Pharmacology Chapter 1: Consumer safety and drug regulations

The FDA, under the direction of the Department of Health and Human Services, mandates which of the following?

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

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?

The potential cost to produce the drug

Records of each controlled substance dispensed, received, or destroyed at the facility where you work must be available for review for what time period?

2 years

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?

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

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?

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

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?

Codeine (C-II)

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?

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?

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

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?

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?

It can only be obtained illegally in the United States.

A client asks why pharmacists must offer counseling before dispensing medication. The office manager explains that this is required by which act?

Omnibus Budget Reconcilation Act

The office assistant is explaining the use of prescription pads to a new employee. What is a good guideline to follow regarding prescription pads?

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

An instructor is explaining the roles of the FDA and DEA in setting standards for drug control. What area does the FDA control?

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?

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

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?

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.

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?

The Federal Food, Drug, and Cosmetic Act

Which of the following was the first federal regulation established for consumer protection in the manufacturing of drugs and food?

The Pure Food and Drug Act

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?

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

Why is it important for health care practitioners to keep a current drug reference available?

To identify controlled substances

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?

USP/NF