A Vital Balancing Act: Multi-Sector Approaches to Preventing Prescription Drug Abuse in the United States while Ensuring Adequate Patient Access to Medications: Part 1
Andrea G. Barthwell, M.D.

Michael C. Barnes, Esq.
DCBA Law & Policy

Vera R. Leopold, B.A.
Human Resources Development Institute, Inc.

Jana L. Wichelecki, B.A.
Human Resources Development Institute, Inc.

Abstract
Prescription drug abuse is an increasing public health concern in the United States. Research shows that many Americans view prescription medications, such as opioid pain relievers, as easier to acquire than illegal drugs and safe to use; meanwhile, studies have documented widespread undertreatment of pain. Due to the complex nature of this problem, the participation of multiple sectors of society – the medical community, state and federal governments, law enforcement, advocacy organizations, and private enterprise – is necessary to adequately address the issue. The Center for Lawful Access and Abuse Deterrence (CLAAD) is an alliance of diverse organizations that aims to develop a balanced approach to preventing prescription drug abuse while simultaneously ensuring sufficient access to medications for patients with a legitimate medical need. This article will describe the consensus recommendations developed by CLAAD. Prescription drug abuse is primarily a public health problem, which must be addressed as such through universal precautionary measures.

Keywords: Prescription drug, opioid, opiate, medicine, pharmaceutical, prescription medication, abuse, misuse, diversion, prescription monitoring, e-prescribing, prescribing, universal precautions, undertreatment of pain, chronic pain, disparities, Medicaid, insurance, fraud, abuse-deterrent, tamper-resistant, formulations, dispensing mechanisms, Ryan Haight, controlled substances, medication disposal, CPT codes, standards of care, online pharmacies, Internet pharmacies, patient identity, urine drug testing, DEA, ONDCP, FDA, doctor shopping, pill mill, rogue pharmacies, national policy, public policy, drug control, multi-sector collaboration, public health, pain relievers, reverse pharmaceutical distribution, academic doping, research, development

I. Introduction
The abuse of prescription medications is a growing public health concern in the United States.  While White House reports show that use of many illegal drugs recently declined (1), the number of people abusing prescription medications has more than doubled over the past decade (2).  Unlike illegal drugs, prescription medications are often readily available because people use them for legitimate medical purposes.  Studies suggest most prescription drug abusers get medications free from a friend or relative who holds a prescription (3).  Meanwhile, as pain relievers are increasingly abused, chronic pain patients continue to be undertreated for their conditions.  Taken together, these facts demonstrate the urgent need for a national policy that reduces prescription drug misuse and abuse without restricting safe access to medications for patients who need them.  To ensure balance in addressing this dual challenge, collaboration among many sectors of society is necessary.

The Center for Lawful Access and Abuse Deterrence (CLAAD) is an alliance that seeks to develop a balanced approach to prescription medication policy by deterring prescription drug abuse while simultaneously protecting safe, lawful medication access for patients.  The CLAAD partnership includes concerned parents and grandparents, members of the pharmaceutical industry, medical practitioners, pain patients, veterans, consumer groups, and drug abuse prevention advocates.  Through CLAAD, these members of the broader family, scientific, health, safety, education, and technology communities have united and reviewed expert recommendations to reach agreement on best practices for reducing the incidence of prescription drug abuse.

CLAAD has worked intensively since early 2008, using expert input from its diverse member groups, to develop these recommendations for addressing prescription drug abuse in a comprehensive and balanced way.  This paper is based on the July 2008 National Prescription Drug Abuse Prevention Policy Consensus Meeting.(4) The policy approaches discussed herein represent the consensus from the meeting.

That which follows is a brief summary of the current state of prescription drug abuse in the United States, as well as specific recommendations on how the medical community, state and federal governments, law enforcement, advocacy organizations, and private enterprise must work together to mitigate this escalating problem.

II. Background

A. Definitions

This article will focus on the abuse of prescription medications, mainly prescription pain relievers.  The authors use the term “pain relievers” to refer to opioid medications such as Vicodin®, OxyContin®, and Percocet®.  People also abuse sedatives, tranquilizers, stimulants, and other pharmaceutical products.  Most of the following discussion and policy recommendations, though, will focus on pain relievers, as they are thought to be the most common type of prescription drug abused, constituting 75 percent of abuse (3). 

The “prescriber” includes not only physicians, but also nurse practitioners and physician assistants, who have prescribing authority in most cases.  These members of the medical community are essential to patient access to care, especially in rural or low-income areas (5,6). 

This article will use the term “prescription drug abuse” to include any inappropriate use of prescription medications, as this phrase is commonly known to the news media, the general public, and policymakers.  We realize that there are several other scientific terms and types of improper use incorporated in this general terminology.  No survey data is available, however, to distinguish these different uses so that they could be effectively addressed.

Additionally, CLAAD regards as imprecise the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health (NSDUH) definition of nonmedical use of prescription medications, which is “use without a prescription of the individual’s own or simply for the experience or feeling the drugs caused” (3).  This definition of nonmedical use does not differentiate between misuse and abuse.  Katz et al.’s definitions of misuse and abuse are more precise (7).  Katz et al. define misuse as “use of a medication (for a medical purpose) other than as directed or as indicated, whether willful or unintentional, and whether harm results or not.”  They define abuse as “any use of an illegal drug; the intentional self-administration of a medication for a nonmedical purpose such as altering one’s state of consciousness, e.g., getting high” (7).  Katz et al.’s well-delineated definitions should be used when describing misuse and abuse.  For the general purposes of this article, however, we will often use the phrase “prescription drug abuse” to encompass these various related definitions.

There are many different motives for improper prescription drug use; people may improperly use prescription medications unintentionally, to self-medicate a problem without a prescription, to experiment, to get high, or because they have become addicted.  Such distinctions are important, as remedial efforts must account for motives.  In its present form, the NSDUH definition of nonmedical use does not provide enough information to help practitioners and policymakers understand which motives are more or less prevalent and to whom preventive or interventional measures must be directed.  Future NSDUH surveys should include questions on motives for use.

It is essential to acknowledge in this paper the distinction between addiction and physical dependence.  The Liaison Committee on Pain and Addiction (LCPA) – which includes representatives of the American Society of Addiction Medicine, the American Academy of Pain Medicine, and the American Pain Society – has developed a group of definitions for addiction-related terms that distinguish addiction from dependence (8).  According to LCPA, addiction is defined as:

[…] a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations.  It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.

Though sometimes interrelated, addiction and physical dependence are separate from one another.  Physical dependence is defined as follows:

[…] a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist (8).

LCPA specifies that these two phenomena are not mutually dependent conditions.  A person can be addicted without being physically dependent or vice versa.  The distinction between physical dependence and addiction is particularly important when addressing patients with pain.  Some patients with chronic pain may be physically dependent on prescription pain relievers in order to carry out daily tasks; however, these patients may not experience craving, compulsive behavior, or other signs of addiction.  Without health care providers’ recognition of this distinction, addiction can be over-diagnosed, leading to undertreatment of pain.

B. Trends

1. Abuse

In 2006 alone, over two million people began using pain relievers improperly (1).  The incidence of abuse is especially high among teens, young adults, and those over 60.  National figures show that since 2002, prescription drug abuse among young adults has increased dramatically (3).  Over the past three years, abuse of prescription medications among 18- to 25-year-olds increased by 17 percent (3).  Additionally, through a review of research published between 1990 and 2006, Simoni-Wastila and Yang concluded that up to 11 percent of older female adults may use prescription medications inappropriately (9).

Increasingly, adolescents are “discovering” and experimenting with prescription medications.  In 2006, according to Substance Abuse and Mental Health Services Administration (SAMHSA) figures, new users aged 12 or older of pain relievers outnumbered new users of marijuana (10).  It is estimated that more than three million teens currently abuse prescription medications (3).  The initiation rates of young people suggest that prescription drug abuse will continue to be an issue well into the future.  Other disturbing trends are appearing as well; for example, the practice of “academic doping” – using medications such as Ritalin® and Adderall® without a prescription with the intent to improve performance on papers or tests – is becoming more prevalent among high school and college students across the country (11).

2. Diversion

Diversion can be defined as the unlawful channeling of regulated pharmaceuticals from legal sources to individuals who abuse these controlled medications.  It can occur at any time as prescription medications travel from the source to the recipient—at the point of the manufacturer, the doctor’s office, the patient, and anywhere in between (12).

A common type of diversion is medication-sharing with family and friends.  According to the 2007 NSDUH, over 70 percent of prescription drug abusers got the medications free from a friend or relative.  By contrast, only four percent of users purchased medications from a drug dealer or other stranger, highlighting the fact that methods used to prevent illicit drug trafficking will not necessarily be appropriate when addressing prescription drug abuse.  New approaches will, therefore, be needed for policymakers tackling prescription drug abuse (3).

The relative availability of prescription medications when compared with illegal drugs and the prevalence of people sharing medications with family members or friends (13) are thought to contribute to prescription drug abuse in the United States.  Another major factor is a problem of perception.  As prescription medications are legal and commonly prescribed, many people may believe that they are inherently safe and do not have harmful effects (14). 

3. Consequences

Taking a medication without an individualized, up-to-date prescription can lead to severe consequences.  Prescription medications may have a harmful – even potentially fatal – effect on one person that the original prescription holder did not experience, especially when multiple medications are taken at once.  The risk increases when people combine prescription medications with illegal drugs or alcohol, as studies show roughly half of teenage users do (15).

The misconception of safety can lull users into taking more and more pills to get high, and overdoses can occur.  Opioid pain relievers are particularly dangerous because they can be very habit-forming, especially for teens, and have a high potential for fatal overdose.  Reports show that teen admissions to treatment facilities for addiction to prescription pain relievers have increased by 300 percent since the mid-1990s, and the number of overdoses brought into emergency departments has also jumped over a similar period of time (10).

A little-discussed danger of misusing prescription medications is that people who abuse opioids, such as OxyContin®, are at risk of graduating to heroin, which has a similar chemical composition and produces a similar high.  OxyContin® is a synthetic opioid that resembles morphine, the organic substance from which heroin is derived (16,17).  In 2006, New England states saw a rash of young people overdosing on opioids and heroin in small towns and suburban areas; for example, the number of opioid-related deaths among young people in Massachusetts that year was five times greater than in 1997.  This increase may be attributed to the growing number of teens trying prescription opioids to get high and the availability of inexpensive heroin (18).

Additionally, an increasing number of accidents connected with prescription drug abuse is being documented.  Drug tests of intoxicated drivers involved in 784 car accidents in West Virginia indicated the presence of prescription medications in their systems more often than illicit drugs (19).  People driving under the influence of prescription medications can cause fatal accidents and harm to others much the same as drivers using alcohol or illegal drugs due to increased reaction time, drowsiness, or confusion. 

Recent legislation and advocacy organizations have been named for people who lost their lives due to prescription drug abuse-related incidents.  The Troy and Alana Pack Foundation is a California-based nonprofit organization that was named in tribute to two children who were killed by a driver who was both drunk and high on prescription medications (20).  The organization, founded by Troy and Alana’s parents, aims to educate the public about traffic safety and to help develop and support traffic safety-related legislation.  To date, the foundation has contributed to the passage of California DUI laws as well as legislation bolstering the state of California’s Prescription Monitoring Program (21,22).  The Coalition to End Needless Death on Our Roadways (also known as END) is another traffic safety nonprofit organization that is committed to reducing impaired driving-related deaths, including incidents in which prescription drug abuse is involved (23).  

C. Undertreatment of Pain
Opioids, despite their potential for abuse, are essential to the management of pain for patients with chronic pain, cancer, or other ailments, including acute pain.  Unfortunately, pain is undertreated for many patients.  For example, in a literature review of publications on cancer-related pain from 1987 through 2007, Deandrea et al. concluded that one out of two patients with cancer-related pain is undertreated (24).  In another study, Won et al. found that while 49 percent of nursing home residents had persistent pain, a quarter of these residents with pain received no pain relievers (25). 

Studies have found that practitioners’ concerns about the regulatory scrutiny surrounding pain relievers due to prescription drug abuse could cause prescribers to undertreat pain (26).  This finding highlights the need for balance in addressing the abuse of prescription medications.

D. Disparities in Treatment
Data on disparities in pain management bring another dimension to the interconnected issues of prescription drug abuse and undertreatment of pain.  Disparities in the prescribing of opioid pain relievers for persons from racial/ethnic minority groups and women have been documented (27).  Studies have found that, of prescription drug abusers, 91 percent are Non-Hispanic white, less than five percent are black, and two percent are Hispanic (28).  In one study of data from the National Hospital Ambulatory Medical Care Survey, however, researchers found that 31 percent of Non-Hispanic white emergency room patients with pain received an opioid, compared with 23 percent of black patients and 24 percent of Hispanic patients (27).  In addition, in their 2003 pain management survey, Green and Wheeler found that physicians were more likely to choose the optimal pain management response for men who underwent prostate surgery than for women following uterine surgery (29).  Health care practitioners must be trained to better assess and implement care that is gender, culturally, and linguistically appropriate.

III. Consensus on National Policy
The abuse of prescription medications is a thorny issue to address because pain relievers and other prescription medications provide needed relief and treatment for many patients.  It is estimated that 50 million Americans suffer from chronic pain per year, and chronic pain is the most common cause of long-term disability in the United States.  Still, research suggests that three out of four chronic pain sufferers do not receive appropriate therapy (30).  Opioid pain relievers are currently the optimal medications used to manage moderate to severe pain as well as to improve the quality of life for people with chronic pain.  At the same time, these opioid medications are among the most commonly abused and sought for diversion (31).  It is imperative that policies and programs be crafted to deal with prescription drug abuse, while simultaneously ensuring that legitimate patient access to medications is not restricted in any way. 

The development of effective prescription medication policies requires multi-sector collaboration, incorporating input from groups that approach the problem from several angles.  To achieve a central principle of balance between patient access and abuse prevention, members of the family, scientific, health, safety, education, and technology communities – in addition to government – must be involved in developing and implementing solutions (32).  This national policy sets forth a systems approach with multiple action-oriented strategies and was developed based on expert input from the pain management field, in addition to the general medical/scientific and drug abuse prevention communities. 

CLAAD’s recommendations take a public health approach to the issue of prescription drug abuse and focus on universal precautionary measures.  The policies recommended herein are necessarily broad, derived from commonalities – yet not unanimity – among numerous groups.  Future studies must collect and analyze outcomes data to craft more specific strategies.  As this paper outlines, the medical community, state and federal governments, law enforcement, advocacy organizations, and private enterprise all must play important roles in addressing the problem of prescription drug abuse.  For example, researchers and the medical community can study the best approach for monitoring pain management, while private enterprise can develop new products that deter abuse.  To prevent duplication of current efforts, all future work to reduce the incidence of prescription drug abuse must build on the existing activities and accomplishments of those committed to solving the problem.

IV. Lawful Access
The diversion and abuse of prescription medications have criminal and legal consequences in numerous scenarios.  Given the intertwined issue of sufficient health care and pain management for patients with a legitimate medical need, however, traditional law enforcement alone can be inadequate, counterproductive, and even harmful.  Prescription drug offenses must, therefore, be pursued with an awareness of the sensitive nature of the situation.

A. Appropriate Involvement of Law Enforcement
Preventing certain types of diversion of prescription medications, especially as the incidence of abuse grows in the U.S., requires the commitment and attention of law enforcement.  Abusers get access to prescription medications in a variety of ways; while drug-sharing among friends and family is a common source, many other types of illicit diversion also occur such as outright theft.  Pills can be stolen in residential or hotel guest situations by cleaning and repair personnel, in home burglaries, in pharmacy robberies and night break-ins, while in transit to their destination, from hospital inventories by workers, and through many other means (12,33).  Studies point to pharmacy theft as a main source of primary diversion – diversion that happens along the distribution chain before a medication ever is prescribed for patient use (34).

People also manipulate or circumvent the prescription process to illicitly obtain medication, constituting another type of diversion.  Forgery occurs when users provide false identities and information to get access to medication or when patients or health care workers alter prescriptions.  “Doctor shopping,” in which people get prescriptions from multiple doctors simultaneously in order to accumulate a larger-than-normal supply of pills, has become a major problem as well.  So-called “pill mills” are clinics that have a reputation for providing prescriptions to patients who do not have a legitimate medical need or for writing prescriptions beyond the legitimately needed number of pills or duration of treatment (12,33).

Despite the many illicit means by which prescription medications reach abusers, most major U.S. cities do not have law enforcement officers assigned to the prevention of prescription drug diversion or abuse (35).  This lack of attention to the problem is due to a number of factors.  Uncovering and stopping prescription medication diversion is seen as less exciting or glamorous than work in illicit drug units to stop street dealers and trafficking.  Other preconceived notions, such as the belief that prescription drug abuse prevention work is too complicated or time-consuming to have a real impact, may be in play as well.  Perhaps most importantly, however, many law enforcement officials—like the general public—simply may not realize that the “almost silent” issue of prescription drug abuse is a problem in their jurisdiction (35).

In order to correct this deficiency in oversight by the law enforcement system, the following steps should be taken:

• State and local investigators must be dedicated to pursuing prescription theft, forgery, and manipulation cases as well as intervening in other cases of criminal diversion, possession, and distribution of prescription medications.
• To direct investigation resources effectively, it is essential to quantify diversion through further research and categorize the different types of illicit access to prescription medications.
• New technology solutions that can achieve heightened coverage of the prescription medication supply chain, such as radio frequency identification, must be employed (36-38). 

Law enforcement can make other regulatory gains simply by streamlining the process by which they pursue diversion cases.  Form 106, the only information system that directly measures primary diversion, offers an example (39).  Registered suppliers of prescription medications that are controlled substances, such as distributors, pharmacies, and hospitals, are required to use Form 106 to report to the U.S. Drug Enforcement Administration (DEA) any losses or thefts of medication.  Formerly, the registrant had to fill out the form by hand and send it to the regional DEA office, which then forwarded it to Washington, D.C., to be manually entered into a database.  This time-consuming process was sped up considerably in October 2008, when the DEA switched to an electronic form, thereby improving the quality and efficiency of data collection (40). 

CLAAD applauds the DEA for adopting the policy recommendations on Form 106 that it received from the Pain & Policy Studies Group, CLAAD, and Tufts Health Care Institute.  There are still many improvements that could be made at the federal level, however, to optimize data collection and subsequent diversion investigations.  A 2005 study, for example, found that the DEA’s electronic database, which compiles annual data from Form 106, only contained analyzable data from 22 states (34).  Additionally, federal law currently places the investigation of pharmacy theft – a very common type of primary diversion – under the purview of the Federal Bureau of Investigation, even though the DEA is the agency charged with receiving and compiling the data on those pharmacy thefts and losses (personal communication, David Joranson, January 13, 2009).  The federal government must eliminate this jurisdictional split through legislation, giving the DEA jurisdiction to respond to pharmacy thefts, as the DEA has access to the data necessary for investigating these crimes.

Cases Beyond the Reach of Law Enforcement
In criminal cases like those described above, the involvement of law enforcement is clearly necessary.  Cases of prescription-sharing among family members and friends, however, are not pursued by law enforcement, nor would law enforcement’s involvement in these cases be the most appropriate intervention.  Prescription-sharing often stems simply from public misinformation and a lack of understanding about the potential for, and dangers of, prescription drug abuse.  Efforts to address diversion due to medication-sharing should focus on developing and implementing education initiatives to raise public awareness and change the cultural norm (see Section V.C, “Public Education and Awareness Initiatives”).

To maintain the principle of balance between preventing prescription drug abuse and ensuring adequate pain treatment, law enforcement must avoid interfering in medicine and legitimate patient care, just as medical professionals have a duty to avoid contributing to opioid diversion (39).  In cases where doctors are prescribing to abusers, whether intentionally or without knowledge of the abuse, law enforcement must take care to collaborate with the medical community – and, specifically, pain management experts – because of the complex nature of the situation.  Physicians must be approached from a perspective distinct from other parties accused of diversion (34).  It is essential to take into consideration those helped by the doctor as well as those harmed.

Investigators must work with medical experts to differentiate between a case of a doctor purposely prescribing drugs inappropriately, which would constitute a criminal case, and a case of a well-intentioned doctor who needs training on recognizing abuse and/or prescribing opioids, which can be handled administratively.  Arrests and investigations of medical practitioners can leave many legitimate pain patients without the care they need when their doctor’s services are interrupted.  The medical community, law enforcement, and resources in the local community must cooperate with each other to ensure a smooth transition to another provider for such patients and to provide treatment and recovery services for abusers who had been using that doctor as a source of opioids.

B. Insurance Fraud
As part of the multi-sector collaboration that is needed, it is appropriate and essential for insurance companies to identify and pursue cases of insurance fraud related to prescription drug abuse.  Insurance companies have great incentive to be more involved in addressing the issue, not just as a public health concern but for their own protection.  The Coalition Against Insurance Fraud reports that health insurers lose up to $72.5 billion every year because of prescription drug diversion of opioids alone (41).  Insurance carriers would not only realize significant cost savings by better addressing fraud, they also would reduce their liability; insurance company executives could be held liable for a patient death or injury if they knew, or should have known through due diligence, that they were enabling drug abuse (41).

Although insurance companies are somewhat aware of the problem of diversion, many insurers have not taken any consistent or effective steps to address it.  Given that recent studies have described insurance fraud as the “main financier and enabler” of prescription drug diversion, this inaction must be remedied (41).  Companies must form pain management work groups in their special investigation units in order to distinguish between patients with legitimate chronic and ongoing pain needs and insurance clients who are abusing the system.  Insurance companies also must develop protocols and implement better training for their investigators in recognizing and handling prescription drug diversion.  Such training can be facilitated through the National Association of Drug Diversion Investigators, an organization that provides cooperative education and training about the prevention, investigation, and prosecution of pharmaceutical drug diversion (42).

Several types of insurance fraud involving prescriptions have been documented, including the following: doctors intentionally prescribing medications patients do not need for non-diagnosed conditions (43-45), prescription forgery (46), people using someone else’s identity to get medical care and prescriptions through that person’s insurance coverage (41), and patients doctor shopping (47). There are often warning signs that indicate a possible case of prescription drug diversion. The amount and frequency of prescriptions written for individuals should be monitored for detectable patterns such as repeated early refills or large quantities of pills. Insurers also should question prescriptions under the following circumstances:

• When prescriptions have no logical relationship to the diagnosis;
• When medications with significant abuse potential are “off-label,” or prescribed for treatment outside of typical usage; or
• When a patient is using multiple prescribers and/or pharmacies at once.

Additionally, states can reduce the diversion and abuse of prescription medications, as well as their Medicaid expenses, through increased monitoring. Prescription data is readily accessible to all states through their Medicaid databases; in fact, U.S. General Accounting Office (GAO) reports that date back over a decade have recommended that states monitor Medicaid databases (48). Investigators can search these databases to identify trends that could indicate diversion, such as patients who are recipients of the same or similar medications from multiple prescribers at once (personal communication, David Joranson, January 13, 2009).

C. Internet Pharmacy Oversight
Online pharmacies are another source of prescription medication diversion, as some so-called “rogue pharmacies” illicitly sell medications over the Internet without a prescription, attracting new customers through spam email and online advertising. In 2008, the National Center on Addiction and Substance Abuse found that 85 percent of websites advertising or selling controlled prescription medications online did not require a prescription from a patient’s doctor (48). Of the remaining websites, half allowed patients simply to fax a prescription, leaving an opening for fraud or other manipulation of prescriptions.

Reports suggest that comparatively few prescription drug abusers use these rogue pharmacies as their source (3). Also, a 2004 study showed that only four percent of Americans ever bought prescription medications over the Internet and that most of the sites they used required a prescription from a doctor (49). The rogue pharmacies that are in existence, however, are persistent; the same 2004 study found that 55 percent of Internet users reported receiving unsolicited email advertising a prescription medication (49). For the prescription medication users ensnared by these advertisements, rogue pharmacies can lead to devastating consequences.

The case of Ryan Haight is an example of these potential consequences. The federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was named for an 18-year-old who died from an overdose of hydrocodone, a generic form of Vicodin® that he bought online from a pharmacy website without seeing a doctor. The act seeks to eliminate rogue pharmacies by criminalizing the use of the Internet to advertise illicit selling of controlled substances. The act also places stricter requirements on pharmacies that sell controlled substances online, mandating that they first receive a modification of their existing DEA registration and that they make monthly reports of quantities dispensed to the Attorney General. Internet pharmacies must clearly post their compliance, licensure, and contact information on their websites, and prescription medications can only be dispensed over the Internet to a patient with a valid prescription who has seen a doctor at least once in person (50).

The Ryan Haight Act is an excellent example of what can be achieved through multi-sector collaboration, as many organizations from different communities came together to advocate for its successful passage. Instrumental groups and individuals that took on leadership roles in advocating for the act included CLAAD; Educating Voices, Inc.; Save Our Society From Drugs; Ryan’s mother, Francine Haight; and JVP Memorial Fund (51), an organization created by Dan Pearson, whose son also died from the use of prescription pain relievers he bought online and who had pushed a similar bill through the state legislature in Minnesota (52). These invested parties communicated with DEA officials for assistance in analyzing the bill’s provisions and educated influential members of Congress on the urgent need for the legislation.

Beyond legislation, private service providers must prevent rogue pharmacy websites from utilizing their services to conduct their business. There are many ways for service providers to discourage and even interrupt the activities of rogue pharmacies, including the following:

• Financial institutions can flag business entities that have been identified as illicit vendors and refuse to make payments processed by credit or debit cards.
• Internet service providers can block non-certified pharmacy websites.
• Pharmacies legitimately selling prescription medications online must signal their legality to consumers by complying with the requirements of the Ryan Haight Act (see discussion above) and displaying that they are accredited by the National Association of Boards of Pharmacy (NABP) as Verified Internet Pharmacy Practice Sites™. The NABP maintains an online searchable listing of such certified, recommended sites, as well as a listing of non-recommended sites (53).

Efforts to combat rogue pharmacies also must address international pharmaceutical trafficking, as many illicit websites are run from outside U.S. borders. The Ryan Haight Act requires the DEA to provide annual reports to Congress on the agency’s efforts to collaborate with multinational pharmaceutical companies to address global online trafficking of controlled substances. This provision is a good first step towards dealing with illicit international trafficking; however, more work is needed, and the DEA must collaborate with its foreign counterparts in order to be successful.

D. Electronic Systems and Controls
Electronic information-sharing systems hold promise to prevent diversion through secure, interlinked electronic tracking and monitoring systems and must be developed further. Those dedicated to preventing prescription drug abuse should support these innovative methods of detecting diversion, which include e-prescribing, Prescription Monitoring Programs (PMPs), and patient identity tracking systems.

1. E-Prescribing
E-prescribing, in which doctors electronically send their prescriptions directly to pharmacies from the point of care, can improve the prescribing process while minimizing diversion and abuse. The ability to forge or alter prescriptions is reduced, and e-prescription records can be integrated into other medical records, increasing efficiency and cutting down on paperwork. Also, studies have suggested that e-prescribing can significantly lower patients’ medical costs by helping prescribers to find generic or lower-cost medications. The Agency for Healthcare Research and Quality has concluded that use of a complete e-prescribing system could save $3.9 million per 100,000 patients per year (54).

Additionally, e-prescribing offers a key public health benefit by reducing the likelihood of medication errors. The persistent problem of doctors’ illegible handwriting is a familiar joke. Misreading of prescriptions, however, can lead to very serious consequences. According to a 2006 study by the Institute of Medicine, nearly 7,000 people die annually in the United States due to medication errors, often from improperly read or filled prescriptions (55). The associated costs to the health care system of these errors are estimated to be in the billions (56).

While the technology for e-prescribing already exists, it continues to be underutilized. Only two to three percent of prescriptions are issued electronically (57). Most community pharmacies already use a prescription transmission network called SureScripts-RxHub, meaning they are prepared to receive electronic prescriptions without having to update their technology (59). Prescribers, however, have been slow to adopt e-prescribing, due to the associated costs and fees for installing the necessary equipment and software (60). It is estimated that only 10 percent of medical practitioners currently use e-prescribing (61).

In July 2008, Congress passed the Medicare Improvements for Patients and Providers Act of 2008, which includes incentives for physicians to switch to an e-prescribing system. The act is expected to increase the number of physicians using e-prescribing by giving a two percent bonus in 2009 and 2010 to doctors who use e-prescribing for their Medicare patients – with smaller bonuses awarded in subsequent years – and implementing a pay reduction thereafter for those who still do not (62). CLAAD praises Congress for passing this provision, as the monetary bonus should provide encouragement for more doctors to move to an e-prescribing system.

Medical practitioners also may underutilize e-prescribing because the DEA currently prohibits e-prescribing of certain prescription medications under the Controlled Substances Act (CSA). Controlled substances are medications or other substances that are regulated by the federal government under the CSA because of their risks and potential for abuse (62). Controlled medications are categorized into different schedules according to their level of risk. For example, several opioids that are commonly prescribed to treat chronic pain – such as prescription pain relievers like Percocet® and OxyContin® – are regulated by the DEA because they are derivatives of morphine, a Schedule II (high potential for abuse) controlled substance (63). Doctors’ offices are often reluctant to maintain both paper systems and e-prescription systems because of the doubled workload, so they rely on paper for all prescriptions.

In June 2008, the DEA proposed a rule that would address this concern by revising their regulations to allow practitioners to use one e-prescribing system to write prescriptions for all medications, including Schedule II controlled substances (64). As of January 16, 2009, the rule had not been finalized.

Privacy and Security
E-prescribing systems must include a number of safeguards to protect patient privacy and information security. Without proper security measures, these systems could facilitate new, more anonymous routes of diversion that would be even harder to prevent, detect, and/or prosecute. As e-prescriptions are transmitted through a series of intermediaries, unauthorized release of sensitive information due to an error is possible. Authentication of system users is also a necessity.

Safeguards can be instituted for e-prescribing to handle these security concerns. They must be balanced, however, with the overall usability of the system. The DEA-proposed rule, for example, would require two forms of identification (entering a password and scanning a physical device) each time a prescriber uses the system. Such strict measures, though, could negatively impact the feasibility of prescribers’ offices operating such a system. A comprehensive e-prescribing system must be practical for medical facilities to utilize, especially in light of the DEA’s mandate that only a prescriber registered with the DEA can electronically “sign” e-prescriptions, not a non-registered assistant. E-prescribing also must preserve the prescribing authority of nurse practitioners and physician assistants.

An effective, secure e-prescribing system that protects patient privacy holds great potential for reducing prescription forgery and prescription medication diversion. E-prescribing is an important first step to reducing errors, as well as ensuring the legitimacy of prescriptions.

2. Prescription Monitoring Programs
Prescription Monitoring Programs (PMPs) are statewide data collection systems that track patient-specific prescription information. States can use the data to identify trends that likely point to diversion such as people using many different doctors and pharmacies to obtain the same medication. PMPs are an initiative that already has proven effective in deterring doctor shopping and prescription forgery in many states across the U.S., and CLAAD advocates for their continued use and improvement.

The programs have confidentiality safeguards such that information in the system can only be retrieved by authorized users. These authorized users vary by state, but usually include the patient, their physicians and pharmacists, and law enforcement officials. Other users allowed in certain states include licensing boards, Attorneys General, and Medicaid (65).

According to the DEA, 38 states had enacted legislation to mandate a Prescription Monitoring Program as of November 2008, and 11 others had legislation in the developmental stages. These states that now require PMPs represent 98 percent of all pharmacies that are registered with the DEA and 98 percent of medical practitioners and prescribers. Only one state, Wisconsin, had not taken any steps to create a PMP (66). This state, however, uses a different system to monitor the distribution of prescription medication.

While Wisconsin’s system for detecting diversion is not compatible with other state PMPs for data-sharing, its effectiveness and success in multi-agency collaboration suggest that other states should consider incorporating similar strategies into their diversion prevention plans. Since the 1970s, Wisconsin has operated a program by which key agencies with authority to manage different aspects of the state’s controlled substance distribution system collaborate to share data. By integrating crime lab drug evidence, Automation of Reports and Consolidated Orders System—commonly known as ARCOS—data, and information from Wisconsin’s Medicaid database, the agencies are able to identify regions of the state with unusual trends in their prescription medication data, and then flag these areas for further investigation. Through this approach, state officials are able to better identify sources of diversion without putting additional regulatory pressure on medical professionals and patients (personal communication, David Joranson, January 13, 2009).

Electronic PMPs also have been successful. Kentucky runs a particularly effective PMP known as Kentucky All Schedule Prescription Electronic Reporting (KASPER). In 2007, KASPER processed more than 361,000 requests for patient prescription reports, over 93 percent of which were requested by physicians (xxi). The system also provides prescribers with real-time data access, a capability that all states must develop.

Improvements to the implementation of state PMPs would make them even more effective. Training of medical professionals and prescribers in how to interpret and use PMP data would facilitate efficient use of these systems. CLAAD applauds those select state medical boards that currently provide this education and calls on others to follow suit. Also, to encourage more prescribers to embrace PMPs, the American Medical Association (AMA) must update the Current Procedural Terminology® (CPT®) codes to allow for proper record-keeping and reimbursement for the additional administrative time that prescribers use to access PMP data as a billable procedure. CPT® codes are numerical codes assigned by the AMA to every task or procedure that a doctor may conduct; they ensure uniformity and are used by providers, insurance companies, and Medicare (67).

Abusers may attempt to move their doctor shopping to a neighboring state after PMPs take effect in their home state. They also may seek prescriptions from doctors in multiple states, preventing single-state PMPs from revealing a pattern. To reduce these trends, states have begun to coordinate interstate data-sharing systems so that prescription information can be searched across state lines. Through a U.S. Department of Justice (DOJ) pilot program, four states—Kentucky, Nevada, New York, and Ohio—will exchange PMP data in 2009 to test the potential for interstate data-sharing (65). As these capabilities develop, states should establish consistent standards so that data will be accessible, yet secure and confidential.

The average start-up cost for a Prescription Monitoring Program is $350,000, and ongoing costs to maintain the system run from $100,000 to almost $1 million annually (65). Two grant programs are available for states seeking funding to create and maintain their PMPs. The federal Harold Rogers Prescription Drug Monitoring Program grant, administered by the DOJ, awards funds to states while allowing them to set their own requirements for the PMP. The National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER) also established a grant program for PMPs within the U.S. Department of Health and Human Services. In contrast to the Harold Rogers grant, NASPER requires that state applicants collect data on certain types of prescriptions and have the capability to share data with other states (69). While NASPER was passed, it has not currently been funded or implemented.

CLAAD applauds the leadership of members of Congress in sponsoring and working to push NASPER through the federal legislature as well as their ongoing efforts to establish and fund a grant program that is administered from a public health perspective and that encourages interstate data sharing. Indeed, the issue of prescription drug abuse is best approached from such a public health standpoint. The U.S. Department of Health and Human Services certainly must play a key role in reducing the incidence of prescription drug abuse. The current Harold Rogers grant program, however, has largely been successful, and the DOJ is handling funding and implementation systems for prescription monitoring grants very appropriately. Based on its admirable progress so far, the Harold Rogers grant should be continued without interruption.

As with the e-prescribing systems discussed previously, officials administering PMPs must ensure that the systems do not create barriers to pain care patients’ access to their medications. Increased regulatory scrutiny by way of monitoring programs may deter medical professionals from prescribing pain relievers, leaving patients who have a legitimate need without sufficient pain treatment (25). The following guidelines for state PMPs, adapted from the Alliance of State Pain Initiatives’ list of principles, should help differentiate and protect legitimate prescribing while identifying cases of abuse and diversion:

• Patient confidentiality must be protected to the greatest extent possible.
• Individual health care professionals must be granted access to PMP data about their individual patients so they can evaluate those patients’ use of controlled substances.
• Law enforcement agencies should be allowed access to the data, but only when probable cause justifies such access in the course of investigating possible abuse or diversion or when public health officials alert law enforcement to apparent criminal activity (30).

3. Patient Identity Tracking Systems
The success of Prescription Monitoring Programs and e-prescribing in deterring forgery, doctor shopping, and other diversion rests, in part, on the ability to identify individuals and the prescriptions written for them. Electronic records, therefore, must successfully match up with the person physically receiving the prescription. An identity loophole currently exists that undermines that matching. Patients are seldom required to show a driver’s license or other ID as proof of identity when visiting health care facilities or stopping by the pharmacy counter. When patients do show their ID at a clinic, doctor’s office, or pharmacy, there is currently no system in place to determine whether the ID is authentic. It is possible that people could use false identities to receive multiple prescriptions even when a PMP is in place.

ID technology exists to close this loophole. Under the federal Real ID Act of 2005(70), states are required to meet minimum ID verification and security criteria for drivers’ licenses by 2011 at the latest (71). Private companies already produce the scanner technology needed to verify IDs, which could be installed in pharmacies and doctors’ offices. Casinos, for example, often have an identity verification system in place to confirm a person’s identity before paying his or her winnings. These systems transmit the ID to a secure database, which then sends back an “OK” or “not OK” message to the staff accessing the system.

Opportunities exist to integrate a patient identity tracking system with Prescription Monitoring Program data and e-prescribing into a comprehensive electronic prescription medication database. The swipe of a patient’s ID card at the medical facility or pharmacy counter would then verify identity, bring up his or her prescription data in real time, and allow the practitioner to determine whether any alerts have been placed on the account. If developed securely and effectively, the three systems together would become a powerful tool for identifying doctor shopping, falsified or improper prescriptions, and other forms of diversion. Equally important, such a system would alert prescribers and pharmacists to the existence of drug interactions or other errors, thereby further protecting patient health.

Author Information
Michael C. Barnes, Esq.
DCBA Law & Policy

Mr. Barnes is a member of DCBA Law & Policy, a firm that advises on public health policy. In the past, he has worked in an advisory capacity for Alpharma Inc. on issues of a public health nature.

Bio: Mr. Barnes is responsible for strategic growth, business development, and client satisfaction for DCBA Law & Policy and its Center for Lawful Access and Abuse Deterrence (CLAAD).  Prior to establishing DCBA in 2004, Mr. Barnes served as confidential counsel in the Office of National Drug Control Policy, where he provided direction on policy and program matters aimed at reducing the demand for illicit drugs.  Leading up to his presidential appointment, Mr. Barnes worked for The Perles Law Firm.

Mr. Barnes obtained his Juris Doctor degree from George Mason University School of Law. He earned a master’s degree in international economic policy from La Universidad de Belgrano in Buenos Aires, Argentina, where he lived and studied as a Rotary Foundation International Ambassadorial Scholar.  He received his bachelor’s degree summa cum laude from Flagler College.

Andrea G. Barthwell, M.D.
Human Resources Development Institute, Inc.

Dr. Barthwell is a member of EMGlobal LLC, a firm that advises on public health policy.  In the past, she has worked in an advisory capacity for GW Pharmaceuticals Limited and King Pharmaceuticals, Inc., on issues of a public health nature. 

Bio: Andrea Barthwell, M.D., F.A.S.A.M., is the Chief Executive Officer of Human Resources Development Institute, Inc. (HRDI), a community-based behavioral health and human services organization.  Dr. Barthwell served from 2002 to 2004 as Deputy Director for Demand Reduction of the Office of National Drug Control Policy, a President-appointed and Senate-confirmed position.  She is a former president of the American Society of Addiction Medicine.  Dr. Barthwell also is a former member of the National Institute on Drug Abuse and Center for Substance Abuse Treatment National Advisory Councils, as well as the U.S. Food and Drug Administration’s Drug Abuse Advisory Committee.  She earned her undergraduate degree in Psychology from Wesleyan University in Connecticut and received her M.D. from the University of Michigan.  Dr. Barthwell is a member of the global health care and consulting firm EMGlobal LLC.

Vera R. Leopold, B.A.
Human Resources Development Institute, Inc.

Ms. Leopold does not have any conflicts of interest to disclose.

Bio: Ms. Leopold is the Writer/Editor for Human Resources Development Institute, Inc., a behavioral health and human services organization based in Chicago.  She has an undergraduate degree in English Writing from Illinois Wesleyan University in Bloomington, IL, and is currently pursuing a master’s degree in Environmental Studies from the University of Illinois at Springfield.  Her past experience includes writing and editorial work for Illinois Issues magazine, as well as volunteer collaboration with several community organizations.  Most recently, she held a post with a marketing firm that fundraised for non-profits such as D.A.R.E. America. 

Jana L. Wichelecki, B.A.
Human Resources Development Institute, Inc.

Ms. Wichelecki does not have any conflicts of interest to disclose.

Bio: Ms. Wichelecki is the Research and Communications Coordinator for Human Resources Development Institute, Inc., a behavioral health and human services organization based in Chicago.  She has an undergraduate degree in English Writing from the University of Illinois at Chicago.  Her past experience includes writing and editorial work for the Midwest Latino Health Research, Training, and Policy Center, as well as the American Osteopathic Association.

Acknowledgements: The authors would like to thank Dr. John Femino of Meadows Edge Recovery Center, David Joranson of the Pain & Policy Studies Group, and Dr. Nathaniel Katz of Analgesic Research for lending their expertise in the development of this paper.

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71. This initiative continues to be unfunded by the federal government, and many states have requested permission to extend their compliance deadlines in order to plan for and afford implementation of new technology.