1. Pharmaceutical Compounding Individualized Patient Care

2. Outline I.Introduction II.Who governs compounding III.Expected Growth and the Future of Compounding IV.Importance of Quality Standards V.How I can help you

3. I. Introduction

4. Compounding T The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice

5. Compounded Lollipops

6. Role of the Compounding Pharmacist “Individualizing Drug Therapy”

7. History of Pharmacy Compounding in the U.S. In the past, Compounding Was Pharmacy 1900s gave way to commercially prepared pharmaceuticals Many strengths/dosage forms available Economics changed all that Limited strengths/dosage forms “One Size Fits All” approach

8. Types of Compounding Pharmacies Independent Community Pharmacies Chain Pharmacies Hospital Pharmacies Mail-Order Pharmacies Compounding Only Pharmacies – Independent (Human and Veterinary) – Specialty (Home Healthcare, Hospital Contract, etc.) Nuclear Pharmacies

9. Extent of Compounding in the U.S. More than 70% of pharmacies report they do some compounding (NCPA) Virtually all hospitals do compounding All government hospitals compound Even chain stores have compounding centers

10. Reasons for the Growth of Pharmacy Compounding Limited dosage forms Limited strengths Home health care Hospice Nonavailable drug products/combinations – Discontinued Drugs – Drug Shortages* Orphan drugs Veterinary compounding New therapeutic approaches Special Patient Populations

11. SPECIAL PATIENT POPULATIONS Pediatrics Geriatrics Bioidentical Hormone Replacement Therapy Pain Management Dental Patients Environmentally & Cosmetic Sensitive Sports Injuries Veterinary Compounding – Small, Large, Herd, Exotic, Companion

12. Why is there so much compounding? Loss of manufactured drug products Office use Drug shortages Limited drug products for children and the elderly Topical/transdermal administration is increasing

13. Compounded Gummy Bears

14. II. Who governs compounding?

15. Responsible for Compounding State Boards of Pharmacy FDA USP Standards

16. III. Expected Growth and the Future of Compounding

17. Expected Growth Growth in compounding pharmacies to continue Discontinued drugs will continue Drugs in short supply will continue Alternative drug delivery methods Dosing adjustment Short-dated (unstable) drugs Pediatric formulations lacking

18. Pharmacogenomics Based on the individuals human genome Better selection of drugs Better selection of dose Better selection of excipients Compounding may play a major role!

19. Compounded Popsicles

20. IV. Importance of Quality Standards

21. Quality Standards Documentation Standard Operating Procedures Analytical Testing Uniform, Tested Formulas Accreditation Certification

22. V. How I can help you

23. How I can help you Adjust for allergies Convert tablets/capsules into liquids Compound topical gels, creams, etc Make better tasting oral liquids Other

24. Thank You! Any Questions?