Terms and Facts Flashcards
Pharmakon
Greek word from which the word Pharmacy is derived
Plato’s Dialogues defines pharmakon as:
remedy, poison, drug, recipe, charm, medicine, substance, spell, artificial color, and paint.
pharmakopole
a person skilled with pharmakon - a highly diversified skill
shamans
witch doctors
Ancient Pharmacy
- Medicinal substances used since prehistoric times
- Magic was believed to be involved in early medicine
- No early distinction between physician or pharmacy and both classes of healers made their own medicine and treated patients.
Renaissance Pharmacy
(1300-1700 ad)
- Pharmacist and Physician began to seperate into different professions.
- Magic grew to have less of an impact in medicine
guild
- union
- association with rigid supervision
- at close of 12th centurt, Florence Italy physicians and pharmacists formed the first guild.
printing press
had a profound effect on the growth of pharmacy bc it allowed textbooks to be printed and facilitated learning at universities
apothecary shops
reniassance name for pharmacy
apothecary or apothecaries
early name for pharmacist (what the person working in the apothecary shop was called)
apprenticeship system
allowed training under a currenty pharmacist with the goal of learning the profession and opening their own apothecary shop
apothecary apprentices
can be though of as the original pharmacy students
King James I
established western societies first independent pharmacist guild in England during the early 17th century
Community Pharmacies during Renaissance
prepared and dispensed remedies while offering front-line medical advice to their customers
druggists
early designation for pharmacists who sold wholesale to apothecary shops (today: pharmaceutical manufacturers)
War of 1812
- Gave rise to the Hospital Pharmacist
- Pharmacist and Physican now seen as different professions
- Became unethical for physician to have their own pharmacy due to unscrupulus physicians making money by over-prescribing medications to gullible patients
USP
- United States Pharmacopeia
- Est. 1820
- 1st compendium of standard drugs in the U.S.
- Provides standards for both active and inactive ingredients
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Philadelphia College of Pharmacy
- Est. 1821
- 1st pharmacy college in America
APhA
- American Pharmaceutical Association
- Est. 1852
- Began to sponsor and publish the USP and also the National Formulary (NF)
NF
- National Formulary
USP & NF
- United States Pharmacopeia
- National Formulary
- Two books sponsored and published by the APhA (1852) as books of standard pharmaceutical preparations with established quality standards that ensured consistant medicines
Pure Food and Drug Act
- 1906
- Established the USP and NF as the official books of standards for American pharmaceuticals
- Prohibited transportation of adulterated or misbranded food and drugs
- Required drug manufacturers to prove to the FDA the safety and effectiveness of products before they were legally permitted to market them to the public
Edward Parrish
- Successfully proposed that members of the APhA categorize all the various pharmaceutical practitioners as Pharmacists, which formally identified the field as a profession
Pharmacists
- Term first used by Edward Parrish
- 1850’s all apothecaries formally called Pharmacists
- Made and prescribed medicines and remained community medical counselors
AMA
- American Medical Association
- 1905 - initiated a voluntary drug approval program that lasted until 1955 (Through its Council on Pharmacy and Chemicals) conferred no official or legal status to the drug being evaluated.
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JAMA
- Journal of the American Medical Association
- To earn the right to advertise in this journal and other associated medical journals; medicine companies voluntarily submitted evidence for review by the AMA Council on Pharmacy and Chemistry and by other outside experts to support their therapeutic claims for their drug
BSc Degree in Pharmacy
- 1932 - 4-year degree that became the standard for liscencure
- 1962 - became a 5-year degree
PharmDs
- 1990 - liscenure program became a 7-year doctorate program
- Graduates are Doctors of Pharmacy or PharmDs
Elixir Sulfonamide
- 1937
- antibiotic sold for treating childhood infections
- contained poisonous solvent diethylene glycol
- killed 107 people - most were children
- this tragedy dramatized the need for established drug safety before marketing
Federal Food, Drug and Cosmetic Act
- 1938
- Est. the FDA
- established a formal drug approval process – which regulates approval of new drugs for safety, drug labeling, drug recalls, and pharmaceutical factory inspections
- extended control to cosmetics and therapeutic devices
- required new drugs to be shown safe before marketing - starting a new system of drug regulation
- Eliminated the Sherley Ammendment requirement to prove intent to defraud in drug-misbranding cases
- provided that safe tolerances be set for unavoidable poisonous substances
- authorized standards of identity, quality, and fill-of-container for foods
- authorized factory inspections
- added the remedy of court injunctions to the previous penalties of seizures and prosecutions
FDA
- Food and Drug Administration
- Est. 1938 (Federal Food, Drug and Cosmetic Act)
- Regulates prescription and OTC medications
- Supervises the development, testing, purity, safety, and effectiveness of prescription and OTC medications
OTC
- Over-the-Counter
Durham - Humphrey Amendment
- 1951 amendment to the Federal Food, Drug, and Cosmetics Act
- Substantionally changed Pharmacy’s role
- Established Prescription only (legend) and OTC classes of drug products
- Pharmacists were now required to have a Physician’s prescription to dispense many medications that up until 1951 had not been needed except in the case of Narcotics.
- Resulted in Pharmacist recommendation of medications limited to OTC drugs
WWII Technology
- large scale manufacturing of bullets developed during WWI and WWII
- machines were modified and techniques develped to mass produce medications following WWII
- Resulted in the majority of in-shop drug preparation taken away from Pharmacist
- Pharmacist’s focus became dispensing and product safety - a “count and pour/lick and stick” operation
thalidomide
- 1962
- new sleeping pill
- found to have cause birth defects in thousands of babies born in Western Europe
- News reports on the role of Dr. Frances Kelsey, FDA medical officer, keeping the drug off the U.S. market aroused public support for stronger drug regulation
Kefauver-Harris Amendment
- 1962 amendment to the Pure Food and Drug Act
- required drug manufacturers to prove to the FDA the safety and effectiveness of their product before they were legally permitted to market them to the public
- established requirement of human clinical trials to prove safety and efficacy of drugs
- required IND (investigational new drug application) for phased testing of new drugs
- required NDA (new drug application) to market a new drug in the United States
IND
- Investigational New Drug Application
NDA
- New Drug Application
IND and NDA System
- Est. 1962
- Used by the FDA
- required that rigorous and well-controlled clinical trials be performed for new drug approval
- INDs were required to contain toxicology studies and chemistry and manufacturing information to ensure product quality and safety
CSA
- Controlled Substances Act
- Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970
- Enforced by the BNDD (now DEA)
- established a single system of control for both narcotic and psychotropic drugs for the 1st time in U.S. history
- also established 5 schedules that classified controlled substances according to how dangerous they are, their potential for abuse and addiction, and whether they posess legitimate medical value
- still the legal framework from which the DEA derives its authority
BNDD
- Bureau of Narcotics and Dangerous Drugs
- Est. 1970
- Became the DEA
DEA
- Drug Enforcement Agency
- Est. 1973
- Formerally BNDD