2024 Pharmacy Law - Week 13 PDF

Overview ======== Instructor ---------- Dan Telford, PharmD\ dtelford001\@regis.edu Required Reading and References ------------------------------- Abood RR, Burns KA, Frankhauser F. (2025). Pharmacy Practice and the Law, 10th Edition, (TEXTBOOK) - Chapter 7 State Regulation of Pharmacy Pract...

Overview ======== Instructor ---------- Dan Telford, PharmD\ dtelford001\@regis.edu Required Reading and References ------------------------------- Abood RR, Burns KA, Frankhauser F. (2025). Pharmacy Practice and the Law, 10th Edition, (TEXTBOOK) - Chapter 7 State Regulation of Pharmacy Practice (p. 321-341) - Self-Regulation in Pharmacy - Approaches to Regulation - State Boards of Pharmacy - Licensing - Actions Against a License - Actions Against a Pharmacy License - Standards of Practice - Repository or Take-Back Programs - State Hospital Pharmacy Licensure Issues - State Regulation of Long-Term Care Facilities Class Format ------------ - 10 Question iRAT/tRAT - Application exercises to follow the tRAT Learning Objectives =================== Book Objectives --------------- - Identify the advantages and disadvantages of government regulation of professional practice. - Describe the purpose of a state board of pharmacy. - Recognize the functions of a state board of pharmacy. - Discuss the grounds for disciplinary action against a licensed pharmacist. - Describe the process through which disciplinary action is taken against a licensed pharmacist. - Identify how states have specific practice standards for the profession of pharmacy and how standards have expanded in recent years - Describe state regulation of institutional pharmacy practice. Additional Targeted Objectives (Focus areas for RAT) ---------------------------------------------------- 1. Self-regulation a. Know what the term \"Pharmacy Practice Act\" refers to (p.321) b. Know the 3 objectives of pharmacist licensure (p.322) 2. State Boards of Pharmacy c. Know which set of laws allow the creation of Boards of Pharmacy d. Know who or what the State Board of Pharmacy is tasked with protecting (p.323) e. Know which type of individuals a Board of Pharmacy typically composed of (p.324) f. Know the general functions of the National Association of Boards of Pharmacy (NABP) (p.324) 3. Licensure g. Know which individuals and entities the Board of Pharmacy typically oversees licensure for h. Be familiar with the 5 general requirements for licensure listed on p.324 i. Understand the requirement for licensed pharmacies to designate a pharmacist as the \"pharmacist in charge\" (PIC). This individual is responsible for ensuring laws and regulations are complied with in the pharmacy (p.326) 4. Disciplinary actions taken against a License j. Understand which actions State Boards of Pharmacies may take when disciplining pharmacies and pharmacists (See first take away point on p.332 for a good summary) k. Be familiar with the term \"unprofessional conduct\" as a catch all term that can serve as the basis for disciplinary action even if a specific rule or statute has not been violated. (p.330) l. Understand that actions may be taken against an individual, a pharmacy, or the pharmacist in charge (PIC) 5. Standards of Practice m. Know who/what legally defines the practice of pharmacy and the associated standards of practice. n. Be familiar with state\'s approaches to the regulation of ancillary personnel (i.e., pharmacy technicians and clerks) as well as interns. 6. Be familiar with the general continuing education requirements for pharmacists (p.336) 7. Be familiar with the opportunities for expanded scope of practice for pharmacists including: o. Collaborative Practice Agreements p. Limited prescriptive authority q. Statewide Protocols r. Authorization to order and/or administer immunizations Selected Book Take-Away Points ------------------------------ - Self-regulation of the pharmacy profession began in the late 19th century. - Self-governance continues at the state level, which limits the federal authority over the practice of pharmacy. - In the United States, pharmacy is regulated through licensure. - Licensure helps increase the quality of healthcare, reduce the cost of healthcare, and inhibit the criminal abuse of drugs. - State laws that regulate the practice of pharmacy, often called pharmacy practice acts, create state boards of pharmacy. - Most board of pharmacy members are practicing pharmacists and represent the spectrum of pharmacy practice. - Pharmacy boards are responsible for granting licenses to pharmacists and pharmacies, which helps ensure the competence and appropriateness of those practicing pharmacy and the facilities they practice in. - Licensure by the state boards of pharmacy heavily emphasizes structure and process, with less attention to the outcomes of drug therapy. - Pharmacy boards determine the standards that must be met for licensure, which may vary between states. - To become licensed as a pharmacist, state boards require specific criteria, including graduating from a pharmacy school, completing internship requirements, passing licensure exams, and being of good moral character. - Most state boards require passing scores on the NAPLEX and MPJE exams for licensure. - Most state boards of pharmacy allow pharmacists to transfer their license to practice from one state to another, if certain conditions are met. - Pharmacists must renew their licenses periodically, which typically require completion of CPE. CPE Monitor electronically tracks CPE and can be accessed for auditing purposes by pharmacy boards. - State boards of pharmacy also license pharmacies. Some states have different categories of licenses, and most pharmacies are required to have a designated PIC. - State pharmacy boards must confront how or whether to regulate nonresident pharmacies that do not dispense and telepharmacy. - Most states require nonresident (internet and mail order) pharmacies to be licensed within the state they ship medications. NABP has an accreditation process (VIPPS), which requires an active pharmacy domain. - State boards of pharmacy have discretion on how to discipline pharmacies and pharmacists, which could range from public reprimands, monetary civil penalties, license suspension, and/or license revocation. - State boards of pharmacy are required to follow disciplinary procedures specified in their state's pharmacy practice and administrative procedure acts. - Most states require pharmacists and pharmacies licensed in other states to self-report any discipline. One state may, in and of itself, discipline a license because of discipline in another state. - Grounds for discipline include providing false information on applications, violation of any statutes or rules pertaining to the practice of pharmacy, court convictions, moral turpitude, unprofessional conduct, and incompetence. - To help determine what constitutes "unprofessional conduct" or "moral turpitude," many states provide examples within their rules. Such lists should not be considered all-inclusive. - State laws may permit the board of pharmacy the discretion to consider reinstating a revoked license. - Most states have laws in place to assist pharmacists impaired because of drugs or alcohol. - Pharmacy licenses are subject to the same disciplinary actions and penalties as pharmacist licenses. - Circumstances may warrant disciplinary action against the pharmacy license or both the pharmacy and pharmacist license. - States have specific practice standards regarding how pharmacy is to be practiced and who can practice pharmacy in the state. - How each state legally defines the practice of pharmacy is very important, as it will provide for the scope of practice activities in which pharmacists may participate. - State-specific practice standards will address how ancillary pharmacy personnel such as pharmacy technicians may be utilized to assist pharmacists in nonjudgmental dispensing functions. - The current trend for pharmacy technicians in many states is to require registration, licensure, and/or national certification. - Most states recognize pharmacy students as interns, allowing them to perform pharmacist-only functions while under the direct supervision of the pharmacist. - States require pharmacists to be on duty while the pharmacy is open; however, pharmacists may be permitted to take breaks in or out of the pharmacy if specific conditions are met. - All states require pharmacists to complete ongoing CE. CPE Monitor provides an electronic system to help pharmacists, technicians, and state agencies to monitor CE requirements. - Most states now permit pharmacists to participate in CPAs and many permit pharmacists to prescribe certain medications under state protocols. - All states now require pharmacists to incorporate prospective DUR into the dispensing process. - The federal government and some states require pharmacies to take reasonable steps to ensure access to prescription information by LEP individuals. - Many states have drug repository or take-back programs to allow unused drugs to be recycled for patients that could not otherwise afford them. - Although some states include controlled substances in these programs, federal law does not consider this legal. - Drug repository or take-back programs have safety concerns such as adulteration. - Traditional states laws and rules governing pharmacy practice were specific to community pharmacy, therefore requiring states to amend or pass additional laws regarding pharmacy practice in the hospital setting. - Hospitals often utilize pharmacists outside the traditional pharmacy setting; therefore, some states have implemented laws allowing for expanded roles of pharmacy technicians in hospital pharmacies such as with tech-check-tech systems. - States typically regulate pharmacy services provided to LTCFs. - Pharmacy services and products provided to LTCFs must also comply with all legal requirements of prescriptions. - The majority of prescriptions dispensed across the country involve a third-party prescription plan, now called PBMs.