Center for Clinical Research & Behavioral and Social Sciences Research Branch
Division of Extramural Research, NIDCR
The goal of this initiative is to establish effective interventions or programs to manage, reduce, or prevent opioid drug misuse and align the opioid prescribing practices of dental professionals with scientific evidence. To meet this objective, this initiative will accelerate research to: a) establish the efficacy, safety, and optimal medication course for analgesics to manage acute pain, b) implement effective systems to modify dental professional decision-making behaviors towards evidence-based recommendations for acute and chronic orofacial pain management, and c) promote the dental professional’s role in screening for opioid use disorders (OUDs) and individuals at risk for OUDs.
Prescription pain medications, including opioids, are commonly prescribed for the prevention and management of acute post-procedure pain. However, an unfortunate consequence of prescribing opioid medications is the potential for misuse and abuse. In 2016, drug overdose was the leading cause of accidental death in the United States, accounting for 63,632 deaths, including 42,249 (66.4%) that involved an opioid (1). In addition, recent evidence suggests that short-term opioid exposure in opioid-naïve patients is associated with long-term opioid use. Among persons with no opioid prescriptions in the prior six months who are prescribed at least one day of opioids, the probability of continued opioid use at one year is 6.0% (2). Further, a prospective study of 12thgrade students followed through age 23 suggested that use of prescribed opioids before high school graduation is independently associated with a 33% increase in the risk of future opioid misuse after high school among patients with little drug experience and who disapprove of illegal drug use (3). Dentists prescribe approximately 6.4 to 8.0% of opioid analgesics dispensed by outpatient US retail pharmacies annually and are the highest percentage prescriber group for patients between 10 and 19 years of age (4,5). Most opioid prescriptions written by dentists for adolescents and young adults are believed to be provided to manage acute pain after third molar extraction. These prescriptions may increase the risk for misuse, abuse and diversion of prescription medication in this age group.
One factor impacting current prescribing practices is the lack of strong evidence-based guidelines for providers regarding optimal dosing schedules and length of time for which analgesics should be prescribed to manage acute pain following minor surgical procedures. The “CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016” provides recommendations for acute pain management, but cites limited evidence to support the acute pain management recommendations (6). The third molar extraction model is a well-established model for studying acute pain and its relief because it is reproducible and permits the study of healthy subjects without other comorbid conditions. While this model has provided evidence of the good analgesic effects of non-steroidal anti-inflammatory drugs (NSAIDs) on the day of surgery (7), there is a need for studies examining the longer-term (up to 7 days) efficacy, effectiveness and safety profiles of analgesics commonly prescribed for acute pain management following surgery.
Further, studies addressing provider decision making in the clinical setting may be necessary to effectively change opioid prescribing practices. Consistent with the American Dental Association’s Interim Board Policy on Opioid Prescribing and the American Dental Education Association’s Policy Brief on The Role of Dental Education in the Prevention of Opioid Prescription Drug Misuse, there is a need to implement clinical decision support systems and other tools to change opioid prescription behaviors towards evidence-based recommendations for acute and chronic pain management. This would include educating dental providers to recognize symptoms of substance misuse/abuse, screen for OUDs, and refer at-risk patients to treatment. When substance misuse/abuse is identified, it is important to prepare dental professionals for meaningful interactions with their patients to promote effective referrals to care. Finally, unclear expectations and subconscious bias of dental professionals and patients for the experience and management of post-procedure pain can lead to ineffective or risky pain management approaches. By prescribing opioid medication dosed for five to seven days (8), providers may inadvertently convey expectations of severe pain lasting many days. Conversely, patients instructed to use analgesics for high levels of pain only may experience breakthrough pain. While providers, patients, and other stakeholders likely share a similar goal--safe and effective post-procedure pain management--questions about how best to ensure such care remain unanswered.
ALIGNMENT WITH INSTITUTE GOALS AND STRATEGIC PLAN
The objective of this initiative is consistent with the NIDCR Strategic Plan 2014-2019: Objective 1-3: Conduct translational and clinical investigations to improve dental, oral, and craniofacial health and
Objective 2-1: Support research toward precise classification, prevention, and treatment of dental, oral, and craniofacial health and disease. This initiative would support clinical research to address the weak evidence for optimal dosing schedules and length of time for which analgesics should be prescribed to manage acute pain following minor surgical procedures. Further, research promoting the dental professional’s role in recognition of substance misuse/abuse symptoms, screening for OUDs, and referring to treatment would be encouraged. In addition, this initiative would support studies testing opioid prescribing risk mitigation strategies, such as the use of Prescription Drug Monitoring Programs (PDMPs) and counseling prior to prescribing opioids, and those exploring dental provider and patient expectations for acute post-procedure pain.
In April 2018, NIH launched the Helping to End Addiction Long-term (HEAL) Initiativeto speed scientific solutions to stem the national opioid public health crisis. Consistent with NIH’s HEAL Initiative, research supported by this concept would address the role of dentistry in overcoming the opioid epidemic. Examples of research opportunities include, but are not limited to:
- Research to determine the seven-day efficacy of different classes of analgesics to reduce acute post-procedure pain after surgical removal of third molars.
- Research to determine the adverse events associated with use of analgesics for up to seven days after surgical removal of third molars.
- Research to determine the optimal medication course and dosage instructions for analgesicsto manage acute pain following minor surgical procedures, such as tooth extraction, root canal procedures, and implant placement.
- Research to determine the impact of pre-surgical non-opioid analgesics on the need for post-surgical opioid analgesics.
- Research to determine the efficacy of non-opioid pharmacologic and non-pharmacologic treatments for management of chronic orofacial pain conditions.
- Research to implement clinical decision support systems and other interventions designed to modify dental providers’ opioid prescribing behaviors towards evidence-based recommendations for acute and chronic pain management.
- Research to identify best practices for dental providers’ interactions with patients to encourage appropriate evidence-based pain management strategies.
- Studies that propose to design and implement OUD screening in dental care settings, to permit appropriate referral to treatment.
- Research to identify best practices for dental providers’ interactions with patients to promote effective referrals to substance misuse/abuse treatment.
- Research to optimize opioid risk mitigation clinical tools, such as those encouraging the use of PDMPs and counseling, prior to prescribing opioids for pain management.
- Research to explore the dental provider and patient expectations to better manage the acute post-procedure pain experience.
To gain more insights about practitioner prescribing practices and patient preferences, studies would include data collection on providers’ decision-making and prescribing practices to manage post-surgical pain, as well as independent data collection from patients about their pre-procedure expectations for acute pain management and post-procedure pain experience, analgesic medication intake, and adverse events. User-friendly mobile data collection technologies would be considered to ensure complete reporting of data at multiple timepoints.
CURRENT PORTFOLIO OVERVIEW
The NIDCR currently supports a small cluster of projects addressing: a) implementation of a clinical decision support system to encourage dental providers to prescribe non-opioid analgesics for acute post-procedure pain management, b) development of a screening tool for OUDs, and c) dental provider opioid prescribing practices for acute pain management, performed in the National Dental Practice-Based Research Network. The current portfolio is insufficient to address the many remaining knowledge gaps stated above.
- Seth P, Scholl L, Rudd RA, Bacon S. Overdose Deaths Involving Opioids, Cocaine, and Psychostimulants — United States, 2015–2016. MMWR Morb Mortal Wkly Rep 2018;67:349–1358. DOI: http://dx.doi.org/10.15585/mmwr.mm6712a1.
- Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use — United States, 2006–2015. MMWR Morb Mortal Wkly Rep 2017;66:265–269. DOI: http://dx.doi.org/10.15585/mmwr.mm6610a1
- Miech R, Johnston L, O'Malley PM, Keyes KM, Heard K. Prescription opioids in adolescence and future opioid misuse. Pediatrics 2015 Nov;136(5):e1169-77.
- Levy B, Paulozzi L, Mack KA, Jones CM. Trends in opioid analgesic-prescribing rates by specialty, US, 2007-2012. Am J Prev Med. 2015;49(3):409-413.
- Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA 2011 Apr 6;305(13):1299-301.
- Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain- United States, 2016. JAMA 2016;315(15):1624-45.
- Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice. J Am Dent Assoc 2013;144(8):898-908.
- Mutlu I, Abubaker AO, Laskin DM. Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal. J Oral Maxillofac Surg. 2013 Sep;71(9):1500-3.