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Prescription drug abuse: an epidemic dilemma.

If current trends continue, the defining drug problem of the new century will be the nonmedical use of prescribed controlled substances. Although lessons learned in recent decades when the major drug problems were mostly agriculturally-based drugs (especially marijuana, cocaine and heroin) will prove useful, reducing prescription drug abuse will require new strategies, some of which will significantly affect the practice of medicine.

The modern drug epidemic began dramatically in the late 1960s with an explosive increase in heroin addiction. At that time the social costs of drug use were easily seen in the rises in crime and overdose deaths. Some critics of the national drug policy that balanced treatment with law enforcement proposed legalizing, and thus "medicalizing," the drug problem. One goal of this approach was to remove the criminal justice system from drug prevention and treatment. While overdose deaths are once again a central indicator for this new prescription drug epidemic, there is hardly a trace of organized crime involvement. The drug supply in this new epidemic is a short chain connecting physicians and patients to nonmedical prescription drug consumers. In contrast to the picture 40 years ago, today many of the nonmedical drug consumers are medical patients, harkening back to the picture of opiate addiction at the end of the nineteenth century, before the Harrison Narcotics Tax Act of 1914, when most opiate addicts obtained their drugs from physicians or bought them from street peddlers, pharmacists, or through mail order catalogs.

The nonmedical use of prescribed controlled substances will require significant changes in strategy in medical practice, drug development, law enforcement, and public education. Before exploring effective countermeasures to deal with the explosive and continuing growth in prescription drug abuse, it is useful to explore the current state of the nonmedical use of prescribed controlled substances.

EXTENT OF THE PROBLEM

In 2008, over six million persons, or 2.5% of the U.S.

population aged 12 and older, reported past 30-day use of prescription-type psychotherapeutic drugs for nonmedical purposes (SAMHSA 2009a). This is more than the total number of people who abused cocaine, heroin, hallucinogens, MDMA and inhalants combined. The highest rate of abuse of psychotherapeutics occurred among young adults ages 18 to 25, with nearly one third (29.2%) reporting lifetime use (defined in federal drug surveys as having used a drug at least once in one's life). In addition, of the 2.9 million persons who used an illicit drug for the first time, 29.6% initiated illegal drug use by using psychotherapeutics. Since 2005, the number of individuals each year who initiated use of psychotherapeutics has surpassed the number of marijuana initiates; in 2008, 2.5 million individuals used psychotherapeutics for the first time while 2.2 million individuals used marijuana for the first time in the past year.

National data indicate that the nonmedical use of psychotherapeutics has increased substantially since the mid 1990s (SAMHSA 2005). This increase is a reflection of the dramatic increases in the number of prescriptions, in particular for opioid analgesics, issued by physicians to treat pain.

A series of studies utilizing data from the Automation of Reports and Consolidated Orders Systems (ACROS) tracked the distribution of C-II drugs to registrants, including pharmacies. From 1990 to 1996, medical use of four opioid analgesics increased substantially: morphine (59%), fentanyl (1168%), oxycodone (23%), and hydromorphine (19%), while medical use of one opioid analgesic, meperidine, decreased (35%) (Joranson et al. 2000). Similarly, a study of three opioid analgesics confirmed further increases in use from 1997 to 2001: morphine use increased 48.8%, fentanyl use increased 151.2%, and oxycodine use increased 347.9% (Novak, Nemeth & Lawson 2004).

Gilson and colleagues (2004) found similar increases in use of opioid analgesics from 1997 to 2002, leading them to surmise based on reports of abuse of varying opioid analgesics in the Drug Abuse Warning Network (DAWN) surveillance system that increased medical use of opioid analgesics is associated with increased abuse.

Prescriptions for controlled substances have increased faster than for noncontrolled pharmaceuticals. A report from the National Center on Addiction and Substance Abuse (CASA 2005) found that from 1992 to 2002 the number of prescriptions for controlled drugs increased 154.3%; in comparison, in this time period the number of prescriptions for noncontrolled drugs increased 56.6% and the U.S. population rose 13%.

From 1997 to 2007, the number of prescriptions increased 72%; in this same time, the U.S. population grew 11% (Aitken, Berndt & Cutler 2009). Similarly, the number of opioid prescriptions increased 59.5% from 1994 to 2003 (Manchikanti 2006). As prescriptions for controlled substances--especially for opiates--increased, the number of people abusing prescription drugs and the indicators of problems generated by nonmedical use of these pharmaceuticals increased.

Overdose Deaths

In 2006, drug-induced overdose deaths in the U.S. reached a high of over 38,000 (Heron et al. 2009). Overdose deaths have now surpassed the annual number of automotive crash fatalities in 16 states (Stobbe 2009), are more than double the annual number of murders nationwide (17,034; FBI 2007), and are greater than the annual number of suicide deaths (33,300; Heron et al. 2009). These dramatic increases were driven primarily by the nonmedical use of pharmaceutical drugs, particularly by opioid analgesics.

From 1979 to 1990, the rate of unintentional drug overdoses increased an average of 5.3% each year. From 1990 to 2002 this figure jumped an average of 18.1% per year (Paulozzi, Budnitz & Yongli 2006). Warner, Chen and Makuc (2009) showed that deaths involving prescription opioid analgesics tripled from 4,000 in 1999 to 13,800 in 2006 (see Figure 1). Nearly a third (33%) of opioid analgesic overdose deaths involved no other drugs; 17% involved benzodiazepines, 15% involved heroin or cocaine, and 3% involved benzodiazepines in combination with heroin or cocaine. The remaining 16% of opioid analgesic-related deaths involved nonspecific drugs.

Related hospitalizations have also increased. From 1999 to 2006, the number of hospitalizations for poisonings related to opioid analgesic, sedative, and tranquilizer use increased 65% while unintentional poisonings by these three drug categories increased 37% (Coben et al. 2010).

Prescription Drug Use Among Youth

The nonmedical use of prescription drugs is an ongoing problem among young persons. In 2008, 4.7% of high school seniors used OxyContin nonmedically, 9.7% used Vicodin, 5.8% used sedatives, 6.2% used tranquilizers, and 2.4% used Ritalin, a prescription stimulant to treat attention deficit and hyperactivity disorder (ADHD) in the past year (Johnston et al. 2009).

Prescription stimulants to treat ADHD are most commonly misused by undergraduate college student populations with an intent to enhance performance, including improving academics and enhancing the high produced from other drugs including alcohol (Arria & DuPont In press). The nonmedical use of stimulants often signals poor academic performance as well as other problems including other illicit substance use and mental health issues. Most prescription stimulants which are used nonmedically are obtained through legitimate prescriptions intended to treat ADHD; however, some patients sell or give pills to their peers and some patients feign ADHD symptoms to unlawfully obtain drugs for themselves and to redistribute to others.

In a study of undergraduate college students prescribed one or more medications, 61.7% diverted ADHD medication and 35.1% diverted prescription analgesics (Garnier et al. 2010). Clearly youth is a critical group that must be considered when developing prevention strategies and future policies; however, this is not the only population that must be educated about the problems related to nonmedical prescription drug use.

[FIGURE 1 OMITTED]

Drugged Driving

Drivers are operating vehicles while under the influence of prescription medicines both when the medicines are taken by patients for whom they are properly prescribed and by others who do not have their own prescriptions. The recently released 2007 National Roadside Survey of Alcohol and Drug Use by Drivers (NRS) reported that 3.9% of weekend nighttime drivers were positive for prescription drugs (Compton & Berning 2009). In a study of seriously injured motor vehicle crash victims admitted to a Maryland Level-1 shock-trauma center, 10.2% tested positive for opiates and 11.2% were positive for benzodiazepines (Walsh et al. 2004), two classes of prescription drugs most widely abused and most involved with highway crashes.

In a study of West Virginia motor vehicle fatalities, opioid analgesics were present in 7.9% of deceased drivers; 7.9% of drivers were positive for depressants including benzodiazepines (CDC 2006).

While it is unknown whether the drivers in these studies who were positive for prescription drugs had valid prescriptions and were taking them appropriately, the high rates of potentially impairing prescription drugs present in drivers involved in serious and fatal motor vehicle crashes are worrisome.

POLICY OPTIONS TO REDUCE PRESCRIPTION DRUG ABUSE

Nonmedical use of prescription drugs is not only an American problem. The United Nations International Narcotics Control Board (2010) confirms that other countries in all parts of the world, including both developed and developing countries face similarly increasing prescription drug use problems. The U.S. can be a leader in developing policies to improve public health and safety.

Identify and Expand Leadership in the Research and Medical Communities

The first steps to be taken to address the problem of nonmedical use of prescribed controlled substances include soliciting opinions of experts in the problem from medical and research perspectives. Between 2003 and 2009, the Institute for Behavior and Health, Inc. (2009) hosted a series of meetings of an Independent Advisory Committee (IAC) on Prescription Stimulant Abuse, bringing together leaders in the fields most relevant to the study of the nonmedical use of prescribed stimulants, including experts in drug abuse, drug abuse epidemiology, and the research, diagnosis, and treatment of ADHD.

The most recent focus areas of the IAC was determining the extent and consequences of nonmedical use of controlled substances, particularly prescription stimulants, among college students with a special focus on monitoring trends and issues involving the nonmedical use of prescription treatments used to treat ADHD. Meetings and reports produced from these sessions stimulated research about the nonmedical use of prescription drugs.

Create National Public Education Campaigns

A vigorous national education campaign addressing the problem of prescription drug use must be on the scale and of the duration of the decades-long efforts to reduce drunk driving in order to engage the general public, including patients and physicians. Patients, particularly youth, need to understand that these medicines are to be used only for the problems for which they are prescribed and only in the prescribed doses and routes of administration. It is illegal and dangerous to share or sell prescribed medicines and to use them without a prescription. Further, patients of all ages receiving prescribed controlled substances must understand that they are responsible for ensuring that no one else uses their medicines. These drugs should be kept in locked boxes and disposed of when no longer needed to prevent family members, including children, or house guests from accessing them.

Specific guidelines must be developed for physicians to ensure proper procedures and education when prescribing controlled drugs to patients. Physicians need to consider potential misuse and illegal drug distribution each and every time they write a prescription. Arria and DuPont (In press) suggest that physicians screen patients receiving prescriptions for controlled substances for risk factors and provide ongoing monitoring of patients, including routine drug tests, to ensure medicine adherence and to deter diversion.

Develop Abuse-Resistance Drug Formulas

The development of unique abuse-resistant delivery systems of prescribed controlled substances is a promising new strategy to reduce prescription drug abuse while protecting legitimate medical use of controlled substances (Coleman et al. 2005). The most effective of these new formulations modulate the rate at which brain rewarding substances enter the body. Ensuring the relatively steady release of medicine into the bloodstream instead of the rapid surge preferred by abusers achieves treatment goals while frustrating attempts at getting high. Several medicines containing controlled substances are now available in abuse-resistant formulations and many new abuse-resistant strategies are being studied. Recent experiences provide encouraging evidence that this strategy is gaining momentum, although some earlier efforts to produce abuse-resistant formulations were thwarted by the ingenuity of drug abusers who found ways to overcome the protections. Careful post-marketing monitoring of abuse is essential to protect the public health, and manufacturers who successfully produce abuse-resistant drugs should be regulated differently, such as lowering the scheduling of these drugs by the Controlled Substances Act (Arria & DuPont In press). Providing such incentives to pharmaceutical manufacturers to develop abuse-resistant formulations will increase efforts to develop and harness new technologies for prescribed controlled drug delivery and encourage drug sponsors to conduct post-market surveillance of their products to evaluate and mitigate abuse risks.

Prescription Drug Monitoring Programs and Enforcement Efforts

One powerful strategy to reduce nonmedical use of prescribed controlled substances is the wider use and investment in Prescription Drug Monitoring Programs (PDMP). There are 40 states with established PDMPs or which have enacted legislation to create programs (Alliance of States with Prescription Monitoring Programs 2010). PDMPs can help to address both prescription drug abuse and diversion, while supporting legitimate use of prescription drugs, tracking use trends and providing education to appropriate populations (DEA 2010).

PDMPs track prescriptions and have the capacity to identify physicians prescribing controlled substances in excessive quantities, as well as patients collecting prescriptions from multiple sources for unlawful redistribution or personal misuse. These programs help to reduce the number of physicians issuing bogus prescriptions and/or purposefully overly misprescribing drugs as well as patients abusing drugs or selling them to others. While this is especially important for reducing the number of medically unnecessary opiate prescriptions, it may also be useful for reducing the abuse of other forms of controlled substances.

Manchikanti (2006) reports that many of the established PDMPs are not proactive in their efforts to reduce prescription drug diversion and "doctor shopping" and have much room to improve. The lack of uniformity between programs in design and drugs monitored can be a starting point for improving PDMP efforts. PDMPs should continue to be managed at the state level using standardized best practices but ultimately they should become a single, national network, as the Alliance of States with Prescription Monitoring Programs (2010) has encouraged. The exchange of information among state PDMPs is imperative because in many parts of the U.S. it is easy for patients and physicians to cross state borders to evade monitoring. While using PDMPs is promising, the programs currently in use must be improved to achieve the full potential of this prevention strategy.

New law enforcement efforts to identify and prosecute rogue physicians and patients who are selling prescriptions and/or controlled substances are vital to reducing the abuse of drugs. Both physicians and patients need to feel at risk when behaving in ways that endanger public health. These law enforcement efforts will not deter good medical practice but rather reinforce it. The wide use of the criminal justice system, working with medical groups, to identify and prosecute physicians and patients who willfully violate the law is an important public health strategy to reduce prescription drug abuse.

Establish Per Se Drugged Driving Laws

Improvements in prescription drug law enforcement efforts also should include increased drugged driving detection and prosecution. The U. S. Department of Transportation Federal Motor Carrier Safety Administration established regulations governing commercial drivers that make a sharp distinction between drivers who have their own prescriptions for controlled substances and those who do not (Controlled Substances and Alcohol Use and Testing 2004). Drivers who used controlled substances for which they did not have a prescription were termed illegal drug users and any evidence of illegal drug use was a violation of these regulations. This strategy was based on federal rules for safety-sensitive jobs in the workplace. However, these rules do not address the question of how to deal with drivers who have prescriptions for impairing medicines.

Just as drivers are guilty of driving under the influence (DUI) if they operate a vehicle while impaired by alcohol, drivers are also guilty of DUI if they are impaired by medications whether these medicines have been prescribed for them or not. Prescription drug cases should be handled like cases of alcohol use. If an impaired driver has a prescription for the potentially impairing drug, the driver is treated the way a driver aged 21 or older is treated if found to have a blood alcohol concentration (BAC) below the legal limit of 0.08 g/dL. On the other hand, if a driver aged 21 or older has a BAC of 0.08g/dL or higher, this is a violation of the per se law in all 50 states (Vehicles and Traffic Safety 2003; Safety Incentives to Prevent Operation of Motor Vehicles by Intoxicated Persons 2000).

In contrast, for drivers under the legal drinking age, there is no acceptable BAC because alcohol consumption under the age of 21 is illegal. Thus, any detected alcohol in underage drivers is a violation. The analogy to illegal drugs is clear: any evidence of illegal drug use is considered a violation. The per se standard for drugs is now widely used in Western Europe and in 17 U.S. states. The illegal, nonmedical use of prescription drugs is unacceptable and presents a danger to everyone on the road.

The per se standard for alcohol does not apply for drivers aged 21 and older with BACs under 0.08 g/dL or for drivers who test positive for potentially impairing prescribed controlled substances if they have current valid prescriptions for those medicines. In these cases where the per se standard does not apply, the driver can still be prosecuted for driving while impaired.

Improve Treatment: Lessons from Physician Health Programs

Treatment is an important part of any effort to reduce nonmedical use of prescribed controlled substances. The Physician Health Program (PHP) offers a new model of drug treatment that produces exemplary results. In PHP care management, physicians are closely monitored through intense random testing to detect use of any alcohol or other drugs including prescribed controlled drugs, and they must participate in abstinence-based treatment. Formal treatment is followed by long-term support and monitoring and linked to 12-S tep programs like Alcoholics Anonymous and Narcotics Anonymous. Physicians sign monitoring agreements with PHPs that typically last five years. Noncompliance results in further evaluation and/or treatment, reporting to the state licensing board or more serious consequences (DuPont et al. 2009a). If physicians continue to fail to adhere to the zero-tolerance standards or to PHP recommendations, they are removed from the safe harbor provided by the program against impending sanctions and run the risk of losing their medical licenses.

A significant number of physicians in PHPs struggle with the abuse of prescribed controlled substances. In a study of PHPs, opioids were the primary drugs of abuse for 35.9% of physicians and stimulants were the primary abused drug for 7.9% (DuPont et al. 2009a). PHP results are impressive. Of over 904 physicians in 42 PHPs, 78% of participants had zero positive drug tests over a five-year monitoring period; of the 22% of physicians with at least one positive drug test, two thirds never had a second positive test result (DuPont et al. 2009b). These results demonstrate the potential these programs hold for future drug treatment strategies, including treatment for nonmedical use of prescribed controlled substances.

A similar model has been pioneered for use with alcohol- and drug-impaired drivers in South Dakota entitled the 24/7 Sobriety Project. This program requires convicted DUI offenders to be monitored for any use of alcohol or other impairing drugs as a condition of community release. It has shown outstanding results from the same sort of random testing linked to swift and certain consequences that is used in the PHP programs (Caulkins & DuPont 2010).

CONCLUSIONS

Educating the public, patients, and physicians about the misuse and abuse of prescribed controlled substances is an essential part of addressing the growing prescription drug problem. Other solutions to reduce the illegal misuse and abuse of these drugs include incentivizing pharmaceutical companies to develop abuse-resistant formulas, developing a network of PDMP programs in combination with increased law enforcement efforts to reduce illegal sale and distribution of these drugs, and improving prescription drug abuse treatment. Vigorously enforced drugged driving regulations including those that deal with impaired driving due to legally obtained prescription drugs are essential to reducing prescription drug abuse and to improving highway safety. These recommendations hold the promise of significantly reducing the ongoing and growing prescription drug abuse problem in the U.S.

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Robert L. DuPont, M.D., President, Institute for Behavior and Health, Inc., Rockville, MD.

Please address correspondence and reprint requests to Robert L. DuPont, M.D., Institute for Behavior and Health, Inc., 6191 Executive Boulevard, Rockville, MD 20852.
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Author:DuPont, Robert L.
Publication:Journal of Psychoactive Drugs
Date:Jun 1, 2010
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