O’BRIEN PHARMACY: A PRACTICE OVERVIEW
When pharmacists Henry O’Brien and Harry Everett opened the doors 45 years ago, two things were vital: the tradition of pharmaceutical compounding, and the pursuit of perfection. Both of these elements are alive and applied today by pharmacists Eric Everett, Lisa Everett, Kristy Timmons and the entire O’Brien Pharmacy staff, with an average tenure of 12 years.
Combining this ancient heritage of pharmacy with the technology of the 21st Century, O’Brien Pharmacy has few peers. In fact, O’Brien’s is recognized as a national leader in several areas, including sterile products and natural hormone replacement.
But the best ideas in compounding pharmacology are of little value in the face of improper execution. Chemical sourcing, equipment availability, formulation, training and technique are the foundation for the final outcome. A deficiency in any component will have significant consequences and exposure to avoidable risk.
That is why O’Brien Pharmacy leaves nothing to chance. Our chemicals are from a FDA-inspected supplier that analyzes all medications and adjuncts by mass spectrograph and gas chromatography. With more than $1.5 million invested in equipment and facilities, we have what it takes to do it right. Formulas and techniques are the collaboration of our staff pharmacists, with a combined 30 years of experience, and a network of PhD pharmacists and biochemists on call ten hours per day.
Everything related to compounding is defined and addressed in our 150-page policy and procedure manual, from sterile compounding to scheduled validation of products and technique. As a PCAB-accredited ® compounding pharmacy, we are inspected for compliance with applicable United States Pharmacopeia standards, Board of Pharmacy regulations and other stringent quality-control requirements. This, along with our own internal requirements, forms the basis for our extensive policies and procedures and documentation.
In addition, Eric Everett was an original inductee in to the International Association of Compounding Pharmacist’s Full Fellowship program. Only compounding pharmacists with the highest standards and a minimum of 30 continuing education hours in compounding each year are allowed this honor. This also requires recertification every three years and accreditation of the laboratory facilities as well. Eric was also PCCA’s 2002 Pharmacist of the Year (for the U.S., Canada and Australia).
HISTORY OF ASEPTIC COMPOUNDING:
O’Brien Pharmacy is a seasoned veteran of sterile compounding:
- More than 18 years of sterile compounding experience.
- Hyaluronidase1 exceeding 200,000 doses.
- More than 5,000 IV chemotherapy agents.
- More than 7,000 patients treated with compounded IV adenosine solution for cardiac imaging.
- More than 1,000 intrathecal solutions.
- More than 18,000 doses of impotence injections compounded.
- Countless intravitreal injections, ophthalmic preparations and solutions for inhalation dispensed without event.
The above represents thousands of hours of careful calculations, meticulous measurements and practiced techniques.
1O’Brien Pharmacy has the only hyaluronidase independently and scientifically proven superior to Wydase®. J Cataract Refractive Surgery 2001;27:1712-1714
FACTORS IN STERILE COMPOUNDING:
- EVERY preparation is made by a pharmacist, not technician.
- Sterile solutions from raw materials are considered the highest risk category by the USP, ASHP and other governing / regulating agencies.
- As a PCAB-accredited ® compounding pharmacy, we are inspected for compliance with applicable United States Pharmacopeia standards, Board of Pharmacy regulations and other stringent quality-control requirements. This, along with our own internal requirements, forms the basis for our extensive policies and procedures and documentation.
- O’Brien Pharmacy began addressing these issues in 1998, long before they became regulatory.
- Documentation includes:
- Sterility reports on every sterile product. Some preparations receive multi-point sterility tests.
- Endotoxin documentation
- Fifty to 75 potency reports by independent laboratory analysis each year.
- Certificate of Analysis on every raw material on file.
- Individual parameters include:
- pH and buffer systems
- Preservation options
- Our equipment is state-of-the-art, maintained to manufacturer specifications, calibrated and verified as applicable.