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Pharmacy Law and Regulatory

Controlled Substances: Regulatory Overview and Strategies for Preventing Misuse and Diversion

Nina Cimino, Pharm.D.
Assistant Professor at University of Maryland School of Pharmacy
Baltimore, Maryland

ACPE activity # 0204-0000-15-443-H03-T
1 hour (0.1 CEU)

This activity will provide an overview of the laws and regulations governing the management of controlled substances in pharmacy practice. The process for utilizing controlled substances, including procurement, dispensing, and disposal will be covered. Strategies for preventing controlled substance misuse and diversion will also be described, with an emphasis on the role of pharmacy technicians in recognizing and preventing misuse and diversion.

Learning Objectives

  • List the key federal law governing controlled substance prescribing, dispensing, and distribution and describe its impact on pharmacy practice.
  • Describe the process of controlled substance procurement, dispensing, and disposal.
  • Given a patient case, identify strategies which can be used by pharmacy personnel to reduce controlled substance misuse and diversion.
  • On-Demand
  • CE Monograph

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FDA Update 2015: Initiatives Impacting Today's Practice

Kimberly Chiu, Pharm.D.
Consumer Safety Officer, Division of Drug Information
U.S. Food and Drug Administration
Silver Spring, Maryland

Lena Choe, Pharm.D.
Team Leader, Division of Drug Information
U.S. Food and Drug Administration
Silver Spring, Maryland

ACPE activity # 0204-0000-15-225-L03-T
1 hour (0.1 CEU)

Join us for proceedings from the 2015 ASHP Midyear Clinical Meeting. This session will provide pharmacy technicians with an update on initiatives from the FDA including requirements of the Physician Labeling Rule (PLR) for prescription drug labeling and the Pregnancy and Lactation Labeling Rule (PLLR). FDA's proposed rule for Electronic Distribution of Prescribing Information for Human Prescription Drugs will also be highlighted.

Learning Objectives
At the conclusion of this knowledge-based educational activity, participants will be able to

  • Identify key content and format requirements of the "Physician Labeling Rule" for prescription drug labeling.
  • Describe the Pregnancy and Lactation Labeling Rule (PLLR).
  • Explain FDA's proposed rule "Electronic Distribution of Prescribing Information for Human Prescription Drugs."
  • Identify the potential impact of the PLLR and FDA's proposed rule.
  • Describe other 2015 FDA initiatives.
  • On-Demand
  • CE Monograph

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Implementation of the Affordable Care Act: The Role of Pharmacy in Healthcare Reform

Christopher J. Topoleski
Director, Federal Regulatory Affairs
The American Society of Health-System Pharmacists
Bethesda, Maryland

ACPE activity # 0204-0000-14-497-H03-T
1 hour (0.1 CEU)

The Affordable Care Act has brought about a number of changes in healthcare. Many of the programs enacted by the ACA impact pharmacy practice and bring about opportunities for enhanced delivery of care to patients. The pharmacy team is an integral part of implementation of healthcare reform programs. This presentation focuses specifically on the pharmacy technician's role in moving healthcare forward in the United States.

Learning Objectives
After participating in this knowledge-based educational activity, participants should be able to

  • Explain the current health policy environment and the impetus for health care reform
  • Articulate the direction that the provision of healthcare is moving in the United States and the role of non-physician practitioners
  • Identify the various quality incentive and shared savings programs enacted by the Affordable Care Act (ACA) and be able to articulate the differences between them
  • Discuss opportunities for health care professionals, including technicians, to participate in the implementation of various health reform programs as enacted as part of the ACA
  • Podcast
  • On-Demand
  • CE Monograph

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Regulatory Affairs Overview

Al Carter, Pharm.D.
Director, Professional Affairs
Walgreen Company
Deerfield, Illinois

Karla M. Miller, Pharm.D., BCPP
Assistant Vice President
Pharmacy Services and Clinical Therapeutics
Hospital Corporation of America, Clinical Services Group
Nashville, Tennessee
Assistant Faculty
University of Tennessee
Memphis, Tennessee

ACPE activity # 0204-0000-13-432-H03-T
1 hour (0.1 CEU)

This regulatory update will describe in detail the oversight of the Centers for Medicare and Medicaid Services (CMS) as it relates to pharmacy practice. The roles of federal and state agencies will be outlined, including which entities have jurisdiction in specific situations. Faculty will also clarify the documentation required by various regulatory agencies.

Learning Objectives
At the conclusion of this knowledge-based educational activity, participants will be able to

  • Define and explain each major federal and state regulatory agency and its impact on the practice of pharmacy.
  • Explain the jurisdiction granted to each regulatory agency and the existing overlap of federal and state jurisdictions.
  • Describe the documentation requirements for prescription records and retention requirements with many of the state and federal agencies.
  • Podcast
  • On-Demand
  • CE Monograph

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Regulatory Affairs: Regulatory Aspects of Sterile Compounding

Angela T. Cassano, Pharm.D., BCPS, FASHP
President
Pharmfusion Consulting, LLC
Midlothian, Virginia

ACPE activity # 0204-0000-13-437-H03-T
1 hour (0.1 CEU)

Expert faculty will reviewpublished guidelines and standards pertaining to compounded sterile products (CSPs) with a special emphasis on key sections of USP Chapter 797. Pharmacy technicians will learn how to assist with regulatory compliance and patient safety.

Learning Objectives
At the conclusion of this knowledge-based educational activity, participants will be able to

  • Describe published guidelines and standards pertaining to compounded sterile products (CSPs).
  • Explain key sections of USP Chapter <797>.
  • Identify areas of USP Chapter <797> where pharmacy technicians can assist with regulatory compliance and patient safety.
  • Podcast
  • On-Demand
  • CE Monograph

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Risk Evaluation and Mitigation Strategies (REMS): Ensuring Access and Safe Use of Pharmaceuticals with Special Concerns

James M. Hoffman, Pharm.D., M.S., BCPS
Associate Member, Pharmaceutical Sciences
Medication Outcomes and Safety Officer
St. Jude Children's Research Hospital
Memphis, Tennessee

ACPE activity #0204-0000-13-440-H03-T
1 hour (0.1 CEU)

Risk evaluation and mitigation strategies (REMS) have become an established medication safety mechanism. REMS can have a variety of components such as medication guides, communication plans, or elements to assure safe use. In some cases, REMS facilitate continued access to innovative medications with serious risks that otherwise would not be available. As REMS have become a common feature of the medication use process, it is important for pharmacy technicians to understand the rationale for the development of REMS and their potential components.

This educational activity is designed to educate pharmacy technicians about REMS for drugs dispensed by pharmacies in any practice setting. By understanding specific requirements of approved REMS programs and the challenges they can present, pharmacy technicians can contribute to the successful implementation of REMS. Practical strategies pharmacy technicians can take to assist in managing REMS requirements will be described.

Learning Objectives
At the conclusion of this knowledge-based educational activity, participants will be able to

  • Define Risk Evaluation and Mitigation Strategies (REMS) and the rationale for their development.
  • Identify key features of REMS, including their structure, potential components, and the selection process.
  • Describe trends in the number of drugs with REMS requirements and how REMS have changed since they took effect in 2008.
  • Identify challenges and opportunities REMS present to pharmacies.
  • Explain practical approaches to proactively and effectively implement REMS, including the proper distribution of medication guides.
  • Podcast
  • On-Demand
  • CE Monograph

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USP <800>: Strategies for Compliance

Patricia C. Kienle, M.P.A., B.S.Pharm., FASHP
Director, Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions
Laflin, Pennsylvania

Eric S. Kastango, B.S.Pharm, M.B.A., FASHP
President/CEO
Clinical IQ, LLC and CriticalPoint, LLC
Madison, New Jersey

ACPE activity # 0204-0000-15-131-H03-T
2 hours (0.2 CEU)

USP <800> Hazardous Drugs - Handling in Healthcare Settings has been published for public comment and is planned to be official (so, enforceable) in 2016. Though the chapter is based on public documents that have been in the literature since the 1980s, many organizations are not fully compliant with all the containment requirements. This session will summarize the requirements and assist the attendees in developing an Action Plan to prioritize aspects of USP <800>.

Learning Objectives

  • Identify the key hazardous drug containment strategies in USP <800>.
  • List the facility requirements for receipt, storage, compounding, transport, and administration of hazardous drugs required by USP <800>.
  • Describe the cleaning steps required to decontaminate hazardous drug areas.
  • Compare the requirements in USP <800> to OSHA, NIOSH, ASHP, and ONS standards and guidelines.
  • Develop an Action Plan to comply with USP <800> prior to the time it is enforceable.
  • On-Demand
  • CE Monograph

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