Pharmaceutical CompoundingIndividualized Patient Care

Outline

I. IntroductionII. Who governs compoundingIII. Expected Growth and the Future

of CompoundingIV. Importance of Quality StandardsV. 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/compounderrelationship in the course of professional practice

Compounded Lollipops

Role of the Compounding Pharmacist

• “Individualizing Drug Therapy”

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

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?