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Safe and effective use of medications is the responsibility of providers who prescribe the medications and patients who take them.Standards for each component of the drug system act as links in a chain of events that have an important bearing on the competence and effectiveness of drug therapies in medical care.Currently more than 10,000 prescription drugs and biologics (FDA, 1999) and more than 300,000 over-the-counter (OTC) products are on the market in the United States (RSW, 2001).In 2004, 215 prescription and 71 OTC drugs were recalled because of manufacturing and distribution problems or serious adverse reactions (FDA, 2004a).The R&D process involves more than the development of new products; it encompasses the overall generation and disclosure of high-quality data that can be used with confidence by providers and patients in medical care, by providers and technology vendors to populate knowledge bases and clinical decision-support systems, by regulators in assessing benefit/risk balances for protection of the public health, and by researchers for continued innovation and advancement of science and medicine (Califf, 2004).Issues related to study design, data quality, and disclosure can have direct bearing on the development of the medication knowledge base needed to support clinicians and pharmacists in clinical decision making and prescribing; preparation and administration of appropriate dosages; and monitoring of patient response (positive and negative) to a medication, particularly the ability to discern symptoms of disease from effects of the drug.Public availability of information from trials also is necessary to support consumers in their self-care, disease management, and medication self-management.

information or responding to safety-related problems. In the last example, the problem results from an error within the medication-use system itself (e.g., insufficient information).

The regulatory element of the drug system evolved over the past century from being focused on regulating interstate transport and misbranded products to being built on an infrastructure with the goal of reliable standards, processes, and laws to ensure some degree of safety and efficacy in medicinal agents.

The result is a sophisticated, comprehensive drug system encompassing four stages that interact with, support, and reinforce each other to varying degrees (see Figure 2-1): (1) available either through a prescription or OTC.

If standards do not exist, are inadequate, have not been met, or are not enforced at any point along this chain, patient safety and quality of care can be compromised.

For example, restriction on the publication of a drug’s side effects can affect a prescriber’s ability to choose the best drug for a patient or to identify and respond to an adverse reaction in a timely manner; lax enforcement of regulatory requirements for drug labeling can result in product confusion in a high-stress, fast-paced clinical setting; formulary restrictions can force a switch to a medication that may be less appropriate for a patient than the one initially prescribed; or the failure to document all of the medications a patient is taking (including OTCs and dietary supplements) can cause a drug–drug interaction that could have been prevented.

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