sciences are built into the overall drug system (Califf et al., 2002). Integrating the sciences of quality with the biomedical and health sciences will ultimately facilitate the translation of safety and quality in medication use from theory to clinical practice.

As a first order of business, the points at which safety and quality can be compromised must be identified. Currently, the potential for harm is present throughout the system. Harm can be due to any number of factors, many of which are now in the national spotlight, including undisclosed harmful side effects of a drug for specific patient populations; lax follow-through on regulatory responsibility after product approval; human error in prescribing, dispensing, administering, and monitoring effects in patients; and inadequate patient activation and education. This chapter identifies the key issues of the overall drug system that affect safety and quality in medication use. Subsequent chapters in this report provide recommendations for improvement, many of which incorporate the “sciences of quality” mentioned above.


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 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) research and development (R&D), where ideas for new drugs are conceived and candidates are clinically tested; (2) regulatory review by the Food and Drug Administration (FDA) to validate or counter the research findings and ensure proper labeling; (3) manufacture, distribution, and marketing of products that have received regulatory approval; and (4) use of medications available either through a prescription or OTC. Prescription drugs, biologics, and some OTCs follow this model. The product development and regulatory review stages are abbreviated for other OTCs and for generics.

Each element of the drug system is governed by its own set of standards and methods for scientific analysis to advance the safety, quality, and efficacy of products and their use. As the chief protector of the public health, the FDA has responsibility for developing and enforcing the standards in all

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