Pharmacology and Drug Legislation Chapter

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.