1. Aseptic Pharmacy Compounding- Contemporary Issues and Challenges Shan Chikhale, Ph.D. Professor of Pharmacy South College of Tennessee, Inc. Knoxville, TN 37922 pchikhale@southcollegetn.edu (865) 288-5834

2. 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.

3. 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

4. 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.

5. 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!

6. 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

7. We Need To Do This (Sometimes)!

8. We Definitely Don’t Need This! Bing.com/2012 Fungal Meningitis

9. 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

10. 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

11. 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

12. 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

13. 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?

14. Education/Training/Evaluation of Personnel  Storage and BUD  Environment Quality and Control  Patient/Caregiver Training  Quality Assurance Program

15. 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

16. 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).

17. Acknowledgement AFDO South College of Tennessee, Inc.

18. Thank You! Questions or Comments pchikhale@southcollegetn.edu