LAW Flashcards
A non-opiate prescription must be filled within ___________ of date of issue.
6 months
An opiate prescription must be filled within ____________ of date of issue.
14 days
The cutoff for refilling a dangerous drug (or C-V) prescription is __________.
One year
The cutoff for refilling a prescription for a C-III/C-IV is _________.
6 months
Maximum days supply for a “do not fill until” prescription?
90 days
Used to report destruction of controlled substance (natural causes)
DEA Form 41
Used to report lost/stolen controlled substances
DEA Form 106
Used to order C-I/C-II agents
DEA Form 222
Used to order medications if opening a new pharmacy or attempting to get a personal DEA#
DEA Form 224
The use of or exposure to will cause serious adverse health consequences or death
FDA Class I Recall
The use of or exposure to may cause temporary or medically reversible adverse health consequences; or the probability of serious health consequences is remote
FDA Class II Recall
The use of or exposure to is not likely to cause adverse health consequences
FDA Class III Recall
A drug that is filthy, putrid, or decomposed (expired) is considered:
Adulterated
A drug that is falsely labeled or is labeled in a misleading way:
Misbranded
The Ohio Law that constitutes Duty to Report:
OAC 4729:1-4-02
Duty to Report applies when:
An error is a result of reckless behavior/unprofessional conduct AND results in patient harm/death
T/F: Prescribing must be done in the usual course of professional practice & only within the scope of their employment
TRUE
In the old track/trace system of conducting recalls, entire lots had to be pulled from shelves. With serialization, recalls can be conducted on a ___________________.
Package level
Partial fills for C-II’s can take place if:
- Pt is terminally ill or in an ECF
- Fill is requested by pt/prescriber, total # doesn’t exceed total RX #, and total # remaining gets filled within 30 days of written date.
Things that must be documented on the back of a partial fill RX:
- Date dispensed
- # dispensed
- Remaining # authorized to be dispensed
- Prescription # (if different from original)
- Manual initials or other form of positive identification of dispensing pharmacy
Refill authorizations may be orally transferred by prescriber/agent to:
- Pharmacist
- Recording device
- Intern being supervised by RPh
- Certified technicians FOR NON-CONTROLS
Outpatient/Retail label must contain:
- Name/Address of pharmacy
- Full name of pt & prescriber
- Directions
- Date of dispense
- Cautions required by state/fed law
- Serial #
- Drug name & strength (or generic name & distributor)
- Quantity
Institutional drug order must contain:
- Patient name
- Name, strength, dosage form
- Directions (including route)
- Date prescribed
- Prescriber’s Positive ID
Sterile compounding
USP 797
Non-sterile compounding
USP 795
Federal chapter that defines “outsourcing pharmacy compounding” enabling these entities to compound bulk, non-patient specific compounds
FDA 503b (cGMP)
Must notify BoPh within ___________ for:
- Change of name
- Change of address
- Change of employer
- D/C of a terminal distributor’s license
30 days
Must notify BoPh within _________ for:
- Change of RP
10 days
Must notify BoPh _________ for:
- Suspected theft or loss of a dangerous drug
Immediately
T/F: Every pharmacy must have a Responsible Person, who must be a pharmacist
TRUE
Requirements of RP:
- Supervision of dangerous drugs/records/security
- Adequate safeguards are assured to prevent sale/distribution of dangerous drugs by anyone but a pharmacist
- Must be physically present a sufficient amount of time to provide supervision
- Take inventory of controlled substances when changing RPs
Return to stock requirements:
-Pharmacy expiration label (1 year, unless manufacturer outdate sooner)
-Drug remains in container that it was meant to be dispensed in
Pseudoephedrine Maximums
-3.6 g per day
-9 g per 30 days
Things that tech trainees cannot do:
-Accept new verbal prescription orders/verbal refill authorizations from a prescriber
-Stock automated dispensing units, floor stock, and crash carts
-Request refill authorizations
-Send/receive transfers
-Contact prescriber for clarification of prescription
Things that Registered techs cannot do:
-Perform sterile compounding
-Accept new verbal prescription orders/verbal refill authorizations from a prescriber
-Send/receive transfers
-Contact prescriber for clarification of prescription
Vaccine Admin
-Flu/COVID WITHOUT prescription if 7 years of age or older
-All CDC recommended vaccines WITH a prescription if age 7-13
-All CDC recommended vaccines WITHOUT a prescription if 13 years or older
Excludes Rabies vaccine
Other approved RPh Injections
LAI meds allowed if under protocol and HAS a prescription:
-Long acting opioid antagonist for addiction
-Long acting antipsychotic injections
-Hydroxyprogesterone caproate
-Medroxyprogesterone acetate
-Cobalamin (B12)
For immunizations, the ratio of interns to pharmacists is _______.
6 to 1
Ohio Schedule II Opioids
-Fentanyl
-Hydrocodone
-Hydromorphone
-Meperidine
-Methadone
-Morphine
-Oxycodone
-Oxymorphone
-Tapentadol
Ohio Schedule III Opioids
-Buprenorphine
-Codeine
-Dihydrocodeine/ ASA/CaffeineO
Ohio Schedule IV Opioids
-Butorphanol
-Tramadol
Act that prohibits interstate sale of adulterated/misbranded food and drugs
Pure Food and Drugs Act of 1906
Act that created child proof caps
Poison Prevention Packaging Act of 1970
Amendment that defined Legend vs. OTC medications
Durham-Humphrey Amendment of 1951
Act that created the 5 different controlled substance classes
Controlled Substance Act of 1970
For NON-CONTROLLED substances, the RPh may change the following without verification with the prescriber:
- Dosage form
- Drug strength
- Drug QTY
- Directions
As long as:
-Drug is generically equivalent
-Rx is for a human
-DAW is not written
Things that cannot be changed on a prescription:
- Patient name
- Drug name
- Prescriber name
Pharmacist CE Requirements:
- 30 hours every 2 years
- Due on odd years
- 2 hours in law
- 2 hours in med safety
Technician CE Requirements:
- Registered = 10 hours every year (2,2)
- Certified = 20 hours q2years (1,1)
- Due on even years
T/F: Gabapentin qualifies as a drug that does not need to be reported to OARRS
FALSE
NDC Code
12345-6789-0
12345 = Labeler code
6789 = formulation, dosage form, physical form
0 = size and type of package
DEA # Code
AP5836727
-“A” signifies practitioner (could also be B, F, G, or M for mid-level)
-“P” signifies practitioner last name
-Sum of digits (1+3+5) + ((2+4+6)x2)
-Last digit of total sum = last number of DEA number
Emergency C-II Fill
-If deemed an emergency situation
-Prescriber must provide RPh with a written prescription for the emergency med within 7 days
-Abides by partial fill rules
Things that a pharmacist can do under a consult agreement with a physcian:
- Manage a patient’s drug therapy for specified diagnoses or diseases
- Order and evaluate:
-Blood
-Urine
-Other labs/diagnostics related to drug therapy being managed
Pharmacist can enter consult agreement with:
-Physicians
-PAs
-Clinical Nurse Specialists
-Clinical Nurse Midwives
-Certified Nurse Practitioners
