RL 7&3. SJ6&
Journal of Pain and Sppom
1992
iManagement 257
tters
To the Editor: As a medical student and then houseofficer at a large metropolitan medical center in Southern Cali5ornia, there was an unwritten doctrine about pain and the use of opioids. This doctrine, based largely on misconceptions, was passed along from senior houseofficers to junior houseofficers to students. Fmt, all patients who complain of pain and ask for medication, especially those who are young or nonwhite, should be considered drug addicts until proven otherwise. Second, if you write excessive numbers of opioid prescriptions you will be investigated by a government agency. Third, never obtain your own set of triplicate prescription forms; in that way you will have an excuse for not writing outpatient Schedule II opioid prescriptions and thus be less likely a target for investigation, not to mention a target for addicts wanting drugs. Like many doctrines of hazy origin, these were shrouded in myth and mystery. How many prescriptions constitute “excessive”? Who actually monitors prescribing practice, and just what do they monitornumber of pills, number of relills, number of prescriptions? Are you monitored continuously, or is there an audit conducted at some specified interval? In my mind, the drug regulatory system took on the characteristics of the mythical childhood bogeyman. When I left California to start my oncology fellowship in Maryland, I had no special concern about my ability to manage pain and prescribe opioids until my first week in the clinic. My nurse suggested that a certain cancer patient needed something stronger than acetaminophen with codeine. She suggested I prescribe hydromorphone, and I quickly realized that I had no idea how to use this or any other potent opioid as I Q U.S. Cancer Pain Relief Committee, Published by Ekevier,
New York, New
1992
York
had little experience writing outpatient prescriptions for Schedule II drugs. Furthermore, as I struggled to determine the appropriate dose and schedule, I was confronted with all my previous teachings that I should be careful about how I prescribe these drugs or I will get into trouble. Under the tutelage of an enlightened oncology nursing and medical staff, I came to see the error of my ways. It was with amazement and anger that some years later I read a government report about the multiple-copy prescription system that said “the quality of medical care is improved under these systems since practitioners tend to examine their reasons for prescribing more closely.“’ In my experience, onerous drug regulations cause practitioners to examine their prescribing practice and lind more excuses to avoid prescribing opioids-hardly a situation that would lead to better patient care. A study by Sigler and colleagues2 seemed to confirm this by demonstrating that the introduction of a new triplicate prescription system was sufficient to shift physicians’ prescribing practice from Schedule II to non-Schedule II analgesics; however, studies examining the impact on physician practice of controlled substance regulations in general have been nonexistent. In 1990, David Joranson, MSSW, of the University of Wisconsin-Madison Pain Research Group and I designed a survey to begin studying this question in Wisconsin. We were interested in three issues. First, how well did physicians understand current controlled substance regulations and the structure of the drug regulatory system? Second, did fears of regulatory scrutiny cause physicians to alter their prescribing practice? Finally, how did the fear of regulatory scrutiny compare with other well-described fears about prescribing opioid analgesics? The results of our survey of 200 Wisconsin physicians have been published in the W~comin.Medical Journal3
258
Approximately 50% of the questions that assessed knowledge of drug schedule and premibkg limitations were answered incorrectly. A total of 54% percent of respondents indicated that concern about regulatory scrutiny cause them, at least occasionally, to lower the dose or quantity of prescribed medication, limit refills, or prescribe a drug in a lower schedule. Respondents were increasingly concerned about regulatory scrutiny when prescribing to patients with chronic pain or a history of drug abuse or when prescribing to patients for an extended period of time-all factors that may indicate to the physician an increased risk for addiction. Although physicians indicated relatively little concern about rc@atory scrutiny when prescribing for cancer pain, they did note more concern when prescribing opioids for cancer pain than acute pain. Physicians overwhelmingly indicated a fear of addiction was their major concern when prescribing opioids. The importance of this survey is twofold. First, the results indicate that physicians have deficiencies in knowledge of controlled substance regulations, deficiencies that can be improved with education. Second, although prior studies have shown that new regulations can lead to a change in prescribing practice, this is the first study to indicate that a perceived threat from existing regulations is sufficient to alter prescribing practice. Finally, the study reaffirmed that the exaggerated fear of iatrogenic addiction is the single greatest obstacle for physicians to prescribe opioids. The fear of addiction, however, should not be thought of as something separate from fear of regulatory scrutiny as these two issues are intimately related. The drug regulatory system was developed to control the spread of illicit drugs and the negative societal consequence of drug use, namely drug addiction. The history of intimidation of physicians by law enforcement regarding their opioid-prescribing practices in the early to midportion of thii century, combined with strong professional and societal fears of opioid addiction, have served to inhibit opioid prescribing to the present time. Because of these historic forces linking drug addiction with drug regulation, it may be difficult for today’s physicians to distinguish in their own minds between fear of addiction and fear of regulatory scrutiny. Controlled substance regulations serve a nccessary societal function, but specific laws and regulations differ from state to state. Joranson4
vol. 7&i?. 534
Ldtm
1992
has reviewed some of the uniquely restrictive state laws and regulations. Despite the absence of unique or significant additional restrictions in Wisconsin, the physicians in our survey were nonetheless concerned about the risk of reg-ulatory scrutiny. Our study indicates that these fears are sufficient to alter prescribing practice. It is highly likely that in those states with confusing definitions of addiction, multiple-copy prescription programs, and/or restrictive regulatory policies, physician concerns may lead to signifrcant underutilization of opioids. Additional research will help to answer this question. In addition to further research, it is important for regulatory and medical communities to begin working together to design bidirectional education programs. The medical community must educate regulators about the appropriate, controversial, and inappropriate uses of opioids, and the regulatory community needs to educate physicians about current drug regulations, the role of different regulatory agencies, and the investigative process in general. Furthermore, state laws, regulations, and policies that are impediments must be identified and removed. Passage of the revised Uniform Controlled Substance Act by all state legislatures would help to remove some of these impediments.5 Through educational initiatives, together with examination and removal of existing regulatory barriers, the fears and misconceptions that limit opioid use can hopefully be put to rest. David E. Weissman,MD Department of Medicine Medical Collegeof Wisconsin Milwaukee,Wisconsin
Refevemes 1. Multiple copy prescri$on programs resource guide. Washington,DC: US Department of Drug Enforcement Administration,1987:8-9. 2. Sigler KA, Guersney BG, Ingrim NE, et al. Effect of a triplicate prescription law on prescribing of Schedule II drugs.AmJHospPharm 1984;41:108-111. 3. WeissmanDE,Joranson DE, Hopwood ME. Wisconsin physicians’ knowledge and attitudes about opioid analgesicregulations.Wis Med J 1991;90:671-675. 4. Joranson DE. Federal and state regulation of opioids. J Pain Symptom Manage 1990;5:S12-S23. 5 ,loranson DE. A new drug law for the states: an opportunity to affirm the role of opioids in cancer pain relief.J Pain Symptom Manage 1990;5:333-336.
Journal of Pain and Sppom
1992
iManagement 257
tters
To the Editor: As a medical student and then houseofficer at a large metropolitan medical center in Southern Cali5ornia, there was an unwritten doctrine about pain and the use of opioids. This doctrine, based largely on misconceptions, was passed along from senior houseofficers to junior houseofficers to students. Fmt, all patients who complain of pain and ask for medication, especially those who are young or nonwhite, should be considered drug addicts until proven otherwise. Second, if you write excessive numbers of opioid prescriptions you will be investigated by a government agency. Third, never obtain your own set of triplicate prescription forms; in that way you will have an excuse for not writing outpatient Schedule II opioid prescriptions and thus be less likely a target for investigation, not to mention a target for addicts wanting drugs. Like many doctrines of hazy origin, these were shrouded in myth and mystery. How many prescriptions constitute “excessive”? Who actually monitors prescribing practice, and just what do they monitornumber of pills, number of relills, number of prescriptions? Are you monitored continuously, or is there an audit conducted at some specified interval? In my mind, the drug regulatory system took on the characteristics of the mythical childhood bogeyman. When I left California to start my oncology fellowship in Maryland, I had no special concern about my ability to manage pain and prescribe opioids until my first week in the clinic. My nurse suggested that a certain cancer patient needed something stronger than acetaminophen with codeine. She suggested I prescribe hydromorphone, and I quickly realized that I had no idea how to use this or any other potent opioid as I Q U.S. Cancer Pain Relief Committee, Published by Ekevier,
New York, New
1992
York
had little experience writing outpatient prescriptions for Schedule II drugs. Furthermore, as I struggled to determine the appropriate dose and schedule, I was confronted with all my previous teachings that I should be careful about how I prescribe these drugs or I will get into trouble. Under the tutelage of an enlightened oncology nursing and medical staff, I came to see the error of my ways. It was with amazement and anger that some years later I read a government report about the multiple-copy prescription system that said “the quality of medical care is improved under these systems since practitioners tend to examine their reasons for prescribing more closely.“’ In my experience, onerous drug regulations cause practitioners to examine their prescribing practice and lind more excuses to avoid prescribing opioids-hardly a situation that would lead to better patient care. A study by Sigler and colleagues2 seemed to confirm this by demonstrating that the introduction of a new triplicate prescription system was sufficient to shift physicians’ prescribing practice from Schedule II to non-Schedule II analgesics; however, studies examining the impact on physician practice of controlled substance regulations in general have been nonexistent. In 1990, David Joranson, MSSW, of the University of Wisconsin-Madison Pain Research Group and I designed a survey to begin studying this question in Wisconsin. We were interested in three issues. First, how well did physicians understand current controlled substance regulations and the structure of the drug regulatory system? Second, did fears of regulatory scrutiny cause physicians to alter their prescribing practice? Finally, how did the fear of regulatory scrutiny compare with other well-described fears about prescribing opioid analgesics? The results of our survey of 200 Wisconsin physicians have been published in the W~comin.Medical Journal3
258
Approximately 50% of the questions that assessed knowledge of drug schedule and premibkg limitations were answered incorrectly. A total of 54% percent of respondents indicated that concern about regulatory scrutiny cause them, at least occasionally, to lower the dose or quantity of prescribed medication, limit refills, or prescribe a drug in a lower schedule. Respondents were increasingly concerned about regulatory scrutiny when prescribing to patients with chronic pain or a history of drug abuse or when prescribing to patients for an extended period of time-all factors that may indicate to the physician an increased risk for addiction. Although physicians indicated relatively little concern about rc@atory scrutiny when prescribing for cancer pain, they did note more concern when prescribing opioids for cancer pain than acute pain. Physicians overwhelmingly indicated a fear of addiction was their major concern when prescribing opioids. The importance of this survey is twofold. First, the results indicate that physicians have deficiencies in knowledge of controlled substance regulations, deficiencies that can be improved with education. Second, although prior studies have shown that new regulations can lead to a change in prescribing practice, this is the first study to indicate that a perceived threat from existing regulations is sufficient to alter prescribing practice. Finally, the study reaffirmed that the exaggerated fear of iatrogenic addiction is the single greatest obstacle for physicians to prescribe opioids. The fear of addiction, however, should not be thought of as something separate from fear of regulatory scrutiny as these two issues are intimately related. The drug regulatory system was developed to control the spread of illicit drugs and the negative societal consequence of drug use, namely drug addiction. The history of intimidation of physicians by law enforcement regarding their opioid-prescribing practices in the early to midportion of thii century, combined with strong professional and societal fears of opioid addiction, have served to inhibit opioid prescribing to the present time. Because of these historic forces linking drug addiction with drug regulation, it may be difficult for today’s physicians to distinguish in their own minds between fear of addiction and fear of regulatory scrutiny. Controlled substance regulations serve a nccessary societal function, but specific laws and regulations differ from state to state. Joranson4
vol. 7&i?. 534
Ldtm
1992
has reviewed some of the uniquely restrictive state laws and regulations. Despite the absence of unique or significant additional restrictions in Wisconsin, the physicians in our survey were nonetheless concerned about the risk of reg-ulatory scrutiny. Our study indicates that these fears are sufficient to alter prescribing practice. It is highly likely that in those states with confusing definitions of addiction, multiple-copy prescription programs, and/or restrictive regulatory policies, physician concerns may lead to signifrcant underutilization of opioids. Additional research will help to answer this question. In addition to further research, it is important for regulatory and medical communities to begin working together to design bidirectional education programs. The medical community must educate regulators about the appropriate, controversial, and inappropriate uses of opioids, and the regulatory community needs to educate physicians about current drug regulations, the role of different regulatory agencies, and the investigative process in general. Furthermore, state laws, regulations, and policies that are impediments must be identified and removed. Passage of the revised Uniform Controlled Substance Act by all state legislatures would help to remove some of these impediments.5 Through educational initiatives, together with examination and removal of existing regulatory barriers, the fears and misconceptions that limit opioid use can hopefully be put to rest. David E. Weissman,MD Department of Medicine Medical Collegeof Wisconsin Milwaukee,Wisconsin
Refevemes 1. Multiple copy prescri$on programs resource guide. Washington,DC: US Department of Drug Enforcement Administration,1987:8-9. 2. Sigler KA, Guersney BG, Ingrim NE, et al. Effect of a triplicate prescription law on prescribing of Schedule II drugs.AmJHospPharm 1984;41:108-111. 3. WeissmanDE,Joranson DE, Hopwood ME. Wisconsin physicians’ knowledge and attitudes about opioid analgesicregulations.Wis Med J 1991;90:671-675. 4. Joranson DE. Federal and state regulation of opioids. J Pain Symptom Manage 1990;5:S12-S23. 5 ,loranson DE. A new drug law for the states: an opportunity to affirm the role of opioids in cancer pain relief.J Pain Symptom Manage 1990;5:333-336.
