2.  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.  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.  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.  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.  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.  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.  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.  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.  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 NAME  (Generic, Trade Names)   CLASSIFICATION   ROUTE OF ADMINISTRATION   DOSAGE   INDICATION/THERAPEUTIC  USE   COMMON SIDE EFFECTS (LIST 3-4)   NURSING INTERVENTIONS 

15.  Humalog  Novolog  Humulin R  Novolin R  NPH  Lantus, Levimir

16.  Humalog ▪ Cheaper ?  Novolog ▪ Stronger ?  Humulin  Novolin  Rapid acting  Humalog, Novolog  Short acting  Humulin R, Novolin R  Intermediate acting  NPH  Long acting  Lantus, Levemir

19.  Sliding Scale  Insulin Sensitivity Factor ▪ Blood glucose minus target glucose (140) divided by ISF (40)  Carbohydrate Coverage ▪ 1:10 ▪ 1:15 ▪ 1:20

20.  Cheerios20 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.