Texas MPJE, Ultimate Texas MPJE 2022

Texas pharmacist can administer all vaccines - ANSWER True What age can pharmacist administer influenza - ANSWER 7 What is the min age for all other vaccines - ANSWER 14 How many hours for nuclear training - ANS ...

Texas pharmacist can administer all vaccines - ANSWER True What age can pharmacist administer influenza - ANSWER 7 What is the min age for all other vaccines - ANSWER 14 How many hours for nuclear training - ANSWER 700 hours State board is made up of how many members - ANSWER 11 How many pharmacists are on the state board - ANSWER 7 How many techs are on the state board - ANSWER 1 How many public members are on the state board? - ANSWER 3 What are pharmacists requirements to be on the board? - ANSWER resident of texas, actively practicing pharmacy, been licensed for 5 years prior to appointment How long do board members serve - ANSWER 6 years Special CE requirements - ANSWER Texas pharmacy laws or rules 1 hr Pain management 1 hr Prescribing and monitoring controlled substances 2 hrs Mental health awareness 1 hr Preceptor CE if certified preceptor When does license renew - ANSWER every 2 years from birth month Food Drug and Cosmetic Act - ANSWER Established FDA and required new drugs to be proven safe prior to marketing Durham-Humphrey Act of 1951 - ANSWER Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment - ANSWER Required new drugs to be proven safe and effective, established GMPs, FDA jurisdiction over prescription drug advertising Prescription drug market act - ANSWER Bans reimportation of prescription drugs and insulin products produced in the US except by manufacturer. Bans sale, trade or purchase of samples Drug Quality and Security Act - ANSWER Allows facilities that are compounding sterile that are not patient specific to register as outsourcing facility Outsourcing facilities - ANSWER have a licensed pharmacist, report to secretary of HHS every 6 months, be inspected by FDA, report serious ADR within 15 days , label as compounded drug Drug Supply Chain Security Act - ANSWER Requirements for tracing prescription drug products through pharmaceutical supply distribution chain. Transaction data Adulteration - ANSWER contains filthy, putrid, or decomposed substance, prepared or held in unsanitary conditions, manufacturing methods dont conform to GMP, container is composed of poisonous substance, has unsafe color additive, different strength, mixed or packed with substance that reduces strength and quality Misbranding - ANSWER Labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and weight, Rx only, route of admin, special storage instructions, Lot number, expiration, package insert Only pharmacies allowed to work with drug samples - ANSWER Pharmacy owned by charitable organization or government serving indigent population; Class D Three constituents of data required to be provided by manufacturer for each product sold - ANSWER Transaction information, history, and statement Transaction Information constituents - ANSWER Drug name strength dose and NDC, container size and count, transaction date, name and address of seller and buyer Transaction history - ANSWER Prior transaction information for each prior transaction Transaction Statement - ANSWER States seller is authorized for transaction, information and history were provided and are correct, and product is legitimate and has processes to comply with verification requirements, previous seller was legitimate and provided true information Exceptions to distributing without a license - ANSWER Distributing between common ownership, patient specific basis, emergency medical reasons, or minimal quantities to a practitioner for office use Adulteration - ANSWER Actual contents of product is below standard or is unsafe. Misbranding - ANSWER Labeling that is misleading or missing required information, non-compliant with PPA Requirements for manufacturer's label of prescription drugs - ANSWER Manufacturer name and address, drug name, dose quantity, route for non-PO, lot, and expiration, package insert, storage instructions, Rx only legend Requirements for OTC drug labels - ANSWER Principal display panel, including statement of identity of product Manufacturer name and address Net qty of contents Cautions and Warnings Adequate *directions* for use "Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive ingredients, questions followed by phone # Special warning requirement ingredients - ANSWER Yellow #5/6, aspartame, sulfites, mineral oil, wintergreen oil, sodium phosphates (90 mL max), isopreterenol, potassium salts, ipecac syrup, phenacetine, salicylates (max 36 tabs of 81mg), alcohol for analgesics/antipyretics, APAP, NSAIDs FDA Class I Recall - ANSWER Serious ADE or death possible FDA Class II Recall - ANSWER Temporary/reversible ADE or serious ADE remote FDA Class III Recall - ANSWER Not likely to cause ADE When are package inserts required for institutionalized/hospitalized patients? - ANSWER Prior to first administration and every 30 days for OC, estrogen, and progesterone products. Misbranded without insert. Patient package inserts are required for which drugs? - ANSWER oral contraceptives; estrogen-containing products Misbranded without insert iPLEDGE requirements - ANSWER Doctor, pharmacy, and patient are registered, negative pregnancy test, contraceptive use and pregnancy testing, dispensed as blister packs of no more than 30 day supply, no refills Requirements to be considered compounding vs manufacturing - ANSWER Patient specific, done by pharmacist or physician, USP compliance, manufacturer of drug is registered and has certificate of analysis, excipients comply with USP/NF monograph, not a replica of an existing product, drug not withdrawn from market due to safety, no statement from FDA stating difficulty for compounding demonstrating an ADE, 5% rule FDA Orange book - ANSWER Generic equivalency book official name: Approved Drug Products with Therapeutic Equivalence Evaluations A# are drug products the FDA considers to be _______ equivalent and _______ equivalent - ANSWER pharmaceutical and therapeutically B# are drug products the FDA considers to ____ be _______ equivalent and _______ equivalent - ANSWER NOT, pharmaceutical, therapeutically FDA Purple book - ANSWER Biologic interchangablity book official name: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations In Texas, which products may be substituted? - ANSWER generically equivalent or interchangeable products Poison Prevention Packaging Act - ANSWER Regulated by Consumer Product Safety Commission. Requires child-resistant containers for all prescriptions and certain OTC drugs PPPA exemption request from patient/prescriber - ANSWER Only patient can provide blanket request for all future prescriptions. Provider can only request for single prescription PPPA exemptions - ANSWER Bulk containers, drugs distribution to institutionalized patients, OC/estrogens/northindrone in manufacturers package, medroxyprogesterone tablets, nitroglycerin SL, isosorbide chewable up to 10mg, ASA/APAP effervescents, Unit dose potassium supplements, sodium fluoride up to 264mg, anhydrous chloestyramine/colestipol packets, erythromycin granules for PO suspension, erythromycin suspension up to 8g, erythromycin tablets up to 16g, prednisone tabs up to 105mg, methylprednisolone tabs up to 84mg, mebendazole tabs up to 600mg, betamethasone tabs up to 12.6mg, inhalants, pancrelipase, sucrose in glycerol and water Federal Hazardous Communications Standard, who enforces this standard? - ANSWER Requires pharmacies to have a plan including list of hazardous chemicals with SDSs, and to train workers, OSHA Federal Hazardous Substances Act - ANSWER OSHA administers and enforces. Requires labeling of hazardous materials including manufacturer, type of danger, "Keep out of reach of children", handling and storage instructions, written hazard communication plan, Frequency of CMS medication regimen reviews required for LTCF patients - ANSWER Every 30 days; pharmacist reports to 3 ppl (Attending physician, Director of Nursing, Medical Director) PRN orders of psychotropic drugs for LTCF patients (CMS limit) - ANSWER 14 days Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSWER Issues permits for tax free alcohol for pharmacies that use 95% ethanol for compounding TTB ________ tax free alcohol for pharmacies while the _______ enforces - ANSWER regulates, ATFE HIPAA requirement for new patients - ANSWER Obtain written acknowledgement of receipt of Notice of Privacy Practices Allowed PHI disclosures - ANSWER Providing treatment, receiving payment, health care operations, government functions including FAERs, AWARxE. Marketing purposes must have singed authorization from patient Time limit for patient request of PHI - ANSWER Must respond within 30 days, may extend by no more than 30 additional days Tx:15days Time limit for patient request to amend PHI - ANSWER 60 days, may extend by no more than 30 additional days HIPAA's required pharmacy personnel - ANSWER Privacy Official and contact person for complaints Time limit to notify individuals of PHI breach - ANSWER 60 days after discovering Requirement for PHI breach of <500 individuals - ANSWER maintain log of breaches and notify breaches to HHS annually Requirement for PHI breach of >500 individuals - ANSWER Report to HHS and local media within 60 days C-I list - ANSWER HIGH potential for abuse and SEVERE potential for dependence. Opiate derivatives (heroin, dihydromorphine), marijuana, LSD, peyote, mescaline, methaqualone C-II list - ANSWER HIGH potential for abuse which may lead to SEVERE dependence. Narcotics, cocaine, stimulants, amobarbital, secobarbital, pentobarbital C-III list - ANSWER LOWER potential for abuse than CII and may lead to MODERATE or LOW physical dependence or HIGH psychological dependence. Anabolic steroids, ketamine, C-II barbituate suppositories, buprenorphone, codeine up to 90mg/dose, opium combo up to 25mg/dose C-IV list - ANSWER BZDs, carisoprodol, modafinil, phentermine, phenobarbital, tramadol C-V list - ANSWER Codeine up to 200mg/100ml, opium less than 50mg/100ml, pregabalin, lacosamide US Attorney General - ANSWER Head of Department of Justice. Schedules substances with medical recommendations from FDA. DEA form 224 - ANSWER Registration for dispensing controlled substances Distributing - ANSWER No RX - Just selling drugs Dispensing - ANSWER RX is needed and it's for a specific person Verifying a DEA # - ANSWER (1st+2nd+3rd)+2(2nd+4th+5th) Last digit of that equation is last digit of DEA # Time limit to obtain DEA permit upon sale of pharmacy - ANSWER Previous owner can let pharmacy float on their DEA # for 45 days Concentration limit for compounded narcotics - ANSWER 20%, with non-narcotic therapeutic ingredient Pharmacist immunizers need - ANSWER 20 hours CDC training Basic Cardiac Life Support Certification 3hrs CE every 2 years related to vaccinations After administering vaccine on protocol - ANSWER Notify protocol physician within 24 hours Notify PCP within 14 days Requirements for pharmacists who participate in drug therapy management (DTM; clinical pharmacists) - ANSWER Notify TSBP prior to engaging in DTM 6 Hours of CE annually related to drug therapy Inventories must include expired drugs (true/false) - ANSWER True Concentration limits for codeine - ANSWER C-V: 200mg/100ml (0.2%) C-III: 1.8g/100mL or 90mg/dose (1.8%) Concentration limits for opium - ANSWER Texas C-V: 50mg/100mL (0.05%) C-III: 500mg/100mL or 25mg/dose (0.5%) DEA from 222 - ANSWER Ordering C-IIs Copy 1&2 goes to distributed Keep copy 3 Where each copy of DEA-222 goes - ANSWER 1 Brown: supplier 2 Green: DEA 3 Blue: buyer Drugs that have to be alone on DEA-222 - ANSWER Etorphine HCl and Diprenorphine Controlled Substances Ordering System (CSOS) - ANSWER Electronic C-II ordering Amount of time supplier has to send remaining CII order - ANSWER 60 days Non C-II CS invoice requirements - ANSWER Signature of receiving pharmacist, distributor name address and DEA, date of receipt, Drug name, dosage form, strength, units per container, container quantity recieved 5% rule - ANSWER Pharmacies can distribute 5% of annual controlled substance doses dispensed without registering with DEA as a distributor Controlled substance storage requirements for Class A - ANSWER Locked cabinet or dispersed throughout pharmacy Controlled substance storage requirements for Class C - ANSWER C-IIs locked, others dispersed. Class F also required to lock C-IIs Time limit to report significant loss or theft of controlled substances to DEA and TSBP - ANSWER 1 day and immediately DEA From 106 - ANSWER CS theft/significant loss form. Can be amended or wait to fill out until you know details. Schedules requiring "Caution... prohibits the transfer of this drug to any person other than the patient..." - ANSWER C2,3,4 (NOT C5) DEA Form 41 - ANSWER Onsite controlled substance destruction. Must be submitted *14 days before* destruction date How to counts for CS inventories - ANSWER Exact for C2, estimated for C3,4,5 unless container holds > 1000 tablets Circumstances for required perpetual inventory - ANSWER Class C: C-II All controls in remote pharmacy Class C-ASC: controlled substances Class F: controlled substances Required time of keeping CS records - ANSWER 2 years CS records required to be in pharmacy - ANSWER DEA-222 copy 3, prescriptions, inventories Requirements for controlled substance prescription - ANSWER Patient full name,address and age/birthdate drug name strength dose quantity (## and word unless typed) and intended use (intended use req for all RXs in Texas ) practitioner name, address, phone number, and DEA number earliest fill date for C-II When controlled substances inventories are required - ANSWER First day pharmacy is open, annually, change in PIC, change in ownership How to obtain permission from DEA to keep shipping and financials at a central locatoin - ANSWER Ask permission, wait 14 days and if not rejection = assume approval. Things pharmacists cannot change on C-IIs - ANSWER Patient name, drug name, physician name, prescription date Requirement for faxed C-III-V - ANSWER Prescriber's original signature - supposed to be a faxed WRITTEN RX Time limit for signature of PIC for CS inventories - ANSWER 3 days excluding weekends and federal holidays Time limit to dispense C2 - ANSWER 21 days from prescription date With May 2021 Board meeting, this will likely change to *30 days* DEA permits faxed rx to serve as original rx in 3 limited situations (Ultimate, pg 86) - ANSWER injectable narcotics LTCF patients narcotics for hospice patients Follow federal rules on fax of C2 Time limit to provide official prescription after emergency C-II - ANSWER 7 days, marked "Authorization for Emergency Dispensing" Who issues C2forms? - ANSWER TSBP Exemptions to the Use of an Official Prescription Form - ANSWER 1. Hospital inpatient orders 2. Hospital inpatients who need emergency quantity of CII on discharge (7 day max) 3. Patients on life flight, EMS, etc. 4. Inmate of TDCJ 5. Animals 6. Therapeutic optometrists administering topical cocaine 7. RXs from out-of-state practitioners when the TSBP has pre-approved the plan 8. Electronic RXs Time limit for transmitting CS prescription information to TSBP - ANSWER 24 hours from completion of fill Information needed for TSBP regarding CS prescriptions - ANSWER 1. Prescription control number, issue and fill date 2. Patient name, age, and address 3. Dispensed drug NDC, quantity 4. Pharmacy's prescription number and DEA number Short term detox length - ANSWER 30 days or less Long term detox length - ANSWER 30-180 days Drugs dispensable under Drug Addiction Treatment Act - ANSWER Subutex (buprenorphine), Suboxone (buprenorphone/naloxone) Quantity restriction for verbal emergency C-II - ANSWER Amount needed to treat patient during emergency period Meth precursor limits - ANSWER 3.6g daily 9g every 30 days 7.5g every 30 days for mail order Meth precursor storage - ANSWER Behind counter or in a within 30 feet of pharmacy counter in a locked cabinet if not behind the counter. Age to buy PSE - ANSWER 16 years old PSE logbook - ANSWER 1. Product name 2. Quantity sold 3. Name and address of purchaser 4. Date and time sold Time limit to complete C2 partial fill - ANSWER 72 hours or 60 days if LTCF Time limit to complete emergency partial fill - ANSWER 72 hours Refills allowed for C3,4,5 - ANSWER 5 times or 6 months OTC controlled substance dispensing requirements - ANSWER Up to 8oz or 48 doses of opium, up to 4 oz or 24 doses of anything else, not same person within 48 hours, buyer is 18 years old, ID required, record book entry Meth precursor log book requirements - ANSWER Product name and quantity, buyer name and address, sale date and time, buyer signature Mail pharmacy/mobile retail vendor meth precursor sales limit - ANSWER 7.5g in 30 days Controls able to be auto-refilled by TSBP - ANSWER C4&5(not3) TSBP requirements for prescription records - ANSWER Three file system (C2, other controls, non-controls) Requirement to sell meth precursors - ANSWER Certificate of Authority from TDSHS for non-pharmacy retailers DATA-waived physician requirement for prescription - ANSWER DEA number with an X Practitioners that can prescribe under own license - ANSWER Physicians (MD, DO), Dentists (DDS, DMD), Podiatrist (DPM), Veterinarians (DVM) Who can perform financial inspections? - ANSWER TSBP only if the complaint is related to financials. T/F: Any financials, sales, or pricing data obtained by the Board during inspection or investigation is confidential. - ANSWER True