Transcript 3:30PM - Compounding Pharmacies - Shan Chikhale, Professor of

Aseptic Pharmacy CompoundingContemporary Issues and Challenges
Shan Chikhale, Ph.D.
Professor of Pharmacy
South College of Tennessee,
Inc.
Knoxville, TN 37922
[email protected]
(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 (SkillsPerformace) 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 <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
AFDO
South College of Tennessee, Inc.
Thank You!
Questions or Comments
[email protected]