Texas MPJE, Ultimate Texas MPJE 2022
Texas pharmacist can administer all vaccines - ANSWER True
What age can pharmacist administer influenza -
... [Show More] 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, [Show Less]