Chapter 2 Regulations

Objectives Define key terms. Describe the roles of OSHA, FDA, and DEA in patient safety. Discuss how drugs are developed. Distinguish between brand, generic, and trade names. Know the slang street names for illegal drugs.

Objectives Discuss why some drugs are more tightly controlled than others. Give an example of a drug from each controlled substances schedule and state why it is classified that way. Discuss the role of allied health professionals in recognizing and reporting impaired patients and professionals.

Regulatory Authorities OSHA FDA DEA

OSHA Occupational Safety and Health Administration Part of Department of Labor Oversees safety for workforce Includes medical workforce

FDA Food and Drug Administration Approves drugs Monitors drugs for adverse reactions Removes drugs from the market if unsafe

Critical Thinking Mr. Dupee is upset that he cannot get a drug he has read about. He knows a website in Mexico where he can order this drug. What are the potential dangers if he orders a drug from another country? How might you discuss this with him?

DEA Drug Enforcement Agency Part of Department of Justice Controls certain substances that are addictive and abused Criminal penalties

Drug Development Clinical trials Phase 1 Safety Phase 2 Efficacy Phase 3 Dosage Phase 4 Continuing Evaluation— MedWatch

Critical Thinking Not all people who volunteer for clinical trials qualify for the research. What do you think might eliminate a patient from clinical trials?

Availability of Medications World wide web has increased access of Americans to drugs from other countries. These drugs are not approved by FDA. These drugs are in experimental stages in United States. These drugs may not be made under safe conditions. These drugs may not be genuine.

Critical Thinking Canadians are protected by the Health Protection Branch (HPB) of the Department of Health and Welfare. Why might it be important for countries to cooperate in drug research?

Names of Drugs Chemical Brand Generic—official Street

Critical Thinking Drug names sometimes reflect what the drug does. Without looking them up, guess for what purpose the following drugs are used. Then check them in your drug reference book:

Controlled Substances Control based on Addictive qualities Abuse potential Criminal prosecution for illegal possession

DEA Schedules Schedule Abuse Potential Example I High Heroin II OxyContin III Moderate Steroids, codeine IV Low Valieum V Limited Cough medicine with codeine

Managing Controlled Substances Keep track of inventory. Watch for drug seekers. Report theft or loss. Carefully dispose of unused medications.

Substance Abuse Maladaptive pattern of behavior Legal and illegal chemical agents Addiction Tolerance Habituation Pain treatment Withdrawal Impairment

Critical Thinking A patient calls frequently and begs for more pain medication. The doctor and staff are frustrated with the repeated requests, which they attribute to drug-seeking behavior. How would you handle this situation?

Impaired Providers Impaired healthcare providers are a danger to patients. Impaired providers must be reported. Notify the Boards of Medicine and Nursing.

Critical Thinking What are the phone numbers and addresses for the Board of Medicine and the Board of Nursing in your state?

Summary What new piece of information in this chapter were you most interested to learn? What questions do you still have about the information in this chapter? Return to Objectives to determine extent of learning.