Pages 1-50 in DS book

Question 1

Abandoned application

Answer 1

applicant fails to complete all application components within 30 days after being notified by the Board of an incomplete application

Question 2

Abandoned application (terminal distributor/wholesaler)

Answer 2

90 days to demonstrate compliance of all laws once completed application submitted

Question 3

Access to drug stock

Answer 3

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

Question 4

Drug

Answer 4

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.

Question 5

Temporary Removal of Drugs from a TDD (3 things)

Answer 5

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

Question 6

Faxed prescriptions when sending to pharmacy (4 things)

Answer 6

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

Question 7

Computer to fax prescriptions (illegal except 2 exceptions)

Answer 7

1.) Rx computer to fax prescriptions operates in CLOSED system
2.) Temporary telecommunication outage for NON-CONTROLLED only

Question 8

Readily Retrievable

Answer 8

Within 3 business days for records to be produced for review

Question 9

Refuse to Grant or Renew

Answer 9

Deny original or continued licensure for a period of at least 24 months

Question 10

Terminal distributor

Answer 10

Pharmacy that sells (dispenses) drug at retail; includes labratories

Question 11

Virtual wholesaler Distributor (4 things)

Answer 11

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

Question 12

Occasional sale

Answer 12

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

Question 13

Personal supervision (direct)

Answer 13

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

Question 14

Federal legend

Answer 14

All Rx drugs must have “Federal Law Prohibits Dispensing Without a Prescription” or “Rx only” on stock bottle

Question 15

Minimum standards of a pharmacy (11 items; 1 specifically for institutional pharmacies)

Answer 15

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

Question 16

4 websites/items a pharmacy must be able to access via internet

Answer 16

Board’s website, LA Writer Ohio laws and rules, The code of laws of the USA, and The Code of Federal Regulations

Question 17

4 items the quality assurance program in an institutional setting must monitor/evaluate

Answer 17

1.) Quality and appropriateness of patient care
2.) Pursue opportunities to improve patient care
3.) Prevention/Detection of drug diversion
4.) Resolve Identified problems

Question 18

10 items that involve the practice of pharmacy in Ohio

Answer 18

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)

Question 19

Drugs Returned to Stock in Pharmacy. When can you do it?

Answer 19

If drug has been dispensed, but not picked up or delivered, never left prescription department, and/or never left control of delivery agent

Question 20

Requirements for Drugs Returned to Stock in pharmacy (7 conditions must be met)

Answer 20

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

Question 21

Two requirements if returning drugs to stock after delivery agent came back with it

Answer 21

1.) Had to be dispensed in tamper evident container/package prior to leaving pharmacy
2.) Be in manufacturer’s original tamper evident packaging

Question 22

Consult agreements (5 entities can be in a CA with RPH)

Answer 22

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

Question 23

3 requirements for entering a CA

Answer 23

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

Question 24

6 things that a pharmacist is authorized to do in a CA

Answer 24

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!!!!

Question 25

Who can terminate a CA? (3 people)

Answer 25

Pharmacist, physician, or patient/individual who gave consent for patient

Question 26

How long is a CA good for?

Answer 26

2 years, then can be renewed

Question 27

What are the 4 things that must be in writing for a CA?

Answer 27

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

Question 28

Consent required for CA (4 items); RPH must tell patient these things

Answer 28

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

Question 29

7 acceptable communication methods between RPH and provider for CA (Same methods can be used for Written Notice (confirmation of delivery)

Answer 29

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

Question 30

If the RPH in a CA is an agent of the prescriber they must do 3 things when issuing prescriptions

Answer 30

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

Question 31

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?

Answer 31

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

Question 32

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)

Answer 32

Physicians, podiatrists, vets, dentists, NPs, optometrists

Question 33

When healthcare professionals dispense drugs from their office do they need to be labeled/packaged according to pharmacy regulations?

Answer 33

Yes and records of purchase/dispensing must be maintained as well

Question 34

Emergency dispensing, not including C-II's, conditions that must be met in order to comply with law for emergency dispenses (8 main items)

Answer 34

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)

Question 35

4 things must be kept on record when doing emergency dispensing

Answer 35

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

Question 36

If a co-pay or deductible is waived who is responsible, individual RPh or business?

Answer 36

The business or TDD is responsible, NOT individual

Question 37

If the cost of an Rx is cheaper cash than with co-pay do you have to say anything?

Answer 37

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

Question 38

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?

Answer 38

72 hours

Question 39

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?

Answer 39

Within 10 days

Question 40

How soon should statement of preceptor be submitted to board of pharmacy after beginning work as an intern?

Answer 40

Within 30 days of starting

Question 41

Name the professional duties an intern can perform (positive ID of both supervising RPH and intern for these) (13 items)

Answer 41

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

Question 42

How many hours are required for foreign pharmacy graduates in Ohio and those not completing a PharmD degree

Answer 42

1740 total; 500 can be from a site other than a pharmacy licensed as a TDD

Question 43

When must foreign pharmacy graduates report hours obtained in the previous year? (specific date)

Answer 43

March 1st

Question 44

Phoned-in prescriptions/refill authorizations from prescriber/agent as an intern (6 conditions required)

Answer 44

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

Question 45

Transfer conditions required for interns to do them (2 conditions required that are different than phoned-in prescriptions_

Answer 45

1.) ONLY for non-controlled 2.) Must provide positive ID BEFORE dispensing of both intern and RPH for the received prescription copy

Question 46

What 4 changes require 30 day notice to the Board?

Answer 46

1.) Name change 2.) Address change 3.) Employment change 4.) Discontinuing business

Question 47

Which change only requires 10 day notice to the Board?

Answer 47

Change in responsible RPH

Question 48

Date of Terminal Distributor's license renewal (includes lab)

Answer 48

April 1st

Question 49

Date of Wholesalers license renewal

Answer 49

July 1st

Question 50

Date of RPH/intern license renewal

Answer 50

Sept 15th

Question 51

How long must hard copy non-controlled be kept on file electronically after being scanned in before being destroyed?

Answer 51

180 days

Question 52

Price information to patient (2 things)

Answer 52

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

Question 53

Ratio for immunizations intern to pharmacist

Answer 53

6 interns to 1 pharmacist

Question 54

True or false: C-V's can only have 5 refills on them

Answer 54

False, Years supply is allowed for C-V/non-controls

Question 55

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?

Answer 55

If doing it for medication synchronization

Question 56

After a hard-copy controlled substance prescription is scanned in are you able to destroy the original?

Answer 56

No, cannot destroy at any point in time

Question 57

What are the 9 parts of a prescription required for both non-controls and controls?

Answer 57

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

Question 58

What 3 additional parts are needed for a control prescription?

Answer 58

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)

Question 59

What 4 changes can a pharmacist make to a prescription without consulting prescriber?

Answer 59

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)

Question 60

What 3 changes can a pharmacist make AFTER consulting with prescriber?

Answer 60

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)

Question 61

When dispensing multiple simultaneous refills, what are the 3 possible things the prescription must be for?

Answer 61

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

Question 62

What is the max day supply a multiple simultaneous refill can be for?

Answer 62

90 days

Question 63

If a patient wants to do multiple simultaneous refills, but physician prohibits this, can it be overruled?

Answer 63

No physician is able to prohibit this and it cannot be overruled

Question 64

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?

Answer 64

No, would have to do the one refill separate from the other new script.

Question 65

This category of Terminal Distributor's license can only dispense single dose injections of IV fluids

Answer 65

Category I

Question 66

This category of Terminal Distributor's license can dispense any dangerous drug

Answer 66

Category II

Question 67

This category of Terminal Distributor's license can dispense controlled substances

Answer 67

Category III

Question 68

ACPE program codes

Answer 68

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

Question 69

In what ways can a prescriber indicate dispense as written?

Answer 69

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

Question 70

If DAW is preprinted, typed or written out by nurse does the pharmacist have to abide by the DAW?

Answer 70

No, can dispense generic for any of these three situations

Question 71

If a prescriber orally states DAW to pharmacist does that count the same as being handwritten?

Answer 71

Yes, oral DAW is officially recognized under Ohio Law

Question 72

Can the patient refuse a brand name if prescriber indicates it on the script?

Answer 72

No, not without discussing with prescriber regardless of cost difference

Question 73

Which color book is for bioequivalences?

Answer 73

Orange book

Question 74

Which color book is for the FDA list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations

Answer 74

Purple book

Question 75

What are the 8 requirements for a prescription transfer?

Answer 75

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

Question 76

What 3 things must the RPH receiving the prescription copy document/do?

Answer 76

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

Question 77

What 3 things must the pharmacist transferring the prescription include in the database?

Answer 77

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)

Question 78

If RPH transferring controlled substance, what must be done to the original prescription for the control? (4 things)

Answer 78

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

Question 79

What 9 activities require positive ID from pharmacist?

Answer 79

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

Question 80

Requirements of outpatient prescription labels (10)

Answer 80

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

Question 81

Requirements of inpatient unit dose label (5)

Answer 81

1.) Name, strength, dosage form, route of administration 2.) NDC 3.) Manufacturer or repackager ID 4.) Lot # and exp. date 5.) Special storage conditions

Question 82

Requirements of IV bag labels (inpatient, 7)

Answer 82

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

Question 83

Requirements of IV bag labels (outpatient, 11)

Answer 83

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

Question 84

Inpatient custom med package label requirements (multiple drugs in same package, 7)

Answer 84

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)

Question 85

Label on sample provided by prescriber requirements (3)

Answer 85

1.) Name of prescriber 2.) Patient name 3.) Directions for use

Question 86

Is complimentary supply the same as a sample?

Answer 86

No, complimentary supply is an Rx drug provided to a patient to assist them in the initiation of drug therapy. Not considered a sample.

Question 87

What is required on compounded products made in advance? (5)

Answer 87

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)

Question 88

Customized patient med packages (convenience/compliance packaging) requirements (8)

Answer 88

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

Question 89

What 4 things can exclude drugs from being added to customized med packages?

Answer 89

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

Question 90

Who is considered a practitioner? (11)

Answer 90

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

Question 91

Which practitioners can only write within their scope of practice? (4)

Answer 91

1.) Vets 2.) Optometrist 3.) Dentist 4.) Podiatrist

Question 92

Change of status of prescriber (Death, suspension, etc.), when can meds be dispensed after this? (4 exceptions, 1 rule)

Answer 92

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

Question 93

Patient profile requirements (11 items)

Answer 93

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

Question 94

What is required to be in the drug therapy record on patient profile (11 items)

Answer 94

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)