Law Final Flashcards
The time when internship hours shall be reported to the board
Upon request
The number of days a pharmacy technician has to notify the department of a change in home address or name/address of work
10 days
What three documents could designate the managing pharmacist of a pharmacist
1) Pharmacy license application
2) Most recent amended schedule of operations
3) Most recent license renewal application
Number of pharmacies for which a pharmacist may be the managing pharmacist for at any time
2
Type of pharmacy a pharmacist may be managing pharmacist at any time
One community and one institution
Activity that the managing pharmacist shall be engaged in at each location he or she supervises
Pharmacy practices
The period of time of anticipated continuous absence that requires a managing pharmacist to delegate supervision of the pharmacy to another pharmacist
more than 30 days
The provision of pharmaceutical services at a clinic of a practitioner, a county jail, or a juvenile correctional facility could be examples of what pharmacy type
Remote dispensing site
The person responsible for reporting to the board any changes in the managing pharmacist within 5 days of the change
The pharmacy owner
The activity common to institutional and community delegate-check-delegate eligible products that cannot be delegates
DUR
The frequency that the accuracy rate of each delegate must be checked using the records in the quality assurance log
Quarterly (every 3 months)
When delegate-check-delegate records need to be provided to the board
Upon request
Record of internship hours shall be maintained by who
Either the supervising pharmacist or the pharmacy school
An adult is disposing of a prescription drug at the drug disposal program, they are required to have this from the patient or guardian for each drug being disposed
Written authorization
The length of time written authorization to dispose of a prescription drug by another lay per is valid
24 hours
The persons in a family who may be granted written permission to dispose of a prescription drug from another member in the household
Domestic partner and another related adult
The portion of the definition of Schedule 1 and Schedule 2 substances that is the same
High potential for abuse
Pharmacies, online pharmacies, and these systems often found in long-term care facilities all require certificates of registration to engage in controlled substance activity
Automated dispensing system
Schedule 1 definition
High potential for abuse
No current accepted medical use in treatment in the United States
Lacks accepted safety for use in treatment under medical supervision
Schedule 2 definition
High potential for abuse
Currently accepted medical use in the United States, or currently accepted medical use with severe restrictions
Abuse of the substance may lead to severe psychological or physical dependence
Schedule 3 definition
Potential for abuse less than substances included in schedules 1 and 2
Currently accepted medical use in the treatment in the United States
Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence
Schedule 4 definition
Low potential for abuse relative to substances included in schedule 3
Currently accepted medical use in treatment in the United States
Abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances included in schedule 3
Schedule 5 definition
Low potential for abuse relative to the controlled substances included in schedule IV
Currently accepted medical use in treatment in the United States
Limited physical dependence or psychological dependence liability relative to the controlled substances included in schedule IV
The percent of distribution to another practitioner by a pharmacy allowable without a distributor license
5%
An online pharmacy can perform the activities of this type of pharmacy without requiring a second DEA registration
Retail pharmacy
The part of the DEA form 222 that includes the name and address of the supplier
Part 2
The manner by which schedules that may be ordered are filled in on the DEA form 222
Pre-printed from the DEA
The three drugs require their own DEA form 222 when ordering
Etorphine
diprenorphine
carfentanil
Of the information in Part 2 of DEA form 222, the information that the registrant can leave to the supplier to complete
The DEA number of the supplier
The document that must be included by the supplier with a returned unaccepted DEA form 222
Statement describing why the form was returned
The form used to order Schedule 1 and 2 controlled substances
DEA form 222
Acceptable method for filling in the DEA form 222
Typewriter
Pen
Indelible pencil
Printer
The person/entity responsible for completing the NDC numbers on an order using the DEA form 222
Supplier
The location where a purchaser must write CANCELED when a supplier partially or fully cancels a DEA form 222
The number of packages supplied field
A supplier may transfer a DEA form 222 to an alternative supplier by doing this to the DEA form 222
Endorse the form to another supplier
Number of days a supplier has to fill the remainder of partially filled DEA form 222 order
60 days
The words that must be written on the face of a DEA form 222 if a lost form is subsequently found by the supplier
Not Accepted
The location where paper copies of executed DEA form 222 must be retained
The pre-printed address of the purchaser (registrant) on the DEA form 222
The action required of a purchaser with unused DEA forms 222 if the DEA registrant of the purchaser terminates
Return the unused forms to the DEA
The format of the unique tracking number required on an electronic order for schedule 1 or schedule 2 substances
Last two digits of the year, X, six characters selected by the purchaser-9 digits total
Schedule of testosterone
C3
Schedule of tramadol
C4
Schedule of a product that contains not more than 200mg/100ml of codeine
C5
The schedule of a product that contains not more than 90 mg of codeine per dosage unit
C3
Schedule of LSD
C1
Schedule of most benzodiazepines
C4
Schedule of a product with not more than 1.6grams/100ml codeine
C3
By federal law, samples cannot be
Sold, purchased or traded
FDCA
Food Drug and Cosmetic Act
USP
United States Pharmacopeia
FDA
Food and Drug Administration
Document filed with the FDA to get a drug approved in the United States
New Drug Application (NDA)
Three methods to start the process of moving a prescription drug to non-prescription
New Drug Application (NDA)
New monograph created by the FDA
Citizen petition
Important changes from the Durham-Humphrey Amendment
Authorized refills and verbal prescription orders
Distinguished between prescription and non-prescription orders
FDCA definition of a drug
To diagnose, cure, mitigate, treat, or prevent a disease
As both have the potential to impact the structure and function of the body, this is specifically noted in the FDCA to not be a drug
Food
An article is a drug when this entity makes a health claim of the intent of the drug to diagnose, cure, mitigate, treat, or prevent disease
The manufacturer
The numeric information that needs to be disclosed when making a health care claim of the benefit of a dietary supplement in preventing a nutrient deficiency disease
Prevalence of the disease
FDCA definition of a drug device
An instrument, apparatus, or implant that is intended to diagnose, cure, mitigate, treat, or prevent disease
The act that requires the statement, when applicable: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Dietary Supplement Health and Education Act (1994)
The category of food that is administered orally or by tube under the supervision of a physician intended for specific dietary management of a condition with distinctive nutritional requirements
Medical food
The person or entity who determines how often a periodic review of the prescription orders of the physician assistant should be reviewed
The supervising physician
The therapeutic class of drugs a nurse practitioner cannot prescribe to enhance athletic performance
Anabolic Steroids
The indication of which a nurse practitioner may prescribe schedule 2 controlled substances for pain
Cancer
The title of an eye doctor who can prescribe but is not also a medical physician
Optometrist
The limitation on prescribing imposed on dentists
Within the scope of their practice
In addition to topical agents, the broad class of medication the optometrists can also prescribe
Oral analgesics
The name and amount of the only C2 that an optometrist can prescribe
Hydrocode 15mg per dosage unit
The otherwise legal prescription that a physician in prohibited from writing in Wisconsin
Self-prescribed controlled substances (C2-4)
Providers who can supervise a pharmacy intern administer a drug or device as defined in Wisconsin law
Pharmacist who are also eligible to administer the drug or device
The category of drugs specifically excluded from the laws pertaining to the administration of drugs and devices by pharmacists in Wisconsin
Vaccines
Minimum length of time required of courses of study on administration of drugs and devices in Wisconsin
No specified
Two alternatives when communicating administration of a drug or device to a patient under Wisconsin law
Notifying the prescriber
Entering the information in a common patient record system
Activities that can be delegated from a physician to a pharmacist
Any patient care services
The length of time and from when documentation of delegated patient care services from a physician to a pharmacist must be maintained
5 years from the time of the last delegated patient care act
Providers who may delegate any patient care service to a pharmacist
Physicians
The two entities who must approve written guidelines or procedures for a pharmacist to make therapeutic alternative drug selections in a hospital
The Pharmacy and Therapeutics committee
The medical staff of the hospital
Locations specified where pharmacists perform therapeutic alternative drug selection as part of pharmacy practice
Corrections system
nursing homes
nursing facilities
hospitals
Pharmacy practice definition
Drug product substitution, participating in drug utilization reviews, therapeutic alternative selection and drug regimen screening
Minimum age a pharmacist can administer COVID or Flu vaccines without a prescription allowed by the PREP Act
3
The length of time a prescription for a non-CDC-scheduled vaccine is valid
29 days
The providers who can supervise a pharmacy intern vaccinating
Any medical professional who can also vaccinate
The age limit for pharmacists providing vaccinations based soley on the CDC vaccine schedule (ignoring the PREP act)
6
Category of vaccination an intern may administer to those 6 years and older
Vaccines with a prescription order
Any vaccine that is indicated on the CDC schedule
Credentials required of a pharmacy technician in order to be eligible to vaccinate
Completing the course of study
Being a certified technician
Minimum required length of time of a course of study on vaccine administration for pharmacists
12 hours
Length of time a pharmacist has to update the WIR after administrating a vaccine
7 days
The institution that published the current schedule for vaccines that allow pharmacists to vaccinate without a prescription
CDC
The providers who can supervise a pharmacy technician vaccinating
Pharmacist who are also eligible to vaccinate
The item specified to the drug that N8.07(1) [federal] does not specify as required on a prescription order that Phar7.02(1) [Wisconsin] does
The strength of the drug
The person who is required to sign a prescription order from a PA
The prescribing PA
The delegating practitioner information required on a non-controlled substance order based on M17.06 [federal] that is not an expectation of Phar7.02(1) [wisconsin]
The phone number of the delegating practitioner
The person who must approve the pharmacy designated to receive an electronic order
The patient
The patient needs to tell the practitioner in writing in order to have this information required on the label of a prescription
The indication/symptom/purpose
For non-controlled substance, a common drug element that is not specifically required by law on a prescription order
The dosage form
The person to whom a naloxone prescription order can be written
Anyone
Required elements on a prescription order for a non-controlled substance related to the practitioner
First and Last name
Signature
Address
The drug and dosage form that can be prescribed to a school with a school named on the prescription order instead of the patient
Epinephrine auto-injectors and prefilled syringes
Acceptable patient identifiers on a chart order
First and Last name
Date of birth
MRN
Items a delegate must include specific to him or herself on a prescription order
First and last name
The two requirements on a prescription order for an individual patient to identify the patient
Name and address
The type of prescription order that the law considers a faxed C3-5 prescription order
Written order
The controlled substance schedules that allow for electronic prescription
C2-5
The person for which a fax can serve as the original signed C2 prescription order but only for C2 narcotic substances of any dosage form
Hospice
The time when a controlled substance prescription order expires
It does not
What must be determined by both the provider and the pharmacist in order to prescribe and fill, respectively, a controlled substance
A legitimate medical purpose
Maximum day supply that multiple C2 orders issued at the same time can provide a patient
90 day supply
The prescription requirement specified by the federal Controlled Substance Act for GHB
The medical need of the patient on the face of the prescription
The person resposible for the legitimate medical purpose of prescribed controlled substance
The dispensing pharmacist and the prescribing practitioner
The additional requirement on a C2 prescription order when multiple prescription orders are issued at the same time for a patient
Earliest date to fill
The practitioner category for a person with a DEA registration number that starts with an M
Mid-level practitioner
The task that a prescriber may authorize an agent to do related to controlled substance prescription orders
Orally communicate or faxing the order to the pharmacy
The prescription order that must be used when the same controlled substance prescription order is sent both electronically and as a paper to one pharmacy
What ever is older
The provider who is required by law to include on the prescription order the indicated use of the prescribed controlled substance
Optometrist
The person who shares liability with the prescriber if a prescription is dispensed when an order does not meet DEA regulations
Dispensing pharmacists
The requirement on a controlled substance prescription order for a patient that is not a requirement of non-controlled substances
Drug dosage form
Prescribers DEA number
The person responsible to sign a prescription order completed by an agent of the prescribing practitioner
The prescribing practitioner
With some exceptions, the persons allowed to prescribe controlled substances
DEA registered practitioners
The method expected in the law to keep unauthorized persons from altering electronic prescription orders for controlled substances
Limit electronic access to only authorized persons
The limits on refills for C3 and C4 controlled substances
up to 5 refills within 6 months of the date of issue on the prescription
The number of days an extension can be provided for controlled substances that are out of refills
0
The maximum day supply that a pharmacist may increase a quantity to if otherwise allowable by law
90 days
Outside of specified exception, the type of filling that a pharmacist may not increase the quantity for non-controlled substance with refills
Initial filling
The persons responsible for determining the legitimate medical purpose of controlled substance prescriptions
The prescriber and the pharmacists
According to the federal CSA, the persons who shall provide effective controls and procedures to guard against theft and diversion of controlled substances
Who are all applicants and registrants
Criteria a controlled substance order is legally obligated to meet based on the CSA
Issued for a legitimate medical purpose
Prescribed within the scope of practice
The action that would lead to a person being subject to the penalties provided for violations of the provisions of law relating to dispensing controlled substances
Knowingly filling an invalid prescription
The specific quantity of loss of controlled substances that qualifies as a significant loss as defined by the CSA
Not specified
The phrase that the CSA expects to have been ensured when a controlled substance is both prescribed and dispensed
A legitimate medical purpose
The timeframe required for notification of the DEA if a pharmacy discovers significant loss/left of a controlled substance
1 day
The form required to be completed in the event of a loss or theft of controlled substances
DEA form 106
The timeframe for notification of the board of a theft or loss of controlled substances
1 day
Criteria that would cause a person to not be employable within a pharmacy that would otherwise provide them access to controlled substances
Denied DEA registration
Had to surrender their DEA registration for cause
Convicted of a felony related to controlled substances
Two-word term that is defined as “a consequence of any federal or state administrative, civil, or criminal action resulting from the investigation of the individual handling of controlled substances.”
For cause
The word that must be added to the face of a non-controlled substance paper-based prescription when it is transferred to a different pharmacy
Void
In addition to any remaining refills, the law allows this to be transferred for non-controlled substance prescriptions
The original prescription order
The law allows transferring this between pharmacies for any prescriptions for controlled substances
Any remaining valid refills
The person who can request a transfer of a prescription
the patient
The methods of communication allowed for transfer of a non-controlled substance prescription
verbally, electronically, and by fax
The state to which the law allows transfer of a non-controlled prescription when the pharmacy is in Wisconsin.
Any state
The word that must appear on a prescription order that is transferred from another pharmacy
Transfer
The person(s) who can provide or take a transfer prescription
pharmacist and pharmacy interns
They type of system that allows for refills of orders, whether for non-controlled or controlled substances, to be transferred as long as valid refills remain
Shared computer system
Unlike non-controlled substance order transfers, this cannot be transferred for a C-III, C-IV, and C-V order (wisconsin law)
Original prescription order
Transfers of controlled substance orders, when a shared computer system is not being used, uniquely stipulate the need for this type of communication to always be part of the process
Direct communication between two pharmacists
The entity whose DEA number must be recorded when transferring a controlled substance prescription order from your pharmacy
The DEA number of the pharmacy accepting/receiving the transfer
While the dates and locations of all previous refills must be documented when receiving a transfer order for a controlled substance, this element, while good practice, is not technically listed as a requirement to be documented
Quantity of each previous refill
In addition to the DEA number of the prescriber and the DEA number of the pharmacy originally filling an order being transferred for a controlled substance, the other required DEA number
DEA number of the pharmacy providing the transfer
Along with errors, inadequate instructions, and contraindications/incompatibilities, the reason a contraceptive prescription could be refused to be dispensed
Potentially fraudulent
The term used to refer to a right of a provider to not provide care that conflicts with his or her beliefs
Conscientious objection
With legal term for the time frame expected for dispensing a contraceptive prescription
Without delay
The phrase that must be included on a written or electronic order that is sent subsequent to a C-II substance oral order
Authorized for emergency dispensing
The entity who must be notified if a prescriber fails to provide a written or electronic order subsequent to an oral authorization for a C-II substance
Nearest DEA office
The controlled substance schedules that allow for partial dispensing
C2-5
Along with the pharmacist being unable to supply a full quantity, the reasons why a C-II prescription may be partially filled for a patient who is not terminally ill or in a LTCF
Patient or prescriber asks for a partial fill
Along with the C-II substance is immediately necessary for proper treatment and the prescriber cannot reasonably provide a written order, the criteria that must be met to allow oral authorization of a C-II substance
What is no appropriate alternative treatment is available
The schedules that may require identification be provided when dispensing the medication to someone other than the patient
C2 and C3
The two categories of patients who are eligible for multiple partial fills on the same C-II prescription order
Terminally ill and LTCF
The number of dosage forms that all partial fills combined of a single C-II prescription order cannot exceed
The original quantity of the prescription order
The instance(s) that allow for legal use of marijuana in Wisconsin
none
The number of hours before the remainder of a partially filled C-II prescription order cannot be dispensed
72
The location where prescription drugs are prohibited from being placed for delivery in all circumstances
Public place
The class of drugs that cannot be extended by a pharmacist when there are no more refills on the prescription order
Controlled substances
The number of days that a non-controlled drug can be extended when it is out of refills before a new order is required
7 days
The number of days that a controlled substance that is out of refills can be extended
0 days
The action required of the pharmacist before providing an extension to a patient who is out of refills
Attempt to contact the provider to get a new prescription
The number of times a non-controlled substance that is out of refills can be extended within this timeframe
1 time in a 1 year period
Along with your own pharmacy, the location(s) where a medication may have been refilled that would still allow you to provide an extension when out of refills
Pharmacy in the same chain
The class of drug that is specifically noted in requirements for reporting potential causes of a public health emergency
Antibiotics
The patient personal identifying information that is never appropriate to share when reporting potential causes of a public health emergency
Social Security Number
The length of time a pharmacy has to report a potential cause of a public health emergency to DHS
24 hours
The two INCORRECT drug therapy problems specifically noted to be part of the OBRA 90 mandated profile screening
Incorrect dose or duration of treatment
Along with educational programs and retrospective review, the required element of drug utilization reviews in OBRA 90
Prospective review
The part of the required prospective DUR that is included in the final check of the prescription before dispensing
Screening of the profile for drug therapy problems
The type of interaction required in prospective DUR as part of WI law that is not required as part of OBRA 90
Drug-food interactions
Along with drug-disease contraindications and drug-drug interactions, the other type of interaction that must be screened for as a part of the prospective DUR requirement of OBRA 90
Drug-allergy interactions
The number of verifications that are required for automated technology product verification validation
2500
In addition to the prospective DUR and the label requirements and accuracy, the other required component of final check
Verification of the drug or device
The acceptable quality assay for narrow therapeutic ratio drugs as specified by the FDA
95-105%
Uniquely for extended release products compared to other oral dosage forms, an attribute that does not need to be identical for the products to be therapeutic equivalents
The extended release mechanism
The pharmaceutical term for drug products that are identical in dosage form, route of administration, drug amount, and active drug ingredient
Pharmaceutical equivalents
The term for a drug having less than a 2-fold difference between the median lethal dose (LD50) and the median effective dose (ED50)
Narrow therapeutic index
The required color of a therapeutic equivalent when the reference drug product is pink
None
The pharmaceutical term for drug products that are identical therapeutic moieties but can be different salt/ester forms
Pharmaceutical alternatives
The term for a biological product that can be substituted for a reference product with permission from the prescriber and the patient
biosimilar
The persons who must agree that a prescription can be dispensed with a B rated, lower-cost generic drug product when a prescription is written for the brand product
The patient and the prescriber
A method of indicating no substitutions on the face of the prescription that is specifically forbidden in the law
Pre-printed on the prescription
The specific portion of the definition of pharmacy practice that serves as an alternative to a hospital having to adhere to generic substitution laws
Therapeutic alternative drug selection
An acceptable short-hand notation under the law that would indicate that a prescriber is not allowing an otherwise acceptable generic substitution
NS
The term for a biological product that can be substituted for a reference product without an intervention from the prescriber
Interchangeable
The person who has the final decision on whether to use a B-rated, lower-cost biological product when a prescription is written for the brand product
The prescriber and the patient
The Orange Book rating of a drug product that is therapeutically equivalent to a different drug product rated AB3
AB3
The Orange Book rating of a drug product that is therapeutically equivalent to a different drug product rated BD
None
The rating required to use a different biological product for a prescribed biological product without a prescriber approval, assuming the patient is agreeable
I rated
The letter and position of the letter that designates bioequivalence in The Orange Book
A in the first position
The person who has the final decision on whether to use a I-rated, lower-cost biological product when a prescription is written for the brand product
Patient
The rating required to use a different drug product for a prescribed brand product that is AB3 rated without a prescriber approval, assuming the patient is agreeable
AB3
The law that established the abbreviated new drug application with the goal of lowering medication costs by increasing generic drug options
Hatch-Waxman Amendment
Drug Price Competition and Patent Term Restoration Act
The person who has the final decision on whether to use an A rated, lower-cost generic drug product when a prescription is written for the brand product
The patient
The person who shall select the drug products purchased for subsequent sale and dispensing at a pharmacy
Any pharmacist employed at the pharmacy
The item that a patient may request be added to a prescription label for dispensing
Symptom/purpose/indication
Along with special storage conditions if required and the drug name, strength, and dosage form, the required element on a label for a prescribed drug product in an institutional facility that will be administered by a health care provider
The BUD
The exception to when the label for dispensing of a compounded drug product must include an indication that the preparation is compounded
When it is administered by healthcare personnel
The information about the pharmacy that is required on a dispensed prescription label in Wisconsin that is not a federal requirement
Phone number
The proper method of listing the name of a pet on a prescription label for dispensing
First name, species of animal, last name
The symbol, as defined by federal law, that must not appear on all labeling of an over-the-counter drug at all times prior to dispensing
RX
The law that changed label requirements for dispensed prescriptions relative to the label requirements of manufacturers and distributors for prescription drugs
Durham-Humphrey Amendment
The symbol, as defined by federal law, that must appear on all labeling of drug that requires a prescription at all times prior to dispensing
RX
The setting where the label requirements from Phar 7.05 typically do not apply
The hospital (institutional) setting
The words or initials that may be substituted for a patient name when an antimicrobial drug is dispensed to treat the partner of a patient with a sexually transmitted infection
EPT (Expedited partner therapy)
The drug products whose dispensing labels must include the statement: Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
C2-4
The situation that allows the statement “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” to be omitted from a label for dispensing when it would be otherwise required
The product is dispensed as part of a blinded clincial investigation
For C-III, IV, and V prescriptions administered in an inpatient setting by a healthcare provider, the limitations on dispensing before the label would be required to adhere to the standard labeling for dispensing requirements for C-III, IV, and V controlled substances
34 day supply or 100 dosage units, whichever is less
For a C-II prescription administered in an inpatient setting by a healthcare provider, the number of days supply that can be dispensed before the label would be required to adhere to the standard labeling for dispensing requirements for C-IIs
7 days and cannot be in patient possesion
The specific legal name of packaging that is expected by the PPPA to be child-resistant
Special packaging or complying package
The amount of elemental iron that requires complying packaging based on the PPPA
250mg in the entire package
The persons who may request the use of noncomplying packaging for a drug dispensed pursuant to a prescription order
The patient and prescriber
The law enforced by the Consumer Product Safety Commission (CPSC) that impacts almost all prescription drug packaging
Poison Prevention Act
In addition to labeling with the statement THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN or PACKAGE NOT CHILD-RESISTANT, the conditions by which a manufacturer may sell a household substance in noncomplying packaging
When there is only one size in noncomplying packaging and that same size is also available in complying packaging
The specific age range of children tested in the PPPA complying special packaging tests
42-51 months old
The lengths of time that adults have to pass the PPPA test for opening and closing complying special packaging
5 and 1 minute
Along with dermatological and dentifrice, these products that are exempt from tamper-evident packaging requirements
Insulin and lozenges
The legal requirement of the documentation of a patient requesting noncomplying packaging
None
For the PPA, the passing percents of children subjects who could not access drugs from complying special packaging in 10 minutes without and with demonstration
85% with demonstration and 80% without
The number of times that special packaging may be reused as specified in the PPPA (21 CFR 1700.15)
none
The legal term for a drug product that was not made following expected good manufacturing practices?
