The following is a recap of the recent activities of the Tennessee Board of Pharmacy. TPA staff has compiled the following subjective review of important topics for members.
DECEMBER 2015 RULEMAKING HEARING
The Tennessee Board of Pharmacy met on December 18, 2015, regarding their proposed rule changes. TPA provided the Board with comments relative to these rules. The complete copy of the Proposed Rules can be found on the Tennessee Secretary of State’s website by CLICKING HERE. The Board amended and adopted these proposed rules during their December 18 hearing. The minutes from this meeting can be found by CLICKING HERE. The amended rules will now be sent to the Attorney General’s office for review and approval. This process may take several weeks to months, and TPA will let members know when the final rules have been assigned an effective date.
BOARD OF PHARMACY AND CONTROLLED SUBSTANCE DATABASE AUDIT
On October 20, 2015, the Tennessee Comptroller of the Treasury office released a performance audit report on the Board of Pharmacy and Controlled Substance Database. The audit revealed seven different findings and five observations. Two of the findings dealt directly with the Board of Pharmacy, including the inability of the licensing system to track and monitor the licensing process, and the Board of Pharmacy’s lack of a formal relationship with its recommended peer assistance recovery network (Tennessee Pharmacists Recovery Network). Three of the findings dealt with the Controlled Substance Monitoring Database, while the other two findings were purely administrative in nature.
For a copy of the full report, please CLICK HERE.
Prescription Misfills Involving Look-Alike/Sound-Alike Medications
Several complaints were generated as a result of pharmacists dispensing incorrect medications to patients. In almost all instances, one drug was mistakenly filled for another.
Tips and Resources regarding prescription misfills:
- The Institute for Safe Medication Practices (ISMP) has many practice-based resources on their website, including commonly confused drug names andcommunity pharmacy medication safety tools and resources.
- Pharmacies are strongly encouraged, and often are required through contracts or regulations, to implement and maintain a quality improvement / quality assurance process focused on increasing quality and patient safety. For pharmacies that do not currently have a quality improvement process in place, the Tennessee Pharmacists Association (TPA) recommends Pharmacy Quality Commitment as a program to help pharmacists identify, collect, and report Quality-Related Events (QREs) (i.e., medication errors that reach the patient, “near misses” and unsafe conditions) and analyze the process to improve workflow and decrease harmful QREs.
- The Tennessee Center for Patient Safety (TCPS), a subsidiary of the Tennessee Hospital Association, has also formed the Tennessee Pharmacists Coalition, consisting of pharmacists in health-system settings working on advancing the adoption of proven evidence-based strategies that improve the reliability, safety, and quality of care received in Tennessee hospitals. For information related to the medication safety endorsements or the work of the Tennessee Pharmacists Coalition, contact Jackie Moreland at firstname.lastname@example.org.
Access to the Controlled Substance Monitoring Database (CSMD)
Tennessee law currently requires that every practice site where a controlled substance is dispensed shall provide for electronic access to the controlled substance monitoring database at all times. Practice sites will be assessed a $100 fine for every day that it does not have access. As a reminder:
- All prescribers with DEA numbers who prescribe controlled substances and dispensers in practice providing direct care to patients in Tennessee for more than (15) calendar days per year shall be registered in the controlled substance monitoring database.
- The law permits practitioners to designate health care extenders to check the CSMD. The extenders must act under the supervision of a licensed prescriber or dispenser. A health care practitioner extender is an unlicensed person designated by the pharmacists, who act as an agent of the pharmacist.
- More information is available at https://tn.gov/health/article/CSMD-faq.
Compounding Secret Formulas
Per Tennessee Board Rule 1140-02-.01 (9), it is against Tennessee Board of Pharmacy rules to compound secret formulas. If a compound is requested to be transferred by a patient, the pharmacist must disclose the ingredients to another pharmacy.
Loss of Prescription Drugs, Devices and Related Materials
Per Tennessee Board Rule 1140-03-.09, the pharmacist-in-charge is responsible for immediately reporting to the Board of Pharmacy “any robbery, embezzlement, theft, burglary, or fire or disaster resulting in a loss of prescription drugs, or controlled substances or medical devices or related materials. The report shall include a list, including amounts, of such prescription drugs or controlled substances or medical devices or related materials lost or damaged.” In the case of controlled substances, a DEA Form 106 must be filled out and sent to the DEA, and a copy, or other appropriate documentation, must be sent to the Board of Pharmacy. Furthermore, according to DEA guidelines, the pharmacy “shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.” Contact information for your local DEA Field Division officer can be found HERE. For more information about the DEA’s rules on Theft or Loss of Controlled Substances, please CLICK HERE. The Board also reported that an unfortunate trend has developed relating to employee pilferage, as the increased regulation of hydrocodone combination products has resulted in a rise in pilferage of non-schedule II controlled substances. Common stolen products include acetaminophen and codeine products, tramadol, carisoprodol, and benzodiazepines.
All pharmacy technicians must be registered by the Board of Pharmacy within 90 days of the date of employment. Pharmacy technicians include those who perform those tasks associated with the preparation and dispensing process, outside of the duties that must be personally performed by a pharmacist or pharmacy intern. Exemptions from registration include students enrolled in a formal pharmacy technician training program while performing experiential rotations as a part of the academic curriculum. Registration must be renewed every two years. The pharmacist in charge at each pharmacy practice site is responsible for compliance with these provisions by pharmacy technicians at that pharmacy practice site. Pharmacies can be fined for each month that an unregistered technician is working, so it is important that pharmacies have a mechanism in place to track these registrations.
CLICK HERE for the Board Rule on Technician Registration.
One of the most common fines handed out by the Board of Pharmacy to pharmacists and pharmacies is for failure to counsel patients at the time of dispensing for new prescriptions. Per Board Rule 1140-03-.01, upon the receipt of a medical or prescription order and following a review of the patient’s record, a pharmacist shall personally counsel the patient or caregiver “face-to-face” if the patient or caregiver is present. If the patient or caregiver is not present, a pharmacist shall make a reasonable effort to counsel through alternative means.
Overview of Patient Counseling Requirements:
- New Prescriptions: Pharmacists are required to personally counsel the patient or caregiver “face-to-face” if the patient or caregiver is present. If the patient or caregiver is not present, a pharmacist shall make a reasonable effort to counsel through alternative means.
- Refill Prescriptions: Pharmacists or persons designated by the pharmacist are required to offer for the pharmacist to personally counsel the patient or caregiver. Counseling as described in the Board rule is not required unless requested by the patient or deemed necessary in the professional judgment of the pharmacist.
- Patient or Caregiver Refusal: Pharmacists are not required to counsel a patient or caregiver when the patient or caregiver refuses such counseling.
CLICK HERE for the Board Rule on Patient Counseling.
Refusal to Fill Controlled Substances
Pharmacists are increasingly put in the difficult position of determining whether or not to refuse to dispense controlled substances. To assist pharmacists in this effort, the National Association of Boards of Pharmacy (NABP) and the Anti-Diversion Industry Working Group (ADIWG), a consortium of pharmaceutical manufacturers and distributors, recently released a consensus document and educational video to help pharmacists identify the warning signs of prescription drug abuse and diversion when dispensing controlled substance prescriptions.
This “Red Flags” campaign encourages pharmacists to help combat this national problem by exercising their professional judgment to ensure the prescriptions they dispense were written for a legitimate medical purpose, and to act upon any unusual behavior they observe.
Some “Red Flags” include:
- “Pattern prescribing’’ – prescriptions for the same drugs and the same quantities coming from the same doctor;
- Prescribing combinations or “cocktails” of frequently abused controlled substances;
- Geographic anomalies;
- Shared addresses by customers presenting on the same day;
- The prescribing of controlled substances in general;
- Quantity and strength;
- Paying cash;
- Customers with the same diagnosis code from the same doctor;
- Prescriptions written by doctors for infirmaries not consistent with their area of specialty;
- Fraudulent prescriptions.
Early Refills for Controlled Substances
Pharmacists are often concerned about the requirements regarding early refills for controlled substances. According to the Drug Enforcement Administration (DEA) Pharmacist’s Manual, “a pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription within the meaning and intent of the Controlled Substances Act. 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.” The DEA Code of Federal Regulations Section 1306.04 states that “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.” Early refills are patient requests for refills of prescriptions before the date the patient is scheduled to run out of their medication.
There are limited resources and little guidance from the DEA regarding early refills for controlled substances, which leaves the decision regarding whether or not to refill prescriptions early up to the discretion of the individual pharmacist. While there are certainly instances when early refills may be necessary, the DEA has taken action against dispensers and pharmacists for dispensing early refills for controlled substances in frequent and chronic patterns. In order to justify professional judgment when determining whether or not to refill a controlled substance early, pharmacists are encouraged to:
- Create a written policy for the pharmacy outlining any reasons when early refills of controlled substances should be considered;
- Document any reasons for deviation from the pharmacy’s written policy in the patient’s profile and/or prescription record;
- Document reasons for dispensing an early refill in the patient’s profile and/or prescription record.
Discipline by the Board of Pharmacy
The Board of Pharmacy disciplines pharmacists through a variety of mechanisms.
- Pharmacists may be sent a letter of instruction. A letter of instruction is not kept in the pharmacist’s permanent file with the Board.
- Pharmacists may be sent a letter of warning outlining the infraction of Board rules. A letter of warning is considered formal discipline that will be placed in the pharmacist’s permanent file with the Board.
- A pharmacist’s license may be suspended, revoked, or placed on probation.
- Pharmacists may be assessed civil penalties of no more than $1,000 per violation or, depending on the violation, no more than $1,000 per day.
Automatic Electronic Prescriptions
Electronically transmitted prescriptions have become a convenient way for prescribers to transmit prescriptions directly to the pharmacist. This technology is intended to increase efficiency and decrease medication errors within the prescription process. Per Board rule 1140-03-.04(2), if a prescriber wishes to send an electronic prescription, it must go to a licensed pharmacy of the patient’s choice with no intervening person or entity having access to the order. It is important to note that Board Rules prohibit pharmacists who receive any transmitted order from knowingly participating in any system that restricts the patient’s choice of pharmacy.
UPCOMING BOARD OF PHARMACY MEETINGS
- March 8-9, 2016
- May 10-11, 2016
This review is being provided to members for informational purposes only and should not be considered as legal advice.
For more specific guidance on this information, please contact the Tennessee Board of Pharmacy by phone at 615-741-2718. If you would like to view the Board of Pharmacy meeting in its entirety, CLICK HERE, then click “Board of Pharmacy” in the left-hand panel.