In this episode of Post-Scrip, Henry introduces Jenni Wai, RPh. , MBA, Josh Bolin and Christopher R. Smith, JD, LLM. They discuss the upcoming "Regulatory, Industry and Legal Perspectives on the Future of the DSCSA".

This presentation will provide an update on the final stages of implementation of the DSCSA and anticipated future regulatory efforts. We will begin with a brief high level overview of the DSCSA, including a summary of recent regulatory developments, such as any new regulations or guidance documents issued by the FDA in 2024 with regard to the DSCSA. We will then pivot to address the end of the one-year FDA stabilization period, recent feedback from the pharmacy industry regarding DSCSA compliance concerns, and the readiness of the pharmacy industry to fully implement and obstacles to implementation of the interoperable electronic exchange of transaction data.

 We plan to include a discussion of the tools available to pharmacies to assist with compliance with DSCSA requirements as DSCSA implementation evolves. We will further discuss the challenges that state regulators face with regard to ensuring that dispensers, wholesalers and manufacturers comply with the DSCSA, particularly with regard to ensuring that stakeholders have robust processes for identifying, investigating and responding to suspect and illegitimate products.

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 Marty Allain, JD. They discuss the upcoming "How Drug Manufacturer Restrictions and Recent Court Decisions are Re-Shaping 340B Drug Distribution and Delivery Models".

Pharmaceutical manufacturers continue to restrict the delivery of 340B drug discounts to contract pharmacies in response to the growth of 340B sales, perceived non-compliance with 340B program requirements, and statutory interpretation. These restrictions have a significant financial impact on hospitals, health centers, and other health care providers that participate as “covered entities” in the 340B program.

This presentation will also cover other “hot topics” with respect to 340B contract pharmacy arrangements, including the impact of the U.S. District Court Decision, Genesis vs. Becerra, rejecting a restrictive interpretation of “patient” under the 340B program.

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 Amanda Ward, PharmD, MS, BCGP. They discuss the upcoming "DASPL Class II Capsule Projects". 

As pharmacists continue to move beyond traditional roles in a dispensing pharmacy, state boards of pharmacy may have additional types of licensure pharmacists must have to perform those services. A review of all 50 states boards of pharmacy will reveal if the pharmacists must license their non-dispensing services as a pharmacy or if their licensure as a pharmacist is sufficient.

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 Roger N. Morris, JD, RPh. They discuss the upcoming "Case Law Update". 

ASPL’s annual case law update will provide summaries of court decisions, lawsuits, and settlements from the last twelve months. The presentation will explore a variety of civil and criminal cases at the state and federal level involving pharmacy employment issues, fraud claims by employees and the government (e.g., False Claims Act cases), negligence (malpractice), managed care, disciplinary actions by regulatory boards, controlled substances, and more.

 Whether you are an attorney, pharmacist, compliance officer, or work in any area related to pharmacy law, this fast-paced overview will inform you of the most important legal decisions affecting your practice.

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 Jeff Mesaros, PharmaD, MS, JD. They discuss the upcoming "Pharmacy Law Educators' Session - Using AI in the classroom". 

This session begins with a presentation of using AI in the classroom followed by a panel session addressing implementation and regulation of AI in pharmacy practice.

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 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