This study addressed the quality of the five steps in the medication-use process: selecting and procuring by the pharmacy, selecting and prescribing for the patient, preparing and dispensing, administering, and monitoring effects on the patient. The study examined medication use in a wide range of care settings—hospital, long-term, and community. The term medication encompasses three broad categories of products—prescription and nonprescription drugs and dietary supplements—all regulated by the FDA (see Chapter 2).
According to the FDA (2004), a drug is defined as a substance that is recognized by an official pharmacopeia or formulary; intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; intended to affect the structure or any function of the body (excluding food); and intended for use as a component of a medicine, but not a device or a component, part, or accessory of a device.
Biologic products (including vaccines, blood, and blood products) are a subset of drug products. Biologics are distinguished from other drugs by their manufacturing process—biological as opposed to chemical. Some biologics, principally vaccines (excluding their long-term effects), are within the scope of this study; blood and blood products and tissues for transplantation are excluded.
Drugs include both those that require a prescription and those that do not. Nonprescription drugs are usually termed over-the-counter (OTC). The characteristics of OTC drugs are such that the potential for misuse and abuse is low, consumers are able to use them successfully for self-diagnosable conditions, they can be adequately labeled for ease and accuracy of use, and oversight by health practitioners is not needed to ensure safe and effective use (FDA, 2005).
Dietary supplements, often called complementary and alternative medications, are another group of products often used for medicinal or general health purposes. The Dietary Supplement Health and Education Act of 1994 (P.L. 103-147) defined a dietary supplement as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient cited above. While the primary emphasis of the study was on prescription and OTC drugs, attention was given to dietary supplements as well, and the discussion of drugs often applies also to the latter products.