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Compounding Forum #1: Invitation To Participate

INVITATION TO PARTICIPATE

Compounding Forum (CF) is a new IVT feature that will provide readers an opportunity to discuss pharmaceutical compounded formulations, processes, problems, and related topics.  Pharmaceutical compounding is a specialized skill based on principles of science. The New England Compounding Center disaster in 2012 alerted the entire world population to the criticality of compounded pharmaceutical preparations and the need for expertise in compounding.

Compounded preparations are vital in healthcare practice. Commercial Rx products made by global pharmaceutical companies that are approved by regulatory agencies require sufficient profitability and return on investment; compounded products by 503A and 503B pharmacies do not meet big pharma financial requirements. Compounded preparations are needed by special needs children, long-term-care patients, and others for whom commercial products are not available; compounded preparations are the only source of specialized products for these patients. Pharma industry utilizes 503B compounding pharmacies to prepare clinical formulations. Any effort to increase understanding of compounded preparations, standardize approaches according to technical principles, improve the quality of compounded products, or provide reference for use in actual compounding practice will be a worthwhile endeavor.

WHY NEEDED?

The idea for an ongoing compounding discussion in the IVT journals came from multiple sources. Compounding professionals have commented on the need for fundamental compounding information for supervisory as well as technical personnel. Experienced compounding practitioners are in short supply; the need for competent workers in this industry is competitive. Inexperienced personnel need ongoing continuing education to improve their skills. Training by external organizations is expensive; trained “graduates” are highly recruited. Actual compounding processes and associated details are usually not discussed at professional meetings. Formulations for compounding may be complex and utilize drugs with challenging chemical and physical properties – not all compounded formulation are inherently stable. Aseptic compounding requires specialized technical expertise and ongoing competency certification.

Other Readers

Aside from the direct education of compounding professionals, CF content will also be useful to other IVT readers. Pharma industry personnel will gain greater insight into pharma dosage forms and products through CF content. We envision interest in CF by validation and compliance readers who read IVT journals. Designing a compounded dosage form is essentially equivalent to the initial design of a future commercial product; new drugs are prepared by compounding pharmacies for laboratory and clinical studies. Information presented in CF should be educational and generally useful to all pharma readers.

COMPOUNDING FORUM -- SCOPE AND CONTENT

The goal of CF is to provide basic understanding of principles and approaches for typical compounding projects. This feature will address practical problems in pharma compounding, discuss technical principles related to these problems, describe the skills needed for specific preparations, and emphasize key points for successful performance. If we are able to provide a fundamental understanding of basic concepts to facilitate correct compounding execution in the daily work environment, CF will be a success.

Future topics for discussion will include the general compounding process, i.e., fundamental activities in advance of actual compounding; specific compounded formulations and associated procedures; compounded product stability, standardized procedures, compounded product documentation, and associated topics. Discussion of the above is planned to include technical theory and relevant applications. Corresponding blogs, podcasts, and videos may also be presented to supplement discussion topics as well as to provide additional adult learning methods.

Communication Methods

The multiple communication methods available through IVT will be utilized in CF.  Journal submissions for publication are invited. Blog discussions posted on the IVT Network are more informal and are also welcome. IVT “Voices in Validation” podcasts provide visual and verbal discussion by individuals and groups; information sharing through IVT podcasts has been very well received and very successful. Coupling written and podcast discussions have been effective methods of transmitting content and provide multiple preferred adult learning methods. The IVT Network is currently experiencing tremendous growth in each of our communication vehicles; applying their outreach will contribute to general website value as well as providing contributing individuals with global visibility and recognition.

WE NEED YOUR HELP

The title Compounding Forum was selected to emphasize our desire for reader involvement in this feature. We invite participation and contributions from industry professionals with compounding involvement to help in CF.  We envision brief discussions of individual topics followed by example formulations – brief, clear, and simple. CF will be most successful when compounding personnel and healthcare practitioners who use compounded preparations participate in this endeavor. Please respond in the comments section below with ideas, suggestions, problems for resolution, or topics for discussion.

COORDINATOR AND CONTRIBUTORS

Nishant B. Thakar, PharmD, RPh, is Assistant Professor of Clinical Sciences at Roosevelt University College of Science, Heath, and Pharmacy in Schaumburg, IL 60173.  Dr. Thakar and other future contributors to this feature are well experienced in sterile and non-sterile pharmaceutical compounding as practiced in hospital, academic, long-term care, industry, and community settings.




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