Pharmacology
Ch 4-9
Drug Controls
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Federal Food & Drug Act – 1906
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Durham-Humphrey Amendment – 1951
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Required identification of dangerous or
addictive drugs
Prescription vs non-prescription drugs
Controlled Substance Act – 1970
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Promotes drug education & prevention of
abuse
Legal & Ethical Considerations
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Nursing Responsibilities
Do no harm = nonmaleficence
 Do what is best for patient = beneficence
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http://www.nursingworld.org/ethics/chcode.ht
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How ? ? ?
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Know
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Classification
Effects & adverse
effects
Safe dosages
Actions of drug
Laws governing
administration
Testing
Invitro tests done initially
 Extensive testing on animals before
humans
 Investigational New Drug (IND) status is
next on VOLUNTEER human subjects
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Informed Consent must be obtained first
Phases of Development
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4 Phases
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I - small numbers of healthy subjects
 To
determine optimal dosage ranges
 Determine pharmacokinetics
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II - small numbers of afflicted volunteers
 Monitored
for effectiveness & side effects
 Adjustments to therapeutic dosages done
Phases, con’t.
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III – large numbers of afflicted patients
 Patients
are followed by researchers
 Studies include placebo-controlled and doubleblind
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IV – voluntary studies after being marketed
 Done
by pharmaceutical companies
 Documents proof of effectiveness
 Results gathered for 2 years after release
Ethical Issues
Consideration of ethnicity
 Cultural consideration
 Be cognizant of genetic factors
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Legal Issues
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5 Rights
Dose (amount)
 Drug (medicine)
 Route (po, IM, IV, SC, cutaneous, PR)
 Patient (name, ID band)
 Time
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Legal con’t.
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Nurse Practice Acts
Guide the nurses in a given state
 State & Federal laws
 Facility regulations (policy & procedures)
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Medication Errors
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May involve any person in the med
administration system
Prescriber (physician or NP)
 Transcriber (nurse writing v.o. or t.o.)
 Pharmacy staff (drug preparation)
 Ancillary staff (perhaps involved in transport)
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Preventing Errors
Minimize telephone and verbal orders
 Repeat order, speak clearly
 Get another nurse to listen in
 Spell out loud the name of the drug
 List the reason the pt will take the drug,
i.e. promethezine 12.5 mg prn nausea
 Use only approved abbreviations
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Safeguards
Never ‘assume’ anything
 ALWAYS clarify unclear orders/writing
 Read label 3 times
 ALWAYS use 0 before a decimal ( 0.25)
 Check for pt allergies, update pt info
 Acknowledge/check on pt concerns
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Contributing Factors
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Interpersonal relationships
Assertiveness vs lack of it
 Sense of powerlessness (new nurses)
 Fear or embarrassment of being wrong
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Nurse-patient ratios
Too busy
 Too tired
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Fear of disciplinary actions
Patient Understanding
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Consider developmental stage of patient
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Erikson’s stages, p 70
Consider chronological age of patient
Is pt old enough to understand
 Is pt having difficulty with thought processes
or sensory input
 Consider ethnic or cultural influences
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 Herbals
or alternative medicines
Understanding con’t.
Ensure that pt knows what medicines will
best treat the health problem
 If pt wants to use herbal remedies, discuss
the expected and potential effects
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Also ensure pt is aware of possible
interactions with prescription meds