Pharmacy Law

less

Whos more restrictive state or federal law

state

What does a prescriber have to sign?

every piece of paper interacted with

What is a pharmacist responsible for

every prescription dispensed by a pharmacy

drug

something used in diagnosis, cure, treatment and disease prevention

how can i drug be used for diagnosis?

dyes

what is dangerous drug

a drug that says Rx only

What is a drug of abuse

any prescription drug

is amoxicillin 375 a drug of abuse

yes

terminal distributor

pharmacy selling drugs at retail including labs

personal supervision

pharmacist should be monitoring all staff cant leave building

prescriber

person authorized by ORC to prescribe dangerous drugs or a pharmacist managing drug therapy

Can you fill a prescription from out of state?

yes based on the law of the state it was written, has to be US prescriber

Do faxed perscriptions have to be signed?

yes. manually signed “wet ink”

do refills have to be signed if faxed?

yes, manually signed

Is computer to fax allowed?

no

What are the exceptions to computer fax prescriptions

allowed in a closed system like the wex
telecommunication outage

In what case can you dispense when provider status changes (death often)

essential drugs for life sustaining, prescription issued before change, non controlled 30 day supply, controlled can be 72 H, after dispensing can invalidate rest of prescription

how much can you dispense when a provider dies and you have convo about death?

non controlled 30 days

controlled 72 h

requirements for pharmacist registration

18, have pharmacy degree, minimum requirements, passed licensure, have 5 NAPLEX attempts 5 MPJE

what are important dates

30 days for change of name address employment discontinue business,

10 days when changing head pharmacist

15 days before closing of a pharmacy notify patients of closign

April 1

terminal distributor (pharmacy) lisence renewal

July 1

Wholesaler lisence reneawl

pharamcist liscnece renewal

sept 15 on odd numbered eyar

intern license renewal

sept 15th

What are the minimum standards of a pharmacy

library, equipment, stock of drugs, prescription containers, space and fixtures, hours MUST be posted, personal, internet access

Pharmacy practice in ohio

providing care knowledge judgement and skill from bio chem and other sciences

What are main definitions to pharmacy practice

interpreting prescriptions

dispensing drugs and drug therapy

compounding, counseling people

performing drug regimen reviews, DUR

advising individual and healthcare professionals+ act in contract with physicians

administer immunizations

engaging in administration of drugs

Whos responsible for intern supervision

preceptor

How many interns can a preceptor have?

unlimited

How many interns can work with a pharmacist at once

2

In case of immunization how many interns to pharamcist

6:1 ratio

What needed to receive intern license

apply as intern license, pay a fee, taken professional classes, working towards requirement, documentation that they are taking course

if you get kicked out of school or on leave of absence can you continue intern work?

no, tech work only

If no longer enrolled in school what has to be done

tell internship 72 hours, and return lisence in 10 days

Can pharmacist supervise 2 interns and 3 techs at once?

yes

Profesional duties of an intern

sell schedule 5 drugs, recieve oral prescriptions, transfer and recipt non controlled prescriptions, counsel patients as logn as pharma is in the building, immunizations, compound

how old can interns vaccinate

5 yo and older except for covid

what does it mean when a intern is being supervised

pharmacist is on site in the building

what can you NOT transfer as an intern

controlled substances

Can intern phone in prescriptions controllled?

yes

when taking phone in prescription, what MUSt happen

pharmacist and intern have to provide record on presceription

Rules regarding prescription issuing

legit purpose, signed and dated on day of issue, signed, filled within 6 month

how long are refills allowed for?

1 year from date of issuance (non controlled and schedule V)

6 months, 5 fills for III and IV

Whats the length of filling for opioids

14 days

can your refill C2

NO

what is a preprinted Rx

list and physicians check off what they pick, one drug per form and cant be preprinted

What has to be true for controlled substance quantity

written in both numbers and words, perscribers name written on it two

how many non controlled on form

3

how many controlled on form

1

if refill PRN or as needed how long?

1 year

what is the proceeding for hard copy perscription

180 days kept and then disposed

how long do you have to keep controlled substance documents `

3 years

Parts of a perscripton

name and title, appropriate directions, ICD 10 code says supply

Max days supply dor non controlled

90

if you’re refill stacking or dispensing multiple refills at same tie what applies

non controlled only, maintenance drug or regular drug, only 90 days, had to have been on it for 30 days, insurance might not pay

what conditions need to be met for emergency refill

cant be c2, had to be from your phamacy, if consistant drug supply, can be 30 days, if not then 72 hours, can do two 7 days within a 12 month supply

What are the options for emergency refills

72h, 30d, 7d, 7d (7,7 cant be consecutive)

what must the pharmacist do for every emergency refill

new perscription

can you get your emergency refills at a different chain location

yes but cnt go outside pharmacy company

Who can have keys to pharmacy

only the pharmacist but not the others, badges are ok but not key

When can a pharmacist NOT dispense generic

if DAW or dispense as writen is in THEIR HANDWRITING

whats a generic

identical actives, not listed as FDA as BD or BX (not bioeq)

is oral DAW counted

yes

if a generic is made, what must be written

dispensed as generic

orange book

FDA bioeq book

Purple book

biological products with reference book

How long do controlled substnces hve the be kept on records?

3 years.

How should records be kept

schedule 3, 4, 5 together, noncontrolled, and then 2 by themselevs

How long does a pharmacy have to get rid of outdated durgs

1 year

how many years does a wholesaler have to get rid of old drugs?

2 years

What is important on prescription label?

name of patient, directions, name address phone number of prescriber, date of dispensing, rx number, drug name and strength, quantity

What me disclosed on compounds

“compounded drug product” on teh label

If patient is an animal, how to write name

owner name, name of animal, speciies

How allowed to perscribe

MD, DO, podiatrist, Vet, DDS, optometrist, APN, interns residernts

What is a limited practioner

a prescriber who can only write prescriptions within the scope of their practice like DDS, vet etc.

What is a responsible pharmacist?

the pharmacist in charge, signs the terminal distributors license,

If there is a change in the responsible pharmacist what must you do

notify the board within 10 days

when a responsible oharmacist changes what MUST they do

take a complete invintory on the controlled substances

How many pharmacies can you be the responsible pharmacist for?

only 1

How must C2 be sent?

escript

Rules regarding electronic prescetiption transmittion

• DAW doesnt have to be in writing

• can have muktiple scheduled prescriptions on one

• does not have to have a signature, but if it does has to be disclosed if real or fake

How can electronic controlled subtance be sent?

Must be sent computer to computer, NO fax

If a trasnfer fails what has to happen

call pharmacy to make sure not filled, check patient profile, adn NOTE THAT IT FAILED

can controlled substances be trasnfered?

yes as long as unfilled, but check coorperate rules

How must prescriber calling in identify themselves

FULL NAME. to know if its nurse Dr etc

Can you fill a post dated prescritpion?

NO

What is the limit of do not fill until for scheudle 2

90 days

What is OARRS

controlled substance database for outpatient prescritpions

When is it requried to check oarrs>

• when a patient adds a new controlled substance

• OARRS hasn’t been reviewed for patient in 12 months

• pharmacist has belief that patient received the same OARRS drug from multiple providers

If you live in a boardering county, what might change with OARRS

have to check bordering states monitoring system

Schedule 1 drug

no medicinal use cannot be prescribed

schedule 2

high abuse potential and severe psychological and physical dependance

schedule 3

moderate abuse potential and high psychological dependance, low physical dependance

scheudle 4

lower abuse potential and limited psychological depednance

How to check DEA numebr

add digits 1,3,5

add 2, 4, 6 and multiple by 2

add the two numbers last digit, should match last digit of DEA

How long do you have to fill an opioid analgesic?

14 days within date written on prescription

How much opioid can you dispense for outpatient?

90 day supply for new and refill

Can a physician write an opioid prescription of more than 90 days

yes, its on the pharmacist to say no

for fill within 14 day, what does this not apply to for opioids

schedule 3-5

How long does opioid analgesic have to be dispensed AND pickedup

14 days for fill, but can pick up any time just have to check for medical purpose