Table 1 shows how prescription medicine was placed on the safe end of the thermometer scale more often than nonprescription medicine, indicating a lesser degree of confidence in nonprescription medicine.

Additional evidence confirms consumers' lower level of confidence in nonprescription medicines. Consumers were shown a scale labeled from "Very Safe" to "Not Safe at All." They were asked to choose points on the scale which best described their feelings about the safety of nonprescription medicines and prescription medicines. Most people consider prescription medicines very safe, while indicating they are less certain

about the safety of nonprescription medicines. Nonetheless, about half the people placed nonprescription medicines somewhere on the "safe" side of the scale.

From this, it may be concluded that people have ambivalent feelings about the safety of nonprescription medicines. This conclusion is supported by the fact that twice as many people were unable to choose a point on the scale for nonprescription medicines as were unable to choose for prescription medicines.

Insight into why consumers have these feelings about medicines was gained when they were asked to give their reasons for placing the products

as they did. The reasons given for their statements are shown in Table 2.

The responses concerning nonprescription medicines show a wide range of opinions-13 percent of consumers believe these drugs are safe when used properly; 8 percent believe they are safe if bought carefully; and 8 percent indicate a sort of "blind faith" that such products could not be sold if they were not safe.

But 12 percent of the public said OTC medicines are unsafe because people make mistakes and use them improperly, while another 11 percent said they are unsafe because of possible side effects or allergies.

Surprisingly, 15 percent of the consumers say that people should not take over-the-counter medicines at all!

One of FDA's primary functions is that of assuring the safety and effectiveness of all medicines in America, and the Agency is now engaged in a program to assure even greater safety than ever for over-the-counter medicines. The past several decades have been a period of significant advances in scientific knowledge, including the field of medicine. We now know a great deal more about body functions, and how they are affected by drugs, than we knew even a few years ago. To assure that all drugs on the market are safe and effective, FDA is reviewing OTC drugs to re-evaluate their safety and effectiveness in the light of today's advanced knowledge.

When consumers were asked about their reasons for believing in the safety of prescription medicines,

they gave overwhelming evidence of confidence in the role of the physician.

FDA believes consumers should know that all medicines are powerful and have a potential for harm as well as good. Prescription drugs are the more powerful, and therefore they can be more dangerous if not used properly. Also they may be more likely to cause adverse side effects than over-the-counter medicines. No matter how expert the doctor, each consumer shares the responsibility for safe and proper use of medicines prescribed for him.

In another, quite separate, question concerning reasons why consumers believe medicines in general are unsafe, it was surprising to see how many of them believe unsafe products reach the market. When asked how often they think medicines are put on the market and sold, and then judged unsafe and taken off the market, one-third to one-fourth of

the consumers said this happens a lot, and more than half of them said it happens a little.

The truth is, of 580 new drugs approved by FDA in the past ten years, only 16 have been taken off the market. Of that 16, only three drugs were removed from the market because of safety reasons. The other 13 were removed for technical reasons, such as failure to report to FDA periodically as required by new drug regulations.

Opinions About Labels on OTC Medicines

When people take nonprescription (over-the-counter) medicines, the label is their only source of information about correct use. Since the information on the label is so important, FDA was anxious to learn consumers' opinions about how well labels serve their purpose. Results are shown in Table 3.

A common misconception, one held by 18 percent of consumers, is that over-the-counter drug labels list all the ingredients in the product. Actually, manufacturers are required by law to list only the active ingredients in OTC drugs; inactive ingredients are listed only if the manufacturer chooses.

A significant part of FDA's current review of all OTC medicines is the evaluation of the labeling of these products to see that labels contain complete, clear, and accurate information, to assure wiser use by the public. New labels will be required where necessary.

At the same time, consumers should be aware of their own responsibility to be more careful about reading and following directions on labels, and about reporting bad experiences. Adverse reactions. to medicines should be reported to the nearest FDA District Office and-in the case of prescription medicinesto the physician.

Beliefs About the Role of the Federal Government

Table 4 shows consumers' opinion on the question of who does the most to make medicines safe. Nearly half the consumers-47 percent― believe Government contributes more in this area than other groups. A little less than one-fourth-23 percent-believe drug manufacturers contribute more.

Adds up to more than 100% because of multiple answers.

Most of the public-95 percentknows that the Government does have the authority to stop the sale of any drug on the market which is found to be unsafe.

On the matter of Government testing of medicines, consumers are not so knowledgeable. When asked how often medicines are tested by the Federal Government before they

Question

Group

Government

Companies that make medicines Consumer organizations

Doctors

Pharmacists
Companies that sell medicines
to the public
Individual people
Don't know

can be sold, 30 percent of the consumers say this happens all the time, 34 percent say it happens most of the time. Only 2 percent believe the Government does not test medicines, and 11 percent say they don't know.

The fact is that testing of medicines in the United States is done by manufacturers. Before a new drug is put on the market, the manufacturer must submit a New Drug Application to FDA for complete review and approval. This application includes data on studies as to the safety and efficacy of the product, the chemicals and other materials used in the processing, and the conditions under which the drug will be made. After the product is approved, the manufacturer continues to batch test it regularly. And once a drug is marketed, FDA samples it from time to time to make sure it is being properly made and meets standards.

FDA does test all antibiotics and insulin before these products can be marketed. The law requires that they be tested, batch by batch, to assure

Percent of Public Making

Indicated Choice

46.6%

23.4

12.2

11.0

6.0

2.5

2.0

5.4

109.1%

they are of the proper potency.

All of these procedures combine to produce a very high level of safety in the American drug supply, and this system for assuring safety is so highly regarded throughout the world that it is being copied by other countries.

Conclusions

1. Consumers' answers to survey questions indicate a certain amount of confusion and misconception about medicines.

2. Consumers perceive a difference in the safety of prescription and nonprescription medicines, with prescription medicines regarded as safer.

3. In a number of areas, better communication between FDA and consumers seems indicated. Consumers need to know more about how the safety of medicines is assured, yet alerted to the fact that they have a responsibility, too, in the safe use of medicines.