Law Part 1 Flashcards
Define who has access to drug stock
includes individuals with not only physical access but also influence over the handling of prescription drugs including: purchases, inventories, issuance of medical order.
Define Act of Moral Turpitude
Act or behavior that gravely violates moral sentiment or accepted moral standards of the community and is a morally culpable quality held to be present in some criminal offenses as distinguished from others.
A drug is defined as:
USP recognized article for use in diagnosis, cure, treatment, or prevention of disease in humans or animals.
A faxed prescription form in any situation must be _____
manually signed by the prescriber. Faxed refill authorizations must be manually signed as well.
- must also include the identification number of the fax machine used to transmit the prescription
If an “agent” is sending prescriptions via faxed what should also be on the script?
besides the providers signature it should also have the agents full name
Most Computer to Fax prescriptions are now considered…
illegal, there are a few exceptions
Define a “closed system” where a compute to fax prescription can be done
the scripts are transmitted directly between companies/entities under common ownership and control one or more contracted companies
Other than a closed system computer to fax prescription set up, what is one other way that this viewed as legal?
in a situation where there is a temporary telecommunication outage of the third party intermediate (NON CONTROLLED ONLY)
Pharmacists must disclose drug price information for all drugs except for?
Class 2 drugs
what is defined as readily retrievable?
records that can be produced for review within 3 business days
What is denying original or continued licensure for a period of at least 24 months referred to as?
Refuse to grant or renew
A pharmacy that dispenses (sells) drugs at retail (other than for own use as with a practitioner) - Includes laboratories
terminal distributor
Third Party Logistics Provider
contracts with a manufacturer or wholesaler to provide or coordinate warehousing, distribution, or other services on their behalf but does not take title of prescription drugs or have the responsibility for their sale disposition
Wholesaler Sale
Any sale that is made with the purpose of the purchaser to resell the article purchased or received
Occasional Sale is when
a wholesale sale of a commercially available prescription drug to another terminal distributor or person exempted from being a terminal distributor
the 5% limitation to occasional sales does not apply to the sales, transfers, or deliveries or prescription drugs considered:
- as intracompany (between pharmacies under the same ownership)
what is the federal law definition of a prescription drug?
a drug that is unsafe for use except under the supervision of a practitioner because of toxicity, mode of use, or any other measures necessary to use the drug
Name 5 of the 11 minimum standards for a pharmacy under the pharmacy practice act
- Library
- Equipment
- stock of drugs
- prescription containers
- space and fixtures
- pharmacy hours posted
- personnel and staffing
- catch all: additional minimum standards for specialized pharmacy practices
- internet access
- name tags that include job title
- institutional: quality assurance program
In the pharmacy practice act a pharmacist is required to have internet access to what 4 sources?
- the board of pharmacies website
- LA Writer Ohio Laws and Rules
- the code of laws of the United States of America
- the code of federal regulations
What is evaluated by the required quality assurance program that is required for institutional pharmacies via the Pharmacy Practice Act (4)
- quality and appropriateness of patient care
- pursue opportunities to improve patient care
- prevention and detection of drug diversion
- resolve ID problems
When a prescription is returned to stock after a patient fails to pick it up what is the BUD?
1 year from date the script was dispensed or whenever the bottle used expires (soonest).
Can you remove the label from a prescription bottle (not OG packaging) that is returned to stock?
No! - you may add or modify the existing label is the drug name, dose, and original expiration date are maintained
You may be able to place a new label over the existing one if the drug is verified by a pharmacist or electronic verification system after the admin of a new label
If there is a drug recall, all medication on the shelf that was previously dispensed in a patient bottle should be -
removed from the shelfs unless the pharmacy can determine that medications exact lot number
What are the two conditions that a patient container can be returned to stock after a delivery agent brings them back?
(only needs to meet one)
- it had to have been dispensed in a tamper evident container or package prior to leaving the pharmacy
- dispensed in the manufacturers original tamper evident packaging
What are the two conditions that a patient container can be returned to stock after a delivery agent brings them back?
(only needs to meet one)
- it had to have been dispensed in a tamper evident container or package prior to leaving the pharmacy
- dispensed in the manufacturers original tamper evident packaging
How long is a consult agreement valid for?
2 years
Who can pharmacists enter a consult agreement with?
Physicians
Physician assistants, if entering into a consult agreement is authorized by one or more supervising physician
Clinical nurse specialists, certified nurse-midwives, or certified nurse practitioners, if entering into a consult agreement is authorized by one or more collaborating physicians.
Consult agreements must be in writing and must include:
1.the diagnosis and the diseases being managed
2.description of drugs or categories the agreement involves
3.description of the procedures, decision criteria, and plan the pharmacist is supposed to follow
4.description of how the pharmacist is to comply with the records of each action taken
Comorbid Disease is….
an additional disease that co-occurs with a primary disease. A co-morbid disease may be related to or occur independently of the primary disease
Define Primary Disease
disease that arises spontaneously and is not associate with or caused be a previous disease, but may lead to a co-morbid disease
A consent must be “communicated” to each patient participating in a consult agreement. It must include what 4 things?
- A pharmacist may be utilized in the management of the patients care
- the patient has the right to participate or withdraw from the consult agreement
- this consent may be part of the patient’s initial onset to treatment
- managing pharmacist means a pharmacist managing a patient’s drug therapy pursuant to a consult agreement
Inside a consent agreement what can be outlined in regards to training of pharmacists?
A consent agreement can outline training and experience criteria for the managing pharmacists to manage drug therapy under the agreement.
Can include: privileging or credentials, board certs, CE, etc
Once the consult agreement is completed a pharmacist is consider one of two things:
- Prescriber authorized to issue new or refill drug orders in writing, orally, fax, or electronic prescribing
OR
- Agent of the prescriber
If a pharmacist is an AGENT of a prescriber with a consult agreement the pharmacist must ______
-include required prescriber information of the consulting prescriber (name, address, etc)
- telephone # of where the managing pharmacist can be contacted during business hours
- all positive identification (including manual signature) on the prescription shall be of the managing pharmacist on behalf of the consulting provider
When should you notify the board if a pharmacist is no longer authorized to prescribe controlled substances per the consult agreement?
Within 5 days. The BOP will then void their controlled substance prescriber license
When should a pharmacist’s DEA number from the federal government be submitted to the board by?
must be done within 30 days, or at any point changes are made
When should a pharmacist managing a patient’s drug therapy via consult agreement request and review OARRS report covering one year ? (2)
- adds a controlled substance to the patient’s drug therapy
- adjusts a controlled substances, strength, dose, dosage form, route, or frequency of administration
A practitioner is defined as:
licensed health care professional authorized to prescribe drugs
A pharmacist can dispense or sell a dangerous all drugs EXCEPT ____ without a prescription from a licensed health care professional authorized to prescribe medications …..
Schedule 2
What things are needed in order for a pharmacist to dispense or sell a dangerous drug without a prescription?
(8 things)
- pharmacy record of a RX with no RF or expired for pt
- RPh is unable to contact the prescriber for refills
- in PharmD’s judgement that drug is essential to sustain life - or failure to dispense can cause harm to the patient
- decision of 72 hr or 30 d supply
- record of dispensing and notifying prescriber within 72 hours
- keep records of dispense x 1 yr
- must create a new rx for the emergency refill
- the law does NOT specify that the record for the RX be specific for that pharmacy.
When can a 30 day emergency dispense be considered?
if the patient has been on consistent drug therapy demonstrated by records maintained by the pharmacy. The drug dispensed cannot exceed a 30 day supply OR the standard unit available for the drug if the standard unit exceeds 30 days
(inhaler meant to last 60 days - with instructions)
Can you redispense a medication for a patient after you’ve already dispensed a 30-day emergency fill?
Yes, you can dispense up to a 7 day supply a SECOND AND THIRD time within a 12 month period
When can a pharmacy not charge a patient’s medication to a copay/co-insurance health plan?
when the plan co-pay is more than the cash price! the pharmacy must inform the patient of this cost -savings
What are the 7 criteria for “Registration of Pharmacists” ?
- 18 yo
- good moral character
- attended an accredited pharmacy program
- met minimum intern requirements determined
- passed licensures
- completed naplex + mpje in at most 5 attempts
- any disciplinary action taken by any board of pharmacy must be reported to all boards the person is licensed in
How many members are on the board of pharmacy?
9 that are appointed by the governor
Of the 9 members on the board, how many are pharmacists?
8 !
the 9th individual must be a consumer of at least 60 yo
How long is a term on the board of pharmacy?
4 years! you may be reappointed for one additional four year term
When is the term start date for the board of pharmacy?
July 1st
What type of prescription can an intern not partake in during a transfer?
Controlled Substances - Pharmacist only
What schedule drug can have refills good for 1 year?
C-V
Can an intern consult a patient prior to dispensing simultaneous refills?
No, the law prohibits this and requires that only a pharmacist does this
Who can use the words “pharmacy” or “drug store”
Terminal distributors
When can a pharmacist not dispense a generic?
When the provider has written in their own handwriting in any way that portrays DAW.
A verbal DAW wording reference
When must a pharmacist notify a provider when a biological product was switched for a patient? (provide the additional information they must also give)
5 days
Must also tell them the product name and the manufacturer
Orange Book
FDA generic bioequivalence book
Purple Book
FDA list of licensed biological products
includes exclusivity and biosimilarity or interchangeability evaluation
Name on an RX label for a pet
Last Name of Owner, Name of Animal, Species
EX: McCrory, Lacy Jo, Canine
A small label that is usually placed on a multi dose container must include: (2)
RX number and patient name
When can a patient self medicate at bedside in the hospital?
When it is the same directions as the outpatient label
What must be on a label of a sample provided by prescriber?
Name of the prescriber
Patient Name
Directions
Max Days supply limit for patient medication packages:
31 days
Max Expiration date for patient specific medication packages
6 months
When a change in status for a provider occurs what is the max days supply for a non controlled substance that can be dispensed?
30 days or the standard unit of dispensing
**only valid if the script was written PRIOR to the change of status
When a change in status for a provider occurs what is the max days supply for a Controlled substance that can be dispensed?
72 hour supply
** only valid if the script was written PRIOR to the change of status
After a pharmacist provides the maximum days supply to a patient after a provider change of status what must they do to the remaining refills/qtys?
Must invalidate the remaining portions of the prescription and the remaining portion of the RX.
Define Prospective DUR
conducted at the time a prescription is dispensed
Which DUR is required by law?
PROSPECTIVE
How long is the temporary permission that the BOP gives a pharmacist to be the responsible pharmacist for more than one pharmacy?
Given UP TO 60 days by a board employee until the FULL board decides. Once permission is given it is only good for 1 year.
When must the BOP be notified in a change in responsible pharmacist?
10 days!
A complete inventory must be taken of ALL controlled substances by the new pharmacist on the date of the change
All pharmacists working in a pharmacy must have access to all:
current federal and state laws, regulations and rules governing the legal distributions of drugs in ohio
need nearest poison center number
If a drug leaves the pharmacy and is then re-dispensed it is:
Adulterated
All central pharmacy providing central prescription filling processing services to pharmacies in Ohio MUST:
Be licensed as a terminal distributor of dangerous drugs
Which form of electronic prescriptions for controlled substances considered acceptable?
- Computer to computer
- Computer to Fax
Computer to Computer!
If a prescriber wants to fax a controlled substance what must they do?
Must manually print it out, sign it, and then fax it to the pharmacy
Form that must be sent to the DEA within 1 business day with suspected theft?
DEA Form 106
What vaccine does not need to be reported to a PCP or BoH within 30 days of administration?
Flu Vaccines
How long is the course that pharmacists need to complete in order to give vaccines in Ohio?
5 hours with 1 hour of that time being in person physical participation (technique focused)
In order to give vaccines a pharmacist must have a Physician established protocol…. What does that entail?
Review Q2Y
- length of observation time after admin
- what to do in emergency situations
- method to notify BOH or PCP within 30 days
- be able to immediately provide information to BOP
Finite details for the Physician established vaccine protocol in regards to the vaccine must include…. (7)
- name / strength
- precautions / CI
- intended audience or patient population
- appropriate dosage
- administration schedules
- routes of admin
- injection sites
T/F: A practitioner can request the drug name be omitted from the label.
True
Records from the past 36 months need to be produced in what time frame?
3 business days.
If it is 12 months or less then it needs to be available immediately
T/F: protocol and treatment guidelines must be approved by the BOP?
True
Protocol Definition
definitive set of written treatment guidelines that include definitive orders for drugs and their specific dosages which have been authorized by a prescriber to be used by licensed HCP when administering biologics or vaccines
What types of Naltrexone products should be reported to OARRS?
- if used for OuD, AuD
- if it is a combo product IT DOES NOT NEED TO BE REPORTED
Other than OARRS being able to calculate a patient’s possible risk for OD and Addiction, What other features does it hold? (3)
- ability to message other providers
- ability to search for local addiction treatment providers
- red flags to alert prescribers of patient safety issues
T/F: do emergency rooms have to report to OARRS CS that were dispensed to patients?
True
- so do physicians who dispense their own meds
If a pharmacy sells CS as a wholesaler to other pharmacies or physician offices what must they do in OARRS?
They must also register themselves as a wholesaler so that those sales can be reported to OARRS
In OARRS as a wholesaler what must you report the amount sold as? What about as a TDD?
Wholesaler: Packages
TDD: Total quantity
WS: 100 pill bottle –> sold 30 pills –> 0.3
MED Equation
DS
Describe the MED for Ohio
In ohio the threshold is 80. You can surpass this amount using clinical judgement. This can change daily!!! If a medication is DC’d then it is still calculated in here.
If a patient has an RX still available - once the DS runs out then it is deducted from the MED.
CF for Methadone
3
CF for Fentanyl
7.2
CF for Hydrocodone
1
CF for Tramadol
0.1
CF for Codeine
0.15
CF for Hydromorphone
4
CF for Oxymorphone
3
BUD for compounded liquid
14 days
BUD for a Aqueous based topical liquid
30 days
BUD for gel-based topicals
6 months
Manufacturing requires licensing with:
The FDA and compliance with cGMP. Allows you to produce and sell manufactured medications (in bulk) without patient specific prescriptions
When can you compound commercially available products?
In an event of shortage
If there is a Quality issue when compounding when should the board be notified?
72 hours - utilize the Quality Reporting Form
Done in any event that product quality issue it attributed to a compounded drug dispensed by the pharmacy
Registered Pharmacy Technicians Licenses expire_____
March 31st on every even numbered year
Certified Pharmacy Technicians Licenses Expire ___
September 30th on every even number year
Retailers are prohibited from selling DEXTROMETHORPHAN to people < 18 yo. Who should be carded?
Anyone that looks to be under the age of 25.
If a patients (<18 yo) guardian is not the one who gives consent to dispense an opioid how much can the pharmacist dispense?
72 hour supply
What must be included in a letter to the BoP for record kept off site
(request)
TDD # of the pharmacy
License # of the requestor
Name and Address of the alternative address
Time frame in which the records will be moved off site
If a pharmacy dispenses naloxone must notify the BoP within __ of establishing an approved protocol. If a pharmacy is no longer dispensing naloxone, they must notify the board within ___ of d/c.
30 days, 30 days
The 5% limit does not apply to:
The selling of naloxone
- wholesale to state and local law enforcement agencies
What are the five types of vaccines that a pharmacist can administer?
LAI
Hydroxyprogesterone - pregnant
Medroxyprogesterone - non pregnant
B 12
Medications used for addiction
When must a provider be notified after doing a pharmacist administered injection? (not a vaccine)
7 days
The 5 + injections that a pharmacist may inject requires what training?
At least 1.5 hr of live or home study coursework for EACH of the five types of administered by a pharmacist. (7.5 total)
MINIMUM of 30 minutes live or home study MUST include a review of sterile technique in injectable dosage preparation and administration
A Pharmacist must SELF report within 10 days of:
- any criminal conviction
- convicted or pled guilty, subject to a judicial finding of eligibility for intervention in lieu of conviction or the equivalent in another jurisdiction
- granted entry into a diversion program, deferred prosecution program, or equivalent
- Any disciplinary action taken by another state
- Any medical error result of reckless behavior
T/F: A Pyxis machine is considered an automated pharmacy system
FALSE!
APS - performs operations or activities relative to storage, packaging, compounding, and dispensing, or distributions
A pharmacist must verify the APS has a 99.985% that needs to be continuous for ____
45 days
Limited Category 2 Pharmacies
Are TDD that DO NOT DISPENSE
In order for a pharmacist to dispense NRT without a prescription they must_____
take an approved course
And
Must notify the patients PCP within 72 hours
If a partial fill is done for a C-II how long do you have to do the remainder of the prescription?
30 days of the date issued
All C-2’s are required to be issued electronically except in what situations?
- Temp technical, electrical, or broadband failure
- Nursing home & hospice patients
- prescriber is employed by /under contract with the same entity as the pharmacy
- prescriber does not feel that a electronic rx cannot be issued in a timely manner and pt’s condition is at risk
- RX issued in a health care facility & prescriber determines that an electronic RX would be impractical or would cause delay that would adversely impacts the pt’s medical condition
The C-2 of ONLY electronic prescribing LAW DOES NOT APPLY TO:
prescribers who write 50 or less C-2 a year
T/F: Federal law requires that ALL medicare part D and Medicare Advantage Prescription Drug Plans require ALL controlled substances prescriptions to be issued electronically
True
What 3 things can never be changed on a C-2?
Patient Name
Prescriber Signature
Drug Prescribed
What happens when a pharmacist receives an oral C-2 RX:
The Qty prescribed and dispensed should be enough for the emergency period (may not be 72 hr)
Pharmacists must receive the written RX from the prescriber within 7 days
the oral and written must be attached together with a statement of “authorization for emergency dispensing”
Form 222
Ordering of C-2
Form 224
original registration for DEA license
Form 225
license to manufacture control substances
Form 224a
DEA re-registration form
Form 41
disposal of controlled substances
Form 106
Theft or Loss of controlled substances
By ohio law how often should inventories be conducted?
13 months
Schedule III, IV, and V drugs in package sizes LESS THAN OR EQUAL TO 1000 can be:
estimated for inventory
Schedule III, IV, and V drugs in a package size GREATER THAN 1000 MUST BE :
Must be counted for inventory
Can a C-II qty be estimated?
NO must have a physical and exact amount
When can you receive a fax for a C-2
- nursing home or LTC patients
- hospice pts (will note hospice on rx)
- Compounded sterile product prescription for a narcotic substance
Poisons are deleterious to adult life in quantities of ___ grams or less.
4
PA can prescribe chronic weight loss medications starting ____
with the 4th visit (after 3 visits with the doctor
Can PA prescribe short term weight loss medications?
NO
At what point can a provider write refills for weight loss medications?
after the 3rd FtF visit - can only do 5 times within a 6 month time period
Any changes to the hospital DEA number should be sent to the BOP within:
5 days
What section must a sterile compounding outsourcing facility be registered as “outsourcing facility” under Section:
503B
Define a Class 1 medical Device
good manufacturing practices
pre marketing review; safety
proper labeling trustful advertising
Ex: ice bags, crutches, blood pressure kits
Define Class 2 medical Device
Class 1 + performance standards
Ex: tampons, contact lens, heating pads
(good manufacturing practices
pre marketing review; safety
proper labeling trustful advertising )
Define Class 3 Medical Devices
Class 2 + pre-marketing approval
Manufacturers must demonstrate safety and efficacy
EX: IUD, Pacemakers, heart valves, artificial hips
What 3 security features do medicaid prescriptions require?
- prevent unauthorized copying (blank/completed)
- Prevent erasure or modifying of written info
- Prevent the use of counterfeit RX forms
(thermochromic ink, tamper resistant background, triplicate blanks, numbered blanks)
Who decides the scheduling of drugs?
Attorney. General
Class 1 Drug Recalls
Will cause serious ADR or death
Class 2 Drug Recalls
May temporarily or medically reversible ADR on health or where probability of serious ADR is remote
Class 3 Drug Recalls
Exposure is not likely to cause any ADR
Purple Book
Biosimilar lists and interchangeable biological products
DEA Numbers that start with M
APN
Optometrist
What is the ONE PO steroid that an optometrist can prescribe?
Methylprednisolone (pt has to be 18+, treating an allergy, during episode of illness)
Optometrists cannot prescribe more than (CS)
60 mg of Codeine per dosage unit or 7.5 mg of hydrocodone per dosage unit
MUST BE IN COMBO WITH NON NARCOTIC INGREDIENTS
- 4 DS MAXXXX (for a single episode of illness)
Max pseudoephedrine that is limited in a DAY
3.6 g
Max pseudoephedrine that is max per MONTH
9 g
