Download MPJE - Michigan Flashcards Latest Edition. Real Questions & Correct Answers. Already Grade and more Exams Nursing in PDF only on Docsity!
MPJE - Michigan Flashcards Latest Edition.
Real Questions & Correct Answers. 2025
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4 elements needed to prove negligence - ANS-Duty (counseling, drug product selection, PPPA)
- Breach of Duty (Failure to warn or perform proper DUR, drug selection error, inappropriate supervision of techs)
- Proximate cause (breach of duty must have led directly to damages)
- Damages (prove that damages occurred and they were substantial) A central fill pharmacy must record: - ANS-Date received from originated pharmacy
- Name and address of originating pharmacy
- Date Rx was filled, processed and verified
- ID of RPh responsible for processing & shipping to originating pharmacy or delivery to patient
- Date shipped to originating pharmacy or to patient
- Method of delivery Activities that are violations of the FDCA - ANS-Adulteration
- Misbranding
- Placing an unapproved drug into Interstate Commerce Address or name change needs to be reported to the Board no later than ________ after the change - ANS30 days Adulterated or Misbranded?: Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted for the drug - ANSAdulterated Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable - ANSMisbranded Adulterated or Misbranded?:
Bears unsafe color additive for purposes of coloring only - ANSAdulterated Adulterated or Misbranded?: Consists in whole or in part of filthy, putrid or decomposed substance - ANSAdulterated Adulterated or Misbranded?: Container is composed of poisonous or deleterious substance that may render contains injurious to health - ANSAdulterated Adulterated or Misbranded?: Dosage, frequency, duration or route of admin suggested in the labeling is dangerous - ANSMisbranded Adulterated or Misbranded?: Drug has habit-forming substance and label fails to list name and proportion of substance and "Warning—may be habit forming" - ANSMisbranded Adulterated or Misbranded?: Drug is liable to deterioration and label doesn't warn to that effect - ANSMisbranded Adulterated or Misbranded?: Drug is manufactured in facility in violation of cGMPs - ANSAdulterated Adulterated or Misbranded?: Drug is not dispensed in a childproof container - ANSMisbranded Adulterated or Misbranded?: Drug labeled in official compendium but strength differs from or quality or purity falls below compendium standards - ANSAdulterated Adulterated or Misbranded?: Drug not listed in official compendium and its strength differs from or its quality or purity falls below what is represented on label - ANSAdulterated Adulterated or Misbranded?: False/misleading labeling - ANSMisbranded Adulterated or Misbranded?: If established name or mutli-ingredient products don't identify each active ingredient - ANSMisbranded
Are meds dispensed to an assisted living facility EXEMPT from the Poison Prevention Packaging Act? - ANSNo Are RPh inititals required on all CS invoices? - ANSYes Are there limitations to prescribers delegating dispensing power? - ANSYes, delegated dispensing is limited to a 72 hour supply of the drug(s) Are there restrictions on the sale of needles or syringes? - ANSNo Benzodiazepines and benzodiazepine agonists are generally in which CS schedule? - ANS Can a Canadian DDS prescribe non-controlled or controlled substances? - ANSNo. Can a Canadian MD or DO prescribe controlled substances? - ANSNo. Can a Canadian MD or DO prescribe non-controlled substances? - ANSYes Can a computer send an Rx to a fax machine? - ANSOnly for a non-controlled drug... and a Michigan electronic signature is needed. Can a homeopathic doctor, naturopathic doctor (ND), or chiropracter prescribe in Michigan? - ANSNo. Can a hospital pharmacy house complimentary starter doses of controlled substances?
- ANSNo. Can a hospital pharmacy house complimentary starter doses of non-controlled drugs? - ANSYes, but: A physician (MD or DO) must delegate in writing to a pharmacist at that hospital that the pharmacist can receive and dispense the sample. The pharmacist can then dispense the samples to ANY prescriber (including PA and NP) in the hospital. NOTE: Both the RPh's and physician's names must be on the drug sample for the RPh to receive it.
Can a PA call in an emergency C2? What about an NP? - ANSYes (under delegation); No Can a PA or NP prescribe misoprostal to a woman known to be pregnant, for purposes of abortion? - ANSNo Can a pharmacy inspector seize drug without a warrant? - ANSYes, if they feel drugs are an imminent threat to public health or welfare Can a pharmacy put back to stock and redispense meds from a CPMP that was returned? - ANSNo, they may not be returned to stock or dispensed to ANOTHER patient when returned to pharmacy, but can give it back to the SAME patient Can a pharmacy redispense meds returned from a nursing home? - ANSYes, but only non-CS drugs because the patient doesn't take possession of it. CANNOT take back CS drugs from a nursing home! Can a wholesaler or manufacturer act as a pharmacy? - ANSNo Can an agent of a prescriber call in a CS Rx? - ANSYes Can an agent of the prescriber call in an emergency CII? - ANSNo, it must be a prescriber-to-pharmacist phone call. Can an automated device be located in a prescriber's office? - ANSYes, BUT the device can only dispense to patients and only under control of the prescriber (NOT pharmacy) A pharmacy shall not own, control, or operate an auto device in a prescriber's office Can an optometrist prescribe CII's? - ANSNo Can an out of state DDS prescribe controlled substances? - ANSYes Can an out of state DDS prescribe non-controlled substances? - ANSYes. Can an out of state MD or DO prescribe controlled substances? - ANSYes. Can an out of state MD or DO prescribe non-controlled substances? - ANSYes
Can samples, or "complimentary starter doses", ever be in a community pharmacy? - ANSNo. Can the "X" DEA number be the only DEA number on the buprenorphine Rx? - ANSNo; need "X" DEA number AND regular DEA number Can the Board of Pharmacy send a pharmacist to jail? - ANSNo, they do not govern criminal law Can the pharmacist delegate stocking of an automated device? - ANSYes Can the signing of DEA 222 forms be delegated? - ANSYes, if Power of Attorney to sign 222 is given from DEA registrant to another person WITH A CS LICENSE Can you change the date of issue for an Rx? - ANSYES... but only after speaking with the prescriber to verify Can you dispense ANY medications after the death of a prescriber or patient? - ANSNo, not if you KNOW that they died. If you didn't know, it is not penalized Can you receive mulitple Rxs of a CII medication on the same day? - ANSYes, but only a 90 day supply... and the Rxs have to be clearly marked "do not fill until..." Can you still practice if your license expires? - ANSYes, but only for 60 days after the expiration Can you take back CS drugs from patients? - ANSOnly if there is a recall or if you made a mistake (can't redispense them though) CE Requirements - ANS-If licensed less than 1 yr—no CE required
- If licensed more than 1 yr but <2yrs -- needs 15 hrs CE
- If licensed full 2 yrs—30 hrs CE
- Of the 30 hours, 10 must be "live" and 1 must be pain management
- Max of 12 hrs CE per day Centralized Prescription Processing - ANSThe processing by a pharmacy of a request from another pharmacy to fill or refill a Rx drug order or to perform processing functions (dispensing, performing drug utilization review, completing claims adjudication, obtaining refill authorization, initiating therapeutic interventions)
Consumer Medication Information - ANS-Not a requirement
- It's printed consumer medication information provided to patients at the time a new Rx is filled CS Rx orders for inpatient dispensing require: - ANS-Patient's name
- Prescribers name, address, DEA # (in place of this, the pharmacy may keep a separate list of authorized prescribers that includes prescribers name/address/DEA #)
- Prescriber's signature
- Drug name, dose, administration, frequency
- Date DAW Rules - ANSPrescriber writes "DAW," "d.a.w.," or "dispense as written" in own handwriting (cannot just have a check box on Rx pad) Electronic forms cannot include DAW as a default setting Delegation - ANSAuthorization granted by a licensee to a licensed or unlicensed individual to perform selected acts, tasks or functions that fall within the scope of practice of the delegator and that are not within the scope of practice of the delegatee. Delivery Pharmacy - ANSPharmacy that delivers the filled or refilled Rx to the patient or patient's authorized representative. The delivering pharmacy shall be either the originating pharmacy or CPP center. Describe when the "side effects statement" has to be given to a patient - ANS-Must be given w/ new Rx and all refills
- Does not apply to inpatients in hospital Difference between central processing and central fill? - ANSCentral Processing:
- Staff at central location does processing steps usually done at local site (ex: Rx entry, drug utilization review, insurance adjudication, physician contact for Rx clarifications)
- Once the Rx order is okay, it transmits an electronic Rx order back to the pharmacy Central Fill:
- Staff at central location actually fills the Rx from the original pharmacy.
- May deliver Rx directly to patient or deliver back to originating pharmacy
Do you have to report to the DEA or to the B.o.P. a change in power of attorney for signing DEA 222 forms? - ANSNo Does a copy of the CS inventory need to be sent to the DEA? What about to the B.o.P?
- ANSNo; Yes Does a Patient Package Insert have to be given with EACH refill? - ANSYes Does a person need to present a valid photo ID to purchase a schedule V OTC? - ANSNo? Does a prescriber have to use their "X" DEA number every time they prescribe a buprenorphine product? - ANSOnly need this DEA # when prescribing for drug addiction—if using an off-label use, you don't need to obtain this # (ex: pain) Does a side effects statement have to be given with each refill? - ANSYes Does the DEA registrant have to be a RPh? - ANSNo Does the director of pharmacy of an institution have to be a pharmacist? - ANSYes Does the RPh taking the CS inventory have to sign it? - ANSYes Does vaccine administration by a pharmacist have to be delegated by a physician? - ANSYes Drug Product Selection - ANSAnother brand of a generically equivalent product, identical in dosage form and content of active ingredients These are drugs the RPh can dispense w/out the prescriber's authorization Drugs Exempt from Childproof Packaging - ANSSublingual Nitroglycerin, Potassium supplements, Isosorbide dinitrate 10mg or less (SL or chewable), Erythromycin, Anhydrous cholestyramine (powder), Sodium Fluoride, Betamethasone, Mebendazole, Cholestipol, Prednisone, Norethindrone acetate, Medroxyprogesterone, Sucrase, Methylprednisone, Pancrelipase, Oral contraceptives / Estrogen replacement therapy (HRT) Drugs must be ___________ equivalents to be interchanged. - ANSGeneric
Ephedrine is in which CS schedule? - ANS Ephedrine schedule V exemptions? - ANS1.) Solid dosage forms that combine >400mg of guaifenesin and <25mg of ephedrine per dose, packaged in blister packs of 2 tabs or less per blister 2.) Anorectal preparation containing 5% ephedrine or less Exalgo and Opana are in which CS schedule? - ANS Examples of fraud, waste, and abuse violations - ANS-Inappropriate billing practices
- Rx drug shorting
- Bait and switch pricing
- Rx forging or altering
- Dispense expired or adulterated Rx drugs
- Rx refill errors
- Illegal remuneration
- True out of pocket (TrOOP) manipulation
- Failure to offer negotiated prices of Part D drugs Examples of places where "dispensing prescribers" work - ANSPlanned Parenthood, Methadone Clinics Federal Food Drug & Cosmetic (FDC) Act - ANS-Required new drugs to be shown safe before marketing
- Authorized factory inspections For computerized CS in a community pharmacy, how far back must the records be "readily retrievable"? - ANS16 months For emergency orders on an automated device, in what time frame must the pharmacist review the order? - ANS48 hours For hospice boxes, are precriptions required for the meds contained in the boxes? - ANSYes, the hospice medical director provides the prescriptions For MAPS, when reporting must be done by? - ANSBY the 1st and 15th of every month For meds taken out of an automated device for a patient, what additional information is needed for documentation of the order? - ANS-Unique identity of device accessed
- Individual accessing the device
How long are CIII and CIV Rxs good for? - ANS6 months, or 5 refills How long are non-CS Rxs good for? - ANS1 year from the date issued How long do CS inventory records have to be kept? - ANS2 years How long does a wholesaler have to fill a CII order completely? - ANS60 days How long does Medicare Part D require a pharmacy to keep prescription records? - ANS10 years... this is NOT the law though (5 years is) How long does the CS signature log have to be kept for? - ANS2 years How long is a pharmacy license and CS license good for? - ANS2 years, expires on June 30th How long is it required to keep DEA 222 forms ON-HAND in the pharmacy? - ANS years How long must a copy of the drug receipt be maintained in the pharmacy? - ANS days How long must any pharmacy keep records of prescriptions or medication orders? - ANS5 years How long must pseudophed logbook records be kept? - ANS2 years How long must the CS signature log remain IN the pharmacy? - ANS2 years How many different "prescription files" do you need when filing the Rxs? - ANS3 - one for CII, one for CIII-V, and one for non-CS Rxs How many months of instant access to prescriptions are needed for automated data processing systems (ADPs)? - ANS16 months How many NPIs can a single person obtain? - ANSJust 1 (no matter how many different places they practice) How many prescriptions can be on one sheet of paper? - ANS4 if handwritten 6 if typed / computer-generated
How many times can you transfer a CIII-V Rx? - ANSONCE How must CS be stored in the pharmacy? - ANSAll CS (including CII) can either be locked in a secure cabinet/drawer OR dispersed throughout the non-CS inventory OR a mixture of the two NOTE: CII's are NOT required to be locked up How often does the CSAC (controlled substance advisory committee) meet? - ANSAt least once every 3 months How often must a night box be audited by an RPh? - ANSAt least once every 30 days How often must a pharmacist perform a drug regimen review for LTC facilities? - ANSAt least once a month... on every patient. How often must hospice boxes be inspected? Who can inspect the box? - ANSWeekly; inspected by RPh or hospice employee How often must the list of meds in a night box be reviewed and who reviews them? - ANSAt least once per year; P&T committee reviews them How often, at minimum, must a P&T committee meet? - ANSAt least quarterly How soon must CENTRAL FILL records be readily retrievable? - ANSwithing 48 hours (different than the 72 hours for other pharmacies!) How to validate a DEA number? - ANS-Add 1st, 3rd, and 5th #s = (A)
- Add 2nd, 4th, and 6th #s and times by 2 = (B)
- Add A + B = C
- C should be double digit, and 2nd digit should be last # of DEA# Example: BS 1234563
- Add 1+3+5 = 9
- Add (2+4+6) X 2 = 24
- Add 9+24=
- Last digit in 33 = 3, last digit in DEA# = 3
- Valid
If a pharmacy decides to sell, when should their complete CII inventory be taken? - ANSOn the day they transfer all of their CS If a prescription in a community pharmacy is older than 16 months (and therefore is not stored in the ADP), how soon must an Rx be retrieved if requested by the board? - ANS72 hours If an agent calls in a CS Rx, do you need to record his/her identity? - ANSYes If an intern is no longer actively enrolled in a pharmacy degree program, he/she must notify the B.o.P within _________. - ANS30 days If CIII-V (yes, even C-V) are partial filled, how long are Rxs good for? - ANS6 months from date issued If CS are lost/stolen, WHO do you have to notify and WHEN? - ANSDEA within 1 day B.o.P. within 10 days If license lapses >3 years, do you have to retake the NAPLEX and MPJE? - ANSJust the MPJE If licensed less than two years but more than one year, how much live and pain management CE is needed? - ANSNo live, 1 pain CE If no drug product selection occurs, what drug name(s) should be on the label? - ANSIndicate only the name of the brand prescribed (ex: ZyPREXA, Nexium) If notified of an error with your MAPS reporting, you must fix the error in what time frame? - ANSwithin 15 days If the Power of Attorney to sign DEA 222 forms has his/her privileges revoked or leaves that place of employment, how long does the DEA registrant have to change the record? - ANS6 hours If you spill or break some CS, is this considered a "loss" - ANSNo If you spill or break some CS, what do you do? - ANS-IF some is recoverable, send to reverse distributer using DEA 41 form
- If NOT recoverable, go into your last inventory and makes a notation of what happened --> Sign it and have witness sign it If your records are kept in a central location, the DEA can ask you to bring them back within what time frame? - ANS48 hours In Michigan, do drugs have to be AB rated in the Orange Book to be interchanged? - ANSNo, they just have to be deemed "generic equivalents" Internship hour requirement - ANS1000 hours (500 in the last 18 months of school) Is a prescriber who dispenses samples or "first doses" in ERs considered a dispensing prescriber? - ANSNo Is an alarm required for a pharmacy? - ANSNo; not unless the pharmacy is also a distributor Is computer-to-fax Rxs with ELECTRONIC signature allowed for any Rxs? - ANSYes, only for non-CS Rxs Is fax-to-fax Rxs with manual signatures allowed for all Rxs? - ANS-Yes, for all CIII-V and non-CS
- Only allowed for 3 situations for CII's Is it legal to dispense an FDA-approved drug for an off-label indication? - ANSYes. Is it mandatory to keep an inventory of pseudophed products? If so, how often? - ANSYes, once a year Is there a limit to how many CS scripts you can write on one form? - ANSNo, you just can't mix CII scripts with CIII-V scripts Is there a minimum age requirement for the purchase of dextromethorphan? - ANSNo Is there a quantity restriction on how much of a drug you can prescribe on a single Rx? - ANSNo, not technically. Although for CII Rxs, you cannot exceed a 90 day supply. Ketamine is in which CS schedule? - ANS
OBRA 90 and the Michigan "counseling rule" - ANS-OBRA 90: Requires pharmacists to offer to counsel ALL Medicaid patients or caregiver on the first fill of a new medication (and on refills if deemed necessary)
- Counseling Rule: Michigan requires the ALL patients or caregiver (regardless of insurance carrier) being counseled on the first fill of a new medication.
- NOTE: Info shall be provided if requested for any Rx by the patient or patient's caregiver or agent OBRA 90: Items needed for maintaining records - ANS-Name, address, phone number, DOB (or age), gender
- RPh comments relevant to the client's drug therapy
- Patient history when significant, disease states, known allergies, and drug reactions
- Comprehensive list of medications and relevant devices
- Offer to counsel the patient—they can accept or reject the offer OBRA 90: Items to discuss with patient - ANS-Name and description of the medication
- Route, dosage form, dosage, and duration of drug therapy
- Special directions and precautions
- Common, severe side effects or drug interactions
- Techniques for self-monitoring drug therapy and actions required
- Proper storage
- Prescription refill information
- Action to be taken in the event of a missed dose OTC Labeling - minimum font size? - ANSSize 6 OTC Labeling Requirements - ANS-Active Ingredients
- Purpose
- Uses
- Warnings
- Directions ("Adequate directions for use")
- Other Information
- Inactive Ingredients
- Statement of identity of the drug
- Name & address of manufacturer, packager, or distributor
- Net quantity of contents
- NDC
Package Insert - ANS-Contains essential information for safe and effective use of the drug (Ex. Black Box Warnings)
- Can give to the patient Patient Package Insert - ANS-Community or outpatient pharmacies must give with every dispensing
- Institutional law: must be given before the first administration and every 30 days
- Physician canNOT opt out for a patient
- It is considered misbranded if not given Pentazosine (Talwin) is in which CS schedule? - ANS Preceptor Requirements - ANS-One year of practice
- Arranging intern's training
- Not more than 2 interns per pharmacist on duty at the same time
- Submit training affidavits annually to Board Prescription Drug Marketing Act - ANS-Bans the sale of samples
- Requires drug wholesalers to be licensed by the states
- Restricts reimportation from other countries Pretty much every record in the pharmacy has to be kept for __ years, except prescription records (which are __ years). - ANS2; 5 Quantity requirements for pseudophed and ephedrine products? - ANSMax = 3. grams/day or 9 grams/30-day period Record requirements for delegation - ANS-Printed name of delegatee
- Licensure designation
- Name of delegating prescriber
- Signature of delegatee
- DEA # for both Records pertaining to automated devices (ex: Pyxis) must be kept for how long? - ANS years Requirements for a non-CS Rx? - ANS-Name of patient
- Prescriber's printed name and address (phone number only required if e-Rx)
- Drug name and strength
- Quantity prescribed
