Pharmacology 1

Nur 239
Jean Marie Osborne DNP, RN, ANP-C
REQUIRED TEXTS
DIVISION POLICY
AND
UNDERGRADUATE
HANDBOOK
 Grading Criteria
• Examinations……………………………. 40%
• Homework…………..…………………. 10%
• 2 Math Quizzes………………………… 10%
• Final Exam………………………………… 35%
• Communicating Across the
Curriculum………………………………… 5%
_______

100%
 Laboratory/Skills Requirements
• 2 Skills Modules:
• Re-takes

• Failure to complete each module by the

required date will result in grade deductions.
 Drug Calculation Proficiency
• Students must demonstrate proficiency with
drug calculations by achieving a minimum
grade of 90% on the Level I Drug Calculations
test.
• Students who do not achieve a 90% on their
first attempt will have the opportunity to
retake the assessment prior to the last day of
final exams.
 Pharmacology
• The study of the effects of chemical
substances on living tissues.
• Historically drugs were derived from plants,
animals, minerals. Now: most are synthetic
compounds manufactured in laboratories.
 Pharmacotherapy
• AKA Drug therapy: used to prevent, diagnose,
treat, also to treat signs and symptoms or
cure disease.
• Medications may be given for their local or
systemic effects:
– Local: sunscreen or local anesthetics
– Systemic: circulate through the bloodstream to
their sites of action
1700’s
• Small pox vaccine
• Digitalis (foxglove plant)
• Vt C 1800’s
• Atropine
• Iodine
• Nitrous oxide/ether
• Morphine
• Codeine
– Both extracted from
opium
 1900’s
• Early 1900’s
• Aspirin
• Phenobarbital
• Insulin • 1950’s
• Sulfonamides • Antipsychotics
• Antihypertensives
• 1940’s • Oral contraceptives
• Antibiotics • Polio vaccine
– PCN
– Tetracycline
– Streptomycin
• Antihistamines
 Drug Standards and Legislation
• Before 1906 patent medications and remedies
were sold by medicine men in traveling wagon
shows, drugstores, mail order, and by doctors-
either real or self-titled.
 History
• 1906: First federal Pure Foods and Drug Act
– Passed to protect the public from adulterated or
mislabeled drugs.
– Law required the drug company to declare on the
package label dangerous and perhaps addicting drugs.
– Designated The United States Pharmacopeia as official
standards and empowered the federal government to
enforce them
– Established the U.S. Food and Drug Administration
– Law had many limitations
 History
• 1912: Shirley Amendment
prohibited fraudulent claims of
drug effectiveness.
• 1938: Federal Food, Drug, and
Cosmetic Act-update of drug
legislation due to over 100
deaths in 1937 as a result of
ingesting an elixir. (broadened
FDA powers).
– This act prevented the
marketing of new drugs before
they had been properly tested
for safety before a product
could be sold.
• Durham-Humphrey
Amendment of 1952 further
changed the 1938 drug act:
– Legend drugs could be
dispensed by Rx only
– Legend drug Rx couldn’t be
refilled without physician
authorization
– Some legend drugs could be
prescribed by oral or telephone
instructions
– Some refills could also be
authorized by oral or telephone
means
• This amendment also
recognized OTC’s for which
Rx’s not required
 History
• 1962- Kefauver-Harris
Amendment
– Required proof of both safety
and efficacy before a new drug
could be approved for use
– Thalidomide- agent for change

• Early in the study it was

agreed that each drug would
be rated for effectiveness in
each of its stated indications
according to the following
categories:
• Effective
• Probably effective
• Possible effective
• Ineffective
 History
• 1970: The Controlled
Substance Act- this act was
designed to remedy the
escalating problem of drug
abuse by:
• Promoting drug education
and research into the
prevention and treatment of
drug dependence.
• Strengthening of
enforcement authority
• Establishment of treatment
and rehabilitation facilities
• Designation of schedules, or
categories, for controlled
substances according to
abuse liability
 Schedule of Controlled Substances
Category Abuse Dependence Examples Rules Governing
Potential Liability Prescription
C-I High Severe Heroin, hashish, LSD, No accepted medical use;
GHB restricted to research
C-II High Severe Amphetamines, some Requires specific type of Rx,
opioid narcotics Telephone orders not
(morphine) short acting accepted, refills require new
barbiturates RX
C-III Moderate Moderate Codeine, hydrocodone, Written or telephone Rx is
anabolic steroids, some acceptable. May be refilled 5
CNS stimulants times within 6 months from
date of issuance
C-IV Low Limited Anticonvulsants, muscle Same as C-III drugs
relaxants, sedatives,

C-V Limited Lowest antidiarrheals Many may be obtained

(loperamide) without a Rx.
 Drug Classifications
Therapeutic Classifications
Usually reflect the conditions for which the drugs
are used
– Antidepressants
– Antihypertensives

Chemical Characteristics
– Adrenergics
– Benzodiazepines
 Drug Classifications
• Drugs are classified according to their effects
on particular body systems, their therapeutic
uses, and their chemical characteristics.

• Example: Morphine
– CNS depressant
– Narcotic
– Opioid analgesic
 Nurses Role in Drug Research
• Drug research involves
risk and is estimated to
cost $800 million on
average to develop each
new drug.
• Drug studies take place
in a variety of inpatient
and outpatient settings.
 Basic Ethical Principles
• Four basic ethical principles • The principles of respect for
are relevant to research persons, beneficence, justice,
involving human subjects: and truth telling are integral to
– Respect for persons: client’s the issues of informed consent
choice should be honored and risk-to-benefit ratio in
whenever possible research involving human
• Autonomy- right of self subjects
determination, refuse meds,
refuse research and may
withdraw at any time without
penalty.
– Beneficence-is the duty to not
harm others, to maximize
benefits, and minimize harm
– Justice: all people treated fairly,
equal access to healthcare for
all
– Truth telling: whole truth
 Basic Ethical Principles
Informed Consent
• 2 aspects:
– Participant’s right to be
informed
– Participation is voluntary
• It is the role of the
healthcare provider, not the
nurse, to explain the study
and to respond to questions
• ***It is the nurse’s role to
protect clients from any
anticipated harm***
Risk to Benefit Ratio
• IRB determine that “risks to
subjects are reasonable in
relation to anticipated
benefits, if any, to subjects”
• All possible consequences
of a clinical study must be
analyzed and balanced with
inherent risks and the
anticipated benefits.
 Phases of Human Clinical
Experimentation
• Phase I : trials are primarily designed to assess
safety, determine human dosage, identify
pharmacokinetics, assess for serious adverse
effects. (Healthy volunteers). n= 30
• Phase II : demonstrate the safety and efficacy of
the drug in subjects who have the disease the
drug is designed to treat. N=100
• Phase III and IV: involve large numbers of subjects
with the disease intended for treatment.
Demonstrate the safety and efficacy long term
n= 1,000-3,000.
 Study Designs
• Controlled treatment groups in drug research trials can
receive no drug; a different drug; a placebo, or the same
drug- different dose, route or frequency.
• Open label study: all parties know the treatment group
assignment.
• Single blind: only the subjects are unaware of which group
they are assigned.
• Double blind: neither the HCP nor the subject knows
whether the subject is receiving the experimental or
control form of therapy.
• Triple blind: a HCP collects data and is also unaware of the
subject’s treatment group therefore removing all biases.
 Placebo Effect

• A placebo is a psychological benefit from a

compound that may not have the chemical
structure of a drug effect.
• Effective in ~ 1/3 of persons who take placebo.
• Many clinical drug studies involve a group of
subjects who receive a placebo.
• It is required that participants in drug trials be
told from the start that they may receive a
placebo.
 Nurse Practice Acts
• Every state has its own laws regarding drug
administration by nurses.
 Drug Names
• Each drug has several names:

– Chemical name -drugs chemical structure

– Generic name – (The United States Adopted Name Council)

nonproprietary name for the drug
• No drug company owns this name, each drug has only one generic name
which identifies the active ingredient.
–levofloxacin
– Brand (Trade) name - chosen by the drug company
and is a registered
trademark owned by that
specific manufacturer.
17 year patent.
 Generics
• Usually a drug is ordered by generic:
numerous brand names may exist for the
same drug.
• HCP typically order drugs by generic names to
avoid confusion between brand names that
look and sound alike.
• Lamictal (epilepsy) Lamisil (nail infections)
• Lomotil (diarrhea) Ludiomil (depression)
 Generic Drugs
• Must be approved by the
FDA
• Must be bioequivalent to
the brand name drug (peak
serum concentration and
plasma concentration curve
falls within 80%-125%)-then
they are considered
therapeutically equivalent (
given A rating)
• Generic drugs are usually
cheaper
• Have same active
ingredients
• May have inert fillers and
binders that result in
variations of drug
effectiveness.
• Brand name drugs preferred
for anticonvulsants,
anticoagulants, heart failure
meds (Lanoxin)
• DAW