Chapter 4 Cultural, Legal, & Ethical Considerations

1. Chapter 4Cultural, Legal, & Ethical Considerations

2. 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

3. 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)

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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)

10. HEPARIN (continued) • Assess injection site for hematoma, ecchymosis • Monitor PTT, Hg, Hct, Platelets **Antidote = Protamine Sulfate Refer to Davis Drug Guide for Nurses

11. 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.

12. 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

13. 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

14. Medication Pass Preparation • MEDICATION NAME • (Generic, Trade Names) • CLASSIFICATION • ROUTE OF ADMINISTRATION • DOSAGE • INDICATION/THERAPEUTIC • USE • COMMON SIDE EFFECTS (LIST 3-4) • NURSING INTERVENTIONS

15. Insulin • Humalog • Novolog • Humulin R • Novolin R • NPH • Lantus, Levimir

16. INSULIN • Humalog • Cheaper ? • Novolog • Stronger ? • Humulin • Novolin • Rapid acting • Humalog, Novolog • Short acting • Humulin R, Novolin R • Intermediate acting • NPH • Long acting • Lantus, Levemir

18. Insulin

19. 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

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.