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

The Science of Pharmaceutical Compounding: Non-Sterile Training

ACTIVITY DESCRIPTION

The Practice-based Activity will provide compounding pharmacists and technicians with the competency to prepare current and viable pharmacotherapeutic non-sterile dosage forms. Unique concepts will be taught facilitating a decision-making process the pharmacist and technician can apply in their day-to-day practice.

Consideration will be given to meeting the physician’s prescription and patient-specific need, compliance-related solutions, medical necessity, and legal and regulatory guidelines. A significant emphasis will be placed on quality assurance and quality control as it relates to dosage form design, pharmaceutical calculations and the validation of preparatory procedures that are part of Master Formulation Records.

Practical techniques and technology-related applications are developed through hands-on experience in a compounding laboratory environment where pharmacists and technicians will be trained in all aspects of non-sterile preparatory procedures. Pharmacists and technicians have the opportunity to develop important aspects of a business development and marketing plan.

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 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, 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 customization 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

*For Technicians, please refer to the workbook for Learning Objectives.

ACCREDITATION

This CPD event has been accredited for 48 hours of Group-2 CPD (or 96 CPD credits), suitable for inclusion in an individual pharmacists CPD plan.

APC Accredited CPD

S2016/41: The activity accreditation expires 30 April 2019.

EDITORS

PATRICIA ULLMANN

CPD Coordinator and Compounding Pharmacist, MEDISCA Australia.

NEIL COHEN, BSc

CE Coordinator, LP3 Network Inc.

CONTRIBUTOR

Mark Filosi, BSc, RPh

Compounding Pharmacist and Co-Founder, Family Care Pharmacy

FACILITATORS

Mark Filosi, BS Pharm, RPh

Compounding Pharmacist and Co-Founder, Family Care Pharmacy.

Valentina Karan, B Pharm

Product Development Management, The Compounding Pharmacy Australia; Consultant, MEDISCA Australia.

Kenneth Latta, RPh, BS Pharm, FIACP, FACA

Senior Associate, Gates Healthcare Associates.

Tammy Nguyen, B Pharm

Compounding Pharmacist, Bova Compounding Chemist; Consultant, MEDISCA Australia.

Branko Radojkovic, B Pharm

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

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

Senior Associate, Gates Healthcare Associates.

Claire Targett, B. Pharm

Pharmacist Manager, Judges Pharmacy; Consultant, MEDISCA Australia.

Patricia Ullmann, B. Pharm

Compounding Pharmacist, MEDISCA Australia.

COPYRIGHT

Activity material is Copyright© 2008-2019 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 Inc. assist with the marketing of this activity. LP3 Network Inc. is an independent corporation. LP3 Network Inc. has an established agreement with MEDISCA AUSTRALIA ensuring that it has no influence on LP3 Network Inc. as it relates to activity offerings.

FINANCIAL SUPPORT

An unrestricted educational grant has been provided by MEDISCA Inc. 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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