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
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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
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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?
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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
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Documentation
Standard Operating Procedures
Analytical Testing
Uniform, Tested Formulas
Accreditation
Certification
V. How I can help you
How I can help you
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Adjust for allergies
Convert tablets/capsules into liquids
Compound topical gels, creams, etc
Make better tasting oral liquids
Other
Thank You!
Any Questions?
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