MPJE Michigan – Flashcards
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What changes in pharmacy ownership or operations have to be reported to the state?
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-Provide state board of pharmacy with WRITTEN notification of a change in any partners, stockholders, officers, or member of board of directors (of Pharmacy). -Must notify within 30 days of the change. -Pharmacy licenses are not transferrable between owners.
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What information is required for a pharmacy license? (entity)
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-Each new location pharmacy is to be operated -Pictures of inside/outside w/ descriptions -Self inspection -Fee
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How long is a pharmacy (entity) license valid?
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-2 years and terminated on June 30th -CS license generally ~3 years
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What are the qualifications needed for a pharmacist license?
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-18 or older -Good moral character -No disciplinary actions by any other state Board of Pharm -Degree from Pharmacy School -Fingerprints from State PD/FBI -Criminal Background check -Passed NAPLEX/MPJE (in <5 tries)
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How is a lapsed pharmacist license renewed if lapsed for <3 years?
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-If not renewed within 60 days of June 30th, the license will lapse. -Submit a completed app with fee -Proof of completed CE that are earned within the 2 year period.
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How is a lapsed pharmacist license renewed if lapsed for 3-8 years?
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-New application w/ fee -30 hours of CE completed in past 2 years -Passing MPJE -200 hours within 6 months under personal charge of pharmacist and verification from the personal charge pharmacist
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How is a lapsed pharmacist license renewed if lapsed for >8 years?
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-New application w/ fee -30 hours of CE in past 2 years -Passing MPJE -400 hours within past 6 months under personal charge of pharmacist and verification from the personal charge pharmacist -Passing NAPLEX within 5 tries. If not has to go back to pharmacy school.
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What is a drug control license and who needs one?
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-Prescribers who wish to dispense drugs directly to a patient need a drug control license (except Veterinarians or if dispensing occurs in ER) -Must keep record of these drugs in patients chart for 5 years
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What information must appear on the drug container of a medication a PRESCRIBER dispenses?
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Name/address of location, pt name/MRN, date, prescriber, directions, strength, quantity, expiration
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Are Michigan Board of Pharmacy meetings open to the public?
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Yes, anyone is allowed to come but a request must be made to the secretary/chairsperson.
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What are CE requirements for pharmacists?
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-30 hours of CE every 2 years. -10 hours live presentations -No more than 12 credits day -Cannot do CE's for next renewal period before this one is up.
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T/F All CE must be approved by ACPE for credit.
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True
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What are legal requirements for preceptors?
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-Approved by Board to direct training of intern in a pharmacy -Be engaged in pharmacy practice for 1 year before becoming a preceptor -No more than 2 interns at once -Do training affidavits
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What are pharmacy internship requirements?
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-APPE/IPPE -Limited License=Limited Pharmacist License=Intern License -Must be started P1 year -Enrolled in Pharmacy School -Valid no more than 1 year after graduation -Must complete no fewer than 1,600 hours (work and board approved rotations) -MAX of 40 hours rotations per week -MAX of 16 hours of work during school -400 hours of unconventional internship program (random pharma summer internship) -Work experience does not have to be in state of MI and can be in Canada -Notify board to cancel license within 30 days of dismissal from pharmD program
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Do drugs sold in MI have to be marked with special numbers?
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All prescription only drugs must be marked/imprinted with a symbol, number, company name, words, letter marking, NDC or any combo of these identifiers. For SOLID ORAL dosage forms only. There is an exception for pills too small to have prints on them. Violation can lead to jail and $25k fine
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What is a harmful drug?
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A drug intended to be used by human beings that is HARMFUL because: -Toxicity -Habit forming nature -Potential ADRs Must be Rx only!!!
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What is a deleterious drug?
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A drug other than a proprietary medicine that is likely to be destructive to an adult human in quantities of 3.88 grams or less*
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What is Michigan's law regarding use of child-resistant packaging?
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-Unless requested by patient -Doesn't have to be in writing but should have it for evidence purposes
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What is a prescription under Michigan law?
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-An order for drugs/devices written and signed or transmitted by other means (telephone, electronically) by a prescriber to be filled/dispensed. -Prescribing applies to all drugs (OTC to)
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How are prescriptions communicated from a prescriber to a pharmacy/pharmacist?
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-Handwritten on paper -Oral communication via telephone -Fax or facsimle -Electronic Prescription
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Uniform Prescription Requirement?
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-Name of patient -Name of drug, dose -Date prescribed -Directions for use -Name, address, and phone of prescriber (unless institutional)
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What is a signature for E-prescriptions?
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-The statue defines an "electronic signature" as an electric sound, symbol, or process with the intent to SIGN the record.
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Noncontrolled Federal Legend drug requirements for E-prescriptions?
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-Must comply with confidentiality safeguards (HIPPA) -Contain safeguards ensuring it is not changed/edited after being sent to the pharmacy -Name, address, phone of prescriber -Full name of patient -The electronic signature or other identifier that specifically identifies and authenticates the prescriber -The identity of the pharmacy intended to receive the transmission -cannot include DAW as default setting
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What needs to be on a Controlled Substance E-prescriptions?
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-Use signature or e-signature (Stamps are NOT valid) -Pre-printed/stamped/typed/written name, address and phone number of prescriber -Manually printed name of patient -Address of patient -Prescriber's DEA -Prescriber's signature -Quantity of the prescription drug prescribed (written AND numerical terms) -Date drug was prescribed
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Can a controlled substance (3-5) be transmitted by fax of a printed prescription and by electronic transmission of a printed form?
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yes only C3-5 not C2
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Noncontrolled substance prescription may be transmitted electronically by a system that includes:
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-Combination of security measures -Electronic signature -Appropriate security measure -no substitute is allowed and DAW on the script not one or the other
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What is required when a PA or NP prescribe a controlled medication?
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-DEA number -Their name -Delegating/supervising physician name and DEA
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T/F. A prescription canNOT be used to obtain an office stock of controlled substance for dispensing/admin to patients.
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True....the doctor will have to do this through a distributer using a DEA222 form.
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What needs to be on oral Non-emergency federal legend controlled substance C3-5 prescriptions in community pharmacy?
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-Name, address and phone number of prescriber -Manually printed name of patient -Address of patient -Prescriber's DEA -Quantity of the prescription drug prescribed (written AND numerical terms) -Date drug was prescribed
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Oral orders of C2 orders in community pharmacy?
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-Only for terminal patients -Must be filled within 90 days of issued prescription -Only for hospice/terminal patients
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Refills for Controlled Substance Prescriptions?
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-C3-4 prescriptions can be refileld if authorized by the prescribers up to 5 times within 6 months from the DATE that the Rx was written. -C5 refills can be completed as authorized however long after the date the Rx was written (1 year is the conventional/reasonable thing to do). -C2 prescriptions CANNOT be refilled but the prescriber may authorize/write multiple prescriptions for 90 days...must have do not fill until X date. Do NOT post-date
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T/F: Prescribers can write more than one prescription on a C2 script.
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False
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Can doctors use preprinted blanks for scripts?
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Yes; aslong as they make sure they are circling the proper drug. C2's are not allowed to have more than one drug on the script.
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Nonemergency legend prescriptions in institutions (CS and Noncontrol)
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-Patients name -Prescriber's signature -Name/dose/frequency of admin -Date of medication order -Prescriber's name, address, and DEA (not required if pharmacy has a list of authorized prescribers)*
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Delegated prescribing in medical institutions requirements?
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-Printed name of delegatee -Delegatee and licensure designation -Delegatee DEA -Delegating prescriber/DEA -Delegating prescribes/delegatee signature
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Emergency CS prescriptions in institutions?
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-Oral order of the prescriber must be committed to a written or electronic order in the patient chart by nurse/assitant/pharmacist -Rx must contain the name of prescriber and name of nurse/assistant/orpharm -Order must be sent to pharmacy and prescriber must sign the original order at time of next visit/within 7 days.
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Emergency CS in Community pharmacies?
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-No special rules for Schedule 3-5 dispensing because you can do oral/e-scribe -For C2s: Prescriber must fill out a prescription form and forward the prescription to the dispensing pharmacy 7 days after the oral admin of the C2 -Script sent to pharmacy after 7 days must have "Authorization for Emergency Dispensing" written on it -Emergency exists when prescriber advises pharmacist of the user, appropriate alternative tx is not available, not reasonable for prescriber to write C2 script, quantity dispensed/prescribed is limited for just the emergency period. -Pharmacist must confirm prescriber using their phone numbers in "good faith" -If pharmacist cannot get prescriber to send in script after 7 days must contact LARA immediately
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Constrolled Substance Prescriptions for Terminally Ill Patients?
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-C2 prescriptions for terminally Ill patients do not expire after 90 days after being written -C2 prescriptons for terminally ill patients may be partially filled for up to 60 days after the original date -Fax of C2 if it will be compounded for direct admin by parenteral, IV, IM, SC, or intraspinal infusion by fax.
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How many prescriptions may appear on a written noncontrolled script?
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-4 drug orders per prescription paper (if hand written) -6 prescription orders (if typed)
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Can controlled substance and noncontrolled prescriptions appear on the same written script?
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No they cannot be
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Laws in michigan with mailing/recieving prescriptions?
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-Can recieve and dispense medication via mail
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What are the rules with regard to using federal legend drug automated devices or drug vending machines?
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-Prohibits a pharmacy from owning, controlling, or operating a device used to dispense legend drugs within a prescribers office -Devices must be approved by the state board -Devices can only be stocked by pharmacist or someone under personal charge of pharmacist -Rules are different for inpatients in hospitals
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What are the labeling requirements for Hospice Boxes?
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-Name/address of pharmacy -Name/address of hospice -Name of the pharmacist who last inspected/restocked -Date the box was inspected/restocked -Date on which the drug box will be returned for inspectiion -Number of the drug box
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Hospice Box policy requirements?
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-Maintain box from pharmacy to RN or PA -Assurance the drug is inspected weekly if not used/expired -Storage assigned to RN or PA -Hospice directors responsibility for getting prescriptions from attending physicians
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What must the pharmacy record maintain for Hospice Box?
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-Number of the box -Name of Hospice -Date the box was released to hospice -Expiration date assigned -Date the box is returned to the pharmacy for restocking -Name/Signature of pharmacist who released box -Name/pharmacist who restocked the box
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Can federal legend drugs be returned to community pharmacy?
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No they cannot be returned to stock once they have been dispensed. The pharmacist can take them back but cannot return them to stock...can dispose of them.
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Are there limits on how much of a pharmacy's federal legend inventory may be distributed to other pharmacies?
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No more than 5% of the total annual federal legend inventory can be dispensed to licensed practioners (prescribers AND pharmacies). -If the distributed federal legend drugs are >5% of the annual inventory, the pharmacy is deemed to be a wholesale distributer and needs to get licensed as such.
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Are there limits on how many prescriptions may be compounded by a pharmacy?
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No more than 5% of the total annual precriptions can be compounded -If there are >5% of the annual prescriptions are compounded, the pharmacy is deemed to be a manufacturere and needs to get licensed as such.
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Are the special regulations regarding drug compounding pharmacies?
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-Must be licensed -Must compound upon receiving a prescription or anticipation of receiving prescription based on normal order -Cannot compound commercially available products, biolgics/allergenics, or reconstitute/mix stuff already manufactured. -To provide compounding services in MI a person must be licensed as a pharmacy or manufacturer -Sterlie compounding pharmacies need to be accredited or need to meet USP standards by the board.
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Manufacturer is
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A person (entity) that prepared, produces, derives, propogates, COMPOUNDS, processes, packages or repackages drug on prescription only.
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Outsourcing facilities are regulated by the FDA (T/F)
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True
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Sterile compounding pharmacist record includes?
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-Only for non hospital/health entity -Name/strength/quantity/dosage form compounded -Formula/instructions needed to prepare -Prescription number -Date of preperation -Manufacturer and lot of each ingredient -Expiration/beyond use date -Name of person who prepared it -Name of pharmacist who approved it
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(T/F) A pharmacist cannot distrubute excess compounded pharmaceuticals to other pharmacies for resale.
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True
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(T/F) A pharmacist cannot distrubute excess compounded pharmaceuticals to health care professionals for complimentary starter doses.
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True
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(T/F) A compounding pharmacy can advertise that they compound but cannot advertise a specific medication.
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True
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(T/F) A person cannot compound and manufacture drug products in the same location
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True
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(T/F) A pharmacist can compound non-commercially available sterile/non-sterile preperations based on health professional/patient relationship, or valid prescriptions, anticipation of prescription based on patterns.
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True
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(T/F) The department can license a pharmacy that is compounding sterile/nonsterile prepartations for a precriber or health care facility in LIMITED quantities WITHOUT a prescription.
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True. But this is only the case if the pharmacy is NOT under investigation or if there is no disciplinary status. The following are required to do this: -The name/license of the pharmacist/pharmacy requesting authorization -Name of specific prescriber/health facility/agency that is requesting compounded pharmaceuticals with an affadavit -The reason and what pharmaceuticals are going to be compounded -Anticipated quantities per month/frequency -USP standards/sterility testing
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(T/F) If a compounding pharmacy is aware of an adverse event due to the product they are requried to report it to the Department no later than 10 days after becoming aware of it.
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True
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A pharmacist in a compounding pharmacy is not to compound commercially available products unless...
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-They are modified to produce a significant difference -The commercially available product is not available from normal distribution channels and patient needs it in a timely manner.
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What are controlled substances?
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They are drugs/substances that have been determined by the federal and state government to have a potential for creating an addiction and dependency which lead to forms of abuse -Some of the drugs that are controlled are NOT federal legend and can be bought OTC
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Who controls controlled substances?
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-the DEA (part of DOJ) decides whether a drug will be controlled or not. -FDA (part of HHS) decides whether a substance isa prescription drug or not. -MI board makes laws that are more stringent about controls than the Federal Laws
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Criteria for placing a substance into a controlled schedule?
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Schedule 1: high potential for abuse, no medical use Schedule 2: high potential for abuse, accepted medical use (Narcotics, Stimulants ADHD) Schedule 3:moderate potential for abuse, accepted medical use (Codeine, testosterone/steroids) Schedule 4: low potential for abuse, accepted medical use (Psych drugs, Ultram, Soma) Schedule 5: low potential for abuse, accepted medical use (OTC and Rx)
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Are there any substances excluded from regulation as a controlled substance under MI law?
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Yes, distilled spirits/liquor, wine, beer, and tobaco cannot be designated as controlled substances and are BEYOND control of Board of Pharm Non-narcotic controlled substances OTC but loperamide and Cheratussin are still C5's.
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Are the controlled schedule drugs the same under federal and MI law?
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Yes for the most part -If the federal government changes a schedule the Board will meet within 91 days and change
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What is the law regarding controlled substance inventories ?
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-Federal=less restrictive, MI is more strict but both are followed -DEA requires controlled substance inventories every 2 years (any time of the year) -MI law requires CS inventories every year (within 60 days after May 1 of each year) -Exact count of C1 and C2, estimated count of C3-5 for stock bottles 1000+ -C2's are to be seperated on the inventory sheet
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What is the law regarding controlled substance acquisition records?
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-Keep all acquisition records and invoices for 2 years -Sales receipts kept for 90 days -Must be readily retrievable in 48 hours -Everything but DEA 222 acquisition forms can be kept at a central location -Original prescriptions must be kept for 5 years (10 years for Medicare) -Files: Invoices/Records of C1-2, Invoices/Records C3-5, Invoices/Records for Noncontrolls
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What is the law regarding controlled substance distribution records?
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-Records of all controlled substances distributed to another licensee (other pharmacists, doctors, pharmacies) -Must use DEA222 Form if distributing a C2 -Name, Address, DEA #, quantity/name of CS, date
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What is the law regarding controlled substance prescription records in a Medical Institution?
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-Original orders of C2s must be kept for 5 years -Readily retrievable in 48 hours -After 3 years a duplicate may be made of the original -If kept electronically, print copy immediately and provide original in 48 hours -Must maintain seperate records that have: -# of doses purchased -# of doses dispensed to patients/nursing stations -# of doses administered -# of doses dispensed but not administerd -Annual physical inventory of controls
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What is the law regarding controlled substance records in medical institutions, nursing homes, medical facilities, hospices, and skilled nursing faclities?
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-Medication records for C2-5 have to be kept -Distribution of a CS from nursing station is limited to <25 doses per container -Name/dose of CS -Quantity of CS -Date of delivery -Location/Name of nursing unit -name of distributing pharmacy (address if diff location) -Nursing unit must also keep their own set of records that include: Name of CS, dose admin, date/time dose was given, pt name, signature of person who gave dose
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What is the law regarding controlled substance records for mechanical devices used to administer them?
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-Identity of pharmacist checking accuracy of medications to be stocked/restocked in the device -If a pharmacist delegates, the non-pharmacists name -All records be kept for 2 years from the date of last dispensing
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What is the law regarding controlled substance records for destruction of CS in medical institutions?
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A reasonable individual must record destruction of CS -Quantity destroyed -Manner destroyed in
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What is the MAPS program?
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Requires community based practitioners that dispense CS to tell the state the name, quantity, date, and person the CS was dispensed to. Lets other practitioners see the CS dispensed by others. -Patient identifier (name, address/zip, DOB, driver's license #) -Name/NDC of CS -Quantity -Date -Estimated days supply -Rx number -DEA number of prescriber/pharmacy -MI license number of dispensing pharmacy -information from each practice is uploaded twice every month (1st and 15th).
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What does MAPS stand for?
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Michigan Automated Prescription System
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(T/F) A zero should be entered in identification number area if the patients ID doesn't include a license number or ID #.
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True
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(T/F) For dispensing a control to an animal, put the owner's ID # in the MAPS system.
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True
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(T/F) A pharmacist, dispensing prescriber, or vet who dispenses a CS will need to transmit data via electronic device, computer diskette, compact disc, another medium.
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True
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What are situations where patients/prescribers/pharmacists are exempt from MAPS?
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-When a C2-5 is given directly to patient -When a C2-5 is dispensed from a health facility or prescriber for <48 hours.
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What has the Michigan Legislature stated about prescribing controlled substances drugs?
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-Provides info to health care consumers -Educates health care professionals in pain mgmt -Appointment of an advisory body to study/make recommendations on pain/sympto m mgmt -Educate health care professionals on disciplinary process on wrongdoing -LARA developed and passed out book on pain
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What are the standards used by pharmacists in MI to determine whether a CS prescription is valid?
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-Lack of consistency in doctor-pt relationship -Frequency of prescriptions for the same drug by one prescriber for larger numbers of patients -Quantities beyond those normally prescribed -Unusual doses -Unusual geographic distances
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What are requirements for emergency C2 scripts?
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-Receive prescription within 7 days of emergency -Dispense only for duration of emergency -Has to have AUTHORIZATION FOR EMERGENCY DISPENSING on it -Pharmacist has to notify department if MD doesnt reach back.
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What rules apply with respect to dispensing androgenic anabolic steroids?
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-Schedule 3 -Consult the rule not the statue
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What are requirements for storing controlled substances in a pharmacy?
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-Storing them in a securely locked cabinet or cart -Dispersing them throughout store to prevent theft/diversion -Combination of both...C2 in safe and rest dispersed (most common) -Schedule 1 must be in locked safe anchored to wall
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What are requirements for dispensing C5 without prescriptions (Exempt narcotics)?
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-Medical purpose (not abusive) -Has NOT obtained: More than 240cc (8oz) or 48 solid doses containing opium OR more than 120cc (4oz) or 24 solid doses of any other C5. -Purchaser >18yo -Record/bound book keeping list of transactions (name/address, drug name/quantity, date purchased, pharmacist/intern initials, medical purpose)
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What amount of C5 can be sold without a prescription at any time?
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-240cc (8oz) or 48 solid doses containing opium -120cc (4oz) or 24 solid doses containing other C5
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What are circumstances where C2 can be partially filled?
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-Pharmacy does not have enough to fill the prescription, they can partial and fill the rest within 72 hours (do not do if you cannot obtain completion within 72 hours) -Long term care facilities to patients with a documented illness. Partial filling is allowed if it is documented properly on the back of the original Rx. Valid for no more than 60 days from the original date.
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What are the rules for dispensing ephedrine and ephedrine products?
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-May not purchase >3.6g of ephederine/pseudoepherine in a day. -May not purchase >9g in 30 day period -May not possess more than 12g -Purchase any amt of ephederine to make meth -Jail, fine for doing this
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Who is exempt from the ephederine/pseudoephederine purchasing laws?
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-Someone with a license to deliver, dispense, or possess with intent to manufacture/deliver/possess -Someone with a prescription for pseudofed -Someone who purchases it for retail sale -A person who possesses it in the course of business of selling/transporting/distributing -A product formulation (that the state approves) that doesnt allow conversion to meth -Possession of any pediatric product intended for admin to children <12 yo
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A pharmacy ephederine products in accordance with the pseudophed purchasing laws must:
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-Require purchaser to produce a valid govnt issued photo ID -Maintain a log or sometype of record with: time of purchase, name, address, DOB, amount, description of product (enter it into NPLEx) -Log should be maintained for a minimum of 6 months
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(T/F) Before ringing a customer up for pseudophed a retailer has to send information to NPLEx system. Retailers cannot be required to pay a fee for this NPLEx System.
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True...whenever this is overrided it should be noted in the system log
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(T/F) Ephederine and similar products are listed in schedule 5.
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True except dietary suplements that contain a small amount of ephederine.
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How are thefts or other losses of controlled substances to be reported?
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-Must be reported within 10 days of a discovery of theft/loss of any controlled substance (usually the PIC) -DEA Theft and loss form 106 is filled out immediately which is given to the Board and the local DEA.
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How should phsycians and other prescribers order controlled substances for office use from a pharmacy?
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-Dispensing v. distribution (to another pharmacy or prescriber) -Cannot do this by prescription that says For Office Use -Must use DEA 222 form for C2 -Use drug invoice for C3-5 (one copy for u/ one for md) -Cannot distribute >5% of total prescriptions of the year
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Are there any signficant differences between MI CS laws and Federal?
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-Registration and Licensure: federal laws states a pharmacy must have a DEA number (pharmacists don't). In MI, both pharmacists and pharmacies must obtain a CS license. -CS Inventories: federal law states every 2 years, MI law states every year -Distribution records:Federal states keep DEA222 seperate from C3-5 invoices. State says seperate C2, C3-5 and non-controls -Filing of Prescriptions (federal): Either seperate C2, C3-5, and non controlled. Mix C2-5 and have non-controls. Filing of Prescriptions (state): has to be C2, C3-5, and noncontrols. -C2 Prescriptions: Name, address, DOB (federal). MAPS, federal requirements (state). -C2 Time limit: no time limit (federal). 90 days (state) -C2 Emergency: Federal law states prescriber must send the written Rx within 7 days ("Authorization for Emergency Dispensing"). MI it must be postmarked w/in 7 days. -Prescription Faxing: federal law permits to use fax for controlled Rx but not for C2. MI is the same but lets you recieve e-scripts -Controlled inventory records: for 2 years for MI and federal. -Prescrition records: Federal requires to maintain CS scripts for 2 years. MI requires all scripts 5 years. Medicare is 10 years... -Ordering C2: Federal law w/ a registered DEA # may purchase by assigning power of attorney to sign DEA 222 Form. MI only someone with a valid CS license may sign a DEA 222 form. -Treatment of Narcotic Addiction: Federal says someone who can prescribe CS can administer (not prescribe) something to relieve acute withdrawal. No more than 1 day supply except nuprenorphine (which is 3 days). MI says that the prescriber must be licensed to dispense, administer, or prescribe a narcotic for dependency.
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Marijuana status in MI?
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It is a schedule 1 under federal and state law. Nothing to do with pharmacy yet just for personal use laws. IFF federal law changed marijuana to C2 then it will change stuff but states have 180 days to make changes.
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What should be on a prescription for pharmaceutical grade cannibis?
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Date of Rx written, date rx filled, dosage/instruction for use, % total THC, 2.5 oz, name/address/federal DEA, patient info, product name
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What are grounds for licensure sanctions?
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Violation of general duty -Negligence -Failure to exercise due care -Negligent delegation/supervision -Impaired ability to skillfully practive Personal Disqualification -Incompetence -Substance abuse -Mental/physical incapability -Mental incompetence -Conviction of misdemenor -Lack of good moral character -Conviction of criminal offense Unethical business practices -false/misleading advertising -fraud/deficit in license -outside scope -illegal CS obtaining -Adulter/misberand
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What kinds of penalties are available for disciplining licensure violations?
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-Fines -Reprimanded -Probation -Licenses limited/denied/suspended/revoked
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What licensure violations by other health care providers must be reported to the state?
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Tattletale laws -Licensee is to report any knowledge of violation of another licensee -Confidential reporting -Has to self report within 30 days for other states -Michigan Health professional recovery program
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Certain people cannot be employed by pharmacies if employment allows them access to CS...
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-Someone who the licensee knows to be a substance abuser -Someone whose CS license is suspended/revoked/denied -Someone whose license in another state is under suspicion -Someone who has been convicted of crime involving CS
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(T/F) You can employee a past substance abuser who is in the state program?
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True
