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36 Cards in this Set
- Front
- Back
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The U.S.P. Convention convened in 1820 with three distinct functions:
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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 |
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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 |
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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 |
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THE IMPORT DRUGS ACT 1848
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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 |
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DR. WILEY AND THE POISON SQUAD” 1883 - 1912
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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. |
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BIOLOGICS CONTROL ACT 1902
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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. |
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PURE FOOD AND DRUG ACT 1906
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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) |
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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 |
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U.S. v. JOHNSON 1911
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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 |
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SHERLEY AMENDMENTS 1912
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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 |
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SHERLEY AMENDMENTS 1912
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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 |
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HARRISON NARCOTIC ACT 1914
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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. |
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ELIXIR OF SULFANILAMIDE 1937
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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 |
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ENSOL 1938
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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. |
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The Food, Drug and Cosmetic Act 1938
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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 |
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INSULIN CERTIFICATION AMENDMENTS 1941
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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. |
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DURHAM-HUMPHREY AMENDMENTS 1951
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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) |
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DURHAM-HUMPHREY AMENDMENTS 1951 cont’d
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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 |
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THALIDOMIDE LESSONS 1962
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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 |
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KEFAUVER - HARRIS ACT 1962 Also called the “Drug Efficacy Amendments”
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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 |
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Drug Efficacy Study Implementation (DESI) 1966
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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 |
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Drug Efficacy Study Implementation (DESI) 1966
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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 |
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CONTROLLED SUBSTANCES ACT 1970
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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” |
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THE POISON PREVENTION PACKAGING ACT of 1970 (PPPA)
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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 |
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OTC DRUG REVIEW 1972
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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 |
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MEDICAL DEVICE AMENDMENTS 1976
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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 |
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FEDERAL ANTI-TAMPERING ACT 1982
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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." |
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ORPHAN DRUG ACT 1983
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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. |
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PRICE COMPETITION AND PATENT RESTORATION ACT 1984
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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 |
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PRICE / PATENT RESTORATION ACT continued . . .
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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.” |
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Rx DRUG MARKETING ACT (PDMA) 1986
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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 |
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Omnibus Budget Reconciliation Act (OBRA'90) 1990
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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 |
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Omnibus Budget Reconciliation Act (OBRA'90) 1990
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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. |
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(OBRA'90) continued
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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. |
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PRESCRIPTION DRUG USER FEE ACT (PDUFA) 1992
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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. |
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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 |
