INTENDED AUDIENCE

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

ACTIVITY DESIGN

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

OVERALL LEARNING OBJECTIVES OF SELF-STUDY EVENT 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 customised 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, please refer to the workbook for Learning Objectives.

OVERALL LEARNING OBJECTIVES OF LIVE EVENT FOR PHARMACISTS

1. Defend oneself as a compounding pharmacist before the medical community while advocating the advantages of compounded medications
2. Assess marketing material and marketing messages against a set of criteria to determine its accuracy, appeal, and overall ability to well promote a compounding practice
3. Assess and evaluate expenditures and revenue spreadsheets values over time that is a direct reflection of the costs and earnings of a compounding practice
4. Assess acquisition costs in order to establish the selling price of a compounded medication
5. Arrange one’s own standard operating procedures incorporating System P as a means of their categorization
6. Defend quality, risk, and verification initiatives as a foundation in support of the integrity of the compounding industry
7. Create relationships between control, perform, verify, and document against the six categories of System P; personnel, property, procedure, process, preparation, and patient
8. Construct quality, risk, and verification protocols for each of the six categories of System P
9. Value the requirements under the proposed USP Chapter <800> addressing hazardous drug management and containment; personal protective equipment, hazard communications, medical surveillance, waste management, deactivation and decontamination, handling, storage, preparation, labeling, packaging, shipping, and transportation
10. Value the data from recordings from logs and forms related to standard operating procedures and the corrective measures that should be investigated following an assessment of data that falls outside of acceptable norms, parameters, and specifications. Assess structural, functional, and workflow dynamics-related considerations as it applies to facility design requirements for non-hazardous and hazardous drug compounding
11. Construct relationships between routes of delivery, chemical composition, and generalized preparatory procedures for non-sterile dosage forms
12. Analyse clinical case scenarios utilizing the concepts; be a star, balancing stability and suitability, and customisation with appropriate compromise to aid in the decision-making processes related to medication therapy
13. Support the transition from process development, to master formulation record, and to compounding record through the use of a template designed to incorporate the parameters for all three formulation stages
14. Manage a clinical case scenario through the use of a flow chart to navigate through your decision-making requirements leading to a compounded medication
15. Prepare a broad range of non-sterile dosage forms; hydro-alcoholic gels, rapid dissolve tablets, lollipops, chewable treats for animals, capsules, troches, suppositories, and creams