Texas MPJE 2022 /2023 with complete solution

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Texas pharmacist can administer all vaccines - ANSWER True requires written protocol with MD What age can pharmacist administer influenza - ANSWER 7 Can C2 prescriptions be refilled? - ANSWER n... o therefore no emergency refills What is the min age for vaccines other than the flu? except? - ANSWER 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) 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, in good standing with TSBP members or spouses cant be a lobbyist on behalf of a profession regulated by the board nor an officer/employee to a texas trade association in the healthcare field where can prescriptions be delivered to? - ANSWER -office of prescriber (only a single dose if a CDS that is for admin in the office) -residence of the patient -place of employment if they are there to accept the delivery -hospital or medical facility where the patient is receiving treatment time limit to report to TSBP when a drug has been obtained from a forged prescription - ANSWER immediately upon discovery public members cant have the following and be on the tsbp board - ANSWER licensed by an occupational regulatory agency employed by entity regulated by board or to a texas trade association in the healthcare field more than 10% interest in a business regulated by the board 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 at end of birth month is there a grace period if you forget to renew your license? - ANSWER no pay 1.5x the cost if license is expired <90 days pay 2x the cost if 91-364 days expired Kefauver-Harris Amendment (1962) - ANSWER Required new drugs to be proven safe and effective, established GMPs, gave 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 of 2013 - 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/regulated 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 advertising of drug prices - ANSWER "reminder advertising" exempt from FDA regulations if the following is met: - only purpose is to provide price -contains brand, generic, strength, dosage form, price charged for a specific quantity -may include other services (delivery available) -price should include all charges including delivery (must be separated from drug price) advertising of drug compounding - ANSWER may advertise that it offers the service including that it compounds specific products but cant make any therapeutic claims 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 expired drug counting on tray that has residue inadequate temperature control Misbranding - ANSWER Labeling of a product that is false or misleading or fails to contain required information liable to deterioration unless labeled or packaged accordingly not packaged according to PPPA dangerous to health when used in the manner suggested on label dispensing a prescription without authorization wrong strength drug or directions for use dispensed without meeting rems requirement BUD is past manufacturers exp date Adultered and misbranded - ANSWER Expired drug with false exp date Strength different Not tamper evident packaging what needs to be on a manufacturers label? - ANSWER name and address of manufactuerer/packer/or distributor brand or generic name of drug net quantity and weight of active ingredient per dosage unit Rx only route of admin if not PO special storage instructions if appropriate manufacturers control number (lot number) exp date adequate information for use (PI and med guide or PPI if required) Adulteration - ANSWER Actual contents of product is below standard or is unsafe. Only pharmacies allowed to work with drug samples - ANSWER Pharmacy owned by charitable organization or government AND that are part of a healthcare entity serving indigent population (must be provided at no charge) how often does a pharmacist have to visit a class D pharmacy - ANSWER monthly drugs can be provided at a class D pharmacy (whats on formulary) but what is required for DISPENSING of a drug? - ANSWER can only be dispensed by a pharmacist pursuant to a prescription drug order f Three constituents of data required to be provided by manufacturer for each product sold - ANSWER Transaction information, history, and statement must be maintained for 6 years by each supply chain partner Transaction Information - ANSWER Drug name strength dosage form, and NDC, container size and # of containers, 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 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/distributor/packer name and address Net qty of contents Cautions AND Warnings Adequate *directions* for safe and effective use "Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive ingredients, questions (optional) followed by phone # warning for yellow 5 and 6 - ANSWER in precautions section of label: may cause allergic reaction in certain susceptible persons warning for aspartame - ANSWER in precautions section of label: phenylketourics: contains phenylalanine x mg per x units warning for sulfites - ANSWER rx drugs must contain in the allergy warning in warning section of label warning for mineral oil - ANSWER requires warning to only be taken at bedtime and not be used in infants unless under advice of physician warning for wintergreen oil - ANSWER (methyl salicylate) any drug containing more than 5% must include warning that use other than directed can be dangerous and that it should be kept out of reach from children sodium phosphate limit for OTC - ANSWER more more than 90 ml/container isoproterenol inhalation products warning - ANSWER needs warning to not exceed dose prescribed and to contact MD if difficulty in breathing persists potassium salt preparations for oral ingestions - ANSWER Requires warning regarding nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric coated thiazides with potassium salts ipecac syrup statement that must appear - ANSWER "for emergency use to cause vomiting in poisoning. before use call physician, the poison prevention center, or hospital room immediately for advice" BOXED AND IN RED LETTERS "warning: keep out of reach of children. do not use in unconscious persons" usual dose if 15 ml in people over 1 year of age and may be sold in 30 ml containers phenacetin (acetophenetidin) warning - ANSWER possible kidney damage when taken in large amounts of a long period of time salicylate warning - ANSWER Warning regarding Reye's syndrome Retail containers of 1 1/4 grain (81 mg) tablets cannot be distributed in retail containers containing more than 36 tablets OTC Drugs for Minor Sore Throat warning statement - ANSWER "For temporary relief of minor sore throat" "Warning- Severe or persistent sore throat or sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under the age of 3 unless directed by a physician" alcohol warning - ANSWER Internal analgesics & antipyretics including: ASA, APAP, IBU, naproxen, ketoprofen, etc. are req' to warn consumers to consult Dr before taking these drugs if they consume 3 or more alcoholic beverages per day OTC drugs for contraception containing nonoxynol 9 as the active ingredient - ANSWER subject to several warnings including one that states that the product does not prevent against HIV/AIDS or other STDs and may INCREASE the risk of getting HIV from an infected partner APAP OTC warning - ANSWER must have acetaminophen prominently displayed must warn about liver toxicity must warn not to use with other products that have APAP and to consult before taking with warfarin NSAID OTC warning - ANSWER must clearly say NSAID on the label must contain stomach bleeding warning any iron in a solid dosage form OTC warning - ANSWER "accidental overdose of iron containing products is the leading cause of fatal poisoning in children under 6. keep out of reach of children. call MD or poison control center immediately in case of accidental overdose" tamper evident packaging - ANSWER OTC drugs except (dermatological, dentrifice, insulin, or lozenge products) for sale must be in tamper evident packaging misbranded and adulterated if not packaged properly repackaging of OTC products - ANSWER A Pharmacist that repackages OTC products would be subject to cGMPs and would have to provide tamper-evident packaging and meet all manufacturer label requirements if it is offered for sale to public can only sell in smaller quantity if patient has a prescription for the smaller quantity and would have to meet Rx labeling requirements tamper RESISTANT prescriptions - ANSWER CMS requires all written prescriptions must meet requirements - one or more features to prevent unauthorized copying -one or more features to prevent erasure or modification -one or more features to prevent the use of counterfeit prescription forms can a convicted felon work with CDS? - ANSWER no unless a waiver is granted by DEA FDA Class I Recall - ANSWER Serious ADE or death is reasonably probable FDA Class II Recall - ANSWER Temporary/reversible ADE may happen or chance of serious ADE is remote FDA Class III Recall - ANSWER Not likely to cause ADE FDA medical devices classes - ANSWER I: low risk (dental floss) II: higher risk (syringe) III: highest risk, require premarket approval (heart valves) not all require a prescription but many do class I drugs - ANSWER high potential for abuse and SEVERE potential for dependence animal drugs - ANSWER FDA regulates if it is rx or otc rx can only be dispensed by a licensed vet and must have legend that federal law restricts this drug to use by order of a vet vets can prescribed human drugs too off-label federal transfer warning - ANSW [Show More]

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