We know you’re not always able to take a continuing education course at a specific time and date. That’s why APC also offers our live courses on-demand. Although you can’t ask questions in real time, you get the same CE credit, and you can take the class anytime, anywhere, and review the video as often as you like.
On-demand versions of our live courses usually become available about a week after the live presentation.
BUDs & Stability Studies Under the Proposed New USP Chapters
Mindy Cormier, PharmD, R.Ph.
Beyond-use dates have become a hot topic for compounding pharmacists. This session will review the discussion surrounding non-sterile and sterile beyond-use date appeals, and the importance of beyond-use dating for facilitating workflow efficiencies and patient access to personalized medicine. New requirements for default and extended beyond-use dating according to proposed USP <795> and <797> will be included, as well as what to look for in a stability-indicating study. Attendees will learn how to apply professional judgment in extrapolating stability data for extending beyond-use date.
USP: Minor Chapters, Major Impacts
In this session, our speaker will outline regulatory considerations for USP Chapters and FDA guidelines, and explain USP <61> and USP <62> tests and how they determine if non-sterile products meet quality requirements. The significance of USP <51> preservative-effectiveness testing in compounding, the importance of a container closure system for a drug product, and the test requirements for compounded preparations in USP <1163> will be detailed as well.
The Biopharmaceutical Classification System: What You Should Know
Vanessa Pinheiro, Pharmacist Consultant
This session will look at the classes of the Biopharmaceutical Classification System (BCS) and the importance of drug dissolution for absorption after oral administration of solid dosage forms. Excipients that could impact the dissolution of active pharmaceutical ingredients (APIs), considerations for formulation development when compounding from an API or an existing drug product, and literature related to the BCS and compounding pharmacy will be included.
USP <797> BUDs: An Update
USP Chapters have recently undergone several changes, including standards for beyond-use dates. Our speaker will review USP’s process for standard creation, summarize the revisions proposed for USP <797> and discuss the next steps for the chapters. Attendees will learn where to find the proposed revisions to the chapters and the supplementary materials.
USP <795> BUDs: An Update
Gus Bassani, PharmD
USP Chapters have undergone much change in recent year, including standards for beyond-use dates. Our speaker will review USP’s process for standard creation, summarize the revisions proposed for USP <795> and discuss the next steps for the chapters. Attendees will be provided with information on where to find the proposed revisions to the chapters and the supplementary materials.
Implementing Pharmacogenomic Testing in Your Practice
Peter Clapp, Ph.D. and Lisa Faast, PharmD
Adding pharmacogenomic testing to your pharmacy practice can increase revenues and improve patient outcomes. This session will include a review of single nucleotide polymorphisms (SNPs) in pharmacogenetic analyses and the possible consequences of metabolic enzyme polymorphism on drug disposition. You will learn how to identify potential patients for PGx testing, recognize compensation models for PGx services, and how to market this service to grow your pharmacy.
R&D Roundtable: How Compounders are Aiding Medical Research
Facilitator: Alexander Pytlarz, R.Ph.; Panelists: Linda McElhiney, R.Ph.; Joe Navarra, R.Ph.; and David Mastropietro, R.Ph., Ph.D.
There is a wide range of medical research projects in which compounders are engaged and can be engaged. Our panel of speakers will provide attendees with an understanding of the research protocols under which compounders can engage in supporting medical research projects and explain how to cultivate relationships with medical research and identify R&D opportunities related to compounding.
Cultural Competency & Bias Training
Denise Frank, BPharm, R.Ph., FACA
The Affordable Care Act’s Section 1557, “Nondiscrimination in Health Programs and Activities,” was created to reduce disparities in health care and prohibits discrimination on the basis of sex in federally funded health programs. This session will provide examples of discrimination, and review key provisions of the rule, including enforcement and consequences of noncompliance. Attendees will learn how to recognize types of discrimination and develop a plan for their work setting to become compliant.
Compounder Ethics: The Code as Compliance Strategy
This session will review the new code of ethics adopted by Alliance for Pharmacy Compounding, The Pharmacy Compounding Professional’s Code of Ethics. Characteristics of ethical behavior in the practice of pharmacy and ethical principles as they relate to compounders will be included. Our speaker will also describe frameworks used in ethical decision-making that you can use when confronted with ethical dilemmas.
Veterinary Compounding: Considerations & Clinical Pearls
Deborah Clark, R.Ph.
Compounding for veterinary patients requires special considerations when choosing a route of administration and dosage form for a given species. Our speaker will provide an overview of toxicities to consider when choosing a commercially available drug product or when formulating a compounded product, as well as appropriate dosage forms for the canine, feline and equine patient. Unique dosage form options that may give a better therapeutic outcome in certain species will be included.
When the DEA Comes Calling: Preparing for and Managing that Inspection
What do you do when the Drug Enforcement Administration (DEA) inspector shows up at your pharmacy? What is the extent of DEA inspection authority and what enforcement actions can occur? This session will help you prepare for and know what to expect during a DEA inspection, including do’s and don’ts, policies and procedures, and the importance of conducting a post-inspection mirror audit.
Jim Hrncir and Ashley Berthelot
Explore innovative protocols and opportunities to optimize outcomes for patients suffering from debilitating neuroinflammatory disorders. Paired well with discussions on provider outreach tactics and how to best educate providers on the clinical mechanisms behind these protocols — this program will open the doors to new possibilities.
Controlled Substances & the Corresponding Responsibility of the Pharmacist and Pharmacy Technician
With Erika Fallon, PharmD, RPh
The DEA’s recently revised “Pharmacist Manual” states, “To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a corresponding responsibility rests with the pharmacist who fills the prescription.”
Compounding pharmacists may find themselves uniquely vulnerable to enforcement action and penalties provided for violations of the provisions of law relating to controlled substances. 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Specific challenges include “off-label” usage of controlled substances, novel therapies that are not well established in scientific literature, and unreliable information regarding what other medications patients are taking. This program seeks to educate and equip pharmacists and pharmacy technicians on best practices and strategies to ensure compliance, including recognizing red flags, patients with substance abuse disorders, over-utilization, documentation of diagnosis, and checking the Prescription Drug Monitoring Program (PDMP).
Some Hot Topics Concerning Hazardous Drugs
With L. Rad Dillon, RPh
Despite being available for review for a number of years, confusion and misunderstandings remain concerning USP <800>, especially regarding certain key topics. This presentation will examine two such topics, personal protective equipment and cleaning & disinfection, in a manner that makes the requirements understandable and easy to apply. Material will be organized in an easy-to-understand fashion, making use of tables, charts, and key takeaways. With the official implementation of proposed USP <795> and <797>, as early as a few months away, inspection-ready compliance with USP <800> will be required for all States governed by USP standards, if not already required.
HVAC and Cleanroom Workflow
With Bryan Prince, MBA
One of the most important criteria for the success of a compliant sterile and/or nonsterile compounding room is the HVAC system. USP and ISO have minimum particle count classifications, as well as air changes per hour requirements which are foundational to certifying a cleanroom. Additionally, people and process generate heat and seasons change, all of which affect the performance for the HVAC system connected to the cleanroom. During this presentation, we will clearly define how to design an appropriate HVAC system, taking into account compounding workflow considerations.
Surviving an Inspection
With Melissa Stefko, MBA
In this activity, we will discuss how to prepare for and what to expect during an inspection. We will cover firm’s rights during an inspection, common inspection techniques used by auditors and appropriate responses. Additionally we will go through common items investigated as well as common investigational findings in compounding pharmacies. Lastly, we will also cover how to write an effective response to the regulatory agency.
Even more courses
Through partnerships with LP3 and SeminarWeb, APC offers additional on-demand continuing education classes related to pharmacy compounding from APC and other publishers.