Kansas MPJE Exam 2023 Studyguide

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 1:2 Can increased to 1:3 if 2 are certified Pharmacist to intern ratio in KS? - ANSWER 1:2 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 2. After RPH views Rx Drug order, it shall be reduced to a hard copy 3. RPH exercise profession judgement on validity of drug order 4. Within 7 days, Dr must send written RX (must say "authorized for emergency dispensing" 5. In person within 7 days or postmarked within 7 days 6. Upon receipt, RPH must attach hard copy, if not sent by Dr contact DEA What information can the pharmacist correct on a scheduled II Rx in KS? (6) - ANSWER Address, dosage form, strength, quantity, directions of use, issue date Is identification required prior to picking up an Rx in KS? - ANSWER NO Could a pharmacist dispense an emergency refill without the prescribers authorization? Are there any quantity or days supply restrictions? - ANSWER A refill may be authorized up to a 7 day supply - this does NOT include controlled substances or narcotics Which drugs must be written on a tamper resistant security form? - ANSWER Medicaid prescriptions only Are scheduled V drugs available OTC in kansas? - ANSWER Yes How soon must controlled substance loss or theft be reported in KS? - ANSWER PIC or owner must notify the board within 1 business day What form must be provided to the board following controlled substance loss or theft? - ANSWER DEA 106 form Can a RPH prescribe naloxone to patients and caregivers at risk of opioid overdose in KS? - ANSWER Yes Does KS permit off-site storage of pharmacy records? - ANSWER Yes - prescriptions and drug distribution records If offsite records are requested by an inspector in what time period must the pharmacy retrieve the records? - ANSWER 2 days What/who/how many is studied in pre clinical phase of drug development? Purpose? - ANSWER Animals Relative safety, therapeutic potential 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 200,000 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 (C-R) packaging Break down an NDC for me - ANSWER 10-11 digit code Labeler code - tells you the manufacturer Product code - strength and dosage form Package code - package size and type Benefits provided by the orphan drug act? - ANSWER 1. Tax credit (50%) 2. 7 year period of exclusivity Define an orphan drug - ANSWER Treats diseases that affect 200K people OR No reasonable expectation that the cost will be recovered in salary revenue What was the big deal about hatch waxman? - ANSWER ANDA What must be provided for an ANDA to be approved? (5) - ANSWER Proof that the new drug has the same, active ingredient, ROA, dosage form, strength, and is bioequivalent In what cases can a person bring in a drug from overseas? - ANSWER Quantity is 90 day supply (can't be resold) OR Effective treatment not available in the US, condition is serious, imported under no reasonable risk What is the main thing from OBRA-90? - ANSWER RPH must counsel and perform DUR on all medicaid patients If a products claims to cure, prevent or treat a disease it is considered a....... - ANSWER Drug What can a product claim and get a way with being called a dietary supplement - 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 2. Have adequate written directions 3. 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 2. Toll-free number of the owner 3. Statement advising purchaser to check the date of the product before using 4. Telephone number of the state board of pharmacy Which titles are restricted from being displayed at a place where a PRH is not continuously employed? (3) - ANSWER Drugstore Pharmacy Apothecary What condition must be met in order to display the words "drugstore", "pharmacy", or "apothecary" in the title? - ANSWER An RPH licensed by the state board in continuous employ Can pharmacists repackage poisons? - ANSWER Yes, as long as they conform to applicable packaging and labeling laws Is amygadlin (Laetrile) considered a drug? - ANSWER No What is amygadlin (Laetrile)? - ANSWER I compound found in apricot seeds that has been falsely promoted to cure cancer Are pharmacists allowed to sell amygadlin(Laetrile)? - ANSWER Not unless the first obtain a permit from the secretary of health and environment What supplement requires a pharmacist to get a permit from the secretary of health and environment in order to sell it? - ANSWER Amygadlin (Laetrile) 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 2. Name and address of receiving pharmacy, the date, names of both pharmacists 3. 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 2. Date of issuance and original dispensing, refills (quantity and dates), Rx number, name address and phone number of transferring pharmacy, name of transferring pharmacist 3. Electronic Rx require Rx numbers for each dispensing 4. If for a controlled Rx need DEA of transferring pharmacy and physician What are the appropriate indications for amphetamine prescribing? (8) - ANSWER Narcolepsy Drug induced brain dysfunction Hyperkinesis Depression - psych evaluation Resistant depression Clinical investigation of drug effects - approved by the board Treatment of obesity with controlled substances Other disorders with board approval Can a physician prescribe amphetamine to treat obesity? - ANSWER NO When treating obesity with a controlled substance the physician shall NOT dispense or prescribe more than how many days supply at one time? - ANSWER 30 When must a physician stop treating a patient for obesity with a controlled substance? - ANSWER If a weight loss of 5% of the patients initial body weight does not occur in the first 90 days of treatment Give me 3 examples of a mid-level-practitioner - ANSWER Certified nurse midwife 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