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Common Information

A fundamental principle of pharmacology is that all drugs have multiple actions. Actions that are desirable in the treatment of disease are considered therapeutic, while those that are undesirable or pose risks to the patient are called "effects." Adverse drug effects range from the trivial, e.g., nausea or dry mouth, to the serious, e.g., massive gastrointestinal bleeding or thromboembolism; and some drugs can be lethal. Therefore, an effective system for the detection of adverse drug effects is an important component of the health care system of any advanced nation. Much of the research conducted on new drugs aims at identifying the conditions of use that maximize beneficial effects and minimize the risk of adverse effects.

The intent of drug labeling is to reflect this body of knowledge accurately so that physicians can properly prescribe the drug; or, if it is to be sold without prescription, so that consumers can properly use the drug.

The current system of drug investigation in the United States has proved very useful and accurate in identifying the common side effects associated with new prescription drugs. By the time a new drug is approved by the Food and Drug Administration, its side effects are usually well described in the package insert for physicians. The investigational process, however, cannot be counted on to detect all adverse effects because of the relatively small number of patients involved in premarketing studies and the relatively short duration of the studies.

Animal toxicology studies are, of course, done prior to marketing in an attempt to identify any potential for toxicity, but negative results do not guarantee the safety of a drug in humans, as evidenced by such well known examples as the birth deformities due to thalidomide.

This recognition prompted the establishment in many countries of programs to which physicians report adverse drug effects. The United States and other countries also send reports to an international program operated by the World Health Organization. These programs, however, are voluntary reporting programs and are intended to serve a limited goal: alerting a government or private agency to adverse drug effects detected by physicians in the course of practice. Other approaches must be used to confirm suspected drug reactions and to estimate incidence rates. These other approaches include conducting retrospective control studies; for example, the studies associating endometrial cancer with estrogen use, and systematic monitoring of hospitalized patients to determine the incidence of acute common side effects, as typified by the Boston Collaborative Drug Surveillance Program.

Thus, the overall drug surveillance system of the United States is composed of a set of information bases, special studies, and monitoring programs, each contributing in its own way to our knowledge about marketed drugs. The system is decentralized among a number of governmental units and is not administered as a coordinated function. Still, it would be inappropriate at this time to attempt to unite all of the disparate elements into a comprehensive surveillance program. Instead, the challenge is to improve each segment of the system and to take advantage of new computer strategies to improve coordination and communication.


Common Information Question: 6/7

The author is most probably leading up to a discussion of some suggestions about how to:


centralize authority for drug surveillance in the United States


centralize authority for drug surveillance among international agencies


coordinate better the sharing of information among the drug surveillance agencies


eliminate the availability and sale of certain drugs now on the market


improve drug testing procedures to detect dangerous effects before drugs are approved

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Option(C) is correct

This is an application question, and the correct answer is choice (C).

In the last paragraph, the author suggests that uniting disparate elements into a comprehensive surveillance program is inappropriate at this time. This eliminates choices (A) and (B).

The author suggests, however, that improvements are possible in each segment of the system and urges reliance on computers to improve coordination and communication, so choice (C) is the correct answer.

Choice (D) is wrong because although the author might advocate the elimination of the availability of certain drugs, that is not what the passage is leading up to.

As for choice (E), although the author acknowledges that pre approval studies are not infallible, this notion is too narrow in scope to be the next logical topic for discussion.

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