MPJE NY, Questions with accurate answers. Latest update. 2023/ 100% verified.

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MPJE NY, Questions with accurate answers. Latest update. 2023/ 100% verified. Waiting period for MPJE after failing - ✔✔30 days Adjusting drug regimen shall not... - ✔✔include substu... ting or selecting a different drug which differs from that initially prescribed by pt's physician unless substitution is authorized in order or protocol. RPH can make changes to pt's drug therapy - ✔✔IF authorized in protocol Ordering or performing route patient monitoring fxns - ✔✔may be necessary in drug therapy management. If MD disagrees with professional judgment of RPH - ✔✔Judgment of the MD shall prevail MD part of agreement/protocol authorizing collaborative drug therapy management must be - ✔✔employed with same facility where RPH is employed/affiliated. Cannot use collab drug therapy management if - ✔✔pt or pt's rep consents IN WRITING to such management. Label - ✔✔Info on immediate container (must be on outside wrapper if exists) Labeling - ✔✔Includes all info ON or accompanying drug/device Misbranding - ✔✔Labeling = misleading or fails to reveal facts. Like misleading advertising. Device - ✔✔Instruments, apparatus, contrivances including: components, parts, accessories intended: ---For use in diagnosis, cure, mitgation, tx, prevention of dx in man or animals; or ---To affect the structure or any fxn of the body of man or animals Administer - ✔✔A pt specific order or non-pt specific regimen prescribed or ordered by MD or NP who has practice site in the county. Electronic RX - ✔✔Created, recorded, or stored by electornic means, issued with electronic signature Original hard copy RX - ✔✔If created electronically must be transmitted from MD to RPH by FAX --> MUST BE MANUALLY SIGNED. Electronic Signature - ✔✔Electronic sound/symbol/process, attached to electornic RX, executed by person with intent to sign RX. Limited Permits - Pharmacy Interns - permits employments to pharm interns - ✔✔-Issued to student enrolled in last 2 years of registered program in pharmacy. -Intern may practice as RPH under supervision of RPH -Must be posted at site of employment -Expires 5 years from date of issue -May be renewed ONCE for a period not to exceed TWO YEARS with permission from BOP -Must be relinquished if not licensed within this time. Authorized prescribers - ✔✔-Physicians - MD, DO -Physician assistants (RPA) -Podiatrists (DPM) -Dentists (DMD, DDS) -Vets (DVM) -Optometrists (O.D) -Nurse Practitioners, Certified (CNP) -Mid-Wives (F) NDC - ✔✔XXXXX-XXXX-XX 1) Label code, assigned by FDA, the manufacturer. 2) Product code - strength, dosage form, and formulation 3) Package code - package size Anti-tampering act - ✔✔1) Tamper with interstate commerce with intent to injure person 2) Taint with intent to injure business 3) False info 4) Conspire to tamper Anti-Tampering - ✔✔Hx: Passed by congress in 1984 d/t deaths bc of OTC meds contaminated with cyanide. Tamper resistant package - has indicators or barriers to entry - if breached/missing - expect to show visible evidence that tampering occurred. 1) Distinctive by design, cant be duplicated. 2) Use 1 or more indicator or barrier to entry that employ a characteristic. OTC Labeling Tamper Resistant - ✔✔Must alert consumers of the specific tamper resistant feature of package. Drugs EXEMPT from PPA - ✔✔Pg 12 for list. Cannot reuse any part of CRC in NYS. May reuse glass if new safety closure used. CPSC - consumer product safety commission OTC drugs that require CRC - ✔✔1) APAP 2) ASA / Ibuprofen / ketoprofen / naproxen 3) Dibucaine 4) Diphenhydramine 5) Ethylene glycol > 10% 6) Glue removers containing acetonitrile 7) Human rx drugs 8) Lidocaine 9) Loperamide 10) Methyl salicylate liq > 5% 11) Methyl alcohol 12) Mouthwash w/ 3g or more of ethanol per pckage 13) Perm wave neutralizers w/ Na bromate or K bromate 14) Petroleum distillates Can market one size container w/o cap if it states: for households without young children. If package not child resistant must state: - ✔✔-This package is for households w/o young kids -Package not child resistant CRC Waivers - ✔✔-Pt can do req for individual rx or do blanket waiver for all -MD can only do Non-CRP for one at a time, no blanke. ***MUST DOCUMENT WAIVER REQUESTS. MUST HAVE Tamper-resistant seals OTC - ✔✔All non-rx drug products -Contact lens, tabs -Cosmetic liquid oral hygiene products -Cosmetic vaginal products Exceptions for tamper-res for OTC - ✔✔-Derms -Dentrifrices -Insulin -Throat lozenges -OTC administered by HCP in hospitals -OTCs in vending machines -Prodts via mail, package delivery service etc SAUE - ✔✔senior adult use effectiveness Manu's packaging - ✔✔1) Meds must be in CRC 2) Bulk packaging to be repackaged by RPH doesnt have to be in special packaging 3) Unit packaging from manu must comply with CRC Waiver for CRC - ✔✔Must document waivers, don't need to have sig, pt can say it orally. Prescription Drug Marketing Act - ✔✔1) Proper storage / handling of drugs. 2) Establish maintenance of records 3) Prohibits interstate commerce unless registered with shipping state 4) Bans reimportation of Rx Drugs (except same manu) 5) Bans sale/trade/purchase of samples. 6) Bans traffic in counterfeiting drug coupons 7) Prohibits resale of rx drugs by hospital for drugs purchased at special prices 8) Mandates storage/records of drug samples 9) MD's request for samples in writing 10) Criminal and civil penalties Samples - ✔✔Only practitioners can receive. Pharmacies can receive if requested by practitioner. Written request needed: 1) Name, add, professional designation, sig of MD 2) drug name, quantity, and manu 3) date. ***Manu's must keep ANNUAL inventory. Must keep records for THREE years. Drug Recall - ✔✔-Remove products from market thats: 1) Misbranded. 2) Adulterated. 3) threaten consumer safety. Recall classifications - ✔✔Class I: Cause serious adverse health consequences/death. Class 2: Cause temp or medically reverisble adverse health consquences. Class 3: Not likely to cause adverse health probs Package inserts? - ✔✔OC's, IU devices, estrogen containing products, progestational drug products . In COMMUNITY pharmacy - need inserts EVERYTIME product refilled. In INSTITUTION - req only on intial dispensing and Q 30 days. OTC Labels - KNOW THIS - ✔✔1) Product name 2) Name and addy of manu or distributor 3) list of active or other ing (not amt?) 4) amt of contents (strength of ACTIVE ing) 5) adequate warnings 6) adequate directions for use CMEA - ✔✔3.6g daily limit // 9g monthly limit // 7.5g monthly limit if MAIL SERVICE // Must maintain: product name, quantity, name and addy, date and time, must ask for photo ID. Doesnt apply to 60mg or less. Can prescriber dispense? - ✔✔Prescriber cannot charge pt for more than 72 hrs of meds dispensed EXCEPT======= Prescriber working in hospital / dispense at no charge / greater than 10 miles from pharmacy / dispense in institutional clinic / licensed under Art 135 (vets) of this title / dispense under medical emergency / dispense drug reconstituted by prescriber / dispense allergic extracts // dispense drugs covered under oncology or AIDS protocol All prescription blanks MUST CONTAIN - ✔✔1) ONE SIGNATURE LINE // 2) Statement under lien: rx will be filled generically unless prescriber writes daw in box below // 3) that box 4) Words DISPENSE AS WRITTEN under box 5) profession 6) Imprinted name of prescriber Substitution - ✔✔1) Rx written by brand name, 2) DAW box empty, 3) drug is therapeutically equivalent, 4) less expensive. ****If OOS, give brand at generic price. ***If emergency, give brand at regular price and record on back: date/hour/nature of emergency. Emergency - ✔✔1) Alleviate severe pain. 2) Threaten disability. 3) Take life if not treated. Dosage forms not interchangeable - ✔✔EC tabs CR products Injectable susp suppositories different delivery systems for aerosol and nebulizer drugs Orange book - ✔✔A_ = no bioeq problems// B_= docuemented bioequivalence problems!! /// BX = insufficient data /// O = oil solns // T = topical, C = tabs, caps, D = active ing and dose form, E = delayed release oral, N = aerosol neb delivery system, R = suppository or enema, S = standard deficiencies RPH doesnt have to sub if: - ✔✔1) RPH dispense brand at generic price. 2) Medical emergencies when generic not available. 3) no equivalent exists. Sub issues - ✔✔Pt can't request brand if DAW not written = RPH must calls MD to get auth... NYS Generic sub law doesn't apply to RX's written and filled out of state or vitamins. Applies to NURSING HOMES. EPIC (Elderly pharmaceutical insurance coverage) - ✔✔-Changed lower half of rx blank, prescriber not liable for poor prod, must inform PT that Rx is generic, and indicate in order order - brand or generic? /////// Dispensing = cannot waive or reduce copay, quantity limited to 30 days or 100 dosage units, must be filled in NYS. Claim higher fee, must make emergency delivery at no cost to consumer! EPIC Higher Fee - ✔✔24 hour emergency rx service, medical emergency delivery service at no charge to patient (5 miles), pt drug profiles maintained for all pts, direct pt consultation with every Rx. NYS Medicaid Mandatory Generic Program - ✔✔Encourage prescribers to give A rated generics. If want to give BRAND< must call 24 hour prior authorization call line and answer questions for reason. MUST WRITE ON THE FACE OF RX: 1) Prior auth # 2) DAW in box 3) Words: Brand necessary or brand medically necessary in handwriting. -------RPH must call number and validate. GOOD for 6 MONTHS. Exempt products from mandatory Medicaid Program - ✔✔Coumadin // Gengraf, sandimmune, neoral // clozaril, tegretol, dilantin, zarontin // lanoxin, levothyroxine Poison - ✔✔Drug, chemical, or preparation likely to be DESTRUCTIVE to adult human life in quantity of 60 GRAINS OR LESS.... Schedule A = arsenic, atropine, chloral hydrate, strychnine, hydrocyanic acid.... Schedule B = belladonna, ergot, digitalis, chloroform, mineral and oxalic acids Poison label - ✔✔Name of article, word POISON, name [Show More]

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