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Recently, the subject of chronic opioid therapy for non-malignant pain has gained attention. Studies in non-addicted populations of patients with pain have documented an extremely low incidence, approximately O.1%, of iatrogenic addiction (psychologic dependence).7-9These studies challenge the previously held belief that the risk of iatrogenic addiction was greater than 1%.10-12 Furthermore, several studies in patients with chronic non-malignant pain indicate that a subset of patients exists that will benefit from chronic opioid therapy, a concept that has been historically rejected by medical practitioners and regulatory agencies.13
A complex maze of federal and state controlled substance laws, along with medical and pharmacy practice laws, are currently in place to reduce drug diversion. The effects of these regulations on medical practice and patient care are, however, unknown. This pilot study was designed to assess Wisconsin physicians' knowledge of opioid analgesic controlled substances regulations. In addition, we sought to understand how the perception of possible regulatory scrutiny effects opioid prescribing practice.
The survey consisted of demographic questions about community size, specialty, year of medical school graduation, number of monthly out-patient opioid prescriptions and percent of outpatient opioid prescriptions for potent opioids (morphine, hydromorphone, methadone, levorphanol and meperidine). Physicians were asked if they or someone they knew had ever been investigated in connection with opioid prescription practices.
There were 17 factual questions about regulations including multiple choice questions about opioid schedule and number of refills; true/false questions of the ability to prescribe an emergency supply of Schedule II drugs by telephone and the ability of the Drug Enforcement Administration (DEA) to have a physician's license revoked. Each factual question was assigned one point (best score = 17).
Seven questions were asked about concern of regulatory scrutiny when prescribing opioids in specific clinical situations using a four-point anchored Likert scale (not concerned=1; extremely concerned=4). These included prescribing for acute pain and three sets of paired questions; chronic non-cancer v chronic cancer pain, pain with and without a verifiable cause in a patient with a history of drug addiction, and prescribing Tylenol #3 v hydromorphone for longer than 6 months. The same four-point scale was used to assess fear of regulatory scrutiny when prescribing seven different opioids or dextroamphetamine for outpatient use. A four-point anchored Likert scale (never=1; always=4) was used in four questions to assess how often physicians lower the dose, decrease the quantity, limit the number of refills, or use a drug in a lower schedule because of fear of regulatory scrutiny.
Differences in the mean score of factual knowledge between different groups were tested by Student's t-test. Chi-squared tests were used to assess the relationships between responses to attitude questions and different demographic variables. For analysis by specialty, data were collapsed into two groups, surgical versus non-surgical specialties. For analysis by year of graduation, the data were collapsed into three groups; those graduating between 1981 and 1990, between 1961 and 1980, and before 1960. For analysis of opioid prescribing practice the data was collapsed into two groups; physicians prescribing five or fewer prescriptions per month, and those who prescribe six or more. Analysis of type of opioids was divided into two groups; those never prescribing potent opioids, and those who do prescribe them.
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Table 1.-Demographic information of physicians returning questionnaires.
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Table 2 presents the percentage of correct responses to the questions regarding drug schedule and number of allowable refills.
Physicians who wrote five or fewer prescriptions per month and those who never prescribe potent opioids had fewer correct responses to all these questions than did other physicians.
Sixty-one physicians (68%) correctly knew that emergency telephone prescribing of Schedule II drugs is legal. Fifty-five physicians (61%) incorrectly thought that the DEA has the power to have a physician's medical license revoked for violation of provisions of the federal Controlled Substances Act.
When asked about their perception of the overall risks associated with prescribing outpatient opioids, only 6% of the physicians ranked regulatory scrutiny as their first concern. They were much more concerned with addiction (57%), respiratory depression (20%), tolerance (13%) and miscellaneous opioid toxicities 10%) (percentages add to 106% because of multiple responses for first rank by individual physicians).
When physicians were asked to rank their concerns about the possibility of investigation by a drug regulatory agency for prescribing a range of specific controlled substances, they were least concerned about using acetaminophen with codeine and most concerned about using dextroamphetamine (Table 3). There was no difference in response based on specialty, year of graduation, community size, number or type of opioid prescription practice, with the exception that physicians who wrote no prescriptions for potent opioids compared to other physicians were more concerned about regulatory scrutiny concerning methadone.
When presented with seven clinica1 situations involving the use of opioids, physicians were least concerned about regulatory scrutiny when treating acute pain (Table 4). Physicians were more concerned About using opioids for chronic non-cancer than chronic cancer pain (p <.0001). They were more concerned about using opioids in a patient with a history of drug abuse without a verifiable pain syndrome (eg, migraine, back pain) than with a documented reason to have pain (eg, fracture, cancer) (p <.0001). They were more concerned about refilling hyromorphone for greater than 6 months than Tylenol #3 (p <.0001). Physicians were also more concerned about using opioids for chronic cancer pain than acute pain (p=".01)." There was no difference in response based on specialty, year of graduation, community size, number or type of opioid prescription practice.
When asked about consideration of possible investigation by a drug regulatory agency when writing outpatient opioid prescriptions, 70% of physicians indicated that they never lower the dose of opioid, 58% indicated they never decrease the quantity, 50% indicated they never limit refills, and 60% indicated they never use a drug in a lower schedule. Two percent, however, indicated they always lower the dose, 6% always decrease the quantity, 10% always limit refills and 2% always use a drug in a lower schedule. Forty-nine physicians (54%) indicated they alter at least one of these prescribing practices because of fear of regulatory scrutiny.
Fourteen physicians (16%) indicated that they or someone they knew had been investigated by a drug regulatory agency in connection with opioid prescribing practices. These physicians did not differ from the remaining respondents in terms of overall score on factual questions, specialty, or year of graduation. When asked to rank which regulatory agency was most likely to investigate a physician, 34 physicians indicated the Wisconsin Controlled Substances Board (CSB), 26 chose the DEA, 25 named the Medical Examining Board, and 6 indicated the local police.
Table 2.-Response rate to questions of opioid schedule and number of
allowable refills.
Drug* Percent of correct responses
schedule refills
Propoxyphene (IV/5) 33% 27%
Codeine tablets (II/5) 41 34
Tylenol#3 (III/5) 54 30
Percocet (II/O) 60 67
Methadone (II/O) 50 79
Hydromorphone (II/O) 56 82
Morphine (II/O) 57 84
* The drug name is followed in parenthesis by the schedule designated by
the Wisconsin Uniformed Controlled Substances Act and number of
allowable refills.
Table 3.-Degree of concern about possible drug regulatory investigation
when prescribing outpatient controlled substances.
Percent of respondents rating
1 = not concerned 4 = extremely concerned
Tylenol #3 82% 1
Propoxyphene 72 2
Codeine tablets 53 6
Percocet 39 4
Morphine 31 20
Hydromorphone 26 26
Methadone 26 36
Dextroamphetamine 23 42
State controlled substances laws tend not only to be more strict than federal law, they are also less specific about the public health value of controlled substances. State laws are also more ambiguous about the distinction between intractable pain patients and addicts.14 Some states restrict the amount of a controlled substance that may be prescribed or dispensed at one time; others define terms such as "addict," "habitual user," or "drug dependent person" so that chronic pain patients receiving legitimate prescriptions for opioids may be inappropriately included.14 One state requires physicians to report such patients as addicts; another requires physicians to report any patient treated with a controlled substance for more than a few months.15-17While most states do not attempt to monitor prescribing to patients, nine states have adopted multiple copy prescription (triplicate or duplicate) programs in an effort to deal with diversion problems. The significance of federal and state laws to the physician is that violation may result in loss of controlled substances registration, disciplinary action, or criminal proceedings.
Table 4.-Degree of concern about possible drug regulatory investigation in
different clinical situations
Percent of respondents rating
1- not concerned 4 - extremely concerned
Acute pain, need
opioids <2 weeks 78% 0% Chronic cancer pain, need opioids> one month 71 2
Chronic non-cancer pain,
need opioids > one month 23 11
Patient with history of drug abuse
with a "real" (documented) reason
to have pain 29 18
Patient with history of drug abuse
with pain that can not be verified 6 49
Chronic pain needing refills of
Tylenol #3 > 6 months 23 20
Chronic pain needing refills
of hydromorphone > 6 months 11 52
Although Wisconsin state laws are modeled after federal law, there is no specific recognition in Wisconsin ofthe importance of controlled substances to public health or the treatment of intractable pain. There are no ambiguous definitions of an addict, no requirement for reporting of patients, and there is no multiple copy prescription program. Wisconsin has, however, for several years conducted a vigorous enforcement program to identify and prosecute individual practitioners who violate law by diverting controlled substances, in particular amphetamines. The finding in our study that physicians were more concerned about using amphetamines compared to the opioids may reflect this enforcement policy.
Despite the lack of significant regulatory impediments to opioid prescribing in Wisconsin, the results of this survey suggest that Wisconsin physicians are concerned about regulatory scrutiny and that they have poor knowledge of controlled substance regulations. Many physicians were not aware of regulations about the number of allowable refills, particularly for non-Schedule II opioids, did not know that emergency prescribing of Schedule II drugs is permitted and misinterpreted the DEA's role in state licensing. Physicians who precribed more opioids were better informed about current regulations. Of interest, more physicians chose the CSB as the regulatory agency they thought would be most likely to investigate a physician when in fact the CSB has no investigative authority.
Wisconsin physicians ranked their concern about regulatory scrutiny lower when compared with their concern about addiction, respiratory depression and tolerance. This suggests the patients with chronic pain, whether due to cancer or non-cancer causes are at risk for under-treatment because of physician concern about the perceived risks of opioid addiction and other side effects. It appears the many physicians are unaware of studies that indicate the rarity of iatrogenic addiction and that most opioid side effects can be easily managed.7
Concern about regulatory scrutiny becomes much more significant to physicians when a patient has chronic non-cancer pain, a history of drug abuse or when opioids, in particular a Schedule II opioid, may be needed for more than 6 months. It suggests that patients in these circumstances are at risk for under-treatment because of physician concern about the possibility of regulatory scrutiny.
The majority of physicians indicated they do not lower the dose, prescription quantity or refills, or choose a less potent drug in a lower schedule due to concern for regulatory scrutiny. Fifty-four percent, however, indicated that fear of regulatory scruiny was sometimes great enough to alter at least one of these practices. These findings suggest that a perceived risk of regulatory scrutiny is sufficient to alter medical practice.
Results of this study must be interpreted with some caution because of potential biases. First, a response bias is possible since only 45% of the random sample mailing was returned and data was not collected to compare demographics and prescribing practices between responders and non-responders. Second, a surprisingly large number of physicians indicated personal or other contact with drug regulatory authorities, indicating another potential source of response bias. These physicians, however, did not appear to respond differently from other physicians. Finally, the wide difference in opioid prescribing pattern among respondents makes it difficult to generalize the results of this survey to other populations of physicians. In particular, this data should not be generalized to physicians in other states where the actual regulations and the regulatory limits may be quite different from Wisconsin. This is particularly true for states with triplicate programs. Data from a recent national survey indicates that medical oncologists from triplicate states feel that regulary impediments are a more significant barrier to cancer pain management than oncologists from other states.18 Other studies indicate that physicians from triplicate states change their opioid prescribing practice in response to introduction of a triplicate program, making greater use of drugs that do not require a triplicate prescription.19
In summary, these data suggest that respondents are far more concerned about addiction than regulatory scrutiny when prescribing opioids but that apprehension about regulatory scrutiny increases if the patient has chronic pain, a history of drug abuse or needs a potent opioid for an extended period - all factors that may communicate to the physician an increased risk of addiction. Therefore, patients at greatest risk for under-treatment for pain would appear to be those who need a medication under the circumstances which are associated by the physician with the risk of addiction.
Further research is needed to better identify which physicians, and under what circumstances, patients receive inadequate treatment. State and federal regulatory agencies need to clarify investigative policy with respect to the perceived high risk areas and assist in educating physicians about current regulations, the role of different regulatory agencies, and the investigative process in general. Better communication between regulatory agencies and physicians could lead to more rational use of opioids and better patient care.
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15. New York State Controlled Substances Act, Sect 3302.1
16. New York State Controlled Substances Act, Sect 3372
17. Rhode Island Uniform Controlled Substances Act, Sect 21-28-3.20
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