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Annemarie Daly Linares
excerpted from: Annemarie Daly Linares, Opioid Pseudoaddiction: a Casualty of the War on Drugs, Racism, Sexism, and Opiophobia, 15 Quinnipiac Health Law Journal 89 (2011-2012) (261 Footnotes Omitted)(Student Note)
Pain is one of the most pervasively dreaded of all of the symptoms of illness, and yet, the under-treatment of pain occurs frequently. In the United States, under-treated pain occurs in sixty to seventy percent of patients. Since the 1990's, organizations like the American Pain Society have brought the issue of under-treatment of pain to national attention. In 2000, because of increased national attention on pain, the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) adopted minimal pain management standards for healthcare institutions. The U.S. Congress even emphasized the need for adequate pain control by designating the years 2001 to 2010 the Decade of Pain Control and Research. Despite these efforts, the epidemic of under-treated pain, however, continues today.
There is an imbalance between the current war on drugs and the war on pain. The war on pain is undergirded by legitimate opioid prescribing. Opioid medications produce analgesia by binding to opiate receptors in the brain. Individuals that use opioids recreationally are also familiar with their potential for a euphoric effect. The manner in which the Drug Enforcement Agency (DEA) currently fights the war on illicit opioid drug use undermines the war on pain. The war on pain is fought to preserve the pain patient's right to receive the most efficacious pain therapy available to treat his or her pain. Inadequate pain treatment has harmful physical effects including the development of chronic pain, and destroys people's autonomy, dignity, and decision-making capacity. Chronic pain affects one third of the U.S. population annually. The economic cost of inadequately treated chronic pain in the U.S. is estimated at $100 billion annually. Chronic pain is an epidemic leading to vocational, social, and familial malfunctioning of the individual. Opioid pseudoaddiction, which stems from inadequate pain treatment, is a casualty of racism, sexism, and the war on drugs. This Note offers a proposal for reform to win the war on pain without undermining the DEA's war on illegal drug use.
This Note will primarily address chronic pain since long term, high dose opioids are most controversially used for chronic pain. Chronic pain is pain lasting longer than the usual time period expected for tissue healing, usually more than 3-6 months. Chronic pain, unlike acute pain, has no adaptive purpose; it serves no other purpose than suffering.
The most common patient complaint upon seeking medical attention is pain. While the currently available therapies can relieve up to 90% of patients in pain, physicians are unable to take full advantage of the available therapies leaving their pain patients suffering. Inadequately treated pain patients may turn to illicitly obtained opioids to self-medicate their pain. Opioids are currently the most effective method of treatment for managing moderate to severe pain. Although opioids are still underused, the use of opioids has increased ten-fold over the last twenty years because of the pain advocacy movement.
An interesting medical syndrome, opioid pseudoaddiction, has emerged as a result of physician underutilization of opioids for pain treatment. Weissman and Haddox introduced the term opioid pseudoaddiction in 1989 to describe an iatrogenic syndrome of behavioral changes similar to those seen in opioid addiction. The war on drugs causes opioid pseudoaddiction by deterring physicians from adequately prescribing opioids for the treatment of pain.
Opioid pseudoaddiction describes a syndrome in pain patients who falsely appear to be addicted to opiates. Patients with opioid pseudoaddiction appear to be addicted to opiates because their physicians prescribed inadequate opioid doses causing oligoanalgesia - inadequate pain relief. Inadequately treated pain patients with pseudoaddiction may demonstrate the same drug seeking behavior as those individuals with true opioid addiction. Drug-seeking behaviors include using illicitly obtained opioids, deceiving physicians and pharmacists by losing prescriptions or claiming that pharmacies shorted them, or doctor and pharmacy shopping to obtain duplicate prescriptions. Unlike in true opioid addiction, however, where drug-seeking behaviors persist despite adequate pain relief, drug-seeking behaviors subside in opioid pseudoaddiction when patients achieve adequate pain relief.
In contrast to those with opioid addiction, whose function deteriorates when given more opioids, those with opioid pseudoaddiction function better both physically and psychologically when given optimal opioid pain management therapy. The cure for pseudoaddiction requires an optimization in opioid therapy to produce adequate pain relief. Weissman and Haddox propose two steps for prevention and treatment of pseudoaddiction. In the first step, the healthcare provider must trust the patient's report of pain. In the second step, the healthcare provider then optimizes the patient's pain management therapy. This Note proposes that physicians take these two steps only after utilizing appropriate measures to assess the patient's risk for diversion, drug misuse, and abuse such as using screening questionnaires, checking electronic scheduled drug dispensing databases, and performing urine toxicology screens for opioids and illicit substances. Patients receive the majority of diverted drugs from a single physician and most often share these drugs among family and friends. Studies suggest that quantitative urine drug testing is the best method to determine the use of illicit drugs and the presence of diversion versus patient compliance with prescribed opioid dosing.
Another method to counter diversion involves physician-patient contracts. Physicians also frequently employ physician-patient opioid contracts prior to prescribing an opioid drug. These common patient-physician agreements lay out both the dangers of abusing, misusing, and diverting opioid medications and the responsibilities of the patient. Patients' commitment to their responsibilities is important because patient nonadherence to physician instructions regarding medication use significantly contributes to opioid medication-related deaths. Physician-patient opioid contracts normally contain the following requirements: patients must seek opioid prescriptions from a single provider, have opioid prescriptions dispensed from a single pharmacy to allow for ease of monitoring and prevention of duplicate prescriptions, keep their medications away from others who might illegally use or sell them, submit to random urine drug testing, and avoid misusing their extended release medications by crushing or biting them to achieve a surge of drug effect. Although opioid contracting affects physician liability and documents informed consent of the patient, opioid contracting alone has not been shown to definitively deter opioid drug abuse.
The Background section of this Note will discuss the Controlled Substances Act (CSA), physician persecutions, racism, sexism, and opiophobia as they relate to the under-treatment of pain and development of opioid pseudoaddiction. Then this Note will discuss willful blindness as it relates to physician persecution. The Reform Proposals section will develop a proposal for reform, incorporating education and research, cooperation between the DEA and physicians, a safe harbor for physicians from criminal prosecution, tort liability for under-treatment of pain, reform of organizational standards, pharmacy reform, and a greater role for state medical boards in pain management policy and monitoring.
Background: Opioid Pseudoaddiction
Controlled Substances Act
The war on pain has become a casualty of the war on drugs. A small population of drug abusers now dictates the policy for a much larger population of pain sufferers. Ushering in the war on drugs under President Nixon, the Controlled Substances Act (CSA), passed in 1970, classifies drugs according to addiction potential into schedules I-V. Schedules I-V describe the addiction potential of controlled substances as well as their medical usefulness.
Drugs in schedules I-V have a decreasing potential for abuse - schedule I drugs have the highest potential for abuse and no current medical use, and schedule V drugs have the lowest potential for abuse of the controlled substances. Physicians regularly use schedule II drugs, such as opioids, to treat pain. The CSA requires extensive record keeping and tracking of physician prescribing habits, and pharmacy dispensing of controlled substances. The CSA also requires prescribers to register with the Attorney General and obtain a controlled substances license.
The DEA, a part of the Federal Bureau of Investigation, enforces and administers the CSA. Under the CSA, a physician is criminally liable if he or she prescribes opioid medications for a purpose other than a legitimate medical purpose and outside of the usual course of his professional practice. Prosecutors and federal regulators define legitimate medical purpose, which usurps the physician's prerogative and creates a cavernous schism between the DEA and medical professionals (who value making independent medical assessments and decisions free from government threats of punishment). Importantly, this cavernous schism prevents necessary cooperation between the DEA and physicians to win both the war on drugs and the war on pain.
The CSA also hinders optimal pain management in several other ways. The CSA leads to prosecution of opioid prescribers. Since 2001, the DEA has targeted the prescription and abuse of OxyContin, an opioid analgesic, because of a spate of deaths related to its use. The OxyContin campaign raised scrutiny of opioid medications to the level of illegal, non-prescription street drugs such as cocaine and heroin. Along with the increased scrutiny, physician prosecutions under drug trafficking laws are increasing.
The DEA espouses a policy of balancing pain relief promotion with prevention of pain medication abuse and takes as its responsibility to ensure drugs are not diverted for illicit purposes. Despite the DEA's statement of commitment to the promotion of pain relief, the DEA's enforcement of the CSA unfortunately has a chilling effect on opioid prescribing. Under-treatment of pain is now the norm because of physicians' fears of prosecution. Attorney General Janet Reno initiated a federal campaign which intensified under Attorney General John Ashcroft and has been likened to state-sponsored terrorism to prosecute opioid-prescribing physicians. The government's continued threat under U.S. Attorney General Eric Holder to investigate narcotic prescription practices deters physicians from medically appropriate prescribing because physician practices are dependent upon maintaining a reputation of unimpeachable integrity. A governmental investigation into a physician's practice may serve to destroy a physician's career. Intense media coverage often accompanies physician investigation and prosecution. Because of physician prosecutions, not even the most honest and competent doctors can practice pain medicine with any assurance for safety for themselves or continuity of care for their patients. The DEA and courts treat well-intentioned doctors as drug dealers in the United States.
Almost two-dozen law enforcement agents raided Dr. Frank Fisher's general practice in 1999 and arrested him on drug and homicide charges stemming from opioid prescribing. After not being able to post his $15 million bail, Dr. Fisher, a Harvard Medical School graduate, languished in jail for 5 months before being exonerated of all drug and homicide charges. The State's reckless aggressiveness in implicating Dr. Fisher was inexcusable. One of Dr. Fisher's alleged homicide victims was Rebecca Mae Williams for whom Dr. Fisher prescribed a moderate dose of 160 mg. OxyContin daily for chronic pain. While her boyfriend was driving, Rebecca died in a motor vehicle accident of a hangman's fracture of the neck, open skull fracture, and severe internal injuries. Because she had opioid drugs in her system, the County Medical Examiner determined that she died of an opioid overdose instead of the obvious overwhelming lethal injuries sustained in the motor vehicle accident.
State and federal prosecutors have referred to arrested doctors as being no different than drug kingpins or crack dealers' and they call the doctors' patients drug addicts. Assistant U.S. Attorney Gene Rossi told the Washington Post in 2002 that the Attorney General's Office will root out pain physicians like the Taliban. The Office of National Drug Control Policy plans to propose stricter supervision of pain clinics within the next year. The Obama White House also plans to lobby Congress to require physicians to complete training in opioid prescribing prior to being granted a controlled substances license. What the government fails to recognize is that rather than addressing the actual problem, the regulations punish doctors instead.
On the other hand, patients and patient advocates laud these same doctors as heroes, and these doctors refer to their pain patients as vulnerable and suffering human beings. Current stringent over-enforcement of opioid prescribing laws is causing the already small number of physicians willing to treat chronic pain patients to dwindle. Under-treated pain costs society in terms of absenteeism, depression, alcoholism, family disruption, domestic violence, decreased productivity, and suicide. The economic costs in the United States alone may reach $100 billion annually.
Doctors who prescribe opioids are also shunned by other physicians who will not care for the opioid-prescribing doctor's patients, for fear of getting pulled into any possible future DEA investigations. An opioid-prescribing physician may then have difficulty finding coverage for days off or obtaining consultations from other physicians. Pharmacies, likewise, may refuse to fill opioid prescriptions from physicians who frequently prescribe opioid medications, because of a fear of DEA investigation of their pharmacy. The fear may arise from seeing a large volume of opioid prescriptions coming from a single pain medicine provider, or from actual DEA investigative calls to their pharmacy.
The DEA is charged with enforcement of the CSA, and may jail physicians for overprescribing narcotics. The DEA determines legitimate medical purpose and what constitutes in the usual course of [a physician's] professional practice, which may be interpreted subjectively or objectively. If interpreted subjectively, then the physician's belief that his practice of prescribing opioid medications appropriately provides pain relief, then the belief exonerates him. If interpreted objectively, however, the usual course of his professional practice indicates adherence to accepted medical standards as determined by the medical community. The objective approach to interpretation in this instance penalizes doctors at the cutting-edge of their field because they are beyond the realm of accepted practice.
Physicians and the DEA have clashed over the interpretation of legitimate medical purpose and whether long term high dose opioid prescriptions, often required for adequate chronic pain management, can come within the realm of a legitimate medical purpose. The DEA, however, is not part of the medical community. Decisions of legitimate medical purpose and the usual course of professional practice should be left up to physicians on state medical boards and pain societies - not federal agencies.
Willful Blindness
Physicians are also prosecuted under the theory of willful blindness, which erodes trust in the physician-patient relationship by forcing physicians to suspect patients of diverting, misusing, or abusing prescribed drugs. Prosecuting physicians for willful blindness criminalizes the traditional doctor-patient trust relationship, and contributes to physician opiophobia. Physicians may rightly trust their patients with chronic pain because of the vulnerability these patients have - both from the chronic pain and from the difficulty in demonstrating or verifying the fact of their pain to their healthcare providers. Although doctors' beliefs should be formed with an aim toward discovering the truth, a doctor's obligation to his or her pain patient should slant the doctor in favor of interpretations that favor the patient. Examples of the criminalization of the physician-patient relationship are the cases of Dr. Ronald McIver, who was sentenced to thirty years, and Dr. William Hurwitz, who was sentenced to fifty-seven months, after the doctors were found willfully blind to their patients' diversion of opioid medications. Professor Deborah Hellman posits that willful blindness is morally justified in the setting of a doctor-patient relationship because of the need for doctors to trust their vulnerable patients. Professor Hellman states that the moral justification for willful blindness should be taken into account in determining a physician's culpability. While a physician may be morally justified in willful blindness in some circumstances, if the circumstances permit, the physician should verify their patients' reports, especially in a situation where drug diversion is potentially at stake.
Although the doctor-patient relationship is one traditionally based upon mutual trust, because of the dangers of opioid abuse, misuse, and diversion, the physician should verify and solidify their trust of their patients' reports with quantitative urine toxicology screening, electronic prescription monitoring, and patient-physician opioid contracting. The use of sensory nerve conduction studies, for example, may also objectively determine the location of chronic neck or back pain, reducing the reliance on patient trust. As structural and functional diagnostic modalities for chronic neck and back pain (such as office sensory nerve conduction diagnostic testing) gain wider use, the reliance on a patient's word will be lessened.
These strategies of verifying patients' reports should not be detrimental to the honest physician-patient relationship because the honest patient should continue to have confidence in their physician. Although the honest patient may be annoyed at the scrutiny he or she is subjected to in the physician's office, that patient is usually pleased that the physician is operating in a manner least likely to cause the office to come under DEA scrutiny. The dishonest patient, however, may be likely to become angered and leave the physician's practice in search of another physician who will not verify symptom reports. There will be situations in which the patient's pain symptoms cannot be objectively verified. In those situations, reliance on doctor-patient trust will continue to be of prime importance.
Racism and Sexism
Besides over-exuberant enforcement of the CSA, racism and sexism also contribute to withholding opioid medications, oligoanalgesia, and opioid pseudoaddiction. Unfortunately, racism and sexism thrive in pain treatment. Physicians' treatment choices account for much of the racial disparity in healthcare. Physicians under-treat African-Americans, other minorities, and female patients for pain, compared to whites and especially white males. Among minority groups, untreated pain is highly prevalent.
African-Americans have a documented reduced tolerance to pain in this population. In one pain patient study, African-American males were found to be most likely to perceive discrimination. Reasons that African-Americans and minorities are under-treated for pain include cultural and racial biases that minorities are more frequently either addicted to or will become addicted to opioid medications. For example, the film industry has featured African-Americans as drug abusers. The war on drugs has disproportionately targeted African-Americans, showing evidence of a bias of African-Americans as drug abusers.
Besides being stereotyped as drug addicts, African-Americans and Hispanics have substantial difficulty filling their opioid prescriptions at their local pharmacies, because the pharmacies serving minority communities are much less likely to carry opioid medications. Many pharmacies that do not stock an adequate supply of opioid medications can order the medications within seventy-two hours; however, that seems to be an unacceptably long wait for someone in severe pain. Some pharmacies also decline to order opioid medications when requested by patients, perhaps because they do not want to attract opioid-using clients. Pharmacists' self-reported reasons for not stocking opioid medications include perceived low demand, fear of drug theft from the pharmacy, problems with health insurance reimbursement, and difficulty in compliance with CSA regulations.
Because three African-Americans for every one white individual live under the poverty line, the effect of socioeconomic status cannot be separated from race. Poorer individuals are less likely to have received medical care for pain. African-Americans, therefore, while more likely to suffer from disabling pain, have difficulty accessing the healthcare system. Likewise, lower income Hispanics also are underserved in pain management. Besides socioeconomic factors, Hispanics with chronic pain also tend to have difficulties with the English language and cultural differences from the American mainstream that may impact access to care.
In addition to finding difficulties in obtaining opioid medications, African-Americans also are hampered in their war on pain by opiophobia. Opiophobia thrives in the African-American community because of the stigma of drug abuse, arising from the war on drugs' targeting of African-Americans. African-Americans' poorer access to the healthcare system also leads to decreased access to accurate information about the benefits of opioid treatment for chronic pain.
Physicians also under-treat women's pain more often than men's pain. Women are taken less seriously when they report pain. There are several reasons women are under-treated despite documented lower pain thresholds, lower pain tolerance, and a higher propensity to develop chronic pain. Women are deemed to be able to cope better with pain despite societal notions that men are unwilling to complain or express pain. Additionally, women are more likely to have their pain attributed to psychogenesis. Finally, women are more likely than men to have their pain discounted if they are more physically attractive.
The former head of the National Institutes of Health, Bernadine Healy, describes the indifference in the treatment of women by healthcare providers until women prove themselves as worthy of medical intervention, as the Yentl syndrome. Because of the Yentl syndrome, women receive fewer medical interventions as compared to men, until they prove themselves as ill as men, at which point the gender difference disappears. For example, healthcare providers do not take a woman's chest pain as seriously as a man's chest pain, but if a woman actually has a documented heart attack, then she is treated more equally with men. Similar to the Yentl syndrome, women suffer from pain for longer time periods than men prior to being referred to a pain clinic. Both racism and sexism directly lead to opioid pseudoaddiction in the discriminated-against groups, because of inadequately treated pain in these patients who are seen as either likely to overstate their symptoms or more likely to become drug addicted.
Opiophobia
Besides racism and sexism, opiophobia likewise causes opioid pseudoaddiction. Opiophobia is an unfounded fear of opioid use and resultant reluctance to prescribe, administer, or receive opioid analgesics despite the low risk of addiction. Opiophobia discourages patients, healthcare providers, and pharmacists from seeking, prescribing and dispensing opioid pharmaceuticals. Some patients are afraid to take any opioid medications for fear of becoming addicted. Many physicians are reluctant to prescribe opioid medication because of the largely unfounded fear of creating opiate addicts. Some physicians may opt to not even apply for a DEA license to prescribe opioid and other scheduled drugs. Some physicians put up signs in their reception areas indicating that they prescribe no opiates in their practice. Nurses also limit patient access to opioid medications by declining to administer opioid medications as prescribed for patient pain, both because of fear of creating opioid addicts and fear of opioid side effects. Pharmacists, likewise, may refuse to dispense opioid medication because of fear of patient drug-seeking, opioid abuse, and opioid diversion.
Opiophobia is not unique to America, but is particularly virulent in the United States, given the country's war on drugs. According to the DEA, six million Americans abuse various prescription drugs. The war on drugs has utilized media to broadly focus on the horrors of addiction while failing to distinguish between physical dependency and opioid addiction. Many Americans believe the urban myth that chronic opioid use must be avoided for fear of drug addiction. Opiophobia surpasses the legitimate fear of opiate side effects, such as respiratory suppression and the largely unfounded fear of opiate addiction in the pain patient.
Confusion frequently occurs among health care professionals and patients regarding physical dependence and psychological addiction. Physical dependence is not addiction but a state of adaptation . . . manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation [and] rapid dose reduction. Tolerance, which is also confused with addiction, is not addiction, but a need for increased doses of medication to achieve the same effect. Addiction, however, is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving. Opioid patients are at very low risk of addiction unless they already abuse substances.
Patients may fear their use of opioid medications will cause others to view them as drug addicts. Likewise, patients and their families may falsely believe that opioid medications are likely to be addictive, causing drug-seeking behavior, or that opioid medications will cause feelings of being drugged, confusion, and disorientation. Instead, opioids properly used in the treatment of pain increase patients' levels of daily functioning in the home, community, and workplace.
Western culture's ambivalence toward pain contributes to opiophobia. Patients may believe that requesting pain medication is a sign of moral weakness, an inability to handle suffering. Pain and suffering in our culture has also been seen as a punishment for disobedience to God, and therefore as something to be experienced, not avoided. Western culture views pain as the ultimate ontological fact of humanity, a human experience of a flawed or corrupted universe. Even the word patient comes from the Latin patior--to endure suffering and pain. John Stuart Mill saw pain as the ultimate basis for all human motivation. Western culture furthermore sees pain as building character and perhaps even salutary. Given our culture's deeply entrenched ambivalence towards pain, the prevalence of opiophobia is not surprising and affects every aspect of pain recognition and treatment.
Some pharmacies refuse to fill prescriptions if they have merely been approached by the DEA regarding a particular prescriber. These pharmacies are fearful of being involved in a DEA investigation and will cease filling a doctor's prescriptions if they sense the possibility of a DEA investigation. Such practices make it difficult for patients to find a convenient pharmacy that will fill their prescription for opioid medication. It is not unusual for patients to go to a dozen pharmacies in search of one that will fill their opioid prescriptions.
The prevalence of opiophobia is rampant among physicians, pain patients (especially geriatric pain patients), and society at large. Furthermore, opiophobia causes the chain of events, which leads to opioid pseudoaddiction.
States' Rights
Because opioid pseudoaddiction stems from inadequate opioid use for pain control, any regulation affecting opioid prescription may impact the incidence of opioid pseudoaddiction. The federal regulation at issue here is the CSA, which controls controlled substances prescription by United States physicians. Although states do not have exclusive jurisdiction to regulate healthcare professionals, lack of commitment to federalism in controlling medical practice erodes states' rights. States should have the right to regulate the prescribing and dispensing of controlled substances within their state. Several benefits to federalism are as follows: (1) states can balance actions of a centralized government; (2) state's rights improve accountability; (3) state level decision-making gives citizens more opportunity for participation; (4) state level solutions are better tailored to local needs; (5) state level decision-making allows for experimentation and comparisons between various state programs; and (6) federalism gives citizens choices among various alternatives by choosing their state of residence. Congress has repeatedly made known its intention that the federal government cannot interfere with the rights of states to regulate the practice of medicine. State statutory definitions of the practice of medicine include prescribing medications. The federal Medicare statute states, Nothing in this title [42 USCS 1395 et seq.] shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided. More recent federal enactments such as the Drug Addiction Treatment Act of 2000 have similar provisions that have become essentially boilerplate. The CSA, however, implicates a sizeable federal role in physician prescribing supervision, by determining which medications are controlled substances, and when and how these controlled substances are prescribed. Although there is no Constitutional prohibition against state and federal governments sharing in the regulation of medical practice, the balance of power between the states and the federal government is currently leaning too far to the side of the federal government.
The usurping of states' rights in healthcare regulation alienates physicians who are organized by state medical boards. The DEA, and not the states, currently decides what constitutes legitimate medical practice in opioid prescribing. The lack of connection between how physicians are organized and how they are regulated in the area of opioid prescribing causes antagonism between the medical profession and the DEA. Such antagonism deters the cooperation necessary for a balance to be struck between the war on drugs and the war on pain.
Reform Proposals
Fortunately there are several avenues of potential reform of the problem of opioid pseudoaddiction. Each avenue of reform must strive to rightly-balance the legitimate needs of pain patients to receive adequate analgesia, and the legitimate need for the prevention of diversion and abuse of opioid medications.
This section will address needed education, research, DEA and physician cooperation, diversion and abuse prevention and detection programs, safe harbor, tort liability, intractable pain treatment acts, health organization standards, pharmacies, and state medical boards. Education and research are paramount in combating opiophobia and to educating opioid prescribers on diversion and abuse prevention. The DEA and physicians must cooperate to successfully win the war on drugs while preserving necessary accessible opioid prescribing and dispensing for the pain patient. To preserve physician willingness to prescribe opioids, legislation may give safe harbor to physicians prescribing in good faith, and having an operational diversion and drug abuse prevention and detection program (DAPD). Tort liability for the under-treatment of pain plays a role to further encourage physicians to treat pain adequately whether in the setting of acute, chronic cancer or chronic non-cancer pain. Besides JCAHO standards, institutional policies on adequate pain treatment are also needed. Pharmacist-physician collaboration is necessary to prevent diversion and abuse, and to ensure the availability of opioids in the community for pain patients. The greater role of state medical boards is also required to champion the cause of the pain patient and healthcare provider, and provide support for DAPD programming.
Education and Research
Research and education undergird reform in the war on pain because of widespread inadequate knowledge of pain management. Education of DEA agents, state medical boards, physicians, medical students, pharmacists, and the public on the urban myths causing opiophobia is needed to win the war on pain. Medical schools are notoriously devoid of pain management education. A general lack of physician knowledge about the difference between opioid tolerance or physical dependence and addiction has led to inadequate pain control. The mandatory education of healthcare providers is necessary because opiophobic providers have resisted education and training on the clinical use of opioids. Information dissemination to both the public and to healthcare providers needs to be more efficacious. The White House should participate, along with public interest and professional organizations, in pain management information dissemination.
Along with education and effective dissemination of information, pain research is needed in this frontier of medicine. Pain pharmacotherapy research especially is needed as empiric studies lag behind other areas of medicine such as cardiovascular disease. Researchers need to perform more investigations in the areas of pain management that lack sufficient evidence-based therapeutic guidelines. More research in opioid dosing is needed to determine safe maximal doses to allow maximizing pain management safely. Pharmaceutical research into new forms of opioids with less abuse potential and fewer side effects are greatly needed.
The federal government and private institutions need to fund education and research. Much education can be given and research undertaken under the auspices of pain societies, funds, and study groups such as the American Pain Society, the American Academy of Pain Management, the American Academy of Pain Medicine, the Mayday Fund, the Pain and Policy Studies Group at the University of Wisconsin, the World Institute of Pain, the American Society of Interventional Pain Physicians, and others.
DEA/Physician Cooperation
Cooperation, not antagonism, between the DEA and physicians is necessary for opioid diversion and abuse prevention. Physicians treating pain patients must become experts in diversion and abuse prevention and detection because they are on the front lines of contact with the opioid trafficker. I propose that physicians treating pain patients have a Drug Abuse Prevention and Detection (DAPD) program in their practices. Lawyers, knowledgeable in both health care law and criminal law, may set up DAPD programs. Patients' rights to confidentiality, as enumerated in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), must be protected. The DAPD program should have a specialist in charge of implementing the program's goals. Such a person should have a minimal background equivalent to certified medical assistant, with additional training in drug abuse detection and prevention. The DAPD specialist should report to the prescribing physician, and a healthcare attorney should supervise the DAPD program.
While full implementation of a DAPD program may be feasible only in a practice with at least one full time equivalent pain practitioner because of cost, a scaled-back version of a DAPD program should be implemented in any practice prescribing opioid medications. This would help avoid prescribing opioids to the minority of patients who engage in medication diversion, abuse, or misuse. Such a program should, at the minimum, consist of physician-patient opioid contracting, electronic prescription monitoring, and quantitative urine drug testing to find out which patients are diverting, misusing, or abusing opioid medications. Physician-patient opioid contracting serves to educate patients about safe opioid use, obtains informed consent for opioid use, and lays out specific patient responsibilities (such as safeguarding their medication supply, receiving their medications from a single medical provider and pharmacy, submitting to random urine drug screens, and taking their medications exactly and only as directed). Opioid contracting is well accepted by pain patients seeking medical attention and does not seem to be a detriment to seeking care, even though insufficient data are available on the numbers of pain patients who never seek care and their reasons for not doing so. Many chronic pain patients who have personally experienced or learned of a pain management practice being shut down by the DEA are pleased to see their pain management provider taking full precautions to avoid DEA scrutiny and sanctions, which could include the shutting down of the practice, leaving its patients without a physician.
Of note, seven states have yet to pass electronic prescription monitoring legislation. These electronic prescription monitoring programs are crucial to DAPD because they allow physicians and pharmacists to see all of the opioid prescriptions filled by a given patient within that state, to find patients receiving redundant opioid medications from multiple providers. Urine drug screen indications of diversion, misuse, or abuse include the following: a negative or quantitatively lower than expected urine toxicological screen, which could indicate that the patient is not ingesting the medication as directed but rather diverting the opioids illicitly; or a urine screen positive for substances not prescribed, indicating illicit procurement of drugs or procurement of different opioids from multiple physicians. Opioid contracting, electronic prescription monitoring, and quantitative urine drug screens are needed to ensure the prescribed opioid medications are not being diverted to illicit channels or abused by the patient. Such diversion and abuse is a significant problem in a minority of patients in any pain practice, and can only be adequately redressed by the combination of opioid contracting, electronic prescription monitoring, and quantitative urine drug screens.
Safe Harbor from Criminal Prosecution
Legislation to give safe harbor from criminal prosecution for physicians prescribing in good faith, and having an operational DAPD program incorporating quantitative urine drug testing and electronic prescription monitoring, would facilitate prescribing by reducing the chilling effect of fear of prosecution. Decriminalization of physician overprescribing as determined solely by the DEA (without the recommendation of state medical boards' pain management experts) must occur. Guy Faguet, a former hematology/oncology professor, has even called for the repeal of the CSA and disbanding of the DEA because of the deleterious effects on the war on pain. The Cato Institute has also called for the repeal of the CSA and the disbanding of the DEA in the 2005 Cato Handbook for Congress. While the rush to disband the DEA may be overzealous, decriminalizing good faith prescribing of opioids as determined by state medical board and pain society guidelines would go far towards reducing the chilling effect on current opioid prescribing practices.
Tort Liability for Under-treatment of Pain
Furthermore, there needs to be tough tort liability for under-treatment of pain. Barry Furrow posits four functions of tort liability for inadequate treatment of pain. The first Furrow tort liability function is reinforcing good medical practice through economic disincentives such as malpractice insurance costs, defense costs, and judgments. The second tort liability function is giving voice to patronized, ignored, actively manipulated, or cruelly treated patients. Thirdly, tort liability drives physician and institutional practice towards validated standards of practice. Fourthly, tort law brings forth new duties of care such as informed consent, making referrals to more qualified pain specialists, and placing patients' comfort and wellbeing above one's own interests in avoiding regulatory scrutiny.
Since the medical community has accepted the under-treatment of pain as standard practice, external incentives are required to upregulate the prescribing practices to the level needed to appropriately treat pain. Courts should recognize current pain management guidelines as the standard of care for the treatment of chronic, intractable pain [to] . . . vindicate the rights of the millions of patients forced to endure needless pain . . . . The civil tort system has proven itself a strong force in advancing personal rights and public policy. As author David Morris states, medical malpractice liability first shapes the behavior of clinicians and secondly shapes medical ethics itself. By shaping underlying medical ethics, tort liability does more than just pressure physicians to prescribe opioid medications - tort liability addresses an underlying cause of the problem.
Opponents of tort liability for oligoanalgesia have posited that fewer physicians will practice pain management if liable for under-treatment of pain. This effect is unlikely because more, not fewer, physicians, even if they are not pain management specialists, will be prompted by the threat of lawsuits to prescribe adequate pain therapy for any of their patients in pain. To avoid tort liability, physicians will either need to prescribe pain medications for their pain patients themselves, or timely refer patients to a pain specialist. However, timely referral to a conveniently located pain specialist may be difficult. One study found only 5% of pain patients see a pain specialist, while the rest are treated by their primary care physician. The refusal to treat pain patients by any physician is unacceptable and has been likened to refusing treatment to HIV-positive patients.
Opponents of tort liability for inadequate pain treatment also posit that pain is too subjective to submit to tort liability. Determining physical pain is no more difficult than ascertaining emotional or psychic pain. Pain patients often also have readily verifiable physical abnormalities that correlate with their pain symptoms. The problem of quantifying the damages exists, but such damages could be based upon the impact of the pain on a plaintiff's daily activities.
Tort liability for inadequate pain treatment is also based upon breach of reasonable medical professional standards of pain management, which currently are nebulous. Such nebulous standards for tort liability make it difficult for both patients and physicians to know when the standard has been breached. This physician uncertainty may contribute to the apprehension of physicians in treating pain patients and hence may contribute to inadequate pain treatment because of a lack of physicians willing to see pain patients.
Skeptics of tort liability for inadequate pain management also argue that physicians, being the gatekeepers of controlled substances, should not have an incentive to overprescribe opioids. As long as the patient suffers from significant oligoanalgesia, there is not likely to be an over prescription of opioids especially if computational opioid prescribing is employed. In patients with adequately treated pain, there will not be an incentive to prescribe escalating doses, and hence overprescribe, because the pain is already adequately managed. Currently a norm of under-treatment of pain exists. Adequate pain dosing regimens, therefore, appear to be overprescription when compared to the average dosing regimen. Newer methods such as computational opioid prescribing will allow opioid doses to be better tailored to individual needs and metabolism. DAPD programs also can prevent prescribing to those individuals who choose to divert or abuse opioid medication.
A pitfall in tort liability for inadequate pain treatment is the potential for elevated malpractice premiums for pain medication prescribing physicians. The increased premiums could cause a physician exodus from pain management similar to the exodus of obstetricians due to birth injury malpractice liability driving up obstetrical premiums to unaffordable levels. The malpractice premium argument weighs heavily in the balance, but, if physicians are liable for not treating pain, they may find no alternative other than a drastic career change, which does not involve direct patient care since pain is prevalent in nearly all medical and surgical subspecialties, as well as in primary care. Such an exodus from pain treatment specialties would leave a greater burden on pain management specialists. Overall, tort liability for inadequate pain control has its place in the war on pain, but it is not a panacea, and therefore one needs to look elsewhere for adjuvant weapons to fight the war.
Intractable Pain Treatment Acts
Like tort liability, legislation can also turn greater attention to pain management. Many state legislatures have passed what are generically called Intractable Pain Treatment Acts (IPTAs) to deal with the under-treatment of pain with opioid medications. This wave of IPTAs began in 1989 and hoped to give physicians regulatory relief for prescribing opioid medications for pain. However, there are serious shortcomings in current IPTAs. Current IPTAs are too narrow, contain provisions containing counter-effects, are not nationwide, and lack accountability. Counter-effective provisions include clauses that opioids are to be used as a last resort, required evaluations by at least two physicians prior to prescribing opiates in some states, preclusion of treatment of intractable pain in chemically dependent patients, lack of recommendations for practitioner education, lack of accountability, reasonably prudent physician standards based on custom of under-treatment, lack of applicability to nonphysician opioid prescribers and dispensers, and lack of nationwide coverage.
The provisions that opioids are only to be used as a last resort lack inclusion of guidelines as to what comprises a reasonable effort prior to last resort status being achieved. The required evaluations by two physicians prior to prescribing opioids limit patient accessibility because of increased cost and inconvenience. The preclusion of opioid treatment of chemically dependent patients deprives these patients of pain treatment while undergoing rehabilitation for abuse of other drugs. The lack of recommendations for prescriber education may increase patient accessibility because the barriers for physician opioid prescribing are lower; however, the need for prescriber education is great due to confusion about opioid tolerance, addiction, and optimal dosing. The state IPTAs provide safe harbor for physicians who prescribe opioid medications according to guidelines, but do not require disciplinary actions for those physicians who do not prescribe adequate opioids for pain relief. The lack of accountability for not prescribing adequate opioids contributes to oligoanalgesia.
Reasonably prudent physician standards based on custom of under-treatment contribute to oligoanalgesia and make appropriately-treating physicians appear to be overtreating by comparison. Lack of applicability to nonphysician opioid prescribers and dispensers limits the benefits of IPTAs to physicians, excluding physician assistants, clinical nurse practitioners, and pharmacists, who still have no safe harbor. Lack of nationwide coverage also limits the effectiveness of IPTAs to the states where they are enacted. The number and breadth of IPTA counter provisions squelch an otherwise well-intentioned law to address under-treatment of pain.
Organizational Standards
The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) monitors and certifies the quality of care provided in the United States so pervasively that JCAHO accreditation constitutes compliance with most requirements for Medicare reimbursement. With the implementation of more aggressive pain management standards by the JCAHO in 2000, prescriptions for opioids increased. The 2000 JCAHO pain standards sought to effect change in four ways: by addressing patients' rights, education and training of patients and families, quantitative aspects of pain, and systematic assessment and safe pain management. In hospitals and other healthcare institutions, professional practice standards are traditionally established and enforced by staff leaders who become mentors and models to colleagues. The JCAHO accreditation standards change physician practice through hospital pressure on physicians and other healthcare providers to comply with JCAHO standards, lest the institution lose its accreditation. Although JCAHO requirements ensure documentation of a patient's pain as a fifth vital sign, shortcomings in JCAHO pain management policies include a lack of provision for health care provider education to remove attitudinal barriers to pain management. Institutional policies on pain management need to protect the legitimate needs of patients in moderate to severe pain to receive adequate opioid pain medication, including education to improve both the attitudes and aptitudes of healthcare providers. Otherwise outside of the hospital setting, these physicians may fall back on familiar ways of under-treating pain in the outpatient arena.
Pharmacists and Pharmacies
Standards for pharmacies to carry and dispense opioids would also assist in improving accessibility to pain therapy for those who need it. Pharmacist-physician collaboration in chronic pain therapy is necessary to prevent diversion and abuse, as well as to ensure adequate pain management of the individual patient. Specialty pharmacies for scheduled drugs may be helpful in ensuring that diversion and abuse prevention is occurring during medication dispensing. These pharmacies may also relieve patient difficulties in getting their opioid prescriptions filled at general pharmacies loathe to handling these prescriptions.
These specialty pharmacies would, however, need to be ubiquitous enough for patient convenience, especially in areas where patient transportation is at issue. The specialty pharmacy could be useful in minority communities where currently there are insufficient numbers of pharmacies carrying adequate opioid medications to treat severe pain. The pain specialty pharmacy would allow for greater pharmacist-physician collaboration and therefore better monitoring for abuse, misuse, and diversion of opioid medication. The pain specialty pharmacy would also have the opportunity for greater collaboration with the DEA in prevention of diversion of opioid medication. Although always under the watchful eye of the DEA, closer cooperation with the DEA may allay specialty pharmacies' unfounded fears of DEA investigation. Unfortunately, the pain specialty pharmacy would also likely require heightened security because of the risk of medication theft and may find its clientele stigmatized because of the prevailing opiophobia. While the specialty pharmacy may be a useful adjunct in the war on pain, its presence should not be seen as usurping the responsibility of general pharmacies to provide their clientele with adequate stocks of opioid medications.
Pharmacy legislation may also ameliorate pharmacy opioid stock issues. State legislatures could mandate that pharmacies stock adequate opioid medications to even out the disparity between white and minority community pharmacies. Federal legislation could also connect Medicare Part D pharmacy reimbursement to maintaining adequate opioid stocks. Third party payor reimbursement is a powerful incentive to pharmacies and would likely be an effective means of increasing pharmacy opioid stocks.
State Medical Boards
State medical boards may influence opioid prescribing practices through sanctions, regulations, and guidelines, as well as policy statements. The state medical boards promulgate regulations as official rules legislated and issued by the board. Regulations establish boundaries of acceptable physician conduct. Guidelines issued by medical boards are official statements only without the force of law. Medical board policy statements seek to clarify the board's expectations in matters of concern to the medical community.
Further needs in the war against pain include the greater role of state medical boards championing the cause of the pain patient and his or her healthcare provider, providing accountability for inadequate pain management and support for DAPD programming. In the late 1990s, after state medical boards liberalized standards for prescribing opioids, the use of prescription opioids increased.
Although most state's medical boards have opioid prescribing policies, some have negative language impeding the prescribing of opioid medications. State medical boards can also exert influence through sanctions on healthcare providers that under-treat pain. In 1999, Oregon was the first state medical board to issue sanctions for failure to provide adequate pain relief when the Oregon Board of Medical Examiners (OBME) disciplined Dr. Paul Bilder for failure to provide adequate pain relief to dying patients. The OBME required Bilder to complete a patient-physician communication course, enroll in peer evaluation and education, and continue psychiatric treatment.
While sanctions are necessary, state medical boards should be more proactive and reduce negative language impeding adequate pain management, such as implying that opioids are only to be used as a last resort, implying high dose opioids or opioids for chronic nonmalignant pain are outside legitimate medical practice, confusing physical dependence with addiction, restricting opioid prescription based upon patient characteristics, requiring consultations prior to initiating opioid therapy, and restricting quantities of opioid medication prescribed.
On the other hand, positive pain policy language should be encouraged. Positive policy language could include recognizing the importance of opioid medications for public health, recognizing pain management as a component of primary care practice, addressing practitioners' concerns regarding investigation and prosecution, recognizing that a large number of prescriptions or a large quantity per prescription is not in itself a determinate of inappropriate prescribing, recognizing the difference between physical dependence and addiction, and encouraging adequate pain management.
Successful implementation of medical board policy requires medical board investigator training, policy dissemination to physicians through workshops, websites, and newsletters, and mass media outreach to the general public. Uniformity among state medical board policies could be brought about by adopting favorable pain treatment policies from model guidelines adopted by the Federation of State Medical Boards (FSMB). Many states have adopted FSMB model guidelines for pain management.
Conclusion
Despite the availability of effective pain treatment, many pain patients receive inadequate treatment, if they receive treatment for pain at all. The importance of balancing regulatory control of opioids with the promotion of the legitimate medical use of opioids has previously been espoused. The optimal balance between the war on drugs and the war on pain, however, has yet to be struck. The war on drugs and the war on pain do not have to conflict with each other. Since pain-treating physicians are also on the front lines of contact with the small segment of would-be criminal prescription drug traffickers, physicians must work in concert with the goals of the DEA. The series of solutions enumerated in this Note would allow for a balance to be struck between the rights of pain patients and the need to stop diversion of opioid medications to illicit users without significantly hurting our nation's fight on either battlefront.
. Annemarie Daly Linares is a Juris Doctor Candidate (expected 2014) at Wayne State University Law School. Dr. Linares holds a Medical Doctor degree from the University of Michigan Medical School.
