HSC 343 Clinical Pharmacology
Exam 1 Questions with Verified
Answers
Why study drug laws? - ANSWERS•To practice medicine safely!!
-For your patient
-For yourself
•To keep you informed of what is happening in medicine
•To keep you informed of research/career/medical opportunities
-Evidence-based practice
Chart - ANSWERSkeep a log of all medication given to patient
Pure Food and Drug Act - ANSWERS1. The federal government (Food and Drug
Administration, FDA) may enforce standards of drug strength and purity (Anything could
be considered stong and pure) as
officially designated by the USP (United States Pharmacopoeia) and NF (National
Formulary).
2. Prohibits mislabeling or adulteration of drugs (Putting something in a drug that is not
supposed to be there)
Adulteration - ANSWERS-putting anything in a drug that is not supposed to be there -
Examples: 1. putting supper glue in eye drops 2. putting cyanide in tylenol
Harrison Narcotic Act - ANSWERS1. regulated importation, manufacture, sale, and use
of opium, cocaine, and marijuana
2. repealed and superseded by Controlled Substances Act (1970)
3. worried about addictive substances
4. Early version of controlled substances act
Food, Drug, and Cosmetic Act - ANSWERS1. enforced by the FDA through registration
of all parties involved in the manufacture, sale, and distribution of drugs
2. required adequate testing of a compound to prevent marketing of a possibly toxic
substance. New drugs must be safe as well as pure in order to be introduced into
interstate commerce. But this law still did not require proof of effectiveness
3. covers substances that could be put on or in the body
4. You have to now regiter a new substance with the FDA
5. Illegal drug producers can be prosecuted with this law for not registering with the FDA
,6. Looks at safety
Durham-Humphrey Amendments - ANSWERS1. separated drugs into legend
(prescription) and nonlegend (nonprescription, over-the-counter) categories. The
"legend" must appear on every commercial container of legend drugs: "Caution: Federal
Law Prohibits Dispensing without Prescription."
2. rules for dispensing legend drugs
3. There was a big seperation between Pharmacists and Doctors at this time
Kefauver-Harris Amendments - ANSWERS1. Required proof of efficacy as well as
safety before any new drug could be placed in interstate commerce
2. Guidelines for conducting clinical trials
3. Established the Drug Efficacy Study Implementation (DESI)
4. Establised safety testing
-Done with animals
-Created in response to Thalidomide scandal
-Drugs have to balance efficacy and safety (risk vs. benefit)
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act) -
ANSWERS1. established rehabilitation programs for drug users
2. established control (registration) and enforcement (DEA)
3. regulates export and import of controlled substances
4. Expanded on Harrison Narcotic Act
5. Looks at drugs with a potential for abuse
-Drugs that can cause addiction
-Drugs for pain, sleep, weight loss
6. Who is prescribing this drug, why (for what reason)
-You need a DEA number to prescribe
-Doctors and Nurse Practitioners can prescribe medication
Controlled Substance - ANSWERS• Can be prescription
•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State
Governments
Reinforcing - ANSWERSphysical gain
Physically addicting - ANSWERSwithdrawal (could be deadly)
Psychologically addicting - ANSWERSCoke and meth
Birth control - ANSWERSnot a controlled substance
, Marijuana - ANSWERScontrolled substance
Heroin - ANSWERScontrolled substance
Blood pressure medications - ANSWERSnot a controlled substance
Oxycontin - ANSWERScontrolled substance
Controlled Substances—Federal Classification - ANSWERS-Has 5 schedules
(Schedule I most addictive - Schedule V least addictive) -Drugs can be moved up or
down the schedule by individual states)
Schedule I - ANSWERS-high abuse potential and no accepted medical use in U.S. -
mostly illegal -treat clincial trial drugs as this schedule (even if they are not)
1. investigational drugs
2. opiates: heroin, many synthetic derivatives
3. hallucinogens: LSD, mescaline, peyote, bath salts
4. marijuana (medical marijuana in 21 states an exception), spice
5. methaqualone (Quaalude)
Schedule II - ANSWERS-currently accepted medical use in U.S. with high abuse
potential resulting in severe physical or psychological dependence
1. Rules for Prescriptions
a. written prescription required with prescriber's actual (legal) signature
b. must be dated the same day as signed
c. no refills allowed (someone could steal and sell if patient has more than a 30 days
supply)
d. in an emergency, a verbal order may be given for a limited quantity of drug adequate
to treat the emergency condition, but must be followed by a written prescription within
72 hours. Note: This provision of federal law is not recognized in Alabama since state
law may be more stringent than federal law. THERE ARE NO VERBAL ORDERS
ALLOWED FOR ______________________ PRESCRIPTIONS IN ALABAMA (only
electronic)
e. pain medication
f. Add medication
g. patient needs to be monitored
h. desirable to everyone
i. severe physical or psychological dependence ----> reinforcement
2. Examples:
•Methylphenidate (Ritalin)
•Oxycodone (Oxycontin)
•Morphine
•Meperidine (Demerol)
•Cocaine
Exam 1 Questions with Verified
Answers
Why study drug laws? - ANSWERS•To practice medicine safely!!
-For your patient
-For yourself
•To keep you informed of what is happening in medicine
•To keep you informed of research/career/medical opportunities
-Evidence-based practice
Chart - ANSWERSkeep a log of all medication given to patient
Pure Food and Drug Act - ANSWERS1. The federal government (Food and Drug
Administration, FDA) may enforce standards of drug strength and purity (Anything could
be considered stong and pure) as
officially designated by the USP (United States Pharmacopoeia) and NF (National
Formulary).
2. Prohibits mislabeling or adulteration of drugs (Putting something in a drug that is not
supposed to be there)
Adulteration - ANSWERS-putting anything in a drug that is not supposed to be there -
Examples: 1. putting supper glue in eye drops 2. putting cyanide in tylenol
Harrison Narcotic Act - ANSWERS1. regulated importation, manufacture, sale, and use
of opium, cocaine, and marijuana
2. repealed and superseded by Controlled Substances Act (1970)
3. worried about addictive substances
4. Early version of controlled substances act
Food, Drug, and Cosmetic Act - ANSWERS1. enforced by the FDA through registration
of all parties involved in the manufacture, sale, and distribution of drugs
2. required adequate testing of a compound to prevent marketing of a possibly toxic
substance. New drugs must be safe as well as pure in order to be introduced into
interstate commerce. But this law still did not require proof of effectiveness
3. covers substances that could be put on or in the body
4. You have to now regiter a new substance with the FDA
5. Illegal drug producers can be prosecuted with this law for not registering with the FDA
,6. Looks at safety
Durham-Humphrey Amendments - ANSWERS1. separated drugs into legend
(prescription) and nonlegend (nonprescription, over-the-counter) categories. The
"legend" must appear on every commercial container of legend drugs: "Caution: Federal
Law Prohibits Dispensing without Prescription."
2. rules for dispensing legend drugs
3. There was a big seperation between Pharmacists and Doctors at this time
Kefauver-Harris Amendments - ANSWERS1. Required proof of efficacy as well as
safety before any new drug could be placed in interstate commerce
2. Guidelines for conducting clinical trials
3. Established the Drug Efficacy Study Implementation (DESI)
4. Establised safety testing
-Done with animals
-Created in response to Thalidomide scandal
-Drugs have to balance efficacy and safety (risk vs. benefit)
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act) -
ANSWERS1. established rehabilitation programs for drug users
2. established control (registration) and enforcement (DEA)
3. regulates export and import of controlled substances
4. Expanded on Harrison Narcotic Act
5. Looks at drugs with a potential for abuse
-Drugs that can cause addiction
-Drugs for pain, sleep, weight loss
6. Who is prescribing this drug, why (for what reason)
-You need a DEA number to prescribe
-Doctors and Nurse Practitioners can prescribe medication
Controlled Substance - ANSWERS• Can be prescription
•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State
Governments
Reinforcing - ANSWERSphysical gain
Physically addicting - ANSWERSwithdrawal (could be deadly)
Psychologically addicting - ANSWERSCoke and meth
Birth control - ANSWERSnot a controlled substance
, Marijuana - ANSWERScontrolled substance
Heroin - ANSWERScontrolled substance
Blood pressure medications - ANSWERSnot a controlled substance
Oxycontin - ANSWERScontrolled substance
Controlled Substances—Federal Classification - ANSWERS-Has 5 schedules
(Schedule I most addictive - Schedule V least addictive) -Drugs can be moved up or
down the schedule by individual states)
Schedule I - ANSWERS-high abuse potential and no accepted medical use in U.S. -
mostly illegal -treat clincial trial drugs as this schedule (even if they are not)
1. investigational drugs
2. opiates: heroin, many synthetic derivatives
3. hallucinogens: LSD, mescaline, peyote, bath salts
4. marijuana (medical marijuana in 21 states an exception), spice
5. methaqualone (Quaalude)
Schedule II - ANSWERS-currently accepted medical use in U.S. with high abuse
potential resulting in severe physical or psychological dependence
1. Rules for Prescriptions
a. written prescription required with prescriber's actual (legal) signature
b. must be dated the same day as signed
c. no refills allowed (someone could steal and sell if patient has more than a 30 days
supply)
d. in an emergency, a verbal order may be given for a limited quantity of drug adequate
to treat the emergency condition, but must be followed by a written prescription within
72 hours. Note: This provision of federal law is not recognized in Alabama since state
law may be more stringent than federal law. THERE ARE NO VERBAL ORDERS
ALLOWED FOR ______________________ PRESCRIPTIONS IN ALABAMA (only
electronic)
e. pain medication
f. Add medication
g. patient needs to be monitored
h. desirable to everyone
i. severe physical or psychological dependence ----> reinforcement
2. Examples:
•Methylphenidate (Ritalin)
•Oxycodone (Oxycontin)
•Morphine
•Meperidine (Demerol)
•Cocaine
