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USP <800> Compliant Handling of Hazardous Drugs


Details:
Attendees will receive 8 hours of Continuing Education Hours.
 
Hazardous drugs (HDs) require safe and responsible handling for you and your team, whether medical, nursing, or pharmacy. USP <800> standards are designed to protect your team, environment and patients. Presented by speakers with demonstrated expertise in handling HDs, this program reviews current regulations and recommends best practices concerning all aspects of handling HDs. This CE will give insight into 1) developing and implementing best practices when compounding sterile and nonsterile HD, 2) understanding facility design, quality systems, process flow and risk assessment, and 3) preparing for inspection readiness.
 
Learning Objectives:
 
At the completion of this activity, the participant will be able to:
  1. Provide an overview of USP Chapter <800> for hazardous drug compounding.
  2. Classify hazardous drugs along with risk assessment and approaches for exposure control.
  3. Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them.
  4. Discuss the regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility.
  5. Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards.
  6. Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs.
  7. Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs.
  8. Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs.
 
Faculty:
 
Marc Stranz Pharm.D., Vice President of Compliance for Elwyn Pharmacy Group, a large multi-location independently owned and operated specialty pharmacy offering comprehensive specialty pharmacy services.
Dr. Marc Stranz has more than 30 years’ experience in sterile pharmacy compounding and was an early leader in the infusion industry.  He is a recognized business leader and subject matter expert, his work is part of the core practice standards of the compounding industry established by professional organizations and regulatory bodies. Dr. Stranz’s expertise includes clinical and operational services, regulatory compliance, accreditation, sterile compounding, and design/build of cleanrooms and infusion facilities. Marc has held branch, regional, national and corporate senior level positions with several national infusion providers managing clinical, operational and regulatory infusion policies, procedures and compliance.  He has served on the USP Expert Panel for Sterile Compounding, the Board of Pharmaceutical Specialties Practice Analysis Taskforce in Sterile Compounding, and the Institute of Environmental Sciences and Technology (IEST) Working Group for Controlled Environments per USP Chapter 797. Dr. Stranz has a BS and PharmD from the Medical College of Virginia at Virginia Commonwealth University.  He has served as an intermittent pharmacy surveyor for JCAHO and is currently an ACHC surveyor.  His work is widely published and he speaks to regional and national audiences often.
 
Jon Pritchett, Pharm.D., M.S., FASHP, ACHC Associate Director of Pharmacy
Dr. Jon Pritchett joined Accreditation Commission for Health Care (ACHC) in 2014 as Associate Director of Pharmacy.  He oversees the organization’s compounding programs, the Pharmacy Compounding Accreditation Board (PCAB) and ACHC Inspection Services (AIS). In 2014 Pharmacy Compounding Accreditation Board (PCAB) became a service of ACHC, aligning two organizations ensuring that safety and compliance needs are met in the most efficient and effective manner.  PCAB offers the most comprehensive compliance solution in the industry, with standards based on U.S. Pharmacopeial Convention (USP) guidelines.  PCAB assesses pharmacies that compound medications whether in the retail, hospital, mail order, or closed door setting. Dr. Pritchett directs an extensive on-site survey conducted by an independent expert and annual verification ensures compliance with the sterile and non-sterile pharmacy compounding process defined by USP <795>, USP <797>, and USP <800>. Jon is regularly invited to speak to boards of pharmacy, federal and state legislators and agencies, and pharmacists about USP standards and their implementation.  He has a diverse pharmacy background, most recently as Pharmacy Manager of a PCAB-accredited compounding pharmacy.  During this time he specialized in sterile and non-sterile compounding, and focused on men’ health and veterinary medicine. Dr. Pritchett earned his Doctor of Pharmacy (PharmD) from Campbell University College of Pharmacy and Health Sciences.  He is a member of the International Academy of Compounding Pharmacists (IACP), National Community Pharmacists Association (NCPA), American Society of Pharmacy Law (ASPL), and North Carolina Association of Pharmacists (NCAP).
 
 
How to create an Account:
Please see the instructions here
 
CE Hours
8.0
 
CE units
0.8

Date: Aug 24, 2017 08:30 AM - 05:00 PM

Fee

$395.00

Registration closes on Aug 24, 2017 05:00 PM

Activity Type

  • Knowledge

Target Audience(s)

  • Pharmacists
  • Pharmacy Technicians
  • Nurses
  • Medical Professionals

Accreditation(s)

Accreditation Council for Pharmacy Education
VCU School of Pharmacy Office of Continuing Education is on probation as an accredited provider of continuing pharmacy education by the Accreditation Coutncil for Pharmacy Education

 

 

Registration closes on Aug 24, 2017 at 05:00 PM

Registration Closed  

Objectives

  • Provide an overview of USP Chapter <800> for hazardous drug compounding.
  • Classify hazardous drugs along with risk assessment and approaches for exposure control.
  • Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them.
  • Discuss the regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility.
  • Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards.
  • Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs.
  • Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs.
  • Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs.

Speaker(s)/Author(s)

John Pritchett

Marc Stranz

Activity Number

0294-9999-17-091-L07-T
Date: 08/24/17
Time: 08:30 AM - 05:00 PM
Registration Closed  

Registration Closed  

Objectives

  • Provide an overview of USP Chapter <800> for hazardous drug compounding.
  • Classify hazardous drugs along with risk assessment and approaches for exposure control.
  • Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them.
  • Discuss the regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility.
  • Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards.
  • Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs.
  • Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs.
  • Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs.

Speaker(s)/Author(s)

John Pritchett

Marc Stranz

Activity Number

0294-9999-17-091-L07-P
Date: 08/24/17
Time: 08:30 AM - 05:00 PM
Registration Closed  

Registration Closed  

Objectives

  • Provide an overview of USP Chapter <800> for hazardous drug compounding.
  • Classify hazardous drugs along with risk assessment and approaches for exposure control.
  • Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them.
  • Discuss the regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility.
  • Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards.
  • Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs.
  • Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs.
  • Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs.

Speaker(s)/Author(s)

John Pritchett

Marc Stranz

Date: 08/24/17
Time: 08:30 AM - 05:00 PM
Registration Closed