HISTORY: Almost a forgotten era of medicine, pharmaceutical compounding has made a renaissance in the last 20 years not unlike the exponential progress seen in computers. Physicians are excited, health is enhanced and lives are saved by medications tailored to the specific needs of individuals. This is pharmacogenomics, when medicine is designed for each unique individual. According to the FDA, it is pharmacy of the future.
NEED: Drugs that can’t be patented or have a small patient population are of no interest to drug companies. Rarely do these drugs see the light of day through orphan drug status. Because of this, we receive daily requests from doctors all over the country who need a specialized medication for their patient, including discontinued drugs, different dose or dosage forms, preservative-free formulas and varied concentrations and combinations. While drug companies can make medications for the masses, we can make medicine for you.
DRUG SHORTAGES: Drug shortages are at an all-time high and a cause of concern to many doctors, hospitals and their patients. As a PCAB-accredited compounding pharmacy, O’Brien Pharmacy can help. We can often duplicate a commercial product that has been discontinued, is in short supply or on back order. Call and talk with one of our pharmacists today.
FDA: Custom compounded medications do not require FDA approval and are not classified as investigational or experimental. The FDA recognizes that “compounding is part of the practice of pharmacy/medicine,” and has the full support of the federal courts and Congress.
INSURANCE: Insurance companies are frequently unaware or misinformed about the uses and regulations of compounded prescriptions. They also refuse to recognize and pay for the expensive labor, equipment and testing required of a PCAB-accredited pharmacy. We will not compromise in these areas of quality or safety. As a pharmacy, we cannot accept insurance reimbursement directly because it would be considered fraud under the insurance company’s contracts (which they refuse to negotiate). Compounding pharmacies that bill insurance directly are fined and must refund millions of dollars each year. However, most policies allow for compounded prescriptions and the patient can be reimbursed directly. The rate of patient reimbursement is very high.
RISK MANAGEMENT: Because state and federal compounding regulations and USP standards are not followed by many pharmacies, a compounded medication can have significant variation. Factors like education, equipment, experience, formula, techniques, source of ingredients and product testing determine the ultimate safety and effectiveness of the medication. These factors are also voluntary. PCAB is your assuranc of the nation’s highest standards.
We are an industry leader and invest heavily in training, equipment, the highest quality supplies and finished product testing. Please take a moment to review the information about O’Brien Pharmacy and see what quality means to you and your patients. With 50 years of compounding experience, we take compounding to the highest levels of quality, purity, accuracy and convenience in packaging.
Beyond-Use Dating (expiration date): Expiration dates are developed by a variety of industry-accepted methods, and are evaluated on a case-by-case basis. We have performed potency-over-time studies on many of our preparations and use the results to establish the expiration date. Expirations and storage are indicated on the label.
PRESCRIPTION: Most states and the FDA require a prescription for any compounded medication. Usually the prescriptions are patient-specific, but more and more states allow a prescription to be dispensed for use in the office. Compounded prescriptions for office use cannot be redispensed, relabeled or resold. O’Brien Pharmacy holds the regulations for each state in the highest regard.
MORE INFORMATION: Please call toll-free 800-627-4360.
Thank you for your trust and confidence.