Chapter 4 Cultural, Legal, & Ethical Considerations
Feb 26, 2016
Chapter 4Cultural, Legal, & Ethical Considerations
Controlled Substance Act - 1970 Schedule I – Only w/ approved protocol
▪ Heroin, marijuana Schedule II – Written rx only, no refills
▪ Codeine, morphine, methadone, oxycontin, ritalin, dilaudid Schedule III – Written rx or oral rx, 5 refills in 6 month period, container must have warning
* Tylenol w/ codeine, testosterone Schedule IV – Written or oral rx, 5 refills
▪ Benzodiazepines (valium, xanax); Ambien Schedule V – Written rx or OTC
▪ Cough/cold meds (Robitussin AC); Lomotil
Pharmacology – Drug Development 1. Preclinical testing
▪ 3 ½ years▪ Lab & animal research (rats)▪ Drug evaluated for safety
2. Investigational New Drug Application▪ Drug company files IND with FDA▪ Must be approved or disapproved by FDA within 30
days 3. Clinical Trials
▪ Phase I▪ 1 year, 20-80 healthy volunteers (no disease)▪ Study of a drug’s safety profile & safe dosage▪ Studies Pharmacokinetics (absorption, distrib, metab, excretion)
Pharmacology – Drug Development
Phase II▪ Controlled studies of 100-300 volunteers (people
with disease)▪ To assess drug effectiveness and safe dosage, 2
years Phase III▪ 3 years▪ Involves 1000-3000 patients in clinics & hospitals▪ Use of placebo▪ Physicians closely monitor all patients to
determine safety, efficacy, and adverse reactions
Pharmacology – Drug Development Phase IV
2 years, post-release of drug To further assess therapeutic & adverse
effects Black Box Warning: placed on drug by
FDA if severe reactions are occurring▪ ie: Advair, Accutane
Pharmacology –Drug Development 4. New drug application
Follows completions of all 3 clinical trials Report of all scientific data (100 pages) FDA has 6 months to review and approve
Final approval: New drug available to physicians to prescribe
Drug company must submit periodic reports to FDA
$12 billion in drug research and development per year, rising
Cultural Practices Native American
▪ Harmony w/ nature, evil spirits cause disease Asian
▪ Traditional medicine, herbal remedies African
▪ Folk medicine, “healers” Western
▪ Prevention of disease, education, medications Hispanic
▪ Health = good luck, Illness = bad luck, bad deed▪ Heat and cold remedies instead of medicines
Medication Preparation for Clinical HEPARIN Classification: Anticoagulant,
Antithrombotic Action: Prevents conversion of
prothrombin to thrombin, prevents thrombus formation
Indications: To prevent & treat thromboembolism and PE; also used to maintain IV catheter patency (in low doses)
Contraindications: bleeding, thrombocytopenia, severe liver disease
HEPARIN (continued) Adverse Effects: bleeding, anemia,
pain at injection site Route: IV or subcutaneous;
administer in abdominal tissue Dosage: 5,000 units q 8-12 hr.
(subcut) Nursing Implications:
Assess for S/S bleeding (gums, nose, bruising, black stools, hematuria)
HEPARIN (continued) Assess injection site for hematoma,
ecchymosis Monitor PTT, Hg, Hct, Platelets
**Antidote = Protamine Sulfate
Refer to Davis Drug Guide for Nurses
Heparin Absorption: Quickly absorbed after injection Distribution: Does not cross placenta or enter
breast milk, Highly bound to proteins Metabolism: probably metabolized by lymph
system and spleen, unknown Excretion: removed by lymph system and spleen ½ life: 1-2 hour, dependent upon dosage Onset: 20-60 min. Peak: 2 hrs Duration: 8-12 hrs.
Medication Pass Preparation Warfarin (Coumadin) Classification: Anticoagulant Indication: Prevention and treatment
of venous thrombosis, PE, DVT, atrial fibrillation, MI
Common SE: Bleeding, nausea, fever
Route: *Oral, IV Dosage: Oral – 2.5 – 10mg daily
Medication Pass Preparation Nursing Interventions:
Assess for signs of bleeding Monitor PT/INR, CBC Patients >60 may have greater than expected
INR High Alert medication 3-5 days to reach effective levels Instruct pt. to take med. at same time, evening Avoid foods high in Vitamin K Avoid Aspirin containing products and alcohol
Medication Pass Preparation MEDICATION NAME (Generic, Trade Names) CLASSIFICATION ROUTE OF ADMINISTRATION DOSAGE INDICATION/THERAPEUTIC USE COMMON SIDE EFFECTS (LIST 3-4) NURSING INTERVENTIONS
Insulin
HumalogNovologHumulin RNovolin RNPHLantus, Levimir
INSULIN Humalog
▪ Cheaper ? Novolog
▪ Stronger ?
Humulin Novolin
Rapid acting Humalog, Novolog
Short acting Humulin R, Novolin R
Intermediate acting NPH
Long acting Lantus, Levemir
Insulin
Insulin – refer to handout Sliding Scale
Insulin Sensitivity Factor▪ Blood glucose minus target glucose (140)
divided by ISF (40)
Carbohydrate Coverage▪ 1:10▪ 1:15▪ 1:20
Insulin
Cheerios 20 gm. 8 oz. skim milk 5 gm. 2 slices toast 24 gm. Butter 0 gm. 4 oz. cranberry juice 6
gm. Coffee 10 oz.
0 gm. Splenda 0 gm.