A Vital Balancing Act: Multi-Sector Approaches to Preventing Prescription Drug Abuse in the United States while Ensuring Adequate Patient Access to Medications: Part 2
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.

V. Appropriate Use

A. Best Practices
To begin to solve the dual problem of prescription drug abuse and undertreatment of pain, as well as to address disparities in pain treatment, the medical community must implement universal precautions in prescribing. The adoption of universal precautions for bloodborne pathogens in the late 1980s is a commendable example of the medical community’s successfully implementing a set of universal precautions (1). Prior to the adoption of these universal precautions, the Centers for Disease Control and Prevention had recommended “Blood and Body Fluid Precautions,” which included such basic practices as wearing gloves when dealing with blood and washing hands after any contact with blood, to be used only with patients who were infected or suspected to be infected with bloodborne pathogens, such as HIV (2).

Taking medical histories and performing medical examinations do not always identify patients with bloodborne pathogens. Due to this fact, health care professionals concluded through medical discourse that blood and bodily fluid precautions should be taken with all patients (1). These universal precautions effectively reduced stigma for patients, decreased risk for health care workers and patients, and also improved patient care (3). When applied to prescription drug abuse, the same concept of universal precautions can be implemented to effectively reduce the stigma of pain or substance use disorders, decrease risks and liabilities for prescribers, and improve patients’ pain treatment.

Implementing a universal precautions approach to prescribing – such as Gourlay et al.’s 10 Steps of Universal Precautions in Pain Management – can effectively reduce the incidence of prescription drug abuse while preventing disparities in the treatment of pain (3). Universal precautions, like those outlined in Figure 1, must apply to all patients during all stages of treatment with medications that have the potential to be abused, including initial risk assessment and ongoing monitoring during therapy.

1. Assessment
Assessing patient risk as an essential element of universal precautions in prescribing must be incorporated into the medical community’s best practices. Preexisting problems, such as mental illness or substance abuse history, are risk factors that can lead to opioid addiction. All treatments necessarily involve risks and benefits; an appropriate risk-benefit strategy assesses whether the benefits of a medication outweigh the potential risks. If patients’ risk factors are effectively assessed, their risk level can be determined, and therapy can be designed and monitored accordingly.

Current literature on opioid abuse has identified three categories of risk factors for misuse or abuse (5,6):

• Biological risk factors include age (younger than 45 years), gender, family history of prescription drug or alcohol abuse, and cigarette smoking.
• Psychiatric risks include substance use disorders, preadolescent sexual abuse (in women), and major psychiatric disorder (e.g., personality disorders, anxiety or depressive disorders, bipolar disorders).
• Social risk factors include prior legal problems, a history of motor vehicle accidents, poor family support, and involvement in a problematic subculture.

Several assessment tools have been developed to assess these risk factors before patients are prescribed an opioid (7). Assessing risk should be a universal precaution taken with all patients and should be incorporated as a standard practice when prescribing not just opioids, but any prescription medications with significant abuse potential.

2. Monitoring
Ongoing monitoring of patient opioid therapy also must be incorporated into best practices in pain management. In order to prevent or stop prescription drug abuse, all patients undergoing opioid therapy must be monitored by their physicians. Based on the risk level of each patient, monitoring should include different components. For example, for moderate-risk patients, monthly prescriptions and doctor visits should be required. For high-risk patients, weekly visits should be required. Also, rapid onset formulations should not be prescribed to high-risk patients, while short-acting formulations should be limited (8). The following should be included in routine monitoring for all patients:

• • Urine drug tests, which can substantiate abuse by identifying levels of specific drugs in a patient’s system through advanced technology,
• Prescription Monitoring Programs (as described in Part 1, Section IV.D.2, “Prescription Monitoring Programs”) to monitor patients’ access to pain medications.
• Treatment agreements, which set forth in writing the mutual expectations and obligations of the patient and prescriber and clarify boundaries for the patient (3). Such agreements are an essential part of monitoring.

Ongoing monitoring that utilizes tools such as urine drug tests, Prescription Monitoring Programs (PMPs), and treatment agreements must be a universal precaution taken with all patients who have been prescribed opioids or any medications with significant abuse potential.

CPT® Codes
Incentives for delivering quality care also should be implemented, such as pay for performance for monitoring and documentation of opioid patient functioning. The American Medical Association (AMA) must ensure that new CPT® codes are developed that allow for proper medical documentation and reimbursement for the associated costs of technologically advanced urine/blood testing and analysis of PMP data. It is essential that advanced urine/blood testing be incorporated into current best practices, as these technologies make it possible to identify individual drugs in a patient’s urine or blood, including oxycodone, methadone, fentanyl, and other medications (9); traditional tests cannot distinguish between one opioid and another (personal communication, Femino, January 15, 2009). An advanced test, therefore, can detect whether a patient is taking any opioid medications in addition to the one he or she has been prescribed or if there are abnormally high levels of the prescribed medication in their system (10).

CPT® codes are updated by the AMA’s CPT® Editorial Panel, a 17-member panel authorized by AMA’s Board of Trustees to revise, update, or modify CPT® codes, descriptors, rules, and guidelines (11). In 2007, the AMA updated its CPT® codes to provide for a Screening, Brief Intervention, and Referral to Treatment (SBIRT) code in a faster-than-normal process as a result of collaboration among various groups, including the federal government and practitioners (12). The AMA, the federal government, medical practitioners, and insurance companies should make a similar full-force effort to update CPT® codes to provide for advanced drug testing and PMP data checks, as conducting and documenting these procedures are essential to the prevention of prescription drug abuse.

3. Universal Precautions to Eliminate Disparities
Universal precautions in prescribing also would help to address the current disparities that exist in the treatment and management of patient pain. Through literature review, Green et al. concluded that across all settings and all types of pain – including acute, cancer, and nonmalignant chronic pain – African Americans and Hispanics/Latinos as a group experience disparities in pain perception, assessment, and treatment (13). As noted in Part 1 (section II.D, “Disparities in Treatment”), disparities also have been documented in pain management for women (14,15).

One method of addressing racial and ethnic disparities in treatment is for medical schools to increase their efforts to recruit racial and ethnic minorities, as patient-provider racial concordance is associated with improved patient satisfaction (16). While CLAAD supports these efforts as necessary across the board, medical professionals also must receive training in culturally and linguistically appropriate care in order to effectively address treatment disparities. A universal precautions approach to prescribing, in which consistent assessment and monitoring practices are applied to all patients, is essential to preventing physician bias in pain management and prescribing. Increased recruitment of racial and ethnic minorities into the medical field and cultural competence training, along with universal precautions, must be implemented to eliminate disparities in pain management.

4. Use of Technology
The growing incidence of prescription drug abuse has led to the development of new medications and ways of dispensing them. These technological and scientific advances must be part of universal precautions in prescribing, and CLAAD supports further development in these areas.

Abuse-deterrent Opioid Formulations
New opioid formulations that are less susceptible to abuse can be a technologically-based universal precaution if made available on a wide scale. There are two main types of abuse-deterrent formulations – those that employ a pharmacologic barrier and those that employ a physical barrier. Pharmacologic barriers include:

• Sequestered opioid antagonists, which would release substances that prevent opioids from binding with receptors in the brain if the pills are crushed (17);
• Aversive agents, which would cause unpleasant side effects if taken at higher than therapeutic doses (17); and
• Opioid prodrug formulations, which would contain an opioid that could only be activated in the digestive tract (17).

Formulations that utilize physical barriers, such as hard shells and viscous gels, do not allow full release of the opioid dose if users attempt to crush or otherwise tamper with the pill (18).

Embeda™, developed by Alpharma Inc. (Bridgewater, New Jersey)(19) , is an example of an abuse-deterrent formulation that utilizes a sequestered opioid antagonist. This formulation consists of extended release morphine and sequestered naltrexone. When taken intact orally, the naltrexone, an opioid antagonist, would pass through the body. If Embeda™ were crushed, the naltrexone would be released for the purpose of blocking the effect of the morphine. The user’s inability to experience euphoric effects when this medication is crushed, chewed, or converted to a liquid could deter these forms of tampering for purposes of abuse (20). CLAAD applauds Alpharma Inc. for developing this abuse-deterrent formulation and calls on other pharmaceutical companies to follow its lead.

Abuse-deterrent opioid formulations are an important tool to prevent or reduce prescription drug abuse. Despite their promise, however, these formulations can only be effective in addressing prescription drug abuse as part of a comprehensive plan that includes implementation of informed and consistent assessment, monitoring, and prescribing practices. Prescribing of abuse-deterrent formulations must be incorporated into a universal precautions approach that helps reduce disparities in access to medications.

Novel Dispensing Mechanisms
In addition to abuse-deterrent formulations of pain relievers, new dispensing technologies can be developed to aid in mitigating risk of opioid abuse. Advanced dispensing technologies can be applied in hospitals, clinics, nursing homes, clinical trials, and throughout the supply chain to prevent or reduce opioid addiction and overdose (21).

One such device, called the Advanced Dispensing System (ADS), is currently under development by GW Pharmaceuticals Limited (Salisbury, Wiltshire, U.K.) (22). The ADS is a small device that dispenses medication in a tamper-resistant and secure way. This device, which can be handheld or placed in a fixed location, has features that allow it to provide drug reminders to patients and to recognize and eliminate inappropriate patterns of medication consumption (20). Such mechanisms can be applied as part of universal precautions in prescribing by allowing practitioners to monitor the patient’s progress remotely.

During the July 2008 consensus meeting, CLAAD members listed desirable capabilities for an advanced dispensing device, which include:

• Preventing dose escalation and overdose by locking the patient out if dose or interval is disregarded;
• Documenting patient compliance by tracking when dosages are taken;
• Determining that the intended patient is the one consuming the drug; and
• Facilitating tapering of dosage when an exit strategy is required.
  

These devices also could be used to coordinate physician and pharmacy record-keeping and to manage the supply chain by locking patients out in cases of product recall or expiration. These devices are an essential element in a universal precautions approach; it is important to highlight, however, that they are not a substitute for the comprehensive risk management offered in a universal precautions approach.

B. Training for Medical Professionals
Medical professionals and prescribers need to receive more specialized training in identifying and managing prescription drug abuse. While pharmacists play a key role in dispensing prescription medications, only about half of pharmacists receive training on the identification of prescription drug misuse, abuse, and diversion (23). Additionally, a study of an internal medicine resident clinic found that 57 percent of survey respondents rated their chronic non-malignant pain training as “fair” or “poor” (24). This lack of training is a detriment to efforts to curb prescription drug abuse, as well as efforts to effectively treat chronic pain.

Continuing medical education (CME) should include training for practitioners and pharmacists in recognizing opioid abuse in patients. Also, to equip health care providers with the skills needed for monitoring pain management, they should be trained to interpret and use Prescription Monitoring Program data. Prescribers also should receive training related to abuse-deterrent formulations, including instruction that these medications have risks despite their abuse-deterring qualities. Abuse-deterrent medication training for pharmacists should highlight that prescriptions for abuse-deterrent medications must only be filled with those medications and must not be substituted with traditional formulations. As advanced dispensing mechanisms are adopted, use of these mechanisms also should be incorporated into CME training. Additionally, medical professionals must receive training in culturally and linguistically appropriate care in order to effectively address treatment disparities. Medical schools should incorporate all such training in universal precautions, much like their incorporation of universal precautions for bloodborne pathogens.

In addition to the federal Substance Abuse and Mental Health Services Administration (SAMHSA), there are many non-governmental organizations that are interested in helping to develop and implement training on handling prescription drug abuse, including the Federation of State Medical Boards (25) and individual state medical boards, the American Academy of Physician Assistants, the American College of Nurse Practitioners, major pain associations (e.g., the American Pain Society, the American Academy of Pain Management), the Association for Medical Education and Research in Substance Abuse, the Pain & Policy Studies Group (26,27), and Zero Unintentional Deaths.

C. Public Education and Awareness Initiatives
As mentioned in Part 1 of this article (Section II.B, “Trends”), people tend to perceive prescription medications as safe because they are legal, prescribed by physicians, and widely present in homes; therefore, many people do not recognize the risks associated with improper use (28). These misconceptions are widespread and are held not only by teens and young people, but by parents, law enforcement officers, and the public in general. It is essential for people to be aware of the danger of their medications being passed on to others, and of the risk involved with misuse of those medications. To end the common occurrence of prescription drug-sharing, people must come to view misusing prescription medications as a practice that is just as potentially addictive and dangerous as illegal drug use. Just as wearing a seatbelt is now a recognized public safety measure, so should the locking up and proper disposal of prescription medications become an assumed part of U.S. cultural practices.

Advocacy organizations from the family, anti-drug, and environmental communities, as well as federal and state governments, must develop and implement public education initiatives to change the cultural norm and teach the public that prescription medications must be used only as prescribed, safely stored, and properly disposed of. Prescribers and pharmacists should reinforce these messages when they interact directly with patients to write or fill prescriptions. Given the high prescription drug abuse rates among adolescents (29), consistent drug abuse prevention programs also must be implemented in schools. Prescription drug abuse prevention should be integrated into the curriculum of health, science, math, and physical education classes throughout the school year and should start in earlier grades, middle school at latest.

Commendable national initiatives have already begun. The ZeroDeaths.org campaign calls consumers’ attention to six principles to help reduce unintentional overdose deaths from prescription medications (30). Also, the U.S. Drug Enforcement Administration (DEA) has opened a toll-free international hotline where any person suspecting illegal sale and abuse of pharmaceutical drugs can call anonymously to report it. The number, 1-877-Rx-Abuse, is also open for anyone with information about suspicious Internet pharmacies, especially families who have lost a loved one because he or she obtained prescription medications over the Internet. People can make a report online through the DEA webpage as well (31).

Academic Doping
With the advent of academic doping at colleges and universities, members of the higher education community must become well-informed on the issue of prescription drug abuse. More students are taking medications such as Ritalin® and Adderall® without a medical need or prescription, with the intent of enhancing their concentration or improving their performance on a paper or test to compete in school (32). As this misuse becomes more prevalent, a creeping normalcy is taking hold on campuses, with students claiming that it is just “something people do.” The misconception mentioned earlier, that prescription medications are inherently safe, plays a role as well.

The higher education community must act on this growing problem of academic doping. The use of medication without a prescription must be incorporated into university academic integrity policies and subject to consequences as a form of cheating.

VI. Safe Storage
A heightened public awareness of prescription drug abuse could help reduce medication-sharing among family and friends. Many teens who abuse medications, however, steal pills from the medicine cabinets of parents, other family members, or friends without their knowledge. A 2006 study found that more than three in five teens say prescription pain relievers are easy to get from parents’ medicine cabinets, and over 50 percent of teens say pain relievers are “available everywhere” (27). Education efforts focused on the community also must emphasize the safe storage and disposal of prescription medications to prevent theft and misuse. Public opinion must be changed to adopt a cultural norm more like that of Germany, where people commonly keep medications locked up, and there are few problems with children and teens accidentally or purposely taking parents’ medications (personal correspondence, Albert Kern, German Federal Ministry of Health, July 4, 2008).

Parents and others legitimately using prescription medications must employ precautions such as taking regular inventory of their pills and locking their medicine cabinets. The national Lock Your Meds campaign, sponsored by the National Family Partnership, educates parents on safe storage practices and encourages them to use word of mouth to compel others in their community to also take action. The National Family Partnership offers parents tips for protecting their children from prescription drug abuse (33) and useful resources, such as a home medicine inventory card (34). Other advocacy organizations and federal and state governments must undertake similar public education initiatives to ensure that the locking of medicine cabinets becomes standard practice nationwide.

From a policy perspective, the issue of prescription medication storage parallels the 1990s issue of gun violence and the initiatives to encourage gun owners to lock up their weapons. The success of those efforts, so that it is now commonplace for those legally owning guns to use safety locks or locked cabinets, shows that it is possible to effect a change in the U.S. cultural norm. The comparison is encouraging, as prescription drug abuse prevention is a less controversial societal issue than gun violence prevention. In the past, parental behavior has changed often as a result of public policies on safety, such as in the use of seatbelts, bicycle helmets, and child car seats. Changing behavior to lock up medications should be no different.

Safe storage options include medicine cabinets designed with a lock, lockboxes that can be screwed into the medicine cabinet, and small standalone safes or lockboxes. Lockboxes are readily available at retail stores, but not in pharmacies – the point of sale of pharmaceutical drugs, where consumers are most likely to remember the need for the item. Pharmacies must routinely stock lockboxes and encourage consumers buying over-the-counter or prescription medications to purchase one.

Purchase of a separate lockbox could be avoided entirely if medicine cabinets had a locking capability; most cabinets currently do not. Bathroom fixture manufacturers and home builders must make locking medicine cabinets standard in every home.

VII. Responsible Disposal
Most Americans are aware that they should not throw used car batteries in the trash or pour motor oil down the drain. This awareness is due in large part to public policy, consumer education, and efforts by businesses and constituency groups to educate the public that these practices are harmful. Careless disposal of prescription medications also is harmful, and can serve as a source for individuals who seek to divert pharmaceuticals to inappropriate uses, i.e., prescription drug abuse; similar efforts must be undertaken to teach people how to dispose of their unused medications properly.

People often incorrectly dispose of pills by flushing them down the toilet, which poses an environmental hazard and threat to drinking water, or by simply throwing them away in the bottle, which may permit diversion, in addition to unknown ecological consequences. The misconception that prescription medications can be flushed to safely dispose of them has led to the contamination of drinking water in many areas with low levels of multiple medications, including hormones, anti-depressants, and antibiotics. A 2008 investigative report by The Associated Press found that levels of such drugs could be detected in the drinking water supplies of 17 major metropolitan areas (35). No sewage treatment systems are capable of filtering out pharmaceutical materials; landfills and incinerators release substances from medications into the environment as well. It is not known what health effects the ongoing exposure to small amounts of these drugs may be causing.

The U.S. government, the pharmaceutical industry, medical practitioners, and waste disposal authorities have yet to develop a consistent message or systematic method for consumers to properly dispose of pharmaceutical products. The only advice on disposal currently available to consumers is to mix old medications with cat litter or coffee grounds to make them unpalatable before throwing them away. The U.S. Food and Drug Administration, the U.S. Drug Enforcement Administration (DEA), and the U.S. Environmental Protection Agency – under the coordination of the Office of National Drug Control Policy – must improve this rudimentary, insufficient approach.

Patients are not the only ones left with extra or unwanted medication. Pharmacies, hospitals, hospices, and wholesalers also need to dispose of their recalled or expired pharmaceutical products. In a process known as reverse pharmaceutical distribution, DEA registrants can return medications for potential credit from the manufacturer (36). A number of third-party companies also are registered with the DEA to operate as reverse distributors; they collect the medications and then either send them to the manufacturer or incinerate them (37,38). Consumers, however, are unable to use this system, as the Controlled Substances Act (CSA) prohibits reverse distributors from accepting prescription medications that are controlled substances from consumers who are non-DEA registrants (38).

Small take-back programs for prescription medications, by which consumers can give back their old and unwanted medication, exist in the states of Washington, Maine, Oregon, and California, and in a number of localities (39). The administration of these programs is challenging, though, as systems are not often in place to ensure proper disposal, and there is a substantial risk of diversion due to the large number of individuals involved. One-day prescription medication collection events that are held in some areas, similar to hazardous waste pick-up days, may not be sustainable because they rely on the availability of volunteers and local law enforcement.

To solve this complex problem, CLAAD calls on the DEA to create and administer a national program for medication take-backs from consumers that is easily accessible, uses current infrastructure, tracks the data, and is adequately funded. Unlike in smaller take-back programs, the DEA has the process controls available to ensure the prescription medications are not diverted and are properly disposed. A precedent already exists for an exception to the CSA rule, whereby a reverse distributor can accept from a consumer controlled substance products that are on manufacturer recall (39). The DEA should modify the CSA to allow reverse distribution of any type of unused and expired medications from consumers, based on the existing model for taking back medications that need to be recalled.

Such a program would be greatly beneficial but would require a funding mechanism. Consumer motivation to participate is also a challenge. A take-back program would have to be coupled with strong public education efforts on the importance of safe, environmentally conscious medication disposal. A buy-back program or providing pharmacy coupons in exchange for the unused medication could offer an incentive.

While a reverse distribution program would move old and expired medications out of the reach of potential abusers, it still would not address the issue of final disposal of pharmaceutical products. Government has a responsibility to find a viable solution for this woefully overlooked public health risk. Some reverse distributors are using the incineration of take-back medications to generate energy (40); incineration, however, still releases small amounts of the substances into the air. Environmental organizations and community health advocacy groups must join the effort to modify the CSA to permit national medication take-backs and to develop safe environmental standards for the products’ subsequent disposal. A multi-sector, national policy framework must be developed for prescription medication disposal that prevents environmental contamination as well as prescription drug diversion, abuse, and their public health consequences.

VIII. Research
The policies and practices described above will make an excellent start to addressing the complex issue of prescription drug abuse in a balanced way. Moving forward, however, these policies must be built upon the results of ongoing research into the problem. As noted earlier in this paper, significant research is clearly still needed in many areas of prescription drug diversion and abuse. The long-term need to balance legitimate access to needed medications with the prevention of their diversion and abuse makes careful research and expert input from many invested parties imperative. Government, the private sector, researchers, advocacy groups, and citizens must continue to collaborate to identify and implement optimal solutions that address this public health threat. Only by compiling the following research can invested parties identify best practices and further refine this comprehensive plan.

By developing evidence-based interventions utilizing data about motives for inappropriate use, methods of diversion, and sources of diversion, we can effectively address prescription drug abuse as a public health problem (41). First, research into the differing motives for the improper use of prescription medications is essential to our understanding of the issue. Future NSDUH surveys should seek to separate its general category of nonmedical use into more specific motivation groupings, such as to get high, to self-medicate, or because the individual cannot stop using, among a number of other motives. Several other scientific terms and types of improper use are incorporated into NSDUH’s general terminology, including recreational use, extramedical use, accidental addiction, addiction, and iatrogenic addiction; these should be separately documented. More documentation is especially needed on the incidence of academic doping, an increasingly common phenomenon. By clarifying people’s reasons for illicit use, invested parties can identify and tackle the most common motives for prescription drug abuse as well as develop strategies geared toward addressing each grouping in the most effective way.

Uncovering trends in motives also may reveal a sector of society that is being undertreated for pain and, therefore, driven to find relief through other means. Large, methodologically rigorous, and well-controlled prospective studies should be conducted to determine the rates of opioid misuse and abuse among chronic pain patients. Accidental dependence and addiction to prescription pain relievers also should be studied, along with unintentional opioid-related poisoning deaths. These studies will help to elucidate the interconnection of opioid misuse and legitimate pain care. More studies also are needed to document the undertreatment of pain among various age, gender, and racial/ethnic groups.

Quantifying diversion also is necessary to appropriately direct resources to address the problem. Data must be systematically compiled to determine how many pills are diverted through thefts and losses from the supply chain, the Internet, international smuggling, prescription forgery, doctor shopping, and patients selling or sharing their medication. The Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health (NSDUH) definitions and questions must be improved so that the data provides an accurate estimate of how many prescription opioid dosage units are ingested per year. This number should also be broken down into dosage units for the various means of diversion.

Electronic prescribing and prescription tracking systems offer great potential to reduce fraud, doctor shopping, and other types of diversion; as these systems are implemented more extensively in the U.S., however, we must evaluate the impact of their use. To address critics’ concerns and to continue to improve Prescription Monitoring Programs (PMPs), these programs’ effect on the incidence of drug diversion and abuse must be evaluated. Research must focus on the effect of PMPs on physician prescribing, exploring whether PMPs reduce prescribing due to prescribers’ regulatory concerns. In addition, researchers must evaluate the effect of PMPs on patients with a legitimate medical need for prescription medications that are controlled substances. Based on this research into PMP outcomes, states must modify these monitoring systems to reduce any adverse effect.

The long-term feasibility of a nationwide PMP network and an interlinked patient identity tracking system must be investigated as well. An evaluation of feasibility must include a calculation of the associated costs of a large amount of data-hosting, implementation of the necessary privacy and security infrastructure, and access for all prescribers and pharmacists. These studies will aid in developing a system that is affordable and feasible for prescribers, pharmacists, states, and the federal government.

In the realm of medical treatment, more research is needed, both into technological developments and best practices in prescribing medications with abuse potential. Following the example of universal precautions that was established in the 1980s for blood and bodily fluids, today’s medical community should implement universal precautions in prescribing through professional discourse. Careful research should help to refine the standards of care and best practices that are applied universally to all patients. Researchers can develop and implement a universal precautions pilot program in order to evaluate these new practices and identify areas that need improvement.

The growing field of pharmacogenomics research must include significant attention to pain management as it moves forward. Pharmacogenomics is a branch of pharmacology that seeks to develop treatments that are based on an individual’s genetic responses to various medications. Research in this field will allow practitioners to develop individualized, targeted approaches to pain treatment (42). Through pharmacogenomics, practitioners will be able to assess patients’ likelihood for physical dependence and abuse based on their genetics and the type of medication to be used. Prescribers also will be able to select the type of medication that is most likely to be effective in treating a patient’s pain.

Researchers must seek to develop alternative methods of pain relief delivery, such as pain-relieving medications and advanced dispensing systems that can meet patients’ needs while deterring abuse. One such product under development, GW Pharmaceuticals Limited’s Sativex®, utilizes cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) that act on specific receptors in the brain to provide pain relief without producing significant psychotropic effects (43). Future research should focus on further developing such medications. In addition, the pharmaceutical industry must focus on researching and developing new abuse-deterrent opioid formulations. The private sector must cooperate with the medical community to design advanced dispensing mechanisms that reduce the potential for abuse. The pharmaceutical industry, along with the medical community, must collect and analyze outcomes data related to the effects of novel medications and advanced dispensing mechanisms on the individual level as well as the societal level.

Finally, invested parties must raise awareness in multiple sectors of society about the problem of prescription drug abuse. Researchers can further demonstrate the significance of this problem by assessing the societal costs of prescription drug misuse and abuse in detail. Pilot programs and preliminary data on educational interventions geared toward law enforcement, the medical community, and patients and parents can help researchers to develop the best techniques for reaching different sectors of society. For example, outcomes data on public awareness interventions that focus on the securing and disposing of medications in the home will help researchers to develop further initiatives.

Summary and Conclusion
The involvement required from multiple sectors of society in implementing many of CLAAD’s recommended policies demonstrates that extensive collaboration will be necessary among government and other invested parties to effectively deal with the issue of prescription drug abuse. The U.S. Drug Enforcement Administration (DEA) and other government agencies must seek novel, creative approaches to dealing with this urgent problem. For example, a nationwide take-back system for consumers’ prescription medications would require the DEA to pair with reverse distributors to implement the program nationally, with invested non-profit organizations to use a variety of media for a wide-scale educational push, and with the retail sector to distribute coupons or other incentives.

Multi-sector collaboration, though challenging, is the only way to effectively deal with the complex issue of prescription drug abuse while ensuring the well-being of patients who legitimately need these medications. Policies must reflect that just as anyone can suffer from pain, anyone can also be susceptible to prescription drug abuse. In the future, maintaining the principle of balance between legitimate access and abuse prevention will help the United States make strides towards significant public health improvements, both by better serving pain patients and by deterring potential prescription drug abusers more effectively.

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.

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