Essential Elements of Prescription Analgesic Compounding
Essential Elements of Prescription Analgesic Compounding
Essential Elements of Prescription Analgesic Compounding

Essential Elements of Compounded Sterile Preparations

ACTIVITY DESCRIPTION

The Practice-based Activity will provide the pharmacist and technician with current theoretical knowledge, practical skill and measurable competencies necessary to meet the high standard of practice required for a sterile compounding practice and the autonomy to make informed decisions as they relate to a broad range of performance measures. The activity is comprised of an interactive self-study workbook and a highly dynamic live event staged in a sterile compounding facility. Pharmacists and technicians will be afforded the opportunity to prepare compounded sterile preparations in an ISO class 5 environment. Further, pharmacists and technicians will learn how to conduct all necessary maintenance, control, monitoring and testing procedures to sustain a sterile compounding facility and prepare compounded sterile preparations as they ensure high quality, assess elements of risk and learn how to validate all aspects of sterile compounding practice.

The Practice-based Activity features a series of 16 workstations, each one-hour in duration, and includes four (4) compounded sterile preparations, four (4) simulated sterile preparations, a robust Media-Fill Challenge test, Master Formulation Record design, facility workflow design, risk management assessment development, validation protocol development, observational auditing, automated compounding device training, and a hands-on session related to a series of technologies used in environmental monitoring, measuring, preparation testing, sterilization, sanitization, incubation and validation.

INTENDED AUDIENCE

Pharmacists and Technicians new to sterile compounding or with an existing compounding practice.

ACTIVITY DESIGN

A two part activity; self-study with learning assessment and live event with competency assessment.

HOME STUDY, OVERALL LEARNING OBJECTIVES FOR PHARMACISTS AND TECHNICIANS

  1. Classify traditional compounding pharmacies and outsourcing facilities in order to understand the parameters of practice for each of these two compounding classifications that fall under the new Drug Quality and Security Act H.R3204In Australia: Classify compounding into Simple and Complex in order to understand the parameters of practice for each of these two compounding classifications, and their guideline requirements
  2. Describe the infrastructure and subdivisions of a quality management system for compounding; System P and its related categories
  3. Identify the relevance and impact of Unites States Pharmacopeia chapters and their relationship to a non-hazardous and hazardous compounding practiceDescribe a quality assurance management system addressing SHPA Guidelines, PSA’s Professional Practice Standards, PIC/S
  4. Discuss roles and responsibilities, theoretical and practical skills, and performance verification-related testing
  5. Classify traditional compounding pharmacies and outsourcing facilities in order to understand the parameters of practice for each of these two compounding classifications that fall under the new Drug Quality and Security Act H.R3204In Australia: Classify compounding into Simple and Complex in order to understand the parameters of practice for each of these two compounding classifications, and their guideline requirements
  6. Describe the infrastructure and subdivisions of a quality management system for compounding; System P and its related categories
  7. Identify the relevance and impact of Unites States Pharmacopeia chapters and their relationship to a non-hazardous and hazardous compounding practiceDescribe a quality assurance management system addressing SHPA Guidelines, PSA’s Professional Practice Standards, PIC/S
  8. Discuss roles and responsibilities, theoretical and practical skills, and performance verification-related testing required for personnel involved in non-hazardous and hazardous compounding
  9. Discuss engineering and architectural design concepts and requirements for the safe handling and management of nonhazardous and hazardous drugs
  10. Describe structural, functional, and operational primary and secondary engineering control requirements for the safe handling and management of non-hazardous and hazardous drugs
  11. Relate principles of air pressure differentials, airflow dynamics, and critical first air to sterile compounding
  12. Express the relevance of technology used in non-hazardous and hazardous drug compounding; electromechanical, reusable, disposable, personal protective equipment, safety, emergency, testing, and deactivation/decontamination and disinfection equipment and supplies
  13. Recall procedures involved in the safe handling, maintenance, monitoring, testing and verification of a sterile compounding environment
  14. Describe protocols for the deactivation/decontamination and disinfection of ISO class environments for non-hazardous and hazardous drug compounding
  15. Outline the relative significance of Process Development as it applies to the development of a Master Formulation Recor
  16. Relate the functions of excipients to compounded sterile preparations
  17. Discuss clinical considerations that must be applied to sterile compounding to help to ensure patient safety in a patient-centric practice
  18. Discuss the components of a Master Formulation Record used for compounded sterile preparations
  19. Recall pharmaceutical calculations used in a sterile compounding practice
  20. Repeat a comprehensive series of aseptic techniques related to the compounding of sterile preparations

LIVE EVENT, OVERALL LEARNING OBJECTIVES FOR PHARMACISTS AND TECHNICIANS

  1. Argue in defense of the parameters of a quality management system engaged in sterile compounding for non-hazardous and hazardous drugs
  2. Support standards of practice and scientific principles applicable to sterile compounding for non-hazardous and hazardousdrugs
  3. Defend the application of risk management that addresses sterile compounding and the safe handling and management of non hazardous and hazardous drugs
  4. Propose verification procedures that satisfy the scientific principles of efficacy, reliability, and validity for numerous operational and functional parameters within a sterile compounding practice
  5. Defend a functional and operational facility workflow design schematic for a sterile compounding facility in compliance with standards of practice related to the safe handling and management of non-hazardous and hazardous drugs
  6. Practice gowning, technology transferring, entering, and exiting protocols within ISO class controlled environments
  7. Practice a series of aseptic techniques in consideration of critical first air, touch- and cross- contamination
  8. Practice aseptic techniques used to compound sterile preparations in an ISO class environment and in compliance with the United States Pharmacopeia (USP), SHPA, PIC/S and related standards of practice
  9. Practice aseptic techniques specific to hazardous drug compounding utilising closed system transfer devices
  10. Defend the use of monitoring- and testing- related technologies used in a sterile compounding practice
  11. Assess the use and application of indicators and integrators that serve as controls during environmental monitoring, incubation, terminal sterilisation, and depyrogenation protocols
  12. Manage the use of technologies used for microbial air and surface sampling, non-viable particulate monitoring, filter integritytesting, preparation sterility and endotoxin testing, terminal sterilisation, depyrogenation, disinfection, incubation, and SEC/CSEC/ PEC/C-PEC HEPA filter integrity and airflow dynamics
  13. Demonstrate a robust media-fill challenge test in compliance with USP standards of practice
  14. Manage environmental-, human performance-, and preparation-related audits in compliance with USP and related standards of practice
  15. Assess regulatory-, preparatory-, and clinical- related risk in a sterile compounding practic
  16. Demonstrate the use and functional parameters of an Automated Compounding Device (ACD) used in a sterile compounding practice
  17. Design a Master Formulation Record that consists of pre- and post- qualification requirements related to facility, technology, and personnel, preparation testing, end-stage filtration, terminal sterilisation, inspection, beyond-use dating, packaging, labeling, and shipping

ACCREDITATION

S2016/47: This CPD event has been accredited for 50 hours of Group-2 CPD (or 100 CPD Credits), suitable for inclusion in an individual pharmacist’s CPD plan.

APC Accredited CPD

S2016/47: The activity accreditation period is from 1 May 2016 – 30 April 2019.

EDITORS

PATRICIA ULLMANN

CPD Coordinator and Compounding Pharmacist, MEDISCA Australia.

Neil Cohen, BSc

CE Coordinator, LP3 Network Inc.

CONTRIBUTORS

Mark Filosi, BSc, RPh

Compounding Pharmacist and Co-Founder, Family Care Pharmacy.

Kenneth Latta, RPh, BS Pharm, FIACP, FACA

Senior Associate, Gates Healthcare Associates.

Ken Speidel, RPh, BS Pharm, PharmD, FIACP, FACA

Senior Associate, Gates Healthcare Associates.

FACILITATORS

Joe Cabaleiro, BSc, RPh

Senior Associate, Gates Healthcare Associates.

Mark Filosi, BSc, RPh

Compounding Pharmacist and Co-Founder, Family Care Pharmacy.

Kenneth Latta, RPh, BS Pharm, FIACP, FACA

Senior Associate, Gates Healthcare Associates.

Branko Radojkovic, BPharm

Pharmacist, Royal Prince Alfred Hospital, Consultant, MEDISCA Australia.

KEN SPEIDEL, RPh, BS Pharm, PharmD, FIACP, FACA

Senior Associate, Gates Healthcare Associates.

Patricia Ullmann, BPharm

Compounding Pharmacist, MEDISCA Australia.

COPYRIGHT

Activity material is Copyright© 2006-2019 LP3 Network Inc.

COMPLETION REQUIREMENTS

Activity participants are required to achieve a 75% passing grade associated with a self study learning assessment prior to attending the live event. Full attendance and the completion of an activity evaluation and practical skill set competency evaluation are a compulsory requirement to achieve credit for the live event.

DECLARATIONS AND DISCLOSURES

This activity is independent of any known bias, prejudice or commercial interest. Both MEDISCA Australia and LP3 Network assist with the marketing of this activity. LP3 Network is an independent corporation. LP3 Network has an established agreement with MEDISCA AUSTRALIA ensuring that it has no influence on LP3 Network as it relates to activity offerings.

FINANCIAL SUPPORT

An unrestricted educational grant has been provided by MEDISCA toward the purchase of electromechanical equipment, reusable and disposable devices, protective and safety supplies, and chemicals specific to compounded medications prepared during laboratory sessions.

HOTEL ACCOMMODATIONS

Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.

FOOD AND BEVERAGE

As a matter of activity programming, meals and refreshments during live activities have been provided by MEDISCA Australia.

CANCELLATION AND REFUND POLICY

A written request must be sent to MEDISCA Australia requesting a ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from the live activity event date, then the registrant will receive a 75% refund; 15-30 days is a 50% refund; and less than or equal to 14 days will result in no refund.

TRANSFER POLICY

The transfer policy is only in effect if requested less than or equal to 15 days post original live activity event date. Failure to submit the “Transfer Request” within 15 days post original live activity event date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity event date must be within the current calendar year. Failure to attend the new live activity event will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by MEDISCA Australia based on the number of available seats within the selected live activity event.


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