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Pharmacology DENTALELLE TUTORING WWW.DENTALELLE.COM CHAPTER ONE INFORMATION, SOURCES AND AGENCIES PRESCRIPTION WRITING INTRODUCTION Definition of Pharmacology Defined as the production, preparation and dispensing of a drug •Pharmaco-: drugs •-ology: the study of Pharmacology: the study of drugs Definitions of DRUG • “a therapeutic agent; any substance, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease.” OR • any chemical substance that affects biological systems DEFINITIONS • Over-the-Counter (OTC): drug available to the general public (without a prescription) • Prescription (Rx): usually a controlled substance and requires a written authorization for its use Pharmacology & The Oral Health Care Providers • • • • • • • Obtaining a medical/health history Administering drugs in the office (e.g Fl, *anesthetics) Handling emergency situations (epi. For allergy) Planning appointments (diabetic ct in am vs pm) Choosing self-medication (OTC meds – eg. Advil & Vitamins – Herbals). Discussing drugs (use correct terminology; make sure ct. is aware of drugs and certain oral side effects). Life-long learning (be current – up to date with new drugs) DRUG NAMES – DEFINITIONS CHEMICAL NAME: • • • determined by the drugs’ chemical structure used during the investigative & developmental stage by a company shows the exact chemical composition of the drug DRUG NAMES – DEFINITIONS GENERIC NAME: official name the drug is known globally & in scientific publications drugs listed by the Food & Drug Administration (FDA) by this name – only one name per drug first letter of name is NOT capitalized DRUG NAMES – DEFINITIONS TRADE OR BRAND NAME: • • • • assigned to a drug by a pharmaceutical company which manufactures it commercially usually followed by ® - registered trademark & can only be used by one company – patented for “x” # of years; once expired, generic can be available can have several names first letter of name ALWAYS Capitalized Drug Names – Example #1 Chemical Name: • 4-dimethylaminmo – 1,4, 4a,5,5a,6,11,12a – octahydro -3,6,10,12,12a – pentahydroxy- 6 – methyl – 1,11, dioxo -2 – naphthacenecarboxamide Generic Name: • tetracycline Trade or Brand Name: • Achromycin, Apo-Tetra, Novo-Tetra, Nu-Tetra, Tetracyn Drug Names – Example #2 Chemical Name: • 2-diethylamino-2,6 acetoxylidide Generic Name: • lidocaine Trade or Brand Name: • Xylocaine, Dolicaine, Octocaine Figure 1-1: A COMPARISON BETWEEN THE TRADE AND GENERIC DRUG NAMES OF LIDOCAINE. DRUG SUBSTITUTION • Similar drugs can sometimes substitute each other Drugs can be similar: • Chemically • Biologically • Therapeutically Drug Substitution • Chemically Equivalent – Two formulations of a drug meet established chemical and physical standards • Biologically Equivalent – Two formulations produce similar concentrations in blood and tissues • Therapeutically Equivalent – Equal therapeutic effects during a clinical trial 8 IF oversees: • The Food and Drug Act • The Proprietary or Patient Medicine Act • The Narcotic Control Act • These acts are designed to protect the consumer from fraud, deception, and health hazards due to the use of foods, drugs, cosmetics, and medical devices. • The Department of National Health and Welfare also authorizes substance abuse treatment, including the use of methadone, for narcotic addicts CLINICAL EVALUATION OF A NEW DRUG • A discovered or synthesized compound must pass through many steps before it is approved to become a marketed drug – Animal studies begin by measuring both acute and chronic toxicity – The median lethal dose is determined for several species of animals CLINICAL EVALUATION OF A NEW DRUG • • Long-term animal studies continue, including a search for teratogenic effects – Toxicity and pharmacokinetic properties are also noted – An investigational new drug application (INDA) must be filed before any clinical trials are performed Human studies involve four phases Clinical Evaluation of a New Drug • PHASE I – – Small and then increasing doses are administered to a limited number of healthy human volunteers • Primarily to determine safety Determines biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug Clinical Evaluation of a New Drug • PHASE 2 – Larger groups of humans are given the drug and any adverse reactions are reported to the FDA • Primarily to test effectiveness Clinical Evaluation of a New Drug • PHASE 3 – More clinical evaluation takes place involving a large number of patients who have the condition for which the drug is indicated • Both safety and efficacy must be demonstrated • Dosage is determined Clinical Evaluation of a New Drug • PHASE 4 – Postmarketing surveillance • Toxicity that occurs in clients taking the drug after it is released is recorded • Several drugs in recent years have been removed from the market only after phase 4 has shown serious toxicity ROLE OF THE DENTAL HYGIENIST IN PHARMACOLOGY • Drugs used should be entered into the treatment record, including drug, dose, and route of administration • Any drug recommended or given as a sample to a client should be recorded in the treatment record with the client’s instructions • Drug or herbal supplement history review should include investigation of potential drug effects and modifications of the treatment plan CONTROLLED SUBSTANCE ACT OF 1970 • Requirements of the Act – – – – – Prescriptions for a controlled substance require a Drug Enforcement Agency (DEA) number. Schedules II-V require a written prescription. Schedule II prescriptions must be signed in ink, no refills, phone-ins are emergency only. Schedules III-V can be telephoned in and can have 5 refills over 6 months. Several states require “duplicate” or “triplicate” prescription blanks for Schedule II drugs. 10 PRESCRIPTION WRITING PRESCRIPTION WRITING A prescription is an order for a specific medication for a specific patient at a particular time, with appropriate instructions for how the patient is to use the prescribed medication. PRESCRIPTION FORMAT Parts of a Prescription: In the Past, Latin was used. • Superscription* • Inscription* • Subscription* • Signature* * Required by law to make valid prescription PRESCRIPTIONS - FORMAT Superscription: Includes the patient’s name, address, and age, date, and the symbol (Rx) (Latin for recipe,”{you} take” or “take thou of”) Inscription: Includes the name of the drug, dose (amount needed), and dose form PRESCRIPTIONS - FORMAT Subscription: Includes the directions to the pharmacist. Transcription: or Signature Includes the directions to the patient PRESCRIPTIONS - FORMAT Fig 1-3, p.10 - A typical prescription form 1. 2. 3. 4. Superscription Inscription Subscription Transcription CURRENT PRESCRIPTIONS FORMAT HEADING: • Contains M.D.’s info. & client’s info. Date of the prescription (most commonly missed)* – Name, address & phone # of dental office* – Name, address, age of client* – Weight for children – *(not a legal prescription unless the date is filled in) CURRENT PRESCRIPTIONS FORMAT BODY • Includes the symbol (Rx)* • Name and dose size or concentration (liquids) of the drug* • Amount to be dispensed* • Directions to the patient CURRENT PRESCRIPTIONS FORMAT • Rx symbol is the name of the drug being prescribed • Size – if tablet (milligrams); if liquid (milligrams per millilitre mg/ml) • Quantity to be dispensed is the number of capsules or tablets or millilitres of liquid; the number is written in roman numerals CURRENT PRESCRIPTIONS FORMAT • “Sig.” are the directions to the patient. • Directions must be completely clear and explicit and should include the amount of medication and the time, frequency and route of administration. • The pharmacist will transcribe Latin abbreviations into English on the label when the prescription is filled. CURRENT PRESCRIPTIONS FORMAT CLOSING • Refill information* • Drug enforcement administration number if required • Generic substitution instructions • Signature of Prescriber* *Required by law to make valid prescription The DIN (Drug Identification Number is included in this section if it is a controlled substance (Canada) Example of a Prescription Label CURRENT PRESCRIPTIONS FORMAT **You may see some of these on your tests • ABBREVIATIONS Used to save time but also makes alteration of the prescription by a patient more difficult – – – – – – – – – – – ac: before meals d: day h: hour hs: at bedtime pc: after meals prn: as needed sig: write (label) stat: immediately bid: twice per day tid: three times per day qid: four times per day PRESCRIPTIONS - RECORDS • Record all prescriptions in chart • Record reason for prescription & date written • If photocopy taken - put into client chart, stroke through the photocopy or write “COPY” to prevent the copy from being used for fraudulent purposes