A. Addiction

To understand how addiction is ambiguously defined in state laws, we must first understand how addiction and its components are defined correctly.

The American Society of Addiction Medicine recently defined terms associated with addiction and the physiologic responses associated with opioid treatment for intractable pain. The terms defined below reflect current thought on the differences between addiction and opioid pain treatment.¹⁷

Physical dependence upon an opioid is a physiological state in which abrupt cessation of the opioid, or administration of an opioid antagonist, results in a withdrawal syndrome. Physical dependency on opioids is an expected occurrence in all individuals in the presence of continuous use of opioids for therapeutic or for nontherapeutic purposes. It does not, in and of itself, imply addiction.

Tolerance is a form of neuroadaptation to the effects of chronically administered opioids (or other medications) which is indicated by the need for increasing or more frequent doses of the medication to achieve the initial effects of the drug. Tolerance may occur both to the analgesic effects of opioids and to some of the unwanted side effects, such as respiratory depression, sedation, or nausea. The occurrence of tolerance is variable in occurrence, but it does not, in and of itself, imply addiction.

Addiction in the context of pain treatment with opioids is characterized by a persistent pattern of dysfunctional opioid use that may involve any or all of the following:

• adverse consequences associated with the use of opioids
• loss of control over the use of opioids
• preoccupation with obtaining opioids, despite the presence of adequate analgesia

Individuals who have severe, unrelieved pain may become intensely focused on finding relief for their pain. Sometimes such patients may appear to observers to be preoccupied with obtaining opioids, but the preoccupation is with finding relief of pain, rather than using opioids per se. This phenomenon has been termed ‘pseudoaddiction’ in the pain literature.

Aaron Gilson, Researcher at the Pain and Policy Studies Group at the University of Wisconsin, narrows down the definition of addiction as "drug use despite harm". This would not apply to pain patients as taking opioids actually increases their quality of life.

Ambiguous definition of addiction

According to the American Society of Addiction Medicine, "The clinical implications and appropriate management of physical dependence, tolerance and addiction differ. It is therefore important that clear definitions be established to facilitate identification and appropriate management of these occurrences.^11,17

Because many members of state medical boards continue to believe that physical dependence and tolerance associated with opioid pain treatment is the same as addiction, numerous states’ regulations fail to recognize the difference between physiological responses to opioids for intractable pain and the physiological and psychological responses to recreational drug abuse.^1,17

A survey conducted by The Pain and Policy Studies Group at the University of Wisconsin, confirmed state medical boards’ false belief that physiological responses to opioids are the same for addiction and intractable pain treatment. One question in the survey asked state medical board members to select terms that encompass the definition of addiction and physiological responses to opioid pain treatment. Physical dependence and tolerance held a large majority of the vote.

Table 1. Terms that state medical board members included within their definition of addiction. Each member was required to choose one or more of the following terms to define addiction: physical dependence, psychological dependence, tolerance, other, and don’t know.¹¹ (A question from a survey conducted by The Pain and Policy Studies Group at University of Wisconsin)

As a result of the confusion with the definition of addiction, and specifically with the assumption any type of physical dependence or tolerance is associated with addiction, states fail to establish the difference between intractable pain patients and drug addicts and between physicians and drug dealers. State medical board members need to understand that physical dependence and tolerance are not always associated with addiction, thus opioids taken for intractable pain rarely if ever result in addiction. Once this is done, overregulation and prosecution of legitimate physicians may subside to allow for more adequate intractable pain treatment.

B. Opioid dosage unit limitations

Federal regulations and the DEA state that no limitations should be set for healthcare professionals to administer or dispense opioids for intractable pain patients.⁹ Yet, some state medical boards insist upon regulating pain treatment by using opioid dosage unit limitations, limitations that result in undertreatment of pain because patients may not be able to access the amount of drugs necessary to relieve extreme levels of pain. Many states have dropped dosage unit limitations from their legislature; however several still remain. According to Aaron Gilson of the Pain and Policy Studies Group at the University of Wisconsin, nine states continue to support dosage unit limitations. The states are listed in Table 2.

Table 2. State restrictions for Schedule II controlled substances, including opioids. Note: Many states are ambiguous about their definition. One dosage unit may mean one pill, or it may mean the amount taken at one time.

To average citizens, these amounts may seem like a lot; but for intractable pain patients, most dosage unit limitations add up to only a fraction of what they need to relieve their pain. For example, one pain patient featured on 60 Minutes in 1997 said that he takes 60 pills per day—400 pills per week—to relieve his pain. If this pain patient lived in one of the above states, he wouldn’t receive the amount of medication necessary to relieve his pain. Also, pain patients who need to prescribe medication on mail order may be restricted by dosage unit limitations from a state in which they don’t live.

Dr. William Hurwitz, a pain specialist, said, "If it takes 100 pills a day or 200 pills a day to relieve the pain, that’s what it takes. There’s just no way for me to say, ‘Let’s undertreat them. Let’s make them suffer.’ " ¹²

Not only do pain patients continue to suffer due to restricted dosage unit limitations, but they also acquire increased expenses. Restricted dosage unit limitations require severe intractable pain patients to make multiple visits to their physicians to obtain opioid prescriptions if their required dosage exceeds the states’ allotted dosage amount. As a result of acquiring more prescriptions, pain patients then pay additional dispensing fees at the pharmacy.²

Also, patients suffer due to restricted dosage unit limits because healthcare providers and state medical boards mistake their continual search for pain relief—pseudoaddiction—with addictive behavior. New York state, for example, requires physicians to report their patients who take opioids for an extended amount of time as addicts—a mistake in the definition of addiction and in requiring dosage unit limitations.¹

Ultimately, all of these restrictions result in poor pain management, created and perpetuated by state medical boards and the DEA.

C. Multiple copy prescription programs

In an attempt to discourage drug diversion, some states have adopted a multiple copy prescription program (MCPP). An MCPP typically requires physicians to purchase prescription pads from the state to prescribe controlled drugs under Schedule II, in which most opioids are categorized. When a Schedule II prescription is written, the physician, the pharmacist, and the Narcotics Division of that state each keep a copy for two years.³ The Narcotics Division, in turn, cooperates with the DEA and the state medical board, state and county attorneys, physicians, pharmacists, dentists, and veterinarians to investigate "irregular" prescribing patterns and ultimately contribute to the prosecution of suspected "overprescribing" offenders.³ Those states who have MCPPs are listed in Table 3.

In a July 1998 letter to the National Foundation for the Treatment of Pain, the DEA states that it encourages the development of MCPPs because the data collected from them can be used to:

• develop medical education programs to heighten professional awareness to prescription drug abuse and abuse trends
• target doctor shoppers (patients who seek opioids without a medical reason) and script rings (doctors who sell opioid prescriptions to drug abusers)
• eliminate the need for investigators to spend limited resources searching prescription data by visiting every pharmacy, looking through prescription files, and thus creating an air of suspicion regarding a possible investigative target
• provide a system whereby practitioners can inquire about patients that could potentially be doctor shoppers

Table 3. A list of states with prescription monitoring programs, compiled by the DEA.

Multiple copy prescription programs (MCPPs) do offer an immediate and drastic decrease in the amount of Schedule II drugs prescribed in each state. When states began their multiple copy prescription program, the following reductions in Schedule II drugs resulted: Texas - 64%, Rhode Island - 57%, New York - 54%, Idaho - 50%.¹³

The problem with these numbers is that there is little chance that approximately half of the physicians in those states stopped prescribing opioids because they were afraid of getting caught selling drugs on the black market. Rather, these reductions in opioid prescribing resulted from physicians’ fear of prosecution,³ not because they are drug dealers but because they know their state will interpret their prescribing as such.

Physicians’ fear of being prosecuted results in one of two behaviors—simply not prescribing any pain medication or prescribing less regulated pain medication that causes further, more dangerous side effects than opioids.^14,16,18,19 In fact, a 1996 study, comparing analgesic prescribing patterns between physicians whose states had MCPPs and those without, showed that the "MCPP status is a strong influence in predicting the type of analgesic used…the presence of a state MCPP exerts a negative influence on the probability that a Schedule II analgesic will be prescribed in an office visit, and a strong positive effect on the probability of Schedule III opioid analgesic receipt…If rates of use of Schedule II medications are indeed lower in the MCPP states, patients in those states may experience greater levels of pain than their counterparts in non-MCPP states." ¹⁹

The less regulated drugs that are most often used as alternatives are anti-inflammatory drugs. When taken over extended periods of time as required for intractable pain treatment, anti-inflammatory drugs can cause internal bleeding, ulcers, and kidney, liver, or stomach damage.^14,16 Even worse, one study showed that 17,000 deaths resulted from these opioid alternatives in one year, whereas deaths resulting from opioids was described as "vanishingly small" by Dr. Brian Goldman, a University of Toronto researcher who has studied prescription drug diversion.¹⁴

Ultimately, the MCPPs perpetuate a stigma against adequate opioid treatment that results in the intimidation and prosecution of legitimate physicians who adequately treat intractable pain. Because of these unwarranted prosecutions, the DEA contradicts its conviction that physicians are allowed to exercise their medical judgment to dispense or administer narcotics for extended periods of time for chronic pain.

D. Electronic monitoring systems

The National Foundation for the Treatment of Pain had a conversation with Susan Peine from the DEA, in which she spoke about the DEA’s recommendation that all states’, with or without MCPPs, develop an electronic monitoring system. Using this electronic monitoring system, state medical boards and the DEA can continue to monitor prescribing patterns but on an electronic level. Peine suggested the advantage of the electronic monitoring system is that investigators will no longer visit physicians’ offices to investigate prescribing. Rather, their prescribing patterns will be on file and searchable electronically, allowing for a less intrusive investigation.

As Aaron Gilson, Researcher at the Pain and Policy Studies Group at the University of Wisconsin, points out, however, these programs tack on additional drug schedules to monitor. As you can see in Table 3, all of the states who monitor multiple schedules of drugs have electronic monitoring systems in place. Gilson agrees that these electronic monitoring services are better in the fact that they are less intrusive; however, these electronic monitoring services may be worse than MCPPs because they may perpetuate further stigmas towards opioids that are not only in Schedule II but Schedule III as well.

E. Falsely perceived illegality of opioids for different categories of intractable pain

The Pain and Policy Studies Group at the University of Wisconsin conducted a survey of state medical boards to determine how they perceived the legality and medical appropriateness of opioid treatment for different categories of pain patients for an extended period of time. Approximately 6 board members from 49 states responded. (Massachusetts was not represented.) Seventy-five percent of the respondents were physicians, 15% were public members, 12% were members of osteopathic boards.¹¹ Their responses to this survey are listed in Table 4.

Table 4. State medical board perception of legality and medical appropriateness of opioid treatment for different categories of pain patients for an extended period of time.¹¹ Note: Rows do not total 100% because respondents could give more than one response.

Patient History	Level of perceived legality
	Lawful and generally acceptable medical practice	Lawful, but generally not acceptable medical practice; should be discouraged	Probable violation of medical practice laws and regulations; should be investigated	Probable violation of federal / state controlled substances laws; should be investigated	Don't know
Cancer pain only	75%	14%	5%	5%	7%
Cancer pain with history of opioid abuse	46%	22%	14%	12%	16%
Chronic, non-malignant pain only	12%	47%	32%	27%	7%
Chronic, non-malignant pain with history of opioid abuse	1%	25%	58%	50%	6%
Adapted from Fed Bull.  1992;79(4):15-49.

As you can see from these state medical board responses, opioid treatment is generally accepted for cancer pain only, but very few members understand that opioid treatment is recommended for severe, intractable pain whether due to cancer or not. Some even believe that prescribing opioids for non-malignant intractable pain is a crime worth investigating.

Treating cancer and non-malignant pain in patients who have a history of drug abuse is a controversial and often confusing topic in opioid treatment. One study showed that the patients who abused alcohol alone and who had a support system through family, friends, and/or Alcoholics Anonymous showed no signs of opioid abuse.²⁰ Those patients who abused several substances, which may or may not have included opioids, and did not have a support system through family, friends, or AA tended to abuse opioids during treatment. The signs that the study observed for opioid abuse were:²⁰

• unauthorized dose escalations occurring more than once in a 3-month period
• frequent telephone calls to the clinic numbering more than two calls per month
• "doctor shopping" or receiving opioids from any other physician or from any emergency room visit
• losing or reporting prescriptions as "stolen"
• more than three visits to the clinic without an appointment during a 1-year period
• multiple so-called drug allergies, or intolerance to attempts to change a patient’s opioid to another opioid