Pharmacology and Drug Legislation Chapter

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Questions and Answers

What is the study of the harmful effects of drugs on living tissues?

Toxicology (correct)

Pharmacokinetics

Therapeutics

Pharmacology

Which of the following is NOT considered a typical responsibility of an oral health care provider regarding pharmacology?

Diagnosing systemic diseases based on drug reactions (correct)

Handling emergency situations

Administering drugs in the office

Discussing nutritional supplements with patients

According to the provided content, what does the term 'pharmaco-' refer to?

Harmful effects

Living systems

Drug or medicine (correct)

The study of

Which of these websites is an official source for drug information?

<a href="http://www.fda.gov/medwatch">www.fda.gov/medwatch</a> (B) Signup and view all the answers

What is the term for a drug name that is determined by its chemical structure?

Chemical name (D) Signup and view all the answers

What key requirement was established by the 1984 Drug Price Competition and Patent Term Restoration Act regarding generic drugs?

The active ingredient of the generic product to enter the bloodstream at the same rate as of the trade name product (A) Signup and view all the answers

Which of the following describes a trade name?

A name that typically is all upper case letters (A) Signup and view all the answers

Besides physicians, which of the following professionals are mentioned as able to prescribe or dispense useful pharmaceutical agents?

Dentists (D) Signup and view all the answers

What information is typically included in the heading of a prescription?

Prescriber’s name, address, telephone number, and patient’s details (A) Signup and view all the answers

Which component is found in the body of the prescription?

Rx symbol and drug details (D) Signup and view all the answers

What does the 'Sig:' in a prescription indicate?

Directions for the patient regarding medication intake (A) Signup and view all the answers

Which details are typically found in the closing of a prescription?

Prescriber’s signature and refill instructions (D) Signup and view all the answers

What does the 'Disp:' indicate in a prescription?

Amount of medication to be dispensed (A) Signup and view all the answers

What does it mean for two formulations of a drug to be chemically equivalent?

They meet chemical and physical standards. (C) Signup and view all the answers

Which of the following is an example of a Schedule I controlled substance?

Heroin (D) Signup and view all the answers

What is the primary role of the U.S. Food and Drug Administration (FDA)?

To ensure the safety and efficacy of drugs. (D) Signup and view all the answers

In drug formulation, what does 'biologically equivalent' refer to?

Similar concentrations in blood and tissues. (C) Signup and view all the answers

Which statement best describes the therapeutic equivalence of two drug formulations?

They produce equivalent therapeutic effects. (A) Signup and view all the answers

What is the estimated time and cost associated with bringing a new drug from development to market?

$1.5 billion and 10-15 years. (C) Signup and view all the answers

Who has the authority to enforce narcotic drug regulations in the United States?

Drug Enforcement Administration (DEA) (A) Signup and view all the answers

What classification does codeine (Tylenol 3) fall under in controlled substances?

Schedule III (A) Signup and view all the answers

What is required for prescribing Schedule II drugs?

A DEA registration number (A) Signup and view all the answers

Which of the following statements about Schedule III-IV drugs is true?

They may be refilled up to five times in a six-month period. (D) Signup and view all the answers

What is the purpose of a Black Box Warning?

To draw attention to serious safety concerns (A) Signup and view all the answers

Which of the following is a characteristic of labeled drug use?

FDA-approved indications for use (D) Signup and view all the answers

What defines an orphan drug?

A drug designed for rare medical conditions (A) Signup and view all the answers

What action must be taken if a drug is recalled?

Withdraw from the market due to health risks (A) Signup and view all the answers

Which of the following is a recommended best practice for prescription writing?

Write carefully and legibly (B) Signup and view all the answers

What should a prescriber do to indicate no refills on a prescription?

Indicate 'No refills' clearly (A) Signup and view all the answers

Study Notes

Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing

This chapter covers information sources, regulatory agencies, drug legislation, and prescription writing.

Terms to Know

pharmaco-: Refers to drugs and medicine.
-logy: Refers to the study of a subject.
Pharmacology: The study of drugs and their interactions with living cells and systems.
Toxicology: The study of harmful effects of drugs on living tissues.
Drugs: Synthetically derived compounds, vitamins, minerals, herbs, and prescription and OTC medications, both legal and illegal.

History

Certain plants were observed to alter body functions and awareness.
Useful agents are prescribed and dispensed through medicine, dentistry, pharmacy, nursing, and other healthcare professions (physicians, veterinarians, dentists, optometrists, physician's assistants, nurse practitioners, pharmacists).

Pharmacology and Oral Health Care Providers

Health care providers should obtain patient health history.
They administer drugs in the office environment.
They handle emergency situations.
They plan appointments.
They discuss nonprescription medications.
They discuss nutritional or herbal supplements.
They discuss drugs and their interactions.
They reference Box 1.1 page 3.

Examples of Sources of Information

Mosby's Dental Drug Reference
Lexi-Comp's Drug Information Handbook for Dentistry
www.mayoclinic.com
www.fda.gov/medwatch
www.drugs.com

Drug Names

Chemical name: Determined by the chemical structure of the compound.
Code name: (Example: ibuprofen) - lower case
Generic name: (Example: ibuprofen) - lower case
Trade name: (Example: Motrin, Advil) - upper case

Generic Equivalence and Substitution

1984 - Drug Price Competition and Patent Term Restoration Act: FDA requires the active ingredient of a generic drug to enter the bloodstream at the same rate as the trade name product.

Drug Substitution

Chemically equivalent: Two drug formulations meet chemical and physical standards set by regulatory agencies.
Biologically equivalent: Two drug formulations produce similar concentrations of the drug in blood and tissues.
Therapeutically equivalent: Two drug formulations have an equal therapeutic effect.

Federal Regulations and Regulatory Agencies

Harrison Narcotic Act
U.S. Food and Drug Administration (FDA)
Federal Trade Commission (FTC)
Drug Enforcement Administration (DEA)
Omnibus Budget Reconciliation Act (OBRA)
Websites for more information: https://www.fda.gov/Drugs/default.htm, https://www.dea.gov/index.shtml

Process of New Drug Development

Takes 10-15 years and costs $1.5 billion.
Includes preclinical (synthesis/discovery, animal studies, toxicity/kinetics, teratogenicity studies), clinical (Phase 1, 2, 3, and 4), NDA submission/approval, and post-marketing surveillance phases.

Schedules of Controlled Substances

Table 1-2 lists controlled substances by schedule (e.g., I, II, III, IV, V). Each schedule has different levels of abuse potential; Schedule I has the highest, and Schedule V has the lowest.

Requirements for Prescribing Scheduled Drugs

DEA number required for Schedule II-V drugs.
Schedule II drugs are written in pen and require physician signatures with no refills—emergency prescriptions are possible through phone except for Schedule II drugs.
Schedule III - IV drugs can be refilled, up to 5 refills within 6 months.

Package Inserts (PIs)

Package inserts contain the chemical makeup of the drug, FDA-approved uses, contraindications, warnings, adverse reactions, drug interactions, dose and administration instructions, and how it is supplied.

Black Box Warning

Purpose: to call attention to serious safety concerns associated with the drug.
Educates prescribers and patients about the safety concerns.

Labeled and Off-Label Uses

Labeled use: FDA-approved use of a drug for specific indication.
Off-label use: Use outside of the stated FDA indications.

Orphan Drugs

Drugs developed to treat rare medical conditions.

Drug Recall

Medications are removed from the market due to serious adverse health consequences or death.

Best Prescription Writing Practices

Use correct format.
Write legibly.
Keep copy of prescription in patient's chart.
Avoid Latin abbreviations.
Keep prescription blanks secure.
Write DEA number only when necessary.
Follow state laws for duplicates, triplicates.
Write out ("No refills") instead of using the numeral "0".

Prescription Format

Heading: Prescriber's name, address, phone, patient's name, address, age, phone, date.
Body: Rx symbol, drug name and dose size/concentration, directions (sig). Example: "Drug name # mg tablet Disp: # write out next to number Sig: 1-2 tabs q 4-6 h prn pain"
Closing: Prescriber's signature, DEA number (if required), refill instructions.
Substitution: Permitted or Not permitted.

Prescription Format (Continued)

Example prescription format included showing the different sections.

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Description

Explore key concepts from the chapter on pharmacology, focusing on information sources, regulatory agencies, drug legislation, and prescription writing. Understand important terms related to pharmacology and toxicology while learning about the history of drug usage in healthcare. This quiz is essential for anyone in the health sciences.