Chapter 1: Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing PDF

Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing Chapter 1 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 1  Terms to Know  pharmaco-: Drug, medicine  -logy: Study...

Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing Chapter 1 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 1  Terms to Know  pharmaco-: Drug, medicine  -logy: Study of  Pharmacology: The study of drugs and their interactions with living cells and systems  Toxicology: The study of harmful effect of drugs on living tissues  Drugs: synthetically derived compounds, vitamins, minerals, herbs, prescription, OTC, legal, and illegal Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 2  History  Certain plants were observed to alter body functions or awareness  Useful agents are prescribed and dispensed through medicine, dentistry, pharmacy, and nursing  Physicians, veterinarians, dentists, optometrists, physicians’ assistants, nurse practitioners, pharmacists Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 3  Pharmacology and Oral Health Care Providers  Obtain a health history  Administer drugs in the office  Handle emergency situations  Plan appointments  Discuss nonprescription medication  Discuss nutritional or herbal supplements  Discuss drugs and interactions  Box 1.1 page 3 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 4 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 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 5  Drug Names  Chemical name  Determined by the chemical structure of the compound  Code name  Generic name (ibuprofen) lower case  Trade name (Motrin, Advil) upper case Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 6  Generic Equivalence and Substitution  1984 – Drug Price Competition and Patent Term Restoration Act  The FDA requires the active ingredient of the generic product to enter the bloodstream at the same rate as of the trade name product Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 7  Drug Substitution  Chemically equivalent  Two formulations of a drug meet the chemical and physical standards established by regulatory agencies  Biologically equivalent  Two formulations of a drug produce similar concentrations of the drug in blood and tissues  Therapeutically equivalent  Two formulations of a drug have an equal therapeutic effect Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 8  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)  Review Websites  https://www.fda.gov/Drugs/default.htm  https://www.dea.gov/index.shtml Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 9 Process of New Drug Development 10-15 Years and $1.5 billion from start to shelf Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 10 Schedules of Controlled Substances Table 1-2  I – Heroin, LSD, hallucinogens; highest abuse  II – oxycodone (OxyContin), morphine, amphetamine, secobarbital, acetaminophen hydrocodone (Vicodin) alone or combination  III – codeine (Tylenol 3) mixtures  IV – dextropropoxyphene forms (Darvon), diazepam (Valium)  V – Some codeine-containing cough syrups; lowest abuse potential Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 11  Requirements for Prescribing Scheduled Drugs  DEA number required  Schedule II-IV/V drugs require a prescription  Schedule II drugs must be written in pen with signatures and NO refills, require new written prescription; NO phone in’s unless emergency  Schedule III-IV drugs may not be refilled more than five times in 6-month period; can be called in Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 12  Package Inserts (PIs)  Chemical makeup of drug  FDA-approved indications for use  Contraindications  Warnings  Adverse reactions  Drug interactions  Dose and administration  How supplied Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 13  Black Box Warning  Purpose: To draw attention to safety concerns associated with the drug  Educates both prescriber and patient about serious safety concerns associated with the drug Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 14  Labeled and Off-Label Uses  Labeled use indicates that the FDA has approved the drug for specific use  Off-label use is use outside the stated FDA indications Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 15  Orphan Drugs  Drugs developed to treat rare medical conditions Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 16  Drug Recall  Medications are taken off the market if there is a reasonable probability that use will result in serious adverse health consequences or death Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 17  Best Prescription Writing Practices  Use correct format  Write carefully and legibly  Keep copy of prescription in patient’s chart  Avoid Latin abbreviations  Keep prescription blanks in secure place  Write DEA number only when needed  Follow state laws for duplicates, triplicates  Write out No refills or 0 as opposed to 0 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 18  Prescription Format  Heading  Prescriber’s name, address, telephone number  Patient’s name, address, age, telephone number  Date of prescription Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 19  Prescription Format (Cont.)  Body  Rx symbol  Drug name and dose size or concentration  Directions to patient - Sig:  Rx  Drug name # mg tablet  Disp: # ____ write out next to number  Sig: 1-2 tabs q 4-6 h prn pain (what do these instructions state table1-3?) Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 20  Prescription Format (Cont.)  Closing  Prescriber’s signature  DEA number, if required  Refill instructions  Substitution ______________  Permitted Signature  Not permitted DEA # ________ Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 21  http://medicalschoolhq.net/prescription-writing-101/ Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 22 Anything wrong? Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 23 Copyright © 2016 by Mosby, an imprint of Elsevier, Inc. All rights reserved. 24