2.3 Legal Foundations and National Guidelines for Safe Medication Administration
2.3 Legal Foundations and National Guidelines for Safe Medication Administration
Many federal and state laws, as well as national guidelines, have been established to protect public health and safety related to medication administration. This section will explain how federal and state laws, agencies, and guidelines protect clients from harm from medications.
Federal Agencies, Laws, and Guidelines
Food and Drug Administration
The United States Food and Drug Administration (FDA) protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, as well as the safety of our nation’s food supply, cosmetics, and products that emit radiation.[1] The FDA protects public health by enforcing an official drug approval process based on evidence-based research and issuing Boxed Warnings for medications with serious adverse reactions. These actions are further discussed in the following subsections.
Developing New Drugs
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is the FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents misinformation from being provided to the public, but also provides doctors and clients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and their health benefits outweigh their known risks.
Drug companies conduct extensive research and work to develop and test a drug. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. Before the drug is approved as safe for use in the United States, a team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes a drug’s health benefits outweigh its known risks, the drug is approved for sale. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Next, a series of clinical trials involving volunteers is conducted to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
Visit the FDA’s “Development and Approval Process | Drugs” webpage.
FDA Approval of a Drug
FDA approval of a drug means that data on the drug’s effects have been reviewed by the CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes the following:
- Analysis of the target condition and available treatments: FDA reviewers analyze the condit