Prescription drugs can cure diseases, reduce symptoms and enhance quality of life. The U.S. Food and Drug Administration, or FDA, defines the term drug as an "article intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease." Prescription drugs require a physician's approval and supervision for medications that could be toxic or have a potential harmful effect if not used properly.
Saves Lives
Prescription drugs can save lives. In an article published in The Washington Post in 2007 entitled Yes, New Drugs Save Lives, Frank Lichtenberg reports that access to new prescription drugs increases longevity, and that quicker access to these drugs can result in smaller increases in disability rates. For example, prescription drugs can save and extend the lives of people with heart disease, cancer and autoimmune diseases.
History
The 1938 Food, Drugs and Cosmetics Act gave the FDA the power to regulate therapeutic claims drug manufacturers make with respect to drugs. Under this law the FDA mandates pre-market approval for new drugs that requires drug manufacturers to demonstrate that a new drug is safe before it could be available for sale. The 1962 amendments to this law authorize the FDA to oversee clinical trials, prescription drug advertising and good manufacturing practices. Today, the FDA regulates and oversees the entire prescription drug approval process, advertising, manufacturing and monitoring of prescription drugs sold on the market to ensure they are safe for consumers.
Prescription Drug Advertising
Consumers can learn about prescription drugs from advertisements, according to the FDA. Product claim advertisements present safety, effectiveness and risks of the drug without providing false or misleading information. Reminder advertisements provide the name of the drug without specific uses, benefits or risks. Help-seeking ads describe a disease, such as diabetes, without recommending a specific drug. Drugs with black box warnings on their labels must always present the health risks no matter what type of advertising the product is in. The FDA mandates warnings for drugs that have serious adverse reactions be placed in a black box on the product label and on any advertising.
Product Labeling
The product labeling for a prescription drug, which includes the label affixed to the drug container along with other printed information provided with the prescription, contains vital information about the drug that includes the active substance, how the drug works in the body, what the drug is indicated to treat, the types of patients who should not use the drug, studies that were done to provide evidence of safety and efficacy, adverse effects, dosage and administration and how the drug is supplied.
Patient misunderstanding of the prescription drug label can cause errors in its use and reduce effectiveness of the medication. Research conducted by T.C. Davis and published in the Journal of General Internal Medicine in 2009 demonstrates that patients are more likely to understand and follow instructions on the product label when there is precise wording, including specific time periods such as morning rather than the number of times per day to take medication.
Prescription Drug Abuse
Prescription drug abuse is a problem in the United States. Prescription drug abuse occurs when a person uses a prescription medication for reasons outside of the FDA-approved indication. According to the Substance Abuse and Mental Health Services Administration, 2.5 million people ages 12 and older used psychotherapeutic prescription drugs, such as pain relievers, tranquilizers, stimulants and sedatives, nonmedically for the first time in 2008.
References
- Food and Drug Administration: Sec. 201. [21 U.S.C. 321] Chapter Ii---Definitions 1
- The Washington Post: Yes, New Drugs Save Lives
- Economic History Association: History of Food and Drug Regulation in the United States
- Food and Drug Administration: Prescription Drug Advertising
- "Journal of General Internal Medicine"; Improving Patient Understanding of Prescription Drug Labels; Davis, T.C.; Jan 2009
