PUBLIC HEALTH ADVISORY CONCERNING FENTANYL AND FENTANYL-LACED SUBSTANCES

Board of Pharmacy

 Legislative Update - 2015

Public Chapter 82

This act prohibits the sale of products containing dextromethorphan to persons less than 18 years of age.

Public Chapter 293

This act allows the board of pharmacy to regulate and license third party logistics providers with regard to controlled substances.

Senate Bill 98/House Bill 87

This act allows would allow the Commissioner of Health or his designee to have electronic access to medical records in order to facilitate investigations when responding to an immediate threat to public health. Today the Commissioner of Health or his designee already has this authority but must go to the facility to review the medical records.

Public Chapter 94

This act defines “abuse” and “neglect” for purposes of placing a person on the registry of persons who have abused, neglected, or misappropriated the property of vulnerable individuals specifically within the statutes that govern the Dept. of Health. It does not impact the definitions within the statutes that govern the Dept. of Intellectual and Developmental Disabilities nor the Dept. of Human Services.  It also increases the time within which placement on the registry may be appealed from 30 to 60 days.

Public Chapter 59

This act changes the limits and the identification requirements for products that may be sold containing ephedrine or pseudophedrine. This applies to their salts, isomers and salts of isomers as well.

Public Chapter 26

This legislation deletes the Intractable Pain Act.  This becomes effective on July 1, 2015.

Public Chapter 352

This legislation would decriminalize the possession of cannabis oil as long as all of the following are met:

The oil contains less than 0.9% of THC and is labeled as such by the manufacturer
The person in possession retains proof of the legal order or recommendation from the issuing state
The person in possession retains proof that the person or person’s family member has been diagnosed with intractable seizures or epilepsy by a physician licensed to practice in TN

This legislation does not allow a physician in TN to prescribe, order or recommend the oil. 

This act became effective on April 16, 2015.

Public Chapter 40

This act allows pharmacies to participate in pharmacy drug disposal programs. This act will require rulemaking form the board.

Public Chapter 502

This act allows the Joint Government Operations Committee (the legislative committee that reviews all rules) to stay a rule up to 75 days instead of 60 days.  Present law authorizes the Joint Government Operations Committee to consider the following factors when reviewing rules: authority, clarity, consistency, justification, necessity and reference. This act adds arbitrariness and capriciousness as two new considerations.

Public Chapter 376

This creates the “Tennessee Right to Try Act.” It authorizes eligible patients to utilize investigational drugs, biological products or devices that have completed phase 1 of a clinical trial, but has not yet been approved for general us by the FDA. The clinical trial must be documented by the National Institutes of Health.  An eligible patient is:

someone with an advanced illness that is attested to by the patient’s treating physician and confirmed by a second physician
has considered all other FDA-approved treatment options
has received a recommendation from the patient’s physician for an investigational drug, biological product, or device
has given written, informed consent for the use of an investigational drug, biological product, or device
has documentation from such physician that the patient meets all the aforementioned requirements.

All expenses related to the use of investigational treatment will be borne by the patient.  Manufacturers are authorized to make investigational products available to patients with or without compensation.  This bill specifically prohibits Medicare or any licensing board from taking any adverse action against a licensee based solely on a recommendation for treatment with an investigational product and holds manufacturers and providers harmless if operating in good faith.  This act takes effect on July 1, 2015.

Public Chapter 396

This creates the “Addiction Treatment Act of 2015.”  It prevents certain criminal drug charges from being filed against an individual who is experiencing a drug overdose or is in the company of an individual who is experiencing a drug overdose and seeks or is the subject of a request for medical assistance.  Any such person is immune to penalties for a violation of a permanent or temporary protective order or restraining order or sanctions for a violation of a condition of pretrial release, condition of probation, or condition of parole based on a drug violation.  This immunity does not provide protection against seizure of any evidence or contraband, limit the admissibility of any evidence in connection with the investigation or prosecution of a crime for an individual who doesn’t qualify for the aforementioned exemptions, or limit the authority of a law enforcement officer to detain or take into custody a person in the course of an investigation or to effectuate an arrest for any offense not immune by the aforementioned exemptions.  This immunity only applies to the person’s first such drug overdose.

This bill further mandates that only M.D.’s or D.O.’s are permitted to prescribe buprenorphine for opioid dependence and it may only be prescribed for uses recognized by the FDA unless the patient has a documented opiate addiction, receives treatment from a DEA registered addiction treatment practice, and is counted as one of the total allowable number of patients the provider is allowed to treat.  Only pregnant women, nursing mothers, or patients with a hypersensitivity to naloxone may be prescribed buprenorphine mono.  These provisions do not apply to perioperative surgery or ventilator sedation performed in a licensed facility, or to inpatients and outpatients of a hospital.

The BME and the BOE are required to promulgate rules establishing requirements for licensees to qualify as addiction specialists. 

This act takes effect on July 1, 2015.

Public Chapter 268

This act makes disclosures of protected healthcare information permissible in medical malpractice lawsuits and became effective on April 24, 2015.

Public Chapter 371

This act defines biological product and interchangeable biological product and allows their use under all circumstances unless:

An adverse reaction has previously taken place
The interchangeable has been previously deemed ineffective
Any other clinically based prescriber determined need or the interchangeable biologic is not available

When prescriber determines biological is medically necessary he/she must  

Place these instructions on the prescription showing intent in writing
If orally the prescriber must alert the pharmacist
An electronic communication between prescriber and pharmacist that only the biological product be communicated

When a biologic is issued a pharmacist must

Notify the patient of the substitution on the prescription label

Communication within 5 days to the prescriber by:

Add it to the interoperable electronic medical records system
Communication can be set forth in collaborative pharmacy agreement
That this communication only applies to the original communication and not the refill

Maintain a record of the biologic dispensed

This does not apply if the product if the product is

Is directly dispensed to the patient
Is dispensed in a nursing home or assisted living facility
Vaccines

The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the FDA to be interchangeable.

Public Chapter 261

The act provides for the practice of telehealth. It outlines the following:

Defines a healthcare provider
Establishes a provider-patient relationship by mutual consent and mutual communication
Specifies that telehealth does not create a new standard care
Prohibits any board from creating a more restrictive standard of professional practice for telehealth service
Allows a physician to prescribe by means of telemedicine and follow all prescribing applicable statutes such as checking the Controlled Substance Monitoring Database; however, pain management clinics are not permitted

There is no separate telehealth license required by the Bd of Medical Examiners.

 

 

 

 

 

 

Public Chapter 476

Currently, the top 50 prescribers of controlled substances in the state are annually identified and sent a letter notifying them of their inclusion on this list and asked to respond with a justification for their prescribing patterns.  This legislation expands on this list and requires the top 10 prescribers from all of the combined counties having populations of fewer than 50,000 to also be on this annual list.

Separate from this provision, the bill also specifies that a provider of home medical equipment or services that provides its own company-branded insulin pumps and related supplies does not have to have a physical place of business in the state if the provider maintains an employee presence in the state, is accredited by the Joint Commission on Accreditation of Healthcare Organizations and maintains a 24-7 service telephone number.

This act took effect on April 22, 2015.