Where is the MPJE not administered?
arkansas, california, puerto rico, guam and virgin islands
what is the blueprint of the MPJE?
assesses mastery of pharmacy law as outlined in the MPJE competency statments
what are the three areas of competency for MPJE?
Pharmacy practice, licensure registration certification and
operational requirements, regulatory structure and terms
Rules and regulations
guidelines that define a statue (law) which are made by
administrative agencies.
same legal force of a statute
terms law/rule/regulations are synonymus
policies
principles adopted to reach long -term goals
ex) more restrictive than laws, regulations and rules. everyone has
access to all the drugs in pharmacy but only pharmacist is allowed to
get CIIs out of the safe.
procedures
methods employed to express policies into action in day-to-day operations
statutory law
written laws enacted by federal and state legislature.
statues=statutory law
administrative law
public law issued by administrative agencies to direct the enacted
laws of federal and state governments..
administrative agencies are known as the 4th branch of government
what administrative agencies affect pharmacy practice?
federal agencies-CMS, FDA, FTC and DEA
state agencies- state board of pharmacy, state dept. of health
services and state medicaid
administrative action
when a pharmacist has violated a statute or regulation, or the agency
believes an act has been committed that warrants an investigation.
hearing occurs-fines/warning, license revocation or suspension and
probation could occur
ex) misfill but no harm
criminal action
occurs when a statue is violated.
sanctions include fine, prison sentence or both
ex) misfill with harm and new it was fradulent
civil action
one party brings a lawsuit against another party claiming injury
ex) pt harmed by a misfill on accident
negligence
is a tort, civil or personal wrong.
caused by heedlessness or careless ness that deviates from the
standard of care.
is an unintentional commission or omission of an act that a
reasonable prudent person would or would not do under the given circumstances
comission vs omission
commission- administering the wrong medication, wrong dose, or to
wrong patient.
omission-failing to administer, assess or counsel
elements of negligence to recover damages (4)
duty of care-legal obligation to care
breach of duty-failure to conform to or departure from required obligation
injury/damages-more than physical harm
causation/proximate cause-a reasonable, close and casual connection
or relationship between the defendants negligent behavior and the
resulting damages
pure food and drug act of 1906
prohibited foods and drugs distributed through interstate commerce
from being adulterated or misbranded
pure food, drug and cosmetic act of 1938
107 deaths from diethyl glycol as a vehicle for a sulfanilamide elixir.
required new drugs had to be proven safe when used according to
label and directions.
label must include: directions for use and habit forming warnings.
excluded: levothyronine, nitroglycerine, phenobarbitol, digoxin
Durham-humphrey amendment of 1951
amendment to FDCA.
established legend vs OTC drugs
did not require adequate directions for use--to be done by pharmacist
allowed for refills
required: "caution, federal law prohibits dispensing without a
prescription" on manufacturers label
Kefauver-harris amendment of 1962..
AKA drug efficiency amendment
amendment to FDCA.
created because of thalidomide..flipper babies occurred
required all drugs to be safe and effective.
created good manufacturing practice requirements
FDA regulated rx drug advertising
required informed consent for research subjects in clinical investigations
comprehensive drug abuse prevention and control act of 1970
aka controlled substance act.
foundational fight against drug abuse
created 5 schedules for controlled substances
established explicit record-keeping and inventory requirements
poison prevention packaging act of 1970
children under 5 prone to poison by common household items
if do not comply=misbranding
required OTC and RX drugs to be packaged in child-resistant containers
except-ntg, anhydrous cholestyramine, oral contraceptive and pancrelipase
exception- 1 size of OTC product for elderly in noncompliant
containers...must warn no young children in house
medical device amendment of 1976
amendment of FDCA better justification of medical devices according
to their specific function.
established performance standards and pre-market approval of
medical devices
must be in accordance with good manufacturing practices
outlines 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 drug is to treat rare diseases
<1 in 200,000
hatch-waxman amendment of 1984
amendment to FDCA that streamlines 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.
ANDA must prove bioequivalence between generic and name brand drug
prescription drug marketing act of 1987
placed more stringent controls on the distribution of prescriptions
and samples by:
requiring licensing of prescription drug wholesalers
banning re-importation of prescribed drugs produced in the US
banned sale, trade or purchase of a prescription drug sample
specified storage, handling and record-keeping requirements for
drug samples
prohibited resale of rx drugs purchased by hospitals or healthcare facilities
OBRA 90
omnibus reconciliation act of 1990
expectations of the pharmacist with regards to the pt interaction
primary goal was to save the federal government money by improving
therapeutic obligations.
counseling oblications, prospective DUR and record-keeping mandates
HIPAA
health insurance portability and accountability act of 1996
designed to safegaurd the privacy of protected health information (PHI)
5 key provisions: pharmacies must limit the use of, disclosure of
and requests for PHI
indiviuduals must be informed of the privacy practices of the pharmacy
complicane officer must be identified
all employes must be trained on HIPAA
PHI disclosed to 2nd parties only when engaged by the pharmacy
FDA modernization act of 1997
provided fast-track review of some NDAs with the intent to expedite
approval of drugs used to treat serious or life-threatening conditions
now drug say "Rx only"
removed warning-may be habit forming.
encouraged new research for uses of approved drugs
medicare prescription drug improvement and modernization act of 2003
AKA medicare modernization act MMA
encompasses medicare A-D
established MTM's
combat methamphetamine epidemic act of 2005
part of patriot act
regulated otc sales of ephedrine, pseudoephedrine and
phenylpropanolamine products.. must be in sales limits and min age and
required packaging and self-certification of sellers
medicare tamper-resistance prescription law of 2007
requires physicians and pharmacist to use either electronic
prescriptions or tamper-resistant prescription pads for their medicaid patients
food and drug administration amendments of 2007
requires risk evaluation and mitigation strategies (REMS) on
medications if necessary to minimize the risk associated with certain drugs.
restricted drugs: thalidomide, buprenorphine, clozepine and isotretinoin
patient protection and affordable care act of 2010
everyone must have health ins.
standards for financial and administrative transactions.
stops agreeements between manufacturers that limits or delays
competition by generics
phases out donut hole for medicare D
drug quality and security act of 2013
amendment to FDCA.
addresses issues related to oversight of prescription compounding
and establishes standards for a national track and trace system.
created voluntary registration program for outsourcing facilities.
established a 10 yr plan to electronically track each drug product
unit from manufacturer all the way to the patient
pharmaceutically equivalent vs bioequavilance
pharm- pharmaceutical equivalents if they have the same
active ingredient(s), strength or concentration, dosage form, and
route of administration. They may differ in shape, scoring design,
release mechanisms, packaging, excipients, expiration time, and to
some extent, labeling. SAME ACTIVE INGREDIENT BUT DIFF ADDITIVES!
bio-SAME OUTCOME IN THE BODY AND TARGETS THE SAME THINGS.
Bioequivalent products exhibit comparable bioavailability,
that is, similar rate and extent to which the active ingredient/moiety
is absorbed from a drug product and becomes available at the site of action.
the two major public medical reimbusement programs in us are what?
medicare and medicaid
what is known as the 4th branch of government?
administrative agencies
federal agencies?
CMS- centers for medicare and medicaid services
FDA-federal drug administration
FTC- federal trade commission
DEA- Drug enforcement agency
state agencies?
state board of pharmacy
state dept. of health services
state medicaid
AAC
actual aquisition cost-actual price the pharmacist pays when
purchasing units of a drug product. discounted price from average
wholesale price (AWP)
AARP
american association of retired persons
ADE/ADR
adverse drug experience/reaction
AMP
average manufacturer price- average price paid by wholesalers to a
manufacturer for drugs that are to be sold at retail
ANDA
ABBREVIATED NEW DRUG APPLICATION
CAM
complementary and alternative medicine
CDC
center for disease control
CFR
center for drug evaluation and research
CPSC
consumer product safety commission
CSOS
controlled substance ordering system-electronic substitute for DEA
222 form ordering control 1 and 2 drugs
DHHS
dept. of health and human services
DI
dietary ingredient-may be a vitamin, mineral, herb or other
botanical, an amino acid or another dietary substance that supplements
the diet
DME
durable medical equipment-must stand repeated use, for medical
purposes, it is appropriate for use in the home. ex)wheelchair,oxygen
tanks and walkers
DQSA
drug quality and security act
DRG's
diagnosis related groups-system for hospital inpatients based on
principle diagnosis. reimbursement based on days of stay
DSHEA
dietary supplement health education act
DUR
drug utilization review-a review of Rx drug use, prescribing patterns
or drug utilization by patients. used to determine if appropriate
drugs are being prescribed and if those drugs are being used appropriately
EAC
estimated acquisition cost-est. cost of drug to a pharmacy based upon
health info from DHHS--based on quantity purchased
EHR
electronic health records
EOB
electronic orange book
GRAS
generally recognized as safe
GRASE
generally recognized as safe and effective
HCFA
health care financing administration --formarly responsible for
policies related to medicare
HHA
home health agency
HMO
health maintainance organization
HSA
health savings account
HSD
home use sterile drug products
IND
investigational new drug
JCAHO
joint commission on accreditation of health care organizations
LVP
large volume perenteral
MAC
maximium allowable cost-highest price under a specific plan for a
specific drug
NABP
national association of boards of pharmacy
NDA
new drug application
NIH
national institutes of health
NDI
new dietary ingredient
NonDI
an excipient or other substance used in the manufacture of a dietary supplement
OSHA
occupational safety and health administration
PBM
pharmacy benefits management
PFFS
private fees for service plans that allow you to go to any doctor or
hospital that accepts their terms
PHS
public health service
PI
package insert
PPI
patient package insert
PPO
preferred provider organization-a group of healthcare professionals
who are contractually favored to provide health services to
individuals with a certian plan
SDA
specially denatured alcohol
SNDA
supplemental new drug application
SNP
special needs plan-a category of medicare advantage plan designed for
people living in long-term care facilities and receive both medicaid
and medicare or who have certain chronic disabilities
SP
sterile product or supervising physician
TCAM
traditional, complementary and alternative medicine
TRP
tamper resistant packaging
USAN
united states adopted names
VIPPS
verified internet pharmacy practice site-safe online pharmacies
Medicare prescription drug improvement and modernization act of 2003
MMA-encompasses medicare A-D
explain medicare A-D
A-provides hospital insurance
B- provides medical insurance for physician services
C- medicare managed care (medicare advantage)
D-medicare prescription drug program
MA
medicare advantage-plans that cover everything the original medicare
covered but at a lower cost and extra services
MA-PD
medicare advantage prescription drug plan
PDP
prescription drug plan-cannot enroll in MA and PDP
TrOOP
true out of pocket expense-deductible and cost sharing expenses in
medicare part D
HMOs
require you use only doctors and hospitals in the plans network
except for emergencies or special situations
Except low income patients, how do patients pay?
varies by income. they will pay a monthly premium, an annual
deductible, and have co-payment responsibilities.
can a husband and wife have the same medicare part D plan?
no.
how are co-payments based for part D recipients?
based on 3-4 level tier system
tier1: least expensive generic drug
tier2: preferred brand name drug
tier3:non-preferred brand name drug
tier 4: rarer high cost drugs
What can change over the course of having medicare part D for
insurance for one year related to cost?
Copayment if a drug is moved to another tier. premium and deductible
wont change.
medicare part D coverage gap
donut hole-financial gap between the part D Rx initial coverage limit
and the catastrophic-coverage threshold. this is when the pt pays the
largest amount for prescriptions until reaching the
catastrophic-coverage threshold level.
what are the 6 drug classes that most drug products must be included
in the medicare part D plan?
anticonvulsants antidepressants
antineoplastics antipsychotics
antiretrovirals immunosuppressants
what drugs are generally not covered under medicare part D?
barbituates-Primidone, phenobarbitol, butabarbital
benzodiazepines-xanax, diazepam, lorazepam.
weight loss/gain drugs-belviq, phentermine, contrave, cyproheptidine
helps gain weight
hair growth drugs-finasteride, minoxidil
drugs that increase fertility- clomiphene, finasteride
vitamins,except those with fluoride or prenatal
outpatient drugs for which the manufacturer requires monitoring
how do formulary changes to plans occur?
60 day notice must be given to CMS, state prescription plans,
pharmacies and plan enrollees. except for new black box warning.
also, if pt is being switched, must be allowed to obtain new drug
without penalty for the rest of the year
explain the concept of out of network pharmacies?
if a medicare part d recepient must go to an out of network pharmacy,
they must pay for prescription and then submit a claim. they will get
reimbursed according to the MAC. must pay overage price
medicare enrollment?
3 months before and 3 months after your birthday to enroll. span of 7
months to enroll.
anyone enrolling in medicare may no longer contribute to ___________?
health savings accounts
medigap
used in addition to medicare plan coverage to help with payments. 12
policies available
MTM includes?
medication therapy reviews, pharmacotherapy consults, anticoagulation
management, immunizations, health and wellness programs and many other
clinical services
what is required of medicare part D in regards to MTMs?
must automatically enroll patients unless they opt-out
target enrollment at least quaterly.
sponsers cannot require more than three chronic illness and must
target at least 4 of the following 7 core chronic diseases:
hypertension, heart failure, diabetes, dyslipiemia, respiratory
disease, bone disease, or mental health
offer interventions for prescribers and beneficiaries
report outcomes of CMR
CMR
comprehensive medication review- must include review of meds, offer
interactive consultation and provide consultation summaries
face-to-face or by telephone