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Prescription Safety Act of 2016

By John Williams
SPC Lobbyist

In its continuing war against prescription drug abuse, the Haslam Administration has since 2012 been proposing and passing legislation designed to identify drug-seeking patients and providers that over-prescribe controlled drugs. Chapter 1002 of the Public Acts of 2016, known as the Tennessee Prescription Safety Act, re-wrote the sections of the Code passed in the last four years.

The primary tool is the Controlled Substance Database maintained by the Tennessee Department of Health. The director of the Database will be a pharmacist designated by the Commissioner of Health, in consultation with the Executive Director of the Board of Pharmacy and the Controlled Substance Database Committee.

That Committee is composed of one licensed professional from each of the nine boards regulating a profession which has the authority to prescribe and/or dispense controlled substances, as well as one consumer member from both the Board of Medical Examiners and the Board of Pharmacy. The Commissioner and the Committee have the right to examine the information in the Database “to identify unusual patterns of prescribing, distributing, or dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient type, or location of the healthcare practitioner.” Practitioners who are identified through a review of the information in the Database will be referred to the appropriate licensing board.

The statute describes the purposes of the Database as follows:

1) “to increase the quality of patient care by equipping healthcare practitioners with accurate, timely information that the practitioners can use to determine when patients acquiring controlled substances may require counseling or intervention for substance abuse”; and
2) “to assist in research, statistical analysis, criminal investigations, enforcement of standards of health professional practice, and state or federal laws involving controlled substances.”

All healthcare practitioners who dispense controlled substances must provide the following information to the Database for each controlled substance dispensed:

(A) Prescriber identifier;
(B) Dispensing date of controlled substance;
(C) Patient identifier;
(D) Controlled substance dispensed identifier;
(E) Quantity of controlled substance dispensed;
(F) Strength of controlled substance dispensed;
(G) Estimated days’ supply;
(H) Dispenser identifier;
(I) Date the prescription was issued by the prescriber;
(J) Whether the prescription was new or a refill;
(K) Source of payment; and
(L) Other relevant information as required by rule.

The information must be submitted within one business day. A healthcare practitioner may designate any licensed person and up to two unlicensed persons to act as agents in submitting information to the Database and in checking the Database. The controlled substances to which the reporting requirements apply include all controlled substances in Schedules II-IV and those in Schedule V which have been identified by the Committee as demonstrating a potential for abuse. The following are exceptions to the reporting requirement:

(1) A drug administered directly to a patient;

(2) Complimentary packages of medicinal drugs that are labeled as a drug sample or complimentary drug dispersed to the practitioner’s own patients adequate to treat the patient for a maximum of forty-eight (48) hours in the regular course of practice without the payment of a fee or remuneration of any kind;

(3) A sample of a schedule IV or schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of seventy-two (72) hours or a sample of a non-narcotic schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of fourteen (14) days, provided without charge by a medical doctor, osteopathic physician, advanced practice nurse with certificates of fitness to prescribe, or physician assistant working at a pain management clinic from providing to that practitioner’s patient;

(4) Any drug dispensed by a licensed veterinarian; provided, that the quantity dispensed is limited to an amount adequate to treat the nonhuman patient for a maximum of five (5) days;

(5) Any entity that is registered by the United States drug enforcement administration (DEA) as a narcotic treatment program and is subject to the recordkeeping provisions of 21 CFR 1304.24; or

(6) Any drug dispensed or distributed by a facility; provided, that the quantity dispensed or distributed is limited to an amount that is adequate to treat the patient for a maximum of forty-eight (48) hours.

Healthcare practitioners who prescribe or dispense controlled substances must register with the Database within 30 days after receiving a DEA number.

Information contained in the Database is confidential and not subject to release under the Public Records Act. The information is, of course, available to healthcare practitioners conducting medication history reviews involved in the care of a patient. Healthcare practitioners and their approved agents will be given an identifiable authentication for access to the Database.

Subject to certain restrictions set forth in the law, law enforcement personnel engaged in investigations of possible violations of controlled substance laws will have access to the information in the Database.

When prescribing or dispensing an opioid or benzodiazepine (or other controlled substance designated by the Commissioner or the Committee), a healthcare practitioner or his agent must check the Database “at the beginning of a new episode of treatment” and “at least annually when that prescribed controlled substance remains part of the treatment.” A healthcare practitioner may check the Database when prescribing or dispensing other controlled substances as well.

The only exceptions to the requirement to check the Database when prescribing or dispensing opioids or benzodiazepines are:

(A) The controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care;

(B) The committee has determined that healthcare practitioners in a particular medical specialty shall not be required to check the database as a result of the low potential for abuse by patients receiving treatment in that medical specialty;

(C) 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

(D) 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.

Wholesalers of controlled substances are also regulated by this law. They must report the following information to the Committee:

(1) Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;

(2) Purchaser’s drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;

(3) National drug code number of the actual drug sold;

(4) Quantity of the drug sold;

(5) Date of sale; and

(6) Transaction identifier or invoice number.

Wholesalers must also report “suspicious orders of controlled substances” and “theft or significant loss of controlled substances.”