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Homework answers / question archive / 1)There is a greater quantity of available OTC drugs than prescription drugs                                       2 The FDA is responsible for the safety and effectiveness of prescription drugs but not for the safety and effectiveness of OTC drugs

1)There is a greater quantity of available OTC drugs than prescription drugs                                       2 The FDA is responsible for the safety and effectiveness of prescription drugs but not for the safety and effectiveness of OTC drugs


1)There is a greater quantity of available OTC drugs than prescription drugs














            2 The FDA is responsible for the safety and effectiveness of prescription drugs but not for the safety and effectiveness of OTC drugs.

            3 Prescription drugs have a higher margin of safety than do OTC drugs

            4 Dietary supplements are the most regulated of the three major classes of OTC drugs

            5 The Dietary Supplement Health and Education Act of 1994 requires the FDA to evaluate the effectiveness of dietary supplements

            6 Prior to 1906, drugs did not have to be honestly labeled with regard to their ingredients

            7 The Pure Food and Drug Act of 1906 guaranteed that drugs were useful and safe as long as ingredients were clearly labeled

            8 After the passage of the 1938 Food, Drug, and Cosmetic Act, all new drugs had to be certified as safe and effective when used.

            9 Until an amendment to the FDC Act in 1951, there was no clear distinction between prescription and OTC drugs

            10 The Kefauver-Harris Amendment of 1962 mandated that the effectiveness and safety of new drugs must be proved before the drug is put on the market

            11 Due to the Kefauver-Harris Amendment of 1962, drug companies are required to evaluate the same drug on a regular basis

            12 Establishing an LD50 for a new drug is accomplished prior to clinical trials

            13 Prior to clinical trials, specific tests must be done on pregnant laboratory animals to determine if a drug under development causes birth defects.

            14 If a medication is going to be marketed for a chronic condition, toxicity studies in animals must simulate a period of time that the person uses the drug

            15 Phase 2 trials are typically conducted on healthy human volunteers

            16 Prisoners and medical students are often used during Phase 2 trials

            17 Phase 2 trials utilize a double-blind placebo design

            18 Most drugs that pass Phase 2 trials become approved by the FDA.

            19 Children and the elderly metabolize prescription drugs in the same manner as adults

            20 Drug companies are now required to conduct new studies of drugs already widely used for children.

            21 An IND is submitted to the FDA following the successful completion of Phase 3 clinical trials

            22 Many drugs in development never attain FDA approval for marketing

            23 Phase 4 trials occur after a drug is released to the public.

            24 A drug patent has a fixed duration of 12 years.

            25 The length of time for a patent to be in effect starts when the drug is put on the market.

            26 Bioequivalence refers to two drug compounds having identical chemical and pharmacological effects,

            27 Bioavailability is the rate at which a drug enters the circulation and reaches its site of action.0

            28 The FDA approval process can be shortened for drugs designed to help seriously ill people

            29 As a result of the Kafauver-Harris Amendment of 1962, all OTC and prescription drugs must be determined to be GRAS, GRAE, and GRAHL

            30 OTC antihistamines are stronger at the present time than they have beeb in the past

            31 Monistat, Benadryl, and Pepcid AC are three examples of OTC drugs that were once only available on a prescription basis

            32 Without a doubt, FDA approved drugs are safe.p2-343

            33 In recent years, the priority is to use caution screening drugs that may be potentially harmful, more so than to provide drugs in an expeditious manner

            34 The FDA has recently been approving more drugs than in previous years

            35 In 2007, the FDA approved only 17 new drugs that had never previously been marketed in the U.S., the lowest number in five years

            36 OTC drugs, by definition, do not have any side effects

            37 DAWN reports indicate that the misuse of pain relievers accounts for slightly less than half (about 45 percent) of all suicide-related ED visits

            38 Handwritten prescriptions can be confusing to pharmacists, leading to the inappropriate medication being dispensed

            39 In 2008, the U.S. Pharmacopeia identified double the number of pairs of drug brand names that looked or sounded alike than it had identified in 2004

            40 The FDA estimates that over a period of 20 years, the barcode-based medication administration system will have prevented 500,000 adverse drug events and achieved a 50 percent reduction in the likelihood of medication errors

            41 Aspirin is a common name for the drug, acetaminophen

            42 NSAIDs are only prescription drugs

            43 An antipyretic drug can bring your body temperature down

            44 “Genuine Bayer Aspirin” is the most effective form of aspirin

            45 Aspirin erodes the stomach wall

            46 Aspirin is safe for pregnant women to take because it relieves the pain of childbirth

            47 Reye’s syndrome is a dangerous disease marked by lethargy, nausea, vomiting, disorientation, and coma

            48 Acetaminophen should not be given to anyone under the age of twenty because of a risk of developing Reye’s syndrome.

            49 It is advisable not to administer aspirin to individuals under the age of 20

            50 Acetaminophen is a better analgesic drug than acetylsalicylic acid (ASA) for patients with stomach ulcers.

            51 Acetaminophen is particularly suited for the treatment of inflammation of the joints

            52 Ibuprofen does not interfere with aspirin’s ability to protect against recurring heart attacks.

            53 The advantage of ibuprofen over naproxen is that ibuprofen has a substantially longer duration of action than does naproxen.

            54 The only two FDA-approved active ingredients in sleep aids are both antihistamines

            55 Cough and cold remedies reduce the length of time a cold is in one’s system

            56 Cough and cold remedies can be safely combined with the intake of alcohol.

            57 Cough-and-cold medications, particularly those containing the nasal decongestant pseudoephedrine, do not present health risks in young children.

            58 A pharmaceutical company famous for marketing one type of analgesic drug might also be marketing other types as well

            59 Medications imported from Italy and Canada are more expensive than those available in the United States

            60 Gingko biloba produces modest statistically significant improvement in cognitive functioning in Alzheimer’s patients, but this effect is not found in healthy individuals

            61 Domestically grown ginseng is higher in quality than Asian grown ginseng



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