Exam 2 Flashcards
The origin of pharmacy lie in ______.
Babylon
Around 2600 B.C., Roman drug dealers were found in ____ & the RPh, MD, & Priest were all the ____.
- Kiosks
- Same Person
Around 2000 B.C., a _____ pharmacist worked with ginseng & ephedrine.
Chinese
In early Egypt, the chief pharmacist would practice out of a _____, overseeing other pharamcists.
“House of Life”
Theophrastus is known as the ______ & discovered _______.
- “Father of Botany”
- Anti-Cholinergics
The oldest record of medications that originated in Egypt.
Ebers Papyrus
______ scientists would use human subjects to discover antidotes to poisons.
Roman
Terra Sigillata
- Means “sealed Earth”
- Around 500 B.C., pharmacists would roll out holy soil & put them in capsules in the Mediterranean.
1st Trademark of Drugs
In the mediterranean around 500 B.C. (Terra Sigillata)
Galen
Known as the “Father of Compounding” & he created Cold Creams (130-200 A.D.)
The first apothecary was located in _____, around 792 A.D.
Baghdad
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.
Pharmacopeia
Susan Hayhurst
Considered to be the 1st woman pharmacist in 1729 Philadelphia
Ben Franklin
Established the 1st hospital pharmacy
Jonathan Roberts
Considered the 1st hospital pharmacist
John Morgan
Championed prescription writing by separating the duties of MDs & RPhs
Apothecary
Care setting mostly centered around drug dispensing & counseling
Andrew Cragle
Considered the 1st Apothecary General
A Swedish Parmacist discovered the drug _____.
Morphine
Taxol
Originated from the extract of a Peruvian tree & was used in early pharmacy to treat Breast Cancer.
In ____, conflicts between RPhs & MDs resulted in the formation of the 1st College of Pharmacy with standardized training.
1821
In 1821, Philadelphia College of Pharmacy (PCP) became the ________, as a result of the push for standardized training.
1st College of Pharmacy
Organization intially founded to improve communication between MDs & RPhs.
APhA
William Proctor Jr
Considered to be the “Father of American Pharmacy”
In 1820, this organization created the Gold Standard for quality after its creation by Dr. Squibb, Dr. Remingtn, & Dr. Rice.
USP (U.S. Pharmacopeia)
Dr. Squibb, one of the creators of the USP, also created the 1st drug company _______.
Bristol Mayers-Squibb
Types of Pharmacists in 19th Century U.S.
- Dispensing Physician
- Apothecary Shop
- General Store
- Wholesale Druggist
1st state to issue licensing for pharmacists
South Carolina
In which year did schools swithc to a PharmD program for pharmacy education? (USC was the 1st to offer it)
1992
APhA
American Pharmacists Association
APhA is the ______ & ______ organization, founded in 1852.
- Oldest
- Largest
APhA represents ____ pharmacists & has a strong focus on ____.
- All
- MTM
NCPA
National Community Pharmacists Association
NCPA is the voice of _____ & provides guidance for pharmacy purchasing, founded in 1898.
Independent Community Pharmacists
Pharmacy Today
Published by APhA
America’s Pharmacist
Published by NCPA
ASHP
American Society of Health-System Pharmacists
ASHP accredits _____ & represents hospital RPhs, founded in 1942.
Residency Programs
NPhA
National Pharmaceutical Association
NPhA is dedicated to representing the ideas & views of _______ RPhs & RPh students, founded in 1947.
Minority
AAPS
American Association of Pharmaceutical Scientists
AAPS is the premier organization of all scientists dedicated to the ______, _______, & ________ of drugs.
- Discovery
- Development
- Manufacture
Members of the Pharmaceutical Sciences Department (PhDs) are most like to be members of which organization?
AAPS
ACCP
American College of Clinical Pharmacy
The ______ publication is made by the ACCP & has high impact factor, founded in 1979.
Pharmacotherapy
Members of the Pharmacy Practice Department (PharmDs) are most likely members of which organization?
ACCP
Members of innovative, pallative care clinics & clinical residences are most likely members of which organization?
ACCP
ACPE
Accreditation Council for Pharmacy Education
The ACPE accredits ______ & ________.
- CE programs
- Graduate degree programs
The organization that establishes standards for accreditation & whose Board Directors consist of members of the AACP, APhA, & NABP is ______.
ACPE
AMCP
Academy of Managed Care Pharmacy
The organization that promotes health outcomes & economics, founded in 1988 is ______.
AMCP
Pharmacists working at HMOs & PBMs are most likely members of which organization?
AMCP
A goal of the AMCP is to improve ______ _______ & _____ _____ ______.
- Patient Outcomes
- Health Care Affordability
________ are most likely members of the AACP, colleges & schools accredited by the ACPE are also members of the AACP.
All Pharmacy School Faculty
AACP
American Association of Colleges of Pharmacy
The ____ publishes the American Journal of Pharmaceutical Education & was founded in 1900.
AACP
ISPOR
International Society for Pharmacoeconomics & Outcomes Research
- Strictly for outcomes
_____ is similar to the AMCP & is strictly focused on outcomes, as well as collects data on heath economics
ISPOR
Organizations with focus on outcomes include _____ & ______.
- ISPOR
- AMCP
ASCP
American Society of Consultant Pharmacists
Pharmacists that work with medicare-type patients, geriatrics, are most likely members of _____.
ASCP
NACDS
National Association of Chain Drug Stores
Retail pharmacists are most likely members of _____.
NACDS
BPS
Board of Pharmacy Specialties
The BPS certifies ___ specialty practice areas.
8
The 8 recognized _____ _______ recruit pharmacists that have been certified by the BPS
Specialty Councils
TPA
Tennessee Pharmacists Association
The ____ represents all pharmacists within TN & so is considered an umbrella organization.
TPA
NABP
National Association of Boards of Pharmacy
The NABP administers the _____ & ______ & allows scores to be tranferable between states.
- NAPLEX
- MPJE
______ makes practice exams for licensure exams & designs questions.
NABP
CDER
Center for Drug Evaluation & Research
CDER evaluates the ____ & ____ of prescription & OTC drugs.
- Safety
- Eficacy
Most drugs originate from the ____
CDER
Drug
A substance used to alter the function of the body
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.
“burden of proof”
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.
Elixir of Sulfonamide
As a result of the 1938 FDA act, manufacturers had to provide data based on ____ ____ to show their products were safe before marketed.
Scientific experiments
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.
Prescription Drugs
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 ____ _____ _____ ____ ____ ____.
Compassionate use of Investigational New Drugs (IND)
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 ____ _____.
Critically needed.
The ___ was established in 1973, after a 1970 Act which classified controlled drugs into 5 categories.
DEA
The ___ does not regulate controls.
FDA
Which class of controlled substances are used in clinical research?
CI
Which class of controlled substances are in the market & have the highest potential for abuse?
CII
Which class acronym is used to describe a subset of CIII drugs that are non-narcotic?
IIIN
Which class of controlled substances have the lowest potential for abuse?
CV
Which pregnancy drug category shows no fetal risk or harm?
A
Which pregnancy drug category shows fetal human risk, but its benefits may outweigh the risks?
D
Which pregnancy drug category is contradicted in pregnancy (benefits do not outweigh the risks)?
X
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 _____.
Clinical trials
IRB
Institutional Review Board
The local ___ approves the clinical trial protocols, pharmacists should consider applying for IRBS.
IRB
Which phase of clinical trials conducted on 20-80 healthy volunteers to determine side effects, metabolism, & excretion with focus on safety.
Phase 1 (Safety)
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.
Phase 2 (Safety & Efficacy)
Which phase of clinical trials includes a Double Blind Study, in which randomized patients receive either the drug or a placebo?
Phase 2 (Safety & Efficacy)
Which phase of clinical trials are the manufacturers in negotiation with the FDA about how large the trials of the next phase shoulde be?
Phase 2 (Safety & Efficacy)
Which phase of clinical trials numbers in several hundreds to about 3000 volunteers?
Phase 3 (Safety & Efficacy, varying pops, doses, & other drugs)
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.
Phase 3
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.
60 days.
Which phase of clinical trials does the FDA inspect manufacturing facilities to ensure they meet GMP (Good manufacturing Practice Standards)?
Phase 4 (Post-Market Surveillance)
Which phase of clinical trials are studies conducted after approval by FDA, after the FDA has approved the product for marketing?
Phase 4
Pharmacists are key components of Phase 4 post-marketing surveillance & the ____ program.
Med-Watch
Controlled substances are governed by the
DEA
Sponsor is synonymous with _____, in respect to drug development.
Manufacturer
There are no safe drugs, not even FDA approved ones, always weigh the ______
Risks/benefits
The FDA does not regulate controlled drugs, nor _____
Prices
In the 1950s the ____ analysis of drugs began to be used
Chemical
In the 1980s there was a push to look into ____, leading to synthetic insulin production.
Bio-technology
In 1994, _____ was passed because of the production with regulating supplements.
DSHEA
DSHEA
Dietary Supplement & Health Education Act
In 2009, arguments arose over _____ regulations & an unintended consequence was that the FDA became able to regulate supplements better
Tobacco
Drugs, Food, & Supplements (which can’t be approved for safety/efficacy)
FDA’s categories for human consumption
Theraputic Orphans
Refers to drgus indicated for children, 5-10% of pharmaceutical sales are for children, 25% of approved drgus used on children
BPCA
Best Pharmaceuticals for Children Act
____ was created to provide incentives to sponsors to conduct FDA-requested pediatric studies by granting an additional 6 months of marketing exclusivity
BPCA
PREA
Pediatric Research Equity Act
____ 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.
PREA
HMOs, PPOs, IPAs, & EPOs are types of ____
MCOs
IPAs
Most common type of MCo & have an open system
HMOs
Type of MCO with a closed system
PPOs
Type of MCo with in-network & out-of-network providers & offer higher coverages if in-network providers are used
___ refers to the “sticker price”, used to inflate reimbursement.
AWP (Avergae Wholesale Price)
___ refers to the max that PBMs will pay pharmacies
MAC (Max Allowable Cost)
Key PBM Activities
- Benefit design
- Claims processing
- Formulary management
- Rebate contracting
- Drug utilization review
- Rx network contracting
____ refers to a therapeutic interchange where pharmacists are prompted when it is beneficial for patients to switch to generic drugs.
TIP
MTM
Distinctive service that optimizes therapeutic outcomes & are independent of a medication
ADE
Adverse Drug Events
MTM is beneficial because it:
- Saves money
- Reduces ADEs
- Increases patient adherence
Obra90
Made it mandatory for pharmacists to counsel patients
MTM affects and is beneficial to ___ pharmacy practice areas and patients
All
Patients most likely to benefit from MTM include those in ___ and that have multiple doctors
Transition
___ 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)
MTR (Medication Therapy Review)
MTR
MTR (Medication Therapy Review)
___ 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
PMR
PMR
Personal Medication Review
___ can be Targeted (concerning specific drugs) or Comprehensive (evaluating everything and taking longer)
PMRs
___ 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
MAP
MAP
(Medication-related Action Plan)
The best way to ensure reimbursement for MTM services is to ___ everything, to prove it is making a difference
Document
CMR
Comprehensive Med Review
The term used by insurance providers to show coverage for MTM services is ___
CMR
Which type of PMR is reimbursed by insurance providers at about $100/hour and makes the most significant impacts?
Comprehensive
SOAP is an acronym used to describe the aspects of ___, Subjective, Objective, Assessment and Plan
MTM
A SOAP component, referring to patient reported information, chief complaints, med history, and family history
Subjective
A SOAP component, referring to known allergies, diseases, conditions, labs, and physical exams
Objective
A SOAP component, referring to the ___ of medication-related problems
Assessment
A SOAP component, referring to a course of action
Plan
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
Affordable Care Act
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
Palliative Hospice
RPhs are crucial because of their med expertise in ___ situations in Palliative care and physicians accept their recommendations 95% of the time
EOL (End-of-Life)
The ___ will allow pharmacists to write orders without physician approval
Collaborative Practice Act
The most common diagnoses in ____ care include: 1-Cancer (1/3 of pt.s, Lung most common) 2-Dementia (Alzheimer’s most common)Pulmonary
Palliative Hospice
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
Compounding
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
Transdermal
___ pharmacy care includes an Intensive Care unit and a Neuro Unit, which collectively treat patients with epilepsy, strokes, on ventilators, TPAs, and Vancomycin treatments
Hospital
A typical day for a ____ pharmacist includes being on a consult basis with physicians, training residents, making rounds/work-ups, and writing orders
Critical Care
___ 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
Pediatrics
___ counts as the 1st check in filling pediatric prescriptions at hospitals, the 2nd check is made by the pharmacist filling
CPOE
CPOE
Computerized Physician Order Entry
___ room drugs are triple checked for accuracy
IV
If a paper order is received to fill a pediatric drug, two ___ are involved, one entering the order, the other checking it
Pharmacists
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?
Palliative
Care setting which cares for terminally ill patients with a prognosis of 6 months or less?
Hospice
What is the most common symptom in Palliative Hospice Care, which is difficult to manage?
Shortness of Breath
One of the issues with compounding is that ___ are not keeping up with practice changes, and there are arguments about who should regulate pharmacies
Standards
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
Compounding
___ do not pay for compounds because they are not FDA approved and that decreases drug compliance
PBMs
A new USP policy, Chapter ___, will make drastic changes to regulate compounding
800
A PGY1 General residency and a PGY2 Specialized residency are requirements to pursue a career in _____ pharmacy
Critical Care
5 core elements of MTM
- MAP
- PMR
- MTR
- Intervention/Referral
- Documentation/Follow-Up
A PGY1 Residency (General) is equivalent to ___ of practice experience
3 years
