Drug Names, Sources, and Regulation Practice Questions

73 multiple-choice questions on Drug names, sources, and regulation for paramedic and EMT students, from Chapter 13 (Principles of Pharmacology). Read each question, pick your answer, then tap Show answer to check it and read the explanation.

73 practice questions

1. The generic name of a drug is:

   1. A. The full chemical name describing the molecular structure
   2. B. The trademarked name chosen by the manufacturer
   3. C. A nonproprietary name derived from the chemical name
   4. D. The name recorded on the original drug patent
   Show answer

   Answer: C. A nonproprietary name derived from the chemical name

   Acetaminophen is generic; Tylenol is a trade name. The generic name is usually a shortened form of the chemical name.

2. A trade name is:

   1. A. A standard name used identically in every country
   2. B. A name describing the drug's chemical structure
   3. C. A capitalized brand name owned by the manufacturer
   4. D. A name assigned by the United States Adopted Names Council
   Show answer

   Answer: C. A capitalized brand name owned by the manufacturer

   One generic drug may have many trade names. Trade names are capitalized and may be trademarked.

3. The official name of a drug is:

   1. A. The brand name printed on the manufacturer's package
   2. B. The name listed in the United States Pharmacopeia
   3. C. The name used informally by drug users on the street
   4. D. The name derived from the full chemical formula
   Show answer

   Answer: B. The name listed in the United States Pharmacopeia

   It is usually the generic name followed by USP.

4. Drugs may be derived from:

   1. A. Bacteria and fungi grown in microbial culture only
   2. B. Plants, animals, minerals, and synthesis
   3. C. Synthetic chemicals made in the laboratory only
   4. D. Plant sources only, such as foxglove and poppy
   Show answer

   Answer: B. Plants, animals, minerals, and synthesis

   Digitalis came from foxglove; insulin was once animal-derived. Many modern drugs are synthetic or semisynthetic.

5. A Schedule I controlled substance is defined as one with:

   1. A. Low abuse potential and limited medical use
   2. B. High abuse potential and no accepted medical use in the U.S.
   3. C. Moderate abuse potential and accepted medical use
   4. D. Accepted medical use and low abuse potential
   Show answer

   Answer: B. High abuse potential and no accepted medical use in the U.S.

   Heroin and LSD are examples. Schedule I drugs have no currently accepted medical use in the United States.

6. Which schedule includes most EMS opioids such as fentanyl and morphine?

   1. A. Schedule II
   2. B. Schedule V
   3. C. Schedule I
   4. D. Schedule IV
   Show answer

   Answer: A. Schedule II

   Schedule II drugs have high abuse potential but accepted medical use.

7. Benzodiazepines such as midazolam and lorazepam are generally:

   1. A. Not controlled
   2. B. Schedule I
   3. C. Schedule II
   4. D. Schedule IV
   Show answer

   Answer: D. Schedule IV

   They carry lower abuse potential than Schedule II drugs.

8. A company begins selling a generic version of a brand-name drug after the patent expires. To win FDA approval, the generic must show that it:

   1. A. Repeated the full set of clinical trials
   2. B. Uses the brand's trademarked name
   3. C. Is bioequivalent to the brand product
   4. D. Has a new chemical structure
   Show answer

   Answer: C. Is bioequivalent to the brand product

   Generic drugs are approved through an abbreviated application that shows bioequivalence: the same active ingredient, strength, and route, with a matching rate and extent of absorption. A generic is bioequivalent to the brand product, so it does not have to have repeated the full set of clinical trials; it cannot use the brand's trademarked name, and a new chemical structure would make it a different drug, not a generic.

9. An investigational drug moves through phases of human testing to assess:

   1. A. Bioequivalence to an existing brand
   2. B. Shelf life and storage stability
   3. C. Purity and strength standards
   4. D. Safety, dosing, and effectiveness
   Show answer

   Answer: D. Safety, dosing, and effectiveness

   Phase I focuses on safety; later phases assess effectiveness. Each phase enrolls progressively larger groups. Bioequivalence testing applies to generic versions of approved drugs, and purity and strength standards are set by the USP rather than tested in clinical phases.

10. A drug's indication is:

    1. A. The usual adult dose and route of delivery
    2. B. The condition for which it is given
    3. C. A condition in which it should be withheld
    4. D. The way the drug acts at its receptor
    Show answer

    Answer: B. The condition for which it is given

    Contraindications are reasons to withhold it. The indication is the condition or purpose for which the drug is given.

11. An absolute contraindication means the drug:

    1. A. May be given only after online medical control
    2. B. May be given only at a reduced dose
    3. C. Should not be given in that situation
    4. D. May be given with caution if benefit outweighs risk
    Show answer

    Answer: C. Should not be given in that situation

    Relative contraindications call for weighing risk and benefit. With an absolute contraindication, harm outweighs benefit, so the drug is withheld.

12. Common reliable drug references for EMS include:

    1. A. The patient's or family's description of the drug
    2. B. Manufacturer advertising and promotional materials
    3. C. General internet search results and forums
    4. D. Package inserts, agency drug guides, and poison control
    Show answer

    Answer: D. Package inserts, agency drug guides, and poison control

    Poison control is a fast resource for unusual exposures.

13. The chemical name of a drug describes:

    1. A. Its regulatory schedule
    2. B. Its brand identity
    3. C. Its molecular structure
    4. D. Its manufacturer of origin
    Show answer

    Answer: C. Its molecular structure

    Chemical names (e.g., acetylsalicylic acid) describe the molecule; they are rarely used clinically.

14. Why do EMS protocols and drug references list medications by generic name rather than trade name?

    1. A. One generic name covers every brand
    2. B. Trade names are banned from drug labels
    3. C. Generic names show the drug's DEA schedule
    4. D. Generic names change with each manufacturer
    Show answer

    Answer: A. One generic name covers every brand

    A drug has one generic (nonproprietary) name but may be sold under many trade names, so using the generic name avoids confusion when brands change. Trade names do appear on drug labels, generic names say nothing about the DEA schedule, and it is trade names, not generic names, that change with each manufacturer.

15. 'Advil' and 'Motrin' are examples of:

    1. A. Chemical names for ibuprofen
    2. B. Generic names for ibuprofen
    3. C. Trade names for ibuprofen
    4. D. Official USP names for ibuprofen
    Show answer

    Answer: C. Trade names for ibuprofen

    Trade names are trademarked by manufacturers; the same drug can have several.

16. Which is the official U.S. standard reference for drug purity and strength?

    1. A. Physicians' Desk Reference (PDR)
    2. B. DEA Controlled Substance List
    3. C. U.S. Pharmacopeia (USP-NF)
    4. D. Manufacturer package inserts
    Show answer

    Answer: C. U.S. Pharmacopeia (USP-NF)

    USP-NF sets official standards for drug identity, strength, quality, and purity.

17. Drugs derived from plants include:

    1. A. Insulin, heparin, and Premarin
    2. B. Streptomycin, penicillin, and nystatin
    3. C. Morphine, atropine, and digoxin
    4. D. Calcium chloride and magnesium
    Show answer

    Answer: C. Morphine, atropine, and digoxin

    Opium poppy (morphine), belladonna (atropine), and foxglove (digoxin) are plant sources.

18. Heparin and some insulins historically came from which source?

    1. A. Minerals
    2. B. Animals
    3. C. Plants
    4. D. Synthesis only
    Show answer

    Answer: B. Animals

    Animal sources supplied heparin (porcine/bovine) and early insulins.

19. Mineral-source drugs include:

    1. A. Digoxin, heparin, and insulin
    2. B. Calcium chloride and magnesium sulfate
    3. C. Morphine, codeine, and atropine
    4. D. Penicillin, streptomycin, and cephalexin
    Show answer

    Answer: B. Calcium chloride and magnesium sulfate

    Electrolyte preparations are mineral-derived. Sodium bicarbonate is another mineral-source drug.

20. Which category describes most modern drugs?

    1. A. Inorganic mineral salts
    2. B. Purified animal tissue
    3. C. Natural plant extracts
    4. D. Synthetic or semisynthetic
    Show answer

    Answer: D. Synthetic or semisynthetic

    Most current drugs are manufactured synthetically in laboratories.

21. Recombinant DNA technology produces drugs such as:

    1. A. Morphine and codeine alkaloids
    2. B. Human insulin and vaccines
    3. C. Sodium and potassium chloride
    4. D. Atropine and scopolamine
    Show answer

    Answer: B. Human insulin and vaccines

    Genetically engineered organisms produce human proteins like insulin.

22. Unlike prescription drugs, dietary supplements such as St. John's wort can be sold in the United States without:

    1. A. A Supplement Facts ingredient label
    2. B. A named manufacturer or distributor
    3. C. Federal good manufacturing practice rules
    4. D. FDA review of safety and efficacy first
    Show answer

    Answer: D. FDA review of safety and efficacy first

    Under the Dietary Supplement Health and Education Act (1994), supplements need no FDA premarket review showing safety or efficacy. They must still carry a Supplement Facts ingredient label, list a named manufacturer or distributor, and follow federal good manufacturing practice rules. Patients often leave supplements off their medication list, so ask directly.

23. The DEA primarily regulates:

    1. A. Drug purity and strength
    2. B. Hospital pharmacy staffing
    3. C. Drug advertising claims
    4. D. Drugs with high abuse potential
    Show answer

    Answer: D. Drugs with high abuse potential

    The Drug Enforcement Administration enforces the Controlled Substances Act. Drugs with abuse potential are designated controlled substances.

24. Which drug in a typical paramedic drug box is outside the federal controlled-substance schedules?

    1. A. Ketamine
    2. B. Ondansetron
    3. C. Midazolam
    4. D. Morphine sulfate
    Show answer

    Answer: B. Ondansetron

    Ondansetron is a prescription antiemetic with no abuse potential and is not a controlled substance. Ketamine is Schedule III, midazolam is Schedule IV, and morphine sulfate is Schedule II, so every dose of those must be logged and any waste witnessed.

25. In 2014 the DEA moved hydrocodone combination products, such as hydrocodone with acetaminophen, into:

    1. A. Schedule III
    2. B. Schedule II
    3. C. Schedule IV
    4. D. Schedule V
    Show answer

    Answer: B. Schedule II

    Effective October 2014, hydrocodone combination products were moved from Schedule III to Schedule II because of widespread misuse, so they now carry the same controls as other strong opioids. Schedule IV holds benzodiazepines and tramadol, and Schedule V holds low-dose codeine cough preparations.

26. A patient's home medication is tramadol. Federally, tramadol is:

    1. A. A Schedule II controlled drug
    2. B. An unscheduled prescription drug
    3. C. A Schedule IV controlled drug
    4. D. A Schedule I controlled drug
    Show answer

    Answer: C. A Schedule IV controlled drug

    The DEA placed tramadol in Schedule IV in 2014. It is not a Schedule II controlled drug like most strong opioids, it is no longer an unscheduled prescription drug, and Schedule I is reserved for drugs with no accepted medical use. Tramadol also matters clinically: it lowers the seizure threshold and adds to serotonin toxicity.

27. Ketamine is federally scheduled as:

    1. A. Schedule II
    2. B. Not scheduled
    3. C. Schedule IV
    4. D. Schedule III
    Show answer

    Answer: D. Schedule III

    Ketamine is Schedule III.

28. The Controlled Substances Act of 1970 established:

    1. A. Federal limits on drug pricing
    2. B. The national EMS scope of practice model
    3. C. The Food and Drug Administration
    4. D. The five schedules of controlled drugs
    Show answer

    Answer: D. The five schedules of controlled drugs

    The CSA created the scheduling system based on abuse potential and medical use.

29. The Pure Food and Drug Act of 1906 is best known for:

    1. A. Requiring proof of safety before marketing
    2. B. Banning adulterated and misbranded drugs
    3. C. Requiring prescriptions for narcotics
    4. D. Creating controlled substance schedules
    Show answer

    Answer: B. Banning adulterated and misbranded drugs

    The 1906 Act prohibited adulterated and misbranded foods and drugs in interstate commerce and required labels to disclose certain dangerous ingredients such as opiates and alcohol. Requiring proof of safety before marketing came with the 1938 Food, Drug, and Cosmetic Act, requiring prescriptions for narcotics grew out of the 1914 Harrison Act era, and controlled substance schedules came with the 1970 Controlled Substances Act.

30. The Harrison Narcotic Act of 1914:

    1. A. Regulated and taxed opium and coca
    2. B. Created the Food and Drug Administration
    3. C. Banned all narcotic use nationwide
    4. D. Established the U.S. Pharmacopeia
    Show answer

    Answer: A. Regulated and taxed opium and coca

    It was the first federal control on opioids and cocaine.

31. The Federal Food, Drug, and Cosmetic Act of 1938 required:

    1. A. Generic names on all drug labels
    2. B. Proof of efficacy before marketing
    3. C. DEA registration of all prescribers
    4. D. Proof of safety before marketing
    Show answer

    Answer: D. Proof of safety before marketing

    After the sulfanilamide tragedy, safety testing became mandatory.

32. The Kefauver-Harris Amendment of 1962 added the requirement for:

    1. A. Child-resistant packaging for drugs
    2. B. The controlled substance schedules
    3. C. Proof of safety before marketing
    4. D. Proof of efficacy in addition to safety
    Show answer

    Answer: D. Proof of efficacy in addition to safety

    Following thalidomide, drugs had to be shown effective as well as safe.

33. EMS agencies that carry controlled substances must:

    1. A. Have each paramedic hold a personal DEA license
    2. B. Store them with other medications on the unit
    3. C. Hold DEA registration and log every dose
    4. D. Document them only when a dose is wasted
    Show answer

    Answer: C. Hold DEA registration and log every dose

    Controlled substances require strict chain-of-custody and tracking. Agencies need DEA registration, secure storage, and accountability logs for every dose.

34. A drug's 'package insert' is:

    1. A. The FDA-approved prescribing information
    2. B. A pharmacist's note on dispensing instructions
    3. C. An optional guide with no legal standing
    4. D. A manufacturer's promotional summary
    Show answer

    Answer: A. The FDA-approved prescribing information

    The insert contains indications, dosing, contraindications, and adverse effects.

35. 'Off-label' use means:

    1. A. Use of a prescription drug without a prescription
    2. B. Any use not permitted under federal law
    3. C. Use for an indication not in the FDA labeling
    4. D. Use of a drug after its expiration date
    Show answer

    Answer: C. Use for an indication not in the FDA labeling

    Off-label use is legal under medical direction and common (e.g., ketamine for pain).

36. 'Orphan drugs' are developed for:

    1. A. Short-term hospital use
    2. B. Rare diseases
    3. C. Common conditions
    4. D. Off-label pediatric uses
    Show answer

    Answer: B. Rare diseases

    The Orphan Drug Act incentivizes drugs for rare conditions. Orphan status depends on how rare the condition is, not on the setting of use or on off-label prescribing in children.

37. Which document lists a drug's generic and trade names, class, and dosing for EMS reference?

    1. A. A DEA controlled-substance log
    2. B. A protocol drug reference
    3. C. An FDA MedWatch report form
    4. D. A Safety Data Sheet (SDS)
    Show answer

    Answer: B. A protocol drug reference

    Formularies and references organize drug information for providers. Agency formularies serve the same purpose. A controlled-substance log tracks counts and waste, a MedWatch form reports adverse events, and a Safety Data Sheet covers chemical hazards rather than clinical dosing.

38. The term 'pharmacology' means:

    1. A. The study of drugs and their effects
    2. B. The preparation and dispensing of drugs
    3. C. The science of manufacturing drugs
    4. D. The study of poisons and their antidotes
    Show answer

    Answer: A. The study of drugs and their effects

    Pharmacology encompasses the sources, properties, and effects of drugs. Preparing and dispensing drugs is the practice of pharmacy, not pharmacology.

39. A 'drug' is defined as:

    1. A. Only substances on the DEA schedules
    2. B. Any substance that alters body function
    3. C. Only items that require a written prescription
    4. D. Any food or nutrient taken by mouth
    Show answer

    Answer: B. Any substance that alters body function

    This broad definition includes OTC, herbal, and prescription agents.

40. In 2023 the FDA approved 4-mg naloxone nasal spray for sale:

    1. A. To DEA-registered EMS agencies
    2. B. By prescription to patients on opioids
    3. C. As a Schedule V controlled drug
    4. D. Over the counter, with no prescription
    Show answer

    Answer: D. Over the counter, with no prescription

    In March 2023 the FDA approved Narcan 4-mg nasal spray as the first over-the-counter naloxone, so anyone can buy it without a prescription. Naloxone has no abuse potential, so it is not a Schedule V controlled drug, sales are not limited to DEA-registered EMS agencies, and it is not restricted by prescription to patients on opioids.

41. The abbreviation 'USP' after a drug name indicates:

    1. A. It is a federally controlled substance
    2. B. It meets official USP standards
    3. C. It is approved for over-the-counter sale
    4. D. It is a generic rather than a brand
    Show answer

    Answer: B. It meets official USP standards

    USP designation signifies compliance with official standards.

42. Investigational drugs in phase III trials are:

    1. A. Tested only in laboratory animals
    2. B. Approved and released for general use
    3. C. Tested in large patient groups before approval
    4. D. Sold over the counter during the trial
    Show answer

    Answer: C. Tested in large patient groups before approval

    Phase III is the large-scale pre-approval trial phase. Phase III tests efficacy and safety in large patient groups.

43. Which body assigns the generic (nonproprietary) name to a new drug in the United States?

    1. A. The manufacturer's marketing department
    2. B. The Drug Enforcement Administration
    3. C. The individual state board of pharmacy
    4. D. The U.S. Adopted Names (USAN) Council
    Show answer

    Answer: D. The U.S. Adopted Names (USAN) Council

    The USAN Council selects generic names; manufacturers choose and trademark the trade name.

44. A patient takes Toprol XL (extended-release metoprolol). What is the danger of crushing this tablet before giving it?

    1. A. Crushing frees the full day's dose at once
    2. B. Crushed metoprolol is not absorbed
    3. C. Crushing turns it into a different drug
    4. D. The coating is needed to avoid liver metabolism
    Show answer

    Answer: A. Crushing frees the full day's dose at once

    Extended-release (XL, ER, SR) tablets release drug slowly over many hours. Crushing destroys that design and frees the full day's dose at once, risking bradycardia and hypotension. Crushed metoprolol is still absorbed (that is the danger), crushing does not turn it into a different drug, and the coating does not help it avoid liver metabolism.

45. Which generic-to-trade name pairing is correct?

    1. A. Diphenhydramine - Zofran
    2. B. Ondansetron - Ativan
    3. C. Midazolam - Versed
    4. D. Lorazepam - Benadryl
    Show answer

    Answer: C. Midazolam - Versed

    Midazolam is Versed; ondansetron is Zofran, lorazepam is Ativan, and diphenhydramine is Benadryl.

46. A patient hands you a bottle labeled 'Coumadin.' The generic name of this drug is:

    1. A. Clopidogrel
    2. B. Apixaban
    3. C. Warfarin
    4. D. Heparin
    Show answer

    Answer: C. Warfarin

    Coumadin is the trade name for warfarin, an oral vitamin K antagonist anticoagulant.

47. The generic name for the trade-name drug 'Lopressor' is:

    1. A. Metoprolol
    2. B. Diltiazem
    3. C. Lisinopril
    4. D. Labetalol
    Show answer

    Answer: A. Metoprolol

    Lopressor is metoprolol tartrate, a beta-1 selective blocker.

48. Ketorolac is commonly known by the trade name:

    1. A. Zofran
    2. B. Cardizem
    3. C. Toradol
    4. D. Romazicon
    Show answer

    Answer: C. Toradol

    Toradol is ketorolac, a parenteral NSAID; Romazicon was the trade name for flumazenil.

49. Digoxin immune Fab (DigiFab), the antidote for digoxin toxicity, is made from:

    1. A. Purified extract of foxglove leaves
    2. B. Recombinant human insulin
    3. C. Synthetic potassium salts
    4. D. Antibody fragments raised in sheep
    Show answer

    Answer: D. Antibody fragments raised in sheep

    DigiFab is an animal-source drug: ovine (sheep) antibody fragments that bind digoxin. A purified extract of foxglove leaves is the plant source of digoxin itself, not its antidote. Recombinant human insulin and synthetic potassium salts do not bind digoxin.

50. A patient's medication list includes adalimumab (Humira). The suffix '-mab' tells you the drug is a:

    1. A. MAO inhibitor antidepressant
    2. B. Macrolide antibiotic
    3. C. Monoclonal antibody
    4. D. Beta blocker
    Show answer

    Answer: C. Monoclonal antibody

    Drug names ending in -mab are monoclonal antibodies, biologic drugs made in living cells. Adalimumab blocks TNF and suppresses immunity, so infections may present subtly. An MAO inhibitor antidepressant is phenelzine, macrolide antibiotic names end in -mycin (azithromycin), and beta blocker names end in -olol.

51. Isotretinoin can be dispensed only through an FDA-required program that includes pregnancy testing before each prescription. This type of program is a:

    1. A. Postmarketing MedWatch reporting program
    2. B. Controlled substance schedule
    3. C. Risk Evaluation and Mitigation Strategy
    4. D. Orphan drug designation
    Show answer

    Answer: C. Risk Evaluation and Mitigation Strategy

    A REMS (Risk Evaluation and Mitigation Strategy) is an FDA-required safety program for drugs with serious risks; iPLEDGE for isotretinoin requires pregnancy testing because the drug is a potent teratogen. MedWatch is a voluntary postmarketing reporting program, a controlled substance schedule addresses abuse potential, and orphan drug designation is an incentive for rare-disease drugs.

52. The FDA announces a Class I recall of a medication lot your agency stocks. This means:

    1. A. Using it could cause serious harm or death
    2. B. The label has a minor printing error
    3. C. Use may cause temporary, reversible harm
    4. D. The drug is in short supply but safe to use
    Show answer

    Answer: A. Using it could cause serious harm or death

    A Class I recall is the most serious: there is a reasonable probability that use will cause serious harm or death, so the lot is pulled immediately. A minor printing error on the label with little risk is a Class III recall, temporary or medically reversible harm describes a Class II recall, and drugs in short supply are tracked separately and are not recalled for that reason.

53. Penicillin is an example of a drug originally derived from:

    1. A. A mineral
    2. B. A synthetic laboratory process only
    3. C. Animal tissue
    4. D. A microorganism (mold)
    Show answer

    Answer: D. A microorganism (mold)

    Penicillin was discovered as a product of Penicillium mold, making microorganisms a recognized drug source.

54. Conjugated estrogens (Premarin) are an example of a drug obtained from:

    1. A. Recombinant bacteria
    2. B. A plant source
    3. C. A mineral source
    4. D. An animal source
    Show answer

    Answer: D. An animal source

    Premarin is derived from pregnant mare urine, an animal source.

55. Hydromorphone and oxycodone are best described as:

    1. A. Fully synthetic opioids
    2. B. Natural opium alkaloids
    3. C. Semisynthetic opioids
    4. D. Recombinant peptide hormones
    Show answer

    Answer: C. Semisynthetic opioids

    Semisynthetic drugs start from a natural compound (morphine or thebaine) and are chemically altered.

56. Fentanyl is classified by source as a:

    1. A. Natural opium alkaloid
    2. B. Recombinant peptide
    3. C. Semisynthetic derivative of codeine
    4. D. Fully synthetic opioid
    Show answer

    Answer: D. Fully synthetic opioid

    Fentanyl is manufactured entirely in the laboratory and is not derived from the opium poppy.

57. Which is an example of a Schedule V controlled substance?

    1. A. Fentanyl citrate injection
    2. B. Heroin (diacetylmorphine)
    3. C. Low-dose codeine cough syrup
    4. D. Midazolam injection for sedation
    Show answer

    Answer: C. Low-dose codeine cough syrup

    Schedule V drugs have the lowest abuse potential, such as low-dose codeine cough syrups.

58. Anabolic steroids such as testosterone are placed in Schedule:

    1. A. Schedule II
    2. B. Not scheduled
    3. C. Schedule III
    4. D. Schedule IV
    Show answer

    Answer: C. Schedule III

    Anabolic steroids are Schedule III, with moderate abuse potential and accepted medical use.

59. Which substance is classified as Schedule I?

    1. A. Methamphetamine
    2. B. Fentanyl
    3. C. Cocaine
    4. D. Heroin
    Show answer

    Answer: D. Heroin

    Heroin has no accepted medical use in the U.S.; cocaine, methamphetamine, and fentanyl are Schedule II.

60. Cocaine is Schedule II rather than Schedule I because it:

    1. A. Has a low potential for abuse or misuse
    2. B. Does not cause physical dependence
    3. C. Is available over the counter in some forms
    4. D. Has accepted use as a topical anesthetic
    Show answer

    Answer: D. Has accepted use as a topical anesthetic

    Schedule II drugs have a high potential for abuse but an accepted medical use, such as topical cocaine for nasal procedures; Schedule I drugs have no accepted medical use. Cocaine's abuse potential is high rather than low, it can cause dependence, and no form of cocaine is sold over the counter.

61. A drug label marked 'Rx only' indicates a:

    1. A. Schedule I controlled substance
    2. B. Over-the-counter drug
    3. C. Prescription (legend) drug
    4. D. Regulated dietary supplement
    Show answer

    Answer: C. Prescription (legend) drug

    The 'Rx only' legend means the drug may be dispensed only with a prescription.

62. Over-the-counter (OTC) drugs are those that:

    1. A. Can be sold only by a licensed pharmacist in person
    2. B. Are sold without any FDA review or oversight
    3. C. Are exempt from federal labeling rules
    4. D. Are judged safe for self-use with proper FDA labeling
    Show answer

    Answer: D. Are judged safe for self-use with proper FDA labeling

    OTC drugs are FDA-regulated and judged safe for consumers to use following the Drug Facts label. No prescription is required.

63. Phase I clinical trials primarily evaluate:

    1. A. Safety in a small group of volunteers
    2. B. Effectiveness in thousands of patients
    3. C. Long-term adverse effects after marketing
    4. D. Toxicity and dosing in laboratory animals
    Show answer

    Answer: A. Safety in a small group of volunteers

    Phase I is the first human testing and focuses on safety, tolerability, and pharmacokinetics. Participants are usually a small number of healthy volunteers.

64. Phase IV of drug development refers to:

    1. A. Comparison with placebo before approval
    2. B. Postmarketing surveillance after approval
    3. C. Initial toxicity testing in laboratory animals
    4. D. First-in-human dosing in healthy volunteers
    Show answer

    Answer: B. Postmarketing surveillance after approval

    Phase IV monitors a marketed drug in the general population to detect rare or long-term adverse effects.

65. Before any human testing, a new drug undergoes preclinical testing, which consists of:

    1. A. Laboratory and animal studies
    2. B. Dosing studies in healthy volunteers
    3. C. Postmarketing reports from pharmacists
    4. D. Large randomized trials in patients
    Show answer

    Answer: A. Laboratory and animal studies

    Preclinical work establishes basic safety and pharmacology before an IND allows human trials. These studies assess toxicity and effect.

66. A company files an Investigational New Drug (IND) application with the FDA in order to:

    1. A. Obtain a DEA controlled schedule
    2. B. Begin testing the drug in human subjects
    3. C. Register the drug's trade name
    4. D. Sell the drug over the counter
    Show answer

    Answer: B. Begin testing the drug in human subjects

    The IND must be in effect before clinical (human) trials can start.

67. The FDA's MedWatch program is used to:

    1. A. Schedule new controlled substances
    2. B. Report serious adverse events to the FDA
    3. C. Approve new generic drug names
    4. D. Track EMS agency DEA registrations
    Show answer

    Answer: B. Report serious adverse events to the FDA

    Health care providers and the public can submit adverse event reports to MedWatch for postmarketing safety monitoring. Reporting is voluntary and also covers product problems.

68. The Physicians' Desk Reference (PDR) is largely compiled from:

    1. A. DEA controlled substance records
    2. B. Hospital pharmacy formularies
    3. C. State and regional EMS protocols
    4. D. Manufacturers' package inserts
    Show answer

    Answer: D. Manufacturers' package inserts

    The PDR reprints FDA-approved labeling (package inserts) supplied by manufacturers.

69. A relative contraindication means:

    1. A. The drug is approved only for use in children
    2. B. May be used with caution when benefit outweighs risk
    3. C. The drug must never be given in any situation
    4. D. The drug may be given only for off-label uses
    Show answer

    Answer: B. May be used with caution when benefit outweighs risk

    Relative contraindications call for clinical judgment, unlike absolute contraindications.

70. The Protecting Patient Access to Emergency Medications Act of 2017 allows paramedics to:

    1. A. Skip documentation of controlled drug use
    2. B. Store controlled drugs without DEA registration
    3. C. Prescribe controlled substances for home use
    4. D. Give controlled drugs under standing orders
    Show answer

    Answer: D. Give controlled drugs under standing orders

    The Act amended the CSA to permit EMS agency DEA registration and administration of controlled substances under standing orders or protocols. The EMS agency must be registered with the DEA.

71. DEA Form 222 (or its electronic equivalent) is used to:

    1. A. Report a medication error to the FDA
    2. B. Apply for FDA approval of a new drug
    3. C. Order Schedule I and II substances
    4. D. Document a patient's refusal of care
    Show answer

    Answer: C. Order Schedule I and II substances

    Transfers of Schedule I and II substances require a DEA Form 222 or the CSOS electronic system.

72. Theft or significant loss of controlled substances must be reported to the DEA using:

    1. A. DEA Form 224
    2. B. DEA Form 222
    3. C. DEA Form 106
    4. D. DEA Form 41
    Show answer

    Answer: C. DEA Form 106

    DEA Form 106 documents theft or significant loss of controlled substances. Form 222 is for ordering, Form 41 for destruction, and Form 224 for registration.

73. The Combat Methamphetamine Epidemic Act restricts over-the-counter sales of:

    1. A. Pseudoephedrine
    2. B. Acetaminophen
    3. C. Diphenhydramine
    4. D. Ibuprofen
    Show answer

    Answer: A. Pseudoephedrine

    Pseudoephedrine is a methamphetamine precursor, so it is kept behind the counter with purchase limits and logs.