EXECUTIVE SUMMARY
In light of escalating prescription drug abuse, some physicians now require patients to sign pain agreements before agreeing to prescribe opioids. Some ethical considerations include the following:
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Improper prescribing puts physicians at risks for charges of unprofessional practice, and in extreme cases, even criminal prosecution.
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Drug-addicted patients have sued physicians for malpractice.
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Well-crafted pain contracts aim to help patients understand risks of pain medications.
Failure to prescribe opioid analgesics in a manner that reflects “pharmacovigilance” can expose a physician not only to charges of unprofessional practice, but in extreme cases, even criminal prosecution, warns Ben A. Rich, JD, PhD, emeritus professor of internal medicine (Bioethics) at UC Davis School of Medicine. Malpractice lawsuits alleging the physician’s prescribing led to drug-addicted patients are another concern.
“We are at the convergence of two perfect storms,” says Rich. “The first is the continuing undertreatment of chronic pain. The second is the epidemic of prescription drug abuse.”
Some physicians now ask patients to sign “pain agreements” before prescribing opioids. Such agreements may require patients to agree not to request pain medicines from any other physician, to obtain psychiatric assessments if the physician deems it necessary, and to consent to random drug screening.
Mark P. Aulisio, PhD, professor and chair of the Department of Bioethics at Case Western Reserve University in Cleveland, is unaware of data on the percentage of physicians using pain agreements currently, but suspects the number is growing. “It is reasonable to think that the practice is increasing, given the severity of the heroin epidemic and its relationship to prescription opioid abuse,” he says.
At first glance, pain contracts may seem to be at odds with patient autonomy. “Well-crafted pain contracts can actually enhance and protect patient autonomy in at least two ways,” says Aulisio. When utilized as part of the consent process, they can enhance patient understanding of the risks of pain medications, which include addiction and overdose. “They also typically put safeguards in place to minimize the chances of addiction or overdose,” says Aulisio.
RISKS FOR PHYSICIAN
Generally speaking, says Rich, “pain contracts are an effort to impress upon the patient the need for strict adherence to the terms and conditions upon which the physician is willing to initiate and continue to provide prescriptions of controlled substances for pain relief.” He sees the following ethical concerns:
• Evidence of effectiveness of the agreements is lacking. “It remains an open question whether their use adds to the already well-accepted process of securing a patient’s informed consent to a particular therapeutic regimen, including prescription medications, to an extent that justifies such a legalistic approach that may suggest to some patients that their physician believes they cannot be trusted,” says Rich.
• The document could be used as a means of terminating the physician-patient relationship for any deviation by the patient from the terms and conditions of the contract. “Physicians may erroneously believe that such contracts insulate them from liability for patient abandonment,” says Rich.
• That the agreements are imposed on patients by physicians. “There is commonly a huge disproportionality between what the contract demands of patients versus what the physician is obliged to do, if anything,” says Rich.
In the ED setting, physicians encounter chronic pain patients on very high doses of opioids. “Pain agreements help us greatly, because they represent a premeditated plan between a patient and their treating pain clinician that help us at the moment when there is acute pain,” says Scott G. Weiner, MD, MPH, FAAEM, FACEP, an assistant professor of emergency medicine at Harvard Medical School in Boston. Weiner is also an attending emergency physician at Brigham and Women’s Hospital.
He likens pain agreements to having advance directives for life support. “The worst time to think rationally about if you’d like to be resuscitated or placed on a ventilator is in the stressful moment when it is needed,” he says, adding that the same is true for patients making decisions about medications when in severe pain.
Weiner says pain agreements should honor the ethical principles of patient autonomy and non-maleficence. “Opioid medications can be extremely dangerous, leading to respiratory arrest, severe dependency, and even paradoxical hyperalgesia,” notes Weiner.
Agreements often specify that patients will only get opioids from one provider. “This has also been helpful in the ED when I see such patients,” says Weiner. “Sometimes they request that I use alternative medications to opioids to help alleviate their pain.”
In Weiner’s experience, the agreements can improve the patient/physician relationship. “A set of ‘rules’ is established, that both patient and physician have agreed to follow,” he explains.
SOURCES
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Mark P. Aulisio, PhD, Professor and Chair, Department of Bioethics, Case Western Reserve University/Director, Center for Biomedical Ethics, MetroHealth Medical Center, Cleveland, OH. Phone: (216) 368-0724. Fax: (216) 368-8713. Email: [email protected].
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Ben A. Rich, JD, PhD, Emeritus Professor of Medicine (Bioethics) at UC Davis School of Medicine, Sacramento. Phone: (916) 734-6010. Fax: (916) 734-1531. Email: email: [email protected].
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Scott G. Weiner, MD, MPH, FAAEM, FACEP, Assistant Professor of Emergency Medicine, Harvard Medical School, Boston, MA. Phone: (617) 732-5640. Fax: (617) 264-6848. Email: [email protected].
