The ASAM Principles of Addiction Medicine 5th Edition

111. Clinical, Ethical, and Legal Considerations in Prescribing Drugs with Abuse Potential

James W. Finch, MD, Theodore V. Parran, Jr., MD, FACP, Bonnie B. Wilford, MS, and Stephen A. Wyatt, DO

CHAPTER OUTLINE

■  FACTORS THAT CONTRIBUTE TO INAPPROPRIATE MEDICATION PRESCRIBING AND USE

■  UNIVERSAL PRECAUTIONS IN PRESCRIBING CONTROLLED DRUGS

■  LEGAL REQUIREMENTS IN PRESCRIBING CONTROLLED DRUGS

■  CONCLUSIONS

Many medications in common use have a clearly documented potential for misuse and dependence. These include opioid analgesics, stimulants, sedative– hypnotics, cannabinoid-like medications, and miscellaneous substances. Although widely varying in terms of their effects on the brain, all at least indirectly trigger an acute surge of dopamine from the ventral tegmental and nucleus accumbens regions of the brain to the prefrontal cortex, thereby producing brain reward and euphoria. This is what gives them their potential for misuse, abuse, and addiction.

The Drug Enforcement Administration (DEA) addresses this issue by placing certain medications into schedules that relate to their presumed relative risk of misuse (which tends to be related to the speed of onset and intensity of the dopamine surge). It is important for clinicians to recognize that these schedules provide only a rough estimate of a specific drug’s potential for misuse and diversion. Moreover, many medications may have a high risk of misuse for one individual but not another. Such drugs have the potential to lead to addiction primarily in individuals whose brains are vulnerable to addiction; they pose relatively little risk to individuals who do not have a vulnerability to substance use disorders.

In addition, an array of nonscheduled medications (prescription and over the counter [OTC]) also have a potential for misuse.

It is important to emphasize that medications that have a potential for abuse also can be valuable therapeutic tools in the treatment of pain and other medical and psychiatric conditions, even in persons who have a history of substance use disorder. This challenging interplay of potential risk and benefit requires that any decision to prescribe such medications must be made judiciously and with attention to appropriate assessment, informed consent, and careful patient monitoring.

The decision as to whether to prescribe a controlled substance is further complicated by prescribers’ understandable concern about legal and regulatory scrutiny. Most physicians who prescribe controlled substances do so in a legitimate manner that does not warrant, or receive, scrutiny by federal or state law enforcement or regulatory agencies. In fact, fewer than 1 in 10,000 physicians has lost a DEA registration to prescribe controlled substances on the basis of a DEA investigation of his or her prescribing (1).

Unfortunately, a number of high-profile cases brought against physicians for inappropriate prescribing (2) have led some experts to predict that the publicity surrounding such cases will have a “chilling effect” on physicians’ willingness to prescribe certain medications and patients’ willingness to use them (3). In turn, this may lead to under-treatment or inadequate treatment of very common conditions such as chronic nonmalignant pain. Fear of adverse actions by regulatory and law enforcement officials need not deter the effective management of patients if physicians approach the diagnosis, treatment, and recordkeeping processes with care (4).

Patients who have a history of or an active substance use disorder pose a special challenge in relation to the use of controlled drugs. Such patients are at substantially elevated risk for misuse of controlled medications such as opioid analgesics, benzodiazepines, and stimulants, and even legitimate use of such medications can kindle or reawaken drug cravings and precipitate relapse.

On the other hand, individuals with substance use disorders also are at elevated risk of physical and emotional trauma, chronic pain, debilitating mood disorders, attention deficit hyperactivity disorders, and stressful life conditions. Untreated pain and psychiatric conditions not only cause suffering in and of themselves but also are strong triggers for relapse to substance misuse. The physician thus faces the dilemma of deciding whether such medications can be used safely in certain patients or, if not, how to provide effective treatments without the use of controlled drugs.

FACTORS THAT CONTRIBUTE TO INAPPROPRIATE MEDICATION PRESCRIBING AND USE

Factors that contribute to inappropriate prescribing of medications include (a) physician uncertainty as to prevailing standards of care, (b) inadequate medical evaluation and workup of the sources of and treatments for the patient’s disorder, (c) unclear or conflicting clinical guidelines, (d) physician concerns that prescribing adequate amounts of medication will result in unnecessary scrutiny by regulatory authorities, (e) physician misunderstanding of the causes and manifestations of drug dependence and addiction, (f) physician fear of causing addiction or being deceived by a patient, (g) physician behaviors that have been described as “confrontation phobia” and “hypertrophied enabling,” and (h) inadequate physician education about regulatory policies and processes (314).

Inappropriate treatment also can result from a mistaken belief that complete eradication of symptoms is an attainable goal and one that can be achieved without disabling adverse effects. In fact, the goals of treatment with controlled drugs or any medication ought to involve (a) patient safety; (b) reasonably attainable improvement in symptoms and overall function; (c) improvement in associated symptoms such as sleep disturbance, depression, and anxiety; and (d) avoidance of unnecessary or excessive use of medications (6,15). Effective means of achieving these goals vary widely, depending on the type and causes of the patient’s problem, concurrent medical or psychiatric diagnoses, and the preferences of the physician and the patient.

Patients share with physicians a responsibility for appropriate use of prescribed medications (16,17). This responsibility encompasses providing the physician with complete and accurate information and adhering to the treatment plan. Some patients—intentionally or unintentionally— are less than forthcoming or have unrealistic expectations regarding the need for therapy or the amount of medication required. Other patients may begin to use medications as prescribed and then slowly deviate from the therapeutic regimen. Still others may not comply with the treatment plan because they misunderstood the physician’s instructions. Some patients share their drugs with others without intending harm (a pattern of misuse that is seen quite often among older adults (9)). There also are patients who deliberately misuse or are addicted to prescription medications and who mislead, deceive, or fail to disclose information to their physicians in order to obtain such medications so as to sustain their addiction and avoid withdrawal (1618).

Patients’ carelessness in leaving drugs where they can be stolen by visitors, workers, and family members is another important source of diversion. Thus, a prescription that is quite appropriate for an elderly patient may ultimately contribute to the death of a young person who visits or lives in the patient’s home. Therefore, the physician’s duty includes not only appropriate prescribing but also appropriate education of patients regarding the secure storage of medications and their safe disposal once the course of treatment is completed (18).

A more problematic individual is the criminal patient, whose primary purpose is to obtain drugs for resale. Whereas most addicted patients seek a long-term relationship with one or more prescribers, criminal patients sometimes move rapidly from one prescriber (or dispenser) to another. Such individuals often visit multiple practitioners in a day (a practice known as “doctor shopping”) and travel from one geographic area to another in search of unsuspecting targets (13,16). Physicians’ attention to patient assessment, obtaining and reviewing records from past prescribers, and the routine use of state prescription drug monitoring programs (PDMPs), where available, have been cited as effective ways to identify individuals who engage in such criminal activities (19).

UNIVERSAL PRECAUTIONS IN PRESCRIBING CONTROLLED DRUGS

Judicious prescribing of medications with abuse potential requires thoughtful application of several broadly accepted elements of good medical care to this particular area of practice. Wherever possible, the strategies for safe and appropriate prescribing presented here are supported by the weight of clinical evidence (2025). At the least, they reflect considerable clinical experience. This chapter employs an approach described as “universal precautions” to emphasize its similarity to the infectious disease model of the same name. The key steps of universal precautions in prescribing controlled drugs have been defined by Gourlay and Heit as follows (26):

1.  Conduct an initial patient assessment and risk stratification, and make a diagnosis with an appropriate differential.

2.  Discuss the proposed treatment plan with the patient, and obtain his or her informed consent.

3.  Execute a written treatment agreement that sets forth the expectations and obligations of both the patient and the treating physician.

4.  If prescribing medications, initiate an appropriate trial of medication therapy.

5.  Monitor the patient’s response to therapy, and use that information to decide whether to continue, revise, or terminate medication therapy.

6.  Keep careful and complete records of the initial evaluation and each follow-up visit.

As presented here, the concept of universal precautions recognizes that all patients are at some level of risk for misuse of prescribed medications, however small, and that the risk level initially can only be estimated, with the estimate modified over time as additional information is obtained. By acknowledging the fact that there are no signs that invariably point to or exclude substance use disorder, the concept of universal precautions encourages a consistent and respectful approach to all patients, thus minimizing stigma, improving patient care, and reducing overall risk (26).

Conduct an Initial Patient Assessment and Risk Stratification, and Make a Diagnosis with an Appropriate Differential

The purpose of the patient assessment is to elicit information needed to arrive at a diagnosis and to determine the relative risks posed by various potential treatments. This involves identifying a clear indicationfor potential prescribing and ruling out contraindications to such prescribing. Assessment also involves determining whether a medication is appropriate in terms of its potential efficacy relative to available alternatives. For example, a complaint of pain is not in itself sufficient to indicate the need for an opioid analgesic, just as the presence of anxiety does not necessarily indicate the need for a benzodiazepine. Rather, presenting complaints initiate a process that attempts to identify the clinical syndrome and the clinical need for medications.

Assessment also involves risk stratification, that is, screening for relative or absolute contraindications to the use of controlled drugs and evaluating the risks posed by other available therapies or no pharmacologic therapies.

The nature and extent of the initial assessment depend on the patient’s presenting complaint and the context in which it occurs. Thus, meaningful assessment of a chronic condition usually demands a more detailed evaluation than assessment of an acute condition. For example, with a patient whose presenting complaint is chronic pain, the physician typically would assess the nature and intensity of the pain, past and current treatments, any underlying or co-occurring disorders and conditions, and the effect of the pain on the patient’s physical and psychological functioning (22).

For every patient, the initial workup should include a system review and relevant physical examination, as well as appropriate laboratory tests (2224). Such investigations help the physician address the nature and intensity of the presenting complaint, as well as any secondary manifestations, such as effects on the patient’s sleep, mood, work, relationships, valued recreational activities, and alcohol, tobacco, and other drug use.

Social and vocational assessment is useful in identifying supports and obstacles to treatment and rehabilitation; for example, does the patient have good social supports, housing, and meaningful work? Is the home environment stressful or nurturing? (8).

Finally, it is valuable to obtain corroborating information from the physician who most recently prescribed for the patient, from the state PDMP if available, and from one or more significant others. The patient’s cooperation in giving consent for the release of this information is essential to safe prescribing.

Use of a validated screening tool such as the Screener and Opioid Assessment for Patients with Pain (SOAPP-R (30)) or the Opioid Risk Tool (31) or the three-question “pain, enjoyment, and general activity” (PEG) scale (27) can save time in collecting and evaluating the information and determining the patient’s level of risk.

Substance Use History

Assessment of the patient’s history of alcohol, tobacco, or other drug abuse and relative risk for medication misuse or abuse is an important component of the initial evaluation (9,1520) and ideally should be completed prior to a decision as to whether to prescribe (28). This can be done through a careful clinical interview, which also should inquire into any history of physical, emotional, or sexual abuse because those are risk factors for substance misuse (29). Such a history should involve the use of validated substance abuse screening tools as well as the answers to very specific questions, such as the following:

■  “In the past 6 months, have you taken any medications to help you calm down, keep from getting nervous or upset, raise your spirits, or make you feel better?”

■  “Have you been taking any medications to help you sleep? Have you been using alcohol for this purpose?”

■  “Have you ever taken medication to help you with a drug or alcohol problem?”

■  “Have you ever taken medication for a nervous stomach?”

■  “Have you taken medication to give you more energy or to cut down on your appetite?”

The patient’s substance use history should include questions about use of alcohol and OTC preparations. For example, certain OTC dietary supplements have mood-altering capabilities and often are misused. Many OTC cold preparations contain alcohol and other central nervous system (CNS) depressants or stimulants and should not be used in combination with prescribed medications that have CNS effects. A positive answer to any of these questions warrants further investigation.

Information provided by the patient is a necessary but not sufficient part of the evaluation process. Reports of previous evaluations and treatments should be confirmed by obtaining records directly from those providers, if possible. Patients sometimes provide fraudulent records, so it is important to request records directly from the other providers.

If possible, the patient evaluation also should include corroborating information from family members and/or significant others, who should be asked about (a) the patient’s current level of function as compared to the level of function in the past; (b) the family’s goals for restoration of the patient’s function; and (c) the family’s assessment of the patient’s risk of drug misuse, as through the F-CAGE. Patients who resist efforts to obtain such corroboration from family members or significant others require closer evaluation.

Where available, the state PDMP should be consulted to determine whether the patient is receiving prescriptions from other physicians. The date on which the PDMP was consulted and any information obtained there should be added to the patient record. In providing treatment to a patient who is taking one or more medications prescribed by another physician, full communication among all health care providers is essential to patient safety (18).

The physician’s decision as to whether to prescribe a controlled substance should reflect the totality of the information collected, as well as the physician’s own knowledge and comfort level in prescribing such medications and the available resources for patient support (1618). In reaching such a decision, it is important to recognize that not every substance abuse history indicates the same level of risk and that a history of substance misuse may be a relative rather than an absolute contraindication to prescribing. For example, active addiction is different than a history of addiction, and a history of addiction with appropriate treatment and attention to ongoing recovery is different than no active attention. The issue of “cross addiction”—the concept that addiction to one class of drugs substantially raises the risk of addiction to a different class of drugs (32)—also needs to be considered.

Discuss the Proposed Treatment Plan with the Patient, and Obtain Informed Consent

Once established, the treatment plan and goals should provide clear-cut, individualized objectives to guide the choice of therapies (26). The treatment plan should contain information supporting the selection of all therapies, both pharmacologic and nonpharmacologic.

It also should specify the objectives that will be used to evaluate treatment progress, such as relief of symptoms, patient safety, and improved physical and psychosocial function (24,25). The plan should document the need for any further diagnostic evaluations, consultations, or referrals and list other therapies that have been considered (33).

Use of a written informed consent is recommended (17,18,23) (see the section on Legal Requirements for a detailed discussion of informed consent).

Document Decisions in a Written Treatment Agreement

Treatment agreements are used to outline the joint responsibilities of the patient and physician (2325). Typically, they address the following:

The goals of treatment in terms of symptom management, restoration of function, and safety

■  The patient’s responsibility for safe medication use (e.g., by not using more medication than prescribed or using the medication in combination with alcohol or other substances, by storing the medication in a secure location, and by safe disposal of any unused medication)

■  The patient’s responsibility to obtain his or her prescribed medication from only one physician or practice

■  The patient’s permission to contact corroborators (such as prior prescribers and significant others) to support the initial history as well as to corroborate reports of ongoing functional improvement

■  The patient’s agreement to periodic drug testing (as of blood, urine, hair, or saliva)

■  The physician’s responsibility to be available or to have a covering physician available to care for unforeseen problems and to prescribe scheduled refills

The medical record should document the presence of one or more recognized medical indications for prescribing (34) and reflect an appropriately detailed patient evaluation, including risk stratification and screening for contraindications (2325). Even when sound medical indications have been established, physicians typically consider three additional factors before deciding to prescribe:

1.  The severity of symptoms, in terms of the patient’s ability to accommodate them. Relief of symptoms is a legitimate goal of medical practice, but using psychoactive drugs in an effort to achieve complete relief of symptoms usually is unrealistic and may be dangerous.

2.  The patient’s reliability in taking medications, noted through observation and careful history taking. The physician must assess a patient’s susceptibility to drug misuse before prescribing any psychoactive drug and weigh the benefits against the risks. The potential development of dependence in patients on long-term therapy should be monitored on an ongoing basis.

3.  The dependence-producing potential of the drug. The physician should consider whether a drug with less potential for abuse, or even a nondrug therapy, would provide equivalent benefits. Patients should be warned about possible adverse effects caused by interactions between the prescribed medication and other drugs, including alcohol.

All of these factors should be weighed before making a decision to prescribe (2325).

Initiate an Appropriate Trial of Medication Therapy

Medication therapy should be presented to the patient as a therapeutic trial or test for a defined period of time and with specified evaluation points. The physician should explain that progress will be carefully monitored for both benefit and harm in terms of the effects of the medication on the patient’s symptoms, function, and quality of life, as well as any adverse events or risks to safety (2225).

Drug Selection and Dosing

Rational drug therapy demands that the efficacy and safety of all potentially useful drug classes be reviewed for their relevance to the patient’s disease or disorder (35) and the patient’s risk for medication misuse, abuse, and addiction.

When the optimum drug has been selected, the dose, schedule, and formulation should be determined. These choices often are just as important in optimizing drug therapy as the choice of drug itself. Decisions involve (a) the dose, based not only on the patient’s age, weight, and size but also on the severity of disease, possible loading dose requirements, the presence and extent of drug tolerance, and the presence of potentially interacting drugs; (b) the timing of administration, as by using a bedtime dose to minimize problems associated with sedative effects; (c) the route of administration, chosen to improve compliance/adherence as well as to attain peak drug concentrations at the desired time and speed; and (d) the drug formulation (e.g., selecting a patch in preference to a tablet or an extended-release rather than an immediate-release formulation).

At the time a drug is prescribed, patients should be educated that it is illegal to sell, give away, or otherwise share their medication with others, including family members. The patient also should be informed that his or her obligation extends to keeping the medication in a locked cabinet or otherwise restricting access to it, as well as safely disposing of any unused supply.

Finally, the physician should convey to the patient through attitude and manner that any medication, no matter how helpful, is only part of the overall treatment plan.

Special Precautions with New Patients

Many experts recommend that additional precautions be taken when prescribing a controlled drug to a new patient. Such precautions might include the following:

■  Assessment: In addition to the patient history and examination, the physician should determine which physician(s) has been caring for the patient, what medication(s) has been prescribed for which indications, how recently such medications were prescribed, and what substances (including alcohol, illicit drugs, and OTC products) the patient has used and how recently. Medical and pharmacy records should be obtained (with the patient’s consent) to verify this information. At a minimum, the patient’s identity should be verified by asking for proper identification.

■  Quantities: In nonemergency situations, the physician should prescribe only enough of a controlled drug to meet the patient’s needs until the next appointment. The patient should be required to return to the office for additional prescriptions, as telephone orders do not allow the physician to reassess the patient’s continued need for the medication.

■  Emergencies: In emergency situations, the physician should prescribe no more than 1 day’s supply of a drug and arrange for a return visit.

Monitor the Patient’s Response to Therapy

Frequent monitoring visits should be scheduled while the treatment plan is being initiated and the medication dose adjusted (36,37). As the patient is stabilized in the treatment regimen, follow-up visits may be scheduled less frequently. (However, if the patient is seen less than monthly, arrangements must be made for the patient to obtain a refill or new prescription as needed.)

Asking the patient to keep a log of signs and symptoms gives him or her a sense of participation in the treatment program and facilitates the physician’s review of therapeutic progress and adverse events.

For some conditions, validated patient questionnaires such as the Current Opioid Misuse Measure (38) can be used to monitor patients for medication misuse. Periodic pill counts also are a useful strategy to confirm medication adherence and to minimize diversion (e.g., selling, sharing, or giving away medications). As outlined above, obtaining permission to contact prior prescribers is an essential part of patient safety, and periodic contacts with significant others to corroborate the patient’s functional status and identify risky behaviors are very important in ensuring patient safety.

Almost all states have enacted laws that establish PDMPs to facilitate the collection, analysis, and reporting of information on the dispensing of controlled substances. Most such programs employ electronic data transfer systems, under which prescription information is transmitted from the dispensing pharmacy to a state agency, which collates and analyzes the information (19,39). Where real-time data are available, routine use of PDMPs can help to prevent prescription drug misuse and diversion by allowing the physician to determine whether a patient is receiving prescriptions for controlled substances from other physicians, as well as whether the patient has filled or refilled prescriptions for any controlled drugs the physician has ordered (40). PDMP information can be very helpful in assessing the patient’s level of physical tolerance and thus is an important contributor to patient safety.

Therapeutic drug testing also is useful in monitoring adherence to the treatment plan, as well as in detecting the use of nonprescribed drugs (41,42). Drug testing is an important monitoring tool because patients’ self-reports of medication use can be unreliable and behavioral observations may detect some problems but not others (43). However, physicians need to be aware of the limitations of available tests (such as their limited sensitivity for many opioids) and take care to order tests appropriately (44). For example, when a drug test is ordered, it is important to specify that it include the specific drug being prescribed (41). Because of the complexities involved in interpreting drug test results, it is advisable to verify significant or unexpected results through confirmatory studies and consultation with the testing laboratory’s toxicologist or a clinical pathologist (41,42).

Test results that suggest possible misuse of the prescribed medication or other drugs should be discussed with the patient. It is helpful to approach such a discussion in a positive, supportive manner, so as to strengthen the physician–patient relationship and encourage healthy behaviors (as well as behavioral changes where needed). Both the test results and subsequent discussion with the patient should be thoroughly documented in the medical record (41).

Whenever the physician is concerned about a patient’s behavior or clinical progress (or the lack thereof), it is advisable to seek a consultation with an expert in the disorder for which the patient is being treated. If there is concern about possible medication misuse or diversion, consultation with an expert in addiction medicine also is advised. Physicians place themselves and their patients at risk if they continue to prescribe controlled drugs in the absence of such consultations.

Based on the Patient’s Response, Decide Whether to Continue, Revise, or Terminate Medication Therapy

No treatment regimen should be left open ended. Throughout the course of therapy, the physician and patient should regularly weigh the potential benefits and risks of continued treatment and determine whether such treatment remains appropriate (23,37). Continuation, modification, or termination of medication therapy should be contingent on (a) evidence of the patient’s progress toward the established treatment objectives and (b) the absence of substantial risks or adverse events, such as overdose or diversion (4547) (see Table 111-1).

TABLE 111-1 IDENTIFYING AND RESPONDING TO PRESCRIPTION DRUG ABUSE

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Data from Isaacson JH, Hopper JA, Alford DP, et al. Prescription drug use and abuse: risk factors, red flags, and prevention strategies. Postgrad Med 2005;118:19.

A satisfactory response to treatment would be indicated by reduced severity of symptoms, increased level of function, and/or improved quality of life (33). Information from family members or other caregivers should be considered in evaluating the patient’s response to treatment (3,8,23,24). Use of measurement tools to assess the patient’s level of pain, function, and quality of life (such as a visual analog or numerical scale) can be helpful in documenting therapeutic outcomes (37,46,48).

If a decision is made to continue medication therapy, the treatment plan may need to be adjusted to reflect the patient’s changing physical status and needs, as well as to support safe and appropriate medication use (3). Steps such as simplifying the drug regimen and offering additional patient education can improve adherence, as can phone calls to patients, home visits by nursing personnel, convenient packaging of medication, and monitoring of serum drug levels (2325). On the other hand, it is not advisable to have family or friends supervise the patient’s medication use (except for pediatric or geriatric patients), because placing such an individual between a patient who demonstrates aberrant medication use behaviors and that the patient’s supply of medications can be dangerous for both parties.

If the results of ongoing monitoring indicate that the treatment plan needs to be modified (e.g., because the patient’s symptoms are not responding to the medication or because there is evidence of problematic medication use behaviors), the treatment agreement may need to be adjusted to include more frequent visits, smaller prescriptions with fewer or no refills, callbacks for pill counts or random drug screens, or referral for adjunctive addiction-related or psychotherapeutic treatment (26).

Reasons to Stop Prescribing

Reasons for discontinuing medication therapy include resolution of the condition being treated, emergence of intolerable side effects, inadequate medication effect, failure to improve the patient’s quality of life despite aggressive titration, evidence of deteriorating function, or significant aberrant medication use (49,50).

Evidence of misuse of prescribed medications demands prompt intervention (45). Patient behaviors that require such interventions typically involve multiple early requests for refills, multiple reports of lost or stolen prescriptions, obtaining controlled medications from multiple sources without the physician’s knowledge, intoxication or impairment (either observed or reported), and pressuring or threatening behaviors (16,18). The presence of illicit or unprescribed drugs in drug tests also requires action on the part of the prescriber.

Some so-called “drug-seeking” behaviors are more closely associated with medication misuse than others (49,50). Most worrisome is a pattern of behavior that suggests recurring misuse, such as unsanctioned dose escalations, deteriorating function, and failure to comply with the treatment plan (18).

Documented drug diversion or prescription forgery, obvious impairment, and abusive or assaultive behaviors require a firm, immediate response (20,45). Indeed, failure to respond can place the patient and others at significant risk of adverse consequences, including accidental overdose, suicide attempts, arrests and incarceration, or even death (3).

When such events arise, it is important to separate the person of the patient from the behaviors triggered by the disease, by demonstrating a positive regard for the person but no tolerance for the behaviors. The essential steps are (a) to stop prescribing, (b) to inform the patient that continued prescribing is not clinically supportable and thus not possible, (c) to urge the patient to accept a referral for assessment by an addiction specialist, (d) to educate the patient about signs and symptoms of spontaneous withdrawal and urge the patient to accept referral for medically managed detoxification or to go to the emergency department if withdrawal symptoms occur, and (e) to assure the patient that he or she will continue to receive care for the presenting symptoms or condition, but without continued prescribing of controlled drugs (3).

Identification of a patient who is abusing a prescribed controlled drug presents a major therapeutic opportunity. The physician should have a plan for managing such a patient, typically involving work with the patient and the patient’s family, referral to an addiction expert for assessment and placement in a formal addiction treatment program, long-term participation in a 12-step or other mutual help program such as Alcoholics Anonymous or Narcotics Anonymous, and follow-up of any co-occurring medical or psychiatric conditions (15,18).

Discontinuing Medication Therapy

When a decision is made to discontinue medication therapy, any patient who has become physically dependent on a prescribed medication should be provided with a safely structured tapering regimen (50). The physician must determine whether such discontinuation constitutes a clinical emergency (requiring referral for inpatient withdrawal management), an urgent situation (requiring a rapid structured taper over several weeks), or a nonurgent situation (involving a gradual taper over several months). Withdrawal typically can be managed on either an inpatient or an outpatient basis by the prescribing physician or through referral to an addiction specialist (18).

When tapering, it is important to be realistic regarding the patient’s ability to comply and to tailor the program accordingly. Much smaller prescription allotments, more frequent check-ins and drug screens, and greater involvement of family or other caregivers may be required. If at some point it becomes clear that, in spite of these measures, the patient is not able to comply with the tapering plan, alternatives such as discontinuation of prescribing and referral for inpatient or outpatient detoxification or referral for substitute agonist therapy with methadone or buprenorphine may be advisable.

In all cases, patients should be given the benefit of the physician’s concern and attention. It is important to remember that even drug-seeking patients can have very real medical problems that demand and deserve the same high-quality medical care offered to any patient. Also, the termination of therapy with a controlled drug should not mark the end of treatment, which should continue with other modalities, through either direct care or referral to a specialist, as appropriate (18).

LEGAL REQUIREMENTS IN PRESCRIBING CONTROLLED DRUGS

To legally prescribe, dispense, or administer a controlled drug, a physician must be (a) registered with the U.S. Drug Enforcement Administration, (b) licensed by the state in which he or she practices, and (c) acting in compliance with all applicable federal and state laws and regulations (4,39). The legal requirements for prescribing controlled drugs generally rest on the principles of the “usual course of medical practice,” which involves an appropriate patient evaluation (including a patient history, physical examination, laboratory evaluation, record review, and workup) and a legitimate medical purpose (e.g., documentation of a clear diagnostic indication for prescribing a controlled drug as well as screening for contraindications). These criteria are met in the medical practice of the vast majority of physicians.

The Physicians’ Manual of the U.S. Drug Enforcement Administration and any relevant documents issued by the state medical board discuss specific rules and regulations governing the prescribing of controlled substances (51). Additional resources are available on the DEA’s Web site (at www.deadiversion.usdoj.gov), as well as from the medical licensing board in each state.

Informed Consent

An informed consent document serves multiple purposes. For example, it can (a) provide information about the risks and benefits of the pharmacologic therapy, (b) promote adherence to the treatment regimen, (c) limit the potential for inadvertent drug misuse, and (d) improve the efficacy of the treatment program. Specific topics addressed in most informed consent documents include the following (4547):

■  The potential risks and anticipated benefits of therapy

■  Potential side effects (both short and long term) of the medication, such as constipation and cognitive impairment

■  The likelihood that tolerance to and physical dependence on the medication will develop

■  The risk of drug interactions and other side effects

■  The risk of impaired motor skills (affecting driving and other tasks)

■  The risk of medication misuse, dependence, and overdose

■  The physician’s prescribing policies and expectations, including the number and frequency of prescription refills, as well as the physician’s policy on early refills and replacement of lost or stolen prescriptions or medications

■  Specific reasons for which drug therapy may be modified or discontinued (including failure to meet treatment goals as well as violation of the policies and agreements spelled out in the treatment agreement and/or informed consent)

The informed consent should be signed by both the treating physician and the patient and a copy retained in the patient’s medical record. It is helpful to give the patient a copy of the informed consent to carry with him or her, to document the source and reason for any controlled drugs in his or her possession. Some physicians provide a laminated card that identifies the individual as a patient of their practice. This is helpful to other physicians who may see the patient and in the event the patient is seen in an emergency department.

The Prescription Order

The federal Controlled Substances Act (CSA) (39) defines a “lawful prescription” as one that is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Careful execution of the prescription order can prevent manipulation by the patient or others intent on obtaining drugs for nonmedical purposes. For example, federal law requires that prescription orders for controlled substances be signed and dated on the day they are issued.

Under federal law, every prescription order must include at least the following information (39):

Name and address of the patient

Name, address, and DEA registration number of the physician

Signature of the physician

Name and quantity of the drug prescribed

Directions for use

Refill information

Many states impose additional requirements, which the physician can determine by consulting the medical licensing board in his or her state (4). In addition, there are special federal requirements for drugs in different schedules of the federal CSA, particularly those in Schedule II (see the sidebar to this chapter).

Drug seekers are constantly on the lookout for blank forms but also use the names of physicians who recently retired, left the state, or died. Therefore, storing blank prescription order forms in a safe place—as opposed to leaving the pads in examining rooms—is a sound practice.

Note: The physician should immediately report the theft or loss of blank prescription forms to the nearest field office of the federal DEA and to the state board of medicine or pharmacy.

Maintaining Adequate Medical Records

In the event of a legal, regulatory, or civil (malpractice-related) challenge, detailed medical records documenting what was done and why are the foundations of the physician’s defense. Every physician needs to know and understand the federal requirements for recordkeeping, as well as the laws and regulatory requirements of the state in which he or she practices. This is important because state laws and medical board rules may differ substantially from the federal requirements and from one state to another. The board of medical licensure or the board of pharmacy (or their equivalent) in each state can provide information about the relevant requirements. At a minimum, patient records should contain the following information (18,45):

1.  Patient history and physical examination: The patient record must include a history of all controlled drugs used to treat the patient, any history of illicit substances, and any patient allergies. Regimens tried and failed also should be documented. Medical records obtained from providers who have treated the patient in the past should be included. (Caution should be exercised in accepting records supplied by patients, as these occasionally are fraudulent.) The medical record also should include information about the patient’s personal and family history of alcohol, tobacco, and other drug use, as well any personal history of major depression or other psychiatric disorder.

2.  Treatment plan: The treatment plan and goals should be documented in the record so that there is evidence of clear-cut, individualized objectives to guide the choice of therapy. If the patient improves after a brief trial, that should be documented in the record, as should regimens tried and failed.

3.  Consultation reports: Whenever the best clinical course is not clear or the patient’s response is not as expected, consultation with another physician should be obtained. Generally, the results of the consultation should be discussed with the consulting physician and a written consultation report added to the patient’s medical record.

4.  Prescription orders: The patient record must include all prescription orders, whether written or telephoned. Written instructions for the use of all medications should be given to the patient and documented in the record. The prescription order itself should specify both the milligram dose and the volume of medication to be taken. Confusion related to ambiguous orders can lead to tragic outcomes, especially early in treatment. The physician should clearly specify the dose and formulation and how often the medication should be used.

5.  Informed consent and treatment agreement: As noted earlier, a written informed consent and a treatment agreement signed by both patient and physician can be helpful in establishing a set of “ground rules” and appropriate expectations (52).

6.  Monitoring visits: Medication monitoring visits are billable and can be performed by a nurse. They should be carefully documented in the medical record, in the same manner as a visit with the physician.

7.  Treatment progress/outcomes: The patient’s record should clearly reflect the decision-making process that led to any given medical outcome.

Good records demonstrate that a service was provided to the patient and that the service was medically necessary. Even if the outcome is less than optimal, thorough records protect the physician as well as the patient (18,53).

CONCLUSIONS

Like all clinical tools, medications with the potential for misuse, abuse, and addiction must be considered in terms of potential risks and benefits. Such medications can be effective in managing a number of challenging clinical syndromes but also are the source of serious morbidity and mortality if misused.

It is the premise of this chapter that judicious use of these medications, with attention to proper assessment, collaborative informed consent and treatment planning, adequate monitoring, and intervention as needed, can minimize the likelihood of medication misuse and the attendant risks.

Attention to these elements, along with careful record-keeping, also may serve to lessen physicians’ concerns about regulatory or legal scrutiny. However, the physician must be able to demonstrate that he or she knows when it is and is not safe to prescribe such medications and how to discontinue their use while offering the patient appropriate alternative treatments.

Drug Control Policy: History and Future Directions

Robert L. DuPont, MD, FASAM and John J. Coleman, PhD

In the United States, drug control policy reflects the interests of multiple government agencies at the international, national, and state level (and occasionally at the local level, through zoning codes and other ordinances).

INTERNATIONAL TREATIES

Since 1912, international drug control treaties have required governments to restrict the production, distribution, and consumption of psychoactive drugs to medical and scientific use (1). While such treaties have created stringent control mechanisms, they also have required international organizations to work with national governments to ensure that the restrictions are not so rigid as to limit patients’ legitimate access to essential medications (2).

FEDERAL LAWS AND REGULATIONS

In the United States, the first federal law on drug distribution was enacted in 1914 (3). Since that time, many laws have been enacted by Congress to regulate controlled substances, including prescription drugs with abuse potential, illicit or “street” drugs, and chemical precursor chemicals and equipment used to manufacture illicit drugs. In 1970, the Comprehensive Drug Abuse Prevention and Control Act (Public Law 91–513) consolidated more than 50 federal drug laws into one comprehensive statute.

Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and purity of human and veterinary drugs, biologic products, and medical devices, as well as the nation’s food supply, cosmetics, and products that emit radiation (4). Pursuant to the CSA of 1970, the FDA shares with the DEA the responsibility for scheduling any drug that has a stimulant, depressant, or hallucinogenic effect on the CNS if it has abuse potential. The decision of the Secretary of Health and Human Services (the parent department for the FDA) is binding on the attorney general’s authority (delegated to DEA) to schedule a drug (5).

Drug Enforcement Administration

The federal CSA of 1970 (CSA; Title II of the Drug Abuse Prevention and Control Act (6)) created a system for classifying prescription drugs according to their importance in medical use and their potential for abuse. The Act requires written prescriptions for Schedule II drugs, regulates recordkeeping and refills, creates information systems to detect diversion, and establishes a system of criminal penalties for violations.

The CSA recognizes that controlled substances are essential to the public health and that the availability of these medications must be protected. The Act begins by stating that “many of the drugs included within this sub-chapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people” (6, p. 834).

The DEA is charged with enforcing the provisions of the Act that regulate the manufacture, purchase, prescribing, and dispensing of controlled substances, including (a) registration of physicians, pharmacists, and other handlers; (b) recordkeeping and inspection requirements; (c) quotas on manufacturing; (d) restrictions on distribution; (e) restrictions on dispensing; (f) limitations on imports and exports; (g) conditions for storage of drugs; (h) reports of transactions to the government; and (i) criminal, civil, and administrative penalties for illegal acts.

Prescribing Authority

Physicians and other properly licensed professionals may prescribe, dispense, and administer controlled drugs for legitimate medical purposes and in the course of professional practice if they have a state license to practice their profession and a valid controlled substances registration with the DEA (6).

Other CSA Requirements

The CSA also provides that no prescription order for drugs in Schedule II may be refilled. Emergency telephone prescriptions for drugs in Schedule II may be dispensed if the practitioner furnishes a written, signed prescription order to the pharmacy within 72 hours and limits the amount ordered to what is needed during the emergency period (6). In November 2007, DEA issued a final rule permitting an individual practitioner to issue, if warranted, multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. Prescriptions (other than the first one) must include in the text instructions for the dispensing pharmacy not to dispense before a specific date (6).

Prescriptions for drugs in Schedules III and IV may be refilled up to five times within 6 months after the date of issue, if authorized by the prescriber (6).

Drug Samples

The CSA does not prevent physicians from receiving or dispensing drug samples of controlled substances; however, such physicians are required to submit a written request to the registrant supplying the samples, specifying the identity of the drug sample and the quantity requested (6). Appropriate records of sample distribution must be maintained by the physician.

Information on the CSA, as well as updates on specific scheduling decisions, is available at the DEA’s Web site (www.deadiversion.usdoj.gov (7)).

Office of National Drug Control Policy

The Office of National Drug Control Policy (ONDCP) advises the president on drug-related issues and produces the annual National Drug Control Strategy, outlining the administration’s drug policy priorities and actions (8). Prior to the founding of ONDCP by the Anti-Drug Abuse Act of 1988, the White House was advised on drug policy by the Special Action Office for Drug Abuse Prevention (SAODAP), established in 1971.

The reach of ONDCP extends beyond national policies, providing leadership to states on local drug control initiatives.

STATE REQUIREMENTS

Information in Table 111-2 reflects federal law. Under the uniform CSA, which mirrors the administrative and civil provisions of the federal CSA, states perform many of the same tasks as the federal agencies, often using similar or identical statutes. A state, for example, may place a drug on a state schedule even if it is not federally controlled (e.g., tramadol and pseudoephedrine are controlled substances in several states but not under federal law). Prescribers are advised to familiarize themselves with the applicable state laws and regulations in the state(s) where they practice.

TABLE 111-2 CRITERIA FOR SCHEDULING CONTROLLED SUBSTANCES

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The federal CSA prohibits states from establishing laws that conflict with or are less restrictive than federal law. This is particularly relevant today, given the recent passage of laws legalizing cannabis in Colorado and Washington State, in violation of federal law. The courts will likely litigate this apparent conflict.

The Federation of State Medical Boards (FSMB) has developed model guidelines called Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. (9). Since 1998, these guidelines have been accepted and recommended for use by most state medical boards. The guidelines are intended to improve the standards of care for pain patients while ensuring the security of the controlled substances used for this purpose. These policy guidelines were last updated and released by the Federation in July, 2013.

FUTURE DIRECTIONS

Federal efforts to address what the White House has called the “silent epidemic of prescription drug abuse” have largely failed to reduce this serious public health problem despite scores of criminal cases brought by the DEA against criminal agents, errant practitioners, and others suspected of diverting controlled substances. On the regulatory front, the FDA, required by Congress in 2007 to add drug abuse and overdose to its Risk Evaluation and Mitigation Strategy (REMS) program, has fared no better. In fact, an inspector general’s report recently faulted the FDA for the program’s lack of effectiveness (10).

Faced with a burgeoning prescription drug abuse problem, several states have developed innovative laws and regulations. Four states—Ohio, Kentucky, Florida, and Washington—have enacted laws to curtail prescription drug diversion and abuse. State medical boards through their rulemaking and licensing authority have the ability to regulate the health care industry, from the practice of medicine to the dispensing of drugs. They may promulgate standards of care, authorize or ban the dispensing of controlled substances by physicians, establish rules for the ownership and operation of pain clinics, and even set daily dosing limits for opioid therapy.

States also can legislate the use of prescription drug monitoring programs (PDMPs). Forty-nine states and at least one US territory have established, or agreed to establish, PDMPs to track prescriptions issued and dispensed for controlled substances (11). PDMP information is sent electronically from dispensing pharmacies to a state-managed database, from which it may be accessed by practitioners and state officials, including regulatory and law enforcement authorities. For now, at least one state (Kentucky) requires practitioners to query the state’s PDMP before prescribing a Schedule II or Schedule III controlled substance containing hydrocodone (12). However, it is too early to assess the effectiveness of the new laws in Ohio, Kentucky, and Washington.

These state actions are not universally embraced by practitioners and their patients. Some fear they will impede the flow of needed medicines to legitimate patients. Some members of the medical community object to what they view as arbitrary standards of care. In Washington, for example, a law requires practitioners to refer patients to a pain specialist for consultation before prescribing the equivalent of 120 mg of morphine per day. Despite these criticisms, other states are likely to adopt these approaches to reduce the abuse of prescribed controlled substances.

Statistics on overdoses and deaths attributed to the misuse of prescription drugs are measured and reported by the Centers for Disease Control and Prevention (CDC). For example, on February 20, 2013, the CDC reported that nearly 60% of 22,134 drug overdose deaths in 2010 involved prescription medications. Opioid analgesics (such as oxycodone, hydrocodone, and methadone) were involved in 16,651 of these overdose deaths or about three in every four deaths (15). The anticipated beneficial results of new laws would be a reduction in these mortality figures. To complete the analysis, however, any adverse consequences of the new laws also must be quantified. To date, however, there are no solid data—only anecdotal reports. Until there are better data to measure risks, scientific assessment of the balance between drug control and drug access—which experts have identified as the policy goal—remains elusive.

Future solutions may come from unexpected places. In addition to state-based changes, the future development of abuse-resistant formulations by the pharmaceutical industry has significant potential to reduce prescription drug abuse (16). Targeted and aggressive federal leadership to support these efforts could dramatically increase the likelihood that more and better abuse-resistant formulations of controlled substances will significantly reduce the abuse of these medicines. In January 2013, the FDA published industry guidance for developing and evaluating abuse-deterrent opioid analgesics (17).

The fundamental goal in all these changes is to limit interference with appropriate medical prescribing while simultaneously preventing, identifying, and reducing the diversion of controlled substances and abuse of prescription drugs.

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1.United Nations (UN). Single convention on psychotropic drugs, 1971. New York: United Nations, 1977.

2.World Health Organization (WHO). Ensuring balance in national policies on controlled substances: guidance for availability and accessibility of controlled medicines, 2nd ed. Geneva, Switzerland: World Health Organization, 2011.

3.Harrison Narcotic Act, 1914.

4.Food and Drug Administration (FDA). About FDA: what we do. Rockville, MD: Food and Drug Administration, 2013. Available at: http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

5.Comprehensive Drug Abuse Prevention and Control Act, Title II: Controlled Substances Act. Pub. L. No. 91–513, 84 Stat. 1236, Title 21, United States Code, Sect 811(f). Federal Register, 1970. Available at: http://www.gpoaccess.gov/uscode/

6.Code of Federal Regulations. Refilling prescriptions, issuance of multiple prescriptions; 21 CFR 1306.12. Federal Register, 2012. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol9/pdf/CFR-2012-title21-vol9-part1306.pdf

7.Drug Enforcement Administration (DEA). Physician’s Manual: An Informational Outline of the Controlled Substances Act of 1970. Washington, DC: DEA, U.S. Department of Justice, 1994.

8.Office of National Drug Control Policy (ONDCP). National Drug Control Strategy, 2012. Washington, DC: ONDCP, Executive Office of the President, The White House, 2012.

9.Federation of State Medical Boards (FSMB). Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. Euless, TX: The Federation, 2013.

10. Department of Health and Human Services (DHHS), Office of Inspector General. FDA lacks comprehensive data to determine whether Risk Evaluation and Mitigation Strategies improve drug safety. Washington, DC: Department of Health and Human Services, 2013. Available at: https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf

11. Alliance of States with Prescription Monitoring Programs (ASPMP). PMP Program Status Map. The Alliance, 2013.

12. General Assembly of the Commonwealth of Kentucky. An act relating to controlled substances and declaring an emergency: House Bill 217. State of Kentucky, 2013. Available at: http://www.lrc.ky.gov/record/13RS/HB217.htm

13. Drug Enforcement Administration (DEA), Office of Diversion Control. Automation of Records and Consolidated Orders System (ARCOS); Unpublished data from 2007 to 2011 (Obtained August 2012, by John J. Coleman, PhD, via Freedom of Information Act). Washington, DC: Drug Enforcement Administration, 2012.

14. House of Representatives, Subcommittee on Commerce, Manufacturing and Trade, Committee on Energy and Commerce; 111 Congress, 2nd Sess., Prescription Drug Diversion: Combating the Scourge. Washington, DC: Federal Register, 2012.

15. Centers for Disease Control and Prevention (CDC). Opioids drive continued increase in drug overdose deaths: Drug overdose deaths increase for 11th consecutive year. Atlanta, GA: Centers for Disease Control and Prevention, 2013. Available at: http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html

16. Coleman JJ, Schuster CR, DuPont RL. Reducing the abuse potential of controlled substances. Pharma Med 2010;24(1):21–36.

17. Food and Drug Administration (FDA), Center for Drug Evaluation and Research. Guidance for industry: abuse-deterrent opioids—evaluation and labeling. Rockville, MD: Food and Drug Administration, 2013. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf

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