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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.