1. Mosby items and derived items © 2011, 2007, 2004 by Mosby, Inc., an affiliate of Elsevier Inc. Cultural, Legal, and Ethical Considerations Winter 2013 1

2. 10/11/2015 2 Schedule Abuse Liability Approved Medical Use Availability Examples Schedule IHighNo investigational use only  LSD, mescaline, peyote  Heroin,  Heroin, marijuana Schedule IIHighYes written prescription with no refills  amphetamine, methamphetamine, cocaine  codeine, levorphanol, meperidine methadone, morphine, opium  amobarbital, pentobarbital, secobarbital  phencyclidine Schedule III Moderately High Yes written or telephone prescription with refills  Tylenol with codeine, paregoric  chlorphentermine  anabolic steroids Schedule IVModerateYes written or telephone prescription with refills  chloral hydrate  chlordiazepoxide, diazepam, flunitrazepam  meprobamate  methohexital, phenobarbital Schedule VLowYes prescription not necessary  Robitussin A-C (contains less than 100 mg codeine per 100 ml) 10/11/20152 Winter 2013 2

3.  Investigational new drug (IND) application  Informed consent  U.S. FDA drug approval process  Preclinical testing  Clinical studies  Investigational drug studies  Expedited drug approval Winter 2013 3

4.  Preclinical investigational drug studies  Informed consent  Clinical phases of investigational drug studies  Phase I  Phase II  Phase III  Phase IV Winter 2013 4

5. 10/11/20155  CLINICAL TRIALS FOR NEW DRUGS  ANIMAL STUDIES  PHASE I – DRUGS ARE GIVEN TO A SMALL GROUP OF HEALTHY VOLUNTEERS SAFE DOSAGES ROUTES OF ADMINISTRATION ABSORPTION, METABOLISM, EXCRETION, TOXICITY ADVERSE EFFECTS ADVERSE EFFECTS Winter 2013 5

6. 10/11/20156  PHASE II  DOSES ARE GIVEN TO A SMALL GROUP OF PATIENTS WITH THE DISEASE OR SYMPTOM  PHASE III  LARGE GROUP OF PEOPLE – PLACEBO, DOUBLE BLIND STUDY DOUBLE BLIND STUDY  PHASE IV  FDA EVALUATES THE DATA FOR POSSIBLE APPROVAL  FOLLOW-UP STUDIES POST MARKETING SURVEILLANCE Winter 2013 6

7.  Assess the influence of a patient’s cultural, beliefs, values, and customs  Drug polymorphism  Compliance level with therapy  Environmental considerations  Genetic factors  Varying responses to specific drugs Winter 2013 7

8.  Changing national demographics  Influence of ethnicity and genetics  Rapid and slow acetylators  Examples of various ethnic groups found in the U.S.  Asian  African American  Hispanic  Native American  Caucasion Winter 2013 8

9.  Health beliefs and practices  Past uses of medicine  Folk remedies  Home remedies  Over-the-counter drugs and treatment  Herbal remedies Winter 2013 9

10.  Usual response to illness  Responsiveness to medical treatment  Religious practices and beliefs  Dietary habits Winter 2013 10