Focus on Pharmacology: Essentials for Health Professionals, 3e (Moini)

Chapter 5 Law and Ethics of Medications

1) Amphetamines are most commonly classified as which type of scheduled drug?

A) Schedule I

B) Schedule II

C) Schedule III

D) Schedule IV

Answer: B

Explanation: B) Amphetamines and codeine are usually listed as Schedule II drugs, although specific products containing smaller quantities of Schedule II substances–usually combined with noncontrolled substances–are listed as Schedule III or IV.

2) Certificates of registration for pharmacist licensure are granted in most states for a period of:

A) 1 to 2 years

B) 2 to 3 years

C) 3 to 4 years

D) 4 to 5 years

Answer: A

Explanation: A) Most states guarantee licensure for 1 to 2 years. Continuing education must be undertaken so pharmacists and pharmacy technicians remain on the cutting edge of new advancements in their practice. This relatively short period of licensure (before having to become relicensed) helps to ensure better quality of skills, abilities, and continuing growth of knowledge.

3) Medical facilities must comply with the Bloodborne Pathogens Standard and be able to prove their compliance to:

A) CDC inspectors

B) DEA inspectors

C) FDA inspectors

D) OSHA inspectors

Answer: D

Explanation: D) OSHA is the regulatory agency that inspects medical facilities and requires compliance with the Bloodborne Pathogens Standard. The other agencies listed focus on different types of regulatory activities.

4) In the United States, drug legislation began in the:

A) 1700s

B) 1800s

C) 1900s

D) 1950s

Answer: C

Explanation: C) Drug legislation in the United States began in the 1900s. Before that, there was little regulation for the way drugs were manufactured, tested, packaged, or sold. This correct answer rules out the "1950s" as being a possible choice because the first drug legislation occurred early in the century.

5) The Comprehensive Drug Abuse Prevention and Control Act of 1970 is concerned with certain drugs called:

A) OTC drugs

B) prescribed drugs

C) generic drugs

D) controlled substances

Answer: D

Explanation: D) This act is concerned with controlled substances. The other choices cannot be correct because OTC drugs are sold without a prescription, requiring no governmental controls except to regulate that they are safely manufactured with the proper amounts of approved ingredients; all prescription drugs do not fall under the heading of "controlled substances," which this act is concerned with; and "generic drugs" includes many substances outside the scope of those that are controlled by this act.

6) The first Pure Food and Drug Act was passed by Congress in:

A) 1806

B) 1851

C) 1906

D) 1951

Answer: C

Explanation: C) This act was passed in 1906–early in the 20th century, also known as the 1900s. Before 1906, drugs such as opium were freely advertised and sold to consumers with no control as to how much of the drug was purchased, ingested, resold, and so on. The other dates in this question are not correct; before 1906, there were no drug acts, and by 1951, many different acts had already taken effect.

7) Diethylene glycol, the poison that caused the sulfanilamide disaster of 1937, is used today as:

A) soap

B) antifreeze

C) gasoline

D) diesel fuel

Answer: B

Explanation: B) Diethylene glycol is used today as antifreeze. It has a pleasant color and taste but is deadly if consumed. This substance was mixed with sulfanilamide and sold as a sore throat remedy, with no testing as to its toxicity. A total of 107 reported deaths occurred as a result.

8) Thalidomide was being sold as a sleeping pill outside the United States when it was discovered that the drug could harm:

A) elderly patients

B) female patients

C) fetuses during the first trimester of pregnancy

D) children allergic to penicillin

Answer: C

Explanation: C) Thalidomide caused serious malformations of fetuses during the first trimester of pregnancy, including missing or deformed limbs. The drug is currently used for special conditions, such as to treat leprosy, but it cannot be used by pregnant mothers (especially during the first trimester).

9) The nation's only legal drug enforcement agency is called the:

A) FDA

B) DEA

C) CDC

D) FTC

Answer: B

Explanation: B) The DEA is the only legal drug enforcement agency in the United States. The other choices stand for Food and Drug Administration, Centers for Disease Control and Prevention, and Federal Trade Commission.

10) In the United States, drugs that treat diseases affecting 200,000 people or fewer are called:

A) orphan drugs

B) OTC drugs

C) scheduled drugs

D) controlled substances

Answer: A

Explanation: A) Orphan drugs treat fewer than 200,000 people in the United States. The government offers special incentives for their development and marketing, including tax breaks and a 7-year monopoly on their sale by the company that develops them. OTC drugs are simply over-the-counter drugs, and scheduled drugs are listed in the five drug schedules, which list controlled substances and how they may be used.

11) Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?

A) Safe Medical Devices Act of 1990

B) Prescription Drug Marketing Act of 1987

C) Orphan Drug Act of 1983

D) Drug Abuse Control Amendment of 1965

Answer: B

Explanation: B) The Prescription Drug Marketing Act of 1987 controls drug reimportation. The Safe Medical Devices Act concerns patient harm caused by a medical device, the Orphan Drug Act controls the development and marketing of drugs that treat fewer than 200,000 people in the United States, and the Drug Abuse Control Amendment permitted authorized registrants to manufacture stimulant drugs.

12) Anabolic steroids are derived from:

A) vitamins

B) minerals

C) hormones

D) enzymes

Answer: C

Explanation: C) Anabolic steroids are derived from hormonal substances related to estrogen, progestins, testosterone, and corticosteroids. They are regulated under the CSA. Vitamins and minerals are available OTC, and enzymes are naturally found in the human body; hence, none of these fit the criteria of the uses for anabolic steroids.

13) OSHA's mission is to ensure:

A) that drugs are not sold across international borders

B) that orphan drugs are regularly developed in the United States

C) compliance with the requirements of scheduled drugs

D) workplace safety and a healthy workplace environment

Answer: D

Explanation: D) OSHA, which is part of the Department of Labor, is concerned with safe and healthy workplaces. The other choices are incorrect because they are outside the scope of OSHA's activities. The DEA controls all illegal drug activities, such as the import and export of drugs and the legalized use of scheduled drugs. Orphan drugs are governed by the Orphan Drug Act of 1983.

14) HIPAA stands for:

A) Health Insurance Protection Amendment Act

B) Hospital Intern/Physician Accountability Act

C) Health Insurance Portability and Accountability Act

D) Health Insurance Protection and Associated Amendments

Answer: C

Explanation: C) HIPAA stands for the Health Insurance Portability and Accountability Act. The other choices are not actual names of acts but use the HIPAA initials, and all appear to be realistically possible names for the act.

15) All drug administration laws are initiated, implemented, and enforced by the:

A) DEA

B) FDA

C) CDC

D) HIPAA

Answer: B

Explanation: B) Although it would seem that the DEA might be the correct choice, it is important to understand the distinction between the DEA and the FDA (which is the correct choice for this question). The FDA controls all drug administration laws. The DEA enforces controlled substance laws and regulations. The other choices the CDC and the HIPAA are incorrect because drugs are not the focus of the CDC, and HIPAA is concerned with health insurance.

16) The CDC's primary function is to issue:

A) infection-fighting drugs

B) regulations about drugs for specific diseases

C) infection control regulations

D) black box warnings

Answer: C

Explanation: C) The CDC primarily issues infection control regulations. It focuses on worldwide diseases, either common or rare. Current worldwide concerns include SARS and bird flu. The other choices are incorrect because they all relate to drugs and drug packaging, which are outside the scope of the CDC.

17) Pharmacy practice is primarily governed by:

A) pharmaceutical associations

B) federal law

C) poison control centers

D) state law

Answer: D

Explanation: D) State law is the main controller of pharmacy practice. Federal law does not govern pharmacy practice but may become involved in pharmacy practice disputes based on appeals. Pharmaceutical associations do not have any legal governing authority. Poison control centers are concerned with treating poisonings, not governing.

18) Standards of behavior and the concept of right and wrong beyond legal considerations are known as:

A) empathy

B) ethics

C) confidentiality

D) ordinances

Answer: B

Explanation: B) Ethics are standards of behavior outside the scope of law; hence, this is the correct choice. The other choices are incorrect because empathy concerns the ability to understand another person's position, confidentiality involves the keeping of patient information secure and safe from others who have no right to have access to it, and ordinances are specific legal rulings.

19) Drug samples:

A) may be sold to any qualified person

B) traded between people for other drugs that they may require

C) may not be sold unless to another physician

D) may not be sold

Answer: D

Explanation: D) Drug samples may not be sold. They are provided by drug companies so physicians can give them out free of charge as samples; this is to promote future sales of these drugs. Trading drugs between different people is not a legal activity. The patient who is intended to take a drug–whether it is a free sample or a prescribed, purchased drug–is the only one who should take it.

20) Which type of drug cannot be sold without a prescription?

A) Legend

B) OTC

C) Aspirin

D) Acetaminophen

Answer: A

Explanation: A) Legend drugs cannot be sold without a prescription. OTC means over the counter, not requiring a prescription. Aspirin and acetaminophen are examples of OTC drugs.

21) Which types of scheduled drugs have "high abuse potential"?

A) Schedules I and II

B) Schedules II and III

C) Schedules I and V

D) Schedules IV and V

Answer: A

Explanation: A) Schedules I and II contain drugs with "high abuse potential." The schedules range from Schedule I (the highest abuse potential) to Schedule V (the least abuse potential).

22) Which governing agency approves the investigational use of drugs on humans?

A) HIPAA

B) CDC

C) DEA

D) FDA

Answer: D

Explanation: D) The FDA approves investigational use of drugs on humans. Again, the FDA is concerned with all drug administration laws. The DEA enforces drug laws, and the CDC is concerned with disease prevention. HIPAA focus on insurance coverages.

23) Allied health professionals must use confidentiality in all areas that concern:

A) medications and their sale

B) medications and their adverse effects

C) medications and their administration

D) medications and their relationship to allergies

Answer: C

Explanation: C) Confidentiality must be used concerning medications and their administration. The other choices are incorrect because allied health-care workers may, for example, discuss with patients, questions about medications that they may sell; the adverse effects of medications; and, of course, whether a patient's allergies may affect the use of a certain medication.

24) Which type of pharmacy requires special procedures because of the possible exposure to chemotherapy?

A) Investigational pharmacy

B) Compounding pharmacy

C) Institutional pharmacy

D) Nuclear pharmacy

Answer: D

Explanation: D) Nuclear pharmacy is concerned with chemotherapy and requires special procedures as well as special precautions. It is the first specialty area of pharmacy for which a special regulation at the state level has been established. The other choices are incorrect because they do not focus on chemotherapy preparations and have lower levels of danger to pharmacy staff.

25) Prescription pads must be used only for:

A) writing prescriptions for medications

B) writing down incoming calls from other physicians

C) writing instructions for patients on the use of free samples

D) writing directions to the pharmacy for patients

Answer: A

Explanation: A) Prescription pads must be used only for writing prescriptions for medications. They should be kept secure so patients cannot remove blank pads from the office, and no other sort of communication should be written on them because of the possibility of them being erased and reused with forged prescription information. Physicians are 100% liable for prescriptions that come from their offices, and prescription pads should be carefully safeguarded from misuse.

26) Which type of schedule drug is NOT approved for medical use in the United States?

A) Schedule IV

B) Schedule III

C) Schedule II

D) Schedule I

Answer: D

Explanation: D) Schedule I drugs are not approved for medical use in the United States. All other scheduled drugs are approved for medical use in the United States, so all the other choices are incorrect.

27) Why is heroin considered a Schedule I drug but cocaine is considered a Schedule II drug?

A) Because heroin only comes from overseas

B) Because cocaine is found in many food products

C) Because cocaine has accepted medical use in the United States but heroin does not

D) Because heroin comes from the poppy plant, which is illegal to grow

Answer: C

Explanation: C) Cocaine has accepted medical use but for only very specific conditions; heroin has no accepted medical use. It does not matter where these drugs originate from concerning their assigned drug schedule. Cocaine is not used in food products. Poppy plants are not illegal to grow; only the manufacturing of heroin from them is illegal in the United States.

28) Today, federal regulations prohibit the use of drugs that would be:

A) detrimental to consumers

B) too expensive for some patients

C) not strong enough for the prescribed condition

D) too strong for the prescribed condition

Answer: A

Explanation: A) Federal regulations prohibit the use of drugs that would be detrimental to consumers. The effectiveness or lack of effectiveness of a drug does help physicians to pinpoint the most correct drug to use in treating a condition but is not something that causes the drug to be prohibited from use. The cost of a drug is based on its formulation, strength, depth of research and development, fair market value, and many other concerns, but the federal government does not prohibit the use of a drug just because of its cost.

29) Severe psychological or physical dependence may result from abuse of which of the following types of scheduled drugs?

A) Schedule II

B) Schedule III

C) Schedule IV

D) Schedule V

Answer: A

Explanation: A) Schedule II drugs may result in severe psychological or physical dependence. The other schedules contain drugs whose psychological or physical dependence potential is less than that in Schedule II.

30) Which of the following types of agents are sometimes used by athletes to increase physical performance and require a prescription?

A) Catabolic steroids

B) Anabolic steroids

C) Sterols

D) Protein supplements

Answer: B

Explanation: B) Anabolic steroids are often in the news because of their use by athletes to increase physical performance and because they are often obtained illegally for this purpose. Catabolic steroids do not have the same desired action as anabolic steroids. Sterols are not used for these purposes. Protein supplements, although they help to increase energy and muscle mass, do not require a prescription.