Vol. 3 No. 13

The state Prescription Drug Monitoring Program has been instrumental in stopping the opioid epidemic and in preventing future generations from inheriting this disease. I want to thank past-chair Dr. Jill Rosenthal for her leadership of the PDMP Foundation board of directors and her dedication in helping healthcare professionals to better understand the state’s opioid epidemic. It was an honor to work under Dr. Rosenthal’s leadership during her terms of service with the foundation. 

As a Direct Support Organization to the Florida Department of Health state Prescription Drug Monitoring Program the foundation’s role continues to be to provide alternative funding for outreach and education programs directed toward those healthcare professionals who are registered to use the PDMP database to check patient records before prescribing or dispensing a Scheduled II to V controlled substance. The foundation also assists in providing information on use of the database to law enforcement agencies when they are involved in active criminal cases of prescription drug fraud, abuse, or diversion.

The PDMP Staff also continues to work on the Center for Disease Control and Prevention Overdose Data to Action Grant (OD2A) deliverables. The grant was extended through August 31, 2023, to provide funds for the live presentation of the peer-to-peer course on best practices for use of the PDMP database to heath care professionals in Palm Beach and Broward Counties. The course is scheduled for Monday August 21, 2023, at the Florida Atlantic University Student Union beginning at 6:00 p.m. It will be held in conjunction with the two county health departments which are state jurisdictions participating in the OD2A grant. Speakers for the course include Dr. Rosenthal, PDMP Legal Counsel Jason Winn, Esq., Dr. Joshua Lenchus, past president Florida Medical and Florida Osteopathic Medical associations, and PDMP Executive Director Bob Macdonald. Prior to the course, staff of the Palm Beach and Broward health departments will provide an update on the Opioid Education Academic Detailing programs they have offered to health care professionals in their communities.

[Dr. Lee Ann Brown, DO, FAAPMR, currently serves as Acting Chair of the Florida PDMP Foundation Board of Directors. Dr. Brown is board certified in both Physical Medicine and Rehabilitation and Pain Management.  She is the Chief Executive Officer of the Spine Pain and Orthopedic Injury Center in Clearwater, Florida and is the Immediate Past-President of the Florida Osteopathic Medical Association].

IMPROVING BEST PRACTICES FOR PATIENT CARE: CE COURSE 

All prescribers and dispensers are encouraged to take the free course, Improving Best Practices for Patient Care: Optimizing Use of the PDMP Database through CE Broker or through the FMA. Dentists, Pharmacists, Podiatrists, Optometrists, and Nurse Practitioners should take the course via CE Broker; MDs, DOs, and PAs should take the course through FMA.

This course is funded by the OD2A grant from the Centers for Disease Control and Prevention. Objectives of the course include:

• Discuss the E-FORCSE® database and the role of the Florida PDMP Foundation

• Review laws and rules surrounding the prescribing and dispensing of controlled substances

• Understand disciplinary actions related to the PDMP requirements

• Understand the value of PDMP database information

• Discuss prescribing information technology

• Review of the best practices for PDMP utilization

The course can be accessed via CE Broker  or via the FMA.

Following the dental convention, the Florida Pharmacy Association held its annual meeting at the JW Marriott, Marco Island. Mr. Hayes, former chair of the Florida Board of Pharmacy, and Mr. Felton represented E-FORCSE at the pharmacy meeting.

The third weekend in July saw Mr. Macdonald and Mr. Felton staffing the E-FORCSE booth at the Florida Sheriffs Association annual summer conference at the JW Marriott, Tampa. FSA President Sheriff Al Nienhuis, Hernando County, is secretary of the PDMP Foundation board of directors.

The last week in July saw Mr. Macdonald and state PDMP program manager Becki Poston attend the annual meeting of the Florida Medical Association at the Hyatt Regency Hotel, Orlando. Dr. Joshua Lenchus, President, Florida Medical Association is a keynote speaker on the PDMP Foundation’s peer-to-peer course on best practices for use of the PDMP database which is available online through the FMA continuing education website for physicians, podiatrists, and physician assistants and on CE Broker for dentists, nurse practitioners and pharmacists.

Following the FMA conference Mr. Hayes represented E-FORCSE at the summer meeting of the Florida Police Chiefs Association. The police chiefs met at the Hyatt Regency, Coconut Point, Bonita Springs.

There will be several conferences in August where E-FORCSE and PDMP Foundation staff will be present. The first weekend of the month has three conferences including the Florida Society of Health System Pharmacists at the Gaylord Palms staffed by Ms. Poston; the Academy of Physician Assistants, at the Rosen Shingle Resort, Orlando, staffed by Mr. Felton; and the Florida College of Emergency Physicians at the Hyatt Regency, Coconut Point, staffed by Mr. Hayes. At the end of the month Mr. Macdonald and Mr. Felton will staff the booth at the Florida Nurse Practitioner Network annual conference at the Marriott World Center, Orlando.

Over the last several months there have been several regulatory changes. From how you can prescribe controlled substances through telemedicine, to new DEA CE requirements for controlled substance prescribing and the updated rules for the Florida Prescription Drug Monitoring Program.

PRESCRIBING CONTROLLED SUBSTANCES AND TELEMDICINE

In Florida, controlled substance prescribing through telemedicine is limited to schedule 3-5, with exceptions for psychiatric disorders, hospital, hospice, and nursing home patients. The Federal limitation for controlled substance prescribing is the Ryan Haigh Act, which requires an in-person visit prior to prescribing through telemedicine. However, as we have discussed in the past, during the global health pandemic, the DEA, DOJ SAMHSA and DHHS, allowed for the prescribing of controlled substances through telemedicine without an in-person visit. These exceptions have been extended through November 11, 2023.

These telemedicine flexibilities authorize practitioners to prescribe schedule II–V controlled medications via audio-video telemedicine encounters, including schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, without requiring an in-person medical evaluation, provided that such prescriptions otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law.

Additionally, for any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID–19 PHE will continue to be permitted via a one-year grace period through November 11, 2024. In other words, if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.

The DEA is looking at several options for prescribing controlled substances using telemedicine. According to DEA, the “goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules.”

DEA said it plans to issue one or more final rules … based on the two proposed rules published on March 1, 2023. DEA anticipates such final rule(s) will extend certain telemedicine flexibilities on a permanent basis to permit the practice of telemedicine under circumstances that are consistent with public health and safety, while maintaining effective controls against diversion.

The proposed rules are NOT effective as of the publishing of this article. However, the proposed rules have several options that would allow for the prescribing of controlled substances through telemedicine, if:

1. A virtual first process where a practitioner can issue an initial prescription for a controlled substance without having conducted an in-person exam of the patient, but only if: 1) the medication is a non-narcotic Schedule III, IV, or V controlled substance (or buprenorphine for treatment of OUD); and 2) the prescribed amount does not exceed 30 days. This is called a “telemedicine prescription.” Before any additional prescribing can occur, the patient must undergo an in-person exam; or,

2. A “qualified telemedicine referral” process where a patient has an initial in-person exam with a practitioner, who subsequently refers the patient to a second practitioner. The second practitioner can have a telemedicine exam of the patient and prescribe a controlled substance without personally conducting an in-person exam of the patient. Under this referral process, the telemedicine practitioner can prescribe Schedule II-V and narcotic controlled substances.

Compared to the original Ryan Haight Act, these new options are expanded flexibilities intended to allow more telemedicine-based care, but are more restrictive than what has been allowed for the past three years under the PHE waivers.  DEA’s proposal will discontinue the ability for telemedicine prescribing of controlled substances where the patient never has any in-person exam (with the exception of an initial prescription period of no more than 30 days’ supply).  Moreover, if the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for OUD treatment), an initial in-person exam is required before a prescription can be issued.

NEW ONE-TIME 8-HOUR TRAINING FOR ALL Drug Enforcement Administration (DEA) REGISTERED PRACTITIONERS

There is a new requirement to take 8 hours of continuing education on treating and managing patients with opioid or other substance use disorders. This applies to all DEA-registered practitioners, excluding only veterinarians. Beginning June 27, 2023, you will be required to check a box on the registration form at renewal or initial registration, affirming the completion of the new training requirement.

While this is a new requirement for educational training, your past training CAN be counted toward this new requirement! If you have already taken courses on opioids or other use disorders, you can use those toward completing this new requirement. If you have already taken the 2-hour prescribing controlled substances, that can count toward the 8 total hours.

Practitioners are lumped into three groups, groups 1 & 2 are exempt, and group 3 must complete or have completed past training sessions.

• Group 1 – All practitioners that are board certified in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, the American Board of Addiction Medicine, or the American Osteopathic Association.

• Group 2 – All practitioners graduating from a medical (allopathic or osteopathic), dental, physician assistant, or advanced practice nursing… school in the United States within 5 years who completed a comprehensive curriculum that included at least 8 hours of training on treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.

• Group 3 – All other practitioners not in groups 1 or 2 must acknowledge completion of at least 8 hours of training on treating and managing, must acknowledge completion of at least 8-hours of training on the treatment and management of patients with opioid or other substance use disorders from the groups listed below.

Key points related to this training are:

1. The training does not have to occur in one session. It can be cumulative across multiple sessions that equal eight hours of training.

2. Past trainings on in the treatment and management of treating and managing patients with opioid or other substance use disorders can count toward a practitioner meeting this requirement. In other words, if you received relevant training from one of the groups listed below—before enacting of this new training obligation on December 29, 2022—that training counts towards the eight-hour requirement.

3. Past DATA-Waived trainings training count towards a DEA registrant’s 8-hour training requirement.

4. Trainings can occur in a variety of various formats, including classroom settings, seminars at professional society meetings, or virtual offerings.

REGULATORY CHANGES TO RULES FOR PDMP 64K-1.002, .003, .004, and .008

Beginning in April of this year, the DOH and PDMP published notice for rule development, and proposed rulemaking to update reporting American Society for Automation in Pharmacy (ASAP) standards for dispensing practitioners and pharmacies reporting controlled substance dispensing to newer version; to add definition of “authenticate” and clarify access through electronic health recordkeeping and pharmacy management systems; to extend the time to report errors or omissions and outline new waiver process; and to define provider authentication process and describe entity responsibilities.

This rulemaking establishes the format for submissions to the Prescription Drug Monitoring Database, describes access to the information in the database by prescribers and dispensers outside Florida using electronic health recordkeeping systems, extends the days to report errors or omissions in reports and outlines new waiver request process, and defines the term “provider authentication” and entity responsibilities.

Effective August 8, 2023 these new rules become effective. For a full listing of the rules regulating the PDMP, please visit https://www.flrules.org/gateway/ChapterHome.asp?Chapter=64k-1 and as always, continue to check the homepage for the PDMP at https://www.floridahealth.gov/statistics-and-data/e-forcse/

LEGAL DISCLAIMER 

The information contained in this document is provided to you "AS IS", does not constitute legal advice, and is governed by our Terms and Conditions of Use. We make no claims, promises, or guarantees about the accuracy, completeness, or adequacy of the information contained in this article.

The PDMP Foundation, its employees, agents, or others that provide information on or through this will not be liable or responsible to you for any claim, loss, injury, liability, or damages related to your use of this article. You should always consult a health care attorney.

[Jason Winn, Esq., Tallahassee, is a 1996 graduate of the University of Maryland and received his Juris Doctorate from Nova Southeastern University - Shepard Broad Law in Ft. Lauderdale, Florida in 2000.  He was admitted to the Florida Bar in 2001. Before opening his private law practice, he worked for the Assistant Public Defender in the Fifth Judicial Circuit.Mr. Winn currently serves as general counsel for the Florida PDMP Foundation, the Florida Osteopathic Medical Association (FOMA), the Florida Podiatric Medical Association (FPMA) and the Florida Hearing Society.]

FOUNDATION ANNUAL GIVING PROGRAM CONTINUES

The Florida PDMP Foundation Annual Giving Program seeks yearly charitable contributions from supporters to help fund upgrades and enhancements for outreach and educational programs for the state PDMP. Tax-deductible contributions can be made directly to the Foundation on its website at: www.flpdmpfoundation.com/donations/.

Contributions can be made by credit card or by sending a check to: The Florida PDMP Foundation, Inc., 10801 Starkey Rd., #104-221, Seminole, FL 33777.

PDMP Foundation E-NEWS Contact Information:

If you have questions about any information that appears in this newsletter or the Foundation’s activities in support of E-FORCSE®, please contact Bob Macdonald, Executive Director, at executive.director@flpdmpfoundation.com.

E-FORCSE^® Contact Information:

For technical assistance, please call 1-877-719-3120. If you have questions specific to state policy, you may contact E-FORCSE® at 850-245-4797 or by e-mail at e-forcse@flhealth.gov.

To create an E-FORCSE^® account, navigate to https://florida.pmpaware.net and click “Create an Account.”