Presentation on theme: "Aseptic Pharmacy Compounding- Contemporary Issues and Challenges Shan Chikhale, Ph.D. Professor of Pharmacy South College of Tennessee, Inc. Knoxville,"— Presentation transcript:
Aseptic Pharmacy Compounding- Contemporary Issues and Challenges Shan Chikhale, Ph.D. Professor of Pharmacy South College of Tennessee, Inc. Knoxville, TN (865)
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 Validation fda.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 Filters fda.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 - 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 AFDO South College of Tennessee, Inc.