aseptic pharmacy compounding-contemporary issues and challenges
DESCRIPTION
Aseptic Pharmacy Compounding-Contemporary Issues and Challenges. Shan Chikhale, Ph.D. Professor of Pharmacy South College of Tennessee, Inc. Knoxville, TN 37922 [email protected] (865) 288-5834. - PowerPoint PPT PresentationTRANSCRIPT
Aseptic Pharmacy Compounding-Contemporary Issues and
Challenges
Shan Chikhale, Ph.D.
Professor of PharmacySouth College of Tennessee, Inc.
Knoxville, TN 37922
(865) 288-5834
This session will focus on contemporary and critical issues surrounding Compounding Pharmacies.
Presentations will highlight the specialized profession and practice of pharmacy compounding, the challenges and needs of this expanding industry.
OUTLINE / OBJECTIVES
Pharmacy Compounding & Compounding Pharmacies
FDA Drug Inspection Highlights & Focus Areas for Compounded Sterile Preparations
Critical need for Education, Training and Evaluation of Aseptic Manipulation (Skills-Performace) and the Compounding of Sterile Preparations
Pharmacy Compounding & Compounding Pharmacies
Historically, pharmacy compounding has been an integral part of pharmacy practice.
Definition…Pharmacy is the science, art and practice of preparing, preserving, compounding and dispensing…
Heritage of pharmacy, spanning some 5000 years, has focused on provision of pharmaceutical products for patients.
Pharmacy Compounding & Compounding Pharmacies
Pharmacists are the only health care professionals that possess the knowledge and skill required for compounding and preparing medications to meet the unique needs of individual patients.
Hence, need for compounding pharmacies and for this industry is growing.
Safe, effective, and high-quality extemporaneously compounded (sterile/non-sterile) products is a must!
Why the Need for Compounding Pharmacies?
Compounding serves unique need of individual patient therapy (tailored medicine).
New evolving dosage forms and therapeutic approaches
Tailoring dose strength/dosage form to individual patient
Hospital, Hospice & Home Health-Care environment has experienced increase in batch production of sterile products.
Non-availability of drug products/combinations
Discontinued drugs, Orphan drugs, Drug shortages
Pediatrics, geriatrics, pain management
Environmentally and cosmetic sensitive patients
Sports injuries, Veterinary compounding
We Need To Do This (Sometimes)!
We Definitely Don’t Need This!
Bing.com/2012 Fungal Meningitis
Inspection Highlights/Focus Areas
Avastin lots released / No Sterility & Endotoxin Testing
Lots distributed / Without Assay for Potency
Aseptic surfaces (environment) / No surface sampling for Microbial Contamination
Autoclaving (& Sterilization) procedures / No Validation
Aseptic Process / No Validationfda.gov/drugs/pharmacy compounding/fda actions
Inspection Highlights/Focus Areas
Non-sterile components / No Documentation
Failed Plate Contamination Test for media fill / No Investigation
Preservative-free, multiple use sterile injectables / BUD of 1000 days
fda.gov/drugs/pharmacy compounding/fda actions
Inspection Highlights/Focus Areas
Drug product / Crystallization/Precipitation
Zosyn/Bupivacain / Incorrect Compounding, Labeling, Packaging
Frozen Gentamin / Shipped without Temperature Control
Aseptic Manipulation (Skills-Performance Challenge) / Staphylococcus, Bacillus, Penicillium detected in products-No Evaluation
Heparin, Famotidine, Bevacizumab (Turbid/Particulate Matter) / No Investigations fda.gov/drugs/pharmacy
compounding/fda actions
Inspection Highlights/Focus Areas
Pharmacist / Kneeling on hands and knees in ISO 7 Clean Room floor
Technician / Wearing non-sterile gown/gloves in Sterile, Aseptic environment
Equipment & Supplies / Obstruction of Airflow-HEPA Filters
Sterilization Cycle Printouts-Parameters / Not Available
Aseptic Processing Area / Ceiling Surface cracked-peeling, Dark stains & White residues on HEPA Filtersfda.gov/drugs/pharmacy
compounding/fda actions
Education/Training/Evaluation of Personnel
Lack of appropriate knowledge, education, qualifications, expertise, physical facilities – in Compounding Pharmacies
Critical need for education, training, assessment and evaluation of all personnel involved (stakeholders)
Introductory Level Education / Performance-Skill Based Training
Sterility, Endotoxin, Microbiological Testing
Aseptic Processing Skills
Sterility Assurance/Level
How much Testing/Sampling is required?
Education/Training/Evaluation of Personnel
Storage and BUD
Environment Quality and Control
Patient/Caregiver Training
Quality Assurance Program
Education/Training/Evaluation of Personnel
USP Chapter <797>
- Responsibility of Compounding Personnel
- Microbial Contamination Risk Levels
- Compounding Accuracy and Sterilization
- Verification of Automated Compounding Devices
- Patient Monitoring & AER
Summary
Pharmacy compounding and compounded (sterile/non-sterile) products are on the rise.
Drug compounding provides significant benefits to patient and health-care system.
Compounding pharmacies are an important industry which needs to be fully supported.
There is critical need for efficient delivery of education and training to enhance learning of all personnel (stakeholders).
Followed by full assessment and evaluation of learning for all personnel involved (stakeholders).
Acknowledgement
AFDOSouth College of Tennessee, Inc.
