Dentistry should be proud of its history of providing responsible pain relief, as well as becoming more cautious in prescribing opioid medications when other safer pharmacologic options exist. Our training directs us to first eliminate the source of dental pain and prescribe analgesics only as adjunctive relief. Prescriptions must be written for a legitimate dental purpose and for a patient of record. Through self-regulation, the dental profession must continue to establish pain management guidelines based on scientific evidence and clinical experience to avoid further regulatory action restricting our prescribing privileges, which remain one of our most powerful therapeutic tools.
Dentistry has been on the forefront of acute pain management for more than 200 years, and continues to have an obligation to focus on “rational prescribing” with their patients.
The opioid use crisis and concerns over controlled substance risk have changed practice patterns throughout health care.
As the role of dentistry has expanded, dentists have an increasing obligation to assess and mitigate risk for their patients, and regulatory agencies are increasingly mandating strategies for risk assessment.
Common violations of legal and regulatory requirements made by practicing dentists are reviewed, and strategies to maximize safe prescribing practices are outlined.
From a public policy perspective, past dental practice patterns have had an impact on the opioid epidemic. In one of the earlier conferences on controlled substance risk within the practice of dentistry, Denisco and colleagues concluded that “dentists cannot assume that their prescribing of opioids does not affect the opioid abuse problem in the United States.” The American Dental Association’s (ADA’s) recent policy on opioid prescribing focuses on the important role in dentistry with respect to minimizing the impact of the opioid crisis. In response to these recommendations, dentists need to understand the legal, regulatory, and ethical environment surrounding dental pain management. As the nature and characteristics of the prescription opioid crisis have evolved, so do the legal and regulatory parameters. Hence, dentists need to keep abreast of advances in pain management practices and policies and guidelines.
History of opioids and pain management
Prescribing patterns for the management of acute pain have changed over the years, ranging from extreme conservatism following the passage of the Harrison Narcotic Act in 1914, which for the first time in US history made the possession of opioid-containing medications illegal without a prescription, to the period of liberal opioid prescribing beginning in the 1990s. At that time, pain specialists and advocacy groups began to complain that government regulations, policies, and pain management guidelines presented barriers to adequate pain relief. As a result, a dramatic increase in demand for prescription opioids occurred, and by 2010, opioid prescribing had increased dramatically with corresponding increases in overdoses and deaths. As a consequence of the current opioid crisis, government and regulatory agencies are now paying close attention to prescribing practices, and this increased scrutiny is affecting the dental profession as well.
All prescribers have a responsibility to minimize the potential for drug misuse and diversion while maintaining legitimate access to opioids for patients in need of such analgesic treatment., , , The ADA statement on the use of opioids in the treatment of dental pain recommends that dentists reduce the need for “just-in-case” prescriptions for dental pain. The statement covers the complexities of modern pain management in dentistry, including the nature of drug addiction, ways to screen patients for potential substance use disorders, and techniques for motivating at-risk individuals to seek appropriate treatment. Additional recommendations of the ADA include following the US Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines for chronic pain when appropriate, using their state’s Prescription Drug Monitoring Program database, completing continuing education, and prescribing nonopioids as the first-line therapy for acute dental pain. The ADA supports statutory limits on opioid dosage and duration of no more than 7 days for the treatment of acute pain, consistent with CDC evidence-based guidelines. The Association’s position is that as a profession, dentists can still do more to keep opioids from becoming a potential source of harm. The ADA also promotes interprofessional cooperation by working together with physicians, pharmacists, and other health care professionals, policy makers, and the public. Recent studies suggest that the specific issues currently facing the dental profession are the disproportionate number of opioid prescriptions written by dentists for teenagers and young adults who are at increased risk of developing substance abuse issues. Dentists are the leading source of opioid prescribing for adolescents and young adults because they are most likely to present with third molar issues. Often patients do not consume the entire prescription and a number of pills are left over and subject to diversion. The adherence with evidence-based guidelines recommending nonsteroidal anti-inflammatory drugs and acetaminophen as first-line analgesics, which are more effective than opioids, will help minimize diversion and opioid misuse.
When required, the prescribing of opioids is appropriate only after risk assessment and cooperation with other medical disciplines. The basic principles of prescribing for the management of dental pain are outlined in Box 1 .
Conduct a medical and dental history to determine current medications, potential drug interactions and history of substance abuse.
Follow and continually review Centers for Disease Control and Prevention and state licensing board recommendations for safe opioid prescribing.
Register with and use prescription drug monitoring programs (PDMPs) to promote the appropriate use of controlled substances for legitimate medical purposes, while deterring the misuse, abuse, and diversion of these substances.
Have a discussion with the patient about responsibilities for preventing misuse, abuse, storage, and disposal of prescription opioids.
Consider treatment options that use best practices to prevent exacerbation of or relapse of opioid misuse.
Consider nonsteroidal anti-inflammatory analgesics or acetaminophen as the first-line therapy for acute pain management.
Recognize multimodal pain strategies for management for acute postoperative pain as a means for sparing the need for opioid analgesics.
Consider coordination with other treating clinicians, including pain specialists, when prescribing opioids for the management of chronic orofacial pain.
Be aware that practicing in good faith and using professional judgment regarding the prescribing of opioids for the treatment of pain should not result in discipline for the willful and deceptive behavior of patients who successfully obtain opioids for nondental purposes. Good dental treatment records should support your prescribing decisions.
Dental students, residents and practicing dentists, and dental hygienists are encouraged to seek continuing education in addictive disease and pain management as related to opioid prescribing.
Despite adhering to these principles, the dentist may be subjected to manipulation, deception, or various types of prescription misuse by the patient, which could result in diversion of opioid pills. These actions come in different forms.
The use of written prescriptions represents a liability for the prescriber, as the script can be altered or forged. A survey from West Virginia documented the various ways that opioids can be illegally obtained in the dental practice (see Box 2 ).
Fake pain symptoms: 43%
Patient claims lost/stolen prescription: 28%
Forged written prescription: 14%
Altered pill number: 14%
Fake prescription call-ins: 9%
Stolen prescription pads: 9%
Altered numbers on prescriptions: 9%
Electronic prescribing, allowing prescribers to electronically write prescriptions for controlled substances and permitting pharmacies to receive, dispense, and archive these e-prescriptions will help to curb these abuses. Electronic prescribing for controlled substances (EPCS) will also provide more robust audit trails and “identity proofing” responsibilities for prescribers and vendors. E-prescribing is legalized in all states and the District of Columbia with 82% of retail pharmacies fully enabled to accept these electronic prescriptions. E-prescribing is not mandated by the federal government; however, states are empowered to regulate prescribing. For example, in New York State, EPCS is required for both legal and controlled substances; however, adoption has been slow because of implementation complexities. In Massachusetts, mandatory electronic prescribing has been delayed until January 1, 2021.
The ADA has stated that dentists who are practicing in good faith and who use professional judgment in prescribing opioids for the treatment of dental pain should not be held responsible for the willful and deceptive behavior of patients. Dentists still need to be aware of these deceptive practices and make every effort to avoid the 2 most common deceptions: diversion and doctor shopping. Good treatment records documenting findings, diagnoses, and treatment plans will help support the dentist’s decision to prescribe opioids when appropriate.
Drug diversion is defined as the intentional transfer of a substance outside the guidelines set forth by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), state licensing boards, and prescribing health care professionals. Drug diversion is typically motivated by money or a substance use disorder. Controlled substances can be diverted at several steps along the course from manufacturer to patients and beyond. (p2) Excessive prescribing contributes to drug diversion, as unused medications increase available inventory subject to potential abuse. Dentists are obligated to prescribe in a responsible manner, guarding against diversion while ensuring that patients have an adequate supply of analgesics for control of dental pain. Dental practices are targets for patients with substance use disorders who attempt to inappropriately obtain controlled substances for nondental purposes, creating a challenge to determine which patients are presenting for legitimate dental purposes and which are presenting with the conscious goal of feigning discomfort to obtain controlled substances.
Doctor shopping is a common technique used by patients whereby they frequent multiple providers complaining of the same problems to obtain multiple controlled substance prescriptions either for themselves or others. Although it is not possible for the dental practitioner to screen out all drug seekers, a thorough clinical examination, review of states’ prescription drug monitoring programs (PDMPs) and documentation will help protect and support the dentist should scrutiny by the DEA, licensing authorities, or law enforcement occur. Strategies to mitigate risk should include documenting clinical and radiographic findings, asking patients for photo identification, and formulating a diagnosis and treatment plan, even if the treatment plan is as simple as referring to a specialist. Dental hygienists and other staff members are often an excellent source of information on patient drug-seeking behavior. An observant front desk receptionist may be in the best position to notice unusual or aberrant behavior and can pass this information along to the dentist. (p145−146)
Prescription Drug Monitoring Programs
PDMPs provide one of the most important vehicles for risk mitigation, and details of these programs are discussed in “ Special Screening Resources: Strategies to Identify Substance Use Disorders, Including Opioid Misuse and Abuse ” by Keith and Hernández-Nuño de la Rosa in this issue. The issue of liability for using or not using the PDMP databases has not been clearly defined in all jurisdictions and depends on the current laws of each state. Nonetheless, the prescribing dentist does have a duty to warn the patient about the adverse effects of the medications prescribed, and practice with reasonable care and in good faith when prescribing medications for pain control. ,
PDMP databases can ensure safe and effective pain management for their patients. They also provide an excellent opportunity to discuss these risks with the patient. The dentist should check with their state dental societies and licensing boards for up-to-date information on applicable state regulations. Although prescribers are not required to obtain the patient’s permission to access the PDMP in most states, it is recommended that the prescriber initiate a conversation with the patient, as well as cotreating, and the patient’s other health care providers. If significant misuse or abuse is suspected about the PDMP search, dentists also are within their rights to contact the DEA or the local police department. As with all communications, patient care is maximized, and the dentist’s risk is reduced when any of these actions are fully documented.
Proper documentation is the professional and legal responsibility of all dental practitioners. Not only do dental records provide for continuity of care when treatment is transferred from one provider to another, but they provide a legal record to document that care has been provided according to professional standards. It is important to remember that judges, juries, dental board members, and lawyers maintain that “if it wasn’t documented, it wasn’t done.” This policy applies to all visits, telephone conversations with patients and other care givers, prescriptions, and other clinically related issues. Accurate dental records are essential not only when documenting treatment but also when prescribing medications. (p171) Typically, it is beneficial to record exact quotes from the patient, conversations with treating providers, and contacts with law enforcement.
Specific documentation for a controlled substance treatment plan also is essential. Some states require a written informed consent before prescribing opioids even for short-term treatment of acute dental pain. States are legislating the prescribing of opioids more frequently and more aggressively with limitations on the amount of medication that can be prescribed, and the steps prescribers need to take to avoid diversion. For example, Massachusetts requires that the PDMP be queried every time a Schedule II or III medication is prescribed and limits the quantity of an initial opioid prescriptions to a 7-day supply. In addition, Massachusetts requires that dentists discuss substance abuse risks, disposal of unused medication, and the option to have prescriptions filled for fewer quantities when prescribing Schedule II medications. It is important to document in the patient treatment record that this discussion has taken place.
Treatment agreements addressing the clinician and patient rules for prescribing, using, and refilling controlled substances are common when opioids are written on a chronic basis. Although less common in dentistry, patients taking opioids under supervision of their primary care physician, pain specialist, or addiction specialist will have a controlled substance agreement in place. The general terms include provisions that the patient agrees to get prescriptions from only 1 prescriber; use 1 pharmacy; not use alcohol, other opioids, or illicit drugs or substances; submit to pill counts and random urine tests; and agree to participate in other treatments as indicated. If a patient has an agreement of this sort and requires dental surgery for which an opioid may be necessary, it is incumbent on the dentist to check with the primary prescriber to discuss a time-limited and dose-limited increase in opioids for the postoperative period.
Dentists always practice “universal precautions” with respect to infection control. It is now strongly recommended that they adopt similar practice precautions when considering prescribing an opioid pain medication for a patient. The use of the Risk Assessment Checklist, as outlined in ” Dentistry’s Role in Assessing and Managing Controlled Substance Risk: Historical Overview, Current Barriers, and Working Toward Best Practices by Dhadwal and colleagues in this issue, ensures that all aspects of the decision-making process from initial examination and assessment to writing the prescription and subsequent follow-up are conducted in a safe, efficient, and responsible manner.
Disposal of controlled substances
When prescribing controlled substances, many states now require practitioners to advise patients how to store and dispose of unused medications in a safe fashion. Most police stations and many pharmacies have disposal bins in their lobbies where the public may dispose of unused medication with no questions asked. The FDA has specific recommendations regarding the disposing of controlled substances. The prescription bottle label should be removed or scratched out with a marker to cover up any identifying information. (p153)
Common regulatory violations by dental practitioners
Abuse, misuse, and diversion sometimes occur when dentists prescribe controlled substances for themselves, staff, family, or friends who are outside the scope of dentistry. Dental boards are known to discipline dentists for prescribing outside the scope of their practice even for antibiotics and cough and cold medication. Excessive prescribing of controlled substances even for patients of record, if not substantiated in patients’ records, could result in serious consequences, including referral to the DEA. (p170) For those dentists personally suffering from a substance use disorder, the temptation to abuse one’s prescribing privileges can have disastrous consequences.
The DEA’s mission is to enforce the controlled substances laws and regulations. The agency can initiate a practice inspection if a violation of these laws is suspected. Furthermore, a review of the dental practice’s opioid prescribing history can become a part of a dental licensing board’s inspection initiated as a result of other dental practice license violations (eg, infection control). Many states also require the dentist to complete biennial training on safe and effective opioid prescribing/pain management. Even if a dentist does not write prescriptions, Massachusetts requires that the dentist maintain a valid controlled substance state registration for the sole purpose of ordering/replenishing the emergency drug kit required for each dental office. It is each dentist’s responsibility to know what is expected to comply with state and federal regulations.
The best way to prepare for DEA or state licensing board inspections is to maintain accurate and comprehensive practice and dental treatment records that demonstrate that one has prescribed within the accepted standard of care. Should a dentist keep controlled substances in his or her office, regulatory agencies will want to be convinced that this is being done in a safe and secure manner. The DEA has a standing policy not to interfere with the doctor-patient relationship and dictate how providers prescribe. On the other hand, should a dentist be an outlier, that is, prescribing many more opioids than similar providers, or prescribing or giving refills without an examination, he or she will receive heightened scrutiny by the DEA. Dentists’ treatment records should support their clinical decisions to prescribe. Care should be taken to document the findings, diagnosis, and treatment plans, and to assess pain levels and obtain informed consent when prescribing opioids. Although use and documentation of PDMP results is required in most states, the issue of liability for using or not using the PDMP databases has not been clearly defined in all jurisdictions. A brief review of the DEA Web site of cases that this agency brought against prescribers during 2004 to 2019 identifies a series of cases involving dentists. Box 3 lists common issues reported in legal cases before the DEA. Details involving each individual case may vary. Some allegations involve illegal distribution and trafficking of controlled substances, record-keeping violations. money laundering, prescribing opioids for sex, and involvement in a “pill mill.” Box 4 lists specific details for several complex cases that involved controlled substances and the practice of dentistry.