Chapter 1:
Information, Sources,
Regulatory Agencies,
Drug Legislation, and
Prescription Writing
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Chapter 1 Outline

Information, Sources, Regulatory Agencies,
Drug Legislation, and Prescription Writing

History
 Pharmacology and oral health care providers
 Sources of information
 Drug names
 Federal regulations and regulatory agencies
 Clinical evaluation of a new drug
 Drug legislation
 Prescription writing
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2
Information, Sources, Regulatory
Agencies, Drug Legislation, and
Prescription Writing


Pharmacology


Haveles (p. 2)
Derived from Greek prefix pharmaco-, meaning
“drug” or “medicine,” and Greek suffix -logy,
meaning “study”
Dorland’s Illustrated Medical Dictionary

Any chemical compound used on or administered
to humans or animals as an aid in the diagnosis,
treatment, or prevention of disease or other
abnormal condition, for the relief of pain or
suffering, or to control or improve any physiologic
or pathologic condition
cont’d…
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3
Information, Sources, Regulatory
Agencies, Drug Legislation, and
Prescription Writing

These definitions are not complete


Birth control pills are indicated for treatment of
which disease?
A large group of substances (drugs?) have
been categorized as “dietary supplements”


These substances may have pharmacologic
effects on the body, but by law are not classified
as drugs
This classification avoids U.S. Food and Drug
Administration (FDA) approval for efficacy and
safety required for drugs
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4
History


Certain plants were found to alter body
functions or awareness


Haveles (pp. 2-3)
Observations were made about which plant
products produced predictable results
Useful agents are prescribed and dispensed
through medicine, dentistry, pharmacy, and
nursing
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5
Pharmacology and Oral Health
Care Providers


Haveles (pp. 3-4) (Table 1-1)
Competencies are tasks that oral health care
providers should be able to perform

To perform each competency, certain facts or
concepts must be accessed
 Decisions that surround performing a competency
depend on foundation knowledge
 Thought, facts, reasoning, and problem solving
are involved in making decisions about each
patient
cont’d…
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6
Pharmacology and Oral Health
Care Providers


Haveles (pp. 3-4)
Knowledge of pharmacology is required to
perform functions such as








Obtaining a health history
Administering drugs in the office
Handling emergency situations
Planning appointments
Nonprescription medication
Nutritional or herbal supplements
Discussing drugs
Life-long learning
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7
Sources of Information


Sources include reference texts, association
journals, and the Internet


Haveles (pp. 4-6) (Tables 1-2, 1-3)
Each publication may be judged on lack of bias,
publication date, readability, degree of detail, and
price
Every dental office should have at least one
reference book that lists names of both
prescription and over-the-counter (OTC)
drugs

A standard pharmacology textbook would be
helpful in understanding the reference books
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8
Selected Drug Information
References







Haveles (p. 5) (Table 1-2)
American Health-Systems Formulary Service
United States Pharmacopeia-Drug Information
(USP DI)
Drug Facts and Comparisons
Physicians’ Desk Reference (PDR)
Handbook of Nonprescription Drugs: An
Interactive Approach to Self-Care (OTC
Handbook)
PDR for Nonprescription Drugs, Supplements,
and Herbs
cont’d…
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9
Selected Drug Information
References







PDR for Herbal Medicines
Natural Products: A Case-Based Approach for
Health Care Professionals
Merck Manual for Medical Information
Drug Interaction Facts
Mosby’s Dental Drug Reference
Lexi-Comp’s Drug Information Handbook for
Dentistry
Goodman and Gilman’s The Pharmacologic
Basis of Therapeutics
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10
United States Pharmacopeia-Drug
Information (USP DI)

Volume 1: Drug Information for the Health
Care Provider


Provides the health professional with necessary
information regarding basic pharmacology and
pharmacokinetics, dosing, adverse reactions, and
drug interactions
Volume 2: Advice for the Patient

Includes appropriate information on
pharmacology, pharmacokinetics, dosing, adverse
reactions, and drug interactions
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11
Physician's Desk Reference
(PDR)

Most common reference book in the dental
office



Information provided comes directly from the
manufacturer’s package insert
Manufacturers are listed alphabetically
Drugs are listed alphabetically within each
manufacturer’s section
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12
Mosby’s Dental Drug Reference

Drugs are presented alphabetically by
generic name


Includes indications, contraindications, dental
considerations, and pharmacologic classification
An alphabetic cross-index offers access to both
brand and generic name drugs
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13
Lexi-Comp’s Drug Information
Handbook for Dentistry

Contains concise lists of drug attributes and
sections relevant to dentistry for each drug

Each monograph contains up to 32 fields of
information, including dosage, local
anesthetic/vasoconstrictor precautions, drug
interactions, and effects on dental treatment
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14
Drug Names


Haveles (pp. 4, 6)
All drugs have at least two names, and many
have more

Chemical name
• The name determined by the chemical structure of the
compound
• A code name may be used as well
cont’d…
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15
Drug Names

Trade name
• The name given if a compound is found to be useful and
if the determination is made that it will be marketed
• Capitalized, usually chosen so it can be easily
remembered and promoted commercially
• Registered as a trademark, property of the registering
company
• Protected by Federal Patent Law for 20 years
cont’d…
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16
Drug Names

Generic name




The “official” nonproprietary name given the drug
before it is marketed
Each drug has only one generic name
Selected by the U.S. Adopted Name Council
(USAN)
Not capitalized
cont’d…
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17
Drug Names


Haveles (p. 6) (Fig. 1-1)
Example


Generic name: Lidocaine
• Only one name
• First letter lowercase
Trade name: Xylocaine, Octocaine
• More than one name
• First letter capitalized
cont’d…
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18
Drug Names


Haveles (p. 4)
After the original manufacturer’s patent
expires, other companies can market the
generic drug under a trade name of their
choosing

When a patient states an allergy to a particular
trade name of a drug, the practitioner must know
the generic name of the drug so the patient is not
given another brand of the same generic drug
cont’d…
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19
Drug Names

This book uses generic names because only
one generic name is given for each drug


Trade names (proprietary names) appear in
parentheses after the generic name
A problem occurs in naming multiple-entity
drugs

These drugs are difficult to discuss by generic
name because they contain several ingredients
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20
Drug Substitution


Haveles (p. 6)
The question of generic equivalence and
substitution arises in the discussion of
generic and trade names

After 17 years, the patent of the original drug
expires, and other companies can market the
same compound under a generic name
cont’d…
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21
Drug Substitution

In 1984, Congress passed the Drug Price
Competition and Patent Term Restoration Act,
which allowed generic drugs to receive
expedited approval

The FDA still requires the active ingredient of the
generic product to enter the bloodstream at the
same rate as the trade name product
cont’d…
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22
Drug Substitution

Drugs can be judged “similar” in several ways



When two formulations of a drug meet the
chemical and physical standards established by
the regulatory agencies, they are termed
chemically equivalent
When the two formulations produce similar
concentrations of the drug in blood and tissues,
they are termed biologically equivalent
When the two formulations prove to have an equal
therapeutic effect in a clinical trial, they are termed
therapeutically equivalent
cont’d…
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23
Drug Substitution

A preparation can be chemically equivalent
yet not biologically or therapeutically
equivalent


These products differ in bioavailability
Before generic drugs are marketed, they
must be shown to be biologically equivalent,
which would make them therapeutically
equivalent
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24
Top 200 Drugs


Haveles (p. 6, Appendix A)
Appendix A lists the 200 drugs most often
prescribed in 2008


The rank order appears in the right column of the
appendix
This number represents the position that the drug
appears in the top 200
cont’d…
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25
Top 200 Drugs

Both generic and trade names appear on the
list, depending on how the prescription is
written

The oral health care provider must become
familiar with these names because patients may
know the names of the drugs they are taking but
not know how the names are spelled
 Accurate spelling permits the drugs to be
accessed in reference sources
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26
Federal Regulations and
Regulatory Agencies


Haveles (pp. 6-7)
Many agencies are involved in regulating the
production, marketing, advertising, labeling,
and prescribing of drugs

Harrison Narcotic Act
 U.S. Food and Drug Administration (FDA)
 Federal Trade Commission (FTC)
 Drug Enforcement Administration (DEA)
 Omnibus Budget Reconciliation Act (OBRA)
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27
Harrison Narcotic Act


Established regulations governing the used of
opium, opiates, and cocaine in 1914


Haveles (pp. 6-7)
Marijuana laws were added in 1937
Before this law, mixtures and OTC
medications could contain opium and cocaine
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28
U.S. Food and Drug
Administration (FDA)


Haveles (p. 7)
Part of the U.S. Department of Health and
Human Services (USHHS)



Grants approval so that drugs can be marketed in
the United States
Requires physical and chemical standards for
specific products and quality control in drug
manufacturing plants
Determines which drugs can be sold by
prescription and OTC and regulates the labeling
and advertising of prescription drugs
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29
Federal Trade Commission (FTC)


Haveles (p. 7)
Regulates the trade practices of drug
companies

Prohibits the false advertising of foods,
nonprescription (OTC) drugs, and cosmetics
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30
Drug Enforcement Administration
(DEA)

Part of the Department of Justice


Administers the Controlled Substances Act of
1970
Regulates the manufacture and distribution of
substances that have a potential for abuse,
including opioids (narcotics), stimulants, and
sedatives
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31
Omnibus Budget Reconciliation
Act (OBRA)

Pharmacists must provide patient counseling
and a prospective drug utilization review
(DUR) for Medicaid patients


Many state boards of pharmacy are interpreting
this law to apply to all patients
Dental patients who have their prescriptions
filled at a pharmacy should receive
counseling form the pharmacist about their
prescription
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32
Clinical Evaluation of a New Drug


Haveles (p. 7) (Fig. 1-2)
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
cont’d…
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33
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
cont’d…
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34
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
cont’d…
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35
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
cont’d…
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36
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
cont’d…
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37
Clinical Evaluation of a New Drug

Phase 4

Postmarketing surveillance
• Toxicity that occurs in patients 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
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38
Drug Legislation



History
Food and Drug Act of 1906


Haveles (pp. 7-8)
The first federal law to regulate interstate
commerce in drugs
Harrison Narcotic Act of 1914


Provided federal control over narcotic drugs
Required registration of all practitioners
prescribing narcotics
cont’d…
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39
Drug Legislation

Food, Drug, and Cosmetic Act of 1938


Prohibits interstate commerce of drugs not shown to
be safe and effective
Durham-Humphrey Law of 1952



Requires that certain types of drugs be sold only by
prescription
Requires the drugs be labeled “Caution: Federal law
prohibits dispensing without prescription”
Prohibits refilling a prescription unless directions to
the contrary are indicated on the prescription
cont’d…
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40
Drug Legislation

Drug Amendments of 1962 (Kefauver-Harris
Bill)


Manufacturers were required to demonstrate the
effectiveness of drugs, to follow strict rules in
testing, and to submit to the FDA any reports of
adverse effects from drugs already on the market
Manufacturer’s were also required to list drug
ingredients by generic name in labeling and
advertising and to state adverse effects,
contraindications, and efficacy of a drug
cont’d…
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41
Drug Legislation

Drug Abuse Control Amendments of 1965


Required accounting for drugs with a potential for
abuse, such as barbiturates and amphetamines
The Controlled Substance Act of 1970

Sets current requirements for writing prescriptions
for drugs often prescribed in dental practice
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42
Scheduled Drugs


Haveles (p. 8) (Table 1-4)
Federal law divides controlled substances
into five schedules according to their abuse
potential



Rules differ depending on the drug’s schedule
New drug entities are evaluated and added to the
appropriate schedule
Drugs may be moved from one schedule to
another if changes in abuse patterns are
discovered
cont’d…
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43
Scheduled Drugs

Current requirements for prescribing
controlled drugs


Any prescription for a controlled substance
requires a DEA number
All schedule II through IV drugs require a
prescription
cont’d…
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44
Scheduled Drugs

Any prescription for schedule II drugs must be written
in pen or indelible ink or typed
• A designee may write the prescription, but the prescriber
must personally sign the prescription in ink and is responsible
for what the designee has written

Schedule II prescriptions cannot be telephoned to the
pharmacist (except at the discretion of the pharmacist
for an emergency supply to be followed by a written
prescription within 72 hours)
cont’d…
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45
Scheduled Drugs

Because schedule II prescriptions cannot be refilled,
the patient must obtain a new written prescription to
obtain more medication
 Certain states require the use of “triplicate” or
“duplicate” prescriptions for schedule II drugs
 Prescriptions for schedule III and intravenous drugs
may be telephoned to the pharmacist and may be
refilled no more than five times in 6 months, if so
noted on the prescription
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46
Prescription Writing


Measurement



Metric system
Household measures
Prescriptions


Haveles (pp. 8-11)
Format
Explanations accompanying prescriptions
cont’d…
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47
Prescription Writing



Correctly written prescriptions will save time
Carefully written prescriptions are less likely
to result in mistakes
The dentist can save the patient’s and
pharmacist’s time with extra effort when
unusual prescriptions are written

Problems will be minimized if the unusual is
explained
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48
Measurement


Haveles (p. 9)
Metric system


In pharmacy, the primary measuring system is the
metric system
Scientific calculations use a base of 10
• The metric system, based on 10, is the language of
scientific measurement

Only metric units should be used in scientific
measurement
cont’d…
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49
Measurement



The basic metric unit for weight is the
kilogram (kg)
The basic metric unit for volume is the liter (L)


Haveles (p. 9) (Table 1-5)
One milliliter (ml), or one-thousandth of a liter, is
exactly 1 cubic centimeter (cc)
Solid drugs are dispensed by weight
(milligrams [mg]) and liquid drugs by volume
(milliliters [ml])
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50
Household Measures


Clinicians direct the pharmacist to dispense a
liquid in milliliters


Haveles (p. 9)
It is generally converted by the pharmacist into
household measures to be included in directions
to the patient
Liquids are converted into teaspoonfuls (5 ml)
and tablespoons (15 ml)

A calibrated dosing cup should be used
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51
Prescriptions


Haveles (pp. 9-11) (Fig. 1-3)
Format


The part of the prescription are divided into three
sections
• Heading
• Body
• Closing
Abbreviations
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52
Heading


Haveles (p. 9)
Contains the following



Name, address, and telephone number of the
prescriber (printed on prescription blank)
Name, address, age, and telephone number of the
patient (written)
Date of the prescription
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53
Body




The Rx symbol
Name and dose size or concentration
(liquids) of the drug
Amount to be dispensed


Haveles (pp. 9-10) (Fig. 1-3)
For tablets and capsules, “Dispense” is often
replaced with #, the symbol for a number
Directions to the patient
 Preceded by the abbreviation Sig:
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54
Closing



Prescriber's signature
DEA number, if required



Haveles (p. 10)
Needed for controlled substances
Often used by insurance companies as an
identifier
Refill instructions
cont’d…
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55
Closing


Haveles (p. 10) (Fig. 1-4)
All prescriptions must be labeled with the name
of the medication and its strength


The name, address, and telephone number of the
pharmacy, the patient’s and dentist’s names, the
directions for use, the name and strength of the
medication, and the original date and the date filled
(refilled) are required
The quantity of medication dispensed and number of
refills remaining may be noted
cont’d…
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56
Closing


Haveles (p. 11)
In most states, before a dentist can legally
write a prescription for a patient, the following
two criteria must be met

Patient of record: The person for whom the
prescription is being written is a patient of record
 Dental condition: The condition for which the
prescription is being prescribed is a dental-related
condition
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57
Abbreviations
 Haveles (pp. 9, 11) (Table 1-5)

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
cont’d…
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58
Abbreviations






prn: as needed
sig: write (label)
stat: immediately
bid: twice per day
tid: three times per day
qid: four times per day
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59
Explanations Accompanying
Prescriptions


Haveles (p. 11)
The dental health care worker should be able to
answer the patient’s questions about the
prescription


Make sure the patient knows how to take the
medication, what precautions to observe, and the
reason for taking the medication
Information about consequences of noncompliance
should be included
cont’d…
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60
Explanations Accompanying
Prescriptions

The dental office should either keep a copy of
each prescription written in the patient’s
record or record the medication, dose, and
number prescribed


A patient should never get home and not know
which drug is the antibiotic and which is the
analgesic
Side effects should be noted on the label
cont’d…
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61
Explanations Accompanying
Prescriptions

Prescription blanks should be kept in a
secure place

The dental health care worker should watch to see
they are not scattered around the office
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62