RX PREP Chapter 4: Pharmacy Practice Flashcards
When a pharmacist signs off on an order, what are they saying that has been evaluated?
allergies
C/I
warnings
AE
DI
for compounded preparations, the quality of the product is the legal responsibility of who
the pharmacist – not the tech who prepared it
______ is a formal relationship between a pharmacist and another healthcare provider or provider group
CPA
a CPA may allow the pharmacist to do what
initiate, modify, and or monitor drug therapy
is a pharmacist manager interchangeable with PIC in some states?
yes
who is the primary person responsible for the legal operations of the pharmacy
PIC
what can happen to a PICs license if inappropriate or illegal actions occur at the pharmacy? (lack of counseling, manufacturing, posing as compounding, drug diversion, incorrect record keeping, improper staff ratios)
warnings, suspensions, revocation
a pharmacist is a precasting a student giving a vaccine but the pharmacist isn’t trained or certified. is this legal?
no pharmacist must be trained in what the intern is doing
some states that permit tech check tech programs, bypass the need for pharmacist approval in certain circumstances
true
often with additional technology
what can techs duties be under supervision of a rph
enter prescriptions into the pharmacy computer
communicate with patients and insurance companies
fill prescriptions, including removing drugs from stock, counting drugs, placing drugs into containers and labeling the container
compound sterile and non sterile meds
stock medications in ADC and emergency crash carts
clerks cannot be subject to license suspension or revocation since they do not have a license issued by the board
true
can clerks fill scripts?
np
what are typical functions clerks can do?
accepting prescriptions at the drop off window
verifying the patients insurance coverage
completing the transaction at the point of sale
which amendment established the criteria for determining if a drug should be available by rx only?
durham-humprhy amendment
an oral prescription must be immediately reduced to writing form
yes
electronic prescribing is now highly encouraged or required in some states
true
the NABP recommends that a prescription should minimally contain
patient info (name address)
prescribers info (name, license, address)
drug info (name, strength, dosage form, quantity)
directions for use, refills and issue date
prescribers signature
federal law mandates that ______ prescriptions must be written on tamper-resistant security forms in order to be eligible for reimbursement by states Medicaid programs
outpatient medicaid
The security forms that outpatient medicaid prescriptions are written on must contain at least three tamper-resistant security features. This applies to oral, faxed, and electronic prescriptions
false, just oral and faxed
The CMS required features must include at least ____ feature from each of the following categories:
1) prevents duplication (the word VOID appears when photocopied or faxed)
2) prevents the erasure or modification of the written information
3) prevents the use of counterfeit forms (pre-printed serial numbers, watermarks or microprint signature line)
one
by law, what healthcare providers can prescribe?
physicians
dentists
podiatrists
vets
NP
Rph
optometrists
naturopathic
T/F
physicians have unlimited, independent prescribing authority in all states
true
*all other prescribers can only prescribe within their SCOPE of practice and or under a physician directed prorocol
in order to fill a prescription, what must exist
a prescriber patient relationship
the NABP recommends that each of these conditions should be met for the prescription to be considered valid
a patient has a Medical complaint
a medical history has been taken
a face to face physical examination or telemedicine examination adequate to establish the medical complaint has been performed by the prescribing practitioner
a logical connection exists between the medical complaint, the medical history, the physical examination and the drug being prescribed
T/F
the American medical association recommends against physicians treating themselves or immediate family members
true
*the DEA does not address this prescribing, but individual state medical boards and pharmacy boards can prohibit or limit it
Some states limit this to medical emergencies, short term or minor issues or CIIs, or all scheduled
**LOOK UP IOWA
If a prescriber is treating an immediate family member, what must exist?
a prescriber patient relationship
if a doctor comes in to fill his own prescription, can the pharmacist refuse if they believe they are misusing the drug?
yes
T/F
federal law states that a prescription remains valid after the prescriber has retired or died.
false
does NOT specify
some states address this issue by having the prescription being invalid, other states have the rx as valid until it expires or the remaining refills are exhausted (whichever comes first)
In most cases, a rx written by an out of state prescriber in a different us state or territory is valid/invalid (?) if a true prescriber/pt relationship is present
valid
**see Iowa’s law
are there federal restrictions on receiving meds from a different country?
federal law allows the pharmacist to decide
are prescribers legally allowed to prescribe medications for other purposes if they feel it is safe and effective?
yes
can the drug manufacturer and their drug representatives initiate conversations with healthcare providers regarding off-label use of their drug?
no
ONLY IF DR HAS REQUESTED THE INFO
pharmacist are legally permitted to fill prescriptions for off label indications
true
must use their clinical judgement
what can pharmacists correct on prescriptions when there is an error?
minor errors – misspelling the drug name
if the drug error is not minor, pharmacist should consult with the prescriber and document discussion
is an omission a type of error in which required information on a prescription has been left out?
yes
example number of tablets required
after verification with the prescriber, the prescription can be RE-WRITTEN as an ORAL rx.
refills of prescriptions are permitted as long as the refills were _______ orally or in writing by the prescriber
authorized
schedule III and IC drugs have what time limit in which refills are permitted?
six months
What is the schedule V refill time frame for Iowa?
look it up
some states have it as the same as II and IV
Federal law prohibits refills of schedule II drugs
true
Emergency refills without the prescriber’s authorization –
a pharmacist must do what
- use professional judgment to determine if failure to refill might interrupt the patients ongoing care or if it would have significant adverse effects on their well being
- they must make a reasonable effort to contact the prescriber
What is the emergency refill day supply in Iowa?
72 hours
What is the federal limit of the transfer of non controlled prescriptions?
none
a pharmacist can transfer as long as there are refills
What does the NABP recommend to do when a pharmacy staff member legal transfers a rx to another pharmacy?
1) write or stamp “void” on front side of rx
2) and document on the back:
name and address of pharmacy to which prescription is transferred
name of pharmacist receiving rx
name of person transferring rx
transfer date
What is required of the pharmacyystaff member receiving the prescription?
reduces it to writing and writes transfer on the face of rx
and what’s required for a prescription:
patients info- full name/DOB/ street address
prescriber’s info (name, license designation, address)
drug info (name, strength, dosage form and quantity)
directions for use
refills
issue date
prescribers signature
Due to the durham-humprhy amendment, when a prescription is dispensed to a patient, the container must meet the following specifications:
the label must not be false or misleading
the drug dispensed must not be an imitation drug
the drug must not be sold under the name of another drug
the packaging and labeling must conform to the official compendia standards
if the drug is susceptible to deterioration, it must be packaged and labeled appropriately
What are the federal law requirements for prescription labls
patients name
directions for use
prescribers name
name and address of dispenser
serial or prescription number
date of filling
cautionary statements
***some states may require more – what does Iowa require?
what is the goal of standardizing container labels?
to promote patient understanding of medication usage, increase adherence and reduce medication errors
The USP standards (chapter 17) do/do not apply to inpatient medications
do not
which is correct-
take two tablets twice daily
take 2 tablets in the morning and 2 tablets in the evening
2nd one
this goes for specifying times too, say at 8am and 8pm instead of every 12 hours
what are the critical items on a prescription
patient name
drug name and stregnth
clear and simple directions for use
if a drug’s expiration date is 3/2022 when does it expire?
the end of the month
USP standards state that the BUD for a multiple dose container is no later than either of the following
the expiration date on the manufacturers container
or
one year from the date the drug is dispensed
whichever is first
if the drug is not used and the container is in tact, can unit dose/single dose prescriptions be returned to the pharmacy stock and be re-dispensed?
yes
what system do unit dose packaging have?
barcodes for scanning
to reduce med errors, nurses can scan the patients wristband barcode and the barcode on the unit dose package
can unit dose packages be put in ADCs?
yes
what information should be included on a unit dose prescription in an ADC?
drug name
quantity of active ingredient
BUD
lot number
name of manufacturer, packager, distributor
required cautionary statements
(specific formulations and CS require additional information – liquid formulations must have concentration and total volume listed)
According to the FDA and USP standards, the BUD for unit dose containers is no later than either of the following
1) six months from the date the drug has been repackaged
2) the expiration date on the manufacturers container
whichever is earlier
what act requires child resistant packaging?
90% of adults should be able to open it
PPPA
for many OTC products
most oral prescription drugs
dangerous household chemicals
the PPPa mandates that a new plastic container and closure (ie bottle and plastic cap) must be used for EACH prescription dispensed
true
its meats to avoid damage to the seal from wear and tear
If a glass container is used, what needs to be replaced?
the top closure
who can request drugs in an easy open non CR container?
patient or prescriber
Who can waive the use of a CR container for a single prescription
presriber
the patient can provide a BLANKET waiver for all prescriptions. the patient should document the waiver request with the patients signature
What have drug manufacturers done for people who find it difficult opening CR containers?
PPPA allows manufacturers to package one size OTC drugs in a non CR (easy open) container as long as the same product is also available in a CR container
the package MUST HAVE A WARNING—
“this package is for households without young children” or “package not child resistant”
Which prescription drugs do not require child resistant packaging?
1) select antianginals (SL NTG, SL and chewable isosorbide dinitrate dose <10mg)
2) select oral hormones (OC in memory aid packages, conjugated estrogens in memory aid packs <32mg, norethindrone acetate in memory aid packages <50mg, HRT)
3) select corticosteroids (methylprednisolone tablets with <84mg package, prednisone tabs with <105mg/pack)
4) cholestyramine powder, colestipol powder (<5g/pack), colesevelam powder (<3.75mg/pack)
5) unit dose oral K<50mEq
6) EES granules <8g, oral suspensions, tablets <16g
7) fluoride liquid or tabs with <110mg/package (50mg elemental)
8) pancrelipase tablets, capsules, powder
9) mebendazole tablets <600mg/pack
USP chapter 681 provides guidance on customized patient….
medication packages (“med paks
per USP, what should a medpak contain on the label?
same information required for a prescription label
serial/rx number
name, strength, physical description and total quantity of drug
required storage instructions
date of preparation and BUD
each removal med part should have a label identifying the drug inside that part of the medpack
record keeping of med packs include
the name and address of pt
serial # of rx for each drug
name of manufacturer or labeler and lot number for each drug
information identifying or describing the design, characteristics or specifications of the patient med pack sufficient to allow subsequent prep of an identical med pack
the date of prep ad BUD
any special handling instructions
name or initials of rph who prepared
_______ requires each state to have a drug utilization review program in order to be reimbursed for medicaid services
OBRA
there are two types of DUR required
1) prospective DUR: eval of patients drug therapy prior to dispensing (performed by the dispensing rph)
2) retropesetive DUR: eval of the drug therapy after medication dispensing (performed by the state)
Pharmacists must perform which DUR type for individual medicaid patients prior to dispensing a new prescription OR refill?
prospective DUR
what is the purpose of performing a prospective DUR
to look for following errors:
therapeutic duplication
incorrect dosing
incorrect in treatment duration
CI
drug drug, drug disease and drug allergy ineractions
abuse or misuses
what information should be in a patients profile?
patients name, address, phone number
DOB
gender
comprehensive list of meds (including OTC and natural) or devices previously dispensed
disease state information, drug allergies, intolerances, adverse drug reactions
social history
any relevant pharmacist comments
OBRA requires the individuals STATES to perform a system wide ________ DUR to analyze physicians prescribing habits and assess the appropriate use of certain drugs
retrospective
all information provided by the manufacturer for distribution with the drug, even if it is not physical affixed to the product, is considered part of the
drugs label
what is included in drug labeling
the label on the drug container
written material not approved by the FDA (consumer medication information/CMI)
written material approved by the FDA (patient package insert/PPI, instructions for use/IFU, medications guides, any paperwork required as part of REMS)
the FDA mandates that useful written patient information be prodded to patient with each
new prescription
CMI handouts are the PAPER leaflets of drug information that are put inside the bag or stapled to the outside. These are NOT REVIEWED OR APPROVED BY THE FDA*****
information should be simplified, and explain how to use the drug, receive benefit and avoid harm
When a PPI is not provided to a patient when receiving an oral contraceptive, its considered:
misbranding
***other drugs can voluntarily come with an FDA approved PPI if the manufacturer feels that there are important info
for oral contraceptives, what must be given each time the drug is dispensed in the outpatient or retail setting with both the initial fill and with refills?
PPI
In an institutional setting, such as a hospital or LTC facility, the PPI must be provided to the patient prior to the administration of which doses?
first dose and EVERY 30 DAYS after
what does the FDA require for medication with complicated administration that is intended fo the patient to use at home?
document containing instructions for use
its written by the manufacturer and APPROVED by the FDA
Are med guides FDA approved?
yes
they are used in prescriptions that may have a serious and siginifiant health concern
required in drugs or biologics that require patient education about how to PREVENT serious SE or if adherence is essential for effectiveness
Who must apply the medguides to the dispenser?
manufacturer
by providing the physical handouts or the electronic file so the pharmacy can print them for pt
Do NSAIDS require a med guide?
yes! and antidepressants
When must a medguide be given?
a drug is dispensed in the outpatient setting for patient self-administration without the supervision of a healthcare provider (initial fill and refills)
the first time the drug is dispensed to a healthcare provider for administration to a patient in an outpatient setting
the patient or their caregiver asks for it
the medguide has been revised
REMS
the FDA amendments act of 2007 gave the FDA the authority to
require a REMS from a manufacturers to ensure that the benefits of certain drugs and biologics outweighs the risks.
-FDA can mandate the use of REMS if they feel it has serious safety concerns; this ensures risks are known and are managed adequately
who develops the REMS?
the manufacturer (aka drug sponsor) and gets FDA approval before implementation.
What are the four parts of REMS?
communication plans
elements to assure safe use
implementation systems
medguides
what are examples of a REMS program?
clozapine
isotrentoin (iPLEDGE, no more than 30 day supply)
opioid analgesics
thalidomide (no more than 28 day supply)
what is the federal law for dispensing medications in a community pharmacy
currently is none
what does Iowa require
how many patient specific identifiers must be confirmed before administering med
two (ie medical record number, name)
HIPAA can be shared by what entities?
healthcare professionals
facilities where health care is provided (pharmacies, muring homes, clinics)
health insurance companies
healthcare profesionals must have documented HIPAA training
true
breach can lead to fines and imprisonment
Who is it permissible to share PHI with?
patient
healthcare providers caring for the patient
entities requiring the information for payment or operational purposes (QI, care)
a limited data set can be provided for research, public health or institutional operations
law enforcement (pursuant to a court order, warrant, subpoena, administrative request, to identify or locate a suspect, in response to an information request about a victim of a crime, in response to criminal activity or a death related incident)
The DEA, FDA, medical board inspectors and pharmacy board inspectors (for a public health purpose or drug abuse concern)
organizations related to donation and transplantation of organs and tissues
If a release of PHI is not for the qualified purposes, what must happen
a written authorization from patient
which must include plain language, whom the info will be shared with, the purpose, the right to remove authorization, the expiration date, and patients signature
incidental disclosures are unavailable and are acceptable under HIPAA
true
examples include:
oral coordination of patient care at nursing station
a discussion while on rounds
is redaction an appropriate form of minimizing disclosures of HIPAA?
no!
redaction is editing to censor obscure content
What does HIPAA require regarding the policies in place to protect PHI and whom it can be shared with
site-specific notice
& it should state the patients rights to their own information and be specific that any release beyond what is stated in the policy will require the patient wishes to file a. complaint
Where should the HIPAA privacy notice be placed?
in a prominent location within the pharmacy and on its website
When should the HIPAA privacy notice be given to the patient?
the first day that service is provided and at any other time it is requested
pharmacy should make good effort to obtain the patients written acknowledgement of receiving the notice
one signature for another thing can not be used for this
The signed HIPAA privacy disclosure forms must be kept for how many years? And the patient has a right to request all of their privacy disclosures for the past ___ years?
6 years
6 years
If a pharmacist labels a drug generic as a brand drug or vice versa, it is considered
misbranding
What is the orange book?
it serves as a guide for therapeutically equivalent drugs
“Approved Drug products with theprauetic equivalence evaluations”
on FDA website
For a drug classified as a therapeutically equivalent drug to a reference listed drug (RLD), the drug must meet what two requirements?
pharmaceutically equivalent (contain the same active ingredients, have an identical dosage form and route)
bioequivalent (similar ADME)
what is the first letter in the orange book when a drug is considered therapeutically equivalent to the RLD
A
AB –> in vivo similar
AA, AN (solutions or powders for aerosolization), AO (inj), AP (inj aqueous and non aqueous) and AT (topical) –> in vitro
What does it mean when it is a three character code? (has a # on the end)
there is more than one RLD of the same strength under the same heading
What is a negative formulary?
drugs with a narrow therapeutic index
Are biosimilars considered therapeutically equivalent to the reference product?
no
so a pharmacist can NOT automatically substitute these products for another
there are currently no FDA approved interchangeable biosimilar products
What committee is responsible for creating and updating the formulary, conduct medication use evaluations (MUE/DUE), monitor and report adverse drug events, conduct medication error safety initiatives, and develop clinical care plans and protocols?
P&T
Hospital pharmacists rely on guidance from who to help develop protocols?
ASHP, TJC, ISMP
What are the requirements for death with dignity?
18+
resident of a state who permits this
capable of making and communicating decision
diagnosed with terminal illness that will lead to death in 6 months
two physicians must determine whether the above criteria has been met
**patient must self administer
The FDA permits pharmacies to return prescriptions drugs to suppliers/wholesalers and manufacturers as long as there is
proper record keeping
rx drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be physically separated from other rx drugs until they are destroyed or returned to the supplier
A DEA-authorized collector can collect controlled and non controlled substances, but not…
illicit drugs or sharps from patients
List drugs that are on the FDA flush list
fentanyl (and containing products) hydrocodone (and containing products) oxycodone (and containing products) methylphenidate methadone morphine hydromorphone
What are the exceptions to the resale of prescription drugs
pursuant to a prescription
sales or purchases to other facilities within the same organization
sales to nonprofit affiliates
for emergency reason
(PDMA act)
