Chapter 01: Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition MULTIPLE CHOICE 1. Knowledge of pharmacology aids the dental professional in a. obtaining a patient’s health history. b. administering drugs in the office. c. handling emergency situations. d. selection of a nonprescription medication. e. All of the above. ANS: E
All of the choices are true. Because many of our patients are being treated with drugs, knowledge of pharmacology helps in understanding and interpreting patients’ responses to health history questions. Knowledge of the therapeutic and adverse effects of medications obviously helps in their proper administration in the office. Emergency situations may be caused by drugs or treated by drugs; thus, knowledge of pharmacology is of great help, especially because a rapid response is sometimes required. A clear understanding of the concepts of drug action, drug handling by the body, and drug interactions will allow the dental practitioner to make proper judgments and grasp the concepts relevant to new drug therapies on the market. DIF: Application REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental Hygienist (Medication Administration), Role of the Dental Hygienist (Emergency Situations), Role of the Dental Hygienist (Nonprescription Medication) | pp. 2-3 OBJ: 1 TOP: NBDHE, 6.0. Pharmacology 2. Which of the following statements is true regarding planning appointments? a. Whether or not patients are taking medication for systemic diseases is of little
consequence in the dental office. b. Asthmatic patients should have dental appointments in the morning. c. Diabetic patients usually have fewer problems with a morning appointment
compared with afternoon appointments. d. Both B and C are true. ANS: D
Asthmatic patients who experience dental anxiety should schedule their appointments when they are not rushed or under pressure early in the morning. Diabetic patients usually have relatively fewer problems with a morning appointment. Patients taking medication for systemic diseases may require special handling in the dental office. DIF: Comprehension REF: Role of the Dental Hygienist (Appointment Scheduling) | p. 3 OBJ: 1 TOP: NBDHE, 6.0. Pharmacology
3. Nutritional or herbal supplements a. carry the U.S. Food and Drug Administration (FDA) approval for disease states. b. are not drugs. c. can cause adverse effects. d. will not interact with other drugs the patient may be taking. ANS: C
Nutritional or herbal supplements are quite capable of causing adverse effects. The majority of nutritional or herbal supplements do not carry FDA approval for treating disease states. These supplements are drugs and can cause adverse effects and interact with different drugs. DIF: Comprehension REF: Role of the Dental Hygienist (Nutritional or Herbal Supplements) | p. 3 OBJ: 1 TOP: NBDHE, 6.0. Pharmacology 4. Which type of drug name usually begins with a lowercase letter? a. Brand name b. Code name c. Generic name d. Trade name ANS: C
Before any drug is marketed, it is given a generic name that becomes the “official” name of the drug. Each drug is assigned only one generic name selected by the U.S. Adopted Name Council, and the name is not capitalized. The brand name is equivalent to the trade name and is capitalized. Although the brand name is technically the name of the company marketing the product, this term is often used interchangeably with the trade name. The code name is the initial term used within a pharmaceutical company to refer to a drug while it is undergoing investigation and is often a combination of capital letters and numbers, the letters representing an abbreviation of the company name. DIF: Comprehension REF: Drug Names | p. 4 OBJ: 3 TOP: NBDHE, 6.0. Pharmacology 5. A drug’s generic name is selected by the a. pharmaceutical company manufacturing it. b. Food and Drug Administration (FDA). c. U.S. Adopted Name Council. d. Federal Patent Office. ANS: C
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by the U.S. Adopted Name Council. The generic name is not selected by the FDA or the Federal Patent Office. The pharmaceutical company manufacturing the drug clearly has an influence on the generic name given its drug, but the final decision is not the company’s. DIF: Recall REF: Drug Names | p. 4 TOP: NBDHE, 6.0. Pharmacology
OBJ: 3
6. Which of the following is true concerning generic and trade names of drugs? a. A drug may only have one generic name and one trade name.
b. A drug may only have one generic name, but it may have several trade names. c. A drug may have several generic names, but it may only have one trade name. d. A drug may have several generic names and several trade names. ANS: B
Each drug has only one generic name but may have several trade names. For each drug, there is only one generic name. It is not capitalized, and it becomes the “official” name of the drug. The pharmaceutical company discovering the drug gives the drug a trade name. The trade name is protected by the Federal Patent Law for 20 years from the earliest claimed filing date, plus patent term extensions. Although the brand name is technically the name of the company marketing the product, it is often used interchangeably with the trade name. DIF: Comprehension REF: Drug Names | p. 4 OBJ: 3 TOP: NBDHE, 6.0. Pharmacology 7. Two drugs that are found to be chemically equivalent, but not biologically equivalent or
therapeutically equivalent are said to differ in a. potency. b. efficacy. c. bioavailability. d. therapeutic index. ANS: C
A preparation can be chemically equivalent yet not biologically or therapeutically equivalent. These products are said to differ in their bioavailability. The potency of a drug is a function of the amount of drug required to produce an effect. The efficacy is the maximum intensity of effect or response that can be produced by a drug. The therapeutic index is the ratio of the lethal dose for 50% of the experimental animals divided by the effective dose for 50% of the experimental animals. If the value of the therapeutic index is small, toxicity is more likely. DIF: Recall OBJ: 4
REF: Drug Names (Drug Substitution) | p. 5 TOP: NBDHE, 6.0. Pharmacology
8. How many years must pass after a drug patent expires before other drug companies can market the
same compound as a generic drug? a. 20 years b. 17 years c. 7 years d. 0 years ANS: D
Once a drug patent expires, competing companies may immediately market the same compound in generic form. The pharmaceutical company discovering the drug gives the drug a trade name. The trade name is protected by the Federal Patent Law for 20 years from the earliest claimed filing date, plus the patent term extensions. DIF: Application OBJ: 4
REF: Drug Names (Drug Substitution) | p. 5 TOP: NBDHE, 6.0. Pharmacology
9. Two drug formulations that produce similar concentrations in the blood and tissues after drug
administration are termed a. chemically b. biologically c. therapeutically
equivalent.
ANS: B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations (bioequivalence, for short). Chemical equivalence indicates that two formulations of a drug meet the chemical and physical standards established by the regulatory agencies. Therapeutic equivalence means that two formulations produce the same therapeutic effects over the same duration. DIF: Application OBJ: 4
REF: Drug Names (Drug Substitution) | p. 5 TOP: NBDHE, 6.0. Pharmacology
10. The federal body that determines whether a drug is considered a controlled substance and to which
schedule it belongs is the a. Food and Drug Administration (FDA). b. Federal Trade Commission (FTC). c. Drug Enforcement Administration (DEA). d. U.S. Pharmacopeia (USP). ANS: C
The DEA regulates the manufacture and distribution of substances with abuse potential. Hence prescriber DEA numbers must appear on prescriptions for controlled substances. The FDA does not have any special powers in regard to drugs of abuse. The FTC regulates commerce and advertising claims of foods, over-the-counter (OTC) products, and cosmetics. The USP regulates the uniformity and purity of drugs. DIF: Comprehension REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) | p. 5 OBJ: 5 TOP: NBDHE, 6.0. Pharmacology 11. Which federal regulatory agency decides which drugs require a prescription and which drugs may be
sold over-the-counter (OTC)? a. FDA b. OSHA c. FTC d. DEA ANS: A
The Food and Drug Administration (FDA) is part of Department of Human and Health Services (DHHS), and determines what drugs may be sold by prescription and OTC and regulates the labeling and advertising of prescription drugs. The Occupational Safety and Health Administration (OSHA) ensures the safety and health of workers in the United States by setting and enforcing standards. The Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohibits the false advertising of foods, nonprescription (OTC) drugs, and cosmetics. The Drug Enforcement Administration (DEA) is a part of the Department of Justice and regulates the manufacture and distribution of substances that have a potential for abuse, including opioids, stimulants, and sedatives.
DIF: Recall REF: Federal Regulations and Regulatory Agencies (US Food and Drug Administration) | p. 5 OBJ: 5 TOP: NBDHE, 6.0. Pharmacology 12. Which federal regulatory body regulates the trade practices of drug companies and prohibits false
advertising of foods, nonprescription drugs, and cosmetics? a. FDA b. FTC c. DEA d. OBRA ANS: B
Consumers who refer to care labels on their clothes, product warranties, or stickers showing the energy costs of home appliances are using information required by the FTC. Businesses must be familiar with the laws requiring truthful advertising and prohibiting price fixing. These laws are also administered by the FTC. When the FTC was created in 1914, its purpose was to prevent unfair methods of competition in commerce. Over the years, the U.S. Congress has passed additional laws giving the agency greater authority to police anticompetitive practices. The FDA grants approval so that drugs can be marketed in the United States. Before the FDA can approve a drug, the drug must be determined to be both safe and effective. The DEA regulates the manufacture and distribution of substances that have a potential for abuse. OBRA (Omnibus Budget Reconciliation Act) is not a regulatory body; it is an act that mandates that pharmacists must provide patient counseling. DIF: Recall REF: Federal Regulations and Regulatory Agencies (Federal Trade Commission) | p. 5 OBJ: 5 TOP: NBDHE, 6.0. Pharmacology 13. An investigational new drug application (INDA) is submitted a. before preclinical trials b. before phase 1 clinical trials c. after phase 2 clinical trials d. before phase 3 clinical trials
.
ANS: B
Preclinical testing usually lasts about 3 years. After the preclinical trials have been completed, an INDA must be filed with the FDA before a drug company can commence phase 1 clinical trials. Animal testing data must be accumulated from preclinical trials before filing an INDA. Phase 1 is the first trial using patients, and phases 2 and 3 follow phase 1. An INDA must be filed before any testing in humans can commence. DIF: Recall OBJ: 6
REF: Clinical Evaluation of a New Drug | p. 5 TOP: NBDHE, 6.0. Pharmacology
14. Phase 1 clinical trials involve all of the following except which one? a. Safe dose range b. Toxic effects of the drug c. Metabolism d. Effectiveness ANS: D
In phase 1 clinical trials, small and then increasing doses are administered to a limited number of healthy human volunteers, primarily to determine safety. This phase determines the biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug. The main purpose of phase 2 is to test effectiveness. Biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug are, in fact, goals of phase 1 clinical trials. DIF: Comprehension REF: Clinical Evaluation of a New Drug | p. 5 OBJ: 6 TOP: NBDHE, 6.0. Pharmacology 15. Which of the following is determined during a phase 3 clinical evaluation of a new drug? a. Effectiveness b. Safety and efficacy c. Dosage d. Both A and B e. Both B and C ANS: E
Both safety and efficacy must be demonstrated during phase 3 of the clinical evaluation of a new drug. Dosage is also determined during this phase. During phase 3, clinical evaluation takes place involving a large number of patients who have the condition for which the drug is indicated. The main purpose of phase 2 clinical evaluation is to test a drug’s effectiveness. DIF: Recall OBJ: 6
REF: Clinical Evaluation of a New Drug | p. 6 TOP: NBDHE, 6.0. Pharmacology
16. Which of the following is a Schedule II controlled substance? a. Heroin b. Propranolol c. Amphetamine d. Dextropropoxyphene (Darvon) ANS: C
Amphetamine, oxycodone, morphine, and secobarbital are all schedule II controlled substances. Heroin is a schedule I substance. Propranolol is a nonscheduled prescription drug. Dextropropoxyphene is a schedule IV substance. DIF: Recall REF: Drug Legislation (Scheduled Drugs [Table 1.2: Schedules of Controlled Substances]) | p. 6 OBJ: 6 TOP: NBDHE, 6.0. Pharmacology 17. Controlled substances in schedule
and do not permit refills. a. II, III, and IV b. II and III c. III and IV d. II only e. III only ANS: D
require a written prescription with the provider’s signature