Dentist run the risks of both civil litigation and criminal penalty when prescribing opioids without taking the proper precautions. Dr. Eric S. Bornstein explains how to predictably and safely prescribe opioid medications.
Eric S. Bornstein, DMD
The practice of prescribing opioids as a first-line analgesic for dental pain is thoroughly engrained in many dentists’ thought processes. Prescribing opioids in this manner presents a range of potential malpractice and criminal problems if a patient either becomes addicted, has an adverse drug reaction, or overdoses. The following article presents a series of topics that will assist dentists in safely and predictably prescribing opioid medications to protect patients and themselves professionally from potential criminal and malpractice claims.
The Hippocratic Oath states the following: “I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel…”1
In the United States, there is no doubt that opioids can be a “deadly medicine.” The most recent statistics from the US Centers for Disease Control and Prevention (CDC) state that America has just broken an all-time drug overdose record, with over 100,000 deaths in the 12 months from November 2020 to November 2021.2 The majority of these overdose deaths had an opioid component to them.
It should not come as news to any dentist that opioids are addictive and deadly. In 1867, the first university-affiliated dental school was formed at Harvard.3 Thirteen years later, Obersteiner described chronic morphinism (morphine addiction) as a demon,4 and Hubbard wrote that an opium habit would hold a person in “shackles of steel.”5
Thirty-seven years later, a dental pharmacology textbook (circa 1917) stated the following concerning dentists prescribing opioids and addiction: “No drug except, perhaps, alcohol is more enticing, nor its continued use more liable to form the drug-habit than opium. It is safest for a dentist never to write a prescription for the drug. With a prescription the patient may be relieved from the pain for which the remedy was prescribed, but subsequently he might get the prescription refilled on the least provocation, and thus the habit be innocently formed.”6
Finally, 100 years after the above-published statement, Florine posed this question in the Journal of Oral and Maxillofacial Surgery: “Which would parents choose for their child: a few days of modestly elevated pain or a 1-in-16 chance of starting what could become a lifelong struggle with addiction, however long that life may last? Fortunately, that choice is not necessary because NSAIDs have consistently been shown to outperform opioids for acute dental pain.”7
Dental opioid prescribing and malpractice
I have performed duties as an expert witness both for and against dentists in malpractice and federal criminal procedures in the last 25 years. I have recently worked on two cases on behalf of dentists indicted for incorrect prescribing and dispensing opioids. If I were hired today by a malpractice attorney on behalf of a patient injured from a dentist’s opioid prescription, the statements reproduced above are from some of the papers that I would present to the prescribing dentist during their deposition. The answers to deposition questions from the defendant dentist regarding their understanding of opioids would help the malpractice attorney glean whether the dentist understood the dangers of today’s “uber opioids” such as hydrocodone (Vicodin) and oxycodone (Percocet).
The key for a dentist to never end up in such adversarial legal positions with the prescription of opioids begins with a modern understanding of opioid addiction. A dentist must also understand the current CDC guidelines and Food and Drug Administration (FDA) warnings on the most frequently prescribed opioids.
CDC opioid guidelines
The CDC’s current guidelines for acute postsurgical pain state the following:8
- Nonopioid therapies should be encouraged as a primary treatment for pain management (e.g., acetaminophen, ibuprofen).
- Do not prescribe opioids with other sedative medications (e.g., benzodiazepines).
- Short-acting opioids should be prescribed for no more than three-to-five-day courses (e.g., hydrocodone, oxycodone).
FDA opioid warnings
The tables below list selected essential warnings from the FDA package inserts for opioid medications that dentists must discuss with their patients before prescribing (see tables 1–4).
In July 2020, the FDA announced that all opioids will now include a labeling change mandating the following to prescribers:13 “Discuss the availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with (prescribed opioid). Consider prescribing naloxone based on the patient’s risk factors for overdose.”
Recommendations for malpractice mitigation
I have read multiple malpractice attorney websites that directly ask potential litigation clients (i.e., injured patients) questions based on the aforementioned CDC guidelines and FDA warnings for opioids. The questions from the malpractice attorneys generally take the following forms:
- Did your dentist suggest nonopioid pain medications before prescribing opioids?
- Did your dentist discuss addiction issues with you before prescribing opioids?
- Did your dentist inquire about all other medications you are taking before prescribing opioids?
- Did your dentist talk about the warnings concerning overdose and taking other drugs with opioids before prescribing?
- Did your dentist discuss a naloxone prescription and its significance with you?
I have concluded that the only way dentists can adequately shield themselves from criminal and malpractice claims in today’s environment if they prescribe opioid medications is to (a) enclose a signed informed consent form in the patient record for every opioid prescription, and (b) make sure they scrupulously follow all applicable state and federal laws and guidelines.14,15
Two necessary statements (in my view) in an opioid informed consent document would be the following; each statement followed by the patient’s initials and date:
- Addiction is a disease that occurs in some individuals. Taking opioids does not necessarily cause addiction. However, if you have risk factors for addiction (such as a strong family history of drug or alcohol abuse) or have had problems with drugs or alcohol in the past, you must notify me since using opioid painkillers may increase the possibility of relapse of these problems. The extent of this risk is not certain. I have notified Dr. ___ of any personal or family history of drug or alcohol abuse.
- I am aware that drowsiness or clouded thinking may make it dangerous for me to drive or operate heavy machinery. Alcohol or other medications that also cause drowsiness may worsen this effect and present a significant danger to me if I take it/them with this medication. I have honestly filled out my medical history and current medications forms and have alerted Dr. ___ to any other medications (legal or otherwise) that I may be taking that would add to the sedation and drowsiness effects of opioid pain medication. I agree not to drive or operate heavy machinery or sign legal documents while I am taking these pain medications or if I feel in any way impaired from this therapy at other times.
An adequately written informed consent document will not guarantee that a patient will not do something stupid with the prescribed opioids or prevent a dentist from getting sued. However, it will make a lawyer think twice about a lawsuit if they see that the patient was adequately and correctly informed about the dangers of the medications and given proper instructions.
Therefore, it is my recommendation that:
- All dentists who prescribe opioids take opioid safety CE courses regularly.
- All dentists prescribing opioids to their patients meet with a qualified attorney and have the attorney draw up a legal informed consent document for their jurisdiction and add it to their patients’ records.
If these steps are not taken, a dentist runs the risks of both civil litigation and criminal penalty.
- Adams F. The Genuine Works of Hippocrates. Vol. II. 1849; Sydenham Society.
- Provisional drug overdose death counts. Centers for Disease Control and Prevention. National Center for Health Statistics. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
- Bethell JT, Hunt RM, Shenton R. Harvard A to Z. Harvard University Press; 2004.
- Obersteiner H. Chronic morphinism. Brain. 1880;2(4):449-465.
- Hubbard FH. The Opium Habit and Alcoholism. 1881; AS Barnes & Company.
- Buckley JP. Modern Dental Materia Medica, Pharmacology and Therapeutics, Including the Practical Application of Drugs and Remedies in the Treatment of Disease. 1917; P. Blakiston’s Son & Co.
- Florine BL. Is it time to relegate routine opioid prescriptions to the oral surgery archives? J Oral Maxillofac Surg. 2020;78(1):5-6.
- Postsurgical pain. Centers for Disease Control and Prevention. Reviewed January 31, 2022. https://www.cdc.gov/acute-pain/postsurgical-pain/index.html
- Acetaminophen codeine phosphate final print label. Center for Drug Evaluation and Research. https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/86681_acetaminophen%20codeine%20phosphate_prntlbl.pdf
- Vicodin. Center for Drug Evaluation and Research. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/088058s027lbl.pdf
- Percodan (oxycodone and aspirin tablets, USP). Center for Drug Evaluation and Research. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf
- Ultram (tramadol hydrochloride) tablets. Center for Drug Evaluation and Research. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf
- FDA requiring labeling changes for opioid pain medicines, opioid use disorder medicines regarding naloxone. US Food and Drug Administration. July 23, 2020. https://www.fda.gov/news-events/press-announcements/fda-requiring-labeling-changes-opioid-pain-medicines-opioid-use-disorder-medicines-regarding
- Cheatle MD, Savage SR. Informed consent in opioid therapy: a potential obligation and opportunity. J Pain Symptom Manage. 2012;44(1):105-116.
- Cohen SP, Hooten WM. Balancing the risks and benefits of opioid therapy: The pill and the pendulum. Mayo Clin Proc. 2019;94(12):2385-2389.