Terms and Facts Flashcards
(107 cards)
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
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.
*
26
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
27
BSc Degree in Pharmacy
* 1932 - 4-year degree that became the standard for liscencure
* 1962 - became a 5-year degree
28
PharmDs
* 1990 - liscenure program became a 7-year doctorate program
* Graduates are Doctors of Pharmacy or PharmDs
29
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
30
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
31
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
32
OTC
* Over-the-Counter
33
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
34
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
35
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
36
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
37
IND
* Investigational New Drug Application
38
NDA
* New Drug Application
39
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
40
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
41
BNDD
* Bureau of Narcotics and Dangerous Drugs
* Est. 1970
* Became the DEA
42
DEA
* Drug Enforcement Agency
* Est. 1973
* Formerally BNDD
43
Drug Price Competition and Patent Term Restoration Act
* 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
clinical pharmacy
* 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
Medicare Prescription Drug and Improvement and Modernization Act
* 2003
* Federally regulated the clinical pharmacy movement
* mandated that patients covered by the act receive counseling when they purchase medications
46
pharmacy assistants
* 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
ASHP
* 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
pharmacy technicians
* 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
PTCB
* Pharmacy Technician Certification Board
* Est. 1995
* Created to advocate a single national standard for pharmacy technician certification
* administeres the PTCE
50
BLS
* Bureau of Labor and Statistics
51
PTCE
* Pharmacy Technician Certification Examination
* 1st administered in 1995
* required by many states to obtain a pharmacy technician liscence through the pharmacy boards
52
ICPT
* Institute for the Certification of Pharmacy Technicians
* Est. 1989
* Now a part of NHA
* in 2005 - established the ExCPT
53
ExCPT
* 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
Pharmacy Act
* 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
JCPP
* 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
ACPE
* 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
PTAC
* 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
health-system
an institution that promotes, restores or maintains health
59
AHFS
* American Hospital Formulary System
60
electrolytes
* sodium
* potassium
* calcium
* carbonate
61
Vitamin
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
ISMP
* Institute for Safe Medical Practices
* maintains a list confused drug names
63
professions
* 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
professionalization
* 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
Pharmacy as a profession
* 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
AACP
American Association of Colleges of Pharmacy
67
State Boards of Pharmacy
Licensing, registration, pharmacy permits, inspection of pharmacies, sanctions
68
USP
* United States Pharmacopeia
* provides standards for drugs, drug products, herbal products, and supplements
* provides guidance on safe preparation of sterile products
69
legend
prescription-only
70
Comprehensive Drug Abuse Prevention and Control Act
* 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
PPPA
* Poison Prevention Packaging Act
* 1970
* Established child-resistant containers
72
OSHA
* 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
Drug Listing Act
* 1972
* Established the NDC (National Drug Code)
* Established the assignment of the NDC numbers for reporting to the FDA
74
NDC
* National Drug Code
75
WHO
* World Health Organization
* Is the international standard setting organization
* Established the ATC system in 1976
76
Omnibus Budget Reconciliation Act
* 1990
* Required pharmacists to councel Medicare recipients to be eligible for payment
77
Dietary Supplement Health and Education Act
* 1994
* Established that manufacturers of dietary supplements don't have to prove efficacy or standardization to the FDA
78
HIPAA
* Health Insurance Portability and Accountability Act
* 1996
* Required confidentiality of patient records
79
Medicare Modernization Act
* 2003
* Created Medicare Part D which provides prescription drug coverage to eligible Medicare recipients
80
CMEA
* 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
Schedule I Drugs
drugs which have:
* high potential for abuse
* have no currently accepted medical use
* LSD
* Heroin
* methamphetamine
82
Schedule II Drugs
Drugs which have:
* highest potential for abuse
* abuse may lead to severe psychological or physical dependence
* morphine
* oxycodone
* methadone
83
Schedlue III Drugs
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
Schedule IV Drugs
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
Schedule V Drugs
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
Class I Drugs
* 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
Class II Drugs
* 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
Class III Drugs
* 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
Class IV Drugs
* 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
Class V Drugs
* Another name for Schedule V Drugs
* Includes
* Many codeine-containing cough/decongestant/ antihistamine
liquids
* Diphenoxylate/atropine (Lomotil®)
* Pregabalin (Lyrica®)
* Lacosamide (Vimpat®)
*
91
DEA form 222
* 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
Scheduled Drug Refills
* 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
DEA Registration Number
* 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
General Prescriber Number
* Unique identifier for anyone who can prescribe medication
* Pharmacy Industry often uses the DEA number as this identifier
95
Valid DEA general prescriber number
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
IUPAC
International Union of Pure and Applied Chemistry
97
USAN
* 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
INN
* World Health Organization's International Nonproprietary Name Committee
* Est. 1953
99
stem
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
USPTO
United States Patent and Trademark Office
101
IMS Health
* 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
ACE
angiotensin-converting-enzyme
103
GERD
gastroesophageal reflux disease
104
NSAID
nonsteroidal anti-inflammatory drug
105
A2RB
angiotensin II receptor antagonist
106
TRT
testosterone replacement therapy
107
BPH
benign prostatic hyperplasia
| (enlarged prostate)
