Chapter 1: Consumer Safety and Drug Regulations

Schedule IV: can be refilled up to five times in six months

Xanax

1983 Orphan Drug Act

gave incentives for developing drugs that treat rare diseases

high abuse potential; not approved for medical use

heroin

Prescription pads should be concealed and ___ .

hidden

1906 Pure Food and Drug Act

established consumer protection

1938 Federal food, drug and cosmetic act

established the FDA

National Drug Code Directory

provides the FDA with a list of all drugs manufactured for commercial distribution

low abuse potential used for cough

Cheratussin AC

DEA

Drug Enforcement Agency

1970 Controlled Substances Act

Established the DEA

FDA

Food and Drug Administration

high abuse; written or e-prescription only

Hydrocodone with Tylenol

NDC

National Drug Code

NF

National Formulary

An athlete requests a prescription for an anabolic steroid (C-III) from her physician. How often can a prescription for a C-III drug be refilled? a. C-III drugs may be refilled up to five times in six months. b. C-III drugs are not approved for medical use in the United States. c. C-III drugs can only be refilled with a new written prescription. d. C-III drugs may be refilled at the discretion of the physician and state regulations.

a. C-III drugs may be refilled up to five times in six months.

A client asks why pharmacists must offer counseling before dispensing medication. The office manager explains that this is required by which act? a. Omnibus Budget Reconcilation Act b. The Pure Food and Drug Act c. The Controlled Substances Act d. The Federal Food, Drug, and Cosmetic Act

a. Omnibus Budget Reconciliation Act

A client asks her health care practitioner if there are any regulations concerning nonprescription medicines. The health care practitioner explains that nonprescription medicines are governed by which act? a. The Federal Food, Drug, and Cosmetic Act b. The Omnibus Budget Reconciliation Act c. The Pure Food and Drug Act d. The Controlled Substance Act

a. The Federal Food, Drug, and Cosmetic Act

Choose whether the guideline for health care practitioners is appropriate or inappropriate. Accurate records of controlled substances must be kept for two years. a. Appropriate b. Inappropriate

a. appropriate

Choose whether the guideline for health care practitioners is appropriate or inappropriate. Each physician must be registered with the DEA to prescribe controlled substances. a. Inappropriate b. Appropriate

a. appropriate

Controlled substances should be: a. Double-locked in medicine drawers b. Left at patient bed stand c. Available only in hospitals d. Readily available in medicine drawers

a. double-locked in medicine drawers

Choose whether the guideline for health care practitioners is appropriate or inappropriate. Prescription pads need to be kept in plain sight for the physician or practitioners to use. a. Inappropriate b. Appropriate

a. inappropriate

A client visits her health care practitioner for her annual physical. She questions the office staff regarding the use of an herbal supplement that she saw advertised on television for weight loss. What information can the health care practitioner share with her client? a. The production of herbal medicines is not regulated by the FDA. b. Herbal medicines are tested by the FDA to determine if they have interactions with prescribed medications. c. Herbal medicines, while not approved by the FDA, are considered harmless. d. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that a dietary supplement is safe before it is marketed.

a. the production of herbal medicines is not regulated by the FDA.

Omnibus Budget Reconciliation ACT (OBRA)

all OTC drugs taken must be documented in the medical record

Drug Standards

assures medication strength, quality, and purity

Records of each controlled substance dispensed, received, or destroyed at the facility where you work must be available for review for what time period? a. 7 years b. 2 years c. 1 year d. 3 years

b. 2 years

Choose whether the guideline for health care practitioners is appropriate or inappropriate. Controlled substances require an up-to-date FDA number. a. Inappropriate b. Appropriate

b. appropriate

An office manager is discussing the prescription policy to her client for some possible medications. Which drug, according to its classification, requires a new written prescription for a refill? a. Valium (C-IV) b. Promethazine with codeine (C-V) c. Codeine (C-II) d. Codeine with Tylenol (C-III)

c. Codeine (C-II)

A client calls her health care practitioner's office to ask about a label on a new prescription bottle that has a warning about drowsiness. What does the office manager know about prescription labels? a. Health care practitioners are required to give the pharmacy appropriate warnings. b. The label is a recommendation provided by the pharmacy. c. The FDA regulations mandate that all prescriptions must include a listing of all active and inactive ingredients, and that certain preparations must include warning labels. d. The DEA enforces the use of warning labels for all medications.

c. The FDA regulations mandate that all prescriptions must include a listing of all active and inactive ingredients, and that certain preparations must include warning labels.

Which of the following was the first federal regulation established for consumer protection in the manufacturing of drugs and food? a. The Federal Food, Drug and Cosmetic Act b. The Foods and Drug Administration c. The Pure Food and Drug Act d. The Controlled Substance Act

c. The Pure Food and Drug Act

A pharmaceutical representative visits the primary care physicians' offices in a community to discuss recently developed medications. What does the 1983 Orphan Drug Act give pharmaceutical companies the financial incentive to do? a. Give samples to health clinics b. Develop medication for orphaned children c. Develop medications for diseases that affect only a small number of people d. Develop medications requested by the local community

c. develop medications for diseases that affect only a small number of people.

Upon leaving the exam room, a client tells her health care practitioner that she is confused regarding her prescription. She asks if a cheaper, generic drug will be weaker than her current prescription. How should the health care practitioner respond? a. Every drug has a different chemical composition that cannot be duplicated. b. The prescribed medication is of better quality but will cost more c. Drug standards assure consumers that the same drug must be of uniform strength, quality, and purity. d. The insurance companies mandate the different strengths

c. drug standards assure consumers that the same drug must be of uniform strength, quality, and purity

An instructor is explaining the roles of the FDA and DEA in setting standards for drug control. What area does the FDA control? a. Concerned with controlled substances only b. Enforces laws against drug activities, including illegal drug use, dealing and manufacturing c. Responsible for the approval and removal of products on the market d. Monitors the need for changing the schedules of abused drugs

c. responsible for the approval and removal of products on the market.

The office assistant discusses the use of a newly marketed orthopedic device to a client. Which of the following is an accurate statement regarding the safety of the device? a. The device is safe to use because a number of clients have used it. b. The manufacturing company is responsible for ensuring the safety of a device before distributing it to the public. c. The FDA ensures basic standards prior to allowing any drug or new product to be marketed. d. The Drug Enforcement Administration handles all the safety requirements of new products.

c. the FDA ensures basic standards prior to allowing any drug or new product to be marketed.

1970 Controlled Substance Act

created 5 schedules of controlled substance

The medical assistant knows that Ritalin is a C-II controlled substance. She explains to her client that C-II medications have what level of potential for abuse? a. C-II medications may lead to limited dependence. b. C-II medications are safe to take as the client sees fit. c. C-II medications have the lowest abuse potential of all controlled substances. d. C-II medications have a high abuse potential and may lead to severe dependence.

d. C-II medications have a high abuse potential and may lead to severe dependence

The FDA, under the direction of the Department of Health and Human Services, mandates which of the following? a. All labels must include a listing of active ingredients; some labels require a listing of inactive ingredients as well. b. All drugs must have "warning" labels. c. All new products must be tested by the FDA before being released to the public. d. Prescription and nonprescription drugs must be shown to be effective as well as safe.

d. Prescription and nonprescription drugs must be shown to be effective as well as safe.

A medical assistant looks in a reference book to determine whether a particular drug is a controlled substance. What is the MOST authoritative standard for officially approved drugs in the United States? a. DEA b. FDA c. OBRA d. USP/NF

d. USP/NF

An older adult client is reluctant to take any prescribed medications and questions her health care practitioner about the production process and safety of her medications. How should the health care practitioner respond? a. Pharmaceutical companies follow their own guidelines. b. Federal laws require all drugs marketed in the United States to meet the minimal standards of strength, purity, and quality. c. Most medications are made outside the United States. d. Insurance carriers set the parameters for drug manufacturing.

d. federal laws require all drugs marketed in the United States to meet the minimal standards of strength, purity, and quality

A client in an emergency room of a hospital is admitted for complaints of chest pains. Upon evaluation, the client states that he used heroin earlier in the day. What should you know about heroin? a. It can be obtained legally through alternative medicine practitioners. b. It can be dispensed to clients in critical care units. c. It can be dispensed by pain management specialists. d. It can only be obtained illegally in the United States.

d. it can only be obtained illegally in the United States.

The narcotic control record: a. Should be kept in the patient's room at all times b. Must be checked but not signed if no discrepancies noted c. Needs to be used only with schedule one narcotics d. Must be checked and signed each time

d. must be checked and signed each time

The office assistant is explaining the use of prescription pads to a new employee. What is a good guideline to follow regarding prescription pads? a. Prescription pads should be easily accessible to health care providers for distribution to clients. b. Prescription pads are distributed in limited numbers to each provider. c. There are no established guidelines regarding prescription pads. d. Prescription pads should be kept in a locked or secure area when not being used.

d. prescription pads should be kept in a locked or secure area when not being used.

A client asks the office assistant about the relative danger of various drugs. She explains that the Drug Enforcement Administration (DEA) classifies drugs that can be abused or are addictive into categories or schedules. Which of the following is NOT a factor when classifying the schedule of a particular drug? a. The potential for abuse or addiction b. The harmfulness of the drug c. The medical value of the drug d. The potential cost to produce the drug

d. the potential cost to produce the drug

Why is it important for health care practitioners to keep a current drug reference available? a. To use for patient education b. To document prescription histories c. To establish pricing d. To identify controlled substances

d. to identify controlled substances

The health care practitioner should ___ expired drugs and old records.

destroy

Controlled substances are required to be ___ -locked.

double

OTC

over-the-counter

Records should be kept for ___ years.

two