EXAM 2 Tennessee Drug Control Act Flashcards
If a pharmacist who works with controlled substances is registered with the Board of Pharmacy how often is it required to obtain a registration?
every 2 years
for every person who manufactures, distributes, dispenses, or is a third-party logistics within Tennessee!
Does any pharmacy of a pharmacy chain need to be registered with the Board of Pharmacy?
Yes - if they work with controlled substances
each principal place of business or professional practice where the applicant manufactures, distributes or dispenses controlled substance
When registering for dealing with scheduled drugs, which schedules can be selected in Tennessee?
All or none
-can’t pick a particular one
federally you can pick the level of schedule (C-II, C-III, C-IV, C-V)
What are the rules regarding maintaining inventory and record keeping in Tennessee?
same as with federal law
-biennially inventory
-filing system (keep C-II separately)
What type of prescription is required for C-II in Tennessee?
electronic Rx
except for:
-Emergency situations defined by federal law
-Dispensed directly by the prescriber to the ultimate user
-Exceptions covered under TCA 63-1-160
-January 2021 start date – waiver available for 1 year
What are the emergencies defined by federal law?
-needs immediate administration
-no appropriate alternative to the C-II
-it is not possible for the practitioner to provide a written Rx before dispensing
???
What is the period of time in which refills can be filled for C-III, C-IV, and C-V) in Tennessee?
6 months and not more than 5 times (unless renewed by the prescriber)
for C-III to C-V (federal law doesn’t say for C-V)
-same as federally (see Pt4)
When is the distribution and dispensing of C-V drugs allowed in Tennessee?
Only for medical purposes
(for example Cheratussin AC)
What is the max daily supply of opioids and Benzos can be dispensed in Tennessee?
not more than a 30-day supply
(only opioids and benzos - doesn’t say anything about C-II stimulants)
How much of a C-II stimulant can be dispensed in Tennessee?
REMINDER
90-day supply
patients can get multiple prescriptions for the same drug for a supply for up to 90 days
same as federally (see Pt3)
A prescriber needs to submit to CMSD when dispensing which drugs.
-Opioids
-Benzos
-Barbiturates
-Carisoprodol
-> the goal is to reduce dispensing by prescribers directly and shift it to prescribing and being dispensed in the pharmacy
What if a prescriber writes a 90-day supply for a benzodiazepine in Tennessee?
dispense a 30-day supply (that’s the limit)
->so it is actually a partial fill then, so there is a remainder of 60 pills that can be filled after the 30 days have past
When shall you submit a report to law enforcement?
NOT ON EXAM but may be on the MPJE
-WITHIN 5 days
-if you actually KNOW that a patient has failed to disclose that he has gotten a controlled substance or the prescription for it from another prescriber within the last 30 days
if you don’t know for sure that they knowingly,
willfully and with intent to deceive to obtain the drug -> it doesn’t apply
What are the requirements of an ID when picking up a controlled substance?
not regulated federally, left to the states
-C-II to C-IV (not C-V)
-specific to benzos, zolpidem, barbiturates, and carisoprodol
-if >7-day supply (only need ID if greater than 7d)
-the person who is picking it (doesn’t have to be the patient) needs a governmental ID, insurance card or be personally known (by someone in the pharmacy)
-if homeless or a minor use professional judgement
-doesn’t count for veterinarian prescriptions, drug samples, inpatients, institutional, mail order, and home deliveries
What are the rules regarding Buprenorphine +/- naloxone in Tennessee?
can only be prescribed for an FDA-approved use:
-for sublingual tablets/fils: opioid use disorder
When is the use of Buprenorphine monotherapy (without naloxone) appropriate in Tennessee?
-pregnant patients
-nursing patients
-documented adverse reaction/hypersensitivity to naloxone
-direct administration by healthcare provider
NPs and Physician assistants can prescribe buprenorphine + naloxone in TN. T/F
Yes with multiple requirements
-must be employed by a mental health center
-has to have a supervising physician
-max 100 patients
-has to discuss tapering once a year
-no monotherapy (has to be with naloxone)
NPs and Physician assistants can prescribe buprenorphine + naloxone outside of an opiate treatment center in TN. T/F
Yes with restrictions
can also prescribe in a hospital - again with restrictions
Are Non-residential office-based opioid treatment centers allowed to dispense buprenorphine?
Yes, and pharmacies too
if a pharmacy delivers to an opioid treatment center they shall report to the Department of health about the quantity delivered
Who makes the decision of scheduled drugs in Tennessee?
Commissioner of Mental Health and Substance Abuse Services (with support of Commissioner of Health)
Which schedule is Gabapentin in Tennessee?
C-V
Which drugs are in C-VI (6) in Tennessee?
-Marijuana (federal its C-I)
-THC
-Synthetic equivalents to substances contained in Cannabis plant
Which drugs are in C-VII (7) in Tennessee?
Butyl nitrite and isomers thereof
When is it not allowed to prescribe, distribute, sell, order, or supply anabolic steroids?
-enhancing performance in sports
-hormonal manipulation to increase muscle mass, strength or weight without medical need
doesn’t say anything about dispensing
What is the equivalent of the federally scheduled listed chemical products (SLCPs) in Tennessee?
Immediate Methamphetamine Precursors
-Ephedrine, pseudoephedrine or phenylpropanolamine, or their salts, isomers or salts of isomers
-or any drug that contains a detectable quantity of ephedrine, pseudoephedrine or phenylpropanolamine or their salts
When does pseudoephedrine doesn’t have to be kept behind the counter in Tennessee?
if t is in an abuse-deterred formulation
What are the maximum limits of pseudoephedrine that can be sold in Tennessee?
-3.6g daily (same as federally)
7.2g per 30 days (federally it is 9g)
-43.2g per 1 year
-> only for OTC products
-> you can dispense whatever the Rx says
Which drugs require the pharmacist for counseling in Tennessee?
Immediate Methamphetamine Precursors
like pseudoephedrine
pharmacist or intern under the supervision of the pharmacist (not the tech)
What does a patient need to bring in order to buy pseudoephedrine?
valid government-issued ID
What information of the customer must be obtained when selling pseudoephedrine in Tennessee?
Purchaser’s name
Purchaser’s address
Product name
Product quantity
Date and time
ID type and number
Seller ID
Where should Immediate Methamphetamine Precursors be stored in Tennessee?
-BTC
OR
-in a locked cabinet in view of and within 25 feet
of the counter
Who owns the data of purchasers who buy pseudoephedrine?
NPLEx: can be seen by pharmacists, healthcare professionals, and law enforcement
-can get an exemption for electronic records
-data must be updated every 24h
-there is a stop alert if the purchaser is over the maximum -> don’t sell
we can’t see how much exactly they have purchased - only that it is over the maximum
When is it allowed to sell Dextromethorphan-containing products?
-older than 18
-emancipated minor
-Need a valid, government-issued, photo ID for proof of age, unless the individual looks at least 30
-Not applicable if the patient has a prescription
