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|House Bill 21|
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Northeast Florida Medicine, Vol. 70, No. 4, April 2019
A Committee-Based Systematic Response to Changes in Controlled Substance Law: The Example of House Bill 21 and UF Health Jacksonville
Date of Release: April 1, 2019
Date Credit Expires: April 1, 2021
Estimated Completion Time: 1 hour
The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “ A Committee-Based Systematic Response to Changes in Controlled Substance Law: The Example of House Bill 21 and UF Health Jacksonville” authored by Alberto E Ardon, MD, MPH, Brittany Johnson, PharmD, Brian Yorkgitis, DO, Joseph Cammilleri, PharmD, BCACP, Christopher B. Scuderi, DO, FAAFP, Jeffrey G. House, DO, FACP, and L. Kendall Webb, MD, FACEP, which has been approved for 1 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.
Alberto E Ardon, MD, MPH, Assistant Professor, Anesthesiology. Brittany Johnson, PharmD, Pain and Palliative Care Stewardship Pharmacist. Brian Yorkgitis, DO, Assistant Professor of Surgery. Joseph Cammilleri, PharmD, BCACP, Ambulatory Care Clinical Pharmacist. Christopher B. Scuderi, DO, FAAFP, Associate Chair of Clinical Operations North, Clinical Associate Professor, Family Medicine. Jeffrey G. House, DO, FACP, Professor of Medicine. L. Kendall Webb, MD, FACEP, Chief Medical Information Officer, Associate Professor of Emergency Medicine and Pediatric Emergency Medicine. All are with UF Health Jacksonville.
Florida House Bill 21 “Controlled Substances” was signed into law in March 2018 and took effect July 1, 2018; it aimed to limit controlled substance prescribing for acute pain and require a review of patients’ prescription history. Compliance with this law required quick action by medical institutions and practices. A multidisciplinary committee-based approach was successfully utilized by UF Health Jacksonville in facilitating the transition of practice to comply with this legislation, and may serve as a model for such endeavors.
1. Understand the critical factors involved with House Bill 21 “Controlled Substances” and implications for compliance.
CME Credit Eligibility:
A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. If you take your test online, a certificate of credit/completion will be automatically downloaded to your DCMS member profile. If you submit your test by mail, a certificate of credit/completion will be emailed within 4 weeks of submission. If you have any questions, please contact the DCMS at 904-355-6561 or firstname.lastname@example.org.
Alberto E Ardon, MD, MPH, Brittany Johnson, PharmD, Brian Yorkgitis, DO, Joseph Cammilleri, PharmD, BCACP, Christopher B. Scuderi, DO, FAAFP, Jeffrey G. House, DO, FACP, and L. Kendall Webb, MD, FACEP report no significant relations to disclose, financial or otherwise, with an commercial supporter or product manufacturer associated with this activity.
Disclosure of Conflicts of Interest:
St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educational activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.
Joint Sponsorship Accreditation Statement:
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.
Opioid abuse, overdose, and opioid-related mortality has steadily increased in the United States (U.S.) over the past decade, and the opioid overdose death rate of 14.6 per 100,000 in Florida presents a public health problem to the population of the state. Prescription opioid medications have been linked to these increasing trends; in 2016, the city of Jacksonville ranked 1st in Florida in hydrocodone deaths. Florida House Bill 21 “Controlled Substances” was signed into law in March 2018 and took effect July 1, 2018; it aimed to limit controlled substance prescribing for acute pain and require a review of patients’ prescription history.
From March to July 1 of 2018, the Pain and Opioid Stewardship Committee at UF Health Jacksonville utilized a multispecialty team-based approach to address preparation across three major themes: 1) Education, 2) Clinical Guidelines, and 3) Implementation and Logistics.
The committee’s most significant recommendations included a compulsory online and live educational program regarding the new law and analgesic management, a concurrent patient education effort, adoption of prescribing guidelines for both primary care and surgical services, a strengthening of naloxone prescribing, advocacy for electronic prescription printing, electronic prompts to aid in clinical decision making, a call for a clear organizational strategy for Prescription Drug Monitoring Program access, and an internal social marketing campaign to raise awareness about upcoming changes in practice.
By the target date of July 1, 92 percent of physicians, midlevel providers, and pharmacists at UF Health Jacksonville had completed the online educational training. Outpatient and perioperative analgesia guidelines were developed and adopted for use by clinicians. An electronic medical record-based approach was utilized to facilitate review of patients’ controlled substance prescriptions and maximize provider compliance with the HB21 prescribing requirements.
In a span of 90 days, the Committee developed and implemented the above changes, facilitating the transition of practice to comply with this legislation. No major issues nor clinical workflow barriers have been elucidated since implementation of the above described measures.
Over the past decade, opioid abuse, overdose and opioid-related mortality has steadily increased across the United States. Currently, Florida ranks 25th in opioid overdoses, with an opioid overdose death rate of 14.6 per 100,000.1 Reflected more locally, in 2016, Jacksonville had 669 opioid-related deaths. According to the 2016 Medical Examiners Commission Drug Report,2 among medical examiner districts, Duval County ranked:
Furthermore, responses to overdose incidents and concurrent use of naloxone had steadily increased in Jacksonville since 2015, and only recently have begun to show a downward trajectory (Figure 1). In 2017, approximately 24 percent of Jacksonville Fire and Rescue Department transports for ingestion/poisoning/overdose were to UF Health and UF Health North, more than any other health system in the city.3
Figure 1: Responses to overdose incidents by Jacksonville Fire and Rescue Department, January 2015 to April 2018. Courtesy Jacksonville Fire & Rescue Department.
While the reasons for the opioid crisis are indeed multifactorial, prescription medications have consistently and increasingly contributed to accidental deaths, both throughout the state and locally. From 2015 to 2016, accidental deaths caused by prescription drugs increased by 151 percent in Jacksonville, and those involved in deaths in combination with alcohol or illicit drugs increased by 74 percent over the same time period.
In a response to the statewide crisis, Governor Rick Scott signed into Florida law House Bill 21 “Controlled Substances” (Section 456.44(3)(d),F.S.), (HB21),4 which established several significant changes to controlled substance prescribing for acute pain. The most significant changes involved with the adoption of this new law are described in Table 1. The law has a direct impact on outpatient opioid prescribing and implications for the clinical care of both opioid-naïve and opioid-tolerant patients. UF Health Jacksonville, being experienced in the care of opioid-exposed patients and acute opioid rescue, quickly recognized the implications of the law on the clinical practice model. The following article describes the organizational methodology used to quickly adapt to this changing landscape.
In January 2018, the Pain and Opioid Stewardship Committee (POST) at UF Health Jacksonville was created to help craft a strategic plan to address analgesic improvement within this healthcare system. As part of its strategic plan, the Committee aimed to 1) acquire relevant data that would allow elucidation of opioid use patterns, incidence of opioid-related adverse events, and identify risk factors for such events, 2) identify aspects of clinical practice that have room for improvement, and 3) directly implement these clinical changes or otherwise make recommendations for said changes. Because of the evident overlap between the controlled substances bill and the mission of the Committee, POST was tasked with overseeing implementation and compliance with HB21 when the law was announced. These responsibilities included developing, implementing, and/or monitoring:
Thus, the need for compliance with HB21 and the organizational goal of opioid stewardship combined to create a unique and timely opportunity for multifaceted quality improvement within UF Health Jacksonville. Following meetings with hospital leadership, legal counsel, clinical department chairs, clinical informatics, and communication with the Florida Board of Medicine, the Committee developed a strategic plan that made recommendations across three major themes: 1) Education, 2) Clinical Guidelines, and 3) Implementation and Logistics, to be implemented in 90 days.
1.1 CLINICAL PROVIDER EDUCATION
Recognizing that medical educational efforts are most successful when delivered in more than one format and on more than one occasion, the committee developed and implemented an educational plan with the objectives of informing clinicians about the HB21 law, providing an overall evidence-based strategy for analgesia and opioid minimization, and educating clinicians about changes in clinical informatics (e.g. EPIC prescribing and PDMP access/documentation) at UF Health Jacksonville.
These objectives were aimed to be achieved via the following mechanisms:
· Online Training
The Committee developed two online learning modules whose topics and objectives were to educate clinical providers regarding the basics of pain assessment, pain control, multimodal analgesia, and opioid minimization, and to provide a review of the controlled substances law and UF Health’s policies and procedures for its application to clinical practice, including changes in electronic medical record (EMR) and PDMP access.
The learning modules would be accessible securely via hospital intranet. Both modules were assigned to all clinical providers and pharmacists and made compulsory. A score of 80% on a post-test was required to complete each module.
· Departmental HB21 Briefings
In order to ensure that all clinical departments had received direct communication from the Committee regarding the three objectives, a physician member of the Committee was assigned to deliver briefings to all 12 clinical departments at UF Health Jacksonville. These briefings were tailored for each department and responsive to their particular concerns.
· Nursing Education
Nursing staff were educated concurrently on the key workflow items involved with implementation of HB 21. This effort incorporated both the online educational briefing modules and an in-person briefing as decided upon by nursing leadership.
The new law also required all physicians with a Florida Medical License and DEA license to complete a two-hour mandatory Continuing Medical Education (CME) course by January 31, 2019. To guide the achievement of board-approved continuing CME on the safe and effective prescribing of controlled substances, the Committee planned to provide up-to-date information regarding organizations providing the required courses.
1.2 PATIENT EDUCATION
Given the significant practice changes involved in opioid prescribing, patient education regarding these issues was deemed to be beneficial. The Committee recommended a patient education program to: 1) explain the time restrictions in acute pain opioid prescribing, 2) disclose that controlled substance prescriptions will require a review of a patient’s controlled substance prescription history, 3) set expectations regarding analgesia and introduce/reinforce the mandatory multidimensional approach to pain practiced at UF Health, 4) provide information about opioid safety and proper disposal, and 5) reinforce awareness that chronic opioid therapy would be coordinated by one clinic/prescriber. Information was planned to be disbursed to patients in electronic format, via patient handouts in clinic, and through provider/patient discussions.
2) Clinical Guidelines
2.1 CLINICAL/PRESCRIBING GUIDELINES FOR ACUTE PAIN
The use of multimodal analgesia has been shown to be effective in treating pain in the primary care setting.5,6,7 Particularly for acute pain, a balanced approach incorporating analgesic agents of multiple mechanisms of action is beneficial, not only for analgesic efficacy but also for opioid use reduction. The Committee thus planned and developed a primary care acute pain guideline to serve as a clear and concise reference for practitioners of all experience levels. Likewise, in conjunction with the various surgical departments, the committee planned to develop surgical-service-specific perioperative analgesic guidelines.
2.2 PRIMARY CARE OPIOID PRESCRIBING RESPONSIBILITY
The Committee recommended that multiple departments establish a coordinated and consistent approach or policy identifying the party responsible for controlled substance prescription at various stages of a patient’s acute, subacute and chronic pain treatment course. Coordination of variables and workflow issues such as patient volume adjustments, follow-up windows, and interdepartmental communication were identified as needing re-examination. The Committee recommended consideration of a joint agreement/policy among primary care clinics, surgical clinics, chronic pain clinics, and addiction specialists to clearly identify ownership, responsibility, and referral process for the management of pain throughout its multiple stages as applicable.
2.3 DOSAGE LIMITATIONS IN PRIMARY CARE
Given the increased risk of opioid-related side effects such as respiratory depression, hyperalgesia, and dependence with a dose greater than 90mg of oral morphine equivalents per day as identified by the Centers for Disease Control and Prevention, the Committee recommended that community medicine departments consider a policy that would require consultation with a chronic pain expert when a threshold of 90mg of daily morphine equivalents is reached.
2.4 RISK OF RESPIRATORY DEPRESSION / NALOXONE
Risk of respiratory depression and consequent need for naloxone has been shown to be increased among patients who have at least one of the following risk factors:8
2.5 CLINIC VISIT REQUIREMENT FOR OPIOID PRESCRIPTION REFILL
Established practice regarding opioid prescriptions at UF Health Jacksonville required an in-person patient visit for any initial or renewal prescription. Although HB21 explicitly authorized electronic prescriptions of controlled substances, the Committee viewed a change in practice facilitating opioid prescriptions in the absence of a clinical visit as detrimental to institutional goals of opioid stewardship. Thus the Committee recommended a continued institutional standard of practice in which a direct physician/patient interaction and evaluation is required whenever any controlled substance schedule II opioid prescription is to be considered.
3) Implementation and Logistics
3.1 CLINICAL INFORMATICS (CI)
The CI team prioritized three main areas to be completed and online in the Electronic Medical Record (EMR) before July 1, 2018.
When HB21 was signed into law, only select units at UF Health Jacksonville used a version of electronic controlled substance prescribing. Patients discharged from some units were given paper scripts. Thus, the CI team decided to pursue the standardization of electronic prescription printing in all units. Expansion to the two most populated wards was achieved by July 2018, and the effort is on-going.
Prescribing adjustments in EPIC.
Changes in the electronic medical record were instituted to provide clinical decision support (CDS) for controlled substance law changes, to advise prescribing workflow, and to facilitate documentation within these prescriptions. These included active reminders/prompts to guide clinicians during the ordering process and adding necessary verbiage on any printed prescriptions as required by law, such as “acute pain exemption,” “for non-acute pain,” etc.
3.2 ORGANIZATIONAL STRATEGY FOR PDMP ACCESS AND INFORMATION USAGE
Although access to the PDMP is open to all physicians who have a DEA number, prior to the implementation of HB21 less than 10 percent of providers at UF Health Jacksonville were registered with this resource. Given new requirements by HB 21, access to the PDMP required a strategized and individualized approach within each clinical environment with the aim of maximizing efficiency of human resources.
As part of an organizational strategy for PDMP access, the committee recommended that UF Health leadership encourage the leaders of each clinical department to motivate their providers to register for PDMP access as well as establish a process for PDMP delegate assignment and registration. Clinic-specific workflows for daily PDMP access were also encouraged. Given the sensitive nature of PDMP data, it was recommended that no PDMP data be scanned into the EMR.
3.3 PROMOTION OF KNOWLEDGE AND BEHAVIOR CHANGE
In addition to the above education interventions, the Committee recommended an internal social marketing campaign incorporating the use of both electronic and print-based communication aimed at increasing awareness of HB21, associated workflow changes, and global strategy for analgesia. Specifically, these communication methods would include frequent and high-priority electronic messages to clinical staff regarding the law and associated changes in practice at UF. The messages would be sent from the offices of the chief medical officer, chief technology officer, or committee chair and would be sent every two weeks over the course of 8 weeks prior to July 1.
In June, the hospital launched the internal social marketing campaign. The principal components of this campaign included an infographic-based poster (Figure 2) and a series of infographic screen savers. The poster and screen saver promoted key information in an infographic format: the law start date, new limits for 3- or 7-day prescriptions, a reminder regarding patients with acute pain requiring opioid prescriptions, and that access to the PDMP would be required.
Both of these items were displayed throughout the health system. Regular electronic messages were sent from hospital leadership to clinical staff regarding the law and associated changes in practice at UF. Clinicians were encouraged to ask questions about the endeavor and such inquiries were addressed as expediently as possible by members of the Committee.
By the July 1 target date, 92 percent of physicians, midlevel providers, and pharmacists had completed the online educational training. The remaining 8 percent of eligible learners completed the education by the end of August 2018. The mean post-test scores for modules 1 and 2 for all learners were 8.6/10 and 8.2/10, respectively.
All clinical departments had received a focused briefing discussing the specifics of HB21, the organizational response to the new law, and the basics of pain control by June 30. Likewise, nursing staff in all hospital units received planned education as decided upon by nursing leadership by July 1.
Patient education was primarily accomplished via handouts in clinic and through provider-patient discussions. A sample patient handout, which was adapted to different clinic settings, was developed and distributed to clinics throughout the health system.
The Committee disseminated information regarding the required CME as it became available. Initially, the CME was only provided by the Florida Medical Association and Florida Osteopathic Medical Association but several other options developed over time. As of late 2018, at least five Florida Board of Medicine-certified courses were available.
With institutional leadership encouragement and coordination, a primary care acute pain guideline was developed and approved (Figure 3). The guideline was adapted by various clinics within the departments of internal medicine and family & community medicine and began to be utilized in June 2018.
Figure 3: Guidelines for Controlled Substances in the Primary Care Patients with Acute Pain
Surgical guidelines were also developed as planned in cooperation with surgical leadership from the departments of oral/maxillofacial surgery, general surgery, obstetrics/gynecology, and orthopedic surgery. These perioperative guidelines (Figure 4) highlighted multimodal analgesic approaches throughout the perioperative period and identified anticipated numbers of opioid analgesic pills to be utilized after certain procedures. The guidelines were adopted into clinical practice by July 2018.
Figure 4: Perioperative Analgesic Guidelines – Example of Oral & Maxillofacial Procedure
Regarding risk of respiratory depression with opioid use, all of the Committee’s recommendations were placed into practice, particularly the avoidance of concurrent opioids and benzodiazepines if possible. Of note, a standing order for naloxone available in all clinic settings where opioids are prescribed for acute or chronic pain was developed and implemented, along with a visual prompt in EPIC which suggests to the provider an order for naloxone when criteria are met. Additionally, an in-person patient visit is still required for any initial or renewal schedule II controlled substance prescription.
IMPLEMENTATION AND LOGISTICS
During the months of April, May and June, a Clinical Decision Support system was developed and implemented into the electronic medical record that guided providers through the necessary changes in prescribing and associated documentation. An example of these changes can be seen in Figure 5, which guides the provider through 1) direct access to the PDMP from the EMR, 2) a description of the purpose of the controlled substance prescription (and printing of the appropriate phrase on the prescription), 3) a comment regarding PDMP access, and 4) tablet dispensation.
Figure 5: Electronic Medical Record Changes Made in Preparation for HB21 Implementation
Precise clinic-specific strategies for PDMP access and workflow were delegated to departmental chairs, who established expectations for access in conjunction with clinic leaders and administration. Personnel tasked with accessing the PDMP varied by clinical site, such that in some clinics the physician would access the PDMP, while in others a physician assistant or advanced practice registered nurse would do so. Likewise, the timing of PDMP access varied, with some clinics querying the database throughout the day, while others would query the database in the morning for all patients scheduled to be seen that day. This model created maximum flexibility while reinforcing the necessity to comply with the PDMP access requirement. All applicable clinical settings were compliant with PDMP access requirements by July 1.
The changes involved with HB 21 are vast and demand attention from clinical institutions given the extensive impact to daily clinical care. The time for planning, organization, and execution of institution-wide changes was drastically limited. However, in a span of 90 days, the Committee developed and implemented multiple and complex changes in clinical workflow, behavior, and documentation, facilitating the transition of practice to comply with this legislation.
The Committee believes that the lessons learned, adaptable to other health institutions, are as follows:
Scale – a far-reaching committee approach may not be practical in a small independent clinic. In that or other limited human resource environments, a top-down approach from a single leader may be more beneficial.
Culture change – eventual culture change that establishes opioid stewardship as the norm should be a goal that supersedes simple compliance with opioid-targeted legislation. However, such a culture change requires educational reinforcement, expectation setting from leadership, and frequent repetition of concepts. This may be a much more difficult goal to achieve.
In conclusion, to the best of the Committee’s knowledge, UF Health Jacksonville has had no significant issue with clinical adaptation to HB21. No significant barriers to successful implementation have arisen thus far. More importantly, the clinical practice changes aimed at judicious opioid use and effective analgesia that were inherently a part of this effort for HB21 implementation can have a positive impact on the healthcare provided to our patients.
1. Florida Opioid Summary [Internet]. NIH National Institute on Drug Abuse; 2018 [updated 2018 Feb; cited Dec 2018]. Available from: https://www.drugabuse.gov/drugs-abuse/opioids/opioid-summaries-by-state/florida-opioid-summary.
2. Florida Medical Examiners Commission. Drugs identified in deceased persons by Florida medical examiners: 2016 annual report. Florida Department of Law Enforcement (FL); 2017 Nov. 64 p.
3. Castleman D. JFRD overdose responses and trend. Jacksonville (FL): Jacksonville Fire & Rescue Department; 2018 Mar 21. 38 p. Available from: https://media.news4jax.com/document_dev/2018/03/22/OD%20Presentation%20Revised%203%2021%202018_1521756304617_11825577_ver1.0.pdf
4. Controlled Substances, H.B. 21, Florida Statute. (July 1, 2018).
5. Crews JC. Multimodal pain management strategies for office-based and ambulatory procedures. JAMA. 2002 aug 7;288(5):629-32.
6. Chou R, Gordon, DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57.
7. Gritsenko K, Khelemsky Y, Kaye AD, et al. Multimodal therapy in perioperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):59-79.
8. Webster LR. Risk factors for opioid-use disorder and overdose. Anesth Analg. 2017 Nov;12(5):1741-8.
To take the test and earn CME credit, click here.
1. Among Florida medical examiner districts in 2016, Duval County ranked:
a. First in hydrocodone deaths
b. Second in fentanyl deaths
c. Third in oxycodone deaths by age
d. All of the above
2. The definition of ‘acute pain’ as specified by House Bill 21 “Controlled Substances” excludes:
a. Pain related to cancer
b. Pain related to palliative care
c. Both A & B
d. Neither A or B
3. Per House Bill 21 “Controlled Substances,” the prescriber must review the prescription drug monitoring program (PDMP) before prescribing a controlled substance:
a. To a patient less than 16 years of age
b. To any patient age 16 or older being examined in clinic on a non-emergent basis
c. When prescribing in the emergency department
d. When providing a 72-hour emergency resupply
4. Risk of respiratory depression is increased among patients who have which of the following risk factors?
a. Use of more than 50mg of morphine equivalents per day
b. Concurrent use of benzodiazepines
c. Concurrent use of long- and short-acting opioids
d. All of the above
5. Useful methods available to educate clinicians about policy changes include all of the following except:
a. Online training
b. Live, in-person briefings
c. Concise, targeted electronic communication (e.g. email)
d. Reliance on communications from the Department of Health or other outside institutions
6. Changes in the electronic medical record that can provide clinical decision support for acute pain prescription-writing include:
a. Active reminders/prompts
b. Adding necessary verbiage on printed prescriptions
c. Specification of expected number of pills to prescribe
d. All of the above
7. For acute pain control, the first step in analgesic management should include:
a. Morphine extended release
b. Concurrent administration of an opioid and benzodiazepine
c. Consideration of anti-inflammatories
d. None of the above
8. The use of a multidisciplinary committee-based approach to address institution-wide change:
a. can facilitate planning, communication, and execution of changes
b. is an extra layer of bureaucracy that obstructs efficacy
c. provides too narrow of a scope for change to occur
d. All of the above
9. Examples of social marketing and communication tactics that can be used for health behavior change include:
a. Printed posters
b. Screen savers
c. Frequent emails
d. All of the above
10. Regarding continuing medical education (CME), House Bill 21 “Controlled Substances” requires how many hours of education on safe and effective prescribing of controlled substances?