question

Misbranding

answer

Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA

question

Adulterated or Misbranded?: False/misleading labeling

answer

Misbranded

question

Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug

answer

Misbranded

question

Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable

answer

Misbranded

question

Adulterated or Misbranded?: Drug has habit-forming substance and label fails to list name and proportion of substance and "Warning—may be habit forming"

answer

Misbranded

question

Adulterated or Misbranded?: If established name or mutli-ingredient products don't identify each active ingredient

answer

Misbranded

question

Adulterated or Misbranded?: Drug is liable to deterioration and label doesn't warn to that effect

answer

Misbranded

question

Adulterated or Misbranded?: Misleading container, imitates another drug or offered for sale under the name of another drug

answer

Misbranded

question

Adulterated or Misbranded?: Dosage, frequency, duration or route of admin suggested in the labeling is dangerous

answer

Misbranded

question

Adulterated or Misbranded?: Pharmacist dispensed a medication without a refill or prescription

answer

Misbranded

question

Adulteration

answer

Failure of drug or device to satisfy FDA purity standards

question

Adulterated or Misbranded?: Consists in whole or in part of filthy, putrid or decomposed substance

answer

Adulterated

question

Adulterated or Misbranded?: Prepared, packaged or held under unsanitary conditions, whereby it MAY have become contaminated w/ filth or MAY have been rendered injurious to health (don't have to prove, just say it MAY have)

answer

Adulterated

question

Adulterated or Misbranded?: Drug is manufactured in facility in violation of cGMPs

answer

Adulterated

question

Adulterated or Misbranded?: Container is composed of poisonous or deleterious substance that may render contains injurious to health

answer

Adulterated

question

Adulterated or Misbranded?: Bears unsafe color additive for purposes of coloring only

answer

Adulterated

question

Adulterated or Misbranded?: Drug labeled in official compendium but strength differs from or quality or purity falls below compendium standards

answer

Adulterated

question

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

answer

Adulterated

question

Adulterated or Misbranded?: Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted for the drug

answer

Adulterated

question

Adulterated or Misbranded?: Pharmacist dispenses expired products

answer

Adulterated

question

Labeling

answer

Anything accompanying the product (ex: package insert, med guide, advertisements, physician's desk reference, side effects statement, promotional material, the actual label, etc.)

question

OTC Labeling - minimum font size?

answer

Size 6

question

Federal Food Drug & Cosmetic (FDC) Act

answer

-Required new drugs to be shown safe before marketing -Authorized factory inspections

question

Prescription Drug Marketing Act

answer

-Bans the sale of samples -Requires drug wholesalers to be licensed by the states -Restricts reimportation from other countries

question

Michigan Board of Pharmacy Members

answer

11 members - 6 RPh and 5 Public

question

Michigan Board of Pharmacy Disciplinary Subcommittee

answer

-2 public and 3 professional members -Vote on disciplinary actions -Must have 1 public member to vote along with the majority for a decision to be made (gives the public members a "super vote")

question

Package Insert

answer

-Contains essential information for safe and effective use of the drug (Ex. Black Box Warnings) -Can give to the patient

question

Patient Package Insert

answer

-Community or outpatient pharmacies must give with every dispensing for the drugs that require one (ex: estrogen products) -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

question

Medication Guide

answer

-Required by FDA on certain products that cause "a serious and significant public health concern" -Required in the community setting with EVERY dispensing (misbranded if not given) -Physician CAN request the patient does not receive one but patient can override this request -Institutional setting: it's unnecessary to dispense b/c there's a professional available at all times to answer questions.

question

Consumer Medication Information

answer

-Not a requirement -It's printed consumer medication information provided to patients at the time a new Rx is filled

question

HIPAA Privacy Policy

answer

-Notice given to every individual -Good faith effort to obtain the patient's written acknowledgment of the receipt of the notice

question

OBRA 90 and the Michigan "counseling rule"

answer

-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

question

OBRA 90: Items to discuss with patient

answer

-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

question

OBRA 90: Items needed for maintaining records

answer

-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

question

Drugs Exempt from Childproof Packaging

answer

Sublingual 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)

question

NDC Number Requirements

answer

Required on all Rx and OTC products

question

When can non-child resistant packaging be used?

answer

-Dispensing to patients in a nursing home/hospital -Drugs to be administered by institutional personnel -Samples, Starter packs -Topical application -Dosage form not intended for oral administration -Bulk containers received by the pharmacy -Unit dose packaging (birth control) -Patient, physician, or caregiver can request exemption

question

Adulterated or Misbranded?: Re-selling a repackaged medication

answer

Misbranded

question

Unit dose packaging expiration dates

answer

6 months, or 25% of the remaining time between the date of repackaging and the original expiration date.... whichever comes first

question

Adulterated or Misbranded?: Drug is not dispensed in a childproof container

answer

Misbranded

question

Activities that are violations of the FDCA

answer

-Adulteration -Misbranding -Placing an unapproved drug into Interstate Commerce

question

OTC Labeling Requirements

answer

-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

question

Can samples, or "complimentary starter doses", ever be in a community pharmacy?

answer

No.

question

Can a hospital pharmacy house complimentary starter doses of non-controlled drugs?

answer

Yes, 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.

question

Can a hospital pharmacy house complimentary starter doses of controlled substances?

answer

No.

question

Drug Product Selection

answer

Another 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

question

Can and should a pharmacist apply drug product selection?

answer

-Pharmacist MAY if he/she wants to (but it is not required). -Pharmacist MUST if the patient asks.

question

What must appear on the drug receipt?

answer

-Brand name of drug dispensed -If no brand name, need name the manufacturer or supplier of the drug -Strength of the drug, if significant -Quantity dispensed -Name and address of pharmacy -Serial number of the Rx -Prescriber's name -Patient's name -Price paid by patient -Date the prescription was most recently dispensed. NOTE: this can appear on the receipt, the drug label, or a combination of the two

question

How long must a copy of the drug receipt be maintained in the pharmacy?

answer

90 days

question

In Michigan, do drugs have to be AB rated in the Orange Book to be interchanged?

answer

No, they just have to be deemed "generic equivalents"

question

What additional items must appear on a drug receipt if drug product selection occurred?

answer

-Difference in cost between the prescribed drug and the dispensed drug (only if the Rx is not run through insurance). -Brand name of the drug OR name of the manufacturer or supplier of the dispensed drug

question

What additional items must appear on a drug label if drug product selection occurred?

answer

-Name of the brand drug prescribed AND name of the brand dispensed -If the drug dispensed does not have a brand name, the generic name must be on the label -If the drug has multiple ingredients, the reference "G.Eq.," "generic," or "generic equivalent" must also appear on the label

question

Drugs must be ___________ equivalents to be interchanged.

answer

Generic

question

DAW Rules

answer

Prescriber 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

question

Can pharmacies advertise that they compound?

answer

No.

question

What drugs can be mailed? And who can mail them?

answer

-Non-controlled Rx can be mailed by the dispenser or practitioner to the ultimate user (patient)—must be wrapped in plain packaging -CS Rx can be mailed between licensees registered w/ the DEA; and the dispenser can mail directly to the patient (practitioners cannot in this case)

question

Which class of recall requires pharmacists to notify patients?

answer

Class 1

question

What classifies a product as a dietary supplement?

answer

Ingredients in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, enzymes, organ tissues, metabolites, extracts or concentrates

question

Is it legal to dispense an FDA-approved drug for an off-label indication?

answer

Yes.

question

Examples of fraud, waste, and abuse violations

answer

-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

question

4 elements needed to prove negligence

answer

-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)

question

Learned Intermediary Doctrine

answer

Manufacturer has legal duty to warn prescribers of drug side effects and adverse reaction that it knows or should know.

question

Describe when the "side effects statement" has to be given to a patient

answer

-Must be given w/ new Rx and all refills -Does not apply to inpatients in hospital

question

Side Effects Statement

answer

"Call your doctor for medical advice about side effects. You may report effects to FDA at 1-800-FDA-1088"

question

Internship hour requirement

answer

1000 hours (500 in the last 18 months of school)

question

How long is a pharmacy license and CS license good for?

answer

2 years, expires on June 30th

question

Address or name change needs to be reported to the Board no later than ________ after the change

answer

30 days

question

If an intern is no longer actively enrolled in a pharmacy degree program, he/she must notify the B.o.P within _________.

answer

30 days

question

Preceptor Requirements

answer

-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

question

CE Requirements

answer

-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

question

If license lapses >3 years, do you have to retake the NAPLEX and MPJE?

answer

Just the MPJE

question

Can you still practice if your license expires?

answer

Yes, but only for 60 days after the expiration

question

What level of blood alcohol content is considered "impaired" when working?

answer

0.05

question

What qualifies as a health facility?

answer

-An ambulance operation, aircraft transport operation, nontransport prehospital life support operation, or medical first response service -Clinical laboratory -County medical care facility -Freestanding surgical outpatient facility -Home for the aged -Hospital -Nursing home -Hospice / Hospice residence

question

What is the 5% rule?

answer

-Manufacturer 5% rule— if the total # of dosage units of all Rx drugs compounded in any consecutive 12mo period is more than 5% of total # of dosage units of Rx drugs prepared by the pharmacy during the 12mo period, that pharmacy must obtain a manufacturer's license -Wholesaler 5% rule—if the total # of dosage units of all Rx drugs distributed in a consecutive 12mo period is more than 5% of total # of dosage units of Rx drugs distributed and dispensed by the pharmacy during the 12mo period, then the pharmacy must obtain a wholesaler's license. -CS 5% rule—if the total # of dosage units distributed in a 12mo period exceeds 5% of the total # of dosage units of all CS distributed and dispensed during the 12mo period, the dispenser shall obtain a license to distribute CS.

question

What is a summary suspension?

answer

"may no longer practice from this point forward"

question

Identify why a licensee must report another licensee

answer

Failure to report = subject to administrative action -However the impaired licensee CANNOT file a lawsuit against the licensee who reported him/her, as long as the reporting was in GOOD FAITH

question

Identify the sanctions the Board can impose.

answer

-Community service -Denial Fine (amt depends on violation, cannot exceed $5,000 for each violation) -Limitation -Probation -Reprimand -Revocation -Restitution -Suspension -Complete educational program CE or a course -Complete a training program -Complete treatment program -Competency exam—mental, physical -Take a professional competence exam (MPJE or NAPLEX or both)

question

Can an out of state MD or DO prescribe controlled substances?

answer

Yes.

question

Can an out of state MD or DO prescribe non-controlled substances?

answer

Yes

question

Can a Canadian MD or DO prescribe non-controlled substances?

answer

Yes

question

Can a Canadian MD or DO prescribe controlled substances?

answer

No.

question

Can an out of state DDS prescribe non-controlled substances?

answer

Yes.

question

Can an out of state DDS prescribe controlled substances?

answer

Yes

question

Can a Canadian DDS prescribe non-controlled or controlled substances?

answer

No.

question

Can an out of state NP or PA prescribe?

answer

No.

question

Can any out of state prescriber other than a DO, MD, or DDS prescribe to Michigan?

answer

No.

question

Can a homeopathic doctor, naturopathic doctor (ND), or chiropracter prescribe in Michigan?

answer

No.

question

What can a OD prescribe?

answer

CIII-V, Non-controlled (no oral corticosteroids) (NO CII)

question

What can a DPM prescribe?

answer

All CS and non-controlled (if within scope)

question

What can a DVM prescribe?

answer

All CS and non-controlled (if within scope)

question

What can a PA prescribe?

answer

All CS and non-controlled (if delegated by MD or DO)

question

What can a NP prescribe?

answer

All CIII-CV, limited CII (7 day supply if patient is being discharged from hospital or free-standing surgical site), and non-controlled (if delegated by MD or DO)

question

What can a NMW prescribe?

answer

The same meds as an NP

question

What can an RN prescribe?

answer

Non-controlled drugs (if delegated by MD or DO)

question

What can an LPN prescribe?

answer

Nothing

question

What can a CRNA prescribe?

answer

Non-controlled substances (if delegate by MD or DO)

question

Delegation

answer

Authorization 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.

question

How does the health professional decide if he/she should delegate a task?

answer

- Must determine the knowledge and skill required to safely and competently complete the delegated task, act, or function... and determine if the delegatee has that knowledge and skill

question

Can an RPh dispense pursuant to an internet Rx? What about an internet questionnaire?

answer

May dispense an internet Rx if: -The Rx was issued pursuant to an existing PHYSICIAN-patient or DENTIST-patient relationship -The Rx is authentic -The prescribed drug is appropriate and necessary for the treatment of an acute, chronic, or recurrent condition May not dispense pursuant to an internet questionnaire.

question

When are tamper-resistant Rxs required?

answer

-If Medicaid pays for part or all of the Rx (both CS and non-CS) -For CS in Medicare Part D programs???

question

Requirements for a Paper Non-Controlled Rx

answer

-Patient name -Prescriber name and address -Drug name & strength -Quantity & directions for use -Number of refills -Dated -Signature of prescriber

question

How many prescriptions can be on one sheet of paper?

answer

4 if handwritten 6 if typed / computer-generated

question

How long are non-CS Rxs good for?

answer

1 year from the date issued

question

How long are CII Rxs good for?

answer

90 days from the issue date (unless for a "terminally-ill" patient getting partial fills... then 60 days)

question

How long are CIII and CIV Rxs good for?

answer

6 months, or 5 refills

question

How long are C-V Rxs good for?

answer

FOREVER

question

Can a computer send an Rx to a fax machine?

answer

Only for a non-controlled drug... and a Michigan electronic signature is needed.

question

What are the 3 situations where a CII can be faxed AND used as the original prescription?

answer

1.) Rx for a LTCF resident 2.) Rx for a hospice patient (in a state-licensed or Medicare-funded hospice program) 3.) If the drug in a Schedule II narcotic that will be compounded for the direct administration by to a patient by IV, IM, SC, or intraspinal infusion (infusion centers).

question

Can you take back CS drugs from patients?

answer

Only if there is a recall or if you made a mistake (can't redispense them though)

question

Can prison pharmacies redispense or resell Rx drugs?

answer

Yes, they are contracted with the department of corrections.

question

How does a pharmacy return unwanted drugs that they purchased?

answer

-Reverse wholesalers (for non-CS and CIII-CV) -For CII meds, need to use a DEA 222 form

question

Can a pharmacy redispense meds returned from a nursing home?

answer

Yes, but only non-CS drugs because the patient doesn't take possession of it. CANNOT take back CS drugs from a nursing home!

question

What is required on an outpatient non-CS drug label?

answer

-Pharmacy name and address -Rx number -Patient's name -Date the Rx was most recently dispensed -Prescriber's name -Directions for use -Name of the medication, unless the prescriber indicates "do not label" -If drug product selection occurred, also need name of manufacturer or supplier -"Discard this medication 1 yr after the date it is dispensed" or earlier beyond use date (earlier date of expiration than 1 yr than the actual expiration date—strike statement)

question

Supervision

answer

Overseeing of or participation in the work of another individual by a health professional licensed, when there is continuous availability of direct communication in person or by radio, telephone, or telecommunication between the supervised and a licensed health professional

question

What are the labeling requirements when a brand is dispensed for another equivalent brand?

answer

Indicate both name of brand prescribed and name of brand dispensed (ex: Bactrim—Septra, Cordarone—Pacerone)

question

What are the labeling requirements when a generic (with no brand name) is dispensed for an equivalent brand?

answer

Indicate the name of the brand prescribed followed by the generic name of the drug dispensed (ex: Motrin 600mg—Ibuprofen, Lanoxin 0.125mg—Digoxin)

question

If no drug product selection occurs, what drug name(s) should be on the label?

answer

Indicate only the name of the brand prescribed (ex: ZyPREXA, Nexium)

question

What is an automated data processing system (ADP)?

answer

The electronic system used to track all patient prescriptions

question

How many months of instant access to prescriptions are needed for automated data processing systems (ADPs)?

answer

16 months

question

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?

answer

72 hours

question

What is a Customized Patient Medication Package (CPMP)?

answer

-Special packages prepared by pharmacist for a specific patient and which contains 2 or more prescribed solid oral dosage forms -Designed and labeled to indicate the day and time or period of time that the contents w/in each CPMP are to be taken

question

What ADDITIONAL labeling requirements are required for Customized Patient Medication Packages (CPMPs)?

answer

-Serial number for CPMP & Rx number -Strength, physical description, and total quantity of each drug product -Date of Rx of CPMP -Expiration date for CPMP -Telephone number of pharmacy -Any other info, statements, or warnings required for any of the drug products

question

What is the maximum expiration date for a Customized Patient Medication Package (CPMP)?

answer

60 days after packaged

question

What records must be kept for CPMPs dispensed?

answer

-Name and address of patient -Serial number of Rx order for each drug product contained in the CPMP -Info identifying or describing the design, characteristics, or specifications of the CPMP sufficient to allow subsequent preparation of an identical CPMP -Date of preparation of the CPMP and expiration date assigned (60days, NOT1yr) -Any special labeling instructions -Name or initials of pharmacist who prepared the CPMP

question

What meds cannot be put into CPMPs?

answer

-USP monograph or official labeling requires dispensing in original container -Drugs or dosage forms are incompatible w/ packaging components or each other -Drugs are therapeutically incompatible when administered simultaneously Drug products require special packaging (ex: NTG, Pradaxa, Proscar, Avodart) -Shall not package together in the CPMP medications that have physical characteristics that make them indistinguishable

question

Can a pharmacy put back to stock and redispense meds from a CPMP that was returned?

answer

No, 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

question

Are Med Guides, PPIs, SE Statements still required to give to the patient if dispensed in a CPMP?

answer

Yes

question

Give examples of medications with REMS programs

answer

Accutane, Clozaril, Thalidomide, Lenalidomide, certain biologics

question

Does the director of pharmacy of an institution have to be a pharmacist?

answer

Yes

question

Do hospital pharmacy personnel have to act under the personal charge of a pharmacist?

answer

No, they act under the supervision of a pharmacist.

question

Do institutional pharmacies have to have a P&T committee?

answer

Yes

question

How often, at minimum, must a P&T committee meet?

answer

At least quarterly

question

How often must a night box be audited by an RPh?

answer

At least once every 30 days

question

How often must the list of meds in a night box be reviewed and who reviews them?

answer

At least once per year; P&T committee reviews them

question

When a nurse or doctor takes a med out of the night box, within what time period does a pharmacist have to review the box?

answer

48 hours

question

What must be on the drug label for meds in a night box?

answer

Drug name, strength, expiration, and lot number

question

What records need to be kept for surgery patients?

answer

-Pre-op meds -Method of anesthesia -Amount of anesthetic when measurable

question

When can a nursing home emergency kit be opened? Who can open it?

answer

-Accessed only on the direct order of a physician -Accessible only to the licensed nurse in charge

question

What must be listed on the outside of an emergency kit for a nursing home?

answer

List of all contents and their expiration dates

question

Who must med errors or drug reactions be reported to IMMEDIATELY in a LTCF?

answer

Charge nurse, physician, or pharmacist

question

How often must a pharmacist perform a drug regimen review for LTC facilities?

answer

At least once a month... on every patient.

question

For hospice boxes, are precriptions required for the meds contained in the boxes?

answer

Yes, the hospice medical director provides the prescriptions

question

How often must hospice boxes be inspected? Who can inspect the box?

answer

Weekly; inspected by RPh or hospice employee

question

What must be on the INSIDE front cover of a hospice box?

answer

A list of the drugs in the box

question

What must be on the OUTSIDE label of a hospice box?

answer

-Name and address of pharmacy -Name and address of hospice -Name of RPh who last inspected and restocked the box -Date the box was last restocked -Date the box was returned to the pharmacy for replacement of drugs -Number of drugs in the box

question

Who may open a hospice box?

answer

An RN or PA on the order of the attending MD/DO or the hospice medical director

question

What must be contained on the hospice box EXCHANGE LOG?

answer

-Box number -Hospice name -Date the box is released -Date the box was returned -Box expiration date -Name and signature of pharmacist releasing the box -Name and signature of the pharmacist who received the returned box

question

Can the pharmacist delegate stocking of an automated device?

answer

Yes

question

What documentation must be kept for automated devices?

answer

-Type of equipment -Serial # -Content -Policies/procedures -Location w/in the facility

question

Can CS be stored in an automated device at a HOSPICE location

answer

No, unless the hospice is location onsite at a hospital

question

Can an automated device be located in a prescriber's office?

answer

Yes, 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

question

For emergency orders on an automated device, in what time frame must the pharmacist review the order?

answer

48 hours

question

How long must any pharmacy keep records of prescriptions or medication orders?

answer

5 years

question

For meds taken out of an automated device for a patient, what additional information is needed for documentation of the order?

answer

-Unique identity of device accessed -Individual accessing the device -Type of transaction (removal, return) -Pharmacist responsible for accuracy of the meds stocked in the device -Patient name -Name, strength, and dosage form of the med

question

Where are CS kept at LTC facilities if no pharmacy is on-site?

answer

CS Cabinet or cart (securely locked)

question

Requirements to OBTAIN a non-CS copy

answer

-Rx # from other pharmacy -# of remaining refills -Be a duplicate of the original Rx -Name of pharmacy issuing the copy -Date the copy was issued

question

Requirements to GIVE a non-CS copy

answer

-Cancel the original Rx -Date the copy was issued -Name of the pharmacy getting the copy -Name or initials of RPh getting the copy

question

Requirements to OBTAIN a CS copy

answer

-Name, address, and DEA # of the pharmacy issuing the copy -Name of the RPh issuing the copy -Transfer date -Date of ORIGINAL Rx -# of original refills -# of refills remaining -Date of last fill -Must write "transfer" on Rx face -Be a duplicate of the original Rx NOTE: Make sure it has NEVER been transferred before!

question

Requirements to GIVE a CS copy

answer

-Name, address, and DEA # of the pharmacy getting the copy -Name of the RPh getting the copy -Write "VOID" on face of Rx -Transfer date

question

How long does Medicare Part D require a pharmacy to keep prescription records?

answer

10 years... this is NOT the law though (5 years is)

question

Requirements to use Centralized Prescription PROCESSING Pharmacies (CPPP)

answer

-Same owner or written contract -Share common electronic file or other technology

question

Centralized Prescription Processing

answer

The 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)

question

Delivering Pharmacy

answer

Pharmacy 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.

question

An originating pharmacy that uses central fill must record:

answer

-Date transmitted to CPPP -Method of transmittal -ID of RPh responsible for transmittal -Name and address of CPPP -Date the delivery pharmacy received the filled Rx was received from CPPP -Name of pharmacy employee who accepted delivery -ID of RPh delivering Rx to patient

question

A central fill pharmacy must record:

answer

-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

question

Difference between central processing and central fill?

answer

Central 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

question

Can CS be delivered directly to the patient from the central fill pharmacy?

answer

No, CS must go back to the original pharmacy for delivery.

question

How soon must CENTRAL FILL records be readily retrievable?

answer

withing 48 hours (different than the 72 hours for other pharmacies!)

question

What ADDITIONALLY must be on the Rx label for a med that was filled using central fill?

answer

Names of both pharmacies involved in dispensing the prescription... the CPPP can have a "unique identifier" on the label

question

What must the originating pharmacy write ON THE FACE of the Rx when central fill was used to fill a CS Rx? What else must be recorded?

answer

-"Central Fill" must be written on the face of the original RX -Record the name, address, and DEA registration number of the central fill pharmacy that the RX was transmitted to -Name of the retail pharmacy RPh transmitting the RX -Date of the transmittal

question

What records must a central fill pharmacy keep when filling a CS?

answer

-Keep copy of Rx fax or electronic -Name, address and DEA # of retail pharmacy received from -Date of receipt -Name RPh filling the Rx -Date of filling -Date delivered to retail pharmacy -Method of delivery

question

Do mercury thermometers require a Rx?

answer

Yes

question

What license must a prescriber obtain to be able to dispense medications?

answer

"Drug control license"

question

If a dispensing prescriber intends to charge a patient for a Rx, what must he/she do first?

answer

-Give the patient the option of taking the Rx to another pharmacy -Inform patient of charge before dispensing -Inform the patient that there is no RPh available

question

Examples of places where "dispensing prescribers" work

answer

Planned Parenthood, Methadone Clinics

question

Dispensing prescribers have to have what designation?

answer

Any INDEPENDENT prescriber (other than a VET)... so MD, DO, DPM, OD, DDS

question

Can dispensing prescribers delegate dispensing power?

answer

Yes, MDs and DOs can delegate dispensing and delivery of Rxs to PAs and RNs

question

Are there limitations to prescribers delegating dispensing power?

answer

Yes, delegated dispensing is limited to a 72 hour supply of the drug(s)

question

Is a prescriber who dispenses samples or "first doses" in ERs considered a dispensing prescriber?

answer

No

question

What is the Cancer Drug Repository Program?

answer

-A pharmacy or health facility may choose to fully participate in this program --> They accept, store and dispense or administer donated drugs/supplies

question

What are the requirements for a drug to be donated to the Cancer Drug Repository Program?

answer

-Donor must state that the donated drug has been properly stored and has never been opened, used, tampered with, adulterated, or misbranded -Donor or representative has to sign -Drug expiration must be at least 6 months out from the donation date -Drug is in original, unopened, tamper-evident unit dose packaging -Packaging includes the drug's lot number and expiration date

question

Who gets priority for the drugs in the Cancer Drug Repository Program?

answer

-1st: Uninsured or insurance doesn't cover drugs/supplies -2nd: Enrollees in Medicare, Medicaid or other public assistance health care programs -3rd: All other state residents diagnosed with cancer

question

What is the charge of the drugs in the Cancer Drug Repository Program?

answer

-Up to 250% of Medicaid dispensing fee or $5.00 (whichever is less)

question

Can CS be dispensed in the Cancer Drug Repository Program?

answer

No

question

Who must obtain an NPI number?

answer

All health care providers who are HIPAA-covered entities.... 1.) individuals (e.g., physicians, nurses, dentists, chiropractors, physical therapists, or pharmacists) 2.) Organizations (e.g., hospitals, home health agencies, clinics, nursing homes, residential treatment centers, laboratories, ambulance companies, group practices, Health Maintenance Organizations (HMOs), suppliers of durable medical equipment, pharmacies, etc.)

question

How many NPIs can a single person obtain?

answer

Just 1 (no matter how many different places they practice)

question

What is the CSAC (controlled substance advisory committee) and what is its purpose?

answer

-13 members—appointed by the governor -Monitor indicators of CS abuse and diversion -Make recommendations

question

How often does the CSAC (controlled substance advisory committee) meet?

answer

At least once every 3 months

question

What is ARCOS and what does it do?

answer

ARCOS (Automation of Reports and Consolidated Orders System)—an automated comprehensive drug reporting system which monitors the flow of DEA CS from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level -Monitors only Schedule I-IV meds (not V)

question

What are the components of a DEA number?

answer

First letter: -Began with "A" "B" or "F" for independent prescribers -Mid Level Practitioners (PA, NP, NMW, OD) begin with "M" Second letter: -First letter last name 7 numbers computer generated -Last number is check digit

question

How to validate a DEA number?

answer

-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=33 -Last digit in 33 = 3, last digit in DEA# = 3 -Valid

question

What is an "X" DEA number?

answer

-For people who prescribe Buprenorphine drug products

question

Who can get an "X" DEA number? Who can prescribe buprenorphine products?

answer

Only an MD/DO can get one of these #s, but an NP/PA can write for Suboxone for an off-label use (e.g. PAIN)

question

Does a prescriber have to use their "X" DEA number every time they prescribe a buprenorphine product?

answer

Only need this DEA # when prescribing for drug addiction—if using an off-label use, you don't need to obtain this # (ex: pain)

question

Can the "X" DEA number be the only DEA number on the buprenorphine Rx?

answer

No; need "X" DEA number AND regular DEA number

question

Do mid level practitioners (PA, NP, NMW) need a CS license to obtain a DEA number?

answer

No; MD and DO do though

question

Can prescribers write an Rx using the DEA number of their institution?

answer

Yes

question

If a pharmacy closes, what must that pharmacy send to the B.o.P?

answer

-DEA Certificate of Registration -Unused Official Order Forms (DEA Form-222) with the word "VOID" across the face of each order form -Current pharmacy license and controlled substance license -Notification of closing date -Indicate where the CS inventories and records will be kept -Notify of disposition of the RX files & RX drugs for both CS and non-controlled substances -How the controlled substances were transferred or destroyed

question

If a pharmacy closes, how long must their CS records be kept?

answer

2 years

question

What schedule of CS are anabolic steroids (testosterone cypionate, etc.)?

answer

3

question

Benzodiazepines and benzodiazepine agonists are generally in which CS schedule?

answer

4

question

Lyrica is in what CS schedule?

answer

5

question

Tramadol is in which CS schedule?

answer

It is not a CS

question

Vicodin, Tylenol #3, and Hycodan syrup are in which CS schedule?

answer

3

question

Robitussin AC is in which CS schedule?

answer

5

question

Exalgo and Opana are in which CS schedule?

answer

2

question

Ketamine is in which CS schedule?

answer

3

question

Pentazosine (Talwin) is in which CS schedule?

answer

3

question

GHB is in which CS schedule?

answer

3

question

Meperidine is in which CS schedule?

answer

2

question

Soma is in which CS schedule?

answer

4

question

Lomotil (diphenoxylate/atropine) is in which CS schedule?

answer

5

question

Ephedrine is in which CS schedule?

answer

5

question

APAP elixir w/codeine is in which CS schedule?

answer

5

question

What CS schedule is Esterified Estrogens/Methyltestosterone?

answer

It is not a CS; Methyltestosterone by itself is a CIII though.

question

Which is a CS: Fiorinal or Fioricet?

answer

Fiorinal (CIII)

question

Ephedrine schedule V exemptions?

answer

1.) 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

question

What is a DEA 222 form used for?

answer

Ordering or moving schedule 2 drugs

question

What is the max number of books of DEA 222 forms a pharmacy can have?

answer

6

question

What does the RPh have to fill out on the DEA 222 form?

answer

-# of packages, size of package, and name of item -Must be signed & dated by a person authorized to sign a registration application

question

Can the signing of DEA 222 forms be delegated?

answer

Yes, if Power of Attorney to sign 222 is given from DEA registrant to another person WITH A CS LICENSE

question

Does the DEA registrant have to be a RPh?

answer

No

question

Are RPh inititals required on all CS invoices?

answer

Yes

question

How long does a wholesaler have to fill a CII order completely?

answer

60 days

question

Who do you report lost/stolen DEA 222 forms to?

answer

The nearest DEA Diversion Field Office (immediately)

question

How long is it required to keep DEA 222 forms ON-HAND in the pharmacy?

answer

2 years

question

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?

answer

6 hours

question

What is needed on the invoice for transferring CIII-V CS to another pharmacy?

answer

-Drug name, form, strength, # -Transfer date -Involved parties' names, addresses, DEA numbers

question

If a pharmacy decides to sell, when should their complete CII inventory be taken?

answer

On the day they transfer all of their CS

question

Does a copy of the CS inventory need to be sent to the DEA? What about to the B.o.P?

answer

No; Yes

question

What form is used for "reverse distributing" of CS?

answer

DEA 41 form (but DEA 222 for CII)

question

How long do CS inventory records have to be kept?

answer

2 years

question

How do you send back CS drugs that are expired?

answer

DEA 41 form

question

If CS are lost/stolen, WHO do you have to notify and WHEN?

answer

DEA within 1 day B.o.P. within 10 days

question

What form is filled out when CS are lost/stolen?

answer

DEA 106 form

question

When can a DEA 106 form NOT be used to report a theft/loss of CS?

answer

If the loss is determined to be "not significant"

question

What must be included on a DEA 106 form?

answer

-Pharmacy name, address, DEA # -Date of loss, type of theft, identifying marks on labels of containers -Name, # local police you notified (although technically not mandatory to report) -Name, strength, form, size of container -NDC # of missing controlled substance

question

If you spill or break some CS, is this considered a "loss"?

answer

No

question

If you spill or break some CS, what do you do?

answer

-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

question

Which records need to be kept on-site?

answer

-Inventories -Prescriptions -DEA 222 forms executed -Electronic Rx records

question

Which records can be kept off-site (central location)?

answer

Financial and shipping records

question

How many different "prescription files" do you need when filing the Rxs?

answer

3 - one for CII, one for CIII-V, and one for non-CS Rxs

question

If your records are kept in a central location, the DEA can ask you to bring them back within what time frame?

answer

48 hours

question

When must CS inventory be taken?

answer

Annually between April 1st and June 30th

question

What must the CS inventory record have on it?

answer

-Date and time (time can just be "start" or "end" of business day) -Name, strength, dosage form, number, and number of bottles of the drug -Name, address, DEA # of licensee -Date and signature from licensee

question

What are the "exact vs. estimate" rules for the CS inventory?

answer

CII's need an EXACT count CIII-V can be estimated, UNLESS the bottle contains >1000 dosage units AND has been opened (then you need an EXACT count)

question

Do hospital inpatient and outpatient pharmacies have to have separate CS licenses?

answer

Only if they maintain SEPARATE inventories

question

How must CS be stored in the pharmacy?

answer

All 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

question

For computerized CS in a community pharmacy, how far back must the records be "readily retrievable"?

answer

16 months

question

Is an alarm required for a pharmacy?

answer

No; not unless the pharmacy is also a distributor

question

Does a Patient Package Insert have to be given with EACH refill?

answer

Yes, if the medication requires a PPI (ex. estrogen products)

question

Does a side effects statement have to be given with each refill?

answer

Yes

question

What kinds of dispensed meds are EXEMPT from the Poison Prevention Packaging Act?

answer

-Dispensing to patients in nursing home/hospital -Drugs to be administered by institutional personnel -Samples -Starter packs -Topically applied drugs -Dosage forms not intended for oral administration -Bulk containers received by pharmacy

question

Are meds dispensed to an assisted living facility EXEMPT from the Poison Prevention Packaging Act?

answer

No

question

What are the laws regarding taking meds out of or into the country?

answer

-Must declare the meds before you leave -NO restriction on quantity you can take out of the country, AS LONG AS it is in the original pharmacy-dispensed container -The MAX quantity is 50 that you can bring into the country (IF you acquired those meds in another country)

question

How long must the CS signature log remain IN the pharmacy?

answer

2 years

question

Requirements of a CS Rx?

answer

Written Rx: -Patient's name and address -Prescriber printed name, address, telephone #, designation, and DEA # -Prescriber date and signed -Drug name, strength, form, and directions -Quantity (written AND numeric... or box check off) -If for an animal, must write the species Verbal Rx: -All requirements of written Rx + List who is the agent (who the order was transmitted by) -Don't need quantity in written AND numeric Electronic Rx: -All requirements of written Rx + Electronic signature of prescriber, Date AND time of Rx, and Identity of pharmacy intended to receive Rx

question

Is fax-to-fax Rxs with manual signatures allowed for all Rxs?

answer

-Yes, for all CIII-V and non-CS -Only allowed for 3 situations for CII's

question

Is computer-to-fax Rxs with ELECTRONIC signature allowed for any Rxs?

answer

Yes, only for non-CS Rxs

question

Is there a limit to how many CS scripts you can write on one form?

answer

No, you just can't mix CII scripts with CIII-V scripts

question

True or False? The pharmacy must create a paper prescription of the electronically transmitted CS script for record keeping purposes

answer

FALSE - not mandated by the DEA... but IS mandated by Medicaid

question

What schedule of CS are Suboxone and Subutex?

answer

3

question

True or False: PAs and NPs can prescribe Suboxone for opioid addiction?

answer

False, they can only prescribe it for pain (off-label use)

question

Can an optometrist prescribe CII's?

answer

No

question

What is the limitation for NPs prescribing CII meds?

answer

Not more than a 7 day period of therapy upon discharge of a patient from an institution

question

Record requirements for delegation

answer

-Printed name of delegatee -Licensure designation -Name of delegating prescriber -Signature of delegatee -DEA # for both

question

Can a PA or NP prescribe misoprostal to a woman known to be pregnant, for purposes of abortion?

answer

No

question

What is the max quantity an NP can prescribe of oxycodone 30mg, 1 tab q8h, #90

answer

#21 (7 day supply) if patient is being discharged from the hospital

question

What is the policy of partial fills of CII meds?

answer

-If unable to supply the full quantity, make notation of partial quantity supplied on face of written RX or in electronic RX record -Supply remainder in 72 hours -If can't fill remainder, must notify prescriber that new Rx is likely needed

question

What is the max partial-fill quantity of a CII that a terminally ill patient can receive?

answer

The full amount (but only until 60 days from issue date)

question

For terminally ill patients receiving partial CII fills, how must the quantity dispensed be recorded?

answer

Note the following on the BACK of the Rx: -Date, quantity dispensed, remaining quantity, RPh identification

question

Can you receive mulitple Rxs of a CII medication on the same day?

answer

Yes, but only a 90 day supply... and the Rxs have to be clearly marked "do not fill until..."

question

What 4 things can NEVER be changed on a prescription?

answer

1.) Drug name 2.) Patient 3.) Prescribing physician 4.) "Do not fill" dates

question

Can you change the date of issue for an Rx?

answer

YES... but only after speaking with the prescriber to verify

question

What are the factors incorporated into "Good Faith" dispensing?

answer

1.) Cannot correlate doctor-patient relationship 2.) Frequency of an Rx for the same drug by 1 prescriber for many patients 3.) Quantities above the norm 4.) Unusual dosages 5.) Unusual geographic distances between patient, pharmacist, and prescriber

question

Requirements for Emergency Dispensing for Schedule II meds?

answer

1) Immediate administration of CS is necessary for proper treatment of the patient 2) Appropriate alternative treatment is not available 3) It's not reasonably possible for the prescriber to provide a written Rx to be presented to the person dispensing the substance before the dispensing 4) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.

question

When must a prescriber provide a written script for an emergency dispensing of a CII?

answer

Within 7 days (or post-marked within 7 days).... if not, notify DEA Diversion Field Office

question

What must appear on the face of a prescriber-written script for an emergency dispensing of a CII?

answer

"Authorization for Emergency Dispensing"

question

Can an agent of the prescriber call in an emergency CII?

answer

No, it must be a prescriber-to-pharmacist phone call.

question

Requirements of CIII-V Rx?

answer

-Patient's name & address -Prescriber's name, address, and phone # -DEA # & professional designation -Drug name, strength, dosage form -Quantity in numeric & written (except verbal Rxs) -Directions -MANUALLY signed by prescriber & DATED for paper and fax-to-fax Rxs -ELECTRONICALLY signed and date/time for computer-to-computer Rxs

question

Is there a quantity restriction on how much of a drug you can prescribe on a single Rx?

answer

Nope

question

If CIII-V (yes, even C-V) are partial filled, how long are Rxs good for?

answer

6 months from date issued

question

Who can take a verbal CS Rx?

answer

RPh or RPh intern

question

How many times can you transfer a CIII-V Rx?

answer

ONCE

question

Can an agent of a prescriber call in a CS Rx?

answer

Yes

question

What is the extra labeling requirement for CS?

answer

"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

question

For MAPS, when reporting must be done by?

answer

BY the 1st and 15th of every month

question

What are the patient identifiers for MAPS?

answer

-Full name -Address, including zip code -DOB -Any one of the following: ----Drivers license # ----State-issued ID # from photo ID ----Number zero (if photo ID does not include one of above, or patient <16)

question

If notified of an error with your MAPS reporting, you must fix the error in what time frame?

answer

within 15 days

question

CS Rx orders for inpatient dispensing require:

answer

-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

question

Within what time frame must CS patient records be readily retrievable for inpatients?

answer

-If current inpatient --> immediately --If discharged patient --> within 48 hours

question

Rules for a verbal CS order in an institution:

answer

1.) Oral order is committed to a written/electronic order in the patient chart by a nurse, PA, or RPh who has communicated DIRECTLY with the prescriber 2.) Order states the name of prescriber & name of who received the verbal order 3.) Order is forwarded to pharmacy 4.) Prescriber signs the original order at time of next visit or within 7 days

question

Hospital CS records should include:

answer

1.) # of doses of CS purchased 2.) # of doses of CS dispensed to individual patients or distributed to nursing stations or both 3.) # of doses administered 4.) # of doses dispensed but NOT administered

question

When distributing CS meds for floor stock in a hospital, what is the "25" rule?

answer

May not deliver more than 25 doses per container.... although the number of containers is unlimited

question

What must be recorded when distributing floor stock CS to a nursing station?

answer

-Name & dose of CS -Quantity -Date of delivery -Location of nursing unit -Name of distributing pharmacy & address (if different from hospital) -Name of distributing pharmacists -Name of individual on nursing unit who receives the CS

question

What must be recorded for "proof of use" for floor stock CS meds?

answer

i. Name of substance ii. Dose administered iii. Date & time given iv. Name of patient v. Signature of individual who gave dose

question

Can CS be dispensed from an automated dispensing system in a LTCF?

answer

Yes

question

What additional requirement is needed for CS to be dispensed from an automated dispensing system in a LTCF?

answer

The pharmacy that supplies the ADS must apply for a separate DEA registration to operate the ADS.

question

Quantity requirements for pseudophed and ephedrine products?

answer

Max = 3.6 grams/day or 9 grams/30-day period

question

What must be recorded in the logbook when someone buys pseudophed?

answer

-Full name, address, and DOB -Date AND Time of sale -Amount AND description of product sold -Description of ID used (license, passport, etc.) -Customer signature

question

Is it mandatory to keep an inventory of pseudophed products? If so, how often?

answer

Yes, once a year

question

Who regulates pseudophed records?

answer

The DEA

question

How long must pseudophed logbook records be kept?

answer

2 years

question

Pretty much every record in the pharmacy has to be kept for __ years, except prescription records (which are __ years).

answer

2; 5

question

Requirements for a non-CS Rx?

answer

-Name of patient -Prescriber's printed name and address (phone number only required if e-Rx) -Drug name and strength -Quantity prescribed -Number of refills (if any) -Dated and signed

question

Do employees have to have special training to sell pseudophed? How often do you have to self-certify to sell pseudophedrine?

answer

Yes; Annually

question

What are the quantity requirements for Schedule V OTC sales?

answer

-Not more than 240cc (8oz) or 48 solid doses of a substance containing OPIUM in any 48 HOUR period -Not more than 120cc (4oz) or 24 solid doses of any other substance listed in sched V (codeine) in any 48 HOUR period

question

What must be recorded in the sales logbook for OTC schedule 5 meds?

answer

-Name and address of patient -Name and address of purchaser if different from patient -Name and quantity of substance purchased -Date purchased -Name OR initials of pharmacist or pharmacy intern who dispensed substance (tech cannot dispense) -Medical purpose for which the medication is being used as determined by the pharmacist (state requirement)

question

Do schedule V OTC inventories have to be taken and mailed in? If so, how often? And to whom?

answer

Yes, annually to the B.o.P

question

What are the laws regarding the amount of marijuana a person with a medical marijuana card can possess?

answer

2.5 ounces, 12 plants, and ANY amount of seeds, stalks, or roots

question

If licensed less than two years but more than one year, how much live and pain management CE is needed?

answer

No live, 1 pain CE

question

What is "placing into interstate commerce"?

answer

Delivering or introducing an adulterated or misbranded drug across state lines

question

When can "placing into interstate commerce" occur?

answer

When you compound a drug with a non-FDA approved ingredient and deliver it across state lines?

question

What are the ONLY 4 reasons for admission to the Health Professional Recovery Program (HPRP)

answer

-Substance abuse (SA) -Chemical dependency (CD) -Mental illness -Use of drugs or alcohol (not meeting SA or CD)

question

Can a pharmacy inspector seize drug without a warrant?

answer

Yes, if they feel drugs are an imminent threat to public health or welfare

question

Can the Board of Pharmacy send a pharmacist to jail?

answer

No, they do not govern criminal law

question

Minimum housing requirements of a pharmacy?

answer

-150 square feet -Fridge of "reasonable capacity" -Sink with hot AND cold running water -Drawers, shelves, storage cabinets, and Rx files (as necessary) -Counter with 10 sq feet of free working surface (4 additional sq ft for each additional RPh)

question

Can you dispense ANY medications after the death of a prescriber or patient?

answer

No, not if you KNOW that they died. If you didn't know, it is not penalized

question

What is the "consumer information notice"?

answer

-Tells the patient they have the right to find out the price of a prescription drug before the pharmacist fills the prescription -Must be posted in community settings

question

What forms are used to a) apply for a DEA registration, and b) renew that registration?

answer

a.) DEA 224 b.) DEA 224a

question

Requirements for ALL electronic Rxs?

answer

-Prescriber name, address, and telephone number -Full name of the patient -Electronic signature of prescriber -Date AND time of Rx -Identity of pharmacy intended to receive Rx -All other drug info required on non-electronic Rxs

question

If an agent calls in a CS Rx, do you need to record his/her identity?

answer

Yes

question

Can a PA call in an emergency C2? What about an NP?

answer

Yes (under delegation); No

question

Do Schedule V OTCs have to be labeled?

answer

Yes; Attach label with pharmacy name and address, date, and pharmacist name

question

Is there a minimum age requirement for the purchase of dextromethorphan?

answer

No

question

Does vaccine administration by a pharmacist have to be delegated by a physician?

answer

Yes

question

Are there restrictions on the sale of needles or syringes?

answer

No

question

Do wholesalers or manufacturers have to be licensed in MI to do business in MI?

answer

Yes

question

Can a wholesaler or manufacturer act as a pharmacy?

answer

No

question

Who does not need a DEA registration?

answer

Pharmacists, pharmacy interns, and pharmacy technicians do not have to register if the pharmacy is properly registered

question

Which "special activities" require a separate DEA number?

answer

- manufacturing - distributing - dispensing - conducting research (C II-V) - conducting instructional activities - conducting a narcotic treatment program - conducting research (C-I) - conducting chemical analysis - importing/exporting - participating in maintenance or detox treatment

question

Records pertaining to automated devices (ex: Pyxis) must be kept for how long?

answer

5 years

question

Do Central Fill pharmacies have to report to MAPS?

answer

Yes if they are the ones who filled the CS. If the originating pharmacy filled the CS, then THEY are the ones who have to report to MAPS.

question

Who must be notified when a pharmacy is being transferred? And in what time frame?

answer

DEA within 14 days (before?)

question

Do unexecuted DEA 222 forms have to be kept ON-SITE in the pharmacy?

answer

No, just executed ones do

question

Can CS inventories be electronic?

answer

No, must be on paper

question

Do CII inventories have to be separated from the rest of the CS inventory?

answer

Yes

question

Does the RPh taking the CS inventory have to sign it?

answer

Yes

question

How long does the CS signature log have to be kept for?

answer

2 years

question

If a drug gets approved as a CS medication, on what day must you add it to the CS inventory?

answer

On the day it is approved as a CS by law

question

Does a person need to present a valid photo ID to purchase a schedule V OTC?

answer

No?

question

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?

answer

No

question

What is the format and color of each DEA 222 form, and where does it go?

answer

Original - copy 1 (brown) --> supplier Duplicate - copy 2 (green) --> supplier then DEA Triplicate - copy 3 (blue) --> kept by purchaser

question

Can multiple units of same item be ordered on same line of DEA form 222?

answer

Yes

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