By American Society for Pharmacy Law (ASPL)
Post-Scrip is the podcast of The American Society for Pharmacy Law. ASPL is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the
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The podcast currently has 27 episodes available.
In this episode of Post-Scrip, Henry introduces Jeffrey S. Baird, JD. They discuss the upcoming "Advising a Pharmacy on Compliance Issues: Ethics Concerns".
Health care attorneys are in a unique place. When they advise health care providers (e.g., pharmacies), there are civil implications, potential criminal implications, and there are ethical challenges.
This program will discuss (i) ethical challenges that health care attorneys face and (ii) steps to address the challenges. Specifically, the program will discuss factual scenarios pertaining to the following ABA Model Rules of Professional Conduct:
Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona
In this episode of Post-Scrip, Henry introduces Kelli A. Boyden, JD; MS Pharmaceutical Sciences (Regulation) (2024). They discuss the upcoming "Key Supreme Court Decisions Impacting Pharmacies".
This presentation will focus on The U.S. Supreme Court’s rulings this year carry real-world effects on the pharmacy industry, including the FDA’s approval of mifepristone and addressing the standard for how courts defer to agencies. We will review these key Supreme Court’s decisions and discuss what the outcomes mean to pharmacy lawyers.
The Supreme Court’s review of the FDA’s approval of mifepristone in FDA v. Alliance for Hippocratic Medicine will shed light on future legal challenges to FDA approvals and resolve one issue in the evolving landscape for pharmacies with respect to dispensing medication abortion drugs.
Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona
In this episode of Post-Scrip, Henry introduces Douglas Braun, PharmaD, RPh, CPh, CSP. They discuss the upcoming "Impact of Inflation Reduction Act on Prescription drug costs, access and the financial impact of Medicare D reimbursement."
The implementation of the Inflation Reduction Act in 2024 has a significant impact on both pharmacies and patients. Patients covered under Medicare Part D will see potentially significant savings from capped insulin costs to major reductions in total out-of-pocket spending.
For patients receiving specialty medications, the IRA will be a huge relief from the financial toxicities that often face a patient and their access to affordable treatment. For pharmacies, it is a mixed bag of results. The reduction in out-of-pocket costs for patients can potentially allow patients to stay on therapy longer which can increase a pharmacy's revenue.
Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona
In this episode of Post-Scrip, Henry introduces Steven Postal, JD. They discuss the ASPL publications editing.
Steve Postal is the Publications Editor at ASPL and the Director of Policy and Regulatory Affairs at NCPA. His areas of expertise include Medicare Part D, compounding, and Medicaid. Before joining NCPA in April 2022, he worked for the American Physical Therapy Association in federal regulatory affairs.
Join us at the 35th annual conference: Developments in Pharmacy Law Seminar, November 7-10, 2024 in Phoenix, Arizona.
In this episode of Post-Scrip, Henry introduces Anthony P. Morreale, PharmD, MBA, BPCS, CPEL, FASHP. They discuss the upcoming "Pharmacogenomic Explosion: Legal and Liability Implications".
This presentation will focus on the rapid advancement of the science and its impact on prescribing and managing drug therapy and the consequences of ignoring pharmacogenomic evidence that is now present in well over 300 FDA approved medication prescribing information documents.
Integration of pharmacogenomic (PGx) testing into clinical practice has accelerated in select practice areas, moving it from a novelty to a standard part of patient care. That’s generally a good thing as it has proven in those areas to improve clinical outcomes. However, as PGx testing becomes a standard of care, failure to implement it could lead to instances where care may not be optimized, raising potential malpractice issues. There are a growing number of pharmacogenomic based legal cases that have been settled or resulted in significant financial judgments that deserve focus for all in the pharmacy and legal professions.
Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona
In this episode of Post-Scrip, Henry introduces Jeanne M. Brennan, BS Pharm, JD, and, William J. Stilling, BS Pharm, MS, JD. They discuss the upcoming Semaglutide as a Case Study for Compounding Legal Issues and Barriers
Semaglutide provides a case study for pharmacists who are trying to meet patient and prescriber needs and who strive to comply with federal and state laws and the explosive demand for semaglutide has created opportunities and risks. This demand has created a nationwide shortage of Ozempic and Wegovy. State boards of pharmacy are responding to complaints against pharmacists who are compounding semaglutide.
Obesity has been a national health epidemic for years. There is an insatiable hunger for weight loss solutions. Americans want to lose weight. Semaglutide appears to be the newest wonder weight loss drug. Patients and prescribers are touting its effectiveness on social media. The New England Journal of Medicine published a study in 2021 that has provided credibility to the weight loss industry. There are also the STEP trials providing dosing guidelines for weight loss.
Join us at the 34th annual conference: Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas
In this episode of Post-Scrip, Henry introduces Mary Canavan, JD and Kyle A. Vasquez, JD, LLM. They discuss the upcoming 340B Program Preservation and Compliance.
In this session, participants will learn how use the 340B statute and guidance to preserve 340B savings. In a climate where manufacturers and payors are uniformly taking action that harms covered entities (and patients), covered entities need to be prepared and start adapting. While manufacturer restrictions have been at the forefront of the 340B industry recently, there are several other stakeholders that are also taking actions that harm 340B savings such as PBMs.
As a result of these actions restricting the use of 340B drugs, covered entities have to become creative with how they internally build out their 340B programs, but due to the limited guidance available, the focus on compliance is more important than ever. This session will walk covered entities through case studies that demonstrate how other covered entities are becoming innovators and adjusting their 340B operations to preserve 340B savings. These models assess several areas of compliance, including: 340B, reimbursement, scope of practice, and telehealth.
Join us at the 34th annual conference: Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas
In this episode of Post-Scrip, Henry introduces Christopher R. Smith, JD, LLM. Henry and Chris discuss the upcoming. Drug Supply Chain Security Act Changes and Implications for Dispensers.
The presentation will provide an overview of the enhanced drug distribution requirements under the DSCSA and DSCSA interoperable electronic exchange requirements starting in November 2023. Specifically, the presentation will discuss the transition to a fully interoperable electronic system for transaction data exchange at the drug package level and compliance requirements for dispensers.
The presentation will further outline new statutory requirements regarding saleable returns and possible changes in government DSCSA enforcement following implementation of the 2023 changes. Finally, our presentation will list the features your pharmacy needs from a DSCSA solution provider, and list resources from the FDA and trade associations that will help ensure that your pharmacy complies with the DSCSA.
Join us at the 34th annual conference: Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas
In this episode of Post-Scrip, Henry introduces Todd A. Nova, J.D. Henry and Todd discuss the upcoming Current Trends in Retail & Specialty Pharmacy Pricing Compliance: Balancing Opportunity and Risk.
The role that retail and specialty pharmacies play in the healthcare delivery system continues to increase in importance as the drug product pipeline continues its inexorable shift to more self-administered and home-infused drugs. This shift has not gone unnoticed by various pharmacy industry stakeholders.
The speakers will also address related compliance investigation considerations, including the process for initiating and conducting compliance reviews under the attorney/client privilege and best practices for ongoing monitoring.
Join us at the 34th annual conference: Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas
In this episode of Post-Scrip, Henry introduces Marty Allain, JD. Henry and Marty discuss the upcoming Emerging Pharmacy Practice Innovation - A Regulatory and Legal Obstacle Course.
The session will discuss the emergence of new and non-traditional pharmacy business models that challenge current regulations and supporting legal foundations. Such models are often funded by venture capitalists and led by entrepreneurs who have been successful in other areas and view the pharmacy environment as a similar opportunity.
Speakers Edward McGinley and Marty Allain have worked with a number of such start-ups and will share with participants their experiences with these new pharmacy strategies and efforts to bring technological and innovative operations to pharmacy. Inherent to the discussion will be the legal and regulatory requirements that serve as needed safeguards and, at times, barriers to change and implementation. Those attending the session will gain a better understanding of changes that are occurring within pharmacy practice and the impact of such changes on existing practices and legal and regulatory requirements.
Join us at the 34th annual conference: Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas
The podcast currently has 27 episodes available.
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