Announcing the Advanced Practice & Health System Portfolio

A New Era of Complexity, A New Standard of Excellence

We stand at the dawn of a new era in pharmacy practice. The fundamental nature of medicine is undergoing a profound transformation, moving away from broad-based treatments and toward a future that is highly personalized, technologically integrated, and systemically complex. This is the era of the pharmacist as a manager of unprecedented complexity—a professional who must navigate everything from a patient’s unique genome to the intricate financial and operational web of the national healthcare system.

The forces driving this change are powerful and relentless: the explosion of specialty biologics and gene therapies, the rising intricacy of clinical trials that bring these miracles to market, and the shift to value-based care models that demand a sophisticated, system-level approach to medication management. This new landscape requires a new type of expert, a new level of practice, and a new, more rigorous standard of validation.

For the past year, the Council on Pharmacy Standards (CPS) has been engaged in its most intensive research and development initiative to date, collaborating with a national panel of the foremost thought leaders in our profession. Our mission was to answer a single question: How do we define and validate expertise at the absolute leading edge of pharmacy practice?

Today, we are proud to provide the answer. To recognize this pinnacle of professional practice, the Council on Pharmacy Standards is honored to unveil the Advanced Practice & Health System Portfolio—our most specialized and rigorous suite of eight certification programs to date.

The Culmination of a Strategic, Evidence-Based Vision

This portfolio is not a reaction to a single trend, but the culmination of a multi-year strategic vision to serve every echelon of the pharmacy profession. Its foundation was laid in our October 2023 Call for Subject Matter Experts, which brought together an elite panel of national leaders from the nation’s top academic medical centers, pharmaceutical companies, and managed care organizations. The subsequent National Job Task Analysis (JTA)—the most specialized in our history—provided a crystal-clear mandate.

The JTA data confirmed three undeniable truths about the future of our profession:

1. The Rise of High-Complexity Therapeutics: The management of high-cost, high-touch specialty pharmaceuticals, including gene and cell-based therapies, is no longer a niche, but a core function of advanced practice that requires a unique blend of clinical and operational skills.
2. The Centrality of Research: The integration of clinical trials and investigational drug services into mainstream health systems demands a specialized workforce that can uphold the highest standards of patient safety and data integrity.
3. The Power of Systems-Level Practice: The pharmacists making the greatest impact are increasingly those who can think and operate at a system level, whether managing a health plan’s formulary, communicating scientific data on behalf of industry, or implementing personalized medicine at scale.

This portfolio is the direct, evidence-based result of that research. It is designed for, and was built by, the practitioners who are actively inventing the future of pharmacy.

An In-Depth Examination of the Advanced Practice & Health System Portfolio

Each certification in this portfolio represents the highest level of specialization, designed for experienced professionals who are recognized leaders in their field.

Certified Advanced Specialty Pharmacist (CASP)

The Professional Imperative: The modern therapeutic landscape is dominated by the rise of specialty pharmaceuticals. These agents, while often life-altering for patients with rare and complex diseases, present a labyrinth of clinical and logistical challenges. The CASP is the expert who navigates this entire patient journey, ensuring access, safety, and optimal outcomes. The Scope of Practice: The CASP’s role transcends traditional clinical pharmacy. It is a hybrid of deep clinical acumen, financial navigation, and logistical mastery. This professional manages the entire specialty medication lifecycle, beginning with the intricate process of securing prior authorizations and connecting patients with co-pay and manufacturer assistance programs to ensure financial access. They are experts in the specific requirements of limited distribution drugs and work within accredited specialty pharmacies (URAC, ACHC) to meet exacting standards for patient management. Clinically, they are responsible for providing advanced education on complex administration techniques (e.g., self-injection), monitoring for subtle but significant adverse effects of novel biologics, and meticulously documenting patient-reported outcomes to demonstrate the value of the therapy. Who Should Certify: This elite certification is designed for pharmacists practicing in health-system specialty pharmacies, PBM- or payer-owned specialty pharmacies, and ambulatory care clinics focused on oncology, transplant, rheumatology, inflammatory bowel disease, and other rare conditions. Validated Competencies: The CASP credential validates a mastery of both the clinical and operational facets of specialty pharmacy. It assesses expertise in the specialty drug pipeline and emerging therapeutics, comprehensive knowledge of REMS program requirements, proficiency with specialty pharmacy data management and reporting, and the ability to lead a patient management program that meets the highest standards of national accrediting bodies.

Certified Clinical Trials Pharmacist (CCTP)

The Professional Imperative: The integrity of a clinical trial—and the safety of its participants—hinges on the meticulous management of the investigational product at the site level. The CCTP is the front-line clinical expert on the research team, dedicated to upholding the highest standards of patient safety and data integrity. The Scope of Practice: The CCTP’s role is deeply embedded in the day-to-day execution of a clinical trial protocol. This is a patient-facing specialty, focused on ensuring every step of the medication-use process is compliant and safe. Their responsibilities include conducting detailed reviews of complex study protocols to ensure feasibility, verifying patient eligibility against intricate inclusion/exclusion criteria, and providing intensive, protocol-specific counseling to trial participants to ensure unwavering adherence and the accurate reporting of adverse events. They are masters of the clinical details, from managing dose modifications based on lab results to educating patients and nurses on the proper handling and administration of investigational agents. Who Should Certify: This certification is for clinical pharmacists who are embedded in research teams, dedicated clinical trial pharmacists within an Investigational Drug Service (IDS), or pharmacists in specialized clinics (e.g., oncology) who have significant responsibilities for managing patients enrolled in trials. Validated Competencies: The CCTP credential validates an expert-level command of Good Clinical Practice (GCP), the principles of human subjects protection as outlined by the Belmont Report and institutional IRBs, and the nuances of the informed consent process. It assesses a deep, clinical understanding of trial design, randomization and blinding procedures, and the pharmacist’s specific role in maintaining the scientific validity of a study from patient enrollment through to study completion.

Certified Investigational Drug Services Pharmacist (CIDSP)

The Professional Imperative: While the CCTP focuses on the clinical execution of a single trial, the CIDSP is the operational and regulatory leader responsible for the safe and compliant management of an institution’s entire portfolio of investigational drug studies. This is a system-level role of immense regulatory complexity and risk. The Scope of Practice: The CIDSP is the Director or Manager of the Investigational Drug Service. They are responsible for creating the institutional infrastructure that allows for safe and compliant clinical research. This includes developing all institutional policies and procedures for investigational drug management, designing and validating workflows for sterile and non-sterile compounding of study agents, and managing the intricate inventory and accountability logs for hundreds of different studies simultaneously. They are the primary point of contact during FDA or sponsor audits and are responsible for the financial management of the IDS, including study budget development and billing for services. Who Should Certify: This certification is designed for the leaders of IDS pharmacies: directors, managers, and senior coordinators at academic medical centers, NCI-designated cancer centers, and other major research institutions. Validated Competencies: The CIDSP credential validates a mastery of the operational and regulatory aspects of investigational drug management. It assesses an expert-level understanding of FDA regulation 21 CFR Part 312 (Investigational New Drug Application). It validates competencies in study budget and contract negotiation, temperature excursion management and documentation, and the use of specialized IDS management software and automation.

Certified Medical Affairs Pharmacist (CMAP)

The Professional Imperative: In an era of evidence-based medicine, the pharmaceutical and biotech industries require scientifically rigorous and ethically grounded professionals to serve as the bridge to the clinical community. The CMAP is this bridge—a scientific expert whose primary role is the accurate, unbiased communication of complex medical information. The Scope of Practice: The CMAP works within a company’s Medical Affairs department, a role distinct from sales and marketing. A prime example is the Medical Science Liaison (MSL), who engages in peer-to-peer scientific exchange with national Key Opinion Leaders (KOLs) to share data, gather insights, and support research initiatives. The CMAP’s responsibilities also include serving as a medical information specialist, contributing to the development of publications in peer-reviewed journals, and providing scientific input for health economics and outcomes research (HEOR) projects. Who Should Certify: This certification is for pharmacists working in Medical Affairs roles within the pharmaceutical, biotech, and medical device industries, including MSLs, medical information specialists, and medical directors. Validated Competencies: The CMAP credential validates a mastery of the unique regulations and ethics governing the communication of medical information from industry. It assesses deep expertise in FDA regulations on scientific exchange and the prevention of off-label promotion, publication ethics and best practices (GPP3), and the critical interpretation of clinical trial design and statistical analysis.

Certified Home Infusion Pharmacist (CHIP)

The Professional Imperative: One of the most significant shifts in modern healthcare is the movement of complex care from the hospital to the home. Home infusion is a rapidly growing, multi-billion-dollar sector of pharmacy that requires a unique fusion of advanced sterile compounding knowledge, clinical management skills, and logistical expertise. The Scope of Practice: The CHIP is a master of all aspects of sterile drug therapy administered outside of a formal healthcare facility. Their role begins with the clinical design of complex parenteral nutrition, anti-infective, inotropic, or chemotherapy regimens that are stable and suitable for home administration. They oversee a USP <797>-compliant cleanroom environment that has the added complexity of coordinating deliveries and patient schedules. They are experts in the selection and management of infusion pumps and ancillary supplies, and they serve as a critical clinical resource for home health nurses, troubleshooting issues related to vascular access devices and patient response to therapy. Who Should Certify: This certification is essential for pharmacists, clinical managers, and directors of pharmacy in the home infusion industry. Validated Competencies: The CHIP credential validates an expert-level understanding of sterile product stability, compatibility, and extended beyond-use dating. It assesses advanced knowledge of pharmacokinetics for commonly infused therapies, expertise in the management of infusion-related complications, and a deep understanding of the complex reimbursement landscape for home infusion services.

Certified Managed Care Pharmacist (CMCP)

The Professional Imperative: The vast majority of healthcare in the United States is filtered through the lens of managed care, where decisions are made to balance cost, quality, and access for large populations. The CMCP is the systems-level pharmacist who architects and manages the pharmacy benefit to achieve this delicate balance. The Scope of Practice: The CMCP is a population health strategist who works for a health plan, pharmacy benefit manager (PBM), or a large integrated delivery network. Their expertise is broad and analytical, focusing on the management of the pharmacy benefit for thousands or millions of members. Their core functions include the design and maintenance of the drug formulary, the development of clinical criteria for prior authorizations, the oversight of drug utilization review (DUR) programs, and the management of Medication Therapy Management (MTM) programs at scale. They are deeply involved in specialty drug management, network contracting, and quality improvement initiatives. Who Should Certify: This certification is designed for pharmacists and leaders working in all areas of managed care, including roles in formulary management, clinical program development, DUR, and pharmacy quality at health plans and PBMs. Validated Competencies: The CMCP credential validates a mastery of the principles of pharmacoeconomics and health outcomes assessment. It assesses a deep understanding of the regulatory environment for health plans (including CMS regulations for Medicare Part D), and expertise in managing quality metrics (e.g., HEDIS, Stars).

Certified Gene Therapy Pharmacist (CGTP)

The Professional Imperative: Representing the absolute cutting edge of modern medicine, gene and cell-based therapies offer the potential for cures but come with unprecedented clinical and logistical complexity. The safe and effective delivery of these transformative—and often astronomically expensive—treatments requires a new type of pharmacy expert to manage the immense risks and intricate workflows. The Scope of Practice: The CGTP is the institutional expert responsible for the entire lifecycle of gene and cell-based therapies. Their role begins in the pre-treatment phase, collaborating on patient evaluation and ensuring all clinical prerequisites are met. They are masters of the complex “vein-to-vein” or “needle-to-needle” logistics, managing the meticulous chain of identity and chain of custody for these personalized products. Their expertise includes overseeing the specific preparation of these therapies, which may occur under highly controlled conditions, and educating the entire care team on the management of unique and severe toxicities, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Who Should Certify: This certification is designed for highly specialized pharmacists at designated centers of excellence, including academic medical centers, NCI-designated cancer centers, and major children’s hospitals that are authorized to administer these therapies. Validated Competencies: The CGTP credential validates a deep, integrated knowledge of molecular biology, virology (related to viral vectors), and immunology. It assesses an expert-level understanding of the complex REMS programs associated with these products, the protocols for managing their unique adverse events, and the operational excellence required to ensure these one-time, potentially curative therapies are delivered safely and effectively.

Certified Pharmacogenomics Pharmacist (CPxP)

The Professional Imperative: The era of personalized medicine is no longer a future concept; it is a clinical reality. Pharmacogenomics (PGx)—the study of how genes affect a person’s response to drugs—is moving rapidly from a research tool to a standard of care for guiding prescribing decisions. An expert is needed to translate complex genetic data into clear, actionable clinical recommendations. The Scope of Practice: The CPxP is the expert interpreter and clinical translator of pharmacogenomic test results. Their primary role is to take a patient’s genetic information (e.g., variants in CYP2D6, VKORC1, or HLA-B) and turn it into a specific, evidence-based prescribing recommendation for a provider. This includes recommending the most appropriate PGx testing, interpreting the resulting lab reports, and using that data to advise on drug selection, dosing adjustments, or the avoidance of certain medications to prevent adverse events. A key function is educating both providers and patients on the clinical implications of their genetic makeup for their medication therapy, now and in the future. Who Should Certify: This certification is ideal for pharmacists in ambulatory care, MTM roles, and dedicated pharmacogenomics consultation services. It is also highly relevant for pharmacists in managed care who are developing policies for PGx testing coverage and implementation. Validated Competencies: The CPxP credential validates an expert’s ability to apply the principles of clinical pharmacology and genetics to individualize medication therapy. It assesses a mastery of genetic terminology, the ability to interpret various PGx lab report formats, and proficiency in applying the evidence-based guidelines from authoritative bodies like the Clinical Pharmacogenetics Implementation Consortium (CPIC) to make definitive, patient-specific recommendations.

An Ecosystem of Advanced Practice

This portfolio doesn’t just recognize individual roles; it maps the entire ecosystem of advanced pharmacy practice in the 21st century. It connects the dots, showing how the insights from a CPxP can guide the therapy choices for a patient managed by a CASP, and how a CGTP manages the complex logistics of the very therapies developed in trials overseen by a CCTP and a CIDSP. It’s a holistic vision for the future of our profession, with a certified pharmacy expert at every critical node.

The Pinnacle of Practice: Eligibility and Details

This portfolio represents the highest tier of certification offered by CPS, designed to recognize true national experts and leaders. The eligibility requirements are therefore our most stringent.

• Candidates must possess a minimum of five (5) years of high-level, specialized practice experience where a majority of their professional responsibilities are directly related to the certification area.
• Completion of a relevant PGY2 residency or fellowship is highly preferred and may substitute for two years of practice experience.
• A portfolio of professional accomplishments, such as relevant publications, national presentations, or significant project leadership, may be required for application review.

Detailed eligibility pathways are now available in the official Candidate Handbooks on the CPS website. Registration for this new portfolio will open on September 1, 2024, with the inaugural testing window beginning on December 1, 2024.

The future of medicine is here. It is complex, it is personalized, and it is system-based. The pharmacists who are leading this future require a credential that recognizes the pinnacle of their expertise. This is that standard.

Validate your role as a leader at the forefront of pharmacy. Explore the Advanced Practice & Health System Portfolio.

The Leadership Team, Council on Pharmacy Standards (CPS)