What is the computerized law exam in most states for licensure?
MPJE
What are the 3 competency areas of the MPJE exam?
Pharmacy practice licensure, registration,
certification, and operational requirements Regulatory
structure and terms
Guidelines that define a statute (or law) which are made by
administrative agencies
Rules and Regulations
Principles adopted to reach long-term goals
Policies
Methods employed to express policies into action in day-to-day operations
Procedures
Written laws enacted by federal and state legislature
Statutory Law
Public law issued by administrative agencies to direct the enacted
laws of federal and state governments
Administrative Law
Administrative agencies are AKA what?
4th branch of government
List some examples of federal agencies
Centers for Medicare and Medicaid Services (CMS)
Food and Drug Administration (FDA)
Federal Trade Commission (FTC)
Drug Enforcement Agency (DEA)
List some examples of state agencies
State Board of Pharmacy
State Department of Health services
State Medicaid
A pharmacist�s wrongful act(s) may subject him/her to:
Administrative action
Civil action
Criminal action
Occurs when a pharmacist has violated a statute or regulation, or the
Agency believes an act has been committed that warrants an investigation
Administrative action
One party brings a lawsuit against another party claiming injury
Civil action
Occurs when a statute is violated
Criminal action
Is an unintentional commission or omission of an act that a
reasonable prudent person would or would not do under the given circumstances
Negligence
A legal obligation to care is called what?
Duty to care
Failure to conform to or a departure from a required obligation
Breach of duty
Includes more than physical harm
Injury/actual damages
A reasonable, close, and casual connection or relationship between
the defendant�s negligent behavior and the resulting damages
Causation/Proximate cause
Pure Food and Drug Act of 1906
Often contaminated, not consistent in strength, and poorly
labeled
Prohibited foods and drugs distributed through interstate
commerce from being adulterated or misbranded
Did not require manufacturers to list ingredients or
directions for use
Did not regulate cosmetics or medical devices
Durham-Humphrey Amendment of 1951
Amendment
to FDCA of 1938 which established 2 classes of
drugs: prescription or �Legend� drugs
defined as a drug that requires medical supervision for safe
use did not require �adequate directions for use� on the
label from the manufacturer adequate directions for use
occurs when the pharmacist places the prescribers directions on the
label of the dispensed product
required
�Caution: Federal law prohibits dispensing without a
prescription� on the manufacturer�s label (AKA �the
legend�) nonprescription or
�over-the-counter� drugs Defined as products that do not
require medical supervision for safe use
�required
�adequate directions for use� on the label from the
manufacturer
�Provided
for oral prescriptions and prescription
refills
Kefauver-Harris Amendment of 1962
Amendment to FDCA of 1938 as a result of public concern about
thalidomide AKA Drug Efficacy Amendment
Required all new
drugs marketed in US to be safe and
effective Requirement extended to products
approved between 1938 and 1962
Created Good
Manufacturing Practice (GMP) requirements
Provided for the
regulation of prescription drug advertising by the Food and Drug
Administration (FDA) Hint:
Nonprescription (OTC) advertising is regulated by the Federal Trade
Commission (FTC)
Required
informed consent for research subjects in clinical
investigations
Comprehensive Drug Abuse Prevention and Control Act of 1970
AKA Controlled Substance Act (CSA)
Legal foundation
of fight against drug abuse
Created 5
�schedules� for controlled substances
Established explicit record-keeping and inventory
requirements
Significant
penalties for violating the CSA
Poison Prevention Packaging Act of 1970
Poisonings by common household products and medicine were
considered to be a leading cause of injury among children under
5 Failure to comply with packaging requirements is considered
a misbranding Legend drugs and controlled dangerous
substances must be packaged in child-resistant containers
Limited exceptions such as sublingual NTG, anhydrous
cholestyramine, oral contraceptives, pancrelipase OTC must
be sold in child-resistant packaging�One exception: manufacturers
may market 1 size of an OTC product for the elderly / handicapped in
noncompliant containers, Package must state "This
Package for Households Without Young Children."
Medical Device Amendment of 1976
Amendment to FDCA of 1938 that provided for better
classification of
medical devices according to their specific
function Established
performance
standards and pre-market approval of
medical devices Required
medical
devices be manufactured in accordance with
good manufacturing practices
Outlined
record keeping and
reporting requirements for
medical devices
Orphan Drug Act of 1983
Provided tax and licensing incentives to manufacturers in
exchange for developing �orphan drugs� Orphan drugs are
used to treat rare diseases affect < 1 in 200,000 persons in the
US
Hatch-Waxman Amendment of 1984
�Amendment to FDCA of 1938 that
streamlined the drug approval
process for generic
products by requiring submission of only an
abbreviated new drug
application (ANDA)
�AKA Drug Price Competition and Patent-Term Restoration Act
�Prior to its enactment, generic manufacturers had to go through a
similar process required for new developed drugs
�ANDA requires the manufacturer to prove bioequivalence between the
generic and brand-name counterpart�Safety and efficacy have already
been proven through extensive testing by the �brand-name� manufacturer
Prescription Drug Marketing Act of 1987
Placed more stringent controls on the distribution of prescriptions
and samples by:
�Required licensing of prescription drug wholesalers
�Banned re-importation of prescription drugs produced into the US
�Banned the sale, trade or purchase of prescription drug samples
�Specified storage, handling and record keeping requirements
for drug samples
�Prohibited resale of prescription drugs purchased by
hospitals or health care facilities
Omnibus Reconciliation Act of 1990
Outlined expectations of the pharmacist with regards to patient
interaction Primary goal of OBRA-90 was to save the federal
government money by improving therapeutic outcomes
pharmacist counseling obligations prospective drug
utilization review requirements�record-keeping mandates
Health Insurance Portability and Accountability Act of 1996
Privacy Rule component of HIPAA took effect on April 14,
2003 Regulations designed to safeguard the privacy of
protected health information (PHI) Imposed 5 key provisions
upon pharmacists/pharmacies: Pharmacies must take
reasonable steps to limit the use of, disclosure of, and the
requests for PHI Individuals must be informed of the
privacy practices of the pharmacy A compliance officer
within the pharmacy will be identified and manage and ensure
compliance All employees working in the pharmacy environment
must receive HIPAA training within a reasonable time after being
hired In situations when PHI disclosure is required, it is
disclosed to the second party only for the purposes for which the
second party is engaged by the pharmacy
Nonprescription advertising is regulated by whom?
FTC (Federal Trade Commission)
FDA Modernization Act of 1997
Provided fast-track review of some NDA�s with the intent to
expedite approval of drugs used to treat serious or life-threatening
conditions Provided clarification under which pharmacies may
extemporaneously compound prescriptions Individual states
should regulate compounding Exempt from GMP standards
Replaced prescription drug legend with �Rx only�
Removed the �Warning-May be habit forming� labeling
requirement Encouraged manufacturers to conduct research for
new uses of currently approved drugs�Requires submission of
supplemental NDA Encouraged manufacturers to perform
pediatric drug studies
Medicare Prescription Drug Improvement and Modernization Act of 2003
�AKA Medicare Modernization Act (MMA)�Encompasses four
programs�Medicare Part A, B, C and D�Established formal
medication therapy management programs
Combat Methamphetamine Epidemic Act of 2005
A part of the Patriot Act Regulates retail
over-the-counter sales of ephedrine, pseudoephedrine, and
phenylpropanolamine products Established sales limits and
record-keeping Regulated product placement Set
minimum age requirements for purchasers Required packaging
for manufacturers Self-certification for sellers
Medicaid Tamper-Resistant Prescription Law of 2007
Requires physicians and pharmacists to use either electronic
prescriptions or tamper-resistant prescription pads for their
Medicaid patients.
Food, Drug and Cosmetic Act of 1938
Any new drug had to be proven safe when used according to label
directions labels had to include: adequate
directions for use habit-forming warnings Applied
to food, drugs, cosmetics and devices First law that
applied to cosmetics and medical devices Drugs marketed
prior to 1938 were exempt from regulation
The Food, Drug and Cosmetic Act of 1938 required that labels must
include what?
Adequate directions for use Habit-forming
warnings
Food and Drug Administration Amendments of 2007
Requires risk evaluation and mitigation strategies (REMS) on
medications if necessary to minimize the risks associated with some
drugs Medication Guides and Communication Plans
Restricted Drug Programs Thalidomide, Buprenorphine,
Clozapine, Isotretinoin
Patient Protection and Affordable Care Act of 2010
�Requires all individuals have health insurance�Requires
standards for financial and administrative transactions�Timely
and transparent claims using standard electronic transaction
format�Stops agreements between manufacturers that limits or
delays competition by generics�Phases out the catastrophic
threshold (�donut hole�) for Medicare Part D
Drug Quality and Security Act of 2013
�Amendment to the Food, Drug, and Cosmetic Act �Addresses issues
related to oversight of prescription compounding and establishes
standards for a national �track and trace� systems for drug
distribution �Created voluntary registration program for
�outsourcing facilitiesӥOutsourcing facilities
are:�subject to certain requirements similar to those that
currently govern traditional drug manufacturers�subject to
inspection by the FDA�Established a 10 year plan to
electronically track each drug product unit from the manufacturer all
the way to the patient
Prohibited foods and drugs distributed through interstate commerce
from being adulterated or misbranded
Pure Food and Drug Act of 1906
Required informed consent for research subjects in clinical investigations
Kefauver-Harris Amendment of 1962
Significant penalties for violating the CSA
Comprehensive Drug Abuse Prevention and Control Act of 1970
Package must state "This Package for Households Without Young Children.
Poison Prevention Packaging Act of 1970
What is the one exception that an OTC must be sold in child resistant packaging?
Manufacturers can market 1 size of an OTC product for the
elderly/handicapped in noncompliant containers
Outlined record keeping and reporting requirements for medical devices
Medical Device Amendment of 1976
Orphan drugs are used to treat rare diseases affect < 1 in 200,000
persons in the US
Orphan Drug Act of 1983
Provided for the regulation of prescription drug advertising by the
Food and Drug Administration (FDA)
Kefauver-Harris Amendment of 1962
Often contaminated, not consistent in strength, and poorly labeled
Pure Food and Drug Act of 1906
Safety and efficacy have already been proven through extensive
testing by the �brand-name� manufacturer
Hatch-Waxman Amendment of 1984
Prohibited resale of prescription drugs purchased by hospitals or
health care facilities
Prescription Drug Marketing Act of 1987
Established explicit record-keeping and inventory requirements
Comprehensive Drug Abuse Prevention and Control Act of 1970
Outlined expectations of the pharmacist with regards to patient interaction
Omnibus Reconciliation Act of 1990
Privacy Rule component took effect on April 14, 2003
Health Insurance Portability and Accountability Act of 1996
Did not require manufacturers to list ingredients or directions for use
Pure Food and Drug Act of 1906
Any new drug had to be proven safe when used according to label directions
Food, Drug and Cosmetic Act of 1938
Did not require �adequate directions for use� on the label from the manufacturer
Durham-Humphrey Amendment of 1951
Defined as a drug that requires medical supervision for safe use
Prescription/Legend drugs
Created Good Manufacturing Practice (GMP) requirements
Kefauver-Harris Amendment of 1962
Required medical devices be manufactured in accordance with good
manufacturing practices
Medical Device Amendment of 1976
OTC must be sold in child-resistant packaging
Poison Prevention Packaging Act of 1970
Drugs marketed prior to 1938 were exempt from regulation
Food, Drug and Cosmetic Act of 1938
Amendment to FDCA of 1938 which established 2 classes of drugs:
Durham-Humphrey Amendment of 1951
Provided tax and licensing incentives to manufacturers in exchange
for developing �orphan drugs�
Orphan Drug Act of 1983
Created 5 �schedules� for controlled substances
Comprehensive Drug Abuse Prevention and Control Act of 1970
Specified storage, handling and record keeping requirements for drug samples
Prescription Drug Marketing Act of 1987
ANDA requires the manufacturer to prove bioequivalence between the
generic and brand-name counterpart
Hatch-Waxman Amendment of 1984
Requirement extended to products approved between 1938 and 1962
Kefauver-Harris Amendment of 1962
Applied to food, drugs, cosmetics and devices
Food, Drug and Cosmetic Act of 1938
Primary goal was to save the federal government money by improving
therapeutic outcomes
Omnibus Reconciliation Act of 1990
Regulations designed to safeguard the privacy of protected health
information (PHI)
Health Insurance Portability and Accountability Act of 1996
Encouraged manufacturers to perform pediatric drug studies
FDA Modernization Act of 1997
Banned the sale, trade or purchase of prescription drug samples
Prescription Drug Marketing Act of 1987
Established formal medication therapy management programs
Medicare Prescription Drug Improvement and Modernization Act of 2003
Established performance standards and pre-market approval of medical devices
Medical Device Amendment of 1976
Required all new drugs marketed in US to be safe and effective
Kefauver-Harris Amendment of 1962
Legal foundation of fight against drug abuse
Comprehensive Drug Abuse Prevention and Control Act of 1970
Self-certification for sellers
Combat Methamphetamine Epidemic Act of 2005
�pharmacist counseling obligations�prospective drug utilization
review requirements�record-keeping mandates
Omnibus Reconciliation Act of 1990
Adequate directions for use occurs when the pharmacist places the
prescribers directions on the label of the dispensed product
Durham-Humphrey Amendment of 1951
Limited exceptions such as sublingual NTG, anhydrous cholestyramine,
oral contraceptives, pancrelipase
Poison Prevention Packaging Act of 1970
labels had to include:
� adequate directions for use
� habit-forming warnings
Food, Drug and Cosmetic Act of 1938
Did not regulate cosmetics or medical devices
Pure Food and Drug Act of 1906
AKA Drug Efficacy Amendment
Kefauver-Harris Amendment of 1962
Defined as products that do not require medical supervision for safe use
Non-prescription/ OTC drugs
Required �adequate directions for use� on the label from the manufacturer
Durham-Humphrey Amendment of 1951
Amendment to FDCA of 1938 that provided for better classification of
medical devices according to their specific function�
Medical Device Amendment of 1976
Banned re-importation of prescription drugs produced into the US
Prescription Drug Marketing Act of 1987
Prior to its enactment, generic manufacturers had to go through a
similar process required for new developed drugs
Hatch-Waxman Amendment of 1984
Imposed 5 key provisions upon pharmacists/pharmacies
Health Insurance Portability and Accountability Act of 1996
Legend drugs and controlled dangerous substances must be packaged in
child-resistant containers
Poison Prevention Packaging Act of 1970
Encouraged manufacturers to conduct research for new uses of
currently approved drugs
FDA Modernization Act of 1997
Encompasses four programs
�Medicare Part A, B, C and D
Medicare Prescription Drug Improvement and Modernization Act of 2003
Required licensing of prescription drug wholesalers
Prescription Drug Marketing Act of 1987
Amendment to FDCA of 1938 as a result of public concern about thalidomide
Kefauver-Harris Amendment of 1962
AKA Controlled Substance Act (CSA)
Comprehensive Drug Abuse Prevention and Control Act of 1970
Required �Caution: Federal law prohibits dispensing without a
prescription� on the manufacturer�s label
Durham-Humphrey Amendment of 1951
AKA Drug Price Competition and Patent-Term Restoration Act
Hatch-Waxman Amendment of 1984
Failure to comply with packaging requirements is considered a misbranding
Poison Prevention Packaging Act of 1970
Provided for oral prescriptions and prescription refills
Durham-Humphrey Amendment of 1951
Removed the �Warning-May be habit forming� labeling requirement
FDA Modernization Act of 1997
Required packaging for manufacturers
Combat Methamphetamine Epidemic Act of 2005
Requires physicians and pharmacists to use either electronic
prescriptions or tamper-resistant prescription pads for their Medicaid patients.
Medicaid Tamper-Resistant Prescription Law of 2007
Placed more stringent controls on the distribution of prescriptions
and samples
Prescription Drug Marketing Act of 1987
Amendment to FDCA of 1938 that streamlined the drug approval process
for generic products by requiring submission of only an abbreviated
new drug application (ANDA)
Hatch-Waxman Amendment of 1984
Restricted Drug Programs�Thalidomide, Buprenorphine, Clozapine, Isotretinoin
Food and Drug Administration Amendments of 2007
Replaced prescription drug legend with �Rx only�
FDA Modernization Act of 1997
Set minimum age requirements for purchasers
Combat Methamphetamine Epidemic Act of 2005
Phases out the catastrophic threshold (�donut hole�) for Medicare
Part D
Patient Protection and Affordable Care Act of 2010
AKA Medicare Modernization Act (MMA)
Medicare Prescription Drug Improvement and Modernization Act of 2003
Medication Guides and Communication Plans
Food and Drug Administration Amendments of 2007
Provided clarification under which pharmacies may extemporaneously
compound prescriptions
FDA Modernization Act of 1997
Established a 10 year plan to electronically track each drug product
unit from the manufacturer all the way to the patient
Drug Quality and Security Act of 2013
Regulated product placement
Combat Methamphetamine Epidemic Act of 2005
Requires risk evaluation and mitigation strategies (REMS) on
medications if necessary to minimize the risks associated with some drugs
Food and Drug Administration Amendments of 2007
Stops agreements between manufacturers that limits or delays
competition by generics
Patient Protection and Affordable Care Act of 2010
Outsourcing facilities are:�subject to certain requirements
similar to those that currently govern traditional drug
manufacturers�subject to inspection by the FDA
Drug Quality and Security Act of 2013
Provided fast-track review of some NDA�s with the intent to expedite
approval of drugs used to treat serious or life-threatening conditions
FDA Modernization Act of 1997
Established sales limits and record-keeping
Combat Methamphetamine Epidemic Act of 2005
Individual states should regulate compounding Exempt
from GMP standards
FDA Modernization Act of 1997
Poisonings by common household products and medicine were considered
to be a leading cause of injuryamong children under 5
Poison Prevention Packaging Act of 1970
Regulates retail over-the-counter sales of ephedrine,
pseudoephedrine, and phenylpropanolamine products
Combat Methamphetamine Epidemic Act of 2005
Created voluntary registration program for �outsourcing facilities�
Drug Quality and Security Act of 2013
Timely and transparent claims using standard electronic transaction format
Patient Protection and Affordable Care Act of 2010
Addresses issues related to oversight of prescription compounding and
establishes standards for a national �track and trace� systems for
drug distribution
Drug Quality and Security Act of 2013
Requires standards for financial and administrative transactions
Patient Protection and Affordable Care Act of 2010
A part of the Patriot Act
Combat Methamphetamine Epidemic Act of 2005
Requires all individuals have health insurance
Patient Protection and Affordable Care Act of 2010
Amendment to the Food, Drug, and Cosmetic Act
Drug Quality and Security Act of 2013
MMA encompasses what 4 programs?
Medicare Part A, B ,C, & D
Provides medical insurance for physician services
Medicare Part B
MMA was signed into law when?
37956
Developed and currently supervises the MMA
CMS (Centers for Medicare and Medicaid Services)
Plans that cover everything the original Medicare covered but may
offer lower costs and extra services
MA (Medicare Advantage)
What does MA-PD stand for?
Medicare Advantage Prescription Drug Plan
MTM stands for:
Medication Therapy Management
Medicare Prescription drug program
Medicare Part D
Provides Hospitalization insurance
Medicare Part A
Medicare prescription drug plans that cover only outpatient drugs and
are intended for people in original Medicare who have no other drug coverage.
PDP (Prescription Drug Plan)
The sum of an individual's deductible and cost sharing expenses in
Medicare Part D
TrOOP (True Out-of-Pocket expense to the individual)
Medicare managed care (Medicare Advantage)
Medicare Part C
What requires that you generally utilize only doctors and hospitals
in the plan's network, except in emergencies or special situations?
HMOs
Since when have Medicare beneficiaries been able to enroll in part D?
38718
The cost to the beneficiary depends on specifically what?
The beneficiary's income
What may be based on a 3 or 4 level tier system?
Co-payments
The tiers of co-payments often consist of:
Tier 1: least expensive generic drug
Tier 2: preferred brand name drug
Tier 3: non-preferred brand name drug
Tier 4: rarer, high cost drugs
True or False: Once the beneficiary has enrolled, the premium and
deductible cannot change from Jan 1-Dec 31 of that year
TRUE
Can the co-pay amount change?
Yes, if the drug is moved to another Tier at some point
How often can the beneficiary change plans in a year?
1 time only, unless there are special circumstances (nursing home,
plan moves into new area, etc.)
The Medicare Part D coverage gap is also referred to as what?
Medicare donut hole
What is the "donut hole"?
Where a patient has to pay higher co-pays for their medications until
the premium is met
When is the "donut hole" expected to be phased out?
2020
In what year did Part D cover vaccinations? What part did it used to
be apart of?
2008, Part B
True or False: All plans can pick and choose the therapeutic
categories that they will or wont cover
False; must have all categories
True or False: Insurers must include all drugs in each category
False; this is not required.
Companies that desire to have their own formularies must have what in place?
Pharmacy and Therapeutics Committee (P & T)
What are the 6 classes that require most drugs to be included?
anticonvulsantsantidepressantsantineoplasticsantipsychoticsantiretroviralsimmunosuppressants
True or False: Research drugs are acceptable in coverage terms
FALSE
True of False: "Off-label" drugs are acceptable in coverage terms
TRUE
What are some drugs that are usually not covered?
barbituratesbenzodiazepinesweight loss/gain
drugshair growth drugsdrugs that increase
fertilityprescription vitamins except prenatal and fluoride
productsoutpatient drugs which manufacturer requires monitoring
If a formulary is going to change for a plan, how long does the
notice have to be?
60 days
If a patient visits an "out-of-network" pharmacy, how do
they go about getting their prescription?
Patient pays out-of-pocket pharmacy price and submits a claim to
Medicare for reimbursement
How long is the Medicare initial enrollment period?
3 months before/3 months after birthday (7 month time span)
Health insurance sold by private insurance companies to fill the
"gaps" in the original Medicare Plan coverage
Medigap policy
Medigap is a.k.a?
Medicare Supplemental Insurance
Broad range of healthcare services provided by pharmacists:
MTM (Medication Therapy Management)
Part D sponsors must target which patients?
Those with multiple chronic disease states (2-3)
Those taking many meds... partners set drug number minimum (2-8)
Are predicted to incur predetermined annual cost from Part D meds
Can sponsors require more than 3 chronic disease states?
No
Chronic illnesses include:
How many must be targeted?
4 must be targeted
Hypertension Heart Failure Diabetes
Dyslipidemia Respiratory Disease (asthma, COPD,
etc.) Bone disease Mental health
Where are specific outcomes of data reported to?
CMS
Reports should include:
Number of CMRs Number of targeted med reviews
Number of prescriber interventions Changes in therapy
directly resulting from MTM interventions
Minimum interventions must include:
CMR (Comprehensive medication review)
How often are reviews to be done?
Quarterly
Sponsors may include interventions such as:
Educational newsletters DUR Refill
reminders Med lists
Targeted medication review may be done how?
Person-to-person computer