Kefauver-Harris Amendment of 1962
The drug efficacy amendment" (Year)
Requires that all medications be safe and effective . Manufactures must file new drug applications with FDA before any human clinicals.
Pure Food and Drug Act of 1906
The purpose was to prohibit the transport or sale of adulterated (altered & causing an undesirable effect) and misbranded (False or misleading labels) food and drugs.
- Did not require labels
-Required that labeled drugs NOT have any false information abo
Durham-Humphrey Amendment of 1951
Prescription drug amendment" ( )
Established 2 classes of drugs
1. Prescription or legend & they must bear RX legend.
2. OTC - over the counter or no prescription
- Authorized pharmacists to take verbal prescriptions over the phone
-Allowed refills on le
Why was the Pure Food and Drug Act Amended in 1937? (107 children)
A manufacturer used a new solvent to compound Sulfa suspension for children( for sore throats). The solvent, diethylene glycol (antifreeze), caused the death of 107 children.
Food, Drug, and Cosmetic Act of 1938 (FDCA)
3. Drugs do what labels claim.
4. Created FDA (Food and Drug Administration).
5. Clarified the definitions of adulterated and misbranded drugs.
Federal legend statement
Caution: Federal Law Prohibits dispensing without a prescription. Also, RX Only
Schedule I (C-I)
Have no use and are illegal in the U.S. Have HIGHEST ABUSE.(Ex): Heroin, Peyote, LSD, and Marijuana.
Schedule II (C-II)
Have accepted medical uses but have a high potential for abuse and dependency. (EX): Cocaine, codeine, morphine, oxycodone, and more. Never expires because you need a new prescription every time.
Schedule III (C-III)
Drugs with an accepted medical use, but a LOWER ABUSE potential as compared to C-II drugs. (EX): anabolic steroids, codeine with acetaminophen, hydrocodone, pentobarbital, and more. (Expires in 6 months: that means 1 refill this time and 5 more after that
Schedule IV (C-IV)
Drugs with an accepted medical use. Has LOW abuse and dependency. (EX): Phenobarbital, Alprazolam, Clonazepam, Diazepam, and more.( expires in 6 months)
Schedule V (C-V)
LOWEST abuse rate and dependency. Most states do not require a prescription for C-V drugs. (EX): Liquid Codeine cough preparations.(Expires in 6 months)
What products were highly abused when Pharmaceuticals were unregulated?
Products that contained Opium and Alcohol
Statutory law
Laws passed by the legislative bodies at the federal, state, and local levels with effects to the Pharmacy profession. (Congress is the body at the federal level)
Regulatory law
Rules and regulations established by agencies of the federal government. Such bodies are the FDA, DEA, and SBOP
Civil law
Laws dealing with the crimes between two private citizens. (Ex): Personal injuries, libel, slander, etc.
Torts
Any civil wrong or personal injury; (Ex): Broken contract, medical negligence, slander, libel, assault, etc.)
Slander
Spoken words to speak falsely about someone.
Libel
Written words to falsely represent someone.
Assault
Threatening another with bodily harm
Battery
Actually causing bodily harm to another
Malpractice
A form of negligence in which the standard of care is not met and was a direct cause of injury
Who has the burden of proof?
The plaintiff
What are the 4 D's of negligence
1.Duty -
2. Dereliction -
3. Damages -
4. Direct cause -
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled Substance Act of (year)" -
Created to combat and control drug abuse
-Placed addictive drugs into 5 schedules
-Formed the DEA
Poison Prevention Packaging Act of 1970
-Created to prevent accidental childhood poisonings from prescription and non-prescription products.
-Law requires safety caps on most prescription and OTC drugs
-Enforced by the Consumer Product Safety Commission
-80% of children under 5 could not open b
Drug Listing Act of 1972
- Gives FDA authority to compile a list of currently marketed drugs
-Every drug is assigned by the manufacturer a unique and permanent product code known as a NDC ( National Drug Code)
NDC (National Drug Code)
(Example) NDC 51285-601-05
1st set - Manufacturer
2nd set - Drug, its strength, and its dosage form
3rd set - package size
Orphan Drug Act of 1983
Orphan drug is a drug that is intended for use by a few patients with rare diseases. Developing these drugs is usually not cost effective. (Ex: (Huntington's, Tourettes, Muscular Dystrophy, etc)
Brand name drugs
When manufacturers bring new patented drugs to market they have exclusive rights to that drug.
Generic drugs
Once the patent expires on the drug, any company can produce that drug and sell it as a generic.
Drug Price Competition and Patent - Term Restoration Act of 1984
-Extended Patents so manufacturers could recoup their research and development costs
-Streamlined the generic drug approval process to increase generic drugs availability for patients
-Allows companies to continue developing drugs and makes drugs cheaper
Prescription Drug Marketing Act of 1987
-Prohibits reimportation of drugs into the US by anyone other than manufacturer
-Prohibits the sale or trading of samples
(Omnibus Budget Reconciliation Act of 1990 (OBRA 1990)
-Requires that Pharmacists complete DUR (Drug utilization reviews) reviews on prescriptions and offer counseling on all new medications
-Requires manufactures to rebate state Medicaid programs
Vitamins, Herbs, and Nutritional Supplements
-Considered nutritional products by FDA
-Considered foods and not drugs
-Not tested or regulated like drugs
Dietary Supplement Health and Education Act of 1994 (DSHEA 1994)
-Manufacturers do not have to prove safety, efficacy, or standardization of nutritional supplements to FDA
- DOES all the FDA to monitor false claims and monitor safety
- Restricts manufacturers from makingt claims that products cure or treat ailments
Health Insurance Portability and Accountability Act of 1996 (HIPPA 1996)
-Patients confidentiality and privacy
- Facilities must provide information to patients on how they protect the patient's health information
Food and Drug Administration Modernization Act
-Passed to update labeling on prescription medications
-Federal legend ("Caution! This drug cannot be distributed without a valid prescription
Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA - Also called Medicare Part D)
- Became effective January 1, 2006
-Provides prescription drug coverage to patients eligible for Medicare benefits
-Patients may pay premiums and deductibles
-Patients must sign up to receive benefits of the program
-This is not an automatic government be
Oversight Agencies
1.Statutory Laws provide a minimum level of standards
2. Federal and State agencies interpret the law and develop written criteria for implementing the law
Regulatory Agencies
-Customer Product Safety Commission
-FDA
-DEA
-SBOP
-NABP
-USP National Formulary
Food and Drug Administration (FDA)
- Has the authority to enforce the law and the ability to create and enforce regulations
Responsible for :
1. Make sure it safe for human use
2. Making sure that drugs are effective
-FDA has no legal authority over pharmacy practice in each state
FDA Implementing process
To implement the law the FDA provides specific guidelines:
1. The drug approval process
2. The advertisement of drugs
3. Recalls of marketed drugs
4.Adverse drug event reporting systems
The drug approval process (with the FDA)
Companies file an investigational drug application (IDA) with the FDA when they find a compound that may be useful in humans
New Drug Application (NDA)
-Filed with the FDA after the first 3 phases of testing are completed.
- This application details all development, testing and proposed labeling and packaging of the new drug.
(note: Out of 10,000 compounds only 1 will make it to FDA approval)
Phase I
Phase I - Tests for safety
The Advertisement of Drugs
-Manufacturers can advertise a drug indication (what its used to treat)
-Manufacturers must disclose:
1. Side effects - This is an unintended effect of taking a medicine
2. Adverse Reactions or Adverse event - In Pharmacology, any unexpected or dangerous
Recalls of Marketed Drugs
-The FDA regulates the recall of drugs from the market
- A recall of a drug is classified by the risk that the drug poses to patients
- There are 3 classes of drug recalls
Recall- Class I
- A reasonable probability that use of the product will cause or lead to serious adverse health events or even death
-Pulls all drugs from market (Wholesaler, Pharmacy, and Patient supplies)
-
Recall - Class III
- Use of this product will probably not cause an adverse health event
- Pulls all drugs from (wholesaler and Pharmacy supplies: not Patients)
*(note) This type of recall is usually a discrepancy in a lot or batch at the manufacturer level.
Recall - Class II
- The use of this product will cause adverse health events that are temporary or medically reversible
-Pulls all drugs from the market ( wholesalers, Pharmacies, and Patient supplies)
Market Withdrawal
Occurs when a product has a minor product violation that would not be subject to FDA legal action
-The facility removes the product or corrects the violation
(Ex) A product removed from the market due to tampering, without evidence of manufacturing or dis
Adverse Drug Event Reporting Systems
Med watch - FDA's Medical Products Reporting Program was created to ensure that products already on the market are safe for use.
Anyone can submit a med watch sheet
Vaccine Adverse Event Reporting System (VAERS)
Co-sponsored by the FDA and the Centers for Disease Control and Prevention
(CDC)
The purpose of VAERS
- To detect possible adverse events associated with vaccines
- collects and analyze information from reports of adverse events
Note - Reports are welcome from all concerned individuals.
Drug Enforcement Agency (DEA)
- Enforces laws concerning legal and illegal drugs (controlled substances)
-DEA issues DEA #'s to prescribers, manufacturers, pharmacies, institutions, wholesalers, and institutions
-Monitors control substance transactions between manufacturers, wholesale
Customer Product Safety Commission
-Enforces the use of child safety cap regulations
-The implementation of this law states;
- Safety caps should be able to be opened by 80% of children under 5 and safety caps should able to be opened by 90% of adults
If a patient wants a drug to be dispen
Safety Caps for the OTC Drugs
-A manufacturer may market 1 container size, of a product, with a non-safety cap
- Any OTC product that does not have a safety cap must contain on the label:
"This package is for households without young children
National Association of the Board of Pharmacy (NABP)
- NABP - Numbers used for insurance transactions
-- Meets several times a year to discuss national trends
- Has no authority over the practice of pharmacy - Developed a MODEL STATE PHARMACY PRACTICE ACT (MSPPA) which individualizes certain aspects of regu
State Board of Pharmacy (SBOP)
- Consists of leaders from the pharmacy community Oversees and implements existing laws/regulations
- Issues licenses to pharmacists and registers pharmacies
- Can suspend or revoke licenses or registrations
liability
Prosecution for misconduct
Why did we need the Kefauver-Harris Amendment of 1962
Pregnant women were given a popular sedative and anti-emetic (nausea) medicine called Thalidomide. It lead to thousands of birth defects in the US. Some babies were born with no arms or legs
Phase II
Tests for effectiveness
Phase III
Tests for dosing
(Each consecutive phase also retests and confirms the findings of the previous phases)
Phase IV
This is the post-marketing phase of the drug study
studies every aspect of the drug profile: Safety, effectiveness, dosage, adverse events, and side effects
Kefauver-Harris Amendment of 1962
The drug efficacy amendment" (Year)
Requires that all medications be safe and effective . Manufactures must file new drug applications with FDA before any human clinicals.
Pure Food and Drug Act of 1906
The purpose was to prohibit the transport or sale of adulterated (altered & causing an undesirable effect) and misbranded (False or misleading labels) food and drugs.
- Did not require labels
-Required that labeled drugs NOT have any false information abo
Durham-Humphrey Amendment of 1951
Prescription drug amendment" ( )
Established 2 classes of drugs
1. Prescription or legend & they must bear RX legend.
2. OTC - over the counter or no prescription
- Authorized pharmacists to take verbal prescriptions over the phone
-Allowed refills on le
Why was the Pure Food and Drug Act Amended in 1937? (107 children)
A manufacturer used a new solvent to compound Sulfa suspension for children( for sore throats). The solvent, diethylene glycol (antifreeze), caused the death of 107 children.
Food, Drug, and Cosmetic Act of 1938 (FDCA)
3. Drugs do what labels claim.
4. Created FDA (Food and Drug Administration).
5. Clarified the definitions of adulterated and misbranded drugs.
Federal legend statement
Caution: Federal Law Prohibits dispensing without a prescription. Also, RX Only
Schedule I (C-I)
Have no use and are illegal in the U.S. Have HIGHEST ABUSE.(Ex): Heroin, Peyote, LSD, and Marijuana.
Schedule II (C-II)
Have accepted medical uses but have a high potential for abuse and dependency. (EX): Cocaine, codeine, morphine, oxycodone, and more. Never expires because you need a new prescription every time.
Schedule III (C-III)
Drugs with an accepted medical use, but a LOWER ABUSE potential as compared to C-II drugs. (EX): anabolic steroids, codeine with acetaminophen, hydrocodone, pentobarbital, and more. (Expires in 6 months: that means 1 refill this time and 5 more after that
Schedule IV (C-IV)
Drugs with an accepted medical use. Has LOW abuse and dependency. (EX): Phenobarbital, Alprazolam, Clonazepam, Diazepam, and more.( expires in 6 months)
Schedule V (C-V)
LOWEST abuse rate and dependency. Most states do not require a prescription for C-V drugs. (EX): Liquid Codeine cough preparations.(Expires in 6 months)
What products were highly abused when Pharmaceuticals were unregulated?
Products that contained Opium and Alcohol
Statutory law
Laws passed by the legislative bodies at the federal, state, and local levels with effects to the Pharmacy profession. (Congress is the body at the federal level)
Regulatory law
Rules and regulations established by agencies of the federal government. Such bodies are the FDA, DEA, and SBOP
Civil law
Laws dealing with the crimes between two private citizens. (Ex): Personal injuries, libel, slander, etc.
Torts
Any civil wrong or personal injury; (Ex): Broken contract, medical negligence, slander, libel, assault, etc.)
Slander
Spoken words to speak falsely about someone.
Libel
Written words to falsely represent someone.
Assault
Threatening another with bodily harm
Battery
Actually causing bodily harm to another
Malpractice
A form of negligence in which the standard of care is not met and was a direct cause of injury
Who has the burden of proof?
The plaintiff
What are the 4 D's of negligence
1.Duty -
2. Dereliction -
3. Damages -
4. Direct cause -
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled Substance Act of (year)" -
Created to combat and control drug abuse
-Placed addictive drugs into 5 schedules
-Formed the DEA
Poison Prevention Packaging Act of 1970
-Created to prevent accidental childhood poisonings from prescription and non-prescription products.
-Law requires safety caps on most prescription and OTC drugs
-Enforced by the Consumer Product Safety Commission
-80% of children under 5 could not open b
Drug Listing Act of 1972
- Gives FDA authority to compile a list of currently marketed drugs
-Every drug is assigned by the manufacturer a unique and permanent product code known as a NDC ( National Drug Code)
NDC (National Drug Code)
(Example) NDC 51285-601-05
1st set - Manufacturer
2nd set - Drug, its strength, and its dosage form
3rd set - package size
Orphan Drug Act of 1983
Orphan drug is a drug that is intended for use by a few patients with rare diseases. Developing these drugs is usually not cost effective. (Ex: (Huntington's, Tourettes, Muscular Dystrophy, etc)
Brand name drugs
When manufacturers bring new patented drugs to market they have exclusive rights to that drug.
Generic drugs
Once the patent expires on the drug, any company can produce that drug and sell it as a generic.
Drug Price Competition and Patent - Term Restoration Act of 1984
-Extended Patents so manufacturers could recoup their research and development costs
-Streamlined the generic drug approval process to increase generic drugs availability for patients
-Allows companies to continue developing drugs and makes drugs cheaper
Prescription Drug Marketing Act of 1987
-Prohibits reimportation of drugs into the US by anyone other than manufacturer
-Prohibits the sale or trading of samples
(Omnibus Budget Reconciliation Act of 1990 (OBRA 1990)
-Requires that Pharmacists complete DUR (Drug utilization reviews) reviews on prescriptions and offer counseling on all new medications
-Requires manufactures to rebate state Medicaid programs
Vitamins, Herbs, and Nutritional Supplements
-Considered nutritional products by FDA
-Considered foods and not drugs
-Not tested or regulated like drugs
Dietary Supplement Health and Education Act of 1994 (DSHEA 1994)
-Manufacturers do not have to prove safety, efficacy, or standardization of nutritional supplements to FDA
- DOES all the FDA to monitor false claims and monitor safety
- Restricts manufacturers from makingt claims that products cure or treat ailments
Health Insurance Portability and Accountability Act of 1996 (HIPPA 1996)
-Patients confidentiality and privacy
- Facilities must provide information to patients on how they protect the patient's health information
Food and Drug Administration Modernization Act
-Passed to update labeling on prescription medications
-Federal legend ("Caution! This drug cannot be distributed without a valid prescription
Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA - Also called Medicare Part D)
- Became effective January 1, 2006
-Provides prescription drug coverage to patients eligible for Medicare benefits
-Patients may pay premiums and deductibles
-Patients must sign up to receive benefits of the program
-This is not an automatic government be
Oversight Agencies
1.Statutory Laws provide a minimum level of standards
2. Federal and State agencies interpret the law and develop written criteria for implementing the law
Regulatory Agencies
-Customer Product Safety Commission
-FDA
-DEA
-SBOP
-NABP
-USP National Formulary
Food and Drug Administration (FDA)
- Has the authority to enforce the law and the ability to create and enforce regulations
Responsible for :
1. Make sure it safe for human use
2. Making sure that drugs are effective
-FDA has no legal authority over pharmacy practice in each state
FDA Implementing process
To implement the law the FDA provides specific guidelines:
1. The drug approval process
2. The advertisement of drugs
3. Recalls of marketed drugs
4.Adverse drug event reporting systems
The drug approval process (with the FDA)
Companies file an investigational drug application (IDA) with the FDA when they find a compound that may be useful in humans
New Drug Application (NDA)
-Filed with the FDA after the first 3 phases of testing are completed.
- This application details all development, testing and proposed labeling and packaging of the new drug.
(note: Out of 10,000 compounds only 1 will make it to FDA approval)
Phase I
Phase I - Tests for safety
The Advertisement of Drugs
-Manufacturers can advertise a drug indication (what its used to treat)
-Manufacturers must disclose:
1. Side effects - This is an unintended effect of taking a medicine
2. Adverse Reactions or Adverse event - In Pharmacology, any unexpected or dangerous
Recalls of Marketed Drugs
-The FDA regulates the recall of drugs from the market
- A recall of a drug is classified by the risk that the drug poses to patients
- There are 3 classes of drug recalls
Recall- Class I
- A reasonable probability that use of the product will cause or lead to serious adverse health events or even death
-Pulls all drugs from market (Wholesaler, Pharmacy, and Patient supplies)
-
Recall - Class III
- Use of this product will probably not cause an adverse health event
- Pulls all drugs from (wholesaler and Pharmacy supplies: not Patients)
*(note) This type of recall is usually a discrepancy in a lot or batch at the manufacturer level.
Recall - Class II
- The use of this product will cause adverse health events that are temporary or medically reversible
-Pulls all drugs from the market ( wholesalers, Pharmacies, and Patient supplies)
Market Withdrawal
Occurs when a product has a minor product violation that would not be subject to FDA legal action
-The facility removes the product or corrects the violation
(Ex) A product removed from the market due to tampering, without evidence of manufacturing or dis
Adverse Drug Event Reporting Systems
Med watch - FDA's Medical Products Reporting Program was created to ensure that products already on the market are safe for use.
Anyone can submit a med watch sheet
Vaccine Adverse Event Reporting System (VAERS)
Co-sponsored by the FDA and the Centers for Disease Control and Prevention
(CDC)
The purpose of VAERS
- To detect possible adverse events associated with vaccines
- collects and analyze information from reports of adverse events
Note - Reports are welcome from all concerned individuals.
Drug Enforcement Agency (DEA)
- Enforces laws concerning legal and illegal drugs (controlled substances)
-DEA issues DEA #'s to prescribers, manufacturers, pharmacies, institutions, wholesalers, and institutions
-Monitors control substance transactions between manufacturers, wholesale
Customer Product Safety Commission
-Enforces the use of child safety cap regulations
-The implementation of this law states;
- Safety caps should be able to be opened by 80% of children under 5 and safety caps should able to be opened by 90% of adults
If a patient wants a drug to be dispen
Safety Caps for the OTC Drugs
-A manufacturer may market 1 container size, of a product, with a non-safety cap
- Any OTC product that does not have a safety cap must contain on the label:
"This package is for households without young children
National Association of the Board of Pharmacy (NABP)
- NABP - Numbers used for insurance transactions
-- Meets several times a year to discuss national trends
- Has no authority over the practice of pharmacy - Developed a MODEL STATE PHARMACY PRACTICE ACT (MSPPA) which individualizes certain aspects of regu
State Board of Pharmacy (SBOP)
- Consists of leaders from the pharmacy community Oversees and implements existing laws/regulations
- Issues licenses to pharmacists and registers pharmacies
- Can suspend or revoke licenses or registrations
liability
Prosecution for misconduct
Why did we need the Kefauver-Harris Amendment of 1962
Pregnant women were given a popular sedative and anti-emetic (nausea) medicine called Thalidomide. It lead to thousands of birth defects in the US. Some babies were born with no arms or legs
Phase II
Tests for effectiveness
Phase III
Tests for dosing
(Each consecutive phase also retests and confirms the findings of the previous phases)
Phase IV
This is the post-marketing phase of the drug study
studies every aspect of the drug profile: Safety, effectiveness, dosage, adverse events, and side effects