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Advanced Non-Sterile Compounding: A futuristic vision

A University of Florida College of Pharmacy accredited Practice-based Activity

Registration and Contact Information:

For more information and to register for this activity

Call 1-844-408-9453 or visit https://education.lp3network.com/live-training/advanced-non-sterile-compounding 

 

Activity Offerings

The following dates represent activities offered for this activity in the 2017 calendar year:

July 29th  – 30th in Aventura, FL


Activity Description

This Practice-based Activity is divided into four sections; modern facility design concepts for non-hazardous, hazardous, and advanced delivery system compounding, establishing a strategic collaborative practice model, working with advanced drug delivery systems, and quality controlled compounding.

The first section explores modern facility design concepts in adherence with current standards of practice. It explores advantages and disadvantages related to the design of compounding facilities for non-hazardous drug and hazardous drug compounding, as well as advanced drug delivery systems that enhance drug absorption. This section explores the many variables that impact facility design, including functional and operational parameters of secondary engineering controls (SECs), containment-secondary engineering controls (C-SECs), primary engineering controls (PECs), and containment-primary engineering controls (C-PECs). Then it explores the inter-relationships between adjacent ECs. The impact and implications of positive and negative pressure requirements, air pressure differential requirements, and air flow dynamics are carefully examined. Furthermore, addressing factors that impede upon functional and operational parameter performance measures helps to establish design strategies for an efficient and effective facility design. Participants will be given the opportunity to complete a questionnaire that helps summarize the parameters of a compounding practice in order to define their own facility requirements. To conclude this section, participants will engage in designing an advanced facility workflow schematic for a non-hazardous, hazardous and advanced delivery system practice. Additional factors pertaining to either non-hazardous or hazardous drug compounding that will be taken into account include positive and negative pressure and related pressure differentials, air changes per hour (ACPH), air velocity, air reuptake, and HEPA filter coverage requirements for air exhaust systems.

The second section challenges the compounding pharmacist to examine a clinically-based collaborative strategy that will redefine the pharmacist, physician and patient relationship. Participants will explore niche market specific collaborative clinical assessment profile variables in an effort to increase communications and relations with prescribers. This will help solidify relations, build confidence with prescribers, build an evidence-based database in support of the compounding practice, and bring a clinical superiority to the patient care challenge.

Section three provides new meaning to the phrase drug delivery system. Research outlining novel concepts in bioavailability optimization for poorly absorbed (large and/or lipophilic) drugs is presented; delivery systems for oral, rectal and topical dosage forms are revealed. This can provide the compounding pharmacist with a clear advantage in the marketplace. A comprehensive set of factors that impact bioavailability is examined in detail. Then each route of delivery further examined; topical, oral, and rectal routes. Relationships between drug agent, barrier to absorption, and base/delivery system are well established and clearly defined. Once the criteria for the utilization, and the guidelines during use, are outlined, these advanced delivery systems are demonstrated. Each route of delivery is then assessed for their respective factors that impede absorption and the corresponding solution to the obstacle presented.

Datasets from quantitative structural activity relationships (QSARs) are used to identify functional characteristics of drug agents. The n-Octanol-Water partition co-efficient, permeability co-efficient, diffusion co-efficient, and distribution co-efficient each reveals unique characteristics or potential activity of drug agents across barriers to absorption. Hydrophilic-lipophilic balance (HLB) and pH are manipulated in the formulation process. Permeation enhancing agents, surfactants, and emulsifying agents are brought together to form the basis of the advanced delivery system. The inter-relationship between these agents held together at specific concentrations result in a relative polarity index conducive to enhanced permeation. The delivery system utilizes and interacts with physical structures within the barrier to absorption to create opportunity for improvement in permeability without deleterious side effects to the barrier itself. The result is a potential for improvement in clinical outcome, potential for reduction in drug concentration requirements in the formulation, and a potential for reduction in deleterious side effects to the patient.

Section four responds to an all important aspect of a compounding practice; that is Quality Controlled Compounding (QCC). QCC can be divided up into three sub-categories; efficacy, reliability and validity. This section applies these three sub-categories to specific pharmaceutical calculations, personnel performance assessment, and process verification all of which increases the quality assurance and quality control of finished compounded preparations. Each of the three sub-categories will be further subdivided allowing the participant to apply a broad range of analytical parameters to the developmental process for a master formulation record that include our newly defined advanced drug delivery systems.

Intended Audience

Experienced Compounding Pharmacists

 

Activity Design

A highly interactive live event with group work. The Activity will include a series of assessments to ensure our appropriate delivery and dissemination of information, and subsequently your successful learning and competency.

 

Overall Learning Objectives of Live Activity

1. Propose a non-sterile compounding facility that takes into account primary and secondary engineering controls for the following parameters of practice; non-hazardous drug, hazardous drug, and advanced delivery system compounding.

2. Assess a non-sterile compounding practice and its day-to-day operation through the use of a questionnaire to assist in determining facility design requirements.

3. Defend proposed functional and operational parameters of a non-sterile compounding facility for its primary and secondary engineering control selection, assigned positive and negative pressure and related pressure differentials, suggested HEPA filter coverage for air exhaust system requirements, and resultant air changes per hour (ACPH), air velocity and air reuptake.

4. Assess a clinically-based collaborative strategy designed to help solidify relations, build confidence with prescribers, build an evidence-based database in support of the compounding practice, and bring a clinical superiority to the patient care challenge.

5. Assess novel concepts in bioavailability optimization for poorly absorbed (large and/or lipophilic) drugs; applies to oral, rectal and topical dosage forms.

6. Assess specific characteristics of quantitative structural activity relationships used to identify functional characteristics of drug agents.

7. Defend the use and application of a quantitative structural activity relationship, n-Octanol-Water partition co-efficient, permeability co-efficient, diffusion co-efficient, distribution co-efficient, as well as the manipulation of the hydrophilic-lipophilic balance and pH of a compounded mixture in support of proposed bioavailability optimization techniques.

8. Value a set of criteria intended to support the compounding pharmacist in the decision-making process to utilize an advanced drug delivery system.

9. Formulate sound clinical judgement before suggesting/utilizing an advanced drug delivery system in the context of individualized patient care.

10. Select and apply quality controlled compounding parameters to ensure the efficacy, reliability and validity of finished preparations.

11. Support the use of unit metered dose calculation methods to ensure drug concentrations are within acceptable margins of error by employing specific pharmaceutical calculations.

12. Compose methods to ensure optimized personnel performance by employing process verification strategies.

13. Compose process development strategies used in the detailing of a master formulation record.

 

Activity Facilitator

A number of highly qualified facilitators involved with this activity, their names, credentials and biographies will be made available upon request.

 

Participant Completion Requirements

Activity participants must be in attendance for the entire live event and complete an activity evaluation as compulsory requirements to achieve credit for the live event.

 

Declarations and Disclosures

The University of Florida College of Pharmacy believes it is important for the reader to be aware of relevant affiliations and financial relationships regarding the development, design and facilitation of this activity and its financial supporter and the financial supporter’s affiliates.

This activity has been approved by the University of Florida College of Pharmacy and is independent of any known bias, prejudice or commercial interest. The University of Florida College of Pharmacy has requested that 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 Inc. ensuring that it has no influence on LP3 Network Inc. as it relates to activity offerings.

 

Accreditation

This activity is accredited by the University of Florida College of Pharmacy in accordance with ACPE Standards for Quality and Interpretive Guidelines. The University of Florida College of Pharmacy has allocated 16 hours of continuing education credit (1.6 CEUs) to this Practice-based activity. The UAN for this live event is 0012-9999-16-004-L04-P (practice-based). The activity accreditation is 01/01/2016-01/01/2019.

Financial Support

An unrestricted educational grant has been provided by MEDISCA Inc.

 

Food and Beverage

As a matter of activity programming, meals and refreshments during live activities have been provided by LP3 Network Inc.

 

Cancellation and Refund Policy

A written request must be sent to LP3 Network Inc.. 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 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.

 

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.

 


ACPE LogoThe University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.