Tennessee State Regulatory Update April 2019
SB870 Concerning Scheduled Controlled Substances
SECTION 3. Tennessee Code Annotated, Section 63-1-160. By January 1, 2020, all pharmacy dispensing software vendors operating in this state shall update their dispensing software systems to allow for partial filling of controlled substances pursuant to this section and submit documentation of compliance to the board of pharmacy. The board of pharmacy is authorized to act against pharmacy dispensing software vendors for non-compliance with this section. Any pharmacist acting in good faith and with reasonable care in the partial filling of controlled substances is immune from disciplinary or other adverse administrative actions if the pharmacy dispensing software system at the pharmacy at which they dispense is not compliant with this section. Nothing in this section conflicts with or supersedes federal law or drug enforcement administration rules authorizing partial dispensing or partial filling of Schedule II prescriptions for terminally ill or long-term care facility patients, or for partial fill of Schedules III-V controlled substances.
SECTION 10. Tennessee Code Annotated, 63-1-164(b). Except as provided in this section, a healthcare practitioner shall not treat a patient with more than a three-day supply of an opioid and shall not treat a patient with an opioid dosage that exceeds a total of one hundred eighty (180) morphine milligram equivalent dose. A healthcare practitioner shall not be required to include an ICD-10 code on any prescription for an opioid of a three-day supply or less and an opioid dosage of less than one hundred eighty (180) morphine milligram equivalent.
SECTION 11. Tennessee Code Annotated, Section 63-1-164(c). A healthcare practitioner may authorize the prescription to be dispensed by partial fill by placing "partial fill" or "PF" on the prescription.
SECTION 15. Tennessee Code Annotated, Section 63-1-164. This section does not apply to opioids approved by the food and drug administration to treat upper respiratory symptoms or cough.
SECTION 17. SECTION 8 of this act shall take effect July 1, 2019, the public welfare requiring it. All other provisions of this act shall take effect upon becoming a law, the public welfare requiring it.
Public Chapter 675 Requires TDH to Accept Opioid Abuse or Diversion Allegations
Effective January 1, 2019, Public Chapter 675 requires registrants to either provide documentation individually to employees or post a sign concerning the reporting of opioid abuse or diversion to TDH. This sign is required to be posted in a conspicuous but non-public location. The Board is communicating this information to ensure compliance with the law and to improve the reporting of abuse and misuse of opioids to the proper authorities.
The information may be provided to each employee individually in writing, documented by the employing entity, or by posting, in a conspicuous location in a non-public area regularly used by employees, a sign at least eleven inches (11") in height and seventeen inches (17") in width stating:
NOTICE: PLEASE REPORT ANY SUSPECTED ABUSE OR DIVERSION OF OPIOIDS, OR ANY OTHER IMPROPER BEHAVIOR WITH RESPECT TO OPIOIDS, TO THE DEPARTMENT OF HEALTH'S COMPLAINT INTAKE LINE: (NUMBER OF INTAKE LINE)
No employee of an entity that prescribes, dispenses, or handles opioids shall be discharged or terminated solely for reporting information in good faith to the department of health.
No person licensed under this title shall suffer an adverse licensure action solely for reporting information in good faith to the department of health.
A person who reports information in good faith to the department of health is immune from civil liability related to the report.
This act became effective January 1,2019.
What does this mean for pharmacists practicing in the state of Tennessee?
- Pharmacists must be aware of the rules and changes effecting the dispensing of opioid prescriptions and the limitation applied, so that physicians and patients can be provided with information around their pain therapy, and pharmacists can ensure they are practicing within the limits of state law.
- All pharmacies must provide guidance to their employees for reporting opioid abuse or diversion to the department of Health. Staff must be trained how to report, and that protection is provided for those who report.
Tennessee State Regulatory Summary- Nov 2018
Senate Bill 2362 / House Bill 2219 PBM Anti Gag Clause
- Establishes that a pharmacy or pharmacist shall have the right to provide an insured information regarding the amount of the insured's cost share for a prescription drug.
Senate Bill 2257 / House Bill 1831 Controlled Substance Dispensing
Required Dispenser CSMD Checks:
- Requires all dispensers (or their delegates) to check the Controlled Substance Monitoring Database (CSMD) prior to dispensing an opioid or a benzodiazepine the first time that human patient is dispensed a controlled substance at that practice site.
- Requires all dispensers (or their delegates) to check the CSMD again at least once every six (6) months for that human patient after the initial dispensing, for the duration of time the controlled substance is dispensed to that patient.
Opioid Prescriptions Written for 3-Day Supply or Less:
- No required CSMD checks for prescribers or dispensers
- No additional documentation requirements or partial fill restrictions
- ICD-10 Codes are not required to be written on prescriptions
- Maximum of 180 cumulative morphine milligram equivalents (MME)
Non-Exempt Opioid Prescriptions:
- Must be partially filled with no more than a 5-day supply (for a 10-day prescription), or partially filled with no more than half the prescribed day supply limit (for prescriptions written for more than 10 days)
- ICD-10 Codes (and "medical necessity" or "surgery", if applicable) must be written on all non-exempt opioid prescriptions
General script limits: No more than a 10-day supply and a maximum of 500 cumulative MME
Surgery: No more than a 20-day supply and a maximum of 850 cumulative MME
Medical necessity: No more than a 30-day supply and a maximum of 1,200 cumulative MME
Exempt Opioid Prescriptions:
- Partial fill requirements do not apply
- MME limits do not apply
- ICD-10 Codes and "Exempt" must be written on all Exempt Opioid Prescriptions
- Exempt conditions: active or palliative cancer treatment, hospice care, diagnosis of Sickle Cell Disease, inpatients of a licensed healthcare facility, patients seen by pain management specialists, patients treated with opioids for 90 days or more in the last year OR who are subsequently treated for 90 days or more, patients on methadone, buprenorphine, or naltrexone, or patients with severe burns or major physical trauma
Senate Bill 2258 / House Bill 1832
Adds Gabapentin as a Schedule V Controlled Substance
Senate Bill 2025 / House Bill 2440 Partial Filling of Controlled Substances
(January 1, 2019 for Opioids; July 1, 2019 for all others)
- Authorizes the partial filling of a controlled substance if the partial fill is requested by the patient or the practitioner who wrote the prescription and the total quantity dispensed through partial fills does not exceed the total quantity prescribed for the original prescription.
- Requires the pharmacist to retain the original prescription at the pharmacy where the prescription was first presented and the partial fill dispensed, and any subsequent fill shall occur at the pharmacy that initially dispensed the partial fill within thirty (30) days from issuance of the original prescription.
- Requires the pharmacist to notify the prescriber of the partial fill and of the amount actually dispensed.
- Requires any person who presents a prescription for a partial fill to pay the prorated portion of cost sharing and copayments.
- Authorizes a pharmacist or pharmacy to charge a dispensing fee to cover the actual supply and labor costs associated with the dispensing of the original prescription for a controlled substance and each partial fill associated with the original prescription.
Senate Bill 1670 / House Bill 1695 Dispensing by Pharmacists in Emergency Situations
- Authorizes a pharmacist in this state, in good faith, to dispense to a patient without proper authorization or a valid prescription, the number of dosages of a prescription drug necessary to allow the patient to secure proper authorization or a valid prescription from the patient's prescriber.
- Prohibits the amount of the prescription drug being dispensed from exceeding a 20-day supply.
- Allows prescription information to be obtained from a prescription label, verbal medical order, verbal prescription order, or any other means determined to be legitimate in the professional judgment of the pharmacist.
Senate Bill 2191 / House Bill 1993 Electronic Prescribing of Controlled Substances (effective January 1, 2020)
- Requires certain prescriptions for a Schedule II controlled substance to be made as an electronic prescription from the person issuing the prescription to a pharmacy.
- Requires the name, address, and telephone number of the collaborating physician of an advanced practice registered nurse or physician assistant to be included on the electronic prescription.
What do these new regulations mean for pharmacists practicing within the state of Tennessee?
- Pharmacists can provide a partial fill for a controlled substance upon a patient or practitioner's request, ensure that all rules are followed, and that standard operating procedure reflect proper documenting and dispensing procedures.
- Ensure that all software and dispensing systems can accept electronic prescriptions for controlled substances by 7/1/2020.
- All pharmacists must review the revisions to the controlled substance list and regulations and ensure that all medications that are now included in the above rule are handled per state and federal CDS guidelines regarding dispensing, recordkeeping.
- Pharmacists can provide emergency prescriptions for certain medications to avoid an interruption in critical therapy for the patient, in the event that the prescriber cannot be contacted for authorization.
- Pharmacists can discuss price savings options with patients, including cash options, without penalty from the PBM. This can help with patient expenditure, and promote therapy initiation and adherence.
Tennessee State Regulatory Summary- 2018
The following laws, summarized below, were enacted by the Tennessee legislature during the 2018 session.
HB 2440 / SB 2025
- Authorizes a partial fill of a prescription of a controlled substance. Effective July 1, 2019.
- A prescription for a controlled substance may be partially filled if:
- The partial fill is requested by the patient or the practitioner who wrote the prescription; and
- The total quantity dispensed through partial fills does not exceed the total quantity prescribed for the original prescription.
- If a partial fill is made, the pharmacist shall retain the original prescription at the pharmacy where the prescription was first presented and the partial fill dispensed.
- Any subsequent fill shall occur at the pharmacy that initially dispensed the partial fill. Any subsequent fill shall be filled within thirty (30) days from issuance of the original prescription.
SB 2191 / HB 1993
- Requires health care prescribers to issue prescriptions for Schedule II controlled substances electronically by July 1, 2020.
HB 1832 Controlled Substance law revisions
- Revises various provisions of law regarding the scheduling of controlled substances and their analogues and derivatives, including updated identifications of drugs categorized in Schedules IV.
What do these new regulations mean for pharmacists practicing within the state of Tennessee?
- Pharmacists can provide a partial fill for a controlled substance upon a patient or practitioner's request, ensure that all rules are followed, and that standard operating procedure reflect proper documenting and dispensing procedures.
- Ensure that all software and dispensing systems can accept electronic prescriptions for controlled substances by 7/1/2020.
- All pharmacists must review the revisions to the controlled substance regulations and ensure that all medications that are now included in the above rule are handled per state and federal CDS guidelines regarding dispensing, recordkeeping.
For full regulatory language, refer to the Tennessee Board of Pharmacy.
