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Kansas MPJE Exam 2023 Studyguide
When does a pharmacist license need to be renewed in KS? - ANSWER Biennially, June 30th
What are the CE requirements in KS? - ANSWER 30hours /2years, board approved, this number is prorated for the year that you are a new grad
Intern hour requirement in KS? - ANSWER 1740 hours
Intern license expiration in KS? - ANSWER 6 years
Regulations on the sale of pseudoephedrine containing products specific to Kansas? - ANSWER Must be 18 or over to purchase
Purchase information must be logged into the national precursor log exchange (NPLEx) BEFORE completing the sale
Products cannot be sold if a "stop sale" alert is generated by NPLEx
Log must include name or initials of dispensing pharmacist
Pharmacist to technician ratio in KS? - ANSWER 1:
Can increased to 1:3 if 2 are certified
Pharmacist to intern ratio in KS? - ANSWER 1:
What tasks can technicians legally perform in KS? - ANSWER Under direct RPh supervision and control may perform:
Packaging
Manipulation
Repetitive
Other non discretionary tasks related to the processing of an Rx or med order
Assist the RPh in the performance of but who does not perform duties restricted to a pharmacist
Regulations regarding patient counseling in KS? - ANSWER RPH or intern must personally offer to counsel on new Rx yearly or if RPH deems appropriate with refills
Verbal counseling must be in person or on the phone
Additional pt information may supplement verbal counseling HOWEVER it is not a substitute
RPH or intern must notify pt if a brand has been substituted for generic
RPH does not need to provide counseling if patient refuses
PRH does not need to counsel if it may be detrimental to patients care or pt/prescriber relationship
Size, design, layout, security features or formatting requirements for Rx pads in KS? - ANSWER Blank forms for written Rx can have 2 signature lines, 1 must say DAW and the other "brand exchange permissible"
Controlled Rx (II-V) can't be issued on Rx blank that is preprinted with drug name, strength, quantity, or directions
How long is a non-controlled Rx valid in KS? - ANSWER One year from the date of issue
How many refills can be on a non-controlled Rx in KS? - ANSWER Unlimited
How long is a schedule III, IV, or V script valid in KS? - ANSWER 6 months
How many times can a schedule III, IV, or V script be refilled? - ANSWER 5 times
How long is a scheduled II script valid in KS? - ANSWER 6 months from the date of issue
How long must Rx records be kept in kansas? - ANSWER 5 years
Which drugs must be reported to the PDMP (KTRACS)? - ANSWER II-IV scheduled drugs
butalbital/APAP/caffeine
Ephedrine or pseudoephedrine
How often does dispensing data need to be reported to the state PDMP? - ANSWER Within 24 hours of dispensing (0 reports may still be filed every 7 days?
6 requirements for emergency verbal scheduled II prescriptions? - ANSWER 1. Limit quantity to treat pt for emergency period
What/who/how many are studied in phase 1 clinical trials? Purpose? - ANSWER Approx 20 healthy subjects
#1 SAFETY, also (SE, AE, PK, PD)
What/who/how many is studied in phase 2 of clinical trials? Purpose? - ANSWER Approx 200 patients (people who have the disease)
Safe and Effective
What/who/how many are studied in phase 3 of clinical trials? Purpose? - ANSWER Approx 2000 patients
Determine if the drug is better than a standard drug treatment
What is submitted after pre clinical trials are completed? - ANSWER INDA (investigational new drug application)
What/who/ how many are studied in phase 4 of clinical trials? Purpose - ANSWER Approx 200,
Post marketing surveillance - long term effects of exposure to the drug
What is submitted after phase 3 of clinical trials? - ANSWER NDA - new drug application or BLA - biological license application
What is submitted to change the label, add a new indication, dosage, strength, or change the way a drug is manufactured? - ANSWER SNDA - supplemental new drug application
How are OTC drugs approved by the FDA? - ANSWER Either NDA process or OTC monograph
If a company submits an OTC drug monograph to the FDA what will the FDA try to determine in order to bring the drug to market? - ANSWER If the drug is generally recognized as safe and effective
What type of form is required for generic drug approval with the FDA? - ANSWER ANDA - abbreviated new drug application
Where should all adverse events from drugs be reported to? - ANSWER Medwatch (FDA)
An unapproved drug will have an NDC number but will not be listed where? -
ANSWER Orange book
Who regulates prescription drug advertising? - ANSWER FDA
Who regulates OTC drug advertising? - ANSWER FTC - federal trade commission
Any false of misleading statements in the advertisement of a drug is considered what? - ANSWER Misbranding
What was the main point of the 1938 FDCA? - ANSWER Safety
A drug is filthy, putrid or decomposed. What is this considered? - ANSWER Adulteration
A drug has been packed or stored in unsanitary conditions where it may have become contaminated. What is this considered? - ANSWER Adulteration
A drug is recognized in official compendium but its strength is different from official standards. What is this considered? - ANSWER Adulteration
A drug is recognized in official compendium but its purity is lower than official standards. What is this considered? - ANSWER Adulteration
There is a lack of required information on the package labeling of an Rx. What is this considered? - ANSWER Misbranding
There is false of misleading product information on a drug. What is this considered? - ANSWER Misbranding
There is a lack of special precautions needed to prevent the decomposition of a drug. What is this considered? - ANSWER Misbranding
There is information that is illegible on a Rx. What is this considered? - ANSWER Misbranding
What is the big take away from the Durham-Humphrey amendment of 1951? - ANSWER Rx vs OTC drugs established
What was the big take away from the Kefauver Harris amendment? - ANSWER Drugs must be safe and effective before coming to market
What was the purpose of the controlled substances act of 1970? - ANSWER Establish a closed system with the purpose of reducing drug diversion
What was the big take away from the poison prevention packaging act of 1970? - ANSWER It requires household substances to be placed in CHILD RESISTANT
ANSWER It addresses a nutrient deficiency, supports health, or is linked to a body function
List the 3 requirements for a drug to be an OTC drug - ANSWER 1. Effective for self diagnosed conditions by the general public
- Have adequate written directions
- Do not require physician supervision
Which part of an OTC drug label that is most likely to be displayed or examined in a retail setting? - ANSWER Principal display panel
Federal regulations require the labeling of what if the content per dosage exceeds the threshold amount set by the FDA? - ANSWER Electrolyte content - (sodium, calcium, magnesium, potassium)
What are the 2 FDA approved drugs for emergency contraception and what is their regulatory status? - ANSWER Levonorgestrel (Plan -B) - Rx and OTC
Ulipristal (Ella) - Rx only
How soon after unprotected sex should Plan B be taken? Ella? - ANSWER Plan B - preferred up to 72 after but can be recommended up to 120 hours
Ella - preferred when it has been 72-120 hours
Which DEA form for registration of pharmacies, hospitals, practitioners or teaching institutions? - ANSWER 224
Which DEA form for registration of manufacturers, distributors, researchers, analytical laboratories, importers or exporters? - ANSWER 225
Which DEA form is for registration for narcotic treatment programs? - ANSWER 363
Which DEA form is used for ordering schedule 1 or 2 drugs? - ANSWER 222
Which DEA form is used for reporting theft, significant loss of controlled substances? - ANSWER 106
Which DEA form is used to record destroyed controlled substances? - ANSWER 41
"A practice of pharmacy in which an RPH performs pharmacy related patient care
functions for a specific patient that have been delegated to a RPH by a physician through a collaborative practice agreement" What is this called? - ANSWER Collaborative drug therapy management
"A signed agreement or protocol voluntarily entered into between an RPH and a physician that provides collaborative drug therapy management" What is this? - ANSWER Collaborative practice agreement
How soon after making a drug or drug therapy change must the PRH initiate contact with the physician? - ANSWER 48 hours
Who must be notified if an RPH has entered into a CPA? - ANSWER The board of pharmacy within 5 business days after the CPA or update has been signed
How often must a CPA be reviewed and updated? - ANSWER At least every 2 years
Who must sign and date a CPA? - ANSWER All physicians and pharmacists involved
Who is entitled to enforce conditions of places that sell drugs (pharmacy, drugstore)? - ANSWER Secretary of Health and Environment
How many different nonprescription drugs can be sold in one vending machine? - ANSWER 12
Which things can't be sold in a vending machine? (4) - ANSWER Poison
Rx only drugs
Ephedrine alkaloid containing drugs
Drugs intended for human use by hypodermic injection
What must labeled on a vending machine? (4) - ANSWER 1. Owner of the machine
Where must an PRH obtain a permit from if they want to sell Amygadlin (Laetrile)
- ANSWER The secretary of health and environment
What must be on the label of DMSO sold OTC? (4) - ANSWER Description of all contents of the solution
Statement of purity
Percent DMSO
Manufacturers name and address
Which types of products does kansas law require require RPH to put BUD's on? - ANSWER Non-sterile compounding/repackaged
Sterile - compounding/repackaged
In the absence of stability data to the contrary, non-sterile solid and liquid dosage forms that are packaged in single unit/unit dose containers have a BUD of... - ANSWER 1 year from date of packaging
OR
Expiration date on manufacturers container whichever comes first
What is the max BUD for a compounded non-sterile preparation that is non-aqueous? - ANSWER Earliest expiration of an ingredient
OR
6 months whichever is earlier
What is the max BUD for a compounded non-sterile preparation that is a water-containing oral formulation - ANSWER Not later than 14 days
What is the max BUD for a compounded non-sterile preparation that is a water containing topical/dermal/mucosal liquid or a semisolid formulation? - ANSWER Not later than 30 days
How many times can a C2 Rx be transferred? - ANSWER NONE
How many times can a CIII-CV Rx be transferred? - ANSWER 1 time
Except if pharmacists share a real time online database then they can transfer up to the number of refills
Who can transfer controlled substance prescriptions? - ANSWER ONLY between two licensed pharmacists
How many times can non-controlled substances be transferred? - ANSWER Up to the number of refills authorized
Can a pharmacy tech perform an Rx transfer in KS? - ANSWER NO
How long must the original and transferred rx's be maintained? - ANSWER 2 years from the date of the last refill
What must the transferring pharmacist write on the invalidated Rx or in the computer record? - ANSWER 1. Void on the face or transferred in the computer
- Name and address of receiving pharmacy, the date, names of both pharmacists
- If controlled, the DEA number of the receiving pharmacy
What must the transferring pharmacist record? - ANSWER 1. The word transfer on the face of the Rx
APRN - advanced practice registered nurse
PA - physicians assistant
Are hypodermic syringes and needles considered drug paraphernalia? - ANSWER Yes
Where can CV OTC's be kept? - ANSWER Behind the counter
Can samples of controlled substances be provided? - ANSWER No, except ezogabine, lacosamide, and Pregabalin (schedule V CNS narcs)
How often dose kansas law require a CS inventory? - ANSWER Every year at least 8 months after the previous inventory
Each pharmacist involved in dispensing a CIII or IV must verify the accuracy by doing what? - ANSWER Signing a hard copy printout, bound book, of separate file within 72 hours of dispensing
If a centralized computer system is used to dispense CIII or IV it must be capable of providing a printout in what amount of time to give to the board? - ANSWER 48 hours
Which drugs to kansas list as "drugs of concern"? (5) - ANSWER Butalbital/APAP/caffeine
Ephedrine
Pseudoephedrine
Promethazine with codeine
Gabapentin
What is the term for drugs that were already on the arrest prior to the FDCA in 1938? - ANSWER Grandfathered
How long is a registration valid for a pharmacy that registers as a dispenser of controlled substances? - ANSWER 3 years
How do you determine if a DEA number is correct? - ANSWER 1st + 3rd + 5th = X
(2nd + 4th + 6th) x 2 = Y
X+Y=Z (last number of z = 7th number)
First letter tell what kind of prescriber (A,B,F for Dr, M for mid level practitioner)
Second letter if the first letter of the last name of the prescriber (for pharmacy it may be last name of pharmacy name)
Where can a pharmacies controlled substance stock be stored? - ANSWER In a locked cabinet
OR
Dispersed throughout the pharmacy stock
Where can C2 records be kept? - ANSWER They must be kept separate from all the other invoices
What are the exceptions to the 72 hour rule for dispensing the remainder of a C RX? - ANSWER Terminally ill patients and long term care patients (60 days)
What is the limit for OTC syrups with codeine (schedule V) in KS? - ANSWER
contains ephedrine, pseudoephedrine, or phenylpropanolamine (EPP)
AND
may be marketed as a nonprescription drug
With what entity must a seller self-certify before selling any scheduled listed chemical product(pseudoephedrine)? - ANSWER The Attorney General
What is the pseudoephedrine 30 day base limit from a mobile retail vendor? - ANSWER 7.5g
In what case does someone not have to sign the PSE logbook or show ID? - ANSWER if the customer buys a single package of PSE containing not more than 60mg
What must purchaser do to get pseudoephedrine? - ANSWER -provide photo ID showing proof of 18 years of age
-sign paper/electronically in logbook that contains (name, address, time and date of sale)
How long must the PSE logbook be maintained? - ANSWER 2 years after the date of purchase
Under what circumstances can a previously dispensed medication be resold? - ANSWER If they are in a unit dose system that contains only one medication which has not reached the patient and is still in tact
In order to participate in donating unused medications to the medically indigent what must a pharmacy do? - ANSWER Submit a written notification to the board of pharmacy
Can unused controlled substances be donated? - ANSWER No
Who is allowed to accept donated medications? - ANSWER "qualifying centers or clinics" - indigent health clinic, federally qualified health center or community mental health center
What entities can donate unused medications? (3) - ANSWER Adult care home
Mail order
Medical care facility
Can a fee be charged to the patient for donated medications? - ANSWER Yes, but only a handling fee not to exceed 200% of the medicaid dispensing fee
Can a physician obtain a controlled substance for general dispensing to patients? - ANSWER NO
Controlled substances can not be issued on what type or prescription blank? - ANSWER Pre-printed with the drug, quantity or directions
When must a CS inventory be performed in relation to a change in PIC? - ANSWER Old PIC - before leaving the position
New PIC - Within 72 hours after starting
Which act was enacted to address the increasing problem of CIII-V drug sales through rogue internet sites? - ANSWER Ryan Haight Online Pharmacy Consumer Protection Act (2008)
- Hospice care patient
How long must the rest of a partially filled C2 rx be dispensed? - ANSWER Within 72 hours of the date of the first partial filling
When can partial fills of C2's be dispensed longer than 72 hours after initial filling? (2) How long after? - ANSWER 1. Pt is in an adult care home
- terminal illness
60 days after date of issue
What must also be included on a prescription written by an APRN? - ANSWER The name, address, and phone number of the responsible physician
What must be indicated when a prescription order is being transmitted by a PA? - ANSWER If it is the direct order of the physician, pursuant to a protocol, or because of an emergency
can optometrists prescribe controlled substances? - ANSWER Yes, if registered by the FDA
Can an optometrist dispense a prescription medication? - ANSWER Yes, but it is limited to a 24hr supply or minimum quantity necessary until rx can be filled by a pharmacist
How long does a pharmacist have to obtain the original rx from a physician for an emergency C2 fill? - ANSWER 7 days
Allowable time to complete a partial fill for C2 for a patient in a LTCF? - ANSWER within 60 days of the date of issuse
allowable time to complete a partial fill for C2 for an ambulatory patient? - ANSWER 72 hours of the first partial fill
Allowable number of times and/or length of time a pharmacist may refill a CIII or CIV if authorized? - ANSWER 5 times or 6 months
Allowable number of times and/or length of time a kansas pharmacist may refill a CV prescription if authorized? - ANSWER 5 times or 6 months
Quantity of drug a pharmacist may dispense on a CII emergency prescription? - ANSWER Enough for the emergency period; Not limited to a specific number of doses
The CS schedule of a preparation containing more than 50mg of morphine per 100ml or per 100g combined with 1 or more active non-narcotic ingredients? - ANSWER Schedule III
The controlled substance schedule of buprenorphine S.L? - ANSWER Schedule III
A drug wholesaler, acting as a supplier, has how much time to complete a DEA Form 222 before it becomes void? - ANSWER Within 60 days of the date of issue
Pharmacists can see no more than how many mL/doses of a codeine-containing CV OTC? in how many hours? - ANSWER 120ml/24doses in 48 hours
