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Flashcards in Terms and Facts Deck (107)
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1
Q

Pharmakon

A

Greek word from which the word Pharmacy is derived

2
Q

Plato’s Dialogues defines pharmakon as:

A

remedy, poison, drug, recipe, charm, medicine, substance, spell, artificial color, and paint.

3
Q

pharmakopole

A

a person skilled with pharmakon - a highly diversified skill

4
Q

shamans

A

witch doctors

5
Q

Ancient Pharmacy

A
  • 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.
6
Q

Renaissance Pharmacy

A

(1300-1700 ad)

  • Pharmacist and Physician began to seperate into different professions.
  • Magic grew to have less of an impact in medicine
7
Q

guild

A
  • union
  • association with rigid supervision
  • at close of 12th centurt, Florence Italy physicians and pharmacists formed the first guild.
8
Q

printing press

A

had a profound effect on the growth of pharmacy bc it allowed textbooks to be printed and facilitated learning at universities

9
Q

apothecary shops

A

reniassance name for pharmacy

10
Q

apothecary or apothecaries

A

early name for pharmacist (what the person working in the apothecary shop was called)

11
Q

apprenticeship system

A

allowed training under a currenty pharmacist with the goal of learning the profession and opening their own apothecary shop

12
Q

apothecary apprentices

A

can be though of as the original pharmacy students

13
Q

King James I

A

established western societies first independent pharmacist guild in England during the early 17th century

14
Q

Community Pharmacies during Renaissance

A

prepared and dispensed remedies while offering front-line medical advice to their customers

15
Q

druggists

A

early designation for pharmacists who sold wholesale to apothecary shops (today: pharmaceutical manufacturers)

16
Q

War of 1812

A
  • 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
17
Q

USP

A
  • United States Pharmacopeia
  • Est. 1820
  • 1st compendium of standard drugs in the U.S.
  • Provides standards for both active and inactive ingredients
    *
18
Q

Philadelphia College of Pharmacy

A
  • Est. 1821
  • 1st pharmacy college in America
19
Q

APhA

A
  • American Pharmaceutical Association
  • Est. 1852
  • Began to sponsor and publish the USP and also the National Formulary (NF)
20
Q

NF

A
  • National Formulary
21
Q

USP & NF

A
  • 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
22
Q

Pure Food and Drug Act

A
  • 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
23
Q

Edward Parrish

A
  • Successfully proposed that members of the APhA categorize all the various pharmaceutical practitioners as Pharmacists, which formally identified the field as a profession
24
Q

Pharmacists

A
  • Term first used by Edward Parrish
  • 1850’s all apothecaries formally called Pharmacists
  • Made and prescribed medicines and remained community medical counselors
25
Q

AMA

A
  • 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.
    *
26
Q

JAMA

A
  • 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
27
Q

BSc Degree in Pharmacy

A
  • 1932 - 4-year degree that became the standard for liscencure
  • 1962 - became a 5-year degree
28
Q

PharmDs

A
  • 1990 - liscenure program became a 7-year doctorate program
  • Graduates are Doctors of Pharmacy or PharmDs
29
Q

Elixir Sulfonamide

A
  • 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
30
Q

Federal Food, Drug and Cosmetic Act

A
  • 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
31
Q

FDA

A
  • 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
32
Q

OTC

A
  • Over-the-Counter
33
Q

Durham - Humphrey Amendment

A
  • 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
34
Q

WWII Technology

A
  • 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
35
Q

thalidomide

A
  • 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
36
Q

Kefauver-Harris Amendment

A
  • 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
37
Q

IND

A
  • Investigational New Drug Application
38
Q

NDA

A
  • New Drug Application
39
Q

IND and NDA System

A
  • 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
40
Q

CSA

A
  • 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
41
Q

BNDD

A
  • Bureau of Narcotics and Dangerous Drugs
  • Est. 1970
  • Became the DEA
42
Q

DEA

A
  • Drug Enforcement Agency
  • Est. 1973
  • Formerally BNDD
43
Q

Drug Price Competition and Patent Term Restoration Act

A
  • Also called the Hatch-Waxman Act
  • 1984
  • expedites the availability of less-costly generic drugs
  • permitted the FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective
  • allows brand-name companies to apply for up to 5 additional years of patent protection for the new medicines they’ve developed. (compensates companies for time lost while their products go through the FDA approval process)
  • Established the Oragne Book and bioequivelance of brand and generic drugs
44
Q

clinical pharmacy

A
  • gained strength and popularity in 1970s and 1980s
  • once again expanded Pharmacy’s focus
  • is a movement that urges pharmacists to take on a vital role in the American healthcare system by providing medication expertise to ensure that patients properly and safely use their medications
45
Q

Medicare Prescription Drug and Improvement and Modernization Act

A
  • 2003
  • Federally regulated the clinical pharmacy movement
  • mandated that patients covered by the act receive counseling when they purchase medications
46
Q

pharmacy assistants

A
  • arose during WWII when many pharmacists were called into active duty leaving a shortage at home that was filled by pharmacy assistants
  • filled the gap created by the war shortage and performed many of the duties previously delegated to the pharmacist
  • Military had an official designation of pharmacy assistant position whose primary role was dispensing duties
47
Q

ASHP

A
  • American Society of Health-System Pharmacists
  • Est. 1942
  • Advocated the use of pharmacy technicians (still called assistants at this time)
  • Encouraged the establishment of technician training programs and representation of technicians in state laws and regulations
  • sought to create distinction between tasks to be performed by professional and nonprofessional staff in hospital and community setting
48
Q

pharmacy technicians

A
  • hospital pharmacy and ASHP advocated the use of pharmacy techs (though still called pharmacy assistants 1950s)
  • Increase in Pharmacist duties from clinical pharmacy allowed for technicians to take on duties of dispensing and administration (1970s on)
  • adding to the demand for pharmacy techs is the critical shortage of pharmacists (present day) allowing for one pharmacist to oversee more than one location in some cases.
  • PharmTs work predominately in hospital and community pharmacies to perform every aspect of medication preparation and dispensing
  • qualifications and responsabilities of pharmacy technicians vary widely from state to state.
49
Q

PTCB

A
  • Pharmacy Technician Certification Board
  • Est. 1995
  • Created to advocate a single national standard for pharmacy technician certification
  • administeres the PTCE
50
Q

BLS

A
  • Bureau of Labor and Statistics
51
Q

PTCE

A
  • Pharmacy Technician Certification Examination
  • 1st administered in 1995
  • required by many states to obtain a pharmacy technician liscence through the pharmacy boards
52
Q

ICPT

A
  • Institute for the Certification of Pharmacy Technicians
  • Est. 1989
  • Now a part of NHA
  • in 2005 - established the ExCPT
53
Q

ExCPT

A
  • Exam for Certification of Pharmacy Technicians
  • the only U.S. national certification test for pharmacy technicians
  • recognized by several pharmacy organizations as a valid instrument for measuring technician competency
54
Q

Pharmacy Act

A
  • State legislation (varies from state to state)
  • recognizes pharmacy techs in its rules and regulations
  • provide rules about:
    • pharmacist-to-technician ratios
    • technician registration and liscensure
    • standard training requirements
    • technician certification
    • scope of practice
  • provides disciplinary procedures for technicians
  • specific requirements for technicians-in-training
55
Q

JCPP

A
  • Joint Commission of Pharmacy Practitioners
  • Est. 1977
  • serves as a forum on matters of common interest and concern to national organizations of pharmacy practitioners and invited liaison members
  • facilitates effective representation of pharmacists on professional, educational, legislative and regulatory issues throught analysis, interpretation, communication and exchange of views on relevant issues.
  • 2015 Mission statement importantly included: “Pharmacists will be the healthcare professionals responsible for providing patient care that ensures optimal medication therapy outcomes. To help make this vision a reality, pharmacists will need the support of well-qualified, competent pharmacy technicians to ensure the pharmacists can fulfill their professional role.”
56
Q

ACPE

A
  • Accreditation Council for Pharmacy Education
  • Est. 1932
  • the national agency for the accreditation of professional degree programs in pharmacy and providers of continuing pharmacy education
57
Q

PTAC

A
  • Pharmacy Technician Accreditation Commission
  • Est. 2013
  • a collaboration between the ASHP and the ACPE
  • serves as the accrediting review committee for pharmacy technician education and training programs
58
Q

health-system

A

an institution that promotes, restores or maintains health

59
Q

AHFS

A
  • American Hospital Formulary System
60
Q

electrolytes

A
  • sodium
  • potassium
  • calcium
  • carbonate
61
Q

Vitamin

A

An organic chemical compound is called a vitamin when the organism cannot synthesize the compound in sufficient quantities and must obtain it through the diet

62
Q

ISMP

A
  • Institute for Safe Medical Practices
  • maintains a list confused drug names
63
Q

professions

A
  • emerged at the end of the middle ages when individuals with specialized skills began to develop and provide non-standardized services such as health, education, religion, and welfare
  • means: “to testify on behalf of” or “to stand for” something
64
Q

professionalization

A
  • the separation of pharmacy and medicine practitioners into different guilds was the start of professionalization as we know it.
  • before this, professional was used only to describe monks who professed their faith in God and lived out thier lives in monastaries.
65
Q

Pharmacy as a profession

A
  • historians date the legal recognition and regulation of pharmacy in the West – as an occoupation separate from medicine – to the 13th century.
  • In the U.S. health professions emerged as distinct professions towards the end of the 19th century as a result of the expansion of the American urban society.
66
Q

AACP

A

American Association of Colleges of Pharmacy

67
Q

State Boards of Pharmacy

A

Licensing, registration, pharmacy permits, inspection of pharmacies, sanctions

68
Q

USP

A
  • United States Pharmacopeia
  • provides standards for drugs, drug products, herbal products, and supplements
  • provides guidance on safe preparation of sterile products
69
Q

legend

A

prescription-only

70
Q

Comprehensive Drug Abuse Prevention and Control Act

A
  • 1970
  • Enforced by the BNDD which became the DEA in 1973
  • Established a single system of control for both narcotic and psychotropic drugs
  • Established five sechedules that classify controlled substances according to how dangerous they are, their potential for abuse and addiction, and whether or not they posess legitimate medical value
71
Q

PPPA

A
  • Poison Prevention Packaging Act
  • 1970
  • Established child-resistant containers
72
Q

OSHA

A
  • Occupational Safety and Health Administration
  • 1971
  • Oversees worker safety for use of chemicals and pharmaceuticals
  • Establishes guidelines for blood-borne and airborne pathogens
  • Approves MSDS (Material Safety Data Sheet)
73
Q

Drug Listing Act

A
  • 1972
  • Established the NDC (National Drug Code)
  • Established the assignment of the NDC numbers for reporting to the FDA
74
Q

NDC

A
  • National Drug Code
75
Q

WHO

A
  • World Health Organization
  • Is the international standard setting organization
  • Established the ATC system in 1976
76
Q

Omnibus Budget Reconciliation Act

A
  • 1990
  • Required pharmacists to councel Medicare recipients to be eligible for payment
77
Q

Dietary Supplement Health and Education Act

A
  • 1994
  • Established that manufacturers of dietary supplements don’t have to prove efficacy or standardization to the FDA
78
Q

HIPAA

A
  • Health Insurance Portability and Accountability Act
  • 1996
  • Required confidentiality of patient records
79
Q

Medicare Modernization Act

A
  • 2003
  • Created Medicare Part D which provides prescription drug coverage to eligible Medicare recipients
80
Q

CMEA

A
  • Combat Methamphetamine Epidemic Act
  • 2005
  • Restricts the placement and sales of products that contain the chemical pseudoephedrine (PSE)
  • PSE is still OTC, but kept behind the pharmacy counter and a logbook is kept of all sales
  • allows for 3.6 grams of PSE per day and 9.0 grams per month
81
Q

Schedule I Drugs

A

drugs which have:

  • high potential for abuse
  • have no currently accepted medical use
    • LSD
    • Heroin
    • methamphetamine
82
Q

Schedule II Drugs

A

Drugs which have:

  • highest potential for abuse
  • abuse may lead to severe psychological or physical dependence
    • morphine
    • oxycodone
    • methadone
83
Q

Schedlue III Drugs

A

Drugs which have:

  • less potential for abuse than Schedule I or II
  • abuse may lead to moderate or low physical depencence or high psychological dependence
    • anabolic steroids
    • codeine and hydrocodone with ASA or APAP
    • certain barbiturates
84
Q

Schedule IV Drugs

A

Drugs which have:

  • low potential of abuse relative to Schedule I, II, or III drugs.
  • abuse may lead to limited physical or psychological dependence
    • Valium
    • Xanax
85
Q

Schedule V Drugs

A

Drugs which have:

  • low potential for abuse relative to Schedule I - IV
  • abuse may lead to limited physical or psychological dependence
    • cough medicines with codeine
86
Q

Class I Drugs

A
  • Another name for Schedule I Drugs
  • Include:
    • Heroin (diacetylmorphine)
    • LSD (Lysergic acid diethylamide)
    • Marijuana (cannabis, THC)
    • Mescaline (Peyote)
    • GHB (gamma-hydroxybutyric acid)
    • Ecstasy (MDMA or 3,4- Methylenedioxymethamphetamine)
    • Psilocybin (“mushrooms,””shrooms”)
    • Methaqualone (Quaalude)
    • Khat (Cathinone)
    • Bath Salts (3,4-methylenedioxypyrovalerone or MDPV)
87
Q

Class II Drugs

A
  • Another name for Schedule II Drugs
  • Include
    • Stimulants
      • Cocaine
      • Methylphenidate (Ritalin®, Concerta®)
      • Methamphetamine or Desoxyephedrine (Desoxyn®)
      • Lisdexamfetamine (Vyvanse®)
      • Dextroamphetamine (Dexedrine®)
      • Amphetamine salts (Adderall®)
    • Opiates
      • Morphine
      • Oxycodone (Percodan®, OxyContin®)
      • Heroin
      • Methadone
      • Hydromorphone (Dilaudid®)
      • Hydrocodone
      • Fentanyl (Sublimaze®, Actiq®, Duragesic®)
      • Codeine
    • Depressants
      • Amobarbital
      • Glutethimide
      • Pentobarbital
      • Phencyclidine
      • Secobarbital
88
Q

Class III Drugs

A
  • Another name for Schedule III Drugs
  • Include
    • Anabolic Steroids
      • Testosterone
      • Methyltestosterone
      • Nandrolone (Durabolin®)
      • Oxandrolone
    • Codeine and acetaminophen preparations (Tylenol #2,#3,#4)
    • Stimulants
      • Phendimetrazine
      • Benzphetamine
89
Q

Class IV Drugs

A
  • Another name for Schedule IV Drugs
  • Includes
    • Phentermine
    • Alprazolam (Xanax®)
    • Zolpidem (Ambien®)
    • Lorazepam
    • Suvorexant (Belsomra®)
    • Lorcaserin (Belviq®)
    • Tramadol (Ultram®)
    • Propoxyphene (Darvon®)
    • Diazepam (Valium®)
    • Triazolam (Halcion®)
    • Clonazepam
    • Phenobarbital
    • Pentazocine
    • Diethylpropion
90
Q

Class V Drugs

A
  • Another name for Schedule V Drugs
  • Includes
    • Many codeine-containing cough/decongestant/ antihistamine
      liquids
    • Diphenoxylate/atropine (Lomotil®)
    • Pregabalin (Lyrica®)
    • Lacosamide (Vimpat®)
      *
91
Q

DEA form 222

A
  • must be used whenever Schedule I or II drugs are bought, sold or transferred between pharmacies or qualified distributors
  • forms are only available through the DEA
  • errors are NOT acceptable on the form
  • incase of an error, the form must be voided and kept on file and a new form used
  • this form is not necessary for schedule III - IV
92
Q

Scheduled Drug Refills

A
  • more restrictive than other prescription drugs
  • Schedule II – NO refills allowed & cannot be called in or submitted electronically unless an absolute emergency or certain criteria are met
93
Q

DEA Registration Number

A
  • assigned by the DEA to a healthcare provider allowing them to write prescriptions for controlled substances
  • Provider’s DEA number must be present on the prescription
  • Legally, this number is used solely for tracking controlled substances
  • is also often used by the Industry as a general prescriber number
94
Q

General Prescriber Number

A
  • Unique identifier for anyone who can prescribe medication
  • Pharmacy Industry often uses the DEA number as this identifier
95
Q

Valid DEA general prescriber number

A

Consists of the following:

  • two letters, six numbers, and one check digit (e.g., AP4756687)
    • First letter is a code identifying the type of registrant (Physician, Dentist, etc.)
    • Second letter is the first letter of the registrants last name
    • Seventh digit is a checksum and is cacculated as follows:
      • add together the first, third and fifth digits
      • add together the second, fourth, and sixth digits and multiply the sum by 2
      • add CALC1,3,5 + (CALC2,4,6) x 2 and call this CHECK
      • the rightmost digit of CHECK (the digit in the ones place) is compared against the checksum digit in the DEA number (digit 7). If they match, then it is a valid DEA number.
96
Q

IUPAC

A

International Union of Pure and Applied Chemistry

97
Q

USAN

A
  • United States Adopted Names Council
  • officially recognized group for selecting nonproprietary names
  • works in conjunction with WHO’s INN and other national nomenclature groups to standardize drug names
98
Q

INN

A
  • World Health Organization’s International Nonproprietary Name Committee
  • Est. 1953
99
Q

stem

A

As related to pharmaceutical nomenclature:

  • Is a standardized syllable that relates to an existing drug family.
  • Stems may be prefixes, suffixes, or syllables within
    the nonproprietary name (infixes).
  • The USAN updates and provides a list of recommended stems that identify important chemical and/or pharmacologic properties.
100
Q

USPTO

A

United States Patent and Trademark Office

101
Q

IMS Health

A
  • Is a company that provides information, services, and technology for the healthcare industry
  • Publishes the Top 200 drugs list based on the previous years total prescriptions by volume dispensed
102
Q

ACE

A

angiotensin-converting-enzyme

103
Q

GERD

A

gastroesophageal reflux disease

104
Q

NSAID

A

nonsteroidal anti-inflammatory drug

105
Q

A2RB

A

angiotensin II receptor antagonist

106
Q

TRT

A

testosterone replacement therapy

107
Q

BPH

A

benign prostatic hyperplasia

(enlarged prostate)