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Editorial: Standardized Formulas
In a recent letter to a compounding pharmacy from a federal agency, the following phrase is mentioned:
"The production of this volume of standardized prescription drug product is �."
It appears that the use of "standardized prescription drug products" is frowned upon, when, in many cases, the development of "standardized monographs" for compounded drugs has been encouraged. I guess I'm confused�should we have standardized formulations for compounding (when appropriate) or not?
As a point of clarification, we are not discussing "volume" here, as volume is not really a distinguishing factor in whether a pharmacy is compounding or manufacturing. (It is the existence of the patient-physician-pharmacist relationship.) I have been in pharmacies where these "letters" have been received and the large volume of compounded medications was the reason cited; the volume prepared by the pharmacy for the infraction was about 10 liters (about 2.5 gallons). They were told that this "large" volume was manufacturing and not compounding. Personally, I'm not acquainted with a manufacturer that only produces a 10-liter batch (unless it is a biotech, extremely potent or related type of product). Also, when would a volume exceed "compounding" and become "manufacturing"? However, certain scenarios, such as a pharmacy that is compounding veterinary preparations (that are commercially unavailable) for a large herd or group of animals may need to prepare a thousand pounds of a preparation to treat thousands of animals, should be considered. Obviously, it is ridiculous to expect the pharmacy that is preparing this volume of preparation to use an 8-ounce mortar and pestle to compound that prescription in "small batches"! USP <795> states, "Equipment is to be of appropriate design and size for compounding and suitable for the intended uses. The types and sizes of equipment will depend on the dosage forms and the quantities compounded."
Some large pharmacies do large volumes and others do not; if they send compounded preparations to other states, they must register in each state and follow the laws and regulations of that specific state. Interstate shipment of prescriptions (even compounded prescriptions) is now "required" by many third-party payors so patients and pharmacists do not have much of a choice. Generally, those that do a large volume incorporate considerable quality-control testing in their procedures.
However, it would be good to have clarification on whether or not we should use "standardized formulas" in compounding! The USP has been around since 1820 with the purpose of standardizing drug substances, excipients, products, and preparations. Standardized formulas should result in fewer errors during a compounding process and more uniformity throughout the U.S. However, it appears that this tenet is not subscribed to by all.
Loyd V. Allen, Jr., PhD, RPh
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Medical error prevention key to reducing healthcare costs.
Preventing medical errors would reduce loss of life and could reduce healthcare costs by as much as 30 percent, according to a study published in Health Services Research. The researchers "tracked insurance claims for 5.6 million enrollees from 2001 to 2002." in this study and concluded that the effects of medical errors continue long after a patient leaves the hospital.
http://www.upi.com/Health_News/2008/07/28/Reducing_medical_errors_cost_effective/UPI-67591217224935
Deaths from medication mistakes at home have risen dramatically over the past two decades, research indicates.
Deaths from medication mistakes at home have increased dramatically during the past two decades," according to data published in the Archives of Internal Medicine. This conclusion was reached after researchers analyzed "nearly 50 million U.S. death certificates," from 1983 to 2004. (Editors note: Pharmacists can play an important role in helping reduce these events through patient counseling)
http://hosted.ap.org/dynamic/stories/M/MED_FATAL_DRUG_ERRORS?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2008-07-28-16-05-56
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