Essential Elements of Compounded Sterile Preparations - Home Study

This knowledge-based activity will provide the pharmacist and technician with the necessary comprehension and know-how to meet current standards of practice required for non-hazardous and hazardous drug sterile compounding. Founded on a unique concept known as System P, participants will learn to appreciate the value of establishing a strong compounding practice infrastructure. System P includes the following divisions: Personnel, Property, Procedure, Process, Preparation, and Patient, as its building blocks. Each component of System P is very much dependent on, and in support of, one another.

Personnel are a compounding pharmacy’s most important asset; this section covers personnel roles and responsibilities, competencies, practical testing requirements in the form of health and hygiene, garbing, media-fill challenge testing, fingertip touch testing, aseptic techniques, hazard communication, and medical surveillance programs.

Personnel work in ISO class cleanroom environments and with technology categorized into electromechanical, reusable, disposable, personal protective equipment, safety and emergency equipment, deactivation/decontamination supplies and chemical agents, testing equipment, and the ingredients used to prepare compounded sterile preparations. The cleanroom, related technology, and chemical supplies make up property.

Procedures are the routine, scheduled activities performed in a compounding practice that encompass the management, maintenance, monitoring, calibration, environmental testing, and decontamination and disinfection protocols that help to ensure safe handling of chemicals, inventory and storage, technology utilization, waste management, and facility and preparation sterility.

In association with process development, preparations, and patients are the detailing process development worksheets, master formulation records, and compounding records. The home study showcases a comprehensive master formulation record template; a critical and required centerpiece for any compounding practice, that can be utilized during the process of establishing formulations, documenting master formulations, and completing compounding records upon receipt of a prescription.

Upon concluding this home study, participants will gain a solid foundation and appreciate the reliance and interdependency between each System P category that is clearly delineated and detailed, fulfilling required standards of practice.


Intended audience


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


Learning Assessment:

Please make sure to complete the home study learning assessment within 60 days of purchase. If this is not possible, please contact the LP3 Network Team.


Learning Objectives

FOR PHARMACISTS:
  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.R. 3204.
  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 practice.
  4. Discuss roles and responsibilities, theoretical and practical skills, and performance verification-related testing required for personnel involved in non-hazardous and hazardous compounding.
  5. Discuss engineering and architectural design concepts and requirements for the safe handling and management of non-hazardous and hazardous drugs.
  6. Describe structural, functional, and operational primary and secondary engineering control requirements for the safe handling and management of non-hazardous and hazardous drugs.
  7. Relate principles of air pressure differentials, airflow dynamics, and critical first air to sterile compounding.
  8. 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.
  9. Recall procedures involved in the safe handling, maintenance, monitoring, testing and verification of a sterile compounding environment.
  10. Describe protocols for the deactivation/decontamination and disinfection of ISO class environments for non-hazardous and hazardous drug compounding.
  11. Outline the relative significance of process development as it applies to the development of a master formulation record.
  12. Relate the function(s) of excipients to compounded sterile preparations.
  13. Discuss clinical considerations that must be applied to sterile compounding to help to ensure patient safety in a patient-centric practice.
  14. Discuss the components of a master formulation record used for compounded sterile preparations.
  15. Recall pharmaceutical calculations used in a sterile compounding practice.
  16. Repeat a comprehensive series of aseptic techniques related to the compounding of sterile preparations.
FOR TECHNICIANS:
  1. Identify the differences between traditional compounding pharmacies and outsourcing facilities under the new Drug Quality and Security Act H.R. 3204.
  2. Describe the infrastructure and subdivisions of a quality management system for compounding; System P and its related categories.
  3. List Unites States Pharmacopeia chapters and their relationship to a non-hazardous and hazardous compounding practice.
  4. List roles and responsibilities, theoretical and practical skills, and performance verification-related testing required in maintaining an appropriate level of competency when performing non-hazardous and hazardous compounding.
  5. Recognize engineering and architectural design concepts required for the safe handling and management of non-hazardous and hazardous drugs.
  6. Recognize structural, functional, and operational primary and secondary engineering controls when compounding and handling non-hazardous and hazardous drugs.
  7. Relate principles of air pressure differentials, airflow dynamics, and critical first air to sterile compounding.
  8. Identify relevant 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.
  9. Recall procedures involved in the safe handling, maintenance, monitoring, testing and verification of a sterile compounding environment.
  10. Relate protocols for the deactivation/decontamination and disinfection of ISO class environments to non-hazardous and hazardous drug compounding activities.
  11. Recognize the importance of process development leading to the development of a master formulation record.
  12. Recognize the function(s) of excipients found in sterile preparation master formulation records.
  13. Recognize clinical considerations a pharmacist-in-charge must consider to ensure patient safety in a patient-centric practice.
  14. Explain how to follow and complete a master formulation record used for documenting compounded sterile preparations.
  15. Recall pharmaceutical calculations used under the supervision of a pharmacist-in-charge in a sterile compounding practice.
  16. Repeat a comprehensive series of aseptic techniques related to the compounding of sterile preparations.

Editors

NEIL COHEN, BSc
CE Program Developer
Disclosure: MEDISCA, Consultant
DAPHNEE LALONDE, BSc, MSc
Continuing Education Supervisor
Disclosure: MEDISCA, Consultant


CONTRIBUTORS:

MARK FILOSI, BS Pharm, RPh
Compounding Pharmacist and Co-Founder, Family Care Pharmacy
Disclosure: Accreditation Commission for Health Care, Surveyor; MEDISCA, Consultant

KENNETH LATTA, BS Pharm, RPh, FIACP, FACA
Senior Associate, Gates Healthcare Associates
Disclosure: Health System Consulting Group LLC, Co-Owner and Consultant; Gates Healthcare Associates, Consultant; Accreditation Commission for Health Care/Pharmacy Compounding Accreditation Board, Surveyor; North Carolina Board of Pharmacy, Consultant; Visante UK, Consultant; Visante, Consultant; MEDISCA, Consultant

CHRISTINE ROUSSEL, PharmD, BCOP
Assistant Director of Pharmacy, Doylestown Hospital 
Disclosure: MEDISCA Consultant

KEN SPEIDEL, BS Pharm, PharmD, RPh, FIACP, FACA
Senior Associate, Gates Healthcare Associates 
Disclosure: Accreditation Commission for Health Care (ACHC), Surveyor; Gates Healthcare Associates, Consultant; MEDISCA, Consultant


Financial support: 


An unrestricted educational grant has been provided by MEDISCA Inc.


CURRENT PROMOTIONS:

20% Off

Use coupon code 20LP318 upon checkout to receive 20% off this educational training. 

Course summary
Available credit: 
  • 3.00 CEU (ACPE)
  • 30.00 Contact Hours
Cost:
$825.00

Total CPE Credits (home study): 30 CPE Hours = 3.0 CEUs
Joint Providership Status (CPE Consultants, LLC / LP3 Network)

Home study activity type: Knowledge-based
Home study UAN: 0864-9999-18-047-H07-P/T for pharmacists and technicians
Home study CPE credits: 30 CPE hours = 3.0 CEUs
Release date: April 20, 2018
Expiration date: April 20, 2021

To receive CPE credits for the home study, participants must complete a learning assessment with a score of 70% and submit a completed evaluation.

accreditorCPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Accreditation Period

Course opens: 
01/01/2016
Course expires: 
01/01/2019

CURRENT PROMOTIONS:

20% Off

Use coupon code 20LP318 upon checkout to receive 20% off this educational training. 

Price

Cost:
$825.00
Please login to Enroll or Add to Waitlist
Cancellation and refund policy: 


There are no refunds, returns, or transfers upon purchase of the home study.