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In the early 1970's, the Food and Drug Administration (FDA) launched an Overthe-Counter (OTC) Drug Review with the objective of creating a uniform market containing medicines that are scientifically proven to be safe and effective for use without supervision of a physician. This project laid the groundwork for the switch policies and generated a tremendous amount of interest for improving or enhancing the concept of patient self-medication and providing a cost-effective alternative routine medical problems. One concern that has been expressed is that as more powerful prescription products enter the OTC market, the associated benefits of the drug may decrease while the risks increase as a result of less intervention by medical professionals. One solution to alleviate this concern may include better labeling and advertising for OTC products. It is established that these educational tools are relied upon by consumers. In this study, a survey was used to obtain information relative to consumer perceptions about usefulness of OTC medicines and the ease of reading and understanding product labels. It was found that 97 percent of consumers use OTCs to some extent. Most consumers responded that they read labels (92%), however, only 32 percent felt that OTC package labels were easy to read. Although more consumers (92%) felt that the labels were understandable, only half of the respondents could accurately define some of the terminology used in current package labeling. A second survey was used for physicians and pharmacists to elicit information about their views of consumer capability and readiness to use switch medicines (Rx-toOTC) in self-care. Only 50 percent of physicians and 74 percent of pharmacists approved of the trend of self-medication and even less (26% and 31 % ) from each group approved of switching prescription drugs to OTC status. Both groups of professionals, (88% of each) said they recommend OTC products, including switches, to their patients. This study showed that both consumers and health care professionals have confidence in OTC products, including those recently switched from prescription _status. It also revealed potential problems in the labeling and advertising of OTCs with respect to the general content of information.

A CRITICAL INVESTIGATION OF THE IMPACT OF LABELING AND ADVERTISING ON THE SAFE AND EFFECTIVE USE OF RX-TO-OTC SWITCH PRODUCTS