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.