Legal and Ethical Considerations

Question 1

HIPPA

Answer 1

health insurance Portability and Accountability Act

• 1996
• maintain privacy regarding protected health information

Question 2

FDA

Answer 2

primary purpose is to protect patients and ensure drug effectiveness

Question 3

U.S. FDA drug approval process

Answer 3

• preclinical testing
• clinical studies
• Investigational drug studies
• Expedited drug approval

Question 4

Why would a drug be pulled off the market?

Answer 4

• rare, unpredictable problems
• more toxic than expected
• safer options available
• dangerous drug interaction
• improper use

Question 5

Zelnorm (tegaserod)

more toxic

Answer 5

-used for constipation associated with IBS
-Removed after linked to ACS and CVA
Later returned to market with restrictions

Question 6

Baycol (cerivastatin)

toxic drug

Answer 6

• approved in 1997 for hyperlipidemia
• SE of rhabdomyolysis
• removed after a greater incidence of rhabdomyolysis noted compared with other statins

Question 7

Seldane (terfenadine)

safer

Answer 7

• became the first non-sedating antihistamine in 1985
• AE of serious/fatal cardiac arrhythmias risk in liver failure patients and when taken with some other medications
• taken off market when allegra was approved

Question 8

Posicor (mibefradil)

dangerous combinations

Answer 8

• approved in 1997 as a CCB used for HTN
• when approved only 3 drugs were known to be contraindicated with Posicor
• post marketing revealed 25 drug contraindications so it was pulled
• FDA reported in 1998 that it had problems

Question 9

Duract (bromfenac)

improper use

Answer 9

• NSAID approved in 1997 for short term management of acute pain
• Liver enzyme elevation noted in trails when used longer than 10 days
• prescribers were sent warning letters about prescribing this too long but the practice continued

Question 10

Schedule I

Answer 10

example: heroin, LSD, PCP, Meth

drugs with high abuse potential and no accepted medical use

Question 11

Schedule II

Answer 11

example: demerol, morphine, oxycodone, amphetamines, barbiturates, hydrocodone
high abuse potential but accepted medial use. Can lead to strong physical and psychologic dependency

Question 12

Schedule III

Answer 12

example: codeine preparations, non-narcotic drugs like testosterone
medically accepted drugs. Abuse potential less than the schedule I or II. may cause dependency

Question 13

Schedule IV

Answer 13

example: diazepam, lorazepam, chloral hydrate

medially accepted drugs. may cause dependence

Question 14

Schedule V

Answer 14

example: opiod-controlled agents for diarrhea and cough like codeine in cough syrup
medically accepted drugs. very limited potential for dependence

Question 15

Nonprescription (OTC) medications

Answer 15

• products available without a prescription for self treatment
• regulation and evaluation of OTCs are under the FDA
• generally they are drugs with fewer side effects that have been out longer