HSC 343 Clinical Pharmacology Exam 1
with complete solutions
Why study drug laws?
•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
keep a log of all medication given to patient
Read More
Pure Food and Drug Act
1. 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
-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
1. 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 repealed and superseded by Controlled Substances Act (1970)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
1. 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
1. 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
1. 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)
1. 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
• 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
physical gain
Physically addicting
withdrawal (could be deadly)
Psychologically addicting
Coke and meth
Birth control
not a controlled substance
Marijuana
controlled substance
Heroin
controlled substance
Blood pressure medications
not a controlled substance
Oxycontin
controlled substance
Controlled Substances—Federal Classification
-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
-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
-currently accepted medical use in U.S. with high abuse potential resulting in
severe physical or psychological dependence
1. Rules for Prescriptions
with complete solutions
Why study drug laws?
•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
keep a log of all medication given to patient
Read More
Pure Food and Drug Act
1. 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
-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
1. 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
1. 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
1. 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
1. 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)
1. 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
• 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
physical gain
Physically addicting
withdrawal (could be deadly)
Psychologically addicting
Coke and meth
Birth control
not a controlled substance
Marijuana
controlled substance
Heroin
controlled substance
Blood pressure medications
not a controlled substance
Oxycontin
controlled substance
Controlled Substances—Federal Classification
-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
-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
-currently accepted medical use in U.S. with high abuse potential resulting in
severe physical or psychological dependence
1. Rules for Prescriptions
