General Pharmacy Laws and Rules Pt 2 Flashcards
Pages 68-98
What ages can pharmacists/interns administer any vaccine to without a prescription?
Ages 13+
What ages can pharmacists/interns administer any vaccine to with a prescription?
Ages 7-13
What ages can pharmacists/interns administer flu and COVID vaccines to without a prescription?
Ages 7+
T/F: Pharmacists can administer allergy shots.
False
At what age can a pharmacist/intern administer a Shingles vaccine based on the FDA approved labeling?
Ages 50+
T/F: Pharmacists/interns can administer an initial dose of the rabies vaccine.
False, can only administer follow-up vaccines and pre-exposure vaccines
For all non-flu vaccines given to adults, the pharmacist/intern must notify the pt’s family physician within how many days?
30 days
What must a pharmacist complete to be able to administer vaccines?
Must complete a 5 hour board approved course that contains at least 1 hour of instruction and physical participation in administration techniques and a test of mastery
Physician-established vaccine protocols must:
Hint - 6 things
1) Describe the length of time a pt must be monitored for after a vaccine
2) Include a method to manage emergencies (anaphylaxis, needle sticks, etc.)
3) Be signed by the physician and maintained by the pharmacist
4) Be reviewed by pharmacist and physician every 2 years
5) Be able to be immediately retrieved for board review when requested
6) List the locations that a pharmacist/intern may given vaccines
For each vaccine to be administered, a vaccine protocol must contain:
Hint - 7 things
1) Name and strength
2) Precautions and contraindications
3) Intended audience or pt population
4) Dose
5) Administration schedules
6) Route(s) of administration
7) Injection sites
For each vaccine administered, what must be included in the records for the encounter?
Hint - 10 things
1) Pt’s name and address
2) Pt’s age and DOB
3) Gender
4) Allergy info
5) Date of administration
6) Vaccine name, strength, and dose
7) Vaccine lot and exp date
8) Route and location of administration
9) Positive ID of administering pharmacist
10) Documented informed consent
Records from the previous 12 months must be retrievable by when?
Must be immediately retrievable
Records from >12 months ago must be retrievable by when?
Must be able to provide within 3 business days
How long must immunization records be kept for?
3 years
T/F: Prescriptions can be dropped off into a secured area within the pharmacy building when a pharmacist is not on duty.
True, so long as a pharmacist is the only person with access to the area and the prescription department hours are posted
T/F: A pharmacy must have a physical barrier or alarm system approved by the board.
True
How often must an alarm system be tested?
Biannually (every 6 months)
How long must alarm testing records be maintained for?
3 years
T/F: All protocols must be approved by the State Board of Pharmacy
True
T/F: All treatment guidelines must be approved by the State Board of Pharmacy
True
T/F: Treatment guidelines can be used to start a patient on a new medication.
False. Treatment guidelines only apply to adjusting a dose or frequency of a specific drug that a prescriber has previously ordered.
T/F: All pharmacists who take care of patients are required to be registered with OARRS
True
What drugs must be reported to the board of pharmacy?
1) CII
2) CIII
3) CIV
4) CV (with Rx and wholesale)
5) gabapentin
6) Medical marijuana
7) Naltrexone products (does not include combo products like Suboxone)
What info must be submitted to the board for OARRS with each Rx?
Hint - 12 things
1) Pharmacy’s DEA #, NPI #, name, address, phone number
2) Pt’s name, address, phone number, DOB, gender
3) Prescriber’s name, NPI #, and DEA #
4) Date Rx was written
5) Date Rx was dispensed
6) Indication of “new” or “refill”
7) # of the refill being dispensed
8) Quantity dispensed
9) Days supply
10) Rx number
11) Source of payment
12) ICD-10 or CDT codes (NC if no code)
How often must info be submitted to the board for OARRS?
Daily
How long is information retained in the OARRS database?
2 years
Who can access information in OARRS?
1) Government representatives (ex. police)
2) Prescribers
3) Pharmacists
4) Patients (can only access their own report)
When must a pharmacist review an OARRS report for a patient?
Hint - 6 instances
1) If the pt is being started on a new OARRS reported med
2) If the OARRS has not been reviewed in the past 12 months
3) If the prescriber is located outside the usual geographic area
4) If the pt is from outside the usual geographic area
5) If the pharmacist believes the pt has received scripts for OARRS drugs from more than 1 prescriber in the last 3 months
6) If the pt is showing signs of potential abuse or diversion
T/F: A pharmacist can give a patient their OARRS report if requested.
False, patients must request their own report from the board
What is the morphine equivalent dose (MED) threshold in Ohio?
80, however this can be exceeded if the pharmacist and prescriber are ok with it (80 is more of a stop and check threshold)
How is morphine equivalent dose calculated?
MED = (strength of drug * conversion factor * quantity) / days supply
Note: if there are several drugs, convert each of them then add them together
What is the conversion factor for oxycodone?
1.5
What is the conversion factor for hydrocodone?
1
What is the conversion factor for tramadol?
0.1
What is the conversion factor for codeine?
0.15
What is the conversion factor for fentanyl?
7.2
What is the conversion factor for methadone?
3
What is the conversion factor for hydromorphone?
4
What is the conversion factor for oxymorphone?
3
When does a medication drop out of the MED calculation/threshold?
When the days supply runs out
Note: discontinued meds are still included in the MED number
What mail service/method must be used to mail prescriptions?
The U.S. Postal Service
T/F: Controlled substances can be mailed to patients.
True
If a prescription is mailed, what package requirements should be met?
The outside of the package should not indicate that the contents of the package contain prescription drugs
What is the definition of compounding?
Preparation, mixing, assembly, packaging, and labeling of one or more drugs
What does cytotoxic mean?
A drug shown to be carcinogenic or mutagenic to humans through active or passive exposure
What is a fluid therapy pharmacy?
A pharmacy where the primary purpose is to compound and dispense parenteral compounded sterile products
What is an outsourcing facility?
A facility that is engaged in anticipatory compounding of sterile drugs and complies with FDA section 503B of the FDC act
T/F: A pharmacy outside of Ohio (nonresident pharmacy) can ship compounded drugs into Ohio
False UNLESS it is for a specific patient or they have obtained the proper licensure and can provide an inspection report less than 2 years old
What is the beyond use date for a compounded liquid?
14 days
What is the beyond use date for a compounded aqueous-based topical?
30 days
What is the beyond use date for a gel-based topical?
6 months
What is the beyond use date for a multi-dose vial with preservatives after it has been opened?
28 days unless the manufacturer specifies otherwise
What is the maximum days supply that can be prepared with anticipatory compounding?
30 days supply
Which USP chapter contains information about compounding sterile products?
USP 797
Which USP chapter contains information about compounding non-sterile products?
USP 795
Which USP chapters are federally enforceable?
Any USP chapter under 1000
What 5 minimum standards must a pharmacy meet in order to compound prescriptions?
1) Inspect and approved the compounding process
2) Perform final check on finished product
3) Be responsible for all records of compounded products
4) Be responsible for proper maintenance, cleanliness, and use of all equipment
5) Personnel will wear appropriate PPE
Which USP chapter contains information about compounding hazardous products?
USP 800
Recordkeeping while compounding must include what 8 items?
1) Name, strength, and dosage form of drugs used
2) Quantity of drugs added
3) Disposal and amount of unused drug during the process
4) Lot number of ingredients
5) Generic manufacturer’s name (if generic is used)
6) Date of compounding
7) Exp date
8) Positive ID of pharmacist responsible
T/F: Compounding should only be done for patient specific orders
True
What is manufacturing?
Bulk compounding of products to be sold to other pharmacies
What is required to legally manufacture medications?
FDA licensing and compliance with cGMP - strict monitoring due to risk of pt harm
T/F: You can compound a commercially available product.
False, except for:
1) In the event of a drug shortage where the product is unavailable
2) A particular ingredient must be avoided due to allergies
3) The pt needed a different dosage form than those available
If there is a product quality issue with a compounded drug dispensed by a pharmacy, when must it be reported to the board?
Within 72 hours
What 3 issues count as a product quality issue?
1) Any incident that causes the compounded drug or its labeling to be mistaken or applies to another article
2) Contamination of the compound (particulates, bacteria, mold, etc.)
3) Any significant chemical, physical, or other change or deterioration of the compound within it’s beyond use date
What is the definition of a drug shortage?
A drug on the FDA drug shortage list that is not commercially available, regardless of reason
What is the 5% rule?
The total amount of a compounded drug supplied to a prescriber (vet) cannot exceed 5% of total dollar sales
T/F: Pharmacies can sell compounded drugs to other pharmacies or wholesalers
False
T/F: The addition of a flavoring agent to a conventionally manufactured drug is considered compounding
False
T/F: Antibiotic oral suspension reconstitution and commercially available topical cream kits are not considered compounding
True
What is a charitable pharmacy?
A pharmacy that has a terminal distributor’s license, is exempt from federal taxation, and is not a hospital
T/F: Charitable pharmacies can dispense non-controlled samples.
True
T/F: Charitable pharmacies can dispense controlled samples.
False
What is the difference between a registered and certified pharmacy technician (requirements)?
Certified technicians have national certification (ExCPT certification or Pharmacy Technician Certification Board)
All other requirements (age 18+, high school diploma/GED, and training) are the same for both
What topics must a pharmacy technician training program include?
Hint - 6 topics
1) Packaging and labeling of drugs
2) Pharmacy terminology
3) Basic drug info
4) Basic calculations
5) Quality control procedures
6) State and federal rules, statues, and regulations (about pretty much everything pharmacy related)
What are the requirements for a pharmacy tech trainee?
Age 18+ with a high school diploma/GED
What date do registered pharmacy tech registrations expire on?
March 31st on even numbered years
What date do certified pharmacy tech registrations expire on?
September 30th on even numbered years
How long is a tech trainee registration valid for?
1 year
What are the CE requirements for a registered tech?
10 hours every 2 years, with 2 hours in pharmacy law and 2 hours in med safety
What are the CE requirements for a certified tech?
“Complete all CE requirements needed to maintain the tech’s certification from an organization that has been recognized by the board”
What is the maximum number of pharmacy tech trainees a pharmacist can supervise at one time?
3 trainees
What is the maximum number of registered/certified techs a pharmacist can supervise at one time?
There is no limit
What type of tech(s) can accept new verbal Rxs for non-controlled substances?
Certified techs
What type of tech(s) can enter or retrieve info from a database or pt profile?
Trainees, registered, and certified techs
What type of tech(s) can prep and affix labels?
Trainees, registered, and certified techs
What type of tech(s) can stock and receive drugs from inventory?
Trainees, registered, and certified techs
What type of tech(s) can count and pour drugs into containers?
Trainees, registered, and certified techs
What type of tech(s) can place drugs into containers prior to dispensing?
Trainees, registered, and certified techs
What type of tech(s) can perform non-sterile compounding?
Trainees, registered, and certified techs
What type of tech(s) can perform sterile compounding?
Trainees and certified techs
What type of tech(s) can package and sell drugs to a pt?
Trainees, registered, and certified techs
What type of tech(s) can send or receive e-scripts between pharmacies that share a database or linked computer system (ex. CVS to CVS)
Trainees, registered, and certified techs
What type of tech(s) can stock automated drug dispensing cabinets, crash carts, or floor stock?
Registered (as long as a barcode and QAP is used) and certified techs
What type of tech(s) can accept verbal refill authorizations for non-controlled drugs as long as there is no change from the original Rx?
Certified techs
What type of tech(s) can request refill authorizations from a prescriber as long as there is no change from the original Rx?
Registered and certified techs
What type of tech(s) can send and receive prescription transfers for non-controlled substances?
Certified techs
What type of tech(s) can contact a prescriber for clarification for a script as long as it does not require professional judgement?
Certified techs
What type of tech(s) can perform diagnostic lab testing?
Certified techs
What type of tech(s) can perform diagnostic testing?
Certified techs
What are some of the disciplinary actions the board can take on an intern or pharmacist in the event of an offense?
Revoke a license, suspend a license, restrict a license, place on probation, reprimand, refuse to renew/grant and ID card, require additional CE, and/or impose a monetary fine
When must a pharmacist/intern return an ID card to the board by if their license is revoked, suspended, or refused?
Within 10 days
What is a summary suspension?
When immediate action is taken against a license, registration, or ID card without a prior hearing and the license is immediately suspended
What is considered to be unprofessional conduct?
Hint - 5 things
Any of the following:
1) False or misleading advertising/displays that promote dangerous drugs
2) Selling an Rx w/o a prescription
3) Knowingly dispensing a med to false/forged prescriptions
4) Failing to maintain complete and accurate records of all drugs received and dispensed
5) Obtaining payment or remuneration by fraud, deception, or misrepresentation
T/F: The board can require a pharmacist/intern to submit a physical or mental examination.
True
T/F: To transfer or sell drugs between locations owned by the same company or individual, the pharmacy must have a wholesaler’s license.
False, a wholesaler’s license is not required
What age must someone be to buy dextromethorphan without a prescription?
18+ years old
By law, proof of age and identity is required to sell dextromethorphan to anyone that appears under the age of _______.
25 years old
