Pharmaceutical Compounding Individualized Patient Care Outline I. II. III. IV. V. Introduction Who governs compounding Expected Growth and the Future of Compounding Importance of Quality Standards How I can help you I. Introduction 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/compounder relationship in the course of professional practice Compounded Lollipops Role of the Compounding Pharmacist • “Individualizing Drug Therapy” 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 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 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 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 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 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 Compounded Gummy Bears II. Who governs compounding? Responsible for Compounding • State Boards of Pharmacy • FDA • USP Standards III. Expected Growth and the Future of Compounding 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 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! Compounded Popsicles IV. Importance of Quality Standards Quality Standards • • • • • • Documentation Standard Operating Procedures Analytical Testing Uniform, Tested Formulas Accreditation Certification V. How I can help you How I can help you • • • • • Adjust for allergies Convert tablets/capsules into liquids Compound topical gels, creams, etc Make better tasting oral liquids Other Thank You! Any Questions?