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The Chilling Effect is No Myth

By David B. Brushwood, R.Ph., J.D.
University of Florida
January 1, 2004

The regulation of controlled substances has a chilling effect on the prescribing and dispensing of opioid analgesics. This is not a myth; it is a reality. But the chilling effect was not created by DEA and it is not DEA’s fault. The reluctance to treat pain has many causes. Everyone in health care and in law enforcement shares the responsibility to overcome the barrier of the chilling effect so that patients in pain can obtain relief of their suffering.

The DEA has recently denied the existence of a chilling effect. In a news release titled “The Myth of the ‘Chilling Effect,’” posted on their website on October 30, 2003, the agency points out that of those doctors registered to prescribe controlled substances (963,385), the number of doctors who were investigated (557), against whom legal action was taken (441) and who were actually arrested (34) was very low in fiscal year 2003. This is not the comforting news the agency intends it to be. Even though “only” 34 doctors (0.01% of registrants) were arrested in fiscal 2003, this number is likely a significant percentage of the doctors who are brave enough to consistently prescribe opioids for chronic pain. Only a tiny handful of the almost one million DEA registrants will do so. The agency chose a misleading denominator in calculating the percent.

Add to the DEA number those additional doctors who were criminally investigated or charged by state authorities along with those who were investigated or charged by licensing agencies, and the numerical rationale for the chilling effect climbs dramatically.

The existence of a chilling effect has been empirically validated. David Joranson and his colleagues at the Pain and Policy Studies Group have shown, through surveys, that physicians prescribe less and pharmacists dispense less, due to awareness of regulatory oversight. The DEA website describes the chilling effect in terms of motorist awareness of traffic laws: “When most Americans encounter a police car parked at the side of the highway, they slow down below the posted speed” it says. The problem in pain management is that when physicians and pharmacists become aware of law enforcement, they practice below the standard of care, prescribing and dispensing less opioid analgesic medication than their patients need.

Controlled substance regulation is like a notorious speed trap. Many people drive much slower than is appropriate under the circumstances, wary of the tiniest possibility that driving at the speed limit will be mistaken for going over it.

Whose fault is this?

• It is the fault of medical schools that do not include sufficient education about pain management in their curricula, and that do not train physicians to prescribe pain medications within appropriate boundaries.
• It is the fault of doctors who over react to perceived regulatory threats and “play it safe” by under prescribing to protect themselves.
• It is the fault of pharmacists who act as “drug cops” and report suspicious medical practices without trying to understand their patients’ therapy through consultation with physicians.
• It is the fault of expert witnesses who criticize prescribing and dispensing as below the standard of care when the practices are perfectly legal but somewhat unusual from the expert’s perspective.
• It is the fault of patients who call themselves addicts when they aren’t, and who erroneously claim their doctors never conduct physical examinations while prescribing whatever the patient asks for.
• It is the fault of prosecutors who over charge physicians and pharmacists with manslaughter and murder when far lesser crimes (or no crimes) have been committed.
• It is the fault of the media for sensationalizing the lurid details of drug diversion and abuse without telling the more important but lackluster story of under treated pain.
• It is the fault of a system that dichotomizes the suffering of pain and the suffering of substance abuse, marginalizing and criminalizing the latter without acknowledging that all suffering is treatable medically and deserves confidential, compassionate care.

Everyone is at fault for the chilling effect. But assigning blame is beside the point. Bickering and finger pointing do not solve problems; they do not improve the functioning of patients in pain.

How can we begin to solve the problem of the chilling effect? First, we must respect DEA and other agencies that have a difficult, but important, job to do. We must improve our screening of patients, and teach patients that securing their medications is a top priority. We must do the right thing for patients, but do it carefully. Second, we must begin a dialogue with local law enforcement to help them understand that many characteristics of good pain practice look just like the “red flags” they have been taught to believe are indicators of criminal misconduct. A productive relationship with law enforcement may lead them to consult early-on when things seem amiss in a medical practice, rather than wait for a small problem to become a big one, and then stage a massive raid with the attendant media frenzy. Third, we must accept that there is some risk in prescribing and dispensing medications at the high doses necessary to treat pain effectively in some patients, and stand together when drug control misidentifies one among us as a drug diverter. Legitimate disagreements on clinical judgment do not mean a crime has been committed. We must consult with each other as colleagues when the inevitable “difficult” patient causes unusual challenges for us.

The temptation to demonize DEA as the culprit in the chilling effect is tempting. Their denial that it even exists leads to alternating tears and laughter. But it’s time to move on. We can all do better. We in health care need to clean our house. Let’s straighten out what we do to contribute to the chilling effect. Then we can expect DEA to do the same.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME). For information about ASLME pain policy projects, go to ASLME.