HOSA Pharmacology

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FDA (food and drug administration)

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Tags and Description

Pharmacology provides HOSA members with the opportunity to gain knowledge and skills regarding the area of healthcare concerned with uses, effects, and modes of actions of drugs.

151 Terms

1

FDA (food and drug administration)

-approve new drugs to be sold in the US -process New Drug Applications (NDA) -regulate package inserts -regulate drug advertising -issue recalls -federal agency

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2

DEA (Drug Enforcement Agency)

-federal agency -enforce the CSA ( controlled substances act) -track controlled substances manufactured and sold -investigates all violations involving controlled substances -set the DEA Sch. Definitions -issue DEA numbers

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3

BOP (Board of Pharmacy) (each state)

-regulate licensing of pharmacists -regulate licensing of pharmacy technicians -set state laws/ requirements -outline the operating guidelines in the pharmacy -investigate violations of the operating guidelines -determine state regulated controlled substances -state agency

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4

Joint Commission on Accreditation of Healthcare Organizations

-watches over healthcare organizations -third party auditors/ regulators for insurance providers

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5

DEA Schedule I

-no accepted medical use -extremely high potential for abuse -high potential for psychological and physical dependency -ex. weed, heroin, mdma

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6

DEA Schedule II

-does have medical use -high potential for abuse -relative potential for psychological and physical dependency -ex. oxycodone, codeine, retalin -no refillls allowed -cannot be "called in" or transmitted electronically unless it is an absolute emergency

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7

DEA Schedule III

-does have medical use -moderate abuse potential exits -ex. vicodin and tylenol w/ codeine

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8

DEA Schedule IV

-abuse potential exists -ex. ambien, darvocet, lorazepam

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9

DEA Schedule V

-lowest abuse potential -ex. cough medicine w/ codeine or anti-diarrheas

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10

DEA Form 222

-must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors

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11

DEA number verification

-add the 1st, 3rd, and 5th digits -add the 2nd, 4th, and 6th digits. double it -add the two totals together. the second digit is the check digit -preceded by two letters: first letter represents the type of practice or institution the DEA number is issued to, the second letter represents the first letter of the practitioner's last name

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12

sig

-tells pharm techs how to dispense it -also printed on the prescription it is dispensed in but translated into regular words for the patient

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13

Expiration dates: DEA Sch II

no expiration

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14

Expiration dates: DEA Sch III thru V

6 months

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15

Expiration dates: Legend Drugs

12 months

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16

Refills: DEA Schedule II

no refills allowed

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17

Refills: DEA Schedule III thru V

-up to 5, but only 5 times -if a patient can only afford 50 at a time then they will only get 250 total

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18

Refills: Legend Drugs

up to 12 months worth

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19

DEA Controlled Drug Prescriptions must contain at least:

-date of prescription issue -patient's name and address -practitioner's name, address, and phone number -drug name -drug strength -dosage form and instructions -exact quantity prescribed -complete directions for use -number of refills authorized -a valid DEA number

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20

Schedule II drug prescription:

-must be manually signed by the practitioner. no exceptions -may not be faxed or called in, except for a valid emergency -may not have any refills

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21

FDA Recall Class I

would be used in a case where there is a probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

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22

FDA Recall Class II

would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequence is remote

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23

FDA Recall Class III

may be used in a situation in which use of a violative product is not likely to cause adverse health consequence, but has violated some FDA regulation

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24

FDA Market Withdrawal

appropriate when a product has a minor violation that would be not subject to FDA legal action. the manufacture must remove the product from distribution markets or correct the violation. "a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal"

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25

FDA Medical Device Safety Alert

used only for medical apparatus equipment. this is when a medical device may present an unreasonable risk of substantial harm. in some cases, these situation also are considered recalls.

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26

NDA Process: Initial Development: Pre Clinical

pre-clinical (animal) testing

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27

NDA Process: Initial Development: Investigational New Drug Review (IND)

-review of pre-clinical trial results -determination of safety to use on humans -authorization to ship across state lines

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28

NDA Process: New Drug Clinical Trials: Phase I

-involves 25-100 volunteers -safety tolerated dosage determined -identification of major side effects -emphasis on safety and maximum tolerated dosages

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29

NDA Process: New Drug Clinical Trials: Phase II

-involves 100-300 volunteers -emphasis on the drug effect against what it's designed to treat -effets compared with similar patients receiving different treatments

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30

NDA Process: New Drug Clinical Trials: Phase III

-involves 300-3000 volunteers -emphasis on the drugs overall effect -effects compared with patients taking placebos -study of different population and different dosages -testing the drug in combination with other drugs -final phase before presenting to FDA for approval

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31

NDA Process: New Drug Post Approval Trials: Phase IV

-ongoing/post approval trials -health-care professionals to report any adverse findings -lasts eternally, as long as the drug is on the market

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32

NDA Process Time

-can usually take 12-15 years -patent only last 20 years from the time the application for patent was filled

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33

Federal Food and Drug Act of 1906

-known as the Pure Food and Drug Act -provided authority for federal inspection of meat products and prohibited the sale of adulterated foods -required that "secret elixirs" containing ingredients like: cocaine, heroin, morphine and alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages -replaced by the Federal Food, Drug and Cosmetic Act of 1938

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34

Narcotic Tax Act of 1914

-known as the Harrison Narcotic Act -provided authority for the IRS to collect taxes on Opiates thru tax stamps -required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS -emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction

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35

Federal Food, Drug and Cosmetic Act of 1938

-known as FDCA 1938 -replaced the Food and Drug act of 1906 -provided better clarification about misbranding definitions -provided better clarification about adulteration definitions -gave the FDA authority to require adequate testing of new drugs for safety

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36

The Durham-Humphrey Amendment of 1951

-created a distinction between "OTC" and "Legend Drugs" -required legend drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription." -emphasis on this act was to insure safety through qualified medical supervision

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37

The Kefauver-Harris Amendment of 1962

-known as the "Drug Efficacy Amendment" -required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval -required drug advertising to be more closely regulated and disclose accurate information about side effects

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38

The Bureau of Narcotics and Dangerous Drugs (BNDD)

-predecessor agency of the DEA -BNDD merged into the DEA in 1973

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39

Drug Abuse Prevention/ Control Act of 1970

-known as the CSA -completely replaced the Harrison Act -required the use of DEA numbers -required comprehensive record keeping and transaction tracking -enforced the DEA under the US Dept of Justice

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40

Poison Prevention Packaging Act of 1970

-also known as the PPPA -designed to reduce the risk of children ingesting dangerous substances -required locking caps on most prescription

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41

Combat Methamphetamine Epidemic Act (2005)

-enacted to regulate the OTC sales of pseudoephedrine -identity and address of each purchaser to be kept for two years -daily sales of regulated products not exceed 3.6 grams -30 day purchase limit not to exceed 9 grams -30 day purchase via mail order not to exceed 7.5 grams

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42

National Drug Code (NDC)

-used to identify legend drugs -part of the drug listing act of 1972

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43

NDC: ####-xxxx-xx

-identifies the drug's manufacturer -number is unique to the maker or re-packager of the product

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44

NDC: xxxx-####-xx

-identifies the product -number unique to the formulation and strength of the product

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45

NDC: xxxx-xxxx-##

-identifies the packaging -unique to the size and quantity of the product

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46

q

every

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47

qH

every hours

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48

qAM

every morning

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49

qPM

every evening

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50

qHS

every bedtime

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51

qD

every day

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52

qOD

every other day

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53

qWK

every week

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54

qMO

every month

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55

q__*

every __ hours

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56

q__H

every __ hours

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57

BID

twice a day

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58

TID

three a day

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59

QID

four a day

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60

X__D

times __ days

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61

TDS

3 times a day

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62

C

with

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63

AC

before a meal

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64

PC

after a meal

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65

HS

at bedtime

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66

PRN

as needed

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67

UD

as directed

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68

AA

of each

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69

QS

quantity sufficient

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70

GTT

drop

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71

OD

right eye

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72

OS

left eye

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73

OU

both eyes

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74

AD

right ear

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75

AS

left ear

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76

AU

both ears

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77

PO

by mouth/oral

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78

SL

sub-lingual

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79

NG

naso gastic

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80

BUCCAL

cheek/gum

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81

PR

rectally

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82

PV

vaginally

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83

SUPP

suppositiory

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84

TAB

tablet

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85

CAP

capsule

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86

IM

intramuscular

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87

SQ

sub-cutaneous

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88

IV

intravenous

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89

IC

intra cardiac

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90

INJ

injection

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91

STAT

immediately

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92

Dosage Form: Enteral Medication

-given orally and pass through the GI tract to be absorbed into the bloodstream and metabolized by the liver -includes oral, naso-gastric, and rectal routes

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93

Dosage Form: Parenteral medication

-injected or placed into the body tissues and do not pass through the liver before entering the bloodstream -can include injections, topical and inhalation reoutes -generally refers to injection

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94

Dosage From: Injectable Drugs

-usually in the form of solution or powders -mixed with a sterile diluent to render an injectable solution

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95

Topical

-applied to the skin surface or a mucous membrane

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96

Tablets

-to form a tablet, the drug is combined with fillers and is them compressed into a hard pellet -available in fast acting, slow released, control released, enteric coated, film coated, sublingual, chewable and other formulations -sublingual tablets are placed under the tongue, wafers are placed on the tongue and buccal tablets are placed between the cheek and gum

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97

Capsules

-to form a capsule, the drug is contained in a cylindrically shaped shell

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98

Caplet

-an oval shaped tablet

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99

Oral Suspension

-drug is mixed with, but not completely dissolved into a liquid -needs to be shaken before administration in order to suspend the drug particles evenly

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100

Syrups

-contain a high concentration of sucrose or sugar to sweeten, for ease of use

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