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Seeking Your Expertise: Participate in the JTA for Compliance & Regulatory Affairs
In the practice of pharmacy, patient safety is paramount. Supporting this mission is an intricate, often invisible scaffolding of laws, regulations, and standards. From the sterile compounding cleanroom to the complexities of federal drug pricing programs, this framework is what allows pharmacists to provide care safely and effectively. The professionals who master this complex world—the compliance officers, the regulatory specialists, the medication safety leaders—are the unsung heroes who protect our patients, our institutions, and the integrity of our entire profession.
The regulatory and compliance landscape, however, is not static. It is a domain of ever-increasing complexity, with shifting guidance from the DEA, Boards of Pharmacy, The Joint Commission, CMS, HRSA, and USP. To date, there has been no single, national standard to recognize the advanced expertise required to navigate this critical field.
The Council on Pharmacy Standards (CPS) is committed to changing that. But before a new standard can be set, it must be meticulously researched and defined by the very professionals who practice it. That is why today, we are officially launching the 2022 National Job Task Analysis (JTA) for Pharmacy Compliance and Regulatory Affairs, and we are inviting you to be a part of this vital, profession-defining research.
The Blueprint of a Credible Credential: Why the JTA Matters
At CPS, every certification program we build begins with the same foundational step: a Job Task Analysis. A JTA is a formal, scientific study used to identify the essential knowledge, skills, and abilities that a professional must possess to perform their job competently and safely. It is the cornerstone of our evidence-based philosophy and the process that ensures every question on our examinations is relevant, fair, and legally defensible.
Our rigorous JTA process involves several key stages:
First, we convene a national panel of distinguished Subject Matter Experts (SMEs) with deep, real-world experience in the practice area.
This SME committee works for several months to systematically define the major work domains and then identify all the specific tasks and knowledge statements associated with that job role.
This comprehensive list is then transformed into a national validation survey.
This survey is where you come in. We distribute the survey to thousands of practicing professionals across the country. By rating each task and knowledge statement on its frequency and criticality to your own job, you are helping to validate the work of the expert panel. Your collective, confidential responses provide the empirical data that determines what is truly essential for competent practice. This data then becomes the official blueprint for the new certification examinations.
Your participation is the most critical step in this entire scientific process. It ensures that the final certification is not based on the opinions of a few, but on the validated consensus of the entire professional community.
Defining the Scope: What Do We Mean by “Compliance & Regulatory Affairs”?
To ensure our research is comprehensive, our SME committee has defined five major domains that constitute the practice of a pharmacy compliance and regulatory specialist. As you read through these, consider how they apply to your own professional responsibilities. If these are the challenges and tasks that define your work, we urgently need your expert input.
Domain 1: Federal and State Law & Regulation
This domain covers the core legal framework governing pharmacy practice. It includes the tasks and knowledge required to ensure compliance with federal and state-level entities, such as the Drug Enforcement Administration (DEA) regarding controlled substance ordering (CSOS), record-keeping, and diversion prevention; Board of Pharmacy (BOP) regulations for licensure, technician supervision, and pharmacy operations; and Food and Drug Administration (FDA) regulations related to drug integrity and recalls.
Domain 2: Accreditation, Quality, and Practice Standards
This area focuses on the standards set by key accrediting and standard-setting bodies. This includes a deep understanding of The Joint Commission (TJC) Medication Management (MM) and National Patient Safety Goal (NPSG) standards; the full suite of relevant United States Pharmacopeia (USP) chapters, including <795>, <797>, and <800> for compounding; and the principles of continuous quality improvement (CQI) to ensure ongoing readiness for accreditation surveys.
Domain 3: Federal Program Compliance and Integrity
This domain addresses the immense complexity of participating in federal healthcare programs. It requires expert knowledge of the Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program, including the prevention of duplicate discounts and diversion, and ensuring patient definition and eligibility criteria are met. It also includes the intricate rules of participation for Medicare and Medicaid, particularly regarding billing, reimbursement, and fraud, waste, and abuse (FWA) prevention.
Domain 4: Risk Management and Medication Safety Systems
This area covers the proactive and reactive systems designed to protect patients from medication-related harm. This includes the tasks of investigating medication safety events using methodologies like root cause analysis (RCA); proactively identifying system vulnerabilities using tools like failure mode and effects analysis (FMEA); managing an effective adverse drug event (ADE) reporting program; and overseeing the safe implementation and use of medication-related technology.
Domain 5: Pharmacy Ethics and Professional Conduct
Finally, this domain addresses the principles and professional responsibilities that underpin all other compliance activities. This includes knowledge of professional liability and malpractice risk, the application of a formal Code of Ethics to complex practice dilemmas, and ensuring the protection of patient privacy and confidentiality under HIPAA and other relevant regulations.
Your Role as a Participant: What to Expect
We invite you to lend your expertise by completing our national survey. We have designed the experience to be as straightforward as possible.
Time Commitment: This is a comprehensive research instrument. We respect your time and want to be transparent about the commitment. We estimate the survey will take approximately 45 to 60 minutes to complete. We recommend you set aside a dedicated block of time in a quiet space to provide your thoughtful responses.
The Survey Experience: After answering a few demographic questions about your practice setting and experience, you will be presented with the lists of task and knowledge statements organized by the five domains above. For each statement, you will use a simple rating scale to indicate how frequently you perform the task and how critical it is to your role.
Confidentiality: Your participation is vital, and your privacy is guaranteed. All individual survey responses are strictly confidential. Your data will be aggregated with thousands of other responses and used only for statistical analysis. No personally identifiable information will ever be published or shared.
Eligibility to Participate: We are seeking participation from pharmacists who have at least three (3) years of practice experience and who spend a significant portion of their professional time (at least 25%) on activities related to one or more of the five domains described above.
Why Your Expertise is Crucial
The quality of our future certification programs depends entirely on the quality of the data we collect today. Broad participation from qualified experts is what ensures the final examination blueprint is accurate, fair, and truly reflective of the profession.
“As a committee, we can bring together a dozen experts in a room to draft a framework based on our collective experience,” says Dr. Samuel Jones, Chair of the CPS Professional Practice & Standards Committee. “But the only way to know if we’ve gotten it right—the only way to build a truly valid, national standard—is to hear from the hundreds of practitioners on the ground who live and breathe this work every day. Your survey response is your vote for what matters most. It is your opportunity to literally define your specialty.”
We recognize that your time is valuable. To thank you for lending your considerable expertise to this important work, and to support your own professional development, we are pleased to offer 1.0 hour of Continuing Pharmacy Education (CPE) credit to all eligible individuals who submit a verified, complete survey response.
If you are a leader in pharmacy compliance, a medication safety officer, a 340B coordinator, a regulatory specialist, or a manager whose role is defined by these challenges, we need to hear from you.
Please click the link below to contribute your expertise and help us build the future standard for pharmacy compliance and regulatory affairs.
The survey will remain open until November 1, 2022. Thank you for your commitment to advancing our profession.
