UAT - Vancouver, BC - May 27-29, 2016

Richmod, BC CA
February 29, 2016 to March 2, 2016

The Practice-Based Activity is divided into five subsections; business, quality, science, preparatory procedures and calculations for dosage forms, and the actual preparation of dosage forms. The activity covers non-hazardous and hazardous drug compounding.

The business subsection brings to light the necessity to build a unique identity, direction, and consistency in the delivery of the marketing message for the participant’s compounding practice. Participants will construct marketing messages, and then rehearse the delivery of those messages while developing verbal communication skills. Participants will also have the opportunity to evaluate marketing material utilizing an assessment tool they can continue to use in their practice.

Financial management through the examination of a start-up cost spreadsheet is compared and contrasted against acquisition cost pricing analyses used to establish the selling price for compounded medications. Expenses incurred to grow a compounding practice are presented across several months. A steady and realistic growth expectation is expressed in a profits only spreadsheet. The number of compounded prescriptions multiplied by their associated selling price enables the establishment of this revenue stream spreadsheet. Participants can then compare the expenditures against the revenues to see clearly the rate of growth over time of net profits for a compounding practice. For a new compounding practice these two spreadsheets can be used as milestones.

The quality subsection features the bringing together of System P, a categorical breakdown of required standards of practice defined by personnel, property, procedure, process, preparation, and patient. This well organized categorization of standards of practice yield equally organized standard operating procedures. No standard operating procedure is complete without a foundation upon which to build it and appropriately designed recording logs and forms for documentation purposes. Hence, the concepts of quality, risk, and verification, as well as control, perform, verify, and document. These two control parameters help to govern over the activities of a compounding practice.

A compounding practice would be remiss if it were to not engage in quality management initiatives. Equally so, an ongoing risk management system need be in place that consistently looks for potential challenges that could affect performance measures of any kind. In order to ensure a compounding practice’s quality of preparation and on a more global scale, industry integrity, a verification system applied before, during, and after the performance of any task need address efficacy, reliability, and validity as three fundamental categories of analytical parameters.

The scientific underpinnings subsection provides practical examples for the participant to apply the balance concept that explores dosage form stability and its suitability for a patient and customization with appropriate compromise as it relates to a compounded medication. However, to build up this subsection a broad range of factors that can affect stability and suitability are examined through case scenario assessments. These cases enable the participant to establish relationships between dosage forms, their respective chemical composition, and the preparatory procedures used in their design. To combine these subjects is to help ensure a compounded medication’s integrity, potency, strength, administration, and bioavailability.

The preparatory procedure subsection introduces the participant to a unique template that can serve well during the process development phase, and act as a master formulation record and compounding record. The actual process of developing a master formulation record affords the opportunity to engage the activity participant in a review of pre-formulation, in-process, and post-formulation qualification factors that when not addressed can result in inappropriate drug concentrations in a compounded medication.

The actual practical and hands-on preparation of dosage forms bridges the gap between theory and practice. Participants will perform pre-formulation calculations, prepare an array of current and popular dosage forms, and adhere to a series of standard operating procedures while formulating in the lab environment. Post-verification procedures will be performed on the dosage forms prepared to learn how to assess the accuracy and precision related to the drug concentration per unit application to within acceptable margins of error as per USP.

This activity culminates with a comprehensive case assessment utilizing all that has been learned during the activity. Select cases will be assigned to small groups of participants that will work collaboratively using a complex flowchart as a guide. A template will be provided requiring detailing on the part of the groups. Verbal presentations of the group’s findings are made while the remaining participants utilize yet another template to assess the presentation. A question and answer period will ensue. This final event affords the highest degree of interactive learning and a means in which to assess one’s own level of competency gained during the entire activity. 

Intended audience

This Activity is suited for Pharmacists and Technicians new to non-sterile compounding or with an existing compounding practice.

Learning Objectives

Overall Learning Objectives 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.
  11. Assess structural, functional, and workflow dynamics-related considerations as it applies to facility design requirements for non-hazardous and hazardous drug compounding.
  12. Construct relationships between routes of delivery, chemical composition, and generalized preparatory procedures for non-sterile dosage forms.
  13. 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.
  14. 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.
  15. Manage a clinical case scenario through the use of a flow chart to navigate through your decision-making requirements leading to a compounded medication.
  16. 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.

Overall Learning Objectives for Technicians

  1. Support the marketing initiatives and critical messages put forth by pharmacy owners; specifically their accuracy, appeal, and overall ability to well promote a compounding practice.
  2. Formulate a healthy opinion surrounding the expenditures and revenues generated by a compounding practice, while reading financial spreadsheets that are a direct reflection of its costs and earnings.
  3. Assess acquisition costs associated with technological and chemical purchases in order to appreciate the selling price of a compounded medication.
  4. Compare standard operating procedure requirements against an established system used for their categorization in an effort to ensure the completeness of SOPs in the compounding pharmacy.
  5. Support the quality, risk, and verification initiatives held by a compounding pharmacy as a foundation for excellence in support of the integrity of the compounding industry.
  6. Create relationships between control, perform, verify, and document against the six categories of System P; personnel, property, procedure, process, preparation, and patient.
  7. Support any and all quality, risk, and verification protocols undertaken by a compounding pharmacy for each of the six categories of System P.
  8. Support the initiatives of a compounding pharmacy in relation to 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.
  9. Value the data from recordings from logs and forms related to standard operating procedures, a shared responsibility between pharmacist and technician, and the corrective measures that should be investigated following an assessment of data that falls outside of acceptable norms, parameters, and specifications.
  10. Assess structural, functional, and workflow dynamics-related considerations, should the technician which to make recommendations for change, 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 so as to gain an appreciation for the preparatory procedures and excipient requirements of a compounded medication.
  12. Assess clinical case scenarios utilizing the concepts; be a star, balancing stability and suitability, and customization with appropriate compromise so as to gain an appreciation for the complexities surrounding dosage form design and its relationship 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. Value a clinical case scenario flow chart that helps the compounder to navigate through 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.
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.

Editors: 

 
Daphnee Lalonde, BSc, MSc
LP3 Network CE Coordinator
Disclosure: MEDISCA Consultant
 
 
 

 
Neil Cohen, BSc
LP3 Network Program Developer
Disclosure: MEDISCA Consultant
Course summary
Available credit: 
  • 2.40 CEU (ACPE)
  • 24.00 Contact Hours
Event starts: 
02/29/2016 - 8:00am
Event ends: 
03/02/2016 - 5:00pm
BC Training Facility
21300 Gordon Way
Unit 153/253
Richmod, BC V6W 1M2
Canada
Cost:
$3125.00
Rating: 
0
BC Training Facility
21300 Gordon Way
Unit 153/253
Richmod, BC V6W 1M2
Canada

Hotel information: 

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 LP3 Network. 

Mark Filosi, BS Pharm., RPh.

Compounding Pharmacist and Co-Founder, Family Care Pharmacy

Disclosure: Accreditation Commission for Health Care, Surveyor; MEDISCA INC., Consultant


 

Marlene Abouassaly, BSc.

Senior Technical Support Services Representative and Supervisor, Medisca Network Inc. & Conference CE Coordinator LP3 Network Inc.

Disclosure: MEDISCA INC., 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 INC., Consultant.

Jennifer Clare, BSc.

Compounding Technician, Medisca Network Inc.

Disclosure: MEDISCA INC., Consultant

Roberto Conte, BS Pharm., RPh.

Manager, Pharmasave Compounding Pharmacy

Disclosure: None

Mindy Cormier, PharmD., RPh.

Pharmacist Consultant, Medisca Network Inc.

Disclosure: MEDISCA INC., Consultant

Bal Dhillon, BSc., RPT.

Pharmacy Manager, Pharmacy Drug Distribution Centre, Lower Mainland Pharmacy Services

Disclosure: None

Quinton Didyk, BSc., BS Pharm., RPEBC

Consultant and Pharmacist/Owner, CPM – The Compounding Pharmacy of Manitoba

Disclosure: Accreditation Commission for Health Care, Consultant; Gates Healthcare Associates, Consultant; MEDISCA INC., Consultant; CPM, Consultant

Mark Filosi, BS Pharm., RPh.

Compounding Pharmacist and Co-Founder, Family Care Pharmacy

Disclosure: Accreditation Commission for Health Care, Surveyor; MEDISCA INC., Consultant

Kristina Krygier, BSc., MSc.

Technical Support Services Representative and Junior Formulation Chemist, Medisca Network Inc.

Disclosure: MEDISCA INC., 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 Inc., Consultant; Accreditation Commission for Health Care(ACHC)/Pharmacy Compounding Accreditation Board (PCAB), Surveyor; North Carolina Board of Pharmacy, Consultant; Visante UK, Consultant; Visante Inc., Consultant; MEDISCA INC., Consultant

David Mastropietro, BS Pharm., PhD., RPh.

Assistant Professor, Department of Pharmaceutical Sciences, Nova Southeastern University College of Pharmacy

Disclosure: MEDISCA INC., Consultant

Priya Parikh, PharmD.

Clinical Staff Pharmacist, Arnold Palmer Hospital for Children and Women

Disclosure: None

Zara Rouse, PharmD., RPh.

Pediatric Satellite Pharmacist, University of Florida Health Shands Hospital

Disclosure: None

Christine Roussel, PharmD., BCOP.

Clinical Pharmacy Manager, Doylestown Hospital

Disclosure: MEDISCA INC., Consultant

Michael Shafor, BSc., PharmD.

IV Oncology, IV Home Health Specialist, and Clinical Pharmacy Manager, Oncology Plus Inc.

Disclosure: None

Raman Sidhu, BSc.

Technical Support Services Representative, Medisca Network Inc.

Disclosure: MEDISCA INC., 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 INC., Consultant


 

Practice-Based Activity

UAN: 0012-9999-16-007-L04-P/T for pharmacists and technicians

Live Event CPE Credits: 24 CPE Hours = 2.4 CEUs

Release Date: January 1, 2016

Expiration Date: January 1, 2019

accreditor

             

The University of Florida College of Pharmacy 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: 
01/01/2017

Price

Cost:
$3125.00
Please login to Enroll or Add to Waitlist
Cancellation and refund policy: 

A written request must be sent to LP3 Network requesting “Cancellation without Transfer” to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from live activity event date, then registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund.

Transfer Policy
 

The transfer policy is only in effect if requested greater than or equal to 14 days prior to original live activity event date. Failure to submit the “Transfer Request” at least 14 days prior to 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 LP3 Network Inc. based on the number of available seats within the selected live activity event.