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Pharmaceutical Compounding Individualized Patient Care

Pharmaceutical Compounding Individualized Patient Care. Outline. Introduction Who governs compounding Expected Growth and the Future of Compounding Importance of Quality Standards How I can help you. I. Introduction. Compounding.

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Pharmaceutical Compounding Individualized Patient Care

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  1. Pharmaceutical CompoundingIndividualized Patient Care

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

  3. I. Introduction

  4. Compounding 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/compounderrelationship in the course of professional practice

  5. Compounded Lollipops

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

  7. History of Pharmacy Compoundingin 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?

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