1. Pharmacology Ch 4-9

2. Drug Controls Federal Food & Drug Act – 1906 Federal Food & Drug Act – 1906 Required identification of dangerous or addictive drugs Required identification of dangerous or addictive drugs Durham-Humphrey Amendment – 1951 Durham-Humphrey Amendment – 1951 Prescription vs non-prescription drugs Prescription vs non-prescription drugs Controlled Substance Act – 1970 Controlled Substance Act – 1970 Promotes drug education & prevention of abuse Promotes drug education & prevention of abuse

3. Legal & Ethical Considerations Nursing Responsibilities Nursing Responsibilities Do no harm = nonmaleficence Do no harm = nonmaleficence Do what is best for patient = beneficence Do what is best for patient = beneficence http://www.nursingworld.org/ethics/chcode.ht m http://www.nursingworld.org/ethics/chcode.ht m http://www.nursingworld.org/ethics/chcode.ht m http://www.nursingworld.org/ethics/chcode.ht m

4. How ? ? ? Know Classification Effects & adverse effects Safe dosages Actions of drug Laws governing administration

5. Invitro tests done initially Invitro tests done initially Extensive testing on animals before humans Extensive testing on animals before humans Investigational New Drug (IND) status is next on VOLUNTEER human subjects Investigational New Drug (IND) status is next on VOLUNTEER human subjects Informed Consent must be obtained first Informed Consent must be obtained first Testing

6. Phases of Development 4 Phases 4 Phases I - small numbers of healthy subjects I - small numbers of healthy subjects To determine optimal dosage ranges To determine optimal dosage ranges Determine pharmacokinetics Determine pharmacokinetics II - small numbers of afflicted volunteers II - small numbers of afflicted volunteers Monitored for effectiveness & side effects Monitored for effectiveness & side effects Adjustments to therapeutic dosages done Adjustments to therapeutic dosages done

7. Phases, con’t. III – large numbers of afflicted patients III – large numbers of afflicted patients Patients are followed by researchers Patients are followed by researchers Studies include placebo-controlled and double- blind Studies include placebo-controlled and double- blind IV – voluntary studies after being marketed IV – voluntary studies after being marketed Done by pharmaceutical companies Done by pharmaceutical companies Documents proof of effectiveness Documents proof of effectiveness Results gathered for 2 years after release Results gathered for 2 years after release

8. Ethical Issues Consideration of ethnicity Consideration of ethnicity Cultural consideration Cultural consideration Be cognizant of genetic factors Be cognizant of genetic factors

9. Legal Issues 5 Rights 5 Rights Dose (amount) Dose (amount) Drug (medicine) Drug (medicine) Route (po, IM, IV, SC, cutaneous, PR) Route (po, IM, IV, SC, cutaneous, PR) Patient (name, ID band) Patient (name, ID band) Time Time

10. Legal con’t. Nurse Practice Acts Nurse Practice Acts Guide the nurses in a given state Guide the nurses in a given state State & Federal laws State & Federal laws Facility regulations (policy & procedures) Facility regulations (policy & procedures)

11. Medication Errors May involve any person in the med administration system May involve any person in the med administration system Prescriber (physician or NP) Prescriber (physician or NP) Transcriber (nurse writing v.o. or t.o.) Transcriber (nurse writing v.o. or t.o.) Pharmacy staff (drug preparation) Pharmacy staff (drug preparation) Ancillary staff (perhaps involved in transport) Ancillary staff (perhaps involved in transport)

12. Preventing Errors Minimize telephone and verbal orders Minimize telephone and verbal orders Repeat order, speak clearly Repeat order, speak clearly Get another nurse to listen in Get another nurse to listen in Spell out loud the name of the drug 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 List the reason the pt will take the drug, i.e. promethezine 12.5 mg prn nausea Use only approved abbreviations Use only approved abbreviations

13. Safeguards Never ‘assume’ anything Never ‘assume’ anything ALWAYS clarify unclear orders/writing ALWAYS clarify unclear orders/writing Read label 3 times Read label 3 times ALWAYS use 0 before a decimal ( 0.25) ALWAYS use 0 before a decimal ( 0.25) Check for pt allergies, update pt info Check for pt allergies, update pt info Acknowledge/check on pt concerns Acknowledge/check on pt concerns

14. Contributing Factors Interpersonal relationships Interpersonal relationships Assertiveness vs lack of it Assertiveness vs lack of it Sense of powerlessness (new nurses) Sense of powerlessness (new nurses) Fear or embarrassment of being wrong Fear or embarrassment of being wrong Nurse-patient ratios Nurse-patient ratios Too busy Too busy Too tired Too tired Fear of disciplinary actions Fear of disciplinary actions

15. Patient Understanding Consider developmental stage of patient Consider developmental stage of patient Erikson’s stages, p 70 Erikson’s stages, p 70 Consider chronological age of patient Consider chronological age of patient Is pt old enough to understand Is pt old enough to understand Is pt having difficulty with thought processes or sensory input Is pt having difficulty with thought processes or sensory input Consider ethnic or cultural influences Consider ethnic or cultural influences Herbals or alternative medicines Herbals or alternative medicines

16. Understanding con’t. Ensure that pt knows what medicines will best treat the health problem 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 If pt wants to use herbal remedies, discuss the expected and potential effects Also ensure pt is aware of possible interactions with prescription meds Also ensure pt is aware of possible interactions with prescription meds