Transcript Chapter 4 Cultural, Legal, & Ethical Considerations


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

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)
 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

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

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

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





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.






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

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 NAME
(Generic, Trade Names)
CLASSIFICATION
ROUTE OF ADMINISTRATION
DOSAGE
INDICATION/THERAPEUTIC
USE
COMMON SIDE EFFECTS (LIST 3-4)
NURSING INTERVENTIONS
Humalog
Novolog
Humulin R
 Novolin R
 NPH
 Lantus, Levimir




Humalog
▪ Cheaper ?

Novolog
▪ Stronger ?


Humulin
Novolin

Rapid acting
 Humalog, Novolog

Short acting
 Humulin R, Novolin R

Intermediate acting
 NPH

Long acting
 Lantus, Levemir

Sliding Scale

Insulin Sensitivity Factor
▪ Blood glucose minus target glucose (140) divided by ISF (40)

Carbohydrate Coverage
▪ 1:10
▪ 1:15
▪ 1:20







Cheerios
8 oz. skim milk
2 slices toast
Butter
4 oz. cranberry juice
Coffee 10 oz.
Splenda
20 gm.
5 gm.
24 gm.
0 gm.
6 gm.
0 gm.
0 gm.