What does the Board require as far as being able to dispense controlled substances? Is being a DEA registrant sufficient?
Shall obtain a registration issued by the board of pharmacy
Must each place of business register, or is one registration sufficient for multiple chain pharmacies, for example?
Separate registration is required at each principal place of business or professional practice
What does the TCA say about dispensing C-IIs without a written prescription? Is it allowed? If so, under what circumstances?
- No CIIs dispensed without electronic Rx except:
a. Emergency situations (defined by federal law)
b. Dispensed directly by prescriber to ultimate user
c. Exceptions covered under TCA 63-01-160
How many refills are authorized on C-III and C-IV medications? How about C-Vs? How long are prescriptions “good” or valid?
- CIII and CIV: no more than FIVE (5) refills
a. Rx good for SIX (6) months from date of issue - CV: ELEVEN (11) refills
a. Rx good for ONE (1) year from date of issue
What is the maximum amount of opioid medications that can be issued by a prescriber at one time? How about benzodiazepines? How about stimulants?
No limits on how many can be issued
What is the maximum amount of opioid medications that can be dispensed by a pharmacist at one time? How about benzodiazepines?
Opioids and BZD: Cannot dispense in quantities greater than a 30 days supply
What must a prescriber do if (s)he dispenses opioids, BZDs, carisoprodol, or barbiturates?
Submit to CSMD
What must a patient disclose to a prescriber specific to controlled substances previously received?
If the person has received either the same controlled substance or a controlled substance of similar therapeutic use from another practitioner within the previous thirty days
If a pharmacist has actual knowledge about a patient attempting to obtain controlled substances in an illegal manner, what steps is (s)he to take? When?
Submit a report to local enforcement within five (5) business days of obtaining such knowledge
What are the ID requirements when dispensing opioids, BZDs, zolpidem, barbiturates, or carisoprodol? When does the requirement apply? What if a patient is known to the pharmacist?
- Specific to CII, CIII, CIV opioids, benzos, zolpidem, barbiturates, and carisoprodol >7 day supply
a. Present valid government issued ID or insurance card (OR be personally known)
b. If homeless and/or a minor, use professional judgment
c. Excludes vet prescriptions, drug samples, inpatients, institutionalized, mail order, and home deliveries
Can buprenorphine tablets be prescribed for the treatment of pain in TN?
NO. This is an off-label use. In TN, this can only be prescribed for FDA-approved use which is opioid dependence
When can buprenorphine monotherapy be legally prescribed for patients with SUDs?
BUP only is limited to pregnant or nursing patients, having adverse rxn to naloxone, or direct admin by healthcare provider
Can NPs and PAs prescribe buprenorphine in TN? If so, what are the stipulations?
- If employed under a community mental health center or FQHC that employs 1 or more physicians who adopted clinical protocols for MAT
a. If facility takes TennCare pts
b. Max 4NP or 4PA per supervising physician
c. 100% chart review
d. Max 50 patients being prescribed BUP at any one time
e. No mono product; max dose: 16mg daily - If employed under nonresidential office-based opiate tx facility
a. Facility takes TennCare patients
b. Max of 2 NP/PA per physician
c. Max 100 pts being prescribed at any one time
d. No mono product; max dose 16mg daily
What are the requirements if a practitioner in TN is prescribing more than 16 mg/day of buprenorphine to a patient? More than 20 mg/day?
- > 16mg/day for 30+ consecutive days; requires documentation of need for high dose
- > 20mg/day for 30+ consecutive days; recommended addiction specialist consult
Can pharmacies sell (distribute) buprenorphine products to nonresidential office-based opiate treatment facilities? What reporting responsibilities does a pharmacy have?
Report to DOH the quantities of BUP that is delivered to nonresidential office-based opiate treatment facilities
What is the definition of “dispense”?
To deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery
What is the definition of “dispenser”?
A practitioner who dispenses
What is the definition of “distribute”?
To deliver other than by administering or dispensing a controlled substance
What is the definition of “immediate methamphetamine precursor”?
Ephedrine, pseudoephedrine or phenylpropanolamine, or their salts, isomers or salts of isomers, or any drug or other product that contains a detectable quantity of ephedrine, pseudoephedrine or phenylpropanolamine, or their salts, isomers or salts of isomers
What is the definition of “marijuana”?
- Means all parts of the plant cannabis, whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, including concentrates and oils, its seeds or resin
- “Marijuana” does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, except the resin extracted from the mature stalks, fiber, oil, or cake, or the sterilized seeds of the plant which are incapable of germination;
- “Marijuana” also does not include hemp, as defined in § 43-27-101;
- The term “marijuana” does not include a product approved as a prescription medication by the United States food and drug administration. Such product shall be designated, rescheduled, or deleted as a controlled substance pursuant to § 39-17-403;
- The term “marijuana” does not include cannabis oil containing the substance cannabidiol, with less than six tenths of one percent (0.6%) of tetrahydrocannabinol, including the necessary seeds and plants, when manufactured, processed, transferred, dispensed, or possessed by a four-year public or private institution of higher education certified by the drug enforcement administration located in the state as part of a clinical research study on the treatment of intractable seizures, cancer, or other diseases; and
- The term “marijuana” does not include oil containing the substance cannabidiol, with less than nine-tenths of one percent (0.9%) of tetrahydrocannabinol, if:
(i)
(a) The bottle containing the oil is labeled by the manufacturer as containing cannabidiol in an amount less than nine-tenths of one percent (0.9%) of tetrahydrocannabinol; and
(b) The person in possession of the oil retains:
(1) Proof of the legal order or recommendation from the issuing state; and
(2) Proof that the person or the person’s immediate family member has been diagnosed with intractable seizures or epilepsy by a medical doctor or doctor of osteopathic medicine who is licensed to practice medicine in this state; or
(ii)
(a) The bottle containing the oil is labeled by the manufacturer as containing cannabidiol in an amount less than nine-tenths of one percent (0.9%) of tetrahydrocannabinol on a printed label that includes the manufacturer’s name and the expiration date, batch number or lot number, and tetrahydrocannabinol concentration strength of the oil; and
(b) The person in possession of the oil retains:
(1) Proof of the legal order or recommendation from the issuing state;
(2) Proof that the person or the person’s immediate family member has been diagnosed with at least one (1) of the following diseases or conditions by a medical doctor or doctor of osteopathic medicine who is licensed to practice medicine in this state:
(A) Alzheimer’s disease;
(B) Amyotrophic lateral sclerosis (ALS);
(C) Cancer, when such disease is diagnosed as end stage or the treatment produces related wasting illness, recalcitrant nausea and vomiting, or pain;
(D) Inflammatory bowel disease, including Crohn’s disease and ulcerative colitis;
(E) Multiple sclerosis;
(F) Parkinson’s disease;
(G) Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
(H) Sickle cell disease; or
(I) Quadriplegia; and
(3) Proof that the person or the person’s immediate family member has a valid letter of attestation, as defined in § 68-7-101
What is the definition of “narcotic drug”?
- Means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
a. Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;
b. Any salt, compound, isomer, derivative, or preparation thereof that is chemically equivalent or identical with any of the substances referred to in subdivision (17)(A), but not including the isoquinoline alkaloids of opium;
c. Opium poppy and poppy straw; and
d. Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof that is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves that do not contain cocaine or ecgonine
What is the definition of “opiate”?
Any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. “Opiate” does not include, unless specifically designated as controlled under § 39-17-403, the dextrorotatory isomer of 3-methozy-methyl-morphinan and its salts (dextromethorphan). “Opiate” does not include its racemic and levorotatory forms.
What is the definition of “pharmacist”?
A licensed pharmacist as defined by the laws of this state, and where the context so requires, the owner of a store or other place of business where controlled substances are compounded or dispensed by a licensed pharmacist; but nothing in this part or title 53, chapter 11, parts 3 and 4 shall be construed as conferring on a person who is not registered or licensed as a pharmacist any authority, right or privilege that is not granted to that person by the pharmacy laws of this state
What is the definition of “practitioner”?
- A physician, dentist, optometrist, veterinarian, scientific investigator or other person licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in this state; or
- A pharmacy, hospital or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in this state
