Pages 1-50 in DS book Flashcards
Definitions, Pharmacy practice act, Some general pharmacy laws/rules
Abandoned application
applicant fails to complete all application components within 30 days after being notified by the Board of an incomplete application
Abandoned application (terminal distributor/wholesaler)
90 days to demonstrate compliance of all laws once completed application submitted
Access to drug stock
physical access AND influence over handling of Rx drugs including purchases, inventories,, issuance of medical order, etc. Does NOT include janitorial, IT, or other staff with limited, supervised access
Drug
Use in diagnosis, cure, treatment, or prevention of disease in humans or animals. Also if intended to affect the structure or any function of the body of humans/animals.
Temporary Removal of Drugs from a TDD (3 things)
1.) licensed HCP to prescribe can temporarily remove Rx drugs to treat current/prospective patients. Return in 24 hrs.
2.) Person authorized to dispense/furnish naloxone must return within 24hrs to TDD
3.) Remov non-controlled Rx drugs/immunizations from TDD for current/prospective pts. Return in 24 hrs
Faxed prescriptions when sending to pharmacy (4 things)
1.) Can be traditional prescription form, but regardless must ALWAYS be manually signed by prescriber. Same goes for faxed refill authorizations
2.) If agent of prescriber sends fax, their full name must be included
3.) Faxed Rx must have all Rx requirements AND ID # of fascimile machine used to transmit prescription, full name of prescriber or agent if applicable
4.) OG prescription will be in patient chart at physician’s office
Computer to fax prescriptions (illegal except 2 exceptions)
1.) Rx computer to fax prescriptions operates in CLOSED system
2.) Temporary telecommunication outage for NON-CONTROLLED only
Readily Retrievable
Within 3 business days for records to be produced for review
Refuse to Grant or Renew
Deny original or continued licensure for a period of at least 24 months
Terminal distributor
Pharmacy that sells (dispenses) drug at retail; includes labratories
Virtual wholesaler Distributor (4 things)
Must be licensed as wholesaler distributor with virtual wholesaler classification
Registered as business entity with state/local
Operate out of a location zoned for commercial use
CANNOT operate out of a residence/personal dwelling
Occasional sale
Wholesale of a commercially available Rx drug to another TDD or person exempted from being a terminal distributor (vet, dentist, physician, etc.) Must follow 5% rule unless they have wholesalers license
- Does not apply to intracompany sales between pharmacies under common ownership or control or among hospitals/healthcare entities under common control
Personal supervision (direct)
RPh shall be physically present in pharmacy or in area where practice of pharmacy is occurring to provide personal review and approval of all professional activities
Federal legend
All Rx drugs must have “Federal Law Prohibits Dispensing Without a Prescription” or “Rx only” on stock bottle
Minimum standards of a pharmacy (11 items; 1 specifically for institutional pharmacies)
Library, equipment, stock of drugs, prescription containers, space and fixtures, pharmacy hours posted, personnel and staffing, “Catch all” additional minimum standards req. for specialized pharmacy, internet access, employee name tag WITH job title and specify tech registration status. Institutional pharmacies must have quality assurance program as well
4 websites/items a pharmacy must be able to access via internet
Board’s website, LA Writer Ohio laws and rules, The code of laws of the USA, and The Code of Federal Regulations
4 items the quality assurance program in an institutional setting must monitor/evaluate
1.) Quality and appropriateness of patient care
2.) Pursue opportunities to improve patient care
3.) Prevention/Detection of drug diversion
4.) Resolve Identified problems
10 items that involve the practice of pharmacy in Ohio
1.) Interpreting prescriptions
2.) Dispensing drugs and drug therapy related devices
3.) Compounding drugs
4.) Counseling individuals with regard to drug therapy, recommending drug therapy related devices, and assisting in selection of drugs/appliances for tx of common diseases
5.) Performing drug regimen reviews with patients
6.) Performing DURs with providers authorized to prescribe drugs when RPh determines an individual with an Rx has a drug regimen that warrants discussion
7.) Advising individual and healthcare professionals treating individual with regard to their drug therapy
8.) Acting pursuant to consult agreement with authorized prescriber(s)
9.) Engaging in the administration of immunizations
10.) Engaging in administration of drugs (LAIs)
Drugs Returned to Stock in Pharmacy. When can you do it?
If drug has been dispensed, but not picked up or delivered, never left prescription department, and/or never left control of delivery agent
Requirements for Drugs Returned to Stock in pharmacy (7 conditions must be met)
1.) Exp date on container (OG manufacturers exp. date OR 1-year from date Rx was dispensed, whichever is less)
2.) Must be kept in Rx bottle it was dispensed with OG patient label on it. Do NOT return to manufacturer bottle. Should not remove label UNLESS: a.) adding/modifying the existing label, adding new label over existing label (same exp. date), if prescription label was placed on OG manufacturer sealed packaging (exp/lot # must be readable)
3.) When dispensing drug to different patient from one that was returned to stock, new container must be used
4.) Store properly
5.) If drug recall, must remove unless pharmacy can determine the exact lot # of the drug in the prescription bottle that was returned.
6.) Cannot return if any sign of tampering/adulteration
7.) Can transfer/sell to intracompany if under common control
NOTE: does NOT apply to inpatients
Two requirements if returning drugs to stock after delivery agent came back with it
1.) Had to be dispensed in tamper evident container/package prior to leaving pharmacy
2.) Be in manufacturer’s original tamper evident packaging
Consult agreements (5 entities can be in a CA with RPH)
1.) Physician
2.) PA if authorized by at least one supervising physician
3.) Certified Nurse Practitioner
4.) Certified Nurse Midwife
5.) Clinical Nurse Specialists
(3-5) if authorized by collaborating physician
NO OTHER PROVIDERS CAN BE IN A CA
3 requirements for entering a CA
1.) Physician has ongoing physician-patient relationship with each patient whose drug therapy is being managed
2.) Diagnosis for which patient has been prescribed drug therapy is within the scope of practice of physician’s practice
3.) Pharmacist has training/experience related to the particular diagnosis for which drug therapy is prescribed
6 things that a pharmacist is authorized to do in a CA
1.) Change duration of treatment for current therapy
2.) Adjust strength, dose, dosage form, frequency, administration, or route of admin.
3.) Discontinue use of drug
4.) Administer drug if drug is included in CA
5.) Add drug to patient’s therapy
6.) Order lab tests related to managing patient drug therapy and if specified within practice protocols, evaluate results related to drug therapy being managed. CANNOT DIAGNOSE!!!!
Who can terminate a CA? (3 people)
Pharmacist, physician, or patient/individual who gave consent for patient
How long is a CA good for?
2 years, then can be renewed
What are the 4 things that must be in writing for a CA?
1.) Diagnoses/diseases being managed and if they are primary/co-morbid diseases
2.) Description of drugs or drug categories the agreement involves
3.) Description of procedures, decision criteria and plan for RPH to follow
4.) Description of how RPH is to comply with records of each action taken and at what regular intervals this will take place
Consent required for CA (4 items); RPH must tell patient these things
1.) Pharmacist may be utilized in management of patient’s care
2.) Patient has right to participate or withdraw from CA
3.) Consent may be part of patient’s initial consent to treatment
4.) Managing RPH means Rph managing patient’s drug therapy pursuant to a CA
7 acceptable communication methods between RPH and provider for CA (Same methods can be used for Written Notice (confirmation of delivery)
1.) Electronic mail that confirms delivery
2.) Interoperable electronic medical records system
3.) Fax that confirms delivery
4.) Electronic prescribing system
5.) Electronic pharmacy record system
6.) Documented verbal communication
7.) Any other method of documented notification as outlined in the CA
If the RPH in a CA is an agent of the prescriber they must do 3 things when issuing prescriptions
1.) Include required information of consulting prescriber
2.) Telephone # where managing pharmacist can be contacted during business hours
3.) All positive ID on the prescription including manual signature shall be of the pharmacist on behalf of the prescriber
If a pharmacist is able to prescribe controlled substances, when do they need to check OARRS and how far back do they need to go?
1.) when changing controlled substance dose, strength, dosage form, route or frequency OR if adding a controlled substance to their therapy
Must go back 1 year in OARRS each time checked
What healthcare professionals that are authorized to prescribe drugs DO NOT need to follow the laws regulating practice of pharmacy when supplying drugs to their patients? (6 of them)
Physicians, podiatrists, vets, dentists, NPs, optometrists
When healthcare professionals dispense drugs from their office do they need to be labeled/packaged according to pharmacy regulations?
Yes and records of purchase/dispensing must be maintained as well
Emergency dispensing, not including C-II’s, conditions that must be met in order to comply with law for emergency dispenses (8 main items)
1.) Pharmacy has record of a prescription for the drug in the name of the patient with either no refills left or the refills have expired
2.) RPh unable to contact prescriber for refill authorization
3.) RPh judgement says the drug is essential to sustain life, continues therapy for a chronic condition, or failure to dispense drug could result in harm to patient
4.) Cannot exceed 30 day supply if on consistent drug therapy, but able to do two additional 7 day supplies in 12-month period
5.) Record dispensing/notify physician within 72 hours of dispensing
6.) Must keep records for one year after sale or dispensing
7.) RPh MUST create new Rx document for the emergency refill
8.) Pharmacy MUST have a record of the prescription (can use real-time database to access patient records if not at that specific pharmacy)
4 things must be kept on record when doing emergency dispensing
1.) Name and address of patient
2.) Name and address of individual receiving drug (If different than patient)
3.) Amount dispensed
4.) Original Rx #
Must keep these records for one year after dispense
If a co-pay or deductible is waived who is responsible, individual RPh or business?
The business or TDD is responsible, NOT individual
If the cost of an Rx is cheaper cash than with co-pay do you have to say anything?
Yes, must always charge the lower amount so if cash price is lower than co-pay/co-insurance than patient must be informed of cost-savings
How soon must a pharmacy intern notify the Board of Pharmacy, his/her current employer or subsequent employer where practicing as an intern that they are no longer enrolled in school of pharmacy?
72 hours
How soon must an intern that is no longer enrolled in school of pharmacy return their pharmacy intern certificate to the state board of pharmacy?
Within 10 days
How soon should statement of preceptor be submitted to board of pharmacy after beginning work as an intern?
Within 30 days of starting
Name the professional duties an intern can perform (positive ID of both supervising RPH and intern for these) (13 items)
1.) Sell Schedule V controlled substances
2.) Receive oral prescriptions (includes controls)
3.) Transfer and receipt of NON-controlled prescriptions
4.) Patient counseling
5.) Immunizations
6.) Document informed consent to administer immunizations
7.) Dispense naloxone
8.) Non-sterile/Sterile compounding
9.) Sending or receiving e-scripts between pharmacies via centralized database
10.) Contacting prescriber/agent for clarification IF it does not req. professional judgement
11.) Performing diagnostic lab testing
12.) Request refill authorizations
13.) Stock automatic drug dispensing unit and floor stock at location licensed as TDD if RPh not physically present as long as they are available to answer q’s, responsible for conducting verifications of intern to prevent diversion, and Rph is responsible for all activities conducted by intern
How many hours are required for foreign pharmacy graduates in Ohio and those not completing a PharmD degree
1740 total; 500 can be from a site other than a pharmacy licensed as a TDD
When must foreign pharmacy graduates report hours obtained in the previous year? (specific date)
March 1st
Phoned-in prescriptions/refill authorizations from prescriber/agent as an intern (6 conditions required)
1.) RPH on duty is responsible for accuracy of Rx given
2.) RPH on duty decides which interns is competent to receive phone Rx’s
3.) Supervising RPH must be immediately available for Q’s
4.) Intern must immediately write Rx down and review it with supervising RPH
5.) Both intern AND supervising RPH must provide positive ID on prescription
6.) Emphasis on RPH only being able to supervise 2 interns at a time
Transfer conditions required for interns to do them (2 conditions required that are different than phoned-in prescriptions_
1.) ONLY for non-controlled
2.) Must provide positive ID BEFORE dispensing of both intern and RPH for the received prescription copy
What 4 changes require 30 day notice to the Board?
1.) Name change
2.) Address change
3.) Employment change
4.) Discontinuing business
Which change only requires 10 day notice to the Board?
Change in responsible RPH
Date of Terminal Distributor’s license renewal (includes lab)
April 1st
Date of Wholesalers license renewal
July 1st
Date of RPH/intern license renewal
Sept 15th
How long must hard copy non-controlled be kept on file electronically after being scanned in before being destroyed?
180 days
Price information to patient (2 things)
1.) Rph must disclose price info EXCEPT for C-II’s
2.) If pharmacy advertises Rx drugs they must include brand, generic, strength, dosage form, and price for specific qty
Ratio for immunizations intern to pharmacist
6 interns to 1 pharmacist
True or false: C-V’s can only have 5 refills on them
False, Years supply is allowed for C-V/non-controls
When is a time that a pharmacist can dispense a drug qty that varies from the prescription by dispensing qty less than 30-day supply?
If doing it for medication synchronization
After a hard-copy controlled substance prescription is scanned in are you able to destroy the original?
No, cannot destroy at any point in time
What are the 9 parts of a prescription required for both non-controls and controls?
1.) Date issued
2.) Name, professional title, and address of prescriber
3.) Telephone # where provider can be contacted during business hours
4.) Full name and residential address of patient
5.) Drug name and strength
6.) Drug quantity
7.) Appropriate and explicit directions (cannot use “take as directed”)
8.) Number of times or period of time for refills (no indication = 0 refills)
9.) Trade name or generic name
What 3 additional parts are needed for a control prescription?
1.) DEA # of prescriber
2.) At least first four digits of ICD-10 code (If dentist, then CDT code required); must enter into OARRS
3.) Days supply (includes gabapentin)
What 4 changes can a pharmacist make to a prescription without consulting prescriber?
1.) Add or change patient’s address upon verification with patient/caregiver
2.) Select generic drug or interchangeable biological product (biosimilar)
3.) Dispense quantity that varies from quantity prescribed as allowed by Ohio Law
4.) Dosage form, strength, quantity, and directions of NON-CONTROLLED DRUG for human patient (Cannot change long-acting vs. short-acting without consultation)
What 3 changes can a pharmacist make AFTER consulting with prescriber?
1.) For any non-control or CONTROL (includes C-II’s), RPH can add/change dosage form, strength, quantity, directions, or issue date
2.) For ALL prescriptions, can add or change days supply, ICD-10 code, CDT code
3.) Add dispense as written or similar phrase (can be from prescriber or agent)
When dispensing multiple simultaneous refills, what are the 3 possible things the prescription must be for?
1.) Maintenance drug taken on regular, recurring basis to treat a chronic condition
2.) Drug to be taken on a regular, recurring basis to PREVENT disease
3.) Contraceptive
CANNOT BE CONTROL
What is the max day supply a multiple simultaneous refill can be for?
90 days
If a patient wants to do multiple simultaneous refills, but physician prohibits this, can it be overruled?
No physician is able to prohibit this and it cannot be overruled
If a patient wants to do multiple simultaneous refills but only has one refill on the prescription with a full year on another prescription for the same drug can they be combined?
No, would have to do the one refill separate from the other new script.
This category of Terminal Distributor’s license can only dispense single dose injections of IV fluids
Category I
This category of Terminal Distributor’s license can dispense any dangerous drug
Category II
This category of Terminal Distributor’s license can dispense controlled substances
Category III
ACPE program codes
01: Disease state management/drug therapy
02: AIDS therapy
03: Law
04: General pharmacy
05: Patient safety
06: Immunizations
07: Compounding
08: Pain management
99: Additional topic areas
In what ways can a prescriber indicate dispense as written?
Must be HANDWRITTEN BY PRESCRIBER and say something to indicate this (DAW, dispense as written, medically necessary, brand only, etc.) CANNOT be written by agent of prescriber
If DAW is preprinted, typed or written out by nurse does the pharmacist have to abide by the DAW?
No, can dispense generic for any of these three situations
If a prescriber orally states DAW to pharmacist does that count the same as being handwritten?
Yes, oral DAW is officially recognized under Ohio Law
Can the patient refuse a brand name if prescriber indicates it on the script?
No, not without discussing with prescriber regardless of cost difference
Which color book is for bioequivalences?
Orange book
Which color book is for the FDA list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
Purple book
What are the 8 requirements for a prescription transfer?
Must be an exact duplicate of original prescription with these 8 things
1.) Original Rx #
2.) Name/address of pharmacy transferring prescription (DEA # if controlled substance)
3.) Date prescription was originally written
4.) Date of the 1st dispense of the prescription
5.) Original # of refills
6.) Date of the last refill
7.) # of valid refills remaining
8.) Full name of transferring pharmacist
What 3 things must the RPH receiving the prescription copy document/do?
1.) Determine prescription being transferred is valid
2.) Reduce prescription to writing and write “transfer” on front of prescription
3.) Record date of transfer on face of prescription
What 3 things must the pharmacist transferring the prescription include in the database?
1.) Date of transfer
2.) Name of pharmacist making transfer
3.) Name and address of pharmacy receiving transfer (DEA # of receiving pharmacy if controlled substance)
If RPH transferring controlled substance, what must be done to the original prescription for the control? (4 things)
1.) Write void on front of original prescription
2.) Record date of transfer on back
3.) Their signature on back
4.) Name, address, DEA # of pharmacy the Rx was transferred to on back
What 9 activities require positive ID from pharmacist?
1.) Prescription information entered into recordkeeping system
2.) Prospective DUR
3.) Dispensing
4.) Patient counseling
5.) Administering adult immunizations
6.) Prescription information reduced to writing from an order received by telephone, fax, or recording device
7.) Compounding
8.) Administering injectable
9.) Any changes made to a prescription or medication order
Requirements of outpatient prescription labels (10)
1.) Name and address of pharmacy
2.) Directions
3.) Full name of patient (or animal)
4.) Full name of prescriber
5.) Date of dispense
6.) Cautions (not aux labels; Federal caution statement (controls only)
7.) Rx # (serial #)
8.) Drug name/strength
9.) Quantity
10.) If drug is compounded, the statement “compounded drug product” shall be on the label
Requirements of inpatient unit dose label (5)
1.) Name, strength, dosage form, route of administration
2.) NDC
3.) Manufacturer or repackager ID
4.) Lot # and exp. date
5.) Special storage conditions
Requirements of IV bag labels (inpatient, 7)
1.) Patient full name
2.) Name/amount of parenteral solution
3.) Name and amount of the drug(s) added
4.) Expiration date or beyond use date
5.) Name and address of institutional pharmacy
6.) Cautionary statements (if req.)
7.) Supplemental labels created by pharmacy must have positive ID of RPH associated with bar code
Requirements of IV bag labels (outpatient, 11)
1.) Name and address of pharmacy and telephone #
2.) Full patient name
3.) Full name of prescriber
4.) Directions/route of admin.
5.) Date of dispensing
6.) Federal caution (if req.)
7.) Name and volume of parenteral solution
8.) Name and amount of drug(s) added
9.) Quantity of drug dispensed if appropriate
10.) Expiration date
11.) Storage conditions
Inpatient custom med package label requirements (multiple drugs in same package, 7)
1.) ID of dispensing pharmacy
2.) Patient’s full name
3.) Date
4.) Name of drug
5.) NDC, bar code, or similar code
6.) Strength
7.) Exp. date (max of 6 months)
Label on sample provided by prescriber requirements (3)
1.) Name of prescriber
2.) Patient name
3.) Directions for use
Is complimentary supply the same as a sample?
No, complimentary supply is an Rx drug provided to a patient to assist them in the initiation of drug therapy. Not considered a sample.
What is required on compounded products made in advance? (5)
1.) Name, strength, qty of each drug used
2.) ID of re-packager by name OR final six digits of TDD license #
3.) Pharmacy control #
4.) Exp. date or beyond use date
5.) “Compounded drug product” indication (does not apply to non-sterile reconstituted drugs or drugs dispensed for use of inpatients)
Customized patient med packages (convenience/compliance packaging) requirements (8)
1.) Each container labeled to indicate day/time of day when contents should be taken
2.) # of drugs in each container cannot exceed capacity of container
3.) 31 day supply limit
4.) Each drug must be properly labeled
5.) Maximum 6 months exp. date OR earliest exp. date of drug in container
6.) Cannot be returned to stock if reaches patient
7.) Cannot be re-dispensed if more than one drug in same container
8.) Can exclude drugs from this packaging due to multiple reasons
What 4 things can exclude drugs from being added to customized med packages?
1.) Drug must be dispensed in original container
2.) Drugs incompatible with each other or with packaging materials used
3.) Drugs therapeutically incompatible when administered together
4.) Drugs require special packaging
Who is considered a practitioner? (11)
1.) MD
2.) DO
3.) Podiatrist
4.) Vet
5.) Dentist
6.) NP
7.) PA
8.) Optometrist (certain exceptions)
9.) Interns
10.) Residents
11.) Out-of-state practitioners
Which practitioners can only write within their scope of practice? (4)
1.) Vets
2.) Optometrist
3.) Dentist
4.) Podiatrist
Change of status of prescriber (Death, suspension, etc.), when can meds be dispensed after this? (4 exceptions, 1 rule)
1.) Drug essential to sustain life or continues therapy for chronic condition
2.) Prescription issued prior to change of status
3.) Non-controls: RPH can dispense up to 30 day supply or standard unit
4.) Controls: RPH can dispense up to 72 hour supply
5.) RPH must invalidate remaining portion after this dispensing and the remaining amount is considered void
Patient profile requirements (11 items)
1.) Full name of patient
2.) Residential address and telephone #
3.) DOB
4.) Gender
5.) Drug-related allergies
6.) Previous drug reactions
7.) History of or active chronic conditions/disease states
8.) Drug therapy record
9.) OTC drugs, herbals, and devices used on routine basis
10.) Pharmacist’s comments relative to drug therapy
11.) Any other information given to pharmacist by patient or caregiver
What is required to be in the drug therapy record on patient profile (11 items)
1.) Rx #
2.) Date of original issuance by prescriber
3.) Name and address of prescriber
4.) Prescriber credentials (DO, MD, PA, etc.)
5.) Directions for use
6.) Brand or generic name and manufacturer
7.) Strength, dosage form and quantity
8.) DEA # of prescriber (for controls only)
9.) Refills
10.) Dispensing date
11.) Refill history (Rx #, drug name, quantity, date dispensed)
