stands at $670 per month. Numerous complex conditions are prioritized in the specialty pharmacy, such as cancer, infertility, HIV/AIDS, rheumatoid arthritis, multiple sclerosis, hemophilia, hepatitis C, Crohn disease, cystic fibrosis, growth hormone deficiency, pulmonary hypertension, and immune disorders.

Biosimilars that show similarity with FDA-approved biologic drugs increase competition that lowers the complexity of drug costs. The first 10 years of biosimilar approval could lead to savings of between $44 billion and $250 billion, since these drugs are on average 25% less expensive than the FDA-approved biologic agents, according to a study by the Rand Corporation.

Specialty medications account for close to 50% of the total drug spend in America. Prior authorization, quantity limits, and step therapy reveal the authorization management requirements for specialty pharmacy. Since 2015, there has been an increase in the number of specialty pharmacies in the United States due to their potential of handling the complexities of cost and appropriate drug access and administration. 

Although there are no specific educational requirements to become a specialty pharmacist, there are available certifications through the Specialty Pharmacy Certification Board (SPCB). The Certified Specialty Pharmacist (CSP) criteria include a bachelor of science degree in pharmacy (BS Pharm) or a Doctor of Pharmacy (PharmD), an active license that lacks restrictions, 30 hours of accredited specialty pharmacy continuing education every 2 years, 3000 hours of specialty pharmacy practice in 4 years, and attestation to code of conduct.

Development of programs that will help in expanding the role of public health pharmacists
Collaborative practice agreements integrate a broad scope of care providers to diagnose and treat patients, thus increasing the role of evidence-based practice. The collaborative patient-centered programs maximize improved quality of therapeutic inputs and reduced costs.

Provision of the collaborative practice agreement programs are initiated by signing formal agreements with multiple care providers, including physicians. The agreements offer platforms for conducting supportive clinical procedures as a pharmacist (specialty or otherwise) by prescribing and implementing assessment protocols after diagnosis by the physician. The programs follow the provision of written and oral consent by patients who benefit from the collaborative practice agreement.

These formal agreements seek to ensure that specialty pharmacists assess patients’ health conditions and medical history in consultation with the physician and multiple care providers. The pharmacist, therefore, provides medication options and also consults insurance companies for cost and formulary considerations.

The intent of signing a formal agreement for collaborative practice is significant because it offers the pharmacist opportunities to offer care similar to that of physicians in times when patients need it most. Collaborating with health care providers, such as physicians, increases the pharmacist’s experience with patient needs to reveal a pathway for developing cost-efficient programs.

The integrated care ensures that drug-related problems are identified, a solution is designed, and adverse events are prevented. Therefore, the evidence-based and patient-centered programs will incline toward the input of the diverse care providers in curing disease, reducing symptoms, slowing progression, and preventing disease. 

How pharmacists can use these programs to collaborate with physicians and other health care professionals to optimize patient health
Multiple health care workers, communities, and pharmacists enter agreements in which licensed health care providers refer patients to the pharmacist for the delivery of specific patient functions. The programs facilitate the implementation of holistic care following diagnosis and treatment, offering benefits to patients after the quality and accessible medications are administered.

Physicians help in identifying risks and causal factors of complex health conditions while pharmacists research and suggest medicines that curb the risk factors, thus optimizing quality-of-life. Multiple care provider reports about health care conditions offer a broad scope of implementing cost-effective drugs by pharmacists, thus increasing the curative, preventive, and maintenance of diseases among target patients.

Elements needed to provide collaborative practice agreement and a sustainable direct patient care pharmacist
Legal elements define the scope of practice in terms of geographical boundaries, registration or eligibility requirements, training, and administrative needs. The patient care element facilitates access to medical records and health care technology, disease state management, education on medications, and service development.

The payment or billing element ensures a wide variability of medication services at cost-efficient means, provision of various billing codes, and as per state and federal laws on provider recognition. The elements enhance the role of the collaborative practice agreements in meeting the goals of optimized quality of care delivery at reduced costs.

Description of benefits and how they help in expanding the role of pharmacist
Benefits of collaborative practice agreements include improved health outcomes, optimized medical use, delivery of quality patient care, promoting the recognition of pharmacy services, and attaining the goals of CMS, which inclines toward cost-efficient measures of meeting complex patient needs. The benefits ensure that pharmacists are recognized and respected for their role in improving patient care while connecting them with diverse or multiple care providers for increased scope of care. Managing complex conditions in a cost-efficient manner as a goal of CMS expands the scope of care since many patients would be attracted to quality services that do not strain them financially. 

Roles of specialty pharmacists and how these roles can be expanded by having a collaborative practice agreement with physicians
Pharmacists could increase their scope of care through implementation of collaborative practice agreements by empowering prescribing, offering advice on clinical support, and monitoring patients immediately after a physician’s diagnosis. A collaborative practice agreement increases the roles of specialty pharmacists other than limiting them to the distribution of medications.

Pharmacists play a crucial role in determining how specific drugs interact with diagnosed disease and comorbidities and offer evidence-based interventions that optimize the quality of life and minimize costs. The figure below shows past and future inputs of pharmacist’s roles in patient care.



The eligibility for a collaborative practice agreement with physicians
State bodies offer authorization for pharmacists to prescribe drugs and provide clinical support to patients. The agreement is effective for cases in which the diagnosis is not needed or already availed by the physicians.

Necessary qualifications for pharmacists to implement protocol and procedures must be identified. The agreement does not include changes to the scope of practice in legislation, does not necessarily translate directly into reimbursement, and state recognition does not equate to federal recognition.
 
About the Authors
Fonda Shu-Ayanji
is a PharmD/MPH candidate at Shenandoah University Bernard J. Dunn School of Pharmacy, anticipated to graduate in Spring 2021.
Jonathan Ogurchak, PharmD, CSP, is the founder and CEO of STACK, a pharmacy compliance management software, and serves as preceptor for a virtual Advanced Pharmacy Practice Experiential Rotation for specialty pharmacy, during which this article was composed.


References
Centers for Medicare and Medicaid. Contract Year 2021 and 2022 Proposed Rule. Feb 2020. https://www.cms.gov/newsroom/fact-sheets/contract-year-2021-and-2022-medicare-advantage-and-part-d-proposed-rule-cms-4190-p-1

Centers for Medicare and Medicaid Services. 2020 Call Letter. April 2019. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf

Elsevier. Drug Topics - Emerging Trends in the Specialty Drug Industry. May 2017. https://www.elsevier.com/__data/assets/pdf_file/0020/317432/Emerging-Trends-in-the-Specialty-Drug-Industry_eBook.pdf

Food and Drug Administration [FDA]. New Drug Therapy Approvals 2019. Jan 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019

Pharmaceutical Care Management Association [PCMA]. What is Biosimilar? June 2016. https://www.pcmanet.org/pcma-cardstack/what-is-a-biosimilar/