chapter 4 legal/professional issues

Question 1

drug approval process

Answer 1

• 1-2 years minimum to approve on average
• can take as long as 5-10 years to approve
• stages: preclinical research-stabilize compound, research disease process anticipate how drug could work, use animal tissue for dosing
  
  • phase 1-test on healthy humans for testing tolerance
  • phase 2-test on diseased patients
  • phase 3-controlled/blind test group
  • post marketing research

Question 2

controlled substance prescribing

Answer 2

• pain is subjective
• if pain persistent refer to pain specialist
• use chemical dependence screening skills
• be aware of drug scams
• use medicine/pain contracts

Question 3

US food and drug administration

Answer 3

• regulates: approval process for new drugs/new indications, official labeling, surveillance of adverse drug events, methods of manufacture/distribution, medical devices, advertising for prescription drugs
• DOES NOT regulate prescribing