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Pharmacology. Ch 4-9. Drug Controls. Federal Food & Drug Act – 1906 Required identification of dangerous or addictive drugs Durham-Humphrey Amendment – 1951 Prescription vs non-prescription drugs Controlled Substance Act – 1970 Promotes drug education & prevention of abuse.
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Pharmacology Ch 4-9
Drug Controls • Federal Food & Drug Act – 1906 • Required identification of dangerous or addictive drugs • Durham-Humphrey Amendment – 1951 • Prescription vs non-prescription drugs • Controlled Substance Act – 1970 • Promotes drug education & prevention of abuse
Legal & Ethical Considerations • Nursing Responsibilities • Do no harm = nonmaleficence • Do what is best for patient = beneficence • http://www.nursingworld.org/ethics/chcode.htm
How ? ? ? • Know • 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 • Informed Consent must be obtained first
Phases of Development • 4 Phases • I - small numbers of healthy subjects • To determine optimal dosage ranges • Determine pharmacokinetics • II - small numbers of afflicted volunteers • Monitored for effectiveness & side effects • Adjustments to therapeutic dosages done
Phases, con’t. • III – large numbers of afflicted patients • Patients are followed by researchers • Studies include placebo-controlled and double-blind • 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
Legal Issues • 5 Rights • Dose (amount) • Drug (medicine) • Route (po, IM, IV, SC, cutaneous, PR) • Patient (name, ID band) • Time
Legal con’t. • Nurse Practice Acts • Guide the nurses in a given state • State & Federal laws • Facility regulations (policy & procedures)
Medication Errors • 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)
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
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
Contributing Factors • Interpersonal relationships • Assertiveness vs lack of it • Sense of powerlessness (new nurses) • Fear or embarrassment of being wrong • Nurse-patient ratios • Too busy • Too tired • Fear of disciplinary actions
Patient Understanding • Consider developmental stage of patient • 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 • 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 • Also ensure pt is aware of possible interactions with prescription meds