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TN Together, Governor Haslam’s program to curb the opioid epidemic, resulted in massive changes in dispensing limits, which took effect on July 1, 2018. During the 2019 legislative session, TPA advocated for important changes to this new law. These changes, which are in Public Chapter 124, took effect on April 9, 2019. Included below are links to reference materials, flow charts, and opioid conversion tables, to help guide implementation of the new law, as well as changes to the law.

Important Links and Resources:

• CDC Pharmacists Brochure
• CDC Opioid Sheet for Patients
• CDC Opioid Guideline Mobile App
• TPA Practice-Based Resource Page
• Centers for Disease Control and Prevention (CDC) Clinical Tools
• Drug Enforcement Administration (DEA) Pharmacist’s Manual
• NABP “Red Flags” Video
• Stepwise Approach Graphic (‘Decision Tree’; updated 4/17/19)
  
• MME Conversion Sheet (Updated 4/12/19)
  
• Key Aspects of TN Together (Updated 4/12/19)
  
• Important Changes to New Legislation (NEW! Added 4/12/19)
  
• Outline of Changes with Passage of Public Chapter 124 on 4/9/19 (New! Added 4/12/19)
• Detailed Summary of Changes with Passage of Public Chapter 124 on 4/9/19 (New! Added 4/12/19)
  

Pharmacists have multiple and complex roles, including reviewing and managing patients’ medication therapies, evaluating new prescription orders as well as concurrent treatments, determining whether medications are appropriately prescribed, and assessing prescription orders for potential forgery or alteration. Pharmacists work every day to:

• Assess. Look for “red flags” that indicate patients might be struggling with opioid use disorder or diverting medications.
• Verify. Validate prescriber DEA registration and patient identification.
• Consult. Check the prescription drug monitoring program (Tennessee Controlled Substance Monitoring Database, or CSMD) as well as the patient record.
• Communicate. Contact the prescriber with questions or concerns, talk to the patient, and submit information to the CSMD.
• Tennessee CSMD Data Collection Manual

To learn more about pharmacists’ roles, read “Pharmacists on the Front Lines: Addressing Prescription Opioid Abuse and Overdose,” a brochure created by CDC.

The DEA warns pharmacists to address and resolve “red flags” that may raise a reasonable suspicion as to the validity of a prescription. Common “red flags” may include:

• Customers requesting brand names by slang terms (“the Ms” or “the Blues”)
• Pattern prescribing, i.e., multiple individuals presenting prescriptions for the same drugs, for the same or similar quantities, and from the same prescriber
• Distance anomalies, i.e., patient and prescriber are in different locations from each other
• People who are not regular patrons or residents of the community showing up with prescriptions from the same prescriber
• Shared addresses by customers presenting the same or similar prescriptions from the same prescriber on the same day
• Family members receiving prescriptions from the same prescriber
• An action against the prescriber by state regulatory boards and/or law enforcement relating to the issuance of controlled substance prescriptions
• A prescription that indicates the customer has been “practitioner shopping” (multiple prescribers at one time)
• Cash payments (in combination with other circumstances)

For more information, watch “Red Flags,” a video created by the National Association of Boards of Pharmacy (NABP) and the Anti-Diversion Industry Working Group (ADIWIG) to help pharmacists identify the warning signs of prescription drug abuse and diversion.

While it is up to the prescribing practitioner to prescribe a controlled substance for legitimate medical purposes, the Drug Enforcement Administration (DEA) also establishes that a corresponding responsibility lies with the pharmacist who fills the prescription. According to Title 21, Section 1306.04 of the DEA’s Code of Federal Regulations, “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment […] and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”

If you find yourself in a situation where you are suspicious of the validity of a prescription for a controlled substance, the following are some steps you can take to make a decision based on your professional judgment:

• Talk to your patient.
• Speak to the prescriber and inquire about dependence and withdrawal.
• Document all correspondence with the prescribing practitioner and office.
• Check the Tennessee Controlled Substance Monitoring Database (CSMD).
• Talk with other pharmacists in your area.
• Verify the prescriber’s DEA registration number, office address and telephone number.
• Pay attention to local, state, and national news.
• Utilize care contracts with patients.
• Establish and implement practice site policies and procedures.
• Report suspicious activity to your local DEA Office.

Pharmacists are required to report any known or suspected TennCare fraud or abuse by the methods explained on the fOffice of Inspector General’s website. If in doubt, rely on your professional judgment.

Pharmacists who have actual knowledge that a person has knowingly, willfully and with intent to deceive obtained or attempted to obtain a controlled substance (“doctor shopping”) must report that information within five (5) business days to the local law enforcement agency. The form to report “doctor shopping” can be found here. Pharmacists can contact your nearest law enforcement agency and/or the Meth and Pharmaceutical Task Force at 423-752-1479, or fax the completed form to 423-267-8983.

Here are some additional Helpful Links and Resources for Healthcare Professionals. For more resources relating to controlled substance diversion, including how to submit a tip to the DEA online, visit the DEA’s Diversion Control Division website.

All healthcare practitioners who prescribe or dispense controlled substances in practice providing direct care to patients in this state by prescribing or dispensing on more than fifteen (15) days in a calendar year total and are required to have a federal drug enforcement administration (DEA) registration pursuant to federal law shall be registered in the Tennessee Controlled Substance Monitoring Database (CSMD). Healthcare practitioners or their agents shall have up to thirty (30) calendar days after receiving a DEA number to register in the database; such privilege shall apply equally to both prescribers and dispensers.

For pharmacists seeking to query a patient’s prescription history, registering to become a user on the CSMD website may be accomplished by navigating to www.TNCSMD.com, clicking on “Register,” and providing all required information. New practitioners must register within 30 days of notification of licensure.

Frequently Asked Questions about the Tennessee CSMD

Tennessee Department of Health’s CSMD webpage

All pharmacists are required to check the Tennessee Controlled Substance Monitoring Database (CSMD) before dispensing an opioid or benzodiazepine to a human patient the first time at that practice site and at least once every twelve (12) months for that human patient after initial dispensing. A pharmacist’s delegate (i.e., pharmacy technician or intern) registered with the CSMD may check the database on behalf of the pharmacist.

However, pharmacists are not required to check, pursuant to statute, if:

1. the controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care;
2. the Controlled Substance Database committee has determined that healthcare practitioners in a particular medical specialty do not have to check as a result of the low potential for abuse by patients receiving treatment in that medical specialty;
3. the quantity of the controlled substance which is prescribed or dispensed does not exceed an amount which is adequate for a single, seven-day treatment period and does not allow a refill; OR
4. the controlled substance is prescribed for administration directly to a patient during the course of inpatient or residential treatment in a hospital or nursing home licensed under Title 68.

Before dispensing, a pharmacist is also required to check the database if he or she is aware or reasonably certain that a person is attempting to obtain a Schedule II-V controlled substance, identified by the Controlled Substance Database committee or the commissioner of the Tennessee Department of Health as demonstrating a potential for abuse, for fraudulent, illegal, or medically inappropriate purposes, in violation of Tennessee Code Annotated § 53-11-402.

Each healthcare practitioner or healthcare practitioner’s agent shall, regarding each controlled substance dispensed, submit to the database all of the following information:

• Prescriber identifier;
• Dispensing date of controlled substance;
• Patient identifier;
• Controlled substance dispensed identifier;
• Quantity of controlled substance dispensed;
• Strength of controlled substance dispensed;
• Estimated days’ supply;
• Dispenser identifier;
• Date the prescription was issued by the prescriber;
• Whether the prescription was new or a refill;
• Source of payment; and
• Other relevant information as required by rule.

The information in the database shall be submitted by a procedure and in a format established by the Controlled Substance Database committee, for each business day but no later than the close of business on the following business day.

Any healthcare practitioner or healthcare practitioner delegate receiving patient-specific information pursuant to subdivision (a)(1), (a)(2), (a)(3), or (a)(4) shall not disclose the information to any person other than:

• The patient to whom the information relates;
• Other healthcare practitioners who are involved or have a bona fide prospective involvement in the treatment of the patient, or healthcare practitioners identified by the information for the purpose of verifying the accuracy of the information;
• Any law enforcement personnel to whom reporting of controlled substances being obtained in a manner prohibited by Tennessee Code Annotated § 53-11-401, or § 53-11-402(a)(3) or (a)(6), is required by § 53-11-309, or any agent of the healthcare practitioner who is directed by the healthcare practitioner to cause a report to law enforcement to be made in accordance with § 53-11-309(a) and (d); or
• A healthcare practitioner or healthcare practitioner delegate who may place a copy of a patient’s report obtained from the database pursuant to this section in that patient’s medical records. Once placed in a patient’s medical records, any copy of a patient’s report obtained from the database pursuant to this section shall be subject to disclosure on the same terms and conditions as medical records under §§ 63-2-101 and 63-1-117.

When assessing a prescription for appropriate prescribing or potential forgery or alteration, maintaining an open line of communication between pharmacists and prescribers is vital.

Pharmacists and prescribers share a common goal of ensuring safe and effective treatment for patients. Pharmacists and prescribers should apply the Guideline and work collaboratively to optimize pain management while preventing opioid abuse and overdose. Establishing and maintaining collaborative working relationships improves patient outcomes.

In the instance of opioid prescribing, the CDC Guideline for Prescribing Opioids for Chronic Pain emphasizes patient safety and encourages prescribers and pharmacists to collaborate in integrated pain management and team-based practice models. Along with the CDC’s guidelines, pharmacists should be familiar with Tennessee’s Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain.

Pharmacists may also utilize risk assessment tools to screen patients for opioid addiction risk. These assessment tools can be used to help guide clinicians on prescribing opioid therapy. The tools are merely aids and should not replace clinical judgment. The most commonly used tool is the Opioid Risk Tool.

As pharmacists, it is imperative to recognize that Tennessee state law protects your professional judgment and your right to refuse to dispense a medication under the conditions below. Tennessee Code Annotated § 53-10-112 states, “A pharmacist shall, by utilizing education, skill, experience and professional judgment, make every reasonable effort to prevent the abuse of drugs which the pharmacist dispenses. In doing so, a pharmacist may decline to dispense to a patient a legend drug which in that pharmacist’s professional judgment, lacks a therapeutic value for the patient or which is not for a legitimate medical purpose.”

If you find yourself in such a scenario, remember that communication is key. Be honest with the patient, don’t blame them, and make sure to let them know that you are there to help.

Oftentimes, because of the trust that patients place in pharmacists, they will come to you for help. Whether for substance abuse, suicide prevention, or other mental health services, it is important for pharmacists to know where to find resources to help patients seeking assistance:

• Tennessee Department of Mental Health and Substance Abuse Services
• Substance Abuse and Mental Health Services Administration (SAMHSA) Help and Treatment Resources

Click here to search the Tennessee Department of Health’s website for a list of licensed pain management clinics.

1. Under Current Search, select “Pain Management Clinics” in the first drop-down menu
2. In the Select-a-County drop-down menu, select “ALL” or a specific county
3. In the Facility Name drop-down menu, search by specific name if applicable

Click here to access TPA’s resource on statewide naloxone collaborative pharmacy practice. Naloxone education for pharmacists can be found here.

The Tennessee Pharmacy Recovery Network, administered through the Tennessee Pharmacists Research and Education Foundation (TPREF), is a resource for pharmacists, pharmacy technicians, and student pharmacists who are in need of assistance and advocacy related to chemical dependency or other sources of impairment. To access the TPRN program online and to learn more about how TPRN works to provide advocacy and support on behalf of impaired pharmacy professionals, click here.

The Tennessee Department of Environment and Conservation sponsors seasonal household hazardous waste collection events for residents. Sharps hazardous waste collected must be in a puncture-proof container.

For a list of community sharps disposal locations, click here. If there are no sharps disposal programs in the patient’s area, patients are encouraged to adhere to the U.S. Food & Drug Administration guidelines for safe needle disposal.

If your patients do not have an FDA-approved container, guidelines suggest placing used needles in a household container such as a laundry detergent or bleach bottle, or a sturdy opaque plastic container with a screw-top lid. When the container is ¾ full, the patient should seal the lid with duct tape, label the container “DO NOT RECYCLE,” and place it in their regular trash.

Below are just a few of the many educational resources to assist pharmacists and patients in combatting prescription drug abuse:

• Cardinal Health Generation Rx: Generation Rx is a program created by Ohio State University and Cardinal Health. Generation Rx provides information about drug abuse and the potential dangers of misusing prescription medications, including resources that target school-aged kids, adults, seniors, and patients.
• National Institute on Drug Abuse
• Above the Influence
• Partnership for Drug Free Kids
• Count It! Lock It! Drop It! Campaign