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Kansas MPJE Exam 2023 Studyguide
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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 1:2 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 effecti ve 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? -Los beneficios de comprar resúmenes en Stuvia estan en línea:
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