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36 Cards in this Set

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The U.S.P. Convention convened in 1820 with three distinct functions:
To select drug substances with the most fully established utility
To form from those substances preparations and compositions that would use their therapeutic powers to the best advantage
To distinguish those substances by convenient and definite names in order to minimize confusion between physicians and apothecaries
USP/NF
The National Formulary
Was originally a separate volume listing monographs for inactive ingredients (excipients) used in the preparation of drug products
It was purchased by and combined with the USP in 1980
Although published as one volume, the USP still lists monographs for active ingredients and formulations and the NF lists those for inactive ingredients
It is published every 5 years
USP/NF Today:
The United States Pharmacopeia/National Formulary provides:
legally recognized standards for drugs and excipients
Specifications for packaging, labeling, and storage
Tests and assays for strength, quality, purity, and identity, as well as specifications for reagents, indicators and solutions
Standards for medical devices, diagnostics, botanicals used as dietary supplements, and vitamins and minerals
THE IMPORT DRUGS ACT 1848
First federal drug act attempting to ensure the quality of drugs
Enacted because of deaths of American troops in Mexico being treated for malaria with adulterated quinine
Provided for laboratory inspection at ports of entry and for detention, destruction or re-exportation of shipments not meeting USP standards
Failed miserably due to lack of enforcement
DR. WILEY AND THE POISON SQUAD” 1883 - 1912
In 1883, Dr Harvey Wiley became the Chief Chemist for the USDA.
In his 29 year tenure of office he was credited for his famous crusade to curb widespread abuses in the production and sale of foods and drugs.
As the nation grew and became more industrialized, the need for packaging and shipping of food became greater.
Various chemicals were used as preservatives including borax, formaldehyde, salicylates and dyes for coloring many of which were toxic
He established the “Poison Squad” to scientifically test foods laced with preservatives to determine their toxic effects.
BIOLOGICS CONTROL ACT 1902
The St. Louis Health Department manufactured it’s own diphtheria antitoxin from equine serum.
A batch of the antitoxin became contaminated with tetanus resulting in the deaths of 12 children
There were no standards of purity or potency other than those devised on an ad hoc basis by local manufacturers and their customers.
This law required the licensing and regulation of the interstate sale of serums and vaccines used to treat or prevent human disease.
PURE FOOD AND DRUG ACT 1906
Signed into congress by President Theodore Roosevelt
Mandated that all drugs be “pure”
Prohibited the interstate commerce (sale) of any misbranded or adulterated foods, drinks and drugs (Referenced USP standards)
PURE FOOD AND DRUG ACT 1906
Adulterated? Misbranded?
Adulterated: not as labeled, differs in strength, quality or purity from that represented or containing filthy, putrid or decomposed substances.
Misbranded: false label statements about the identity or ingredients of the contained drugs
U.S. v. JOHNSON 1911
Dr. Johnson’s Mild Combination Treatment for Cancer
Supreme Court ruled that the 1906 Act did not prohibit false therapeutic claims.
Only false and misleading claims as to the identity of the drug were prohibited.
Dr. Johnson could not be prosecuted even though his claims of curing cancer with the product were entirely false
SHERLEY AMENDMENTS 1912
Prohibited false and fraudulent label claims of therapeutic effectiveness.
The language of this law required that the government prove that the promoter of worthless drugs deliberately lied to defraud the public.
Virtually impossible in most cases
However, this law remained in effect for 26 years
SHERLEY AMENDMENTS 1912
Many drug promoters evaded the intent of the Sherley Amendments by simply transferring the false claims from the labels to their advertising
Narcotics control was unsatisfactory
Over 100 “Soothers” (pediatric syrups) used to stop babies from crying were on the market. They contained varying amounts of morphine, opium and heroin!
AMA, APhA, Chicago Tribune, and Ladies Home Journal all pleaded for better control over narcotics
HARRISON NARCOTIC ACT 1914
Required licensing of those lawfully entitled to engage in the importation, manufacture, production, compounding, selling, and dispensing of opium and coca leaves and all compounds, salts and derivatives and preparations thereof.
Required prescriptions written by licensed physicians, dentists or veterinarians for the dispensing of narcotic drugs.
ELIXIR OF SULFANILAMIDE 1937
Sulfa compounds were miracle drugs in 1937!!
They tasted bad and were difficult to swallow
S.E. Massingill Co. of Bristol, TN developed a palatable, raspberry favored liquid product.
Used diethylene glycol as the solvent
Six gallons of mixture killed some 107 people, mostly children
ENSOL 1938
ENSOL was a biologic product used in cancer therapy.
125,000 bottles were imported into the US and were given “free” by prescribing physicians to patients with cancer.
Six women in Florida died as a result of receiving free ENSOL which was contaminated with tetanus.
The Food, Drug and Cosmetic Act 1938
Required:
drugs to be tested by their manufacturers for safety
drugs to be labeled with essential information and adequate directions for safe use
Drugs too dangerous for self-use exempted from the labeling requirements and require the legend “Caution: to be used only by or on the prescription of a physician, dentist or veterinarian.”
medical devices to be safe and effective
cosmetics to be safe
Mandated the use of (NDA’s) New Drug Applications
Authorized unannounced factory inspection by FDA of manufacturing facilities
INSULIN CERTIFICATION AMENDMENTS 1941
Insulin was discovered in 1921 at the U of Toronto by Banting and Best.
The U of T patented the substance and its manufacturing process and issued licenses so that when commercial manufacturing began, a standardized product with a certified batch assay would result.
HOWEVER.......the patent expired in 1941 and the FDCA was amended to ensure a continued flow of standardized insulin.
DURHAM-HUMPHREY AMENDMENTS 1951
Specifically required that drugs which cannot be used safely without medical supervision must be dispensed only by the prescription of a licensed practitioner and that these drugs bear on their label, the legend “Caution: Federal Law Prohibits Dispensing Without Prescription”
Created two categories of drugs
Prescription (those bearing the legend)
Nonprescription (those sold over the counter and not bearing the legend)
DURHAM-HUMPHREY AMENDMENTS 1951 cont’d
Prohibited refills of prescriptions without the express consent of the prescriber
Provided guidance to the pharmacist as to what minimal information must be included on the prescription label
Name and address of the pharmacy
The date of filling
Name of the prescriber
Name of the patient
Directions for use
Cautionary statements if any
THALIDOMIDE LESSONS 1962
Thalidomide was a new OTC drug marketed in Europe and Canada as a sleeping agent and was taken by hundreds of pregnant women having difficulty sleeping
Thousands of babies were born with “Phocomelia”
Having read the reports of the teratogenic effects of the drug, Dr. Frances O. Kelsey, FDA chief medical officer, refused to release the drug into the US marketplace
KEFAUVER - HARRIS ACT 1962 Also called the “Drug Efficacy Amendments”
Required pharmaceutical manufacturers to:
Establish full disclosure under which the most recent reliable information about Rx drugs be provided with the product in the form of package inserts
prove safety and efficacy of their drug products
register with FDA and be inspected every 2 yrs
have advertising approved by FDA (Transferred from FTC)
provide “informed consent” prior to human trials
Required the FDA to tighten controls over manufacturing and testing to determine drug effectiveness
Required retrospective review of all drugs approved since 1938
Drug Efficacy Study Implementation (DESI) 1966
As a result of the Kefauver-Harris Amendments, the FDA contracted NAS/NRC to evaluate the effectiveness of all prescription drugs approved on the basis of safety alone between 1938 and 1962
Required them to be placed into one of four categories:
-Effective
-Probably effective
-Possibly effective
-Ineffective
Drug Efficacy Study Implementation (DESI) 1966
Approximately 4000 drugs with over 16,000 therapeutic claims that had been approved on the basis of safety alone between 1938 and 1962 were evaluated for effectiveness.
1100 drugs were found to be ineffective
2300 were found to be effective for some therapeutic claims but were required to remove questionable claims from the labeling
About 7000 products containing drugs similar to those under review required relabeling or were withdrawn from the market
CONTROLLED SUBSTANCES ACT 1970
Title II of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
Frequently referred to as the CSA
Created five federal schedules of controlled substances based on their relative potential for abuse and a “closed record keeping system”
THE POISON PREVENTION PACKAGING ACT of 1970 (PPPA)
Administered and enforced by the Consumer Products Safety Commission (CPSC)
Enacted to prevent accidental poisoning in children
Initially required special packaging (child resistant closures) for all prescription drugs and some OTC products
Has been extended to include virtually all household products considered potentially harmful to children
OTC DRUG REVIEW 1972
Further implemented the Drug Efficacy Amendments (Kefauver-Harris 1962)
Analyzed over 300,000 OTC drug products
Created 80 therapeutic categories of active ingredients and their labeling
Classified them into 3 categories:
I-safe and effective, not misbranded
II-not safe and effective or misbranded
III-insufficient data for classification
MEDICAL DEVICE AMENDMENTS 1976
Assures safety and effectiveness of medical devices, including certain diagnostic and laboratory products
Upgraded the FDA regulatory authority over such devices
Registration of manufacturers
Created specific classes of devices
Required pre-market approval
Must abide by Good Manufacturing Practice Regulations (GMP)
records and reporting requirements and performance standards
FEDERAL ANTI-TAMPERING ACT 1982
Enacted in response to the 1982 deliberate contamination of TYLENOL capsules.
Requires tamper resistant packaging on certain OTC products, cosmetics and medical devices
Packages "must have an indicator or barrier to entry which when breached or missing, will provide visible evidence to consumers that tampering has occurred."
ORPHAN DRUG ACT 1983
Provides incentives to manufacturers to research, develop and market drug products intended for the treatment of rare diseases or medical conditions in the U.S.
These products are referred to as “orphans” because commercial markets sufficient to recover the cost of development do not exist.
PRICE COMPETITION AND PATENT RESTORATION ACT 1984
Title I:
Allows FDA to accept Abbreviated New Drug Applications (ANDA’s) for generic versions of post-1962 approved drug products.
Requires that the drugs be bioequivalent (rate and extent of absorption) to the pioneer drugs
Safety and efficacy data not required as long as this information is on file for the pioneer drug
PRICE / PATENT RESTORATION ACT continued . . .
Title II:
Allows extension of the patent life of pioneer drug products for up to five years to cover the time lost during the FDA “review period.”
Rx DRUG MARKETING ACT (PDMA) 1986
Designed to control the distribution of prescription drugs through legitimate channels
Requires states to license wholesale drug distributors
Bans the sale, trade and purchase of Rx drug samples
Requires all requests for drug samples by licensed practitioners to be made in writing and mandates that they keep records
Prohibits resale of Rx drugs by hospitals or other healthcare facilities and charitable organizations
Omnibus Budget Reconciliation Act (OBRA'90) 1990
Also referred to as the Medicaid Prudent Pharmaceutical Purchasing Act
Allows the Federal government to take advantage of discounts that were afforded to large institutional buyers of pharmaceuticals
Omnibus Budget Reconciliation Act (OBRA'90) 1990
Requires pharmaceutical companies give the Healthcare Finance Administration (HCFA) the "best price" for medications purchased for Medicaid recipients.
The "best price" provision was established via a rebate program in which pharmaceutical companies would return to state Medicaid agencies the difference between their best price and the average price of a prescription medication.
(OBRA'90) continued
Pharmacists are required under OBRA'90 to do the following:
1. Report to state Medicaid agencies the NDC numbers for all prescription drugs dispensed for recipients
2. Counsel Medicaid recipients on all new prescriptions which should include basic information about the medication, drug utilization review and intervention.
PRESCRIPTION DRUG USER FEE ACT (PDUFA) 1992
Intended to generate funds to accelerate drug approval.
Authorized FDA to charge pharmaceutical manufacturers fees to help defray the cost of the review process
Has reduced approval time from >30 months to ~13 months.
Health Insurance Portability and Accountability Act 1996
HIPAA
Individuals cannot be denied health insurance coverage
Exclusionary periods limited to 1 year
Exclusionary periods cannot be imposed on previously insured individuals with no break in coverage
Insurers must provide plans for individuals and small companies
Insurers cannot cancel previously available plans
Created the Privacy Rule
Became effective April 14, 2003