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National Drug Intelligence Center |
The National Prescription Drug Threat Assessment 2009 (NPDTA 09) is a collaborative effort between NDIC and DEA to assess the threat posed by the distribution, diversion, and abuse of CPDs in the United States. This assessment draws upon the National Drug Threat Assessment 2009; NDTS data collected by NDIC; regional drug intelligence products prepared by NDIC; open-source information; public- and private-sector research; reporting from federal, state, and local law enforcement agencies; and state-level treatment data. DEA's 21 Domestic Field Divisions assessed the CPD situation in their areas and provided reports that contributed significantly to this assessment. The NPDTA 09 examines and evaluates the principal issues and recent developments pertaining to the diversion and abuse of CPDs; it also updates data and analysis published in the NDIC November 2004 Pharmaceuticals Threat Assessment, Product No. 2004-L0487-001.
The NPDTA 09 focuses primarily on domestic diversion of CPDs and does not discuss the abuse of over-the-counter pharmaceuticals such as dextromethorphan; non-CPDs such as carisoprodol (Soma®); illicitly produced amphetamine, methamphetamine, and fentanyl; or controlled prescription and illicitly produced anabolic steroids.
The distribution and use of CPDs are regulated by the Federal Controlled Substances Act (CSA),7 which classifies controlled substances under one of five schedules according to their potential for abuse, their use in accepted medical treatment in the United States, and their potential for physical or psychological dependence. All businesses that manufacture or distribute CPDs, all health professionals entitled to dispense or prescribe them, and all pharmacies entitled to fill prescriptions must comply with the CSA, Code of Federal Regulations (CFR), and state regulations; this includes registering with DEA and complying with a series of requirements related to drug security and records accountability.
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CPD Schedules CPDs are regulated under the federal Controlled Substances Act (CSA), 21 U.S.C. Section 801, et seq. They are classified under various schedules set forth in the CSA; all are considered to be Schedule II, III, IV, or V drugs. Schedule II prescription drugs have a high potential for abuse and a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of Schedule II drugs may lead to severe psychological or physical dependence. Schedule III prescription drugs have a potential for abuse less than the drugs in Schedule II and a currently accepted medical use in treatment in the United States. Abuse of Schedule III drugs may lead to moderate or low physical dependence or high psychological dependence. Schedule IV prescription drugs have a low potential for abuse relative to the drugs in Schedule III and a currently accepted medical use in treatment in the United States. Abuse of Schedule IV prescription drugs may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III. Schedule V prescription drugs have a low potential for abuse relative to the drugs or other substances in Schedule IV and a currently accepted medical use in treatment in the United States. Abuse of Schedule V drugs may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule IV. For more detailed descriptions of each schedule, see http://www.usdoj.gov/dea/pubs/csa/812.htm. |
Despite the strict requirements of the CSA and regulations under the CFR, CPDs are diverted from legitimate sources for illicit distribution and/or abuse. CPD diversion typically involves individuals who doctor-shop and forge prescriptions, unscrupulous physicians who sell prescriptions to drug dealers or abusers, unscrupulous pharmacists who falsify records and subsequently sell the drugs, employees who steal from inventory, executives who falsify orders to cover illicit sales, individuals who commit burglaries or robberies of pharmacies, and individuals who purchase CPDs from rogue Internet pharmacies.8 CPD diversion also involves the sharing or purchasing of drugs between family and friends or individual theft from family and friends. In some instances CPD diversion involves purchases from strangers or street dealers.
The most commonly diverted CPDs are opioid pain relievers, according to DEA and NSDUH data. Opioid pain relievers are popular among drug abusers because of the euphoria they induce. Opioid pain relievers include codeine, fentanyl (Duragesic®, Actiq®9), hydromorphone (Dilaudid®), meperidine (Demerol®, which is prescribed less often because of its side effects), morphine (MS Contin®), oxycodone (OxyContin®), pentazocine (Talwin®), dextropropoxyphene (Darvon®), methadone (Dolophine®), and hydrocodone/combinations (Vicodin®, Lortab®, and Lorcet®).10 Prescription tranquilizers and sedatives are also commonly abused because they can potentiate the euphoric effect of opioids. The most frequently diverted and abused tranquilizers and sedatives include benzodiazepines such as alprazolam (Xanax®), diazepam (Valium®), and lorazepam (Ativan®); barbiturates such as pentobarbital (Nembutal®), phenobarbital (Luminal®), secobarbital (Seconal®); and zolpidem (Ambien®). Prescription stimulants are also diverted and abused, although to a lesser extent. Commonly diverted and abused prescription stimulants include amphetamines (Adderall®, Dexedrine®) and methylphenidate (Concerta®, Ritalin®).
CPDs can be as dangerous as illicit drugs when misused or abused. When taken by someone other than the patient for whom the medication was prescribed, in a manner or dosage other than what was prescribed, or in combination with other drugs and/or alcohol, CPDs can produce serious adverse health effects such as suppression of respiration. Moreover, unintentional misuse or intentional abuse of CPDs, particularly opioids, often produces feelings of euphoria, which can lead to increased levels of intentional abuse and subsequent tolerance,11 physical dependence,12 or addiction.13
This assessment begins with a discussion of the legitimate distribution and diversion of CPDs, including the impact that increasing the legitimate distribution of prescription opioid pain relievers, methylphenidate, and amphetamine has had on illicit markets. It also discusses the methods used by diverters and distributors to launder proceeds and the methods used by law enforcement agencies to combat CPD diversion. Additionally, the report addresses CPD abuse levels in the United States, regional CPD diversion and abuse trends, and significant CPD-related intelligence gaps; it also estimates future illicit CPD activity.
7.
21 U.S.C. Section 801, et seq.
8.
Rogue Internet pharmacies are schemes established
by a "facilitator" (operator) who employs physicians and pharmacists with DEA registration
numbers to approve and fill prescriptions for CPDs. The doctors approve prescriptions
for drugs without the required in-person physical examination of the patient. The
facilitators often recruit pharmacists who own or are employed at small, independent,
legitimate brick-and-mortar pharmacies, according to DEA.
9.
The brand names provided in parentheses in this paragraph
are examples of the most commonly used brand name drugs. Throughout the remainder
of this assessment, generic drug names are used for clarity and brevity unless specific
brand names are cited in surveys or other studies.
10.
Hydrocodone combination CPDs are manufactured with
acetaminophen, aspirin, or ibuprofen and sold as analgesics or manufactured with
pseudoephedrine, guaifenesin, or phenylephrine and sold as cough preparations. The
most common brand-name analgesic hydrocodone/combination product is Vicodin®.
11.
Tolerance is a physiologic state resulting from
regular use of a drug in which an increased dosage is needed to produce a specific
effect or a reduced effect is observed with a constant dose over time.
12.
Physical dependence occurs when a body adapts to
the presence of a drug and any abrupt cessation, rapid dose reduction, or decreasing
blood level of the drug would result in withdrawal symptoms (restlessness, muscle
and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps, or involuntary
leg movements).
13.
Addiction is a primary, chronic neurobiological
disease characterized by behaviors that include impaired control over drug use,
craving, compulsive use, and/or continued use despite harm.
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