Note: This example is based on fictional products and is condensed. It shows examples of most sections in a real drug monograph, but often does not go into all of the details (e.g., a table of adverse effects is seen, but only a couple items are listed, whereas a full drug monograph would list at least all common and/or serious reactions).
St. Anywhere Medical Center (St. AMC)
Pharmacy & Therapeutics Committee
Drug Evaluation Monograph
|Generic Name: ||artiblood |
|Brand Name: ||MegaBlood |
|Manufacturer: ||MegaPharmics |
|Therapeutic Category: ||Blood substitute |
|Classification: ||AHFS 16:00 Blood Derivatives |
| ||FDA Classification: 1A |
| ||Status: Prescription Only |
|Similar Agents: ||fakered |
Artiblood is a new perfluorocarbon that has many similarities to the only other product in its class, fakered. Both products have the ability to temporarily replace the oxygen-carrying function of red blood cells in patients in whom use of whole blood or packed red blood cells is impossible due to medical or religious reasons. In general, artiblood was found to be more efficacious than fakered; however, it also has been shown to produce a greater number of adverse effects. The adverse effects are mostly gastrointestinal in nature; however, the increased INR can be a problem in some patients. Artiblood is not metabolized in the body, whereas fakered is approximately 50% metabolized to inactive components. These differences are generally not clinically significant, since the dose of either product is unlikely to need adjustment. Fakered is available in several different volume bags, allowing the dose to be matched more closely to the anticipated patient need. While the cost of fakered appears to be lower, a pharmacoeconomic analysis shows that artiblood would produce the greatest cost savings for the institution.
It is recommended that artiblood be added to the Drug Formulary for use restricted to those who cannot use natural blood replacement products because of religious reasons or because suitable blood types are not available, including for use in cardiac catheterization procedures. It is not approved for use as a volume expander, except when in conjunction with the previous indications.
Artiblood is a type of perfluorocarbon, similar to fakered. These products have the unique ability to freely bind with or give up oxygen, depending on the partial pressures of the gas where the product is located (i.e., in the lungs there is an abundance of oxygen, so the product adsorbs oxygen; in the tissues there is a relative deficiency of oxygen, so the product gives up the gas).1,2 The products do not have direct immunologic properties, nor do they have the ability to aid in blood clotting, although there may be some effect on blood clotting (either interference by coating platelets or precipitation of the clotting pathway ...