Evaluations of Drug Use
Believe that life is worth living and your belief will help create the fact. William James
Tests for illicit drugs are not sufficient to diagnose addiction and cannot substitute for a clinical interview and medical evaluation of the patient (Casavant 2002). Hammett -Stabler et al. (2002) point out that the term drug screen is a misnomer, because not all drugs are, and cannot be, tested for routinely. Physicians must decide which drug tests are necessary in each clinical setting, including office-based buprenorphine treatment. Physicians and laboratory personnel must understand the limitations of the assays used, the pharmacokinetic characteristics of the drugs assayed, the parent compound metabolite relationships, and how to interpret laboratory results (Hammett -Stabler et al. 2002). Testing for drugs can be performed on a number of bodily fluids and tissues, including urine, blood, saliva, sweat, and hair. Urine screening is the method most commonly employed. A comprehensive discussion of urine drug testing in the primary care setting can be found in Urine Drug Testing in Primary Care: Dispelling the Myths & Designing Strategies (Gourlay et al. 2002). When selecting drug tests, physicians should consider the cost to patients, as testing for all possible drugs of abuse can be costly.
In buprenorphine treatment, appropriate tests for illicit drug use should be administered as part of patient assessment. Physicians should explain the role of drug testing at the beginning of treatment for addiction. The literature supports the therapeutic utility of random drug testing in clinical settings (Preston et al. 2002). Laboratory test results can be used in the physician patient interaction to further treatment objectives, to address patient denial, and to reinforce abstinence from other drugs. Initial and ongoing drug screening should be used to detect or confirm the recent use of drugs (e.g., alcohol, benzodiazepines, barbiturates) that could complicate management of a patient on buprenorphine.
When a patient requests treatment with buprenorphine, a toxicology screen can help to establish that the patient is indeed using either a prescribed substance such as heroin or a prescribed substance such as oxycodone. A negative test does not necessarily mean that the patient is not using an opioid. It may mean that the patient has not used an opioid within a period of time sufficient to produce measurable metabolic products or that the patient was not using the drug for which he or she was tested. Thus, as with any patient, the physician is alerted to a spectrum of possibilities and works with the patient using the information collected from the toxicology screen.
Several manufacturers produce combination urine collection and test kits that facilitate in-office urine testing. In-office testing facilitates prompt evaluation of clinical parameters and allows the physician to present the results to the patient and to make immediate therapeutic use of the information. However, physicians who do not work in a setting with an onsite, federally regulated laboratory must ensure that they are using in-office testing kits waived from regulatory oversight under the Clinical Laboratory Improvement Amendments (CLIA) law of 1988. See the Clinical Laboratory Improvement Amendment pages on the Food and Drug Administration(FDA)website at: http://www.fda.gov/cdrh/clia/cliawaived.html for more information about the law and CLIA-waived point-of-care testing kits. For the current listing of CLIA -waived urine drug tests, refer to the FDA Web site at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm or search the Food And Drug Administration(FDA) Clinical Laboratory Improvement Amendments (CLIA) database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.
Toxicology testing for drugs of abuse that takes place at scheduled visits cannot be truly random; nevertheless, it is clinically worthwhile. Urine samples should be collected in a room where they cannot be diluted or otherwise adulterated and where patients are not permitted to bring briefcases, purses, bags, or containers of any sort. If these conditions are not feasible, temperature -sensitive strips, specific gravity, and creatinine can be used to minimize the possibility of false or adulterated urine specimens. If the physician's office cannot provide this service, patients can be referred to a facility that is equipped to perform monitored specimen collection. Another option that is sometimes feasible is to collect a sample of oral fluid (saliva) to be sent to a laboratory for testing.
Timely shipment of samples for testing and rapid turn around time for the results are also important issues that should be resolved before undertaking office-based treatment of opioid addiction. If a patient needs drug test results for employment or for legal monitoring, strict chain-of-custody procedures must be followed, and samples should be evaluated by a SAMHSA certified laboratory. If a patient subsequently wants to use the drug test result for other purposes, both the physician and the patient should understand the limits of the office testing and other requirements for the test. Other than for U.S. Department of Health and Human Services and U.S. Department of Transportation, private-sector testing requirements may be less rigorous.
Diagnosis Of Opioid-Related Disorders
After a thorough assessment of a patient has been conducted, a formal diagnosis can be made. Criteria for substance dependence, such as those set forth in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM -IV -TR) (American Psychiatric Association 2000) or the International Classification of Diseases Ninth Edition Clinical Modification: ICD-9-CM, should be used to document a diagnosis of opioid dependence. (This diagnosis is not merely physical dependence on opioids but corresponds to opioid addiction, classically defined as compulsive use despite harm.)
DSM-IV-TR defines several opioid-related disorders. (See figure 3-10.) A DSM-IV-TR diagnosis of either opioid dependence or abuse is based on a cluster of behaviors and physiological effects occurring within a specific time frame. The diagnosis of opioid dependence always takes precedence over that of opioid abuse (i.e., a diagnosis of abuse is made only if DSM-IV-TR criteria for dependence have never been met).
As a general rule, to be considered for buprenorphine maintenance, patients should meet the DSM-IV-TR criteria for a diagnosis of opioid dependence. (See full diagnostic criteria in appendix C.) In rare instances, a patient may be physiologically dependent on opioids and meet DSM-IV-TR criteria for abuse, but not for dependence. In such a case, a short course of buprenorphine may be considered for detoxification. Maintenance treatment with buprenorphine is not recommended for patients who do not meet DSM-IV-TR criteria for opioid dependence.
DSM -IV -TR Material
Criteria for Substance Dependence
A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12 -month period (emphasis ours):
(1) Tolerance, as defined by either of the following:
(a) A need for markedly increased amounts of the substance to
achieve intoxication or desired effect or
(b) Markedly diminished effect with continued use of the same
amount of the substance.
(2) Withdrawal, as manifested by either of the following:
(a) The characteristic withdrawal syndrome for the substance or
(b) The same (or a closely related) substance is taken to relieve or
avoid withdrawal symptoms.
(3) The substance is often taken in larger amounts or over a longer period than was intended.
(4) There is a persistent desire or unsuccessful efforts to cut down or control substance use.
(5) A great deal of time is spent on activities necessary to obtain the substance (e.g., visiting multiple doctors or driving long distances), use the substance (e.g., chain-smoking), or recover from its effects.
(6) Important social, occupational, or recreational activities are given up or reduced because of substance use.
(7) The substance use is continued despite knowledge of having a persistent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., current cocaine use despite recognition of cocaine-induced depression, or continued drinking despite recognition that an ulcer was made worse by alcohol consumption).
With Physiological Dependence: Evidence of tolerance or withdrawal (i.e., either Item 1 or 2 is present).
Without Physiological Dependence: No evidence of tolerance or withdrawal (i.e., neither Item 1 nor 2 is present).
Substance Dependence Course Specifiers
Six course specifiers are available for Substance Dependence. The four Remission specifiers can be applied only after none of the criteria for Substance Dependence or Substance Abuse have been present for at least 1 month. The definition of these four types of Remission is based on the interval of time that has elapsed since the cessation of Dependence (Early versus Sustained Remission) and whether there is continued presence of one or more of the items included in the criteria sets for Dependence or Abuse (Partial versus Full Remission).
Because the first 12 months following Dependence is a time of particularly high risk for relapse, this period is designated Early Remission. After 12 months of early Remission have passed without relapse to Dependence, the person enters into Sustained Remission. For both Early Remission and Sustained Remission, a further designation of Full is given if no criteria for Dependence or Abuse have been met during the period of remission; a designation of Partial is given if at least one of the criteria for Dependence or Abuse has been met, intermittently or continuously, during the period of remission.
The differentiation of Sustained Full Remission from recovered (no current Substance Abuse Disorder) requires consideration of the length of time since the last period of disturbance, the total duration of the disturbance, and the need for continued evaluation. If, after a period of remission or recovery, the individual again becomes dependent, the application of the Early Remission specifier requires that there again be at least 1 month in which no criteria for Dependence or Abuse are met.
Two additional specifiers have been provided: On Agonist Therapy and In a Controlled Environment. For an individual to qualify for Early Remission after cessation of agonist therapy or release from a controlled environment, there must be a 1-month period in which none of the criteria for Dependence of Abuse are met.
The following Remission specifiers can be applied only after no criteria for Dependence or Abuse have been met for at least 1 month. Note that these specifiers do no apply if the individual is on agonist therapy or in a controlled environment (see below).
Early Full Remission: This specifier is used if, for at least one month, but for less than 12 months, no criteria for Dependence or Abuse have been met.
Early Partial Remission: This specifier is used if, for at least one month, but less than 12 months, one or more criteria for Dependence or Abuse have been met (but the full criteria for Dependence have not been met).
Sustained Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met at any time during a period of 12 months or longer.
Sustained Partial Remission: This specifier is used if full criteria for Dependence have not been met for a period of 12 months or longer; however, one or more criteria for Dependence or Abuse have been met.
On Agonist Therapy: This specifier is used if the individual is on a prescribed agonist medication, and no criteria for Dependence or Abuse have been met for that class of medication for at least the past month (except tolerance to, or withdrawal from, the agonist). This category also applies to those being treated for Dependence using a partial agonist or an agonist/antagonist.
In a Controlled Environment: This specifier is used if the individual is in an environment where access to alcohol and controlled substances is restricted, and no criteria for Dependence or Abuse have been met for at least the past month. Examples of these environments are closely supervised and substance-free jails, therapeutic communities, or locked hospital units.
Criteria for Substance Abuse
A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12 -month period:
(1) Recurrent substance use resulting in a failure to fulfil major role obligations at work, school, or home (e.g., repeated absences or poor work performance related to substance use; substance -related absences, suspensions, or expulsions from school; neglect of children or household.
(2) Recurrent substance use in situations in which it is physically hazardous (e.g., driving an automobile or operating a machine when impaired by substance use)
(3) Recurrent substance -related legal problems (e.g., arrests for substance-related disorderly conduct)
(4) Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g., arguments with spouse about consequence of intoxication, physical fights)
The symptoms have never met the criteria for Substance Dependence for this class of substance.
Refer, in addition, to the text and criteria for Substance Dependence. Most individuals with Opioid Dependence have significant levels of tolerance and will experience withdrawal on abrupt discontinuation of opioid substances. Opioid Dependence includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances that are used for no legitimate medical purpose or, if a general medical condition is present that requires opioid treatment, that are used in doses that are greatly in excess of the amount needed for pain relief.
Persons with Opioid Dependence tend to develop such regular patterns of compulsive drug use that daily activities are typically planned around obtaining and administering opioids. Opioids are usually purchased on the illegal market but may also be obtained from physicians by faking or exaggerating general medical problems, or by receiving simultaneous prescriptions from several physicians. Health care professionals with Opioid Dependence will often obtain opioids by writing prescriptions for themselves or by diverting opioids that have been prescribed for patients or from pharmacy supplies.
Other DSM -IV Substance -Related Disorders
ICD -9 -CM
292.82 Persisting Dementia
292.83 Persisting Amnestic Disorder
292.11 Psychotic Disorder with Delusions
292.12 Psychotic Disorder with Hallucinations
292.84 Mood Disorder
292.89 Anxiety Disorder
292.89 Sleep Disorder
292.89 Sexual Dysfunction
292.89 Persisting Perception Disorder (Flashbacks)
292.9 Disorder Not Otherwise Specified
Substance Related Disorders
305.01 Alcohol abuse, continuous
305.02 Alcohol abuse, episodic
305.03 Alcohol abuse, remission
305.00 Alcohol abuse, unspec.
303.00 Alcohol intoxication, acute, unspec.
291.81 Alcohol withdrawal
303.91 Alcoholism, chronic, continuous
304.41 Amphetamine dependence, continuous
304.11 Barbiturate dependence, continuous
305.22 Cannabis abuse, episodic
304.31 Cannabis dependence, continuous
305.62 Cocaine abuse, episodic
304.21 Cocaine dependence, continuous
305.90 Drug abuse, unspec.
305.92 Drug abuse, unspec., episodic
304.90 Drug dependence, unspec.
292.11 Drug-induced paranoia
305.52 Opioid abuse, episodic
304.01 Opioid dependence, continuous
305.1 Tobacco abuse
Source: Reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision. Copyright 2000. (American Psychiatric Association 2000).
Reference: (1) Clinical Guidelines For The Use Of Buprenorphine In The Treatment of Opioid Addiction Chapter 3 Patient Assessment (TIP 40)
Compiled And Edited By: Deborah Shrira Updated: 19 March 2007