Clone of The Science of Pharmaceutical Compounding: Non-sterile Training - Home Study (Prerequisite)


This knowledge-based activity will provide compounding pharmacists and technicians with the necessary understanding of how to manage a non-hazardous and hazardous drug compounding facility, while preparing therapeutic non-sterile dosage forms relevant to today’s medical and market needs.

The activity is centered on core concepts, providing a strong foundation to follow for the compounding pharmacist and technician. These concepts include being a “STAR” (to be morally, ethically, politically, legally, and clinically sound in one’s decision-making), balancing stability with suitability (finding balance between formulation chemistry and dosage form suitability for the patient), compounding with appropriate compromise (acknowledging that with each new route of delivery and delivery system there are potentially new side effects that need to be addressed), compounding by composition (an in-depth look at the chemistry of solutions and dispersions in the form of suspensions and emulsions), and balancing efficiency with effectiveness (doing the right thing right as it applies to business development).

Activity content is subdivided into a unique system, referred to as System P, which is a categorical breakdown of all required standards of practice: Personnel, Property, Procedure, Process, Preparation, and Patient. Each category is defined and detailed. This system places emphasis on quality assurance and quality control through the implementation of standard operating procedures.

The participant will also be introduced to process development, which leads to the establishment of pharmacy practice-specific master formulation records. A master formulation record template is also introduced and serves equally well as a process development record and compounding record that can be implemented in everyday practice. Pharmaceutical calculations are presented in detail, providing even greater assurance of quality control and quality management during the compounding process.

A review of physiological pathways helps the compounder to appropriately select delivery systems that will optimize bioavailability; the optimization of drug absorption without undue deleterious side effects being the goal. Once routes of delivery and delivery system options are decided upon, excipient selection and their use in the compounded mixture are reviewed. Finally, the preparatory procedure itself is addressed with direct relationships to dosage form composition. Generalized preparatory procedures related to combinations of routes of delivery, dosage form, preparatory state-of-matter (solid, semi-solid and liquid), and final state-of-matter are presented.

The core concepts and the components of System P, when combined, make for a formidable infrastructure upon which to establish a new, or redefine an existing, compounding practice.

Intended audience


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

Learning Objectives

FOR PHARMACISTS:
  1. Discuss quality and integrity as they relate to a non-sterile compounding practice by being morally, ethically, politically, legally, and clinically sound in one’s decision-making.
  2. Review the need to find an appropriate balance between dosage form stability and its suitability for a patient.
  3. Explain the concept that for every customized dosage form, there is an expected and appropriate compromise related to that dosage form.
  4. Outline various dosage form compositions in terms of solutions and dispersions (suspensions and emulsions).
  5. Repeat pharmaceutical calculations related to specific dosage forms and preparatory procedures.
  6. Identify excipients and their function(s) in non-sterile dosage form-related delivery systems.
  7. Identify excipient and active ingredient characteristics that will result in stable and suitable dosage forms.
  8. Identify laboratory practices, procedures and preparatory techniques related to the compounding of non-sterile dosage forms.
  9. Describe a broad range of non-sterile preparatory procedures represented by commonly compounded dosage forms.
  10. Express requirements surrounding the needed standard operating procedures, drawn from an understanding of the requirements under the United States Pharmacopeia (USP) and the categorical breakdown of System P.
  11. Describe United States Pharmacopeia standards of practice related to non-hazardous and hazardous drug compounding, covering USP Chapters <795>, <800>, <1160>, <1163>, and <1176>.
  12. Describe facility design, maintenance, and monitoring requirements for non-hazardous and hazardous drug compounding.
  13. Identify deactivation, decontamination, disinfection, and cleaning procedures for non-hazardous and hazardous drug compounding.
  14. Review required personal protective equipment for non-hazardous and hazardous drug compounding.
  15. Recall general personnel roles and responsibilities, including medical surveillance and a hazardous drug management information program.
  16. Outline multiple steps related to process development that leads to the establishment of a master formulation record.
  17. List the requirements of a master formulation record and compounding record.
  18. Relate the balancing of efficiency (doing the right thing) with effectiveness (doing the thing right) from a business perspective.
  19. Recognize, from a business perspective, how to first plan your market, and then market your plan.
FOR TECHNICIANS:
  1. Relate quality and integrity to the day-to-day operations and personal functions of a technician within a non-sterile compounding practice.
  2. List factors that contribute to the balance between dosage form stability and its suitability for a patient.
  3. Explain the concept that for every customized dosage form, there is an expected and appropriate compromise related to that dosage form.
  4. Relate dosage form composition differences and their related preparatory procedures, specifically solutions and dispersions (suspensions and emulsions).
  5. Explain pharmaceutical calculations, in support of a performance checking system, between pharmacist and technician, related to specific dosage forms and preparatory procedures.
  6. Recognize the relevance of excipients and their function(s) in non-sterile dosage form-related delivery systems.
  7. Recognize the relevance of excipient and active ingredient characteristics that will result in stable and suitable dosage forms.
  8. Describe laboratory practices, procedures, and preparatory techniques related to the day-to-day activities of a compounding technician, and to the compounding of non-sterile dosage forms.
  9. Identify non-sterile preparatory procedures related to compounded dosage forms.
  10. Relate standard operating procedures currently in existence in a compounding practice to the requirements of the United States Pharmacopeia.
  11. Outline standard operating procedures related to non-hazardous and hazardous drug compounding, covering USP Chapters <795>, <800>, <1160>, <1163>, and <1176>.
  12. Outline maintenance and monitoring requirements in day-to-day practice, related to non-hazardous and hazardous drug compounding.
  13. Recognize the importance of deactivation, decontamination, disinfection, and cleaning procedures for non-hazardous and hazardous drug compounding.
  14. Outline the use of personal protective equipment for non-hazardous and hazardous drug compounding.
  15. Outline general personnel roles and responsibilities, including medical surveillance and a hazardous drug management information program.
  16. Repeat written procedures related to process development documents that lead to the establishment of a master formulation record.
  17. List the requirements of a master formulation record and compounding record.
  18. Recognize the importance of a pharmacist’s need to balance efficiency with efficacy from a business perspective, as it applies to the day-to-day activities of a compounding practice.
  19. List elements of business practices as they relate to planning the development of a market, and then marketing that development plan.
Financial support: 


An unrestricted educational grant has been provided by MEDISCA Inc.

Editors: 

NEIL COHEN, BSc
LP3 Network CE Coordinator
Disclosure: MEDISCA Consultant



DAPHNEE LALONDE, BSc, MSc
LP3 Network Program Developer
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


 

JOE CABALEIRO, BS Pharm, RPh
Senior Associate, Gates Healthcare Associates
Disclosure: Accreditation Commission for Health Care Consultant; Gates Healthcare Associates Consultant; HealthRx Group Consultant; MEDISCA Consultant

Course summary
Cost:
$0.00


CPE Credits: 24 CPE hours (23 CPE hours general pharmacy + 1 CPE hour law) = 2.4 CEUs
Joint Accreditation Status (University of Florida College of Pharmacy/LP3 Network)
Activity Type: Knowledge-based
UAN: 0012-9999-16-005-H04-P/T for pharmacists and technicians
UAN: 0012-9999-16-006-H03-P/T general law credit for pharmacists and technicians
Release Date: January 1, 2016
Expiration Date: January 1, 2019

To receive CPE credits for the live component, participants must demonstrate full and satisfactory participation, and submit a completed evaluation to the University of Florida College of Pharmacy.

Participants registered in the United States can obtain a statement of credit from their NABP e-profile. The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. Participants registered other than in the United States will receive a statement of credit by mail. 

Accreditation Period

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

Price

Cost:
$0.00
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Cancellation and refund policy: 


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


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