Switch drugs are more readily regulated than other OTCs because they already have received approval for use at prescription level doses. Their manufacturers have only to demonstrate that the lower doses in the OTC versions are effective and that consumers who may have misdiagnosed their symptoms will not be harmed by the drug. The drug regulatory process in the United States is one of the most demanding in the world. Congress requires the FDA, in addition to approving active ingredients, to determine the clarity of labels so that consumers can understand a drug's use, potential adverse effects, and drug interactions. The most difficult safety issues arise when the drugs reach our medicine cabinets.
Experts disagree about how well consumers can self-medicate.
For example, Elaine Brody of the Philadelphia Geriatric Center did research in the 1980s on how the elderly use OTCs. Misuse is a serious problem. Older persons experience two to three times more adverse drug reactions than do younger adults, most often from OTCs. One reason for this is that older persons use more medications. They also consult more physicians, increasing the likelihood of duplications and drug interactions.