chapter 1: information, sources, regulatory agencies, drug legislation, and prescription writing...
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Chapter 1:Chapter 1:
Information, Sources,Information, Sources,Regulatory Agencies,Regulatory Agencies,Drug Legislation, andDrug Legislation, andPrescription WritingPrescription Writing
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
22Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Chapter 1 OutlineChapter 1 Outline
Information, Sources, Regulatory Agencies, Information, Sources, Regulatory Agencies, Drug Legislation, and Prescription WritingDrug Legislation, and Prescription Writing HistoryHistory Pharmacology and oral health care providersPharmacology and oral health care providers Sources of informationSources of information Drug namesDrug names Federal regulations and regulatory agenciesFederal regulations and regulatory agencies Clinical evaluation of a new drugClinical evaluation of a new drug Drug legislationDrug legislation Prescription writingPrescription writing
33Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Information, Sources, Regulatory Information, Sources, Regulatory Agencies, Drug Legislation, and Agencies, Drug Legislation, and
Prescription WritingPrescription Writing Haveles (p. 2)Haveles (p. 2)
Pharmacology Pharmacology Derived from Greek prefix Derived from Greek prefix pharmaco-pharmaco-, meaning , meaning
“drug” or “medicine,” and Greek suffix “drug” or “medicine,” and Greek suffix -logy-logy, , meaning “study”meaning “study”
Dorland’s Illustrated Medical DictionaryDorland’s Illustrated Medical Dictionary Any chemical compound used on or administered Any chemical compound used on or administered
to humans or animals as an aid in the diagnosis, to humans or animals as an aid in the diagnosis, treatment, or prevention of disease or other treatment, or prevention of disease or other abnormal condition, for the relief of pain or abnormal condition, for the relief of pain or suffering, or to control or improve any physiologic suffering, or to control or improve any physiologic or pathologic conditionor pathologic condition
cont’d…cont’d…
44Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Information, Sources, Regulatory Information, Sources, Regulatory Agencies, Drug Legislation, and Agencies, Drug Legislation, and
Prescription WritingPrescription Writing These definitions are not completeThese definitions are not complete
Birth control pills are indicated for treatment of Birth control pills are indicated for treatment of which disease?which disease?
A large group of substances (drugs?) have A large group of substances (drugs?) have been categorized as “dietary supplements”been categorized as “dietary supplements” These substances may have pharmacologic These substances may have pharmacologic
effects on the body, but by law are effects on the body, but by law are not not classified classified as drugsas drugs
This classification avoids U.S. Food and Drug This classification avoids U.S. Food and Drug Administration (FDA) approval for efficacy and Administration (FDA) approval for efficacy and safety required for drugssafety required for drugs
55Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
HistoryHistory
Haveles (pp. 2-3)Haveles (pp. 2-3) Certain plants were found to alter body Certain plants were found to alter body
functions or awarenessfunctions or awareness Observations were made about which plant Observations were made about which plant
products produced predictable results products produced predictable results Useful agents are prescribed and dispensed Useful agents are prescribed and dispensed
through medicine, dentistry, pharmacy, and through medicine, dentistry, pharmacy, and nursingnursing
66Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Pharmacology and Oral Health Pharmacology and Oral Health Care ProvidersCare Providers
Haveles (pp. 3-4) (Table 1-1)Haveles (pp. 3-4) (Table 1-1) Competencies are tasks that oral health care Competencies are tasks that oral health care
providers should be able to performproviders should be able to perform To perform each competency, certain facts or To perform each competency, certain facts or
concepts must be accessedconcepts must be accessed Decisions that surround performing a competency Decisions that surround performing a competency
depend on depend on foundation knowledgefoundation knowledge Thought, facts, reasoning, and problem solving Thought, facts, reasoning, and problem solving
are involved in making decisions about each are involved in making decisions about each patientpatient
cont’d…cont’d…
77Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Pharmacology and Oral Health Pharmacology and Oral Health Care ProvidersCare Providers
Haveles (pp. 3-4)Haveles (pp. 3-4) Knowledge of pharmacology is required to Knowledge of pharmacology is required to
perform functions such asperform functions such as Obtaining a health historyObtaining a health history Administering drugs in the officeAdministering drugs in the office Handling emergency situationsHandling emergency situations Planning appointmentsPlanning appointments Nonprescription medicationNonprescription medication Nutritional or herbal supplementsNutritional or herbal supplements Discussing drugsDiscussing drugs Life-long learningLife-long learning
88Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Sources of InformationSources of Information
Haveles (pp. 4-6) (Tables 1-2, 1-3)Haveles (pp. 4-6) (Tables 1-2, 1-3) Sources include reference texts, association Sources include reference texts, association
journals, and the Internetjournals, and the Internet Each publication may be judged on lack of bias, Each publication may be judged on lack of bias,
publication date, readability, degree of detail, and publication date, readability, degree of detail, and priceprice
Every dental office should have at least one Every dental office should have at least one reference book that lists names of both reference book that lists names of both prescription and over-the-counter (OTC) prescription and over-the-counter (OTC) drugsdrugs A standard pharmacology textbook would be A standard pharmacology textbook would be
helpful in understanding the reference bookshelpful in understanding the reference books
99Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Selected Drug Information Selected Drug Information ReferencesReferences
Haveles (p. 5) (Table 1-2)Haveles (p. 5) (Table 1-2) American Health-Systems Formulary ServiceAmerican Health-Systems Formulary Service United States Pharmacopeia-Drug Information United States Pharmacopeia-Drug Information
(USP DI)(USP DI) Drug Facts and ComparisonsDrug Facts and Comparisons Physicians’ Desk Reference (PDR)Physicians’ Desk Reference (PDR) Handbook of Nonprescription Drugs: An Handbook of Nonprescription Drugs: An
Interactive Approach to Self-Care (OTC Interactive Approach to Self-Care (OTC Handbook)Handbook)
PDR for Nonprescription Drugs, Supplements, PDR for Nonprescription Drugs, Supplements, and Herbsand Herbs
cont’d…cont’d…
1010Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Selected Drug Information Selected Drug Information ReferencesReferences
PDR for Herbal MedicinesPDR for Herbal Medicines Natural Products: A Case-Based Approach Natural Products: A Case-Based Approach
for Health Care Professionals for Health Care Professionals Merck Manual for Medical InformationMerck Manual for Medical Information Drug Interaction FactsDrug Interaction Facts Mosby’s Dental Drug ReferenceMosby’s Dental Drug Reference Lexi-Comp’s Drug Information Handbook for Lexi-Comp’s Drug Information Handbook for
DentistryDentistry Goodman and Gilman’s The Pharmacologic Goodman and Gilman’s The Pharmacologic
Basis of TherapeuticsBasis of Therapeutics
1111Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
United States Pharmacopeia-Drug United States Pharmacopeia-Drug Information (USP DI)Information (USP DI)
Volume 1: Drug Information for the Health Volume 1: Drug Information for the Health Care ProviderCare Provider Provides the health professional with necessary Provides the health professional with necessary
information regarding basic pharmacology and information regarding basic pharmacology and pharmacokinetics, dosing, adverse reactions, and pharmacokinetics, dosing, adverse reactions, and drug interactionsdrug interactions
Volume 2: Advice for the PatientVolume 2: Advice for the Patient Includes appropriate information on Includes appropriate information on
pharmacology, pharmacokinetics, dosing, adverse pharmacology, pharmacokinetics, dosing, adverse reactions, and drug interactionsreactions, and drug interactions
1212Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Physician's Desk Reference Physician's Desk Reference (PDR)(PDR)
Most common reference book in the dental Most common reference book in the dental officeoffice Information provided comes directly from the Information provided comes directly from the
manufacturer’s package insert manufacturer’s package insert Manufacturers are listed alphabeticallyManufacturers are listed alphabetically Drugs are listed alphabetically within each Drugs are listed alphabetically within each
manufacturer’s sectionmanufacturer’s section
1313Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Mosby’s Dental Drug ReferenceMosby’s Dental Drug Reference
Drugs are presented alphabetically by Drugs are presented alphabetically by generic name generic name Includes indications, contraindications, dental Includes indications, contraindications, dental
considerations, and pharmacologic classificationconsiderations, and pharmacologic classification An alphabetic cross-index offers access to both An alphabetic cross-index offers access to both
brand and generic name drugsbrand and generic name drugs
1414Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Lexi-Comp’s Drug Information Lexi-Comp’s Drug Information Handbook for DentistryHandbook for Dentistry
Contains concise lists of drug attributes and Contains concise lists of drug attributes and sections relevant to dentistry for each drugsections relevant to dentistry for each drug Each monograph contains up to 32 fields of Each monograph contains up to 32 fields of
information, including dosage, local information, including dosage, local anesthetic/vasoconstrictor precautions, drug anesthetic/vasoconstrictor precautions, drug interactions, and effects on dental treatmentinteractions, and effects on dental treatment
1515Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names
Haveles (pp. 4, 6)Haveles (pp. 4, 6) All drugs have at least two names, and many All drugs have at least two names, and many
have morehave more Chemical nameChemical name
• The name determined by the chemical structure of the The name determined by the chemical structure of the compoundcompound
• A code name may be used as wellA code name may be used as well
cont’d…cont’d…
1616Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names
Trade nameTrade name• The name given if a compound is found to be useful and The name given if a compound is found to be useful and
if the determination is made that it will be marketedif the determination is made that it will be marketed• Capitalized, usually chosen so it can be easily Capitalized, usually chosen so it can be easily
remembered and promoted commerciallyremembered and promoted commercially• Registered as a trademark, property of the registering Registered as a trademark, property of the registering
company company • Protected by Federal Patent Law for 20 yearsProtected by Federal Patent Law for 20 years
cont’d…cont’d…
1717Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names
Generic nameGeneric name The “official” nonproprietary name given the drug The “official” nonproprietary name given the drug
before it is marketedbefore it is marketed Each drug has only one generic nameEach drug has only one generic name Selected by the U.S. Adopted Name Council Selected by the U.S. Adopted Name Council
(USAN)(USAN) Not capitalizedNot capitalized
cont’d…cont’d…
1818Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names
Haveles (p. 6) (Fig. 1-1)Haveles (p. 6) (Fig. 1-1) ExampleExample
Generic name: LidocaineGeneric name: Lidocaine• Only one nameOnly one name
• First letter lowercaseFirst letter lowercase
Trade name: Xylocaine, OctocaineTrade name: Xylocaine, Octocaine• More than one nameMore than one name
• First letter capitalizedFirst letter capitalized
cont’d…cont’d…
1919Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names
Haveles (p. 4)Haveles (p. 4) After the original manufacturer’s patent After the original manufacturer’s patent
expires, other companies can market the expires, other companies can market the generic drug under a trade name of their generic drug under a trade name of their choosingchoosing When a patient states an allergy to a particular When a patient states an allergy to a particular
trade name of a drug, the practitioner must know trade name of a drug, the practitioner must know the generic name of the drug so the patient is not the generic name of the drug so the patient is not given another brand of the same generic druggiven another brand of the same generic drug
cont’d…cont’d…
2020Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug NamesDrug Names This book uses generic names because only This book uses generic names because only
one generic name is given for each drugone generic name is given for each drug Trade names (proprietary names) appear in Trade names (proprietary names) appear in
parentheses after the generic nameparentheses after the generic name A problem occurs in naming multiple-entity A problem occurs in naming multiple-entity
drugsdrugs These drugs are difficult to discuss by generic These drugs are difficult to discuss by generic
name because they contain several ingredientsname because they contain several ingredients
2121Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug SubstitutionDrug Substitution
Haveles (p. 6)Haveles (p. 6) The question of generic equivalence and The question of generic equivalence and
substitution arises in the discussion of substitution arises in the discussion of generic and trade namesgeneric and trade names After 17 years, the patent of the original drug After 17 years, the patent of the original drug
expires, and other companies can market the expires, and other companies can market the same compound under a generic namesame compound under a generic name
cont’d…cont’d…
2222Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug Substitution Drug Substitution
In 1984, Congress passed the Drug Price In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Competition and Patent Term Restoration Act, which allowed generic drugs to receive Act, which allowed generic drugs to receive expedited approvalexpedited approval The FDA still requires the active ingredient of the The FDA still requires the active ingredient of the
generic product to enter the bloodstream at the generic product to enter the bloodstream at the same rate as the trade name productsame rate as the trade name product
cont’d…cont’d…
2323Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug SubstitutionDrug Substitution
Drugs can be judged “similar” in several waysDrugs can be judged “similar” in several ways When two formulations of a drug meet the chemical When two formulations of a drug meet the chemical
and physical standards established by the regulatory and physical standards established by the regulatory agencies, they are termed agencies, they are termed chemically equivalentchemically equivalent
When the two formulations produce similar When the two formulations produce similar concentrations of the drug in blood and tissues, they concentrations of the drug in blood and tissues, they are termed are termed biologically equivalentbiologically equivalent
When the two formulations prove to have an equal When the two formulations prove to have an equal therapeutic effect in a clinical trial, they are termed therapeutic effect in a clinical trial, they are termed therapeutically equivalenttherapeutically equivalent
cont’d…cont’d…
2424Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug SubstitutionDrug Substitution
A preparation can be chemically equivalent A preparation can be chemically equivalent yet not biologically or therapeutically yet not biologically or therapeutically equivalentequivalent These products differ in bioavailabilityThese products differ in bioavailability
Before generic drugs are marketed, they Before generic drugs are marketed, they must be shown to be biologically equivalent, must be shown to be biologically equivalent, which would make them therapeutically which would make them therapeutically equivalentequivalent
2525Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Top 200 DrugsTop 200 Drugs
Haveles (p. 6, Appendix A)Haveles (p. 6, Appendix A) Appendix A lists the 200 drugs most often Appendix A lists the 200 drugs most often
prescribed in 2008prescribed in 2008 The rank order appears in the right column of the The rank order appears in the right column of the
appendixappendix This number represents the position that the drug This number represents the position that the drug
appears in the top 200appears in the top 200
cont’d…cont’d…
2626Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Top 200 DrugsTop 200 Drugs
Both generic and trade names appear on the Both generic and trade names appear on the list, depending on how the prescription is list, depending on how the prescription is writtenwritten The oral health care provider must become The oral health care provider must become
familiar with these names because patients may familiar with these names because patients may know the names of the drugs they are taking but know the names of the drugs they are taking but not know how the names are spellednot know how the names are spelled
Accurate spelling permits the drugs to be Accurate spelling permits the drugs to be accessed in reference sourcesaccessed in reference sources
2727Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Federal Regulations and Federal Regulations and Regulatory AgenciesRegulatory Agencies
Haveles (pp. 6-7)Haveles (pp. 6-7) Many agencies are involved in regulating the Many agencies are involved in regulating the
production, marketing, advertising, labeling, production, marketing, advertising, labeling, and prescribing of drugsand prescribing of drugs Harrison Narcotic ActHarrison Narcotic Act U.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA) Federal Trade Commission (FTC)Federal Trade Commission (FTC) Drug Enforcement Administration (DEA)Drug Enforcement Administration (DEA) Omnibus Budget Reconciliation Act (OBRA)Omnibus Budget Reconciliation Act (OBRA)
2828Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Harrison Narcotic ActHarrison Narcotic Act
Haveles (pp. 6-7) Haveles (pp. 6-7) Established regulations governing the used of Established regulations governing the used of
opium, opiates, and cocaine in 1914opium, opiates, and cocaine in 1914 Marijuana laws were added in 1937Marijuana laws were added in 1937
Before this law, mixtures and OTC Before this law, mixtures and OTC medications could contain opium and cocainemedications could contain opium and cocaine
2929Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
U.S. Food and Drug U.S. Food and Drug Administration (FDA)Administration (FDA)
Haveles (p. 7)Haveles (p. 7) Part of the U.S. Department of Health and Part of the U.S. Department of Health and
Human Services (USHHS)Human Services (USHHS) Grants approval so that drugs can be marketed in Grants approval so that drugs can be marketed in
the United Statesthe United States Requires physical and chemical standards for Requires physical and chemical standards for
specific products and quality control in drug specific products and quality control in drug manufacturing plantsmanufacturing plants
Determines which drugs can be sold by Determines which drugs can be sold by prescription and OTC and regulates the labeling prescription and OTC and regulates the labeling and advertising of prescription drugsand advertising of prescription drugs
3030Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Federal Trade Commission (FTC)Federal Trade Commission (FTC)
Haveles (p. 7)Haveles (p. 7) Regulates the trade practices of drug Regulates the trade practices of drug
companiescompanies Prohibits the false advertising of foods, Prohibits the false advertising of foods,
nonprescription (OTC) drugs, and cosmeticsnonprescription (OTC) drugs, and cosmetics
3131Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug Enforcement Administration Drug Enforcement Administration (DEA)(DEA)
Part of the Department of JusticePart of the Department of Justice Administers the Controlled Substances Act of Administers the Controlled Substances Act of
19701970 Regulates the manufacture and distribution of Regulates the manufacture and distribution of
substances that have a potential for abuse, substances that have a potential for abuse, including opioids (narcotics), stimulants, and including opioids (narcotics), stimulants, and sedatives sedatives
3232Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Omnibus Budget Reconciliation Omnibus Budget Reconciliation Act (OBRA)Act (OBRA)
Pharmacists must provide patient counseling Pharmacists must provide patient counseling and a prospective drug utilization review and a prospective drug utilization review (DUR) for Medicaid patients(DUR) for Medicaid patients Many state boards of pharmacy are interpreting Many state boards of pharmacy are interpreting
this law to apply to all patientsthis law to apply to all patients Dental patients who have their prescriptions Dental patients who have their prescriptions
filled at a pharmacy should receive filled at a pharmacy should receive counseling form the pharmacist about their counseling form the pharmacist about their prescriptionprescription
3333Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New Drug Clinical Evaluation of a New Drug
Haveles (p. 7) (Fig. 1-2)Haveles (p. 7) (Fig. 1-2) A discovered or synthesized compound must A discovered or synthesized compound must
pass through many steps before it is approved pass through many steps before it is approved to become a marketed drugto become a marketed drug Animal studies begin by measuring both acute and Animal studies begin by measuring both acute and
chronic toxicitychronic toxicity The median lethal dose is determined for several The median lethal dose is determined for several
species of animalsspecies of animals
cont’d…cont’d…
3434Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New DrugClinical Evaluation of a New Drug
Long-term animal studies continue, including Long-term animal studies continue, including a search for teratogenic effectsa search for teratogenic effects Toxicity and pharmacokinetic properties are also Toxicity and pharmacokinetic properties are also
notednoted An investigational new drug application (INDA) An investigational new drug application (INDA)
must be filed before any clinical trials are must be filed before any clinical trials are performedperformed
Human studies involve four phasesHuman studies involve four phases
cont’d…cont’d…
3535Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New Drug Clinical Evaluation of a New Drug
Phase IPhase I Small and then increasing doses are administered Small and then increasing doses are administered
to a limited number of healthy human volunteersto a limited number of healthy human volunteers• Primarily to determine safetyPrimarily to determine safety
Determines biologic effects, metabolism, safe Determines biologic effects, metabolism, safe dose range in humans, and toxic effects of the dose range in humans, and toxic effects of the drugdrug
cont’d…cont’d…
3636Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New DrugClinical Evaluation of a New Drug
Phase 2Phase 2 Larger groups of humans are given the drug and Larger groups of humans are given the drug and
any adverse reactions are reported to the FDAany adverse reactions are reported to the FDA• Primarily to test effectivenessPrimarily to test effectiveness
cont’d…cont’d…
3737Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New Drug Clinical Evaluation of a New Drug
Phase 3 Phase 3 More clinical evaluation takes place involving a More clinical evaluation takes place involving a
large number of patients who have the condition large number of patients who have the condition for which the drug is indicatedfor which the drug is indicated• Both safety and efficacy must be demonstratedBoth safety and efficacy must be demonstrated
• Dosage is determinedDosage is determined
cont’d…cont’d…
3838Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Clinical Evaluation of a New DrugClinical Evaluation of a New Drug
Phase 4Phase 4 Postmarketing surveillancePostmarketing surveillance
• Toxicity that occurs in patients taking the drug after it is Toxicity that occurs in patients taking the drug after it is released is recordedreleased is recorded
• Several drugs in recent years have been removed from Several drugs in recent years have been removed from the market only after phase 4 has shown serious toxicity the market only after phase 4 has shown serious toxicity
3939Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug LegislationDrug Legislation
Haveles (pp. 7-8) Haveles (pp. 7-8) HistoryHistory Food and Drug Act of 1906Food and Drug Act of 1906
The first federal law to regulate interstate The first federal law to regulate interstate commerce in drugscommerce in drugs
Harrison Narcotic Act of 1914 Harrison Narcotic Act of 1914 Provided federal control over narcotic drugsProvided federal control over narcotic drugs Required registration of all practitioners Required registration of all practitioners
prescribing narcoticsprescribing narcoticscont’d…cont’d…
4040Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug LegislationDrug Legislation
Food, Drug, and Cosmetic Act of 1938Food, Drug, and Cosmetic Act of 1938 Prohibits interstate commerce of drugs not shown to Prohibits interstate commerce of drugs not shown to
be safe and effectivebe safe and effective Durham-Humphrey Law of 1952Durham-Humphrey Law of 1952
Requires that certain types of drugs be sold only by Requires that certain types of drugs be sold only by prescriptionprescription
Requires the drugs be labeled “Caution: Federal law Requires the drugs be labeled “Caution: Federal law prohibits dispensing without prescription”prohibits dispensing without prescription”
Prohibits refilling a prescription unless directions to Prohibits refilling a prescription unless directions to the contrary are indicated on the prescriptionthe contrary are indicated on the prescription
cont’d…cont’d…
4141Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug LegislationDrug Legislation
Drug Amendments of 1962 (Kefauver-Harris Drug Amendments of 1962 (Kefauver-Harris Bill)Bill) Manufacturers were required to demonstrate the Manufacturers were required to demonstrate the
effectiveness of drugs, to follow strict rules in effectiveness of drugs, to follow strict rules in testing, and to submit to the FDA any reports of testing, and to submit to the FDA any reports of adverse effects from drugs already on the marketadverse effects from drugs already on the market
Manufacturer’s were also required to list drug Manufacturer’s were also required to list drug ingredients by generic name in labeling and ingredients by generic name in labeling and advertising and to state adverse effects, advertising and to state adverse effects, contraindications, and efficacy of a drugcontraindications, and efficacy of a drug
cont’d…cont’d…
4242Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Drug LegislationDrug Legislation
Drug Abuse Control Amendments of 1965Drug Abuse Control Amendments of 1965 Required accounting for drugs with a potential for Required accounting for drugs with a potential for
abuse, such as barbiturates and amphetaminesabuse, such as barbiturates and amphetamines The Controlled Substance Act of 1970The Controlled Substance Act of 1970
Sets current requirements for writing prescriptions Sets current requirements for writing prescriptions for drugs often prescribed in dental practicefor drugs often prescribed in dental practice
4343Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Scheduled DrugsScheduled Drugs Haveles (p. 8) (Table 1-4)Haveles (p. 8) (Table 1-4)
Federal law divides controlled substances Federal law divides controlled substances into five schedules according to their abuse into five schedules according to their abuse potentialpotential Rules differ depending on the drug’s scheduleRules differ depending on the drug’s schedule New drug entities are evaluated and added to the New drug entities are evaluated and added to the
appropriate scheduleappropriate schedule Drugs may be moved from one schedule to Drugs may be moved from one schedule to
another if changes in abuse patterns are another if changes in abuse patterns are discovereddiscovered
cont’d…cont’d…
4444Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Scheduled DrugsScheduled Drugs
Current requirements for prescribing controlled Current requirements for prescribing controlled drugsdrugs Any prescription for a controlled substance requires Any prescription for a controlled substance requires
a DEA numbera DEA number All schedule II through IV drugs require a All schedule II through IV drugs require a
prescriptionprescription
cont’d…cont’d…
4545Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Scheduled DrugsScheduled Drugs Any prescription for schedule II drugs must be written Any prescription for schedule II drugs must be written
in pen or indelible ink or typedin pen or indelible ink or typed• A designee may write the prescription, but the prescriber A designee may write the prescription, but the prescriber
must personally sign the prescription in ink and is must personally sign the prescription in ink and is responsible for what the designee has writtenresponsible for what the designee has written
Schedule II prescriptions cannot be telephoned to the Schedule II prescriptions cannot be telephoned to the pharmacist (except at the discretion of the pharmacist pharmacist (except at the discretion of the pharmacist for an emergency supply to be followed by a written for an emergency supply to be followed by a written prescription within 72 hours)prescription within 72 hours)
cont’d…cont’d…
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Scheduled DrugsScheduled Drugs
Because schedule II prescriptions cannot be refilled, Because schedule II prescriptions cannot be refilled, the patient must obtain a new written prescription to the patient must obtain a new written prescription to obtain more medicationobtain more medication
Certain states require the use of “triplicate” or Certain states require the use of “triplicate” or “duplicate” prescriptions for schedule II drugs“duplicate” prescriptions for schedule II drugs
Prescriptions for schedule III and intravenous drugs Prescriptions for schedule III and intravenous drugs may be telephoned to the pharmacist and may be may be telephoned to the pharmacist and may be refilled no more than five times in 6 months, if so refilled no more than five times in 6 months, if so noted on the prescriptionnoted on the prescription
4747Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Prescription WritingPrescription Writing
Haveles (pp. 8-11)Haveles (pp. 8-11) MeasurementMeasurement
Metric systemMetric system Household measuresHousehold measures
PrescriptionsPrescriptions FormatFormat
Explanations accompanying prescriptionsExplanations accompanying prescriptions
cont’d…cont’d…
4848Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Prescription WritingPrescription Writing
Correctly written prescriptions will save timeCorrectly written prescriptions will save time Carefully written prescriptions are less likely Carefully written prescriptions are less likely
to result in mistakesto result in mistakes The dentist can save the patient’s and The dentist can save the patient’s and
pharmacist’s time with extra effort when pharmacist’s time with extra effort when unusual prescriptions are writtenunusual prescriptions are written Problems will be minimized if the unusual is Problems will be minimized if the unusual is
explainedexplained
4949Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
MeasurementMeasurement
Haveles (p. 9)Haveles (p. 9) Metric systemMetric system
In pharmacy, the primary measuring system is the In pharmacy, the primary measuring system is the metric systemmetric system
Scientific calculations use a base of 10Scientific calculations use a base of 10• The metric system, based on 10, is the language of The metric system, based on 10, is the language of
scientific measurementscientific measurement
Only metric units should be used in scientific Only metric units should be used in scientific measurementmeasurement
cont’d…cont’d…
5050Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
MeasurementMeasurement
Haveles (p. 9) (Table 1-5)Haveles (p. 9) (Table 1-5) The basic metric unit for weight is the The basic metric unit for weight is the
kilogram (kg)kilogram (kg) The basic metric unit for volume is the liter (L)The basic metric unit for volume is the liter (L)
One milliliter (ml), or one-thousandth of a liter, is One milliliter (ml), or one-thousandth of a liter, is exactly 1 cubic centimeter (cc)exactly 1 cubic centimeter (cc)
Solid drugs are dispensed by weight Solid drugs are dispensed by weight (milligrams [mg]) and liquid drugs by volume (milligrams [mg]) and liquid drugs by volume (milliliters [ml])(milliliters [ml])
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Household MeasuresHousehold Measures
Haveles (p. 9) Haveles (p. 9) Clinicians direct the pharmacist to dispense a Clinicians direct the pharmacist to dispense a
liquid in millilitersliquid in milliliters It is generally converted by the pharmacist into It is generally converted by the pharmacist into
household measures to be included in directions household measures to be included in directions to the patientto the patient
Liquids are converted into teaspoonfuls (5 ml) Liquids are converted into teaspoonfuls (5 ml) and tablespoons (15 ml)and tablespoons (15 ml) A calibrated dosing cup should be usedA calibrated dosing cup should be used
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PrescriptionsPrescriptions
Haveles (pp. 9-11) (Fig. 1-3)Haveles (pp. 9-11) (Fig. 1-3) FormatFormat
The part of the prescription are divided into three The part of the prescription are divided into three sectionssections• HeadingHeading
• BodyBody
• ClosingClosing
AbbreviationsAbbreviations
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Heading Heading
Haveles (p. 9)Haveles (p. 9) Contains the followingContains the following
Name, address, and telephone number of the Name, address, and telephone number of the prescriber (printed on prescription blank)prescriber (printed on prescription blank)
Name, address, age, and telephone number of the Name, address, age, and telephone number of the patient (written)patient (written)
Date of the prescriptionDate of the prescription
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BodyBody
Haveles (pp. 9-10) (Fig. 1-3)Haveles (pp. 9-10) (Fig. 1-3) The The RxRx symbol symbol Name and dose size or concentration Name and dose size or concentration
(liquids) of the drug(liquids) of the drug Amount to be dispensedAmount to be dispensed
For tablets and capsules, “Dispense” is often For tablets and capsules, “Dispense” is often replaced with #, the symbol for a numberreplaced with #, the symbol for a number
Directions to the patientDirections to the patient Preceded by the abbreviation Preceded by the abbreviation Sig:Sig:
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ClosingClosing
Haveles (p. 10)Haveles (p. 10) Prescriber's signaturePrescriber's signature DEA number, if requiredDEA number, if required
Needed for controlled substancesNeeded for controlled substances Often used by insurance companies as an Often used by insurance companies as an
identifieridentifier Refill instructionsRefill instructions
cont’d…cont’d…
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ClosingClosing Haveles (p. 10) (Fig. 1-4)Haveles (p. 10) (Fig. 1-4)
All prescriptions must be labeled with the name All prescriptions must be labeled with the name of the medication and its strengthof the medication and its strength The name, address, and telephone number of the The name, address, and telephone number of the
pharmacy, the patient’s and dentist’s names, the pharmacy, the patient’s and dentist’s names, the directions for use, the name and strength of the directions for use, the name and strength of the medication, and the original date and the date filled medication, and the original date and the date filled (refilled) are required(refilled) are required
The quantity of medication dispensed and number of The quantity of medication dispensed and number of refills remaining may be notedrefills remaining may be noted
cont’d…cont’d…
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ClosingClosing
Haveles (p. 11)Haveles (p. 11) In most states, before a dentist can legally In most states, before a dentist can legally
write a prescription for a patient, the following write a prescription for a patient, the following two criteria must be mettwo criteria must be met Patient of record:Patient of record: The person for whom the The person for whom the
prescription is being written is a patient of recordprescription is being written is a patient of record Dental condition:Dental condition: The condition for which the The condition for which the
prescription is being prescribed is a dental-related prescription is being prescribed is a dental-related conditioncondition
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AbbreviationsAbbreviations
Haveles (pp. 9, 11) (Table 1-5)Haveles (pp. 9, 11) (Table 1-5) Used to save time but also makes alteration Used to save time but also makes alteration
of the prescription by a patient more difficultof the prescription by a patient more difficult ac: before mealsac: before meals d: dayd: day h: hourh: hour hs: at bedtimehs: at bedtime pc: after mealspc: after meals
cont’d…cont’d…
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AbbreviationsAbbreviations
prn: as neededprn: as needed sig: write (label)sig: write (label) stat: immediatelystat: immediately bid: twice per daybid: twice per day tid: three times per daytid: three times per day qid: four times per dayqid: four times per day
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Explanations Accompanying Explanations Accompanying PrescriptionsPrescriptions
Haveles (p. 11)Haveles (p. 11) The dental health care worker should be able to The dental health care worker should be able to
answer the patient’s questions about the answer the patient’s questions about the prescriptionprescription Make sure the patient knows how to take the Make sure the patient knows how to take the
medication, what precautions to observe, and the medication, what precautions to observe, and the reason for taking the medicationreason for taking the medication
Information about consequences of noncompliance Information about consequences of noncompliance should be includedshould be included
cont’d…cont’d…
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Explanations Accompanying Explanations Accompanying PrescriptionsPrescriptions
The dental office should either keep a copy of The dental office should either keep a copy of each prescription written in the patient’s each prescription written in the patient’s record or record the medication, dose, and record or record the medication, dose, and number prescribednumber prescribed A patient should never get home and not know A patient should never get home and not know
which drug is the antibiotic and which is the which drug is the antibiotic and which is the analgesicanalgesic
Side effects should be noted on the labelSide effects should be noted on the label
cont’d…cont’d…
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Explanations Accompanying Explanations Accompanying PrescriptionsPrescriptions
Prescription blanks should be kept in a Prescription blanks should be kept in a secure placesecure place The dental health care worker should watch to see The dental health care worker should watch to see
they are not scattered around the officethey are not scattered around the office
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