Opioid addiction and abuse is an epidemic in the United States today. Physicians face competing medical legal pressures for both under prescribing and over prescribing these medications. I have asked Dr. David Sohn JD, MD, to give his expert opinion on how to navigate these risks.
By: Justin A. Julian, Kristin A. Toy, David H. Sohn
Abstract
Context
Prescription drug abuse and overdose is an epidemic in the United States, creating pressure for physicians to decrease use. At the same time, patients and consumer advocacy groups continue to demand narcotics to control pain, even when the amounts seem excessive. This has created an environment where there are legal risks both for overprescribing, as well as underprescribing, opioid pain medication. This paper reviews these risks and the underlying law and legal precedents in order to help physicians navigate between these competing pressures.
Objectives
This paper is a comprehensive review of the current medical legal environment surrounding the prescribing of narcotic pain medication and suggestions to navigate between these competing pressures.
Methods
We performed MEDLINE, PubMed, Google Scholar, Google News, and DEA and CDC website searches with keywords ‘‘painkiller’’, ‘‘opioid’’, “opioid epidemic”, ‘‘overprescription’’, ‘‘underprescription’, ‘‘lawsuits’’, and “malpractice” to obtain public policy studies, law review articles, news reports, case analyses, and healthcare review articles.
Results
Risks for underprescription include civil lawsuits for negligence and elder abuse. On the other hand, healthcare providers have been found liable for overprescription in cases of illegitimate prescription, addiction, overdose, and when third parties are affected.
Conclusion
The liability surrounding the prescription of controlled substances has been expanding beyond traditional negligence. It is in the best interest of the provider and his patients to navigate these pressures using pain prescribing protocols. Many guidelines from government bodies exist to supplement individual hospital protocols as well.
Introduction
The control of postoperative pain has been a challenge for physicians. Pain can complicate clinical outcomes and reduce one’s quality of life significantly; therefore, it is necessary to be adequately treated. However, it is also clear from the current opioid epidemic that U.S. physicians are prescribing too many opioids, leading to excess pain pills in bathroom cabinets, which then become diverted to illegitimate uses. As such, there are new legal pressures on physicians at both federal and state levels to decrease their prescriptions of opioid pain medications. However, there continues to also be pressures from patients and consumer advocacy groups to adequately treat pain, and they have turned to both the courts and state medical boards to sue and censure physicians who they feel have inadequately treated them. Physicians then are caught between two competing legal pressures: medical-legal risks of under prescribing and medical-legal risks of over prescribing opioid pain medication. This paper is a comprehensive review of the current medical-legal environment surrounding the prescription of narcotic pain medication and suggestions to navigate between these two competing pressures.
Background
In 1997, the American Pain Society introduced the concept of pain control as a basic right of patients. The Joint Commission of Accreditation of Hospitals Organization (JCAHO) codified this in 2001 with the Pain Management Standards and the campaign for “Pain as the Fifth Vital Sign.” Suddenly, physicians were being pressured from both patients and their hospital administrators to control pain as an outcome measure. Consequently, opioid prescriptions increased almost 10 fold in the next decade (1). In 2013, a survey by the Department of Human and Health Services (HHS) concluded that 69.9% of abusers received their narcotics from a doctor, or from a family member who was prescribed medications. Thus, legitimate physicians have unknowingly become the major source of abused opioids in the United States (2).
Now, the United States physician writes on average 82.5 opioid prescriptions per 100 people (3). Additionally, the number of opioid prescriptions has quadrupled from 1999-2014, despite no increase in the amount of pain Americans report (4). One in four of these patients will struggle with addiction (5), which in turn has led our nation to be faced with a severe drug overdose epidemic. From 2000 to 2014, opioid overdose mortality has increased by 200%, and in 2014, the number of drug overdose deaths reached a new high at 28,000, surpassing traffic accidents as the leading cause of accidental death (6). The social impact is also apparent as adolescent usage doubled from 1994-2007 and female overdose mortality increased almost twice as much as males from 1999-2010 (7).
The increase in prescriptions also has severe financial consequences. The {, 1991 #28}Center for Disease Control and Prevention estimated that in 2012, the cost of prescription opioid abuse was around $62 billion dollars. One study estimated that the mean excess costs due to opioid abuse were from $14,054 to $20,546 for patients with private insurance and $5874 to $15,183 for patients with Medicaid (8). This is in part due to the high rate of emergency services used for people with addiction: one thousand emergency room visits per day are due to overdose (9).
The resulting opioid epidemic has created significant legal pressures on physicians to decrease opioid prescriptions. However, at the same time there have been several innovative lawsuits against physicians for not prescribing enough pain medications. This paper reviews the current legal risks to both overprescribing and underprescribing pain medications.
Methods
We performed MEDLINE, PubMed, Google Scholar, Google News, and DEA and CDC website searches with keywords ‘‘painkiller’’, ‘‘opioid’’, “opioid epidemic”, ‘‘overprescription’’, ‘‘underprescription’, ‘‘lawsuits’’, and “malpractice” to obtain public policy studies, law review articles, news reports, case analyses, and healthcare review articles.
Results
Risk of Underprescription
Despite the current opioid crisis, there have been successful innovative lawsuits against physicians for the underprescription of opioid pain medications.
Negligence and Elder Abuse Lawsuits
In 2001, an 85 year old male with terminal lung cancer, respiratory disease, and suspected metastatic back pain was admitted to a hospital. The family requested around the clock administration of IV Demerol, whether the patient was awake or not. The internist refused due to the risk of respiratory depression and death, preferring instead to prescribe the powerful opioid on an as needed basis. The family sued. Initially, they failed to establish any type of breach of duty, as all expert witnesses and the California Medical Board all agreed that the internist met the standard of medical care owed to the patient. Normally, that would be the end of the case. However, the plaintiff’s family sued under a novel theory of elder abuse. Elder abuse statutes were written to prevent nursing homes from neglecting their elderly patrons and ensuring that they would be checked on regularly to prevent starvation, dehydration and sitting for extensive periods of time in feces and urine. However, an innovate plaintiff’s attorney used these statutes to argue that internist violated elder abuse statutes by not prescribing IV Demerol on a continuous basis. The plaintiffs were successful, and were awarded $1.5 million by a jury of their peers. (14).
Similarly, in 1991, a nursing home in North Carolina was found guilty of negligence to provide proper treatment for a 74-year-old man suffering from metastatic prostate cancer. The patient had his treatment reduced and substituted with headache medication and placebos once he arrived at the nursing home despite multiple protests and the original prescriber following an established WHO guideline. The plaintiffs were awarded $15 million. More importantly, this started the conversation on whether a care provider could be found liable for the suffering of a patient who does not receive adequate pain treatment (13).
Interestingly, underprescription is not considered a malpractice claim by definition. Malpractice alleges a deviation from standard of care that results in damages. It is defensible by adherence to standard of care, and is covered by malpractice insurance. This is a new form of liability, stemming in part from California’s Patient Bill of Rights which states: “[a] patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain” and “[b] patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her severe chronic intractable pain.”
State Board Disciplinary action
Lawsuits are not the only legal pressures which physicians may be subjected to with underprescription complaints. State medical boards can and have disciplined physicians with fines, suspension of licensure, and remedial classwork.
In 1999, the Oregon Board of Medical Examiners disciplined a doctor for not prescribing enough narcotics for six patients. Two of the patients included an 82-year-old male with CHF who stated, “he could not breathe” and wanted narcotics, and a 35-year-old female on a ventilator who wanted pain medicine and anxiolytics for “wheezing.” Again, there was no liability here based on failure to provide the normal standards of care. This was prosecution beyond traditional negligence. The physician was ordered to complete communication training, a physician education program, and a psychiatric evaluation as part of his retraining process. As with the previous cases mentioned, prescribing or increasing opioid dosage would have put the patients’ lives at risk (15).
Patient Satisfaction
On top of the pressure from lawsuits and disciplinary action, many pressures to prescribe more can come from the patients themselves. Patients may equate good care with more pain medications, and they may disparage doctors who are not liberal with prescribing them. Also, patients often exhibit behavioral challenges when their medication is tapered. He or she may feel desperate and overwhelmed, and will attempt to convince the prescriber to revert back to the normal usage. If not agreed upon, the patient may accuse the physician of a lack of empathy (“You don’t believe I have real pain”) and arguments about poor quality of pain care with threats to complain to administrators (16).
In these cases, it is often helpful to have a pain medication prescribing protocol agreed upon prior to surgery. This involves the patient ahead of time of what medication will prescribed, and at what intervals. It respects autonomy, and also demands the patient to uphold their obligation to taper their usage. It shifts the discussion from a patient pleading for empathy and more medication to a more shared understanding. In drafting such protocols, it is suggested to stay updated with the most current guidelines on painkiller use through the CDC and state. Additionally, the most effective tool may actually be building a proper rapport with patients and maintaining consistent communication. Many lawsuits filed are a product of a patient’s misconceptions of proper care not matching a physician’s (17).
Risk of Overprescription
When a physician underprescribes, he or she may face monetary and licensure risks. However, criminal liability can result from the risks of overprescription. Over 240 criminal cases have involved convicted physicians from 2004 to March 31, 2016 (18). And, of course, there are the same risks of lawsuits and loss of licensure.
Addiction Liability
A recent West Virginia Supreme Court decision affirmed that opioid addicts can sue their physicians and pharmacies for getting them addicted. In 2015, 29 plaintiffs who were admitted drug addicts and criminals sued four physicians and three pharmacies for their addiction to controlled substances. The West Virginia Supreme Court ruled that patients who become addicted are able to sue pharmacies and doctors for addiction related damages even when the plaintiffs themselves were using the medications in a criminal way. The case upheld that the defendants (physicians and pharmacists) might be responsible for causing or contributing to the plaintiff's addiction and thus their related criminal actions. (19). The ruling that addiction can be the fault of the physician sets a dangerous precedent that has yet been untested. While this is a landmark case in that it is the first time physicians have been ruled liable for ‘causing’ addiction, there have been a number of cases in which physicians have been sued or even prosecuted for their negligence concerning overdose.
Overdose Liability
Doctors may also be sued for when patients overdose on the pain medications prescribed. In April of 2012, a woman in Maine sued her family physician after temporary respiratory depression led to brain damage during sleep. The defending physician was found liable, and $1.9 million dollars in damages was awarded.
Similarly, in May of 2012, an Alabama jury found a physician liable when his patient overdosed and died. The surviving husband sued, and was awarded $500,000 in damages (20).
Criminal charges may also be brought against physicians in overdose cases. One recent case involves a California physician in 2015 who was sentenced to 30 years in prison for second-degree murder. She was accused of negligence due to ignoring numerous ‘red flags’. Overall, there was an estimated 8 overdose deaths, and more than a dozen illegal prescription counts. These rulings highlight the range of guilt by which a physician can be accused for patient overdose: simple lawsuits to murder charges (21). Again, prescribing according to protocols based on the CDC guidelines protect against this scenario. Protocols tie dispensation to legitimate medical uses, preventing accusations of negligence and lack of oversight.
Third party liability
Another risk that can come from over prescription is third party liability. In Massachusetts in 2007, a physician prescribed oxycodone to a 75 year-old male with metastatic lung cancer. The patient fell asleep at the wheel and struck a pedestrian, who then sued the physician for negligently prescribing narcotics without warning of possible sedative side effects. The appeals court found that physicians do have a duty of reasonable care to everyone foreseeably put at risk by the medications prescribed (22). Physicians can be liable if the drugs or combinations of drugs they prescribe are inappropriate or if they do not warn of possible side effects (23). For this reason, dispensation of pain meds should be accompanied by documented warnings of impairment when driving.
Legitimacy of prescription liability
The third and most obvious form of liability directly involves the DEA’s interpretation of the CSA that controlled substances can only be prescribed “for a legitimate medical purpose” and “within the usual course of professional practice”. For instance, in 2015 in Delaware, 2 undercover agents were able to receive controlled substances without having any examinations or tests performed and providing no medical history, resulting in prison sentences (24). Many states require as part of professional standards that a physical exam accompany the dispensation of narcotics. In an interpretation of the Intractable Pain Treatment Act, a physician found to prescribe controlled substances without a physical examination or indication that the drugs were therapeutically required is guilty of unprofessional conduct warranting the revocation of his license (25). Other examples of physicians receiving varying prison sentences in 2015 have occurred in Florida, Alabama, Utah, California, and Kansas.
Overprescribing, as judged by standard of care by state medical boards, has also led to censure, fines, and restrictions on licenses to practice medicine by state medical boards. One pain management doctor treating patients with intractable pain was placed on 2 years probation, received a $4000 fine, and was sent to remedial courses for prescribing excessive amounts of opioids. This was based on testimony of two doctors who were not pain management experts (26). In another case, an Arkansas doctor was placed on 1-year probation. The physician was required to take 50 hours of continued medical education, was restricted from prescribing narcotics, and was subjected to frequent medical board monitoring (27).
The largest of all DEA initiatives occurred in 2015 under the creative name Operation Pilluted. The operation included 280 arrests (including 22 doctors), 4 states (Arkansas, Alabama, Louisiana, Mississippi), and a 15-month operation involving over 1000 federal agents. Search warrants were issued based on phone calls and complaints about exceedingly easy access to oxycodone, xanax and Percocet (28).
Discussion
The single most important tool to navigate the medical legal risks of underprescription and overprescription is to prescribe according to protocols. This protects against underprescription risks by involving the patient at the beginning of the pain plan, and respects their autonomy in the health care process. On the other hand, protocols protect against overprescription risks by tying medications to legitimate medical purposes. This avoids the perception of arbitrary and careless prescribing.
Use Established Guidelines
The most important guideline to consider is the DEA’s interpretation of Title 21 United States Code Controlled Substances which states that prescription can only be issued for 1) a “legitimate medical purpose”, 2) by a registered physician, acting 3) within the usual course of professional practice. With these overarching regulations, the CDC and WHO have released updated recommendations and manuals for physicians.
In early 2016, the CDC released updated guidelines for prescribing opioids for chronic pain management. A total of 12 recommendations and rationales were issued and fall into three areas; 1) determining when to initiate or continue opioid use, 2) opioid selection, dosage, duration, follow-up and discontinuation, and 3) assessing risk and addressing harm of opioid use (29). A decision tree regarding the CDC guidelines is summarized in Figure 1. The issue of narcotics has varied worldwide, and so too have the regulations. It is important to consult guidelines outlined for where one is practicing. For instance, the World Health Organization has published its own guide to prescribing drugs (30).
Several states are also taking steps towards establishing stricter guidelines and protocols for opioid prescriptions. For example in 2017, Ohio signed into legislation new guidelines regarding the treatment of acute pain. New opioid prescriptions are limited to a maximum of 14 days for adults; the dose cannot exceed 30 Morphine Equivalent Daily Dose (MED) per day. If pain persists, re-evaluation is required at 14 days and 6 weeks through the use of standardized pain assessment tools and OARRS checks. If chronic therapy is warranted, a maximum of 80 mg MED per day is to be used, and functionality and re-evaluation is to be evaluated every 3 months.
Document
When prescribing, document a physical exam, and document the discussion of risks of respiratory depression and driving while on sedative medications. These can be included in the protocol itself. When stopping pain medications due to findings of abuse, document this as well to prevent later claims of abandonment.
Remaining educated
The legal and medical landscape regarding painkillers is an ever-changing one. What was once considered appropriate one year may be completely reversed the next. It is vital to the protection of the physician and the health of patients to remain updated on these issues. In order to do so, we suggest making this a regular topic of focus in Continued Medical Education courses, grand rounds, or personal literature searches.
Conclusion
The prescription of controlled substances poses a great challenge balancing between a valuable therapy and a powerful threat. While much of the focus on this epidemic has been on the patients, little has been discussed regarding the responsibilities of those prescribing the medication. It is important to be aware of the liability one carries when in a situation where opioids are an option and what can come of improper disbursement. Across the United States, court cases have highlighted this expanding risk on prescribing a patient too much or too little medication. Risks for underprescription include civil lawsuits for negligence and elder abuse. On the other hand, healthcare providers have been found liable for overprescription in cases of illegitimate prescription, addiction, overdose, and when third parties were affected. To mitigate these risks, a physician should follow a comprehensive protocol and guidelines established by the CDC, and remain educated on the current trend of legal precedents surrounding the topic. If properly followed, physicians will be better able to provide the care their patients require, while avoiding any ill consequences on either side of the stethoscope.
References
1. Baker DW. History of The Joint Commission's Pain Standards: Lessons for Today's Prescription Opioid Epidemic. JAMA 2017;317:1117-1118.
2. Results From The 2013 National Survey on Drug and Health: Summary of National Findings. In: Services USDoHaH, ed. Substance Abuse and Mental Health Service Administration: 2013.
3. Paulozzi LJ, Mack KA, Hockenberry JM, Division of Unintentional Injury Prevention NCfIP, Control CDC. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb Mortal Wkly Rep 2014;63:563-8.
4. Chang HY, Daubresse M, Kruszewski SP, Alexander GC. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010. Am J Emerg Med 2014;32:421-31.
5. Boscarino JA, Rukstalis M, Hoffman SN, et al. Risk factors for drug dependence among out-patients on opioid therapy in a large US health-care system. Addiction 2010;105:1776-82.
6. Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. 2016. Accessed 50-51, 64.
7. Prescription Painkiller Overdoses: A Growing Epidemic, Especially Among Women. In: Center for Disease Control and Prevention, Atlanta, GA: 2013.
8. Meyer R, Patel AM, Rattana SK, Quock TP, Mody SH. Prescription opioid abuse: a literature review of the clinical and economic burden in the United States. Popul Health Manag 2014;17:372-87.
9. Crane EH. Highlights of the 2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. In: The CBHSQ Report, Rockville (MD): 2013.
10. Booth M. Opium: A History, St. Martins Press, 1986.
11. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: controversies, current status, and future directions. Exp Clin Psychopharmacol 2008;16:405-16.
12. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res 2013;6:683-9.
13. Estate of Henry James v. Hillhaven Corp. In: CVS, North Carolina Supreme Court, 1991:64.
14. Bergman v. Wing Chin, MD and Eden Medical Center. In: California Supreme Court, 1999.
15. Oregon Board Disciplines Doctor for Not Treating Patients' Pain. In: The New York Times, 1999.
16. Group WSAMDs. Interagency Guideline on Opioid Dosing for Chronic Non cancer Pain. In: Washington State Agency Medical Director's Group, 2010:55.
17. Sohn DH. Negligence, genuine error, and litigation. Int J Gen Med 2013;6:49-56.
18. Cases Against Doctors. In: U.S. Department of Justice DEA, ed. U.S. Department of Justice, Drug Enforcement Administration., 2016:101.
19. Tug Valley Pharmacy et al v All Plaintiffs. In: LEXIS, West Virginia Court of Appeals, 2015.
20. Physician liability: When an overdose brings a lawsuit. In: amendnews.com, American Medical Association, 2013.
21. Gerber M, Girion L, Queally J. California doctor convicted of murder in overdose deaths of patients. In: Los Angeles Times, Los Angeles: Los Angeles Times, 2015.
22. Coombes v. Florio. In: Massachusetts, Supreme Judicial Court of Massachusetts, Norfolk, 2007.
23. Melville NA. Ability to Drive a Critical Concern in Opiate Prescribing. In: Medscape, Medscape, 2014.
24. Rose A. Delco doc convicted of 99 drug counts in pill mill case. In: Delaware County Daily Times, Delco County Daily Times.
25. Kolnick v. Board of Medical Quality Assurance. In: California Court of Appeals, 1980.
26. Hoover v. Agency for Health Care Administration. In: Florida Circuit of Appeals, 1996.
27. Hollabaugh v. Arkansas State Medical Board. In: Arkansas Circuit of Appeals, 1993.
28. Officer PI. DEA Announces Largest-Ever Prescription Drug Operation. 2015. Available from: https://www.dea.gov/divisions/no/2015/no052015.shtml. 2016.
29. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. Mmwr Recommendations and Reports 2016;65:1-49.
30. Vries TPGMd, Henning RH, Hogerzeil HV, Fresle DA. Guide to Good Prescribing. A Practical Manual. In: World Health Organization Action Programme on Essential Drugs, Geneva: 1993.
A special thanks to Charles Jake, our Associate General Counsel at the Office of Legal Affairs, here on the Health Science Campus at the University of Toledo Medical Center for his review of this article.