Exam 2 Flashcards

1
Q

The origin of pharmacy lie in ______.

A

Babylon

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2
Q

Around 2600 B.C., Roman drug dealers were found in ____ & the RPh, MD, & Priest were all the ____.

A
  • Kiosks
  • Same Person
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3
Q

Around 2000 B.C., a _____ pharmacist worked with ginseng & ephedrine.

A

Chinese

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4
Q

In early Egypt, the chief pharmacist would practice out of a _____, overseeing other pharamcists.

A

“House of Life”

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5
Q

Theophrastus is known as the ______ & discovered _______.

A
  • “Father of Botany”
  • Anti-Cholinergics
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6
Q

The oldest record of medications that originated in Egypt.

A

Ebers Papyrus

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7
Q

______ scientists would use human subjects to discover antidotes to poisons.

A

Roman

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8
Q

Terra Sigillata

A
  • Means “sealed Earth”
  • Around 500 B.C., pharmacists would roll out holy soil & put them in capsules in the Mediterranean.
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9
Q

1st Trademark of Drugs

A

In the mediterranean around 500 B.C. (Terra Sigillata)

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10
Q

Galen

A

Known as the “Father of Compounding” & he created Cold Creams (130-200 A.D.)

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11
Q

The first apothecary was located in _____, around 792 A.D.

A

Baghdad

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12
Q

In Florence, Italy, the 1st official _____ was established by a guild of grocers & pharmacists that came together to establish standards when they found quality issues in drugs.

A

Pharmacopeia

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13
Q

Susan Hayhurst

A

Considered to be the 1st woman pharmacist in 1729 Philadelphia

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14
Q

Ben Franklin

A

Established the 1st hospital pharmacy

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15
Q

Jonathan Roberts

A

Considered the 1st hospital pharmacist

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16
Q

John Morgan

A

Championed prescription writing by separating the duties of MDs & RPhs

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17
Q

Apothecary

A

Care setting mostly centered around drug dispensing & counseling

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18
Q

Andrew Cragle

A

Considered the 1st Apothecary General

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19
Q

A Swedish Parmacist discovered the drug _____.

A

Morphine

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20
Q

Taxol

A

Originated from the extract of a Peruvian tree & was used in early pharmacy to treat Breast Cancer.

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21
Q

In ____, conflicts between RPhs & MDs resulted in the formation of the 1st College of Pharmacy with standardized training.

A

1821

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22
Q

In 1821, Philadelphia College of Pharmacy (PCP) became the ________, as a result of the push for standardized training.

A

1st College of Pharmacy

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23
Q

Organization intially founded to improve communication between MDs & RPhs.

A

APhA

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24
Q

William Proctor Jr

A

Considered to be the “Father of American Pharmacy”

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25
Q

In 1820, this organization created the Gold Standard for quality after its creation by Dr. Squibb, Dr. Remingtn, & Dr. Rice.

A

USP (U.S. Pharmacopeia)

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26
Q

Dr. Squibb, one of the creators of the USP, also created the 1st drug company _______.

A

Bristol Mayers-Squibb

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27
Q

Types of Pharmacists in 19th Century U.S.

A
  • Dispensing Physician
  • Apothecary Shop
  • General Store
  • Wholesale Druggist
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28
Q

1st state to issue licensing for pharmacists

A

South Carolina

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29
Q

In which year did schools swithc to a PharmD program for pharmacy education? (USC was the 1st to offer it)

A

1992

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30
Q

APhA

A

American Pharmacists Association

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31
Q

APhA is the ______ & ______ organization, founded in 1852.

A
  • Oldest
  • Largest
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32
Q

APhA represents ____ pharmacists & has a strong focus on ____.

A
  • All
  • MTM
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33
Q

NCPA

A

National Community Pharmacists Association

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34
Q

NCPA is the voice of _____ & provides guidance for pharmacy purchasing, founded in 1898.

A

Independent Community Pharmacists

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35
Q

Pharmacy Today

A

Published by APhA

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36
Q

America’s Pharmacist

A

Published by NCPA

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37
Q

ASHP

A

American Society of Health-System Pharmacists

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38
Q

ASHP accredits _____ & represents hospital RPhs, founded in 1942.

A

Residency Programs

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39
Q

NPhA

A

National Pharmaceutical Association

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40
Q

NPhA is dedicated to representing the ideas & views of _______ RPhs & RPh students, founded in 1947.

A

Minority

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41
Q

AAPS

A

American Association of Pharmaceutical Scientists

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42
Q

AAPS is the premier organization of all scientists dedicated to the ______, _______, & ________ of drugs.

A
  • Discovery
  • Development
  • Manufacture
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43
Q

Members of the Pharmaceutical Sciences Department (PhDs) are most like to be members of which organization?

A

AAPS

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44
Q

ACCP

A

American College of Clinical Pharmacy

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45
Q

The ______ publication is made by the ACCP & has high impact factor, founded in 1979.

A

Pharmacotherapy

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46
Q

Members of the Pharmacy Practice Department (PharmDs) are most likely members of which organization?

A

ACCP

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47
Q

Members of innovative, pallative care clinics & clinical residences are most likely members of which organization?

A

ACCP

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48
Q

ACPE

A

Accreditation Council for Pharmacy Education

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49
Q

The ACPE accredits ______ & ________.

A
  • CE programs
  • Graduate degree programs
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50
Q

The organization that establishes standards for accreditation & whose Board Directors consist of members of the AACP, APhA, & NABP is ______.

A

ACPE

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51
Q

AMCP

A

Academy of Managed Care Pharmacy

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52
Q

The organization that promotes health outcomes & economics, founded in 1988 is ______.

A

AMCP

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53
Q

Pharmacists working at HMOs & PBMs are most likely members of which organization?

A

AMCP

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54
Q

A goal of the AMCP is to improve ______ _______ & _____ _____ ______.

A
  • Patient Outcomes
  • Health Care Affordability
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55
Q

________ are most likely members of the AACP, colleges & schools accredited by the ACPE are also members of the AACP.

A

All Pharmacy School Faculty

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56
Q

AACP

A

American Association of Colleges of Pharmacy

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57
Q

The ____ publishes the American Journal of Pharmaceutical Education & was founded in 1900.

A

AACP

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58
Q

ISPOR

A

International Society for Pharmacoeconomics & Outcomes Research

  • Strictly for outcomes
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59
Q

_____ is similar to the AMCP & is strictly focused on outcomes, as well as collects data on heath economics

A

ISPOR

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60
Q

Organizations with focus on outcomes include _____ & ______.

A
  • ISPOR
  • AMCP
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61
Q

ASCP

A

American Society of Consultant Pharmacists

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62
Q

Pharmacists that work with medicare-type patients, geriatrics, are most likely members of _____.

A

ASCP

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63
Q

NACDS

A

National Association of Chain Drug Stores

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64
Q

Retail pharmacists are most likely members of _____.

A

NACDS

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65
Q

BPS

A

Board of Pharmacy Specialties

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66
Q

The BPS certifies ___ specialty practice areas.

A

8

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67
Q

The 8 recognized _____ _______ recruit pharmacists that have been certified by the BPS

A

Specialty Councils

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68
Q

TPA

A

Tennessee Pharmacists Association

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69
Q

The ____ represents all pharmacists within TN & so is considered an umbrella organization.

A

TPA

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70
Q

NABP

A

National Association of Boards of Pharmacy

71
Q

The NABP administers the _____ & ______ & allows scores to be tranferable between states.

A
  • NAPLEX
  • MPJE
72
Q

______ makes practice exams for licensure exams & designs questions.

A

NABP

73
Q

CDER

A

Center for Drug Evaluation & Research

74
Q

CDER evaluates the ____ & ____ of prescription & OTC drugs.

A
  • Safety
  • Eficacy
75
Q

Most drugs originate from the ____

A

CDER

76
Q

Drug

A

A substance used to alter the function of the body

77
Q

With the 1912 FDA act, accurate labeling became a requirement because the government held the __________, since it was their responsibility to expose fraud on the part of the seller.

A

“burden of proof”

78
Q

In 1937, _______ was marketed after only being tested for taste & fragrance, leading to the death of several children & poisoning of hundreds. At the same time another product in the market was causing blindess.

A

Elixir of Sulfonamide

79
Q

As a result of the 1938 FDA act, manufacturers had to provide data based on ____ ____ to show their products were safe before marketed.

A

Scientific experiments

80
Q

In 1951, the Durham-Humphrey Amendment defined that _____ _____ could only be given to patients under the care of physicians. Today more providers are able to prescribe.

A

Prescription Drugs

81
Q

In 1991, Dr. Wickizer participated in an FDA program to increase the amount of volunteers for clinical trials & physican access to clinical research for AIDS patients throught the ____ _____ _____ ____ ____ ____.

A

Compassionate use of Investigational New Drugs (IND)

82
Q

In 1997, the FDA Modernization Act allowed the acceleration of drug approval by allowing physicians to prescribe INDs before Phase 3 approval, if they were ____ _____.

A

Critically needed.

83
Q

The ___ was established in 1973, after a 1970 Act which classified controlled drugs into 5 categories.

A

DEA

84
Q

The ___ does not regulate controls.

A

FDA

85
Q

Which class of controlled substances are used in clinical research?

A

CI

86
Q

Which class of controlled substances are in the market & have the highest potential for abuse?

A

CII

87
Q

Which class acronym is used to describe a subset of CIII drugs that are non-narcotic?

A

IIIN

88
Q

Which class of controlled substances have the lowest potential for abuse?

A

CV

89
Q

Which pregnancy drug category shows no fetal risk or harm?

A

A

90
Q

Which pregnancy drug category shows fetal human risk, but its benefits may outweigh the risks?

A

D

91
Q

Which pregnancy drug category is contradicted in pregnancy (benefits do not outweigh the risks)?

A

X

92
Q

PhRMA seeks advice from the FDA prior to submission of an IND application & the application must be reviewed by the FDA & a local IRB before beginning _____.

A

Clinical trials

93
Q

IRB

A

Institutional Review Board

94
Q

The local ___ approves the clinical trial protocols, pharmacists should consider applying for IRBS.

A

IRB

95
Q

Which phase of clinical trials conducted on 20-80 healthy volunteers to determine side effects, metabolism, & excretion with focus on safety.

A

Phase 1 (Safety)

96
Q

Which phase of clinical trials conducted on about 300 people, if there are no unacceptable toxicities found in the previous phase, which focus of effectiveness.

A

Phase 2 (Safety & Efficacy)

97
Q

Which phase of clinical trials includes a Double Blind Study, in which randomized patients receive either the drug or a placebo?

A

Phase 2 (Safety & Efficacy)

98
Q

Which phase of clinical trials are the manufacturers in negotiation with the FDA about how large the trials of the next phase shoulde be?

A

Phase 2 (Safety & Efficacy)

99
Q

Which phase of clinical trials numbers in several hundreds to about 3000 volunteers?

A

Phase 3 (Safety & Efficacy, varying pops, doses, & other drugs)

100
Q

The NDA should be formally filed with the FDA after Which phase of clinical trials, with all human & animal data regarding the drug & manufacturing pans.

A

Phase 3

101
Q

The PDUFA act states that the CDER will review 90% of new drug applications (NDAs) within 10 months after the application is received, & the FDA has ______ to decide if the NDA will even be reviewed before then.

A

60 days.

102
Q

Which phase of clinical trials does the FDA inspect manufacturing facilities to ensure they meet GMP (Good manufacturing Practice Standards)?

A

Phase 4 (Post-Market Surveillance)

103
Q

Which phase of clinical trials are studies conducted after approval by FDA, after the FDA has approved the product for marketing?

A

Phase 4

104
Q

Pharmacists are key components of Phase 4 post-marketing surveillance & the ____ program.

A

Med-Watch

105
Q

Controlled substances are governed by the

A

DEA

106
Q

Sponsor is synonymous with _____, in respect to drug development.

A

Manufacturer

107
Q

There are no safe drugs, not even FDA approved ones, always weigh the ______

A

Risks/benefits

108
Q

The FDA does not regulate controlled drugs, nor _____

A

Prices

109
Q

In the 1950s the ____ analysis of drugs began to be used

A

Chemical

110
Q

In the 1980s there was a push to look into ____, leading to synthetic insulin production.

A

Bio-technology

111
Q

In 1994, _____ was passed because of the production with regulating supplements.

A

DSHEA

112
Q

DSHEA

A

Dietary Supplement & Health Education Act

113
Q

In 2009, arguments arose over _____ regulations & an unintended consequence was that the FDA became able to regulate supplements better

A

Tobacco

114
Q

Drugs, Food, & Supplements (which can’t be approved for safety/efficacy)

A

FDA’s categories for human consumption

115
Q

Theraputic Orphans

A

Refers to drgus indicated for children, 5-10% of pharmaceutical sales are for children, 25% of approved drgus used on children

116
Q

BPCA

A

Best Pharmaceuticals for Children Act

117
Q

____ was created to provide incentives to sponsors to conduct FDA-requested pediatric studies by granting an additional 6 months of marketing exclusivity

A

BPCA

118
Q

PREA

A

Pediatric Research Equity Act

119
Q

____ requires drug companies to study their products in children if they will be used in children, they must be conducted with the same drug & for the same use for whih they were approved in adults.

A

PREA

120
Q

HMOs, PPOs, IPAs, & EPOs are types of ____

A

MCOs

121
Q

IPAs

A

Most common type of MCo & have an open system

122
Q

HMOs

A

Type of MCO with a closed system

123
Q

PPOs

A

Type of MCo with in-network & out-of-network providers & offer higher coverages if in-network providers are used

124
Q

___ refers to the “sticker price”, used to inflate reimbursement.

A

AWP (Avergae Wholesale Price)

125
Q

___ refers to the max that PBMs will pay pharmacies

A

MAC (Max Allowable Cost)

126
Q

Key PBM Activities

A
  • Benefit design
  • Claims processing
  • Formulary management
  • Rebate contracting
  • Drug utilization review
  • Rx network contracting
127
Q

____ refers to a therapeutic interchange where pharmacists are prompted when it is beneficial for patients to switch to generic drugs.

A

TIP

128
Q

MTM

A

Distinctive service that optimizes therapeutic outcomes & are independent of a medication

129
Q

ADE

A

Adverse Drug Events

130
Q

MTM is beneficial because it:

A
  • Saves money
  • Reduces ADEs
  • Increases patient adherence
131
Q

Obra90

A

Made it mandatory for pharmacists to counsel patients

132
Q

MTM affects and is beneficial to ___ pharmacy practice areas and patients

A

All

133
Q

Patients most likely to benefit from MTM include those in ___ and that have multiple doctors

A

Transition

134
Q

___ refers to the fact-finding, face-to face type of MTM where all medications are assessed to identify adherence level, interactions, side effects, etc. (Crestor taken QHS for example)

A

MTR (Medication Therapy Review)

135
Q

MTR

A

MTR (Medication Therapy Review)

136
Q

___ refers to a type of MTM in which you obtain a Comprehensive Record from the patient, and is maintained between the RPh, Provider, and Patient

A

PMR

137
Q

PMR

A

Personal Medication Review

138
Q

___ can be Targeted (concerning specific drugs) or Comprehensive (evaluating everything and taking longer)

A

PMRs

139
Q

___ refers to a type of MTM in which a Course of Action is planned between thepatient and the pharmacist, including breaking down large goals into smaller ones and motivation

A

MAP

140
Q

MAP

A

(Medication-related Action Plan)

141
Q

The best way to ensure reimbursement for MTM services is to ___ everything, to prove it is making a difference

A

Document

142
Q

CMR

A

Comprehensive Med Review

143
Q

The term used by insurance providers to show coverage for MTM services is ___

A

CMR

144
Q

Which type of PMR is reimbursed by insurance providers at about $100/hour and makes the most significant impacts?

A

Comprehensive

145
Q

SOAP is an acronym used to describe the aspects of ___, Subjective, Objective, Assessment and Plan

A

MTM

146
Q

A SOAP component, referring to patient reported information, chief complaints, med history, and family history

A

Subjective

147
Q

A SOAP component, referring to known allergies, diseases, conditions, labs, and physical exams

A

Objective

148
Q

A SOAP component, referring to the ___ of medication-related problems

A

Assessment

149
Q

A SOAP component, referring to a course of action

A

Plan

150
Q

Because MTM is so beneficial and non-pharmacy providers don’t want to do it, the ___ states that Medicare D Plans must cover MTM services for targeted beneficiaries to improve adherence

A

Affordable Care Act

151
Q

In the ____ care setting, a typical day includes, working as a disciplinary team where the RPh is the clinical provider, evaluating patient symptoms and needs, and treating according to prognosis and pain levels

A

Palliative Hospice

152
Q

RPhs are crucial because of their med expertise in ___ situations in Palliative care and physicians accept their recommendations 95% of the time

A

EOL (End-of-Life)

153
Q

The ___ will allow pharmacists to write orders without physician approval

A

Collaborative Practice Act

154
Q

The most common diagnoses in ____ care include: 1-Cancer (1/3 of pt.s, Lung most common) 2-Dementia (Alzheimer’s most common)Pulmonary

A

Palliative Hospice

155
Q

There is a lot of opportunity for pharmacists in ___, because it offers uniquetreatments for patients, and sales/marketing positions to educate physicians about the available products

A

Compounding

156
Q

One of the benefits of compounded drugs is that ___ delivery systems can be used, avoiding systemic toxicity, and reduction in opioid dependence, also decreasing business losses

A

Transdermal

157
Q

___ pharmacy care includes an Intensive Care unit and a Neuro Unit, which collectively treat patients with epilepsy, strokes, on ventilators, TPAs, and Vancomycin treatments

A

Hospital

158
Q

A typical day for a ____ pharmacist includes being on a consult basis with physicians, training residents, making rounds/work-ups, and writing orders

A

Critical Care

159
Q

___ is very dangerous because patients metabolize drugs differently, so physicians write out orders rather than using abbreviations, and pharmacists work with a healthy level of fear

A

Pediatrics

160
Q

___ counts as the 1st check in filling pediatric prescriptions at hospitals, the 2nd check is made by the pharmacist filling

A

CPOE

161
Q

CPOE

A

Computerized Physician Order Entry

162
Q

___ room drugs are triple checked for accuracy

A

IV

163
Q

If a paper order is received to fill a pediatric drug, two ___ are involved, one entering the order, the other checking it

A

Pharmacists

164
Q

Care setting which is a bridge to hospice care and treats patients with no strict prognosis that can live several years, by treating their symptoms and slowing the progression of the disease?

A

Palliative

165
Q

Care setting which cares for terminally ill patients with a prognosis of 6 months or less?

A

Hospice

166
Q

What is the most common symptom in Palliative Hospice Care, which is difficult to manage?

A

Shortness of Breath

167
Q

One of the issues with compounding is that ___ are not keeping up with practice changes, and there are arguments about who should regulate pharmacies

A

Standards

168
Q

USP chapters 795 and 797 cover home infusions/____, and new regulations are coming out to give States the power to regulate compounding pharmacies, but not all state boards currently require USP compliance

A

Compounding

169
Q

___ do not pay for compounds because they are not FDA approved and that decreases drug compliance

A

PBMs

170
Q

A new USP policy, Chapter ___, will make drastic changes to regulate compounding

A

800

171
Q

A PGY1 General residency and a PGY2 Specialized residency are requirements to pursue a career in _____ pharmacy

A

Critical Care

172
Q

5 core elements of MTM

A
  • MAP
  • PMR
  • MTR
  • Intervention/Referral
  • Documentation/Follow-Up
173
Q

A PGY1 Residency (General) is equivalent to ___ of practice experience

A

3 years