Abstract
This chapter provides an overview of the policy and legal environments in which practitioners must function when providing treatment for patients with pain, including when the pain is related to noncancer conditions. The authors describe relevant content of federal laws representing the medication distribution system, such as requirements of practitioner prescribing, as well as state laws and regulatory policies governing health care practice for pain care. Central to this description is the practitioner’s role in providing adequate pain relief while mitigating harms associated with the inappropriate or illicit use of prescribed medications, including considering the role of diversion as a potential contribution to medication-related harms. Practitioners are encouraged to become familiar with, and maintain an understanding of, applicable laws and policies as a means to better achieve these dual outcomes. Knowledge of litigation relevant to pain management also can inform clinical decision-making and patient care by providing examples of the manner in which courts interpret and apply such things as statutes, regulations, constitutional principles, and clinical practice guidelines. Legal cases involving pain management are presented from the four primary domains of law: administrative proceedings, civil litigation, criminal litigation, and constitutional cases. Together these cases offer valuable insights into the legal dimensions of prevailing professional standards for pain management practice. Discussion of these cases also endeavors to highlight the evolution of case law as the sociopolitical climate regarding pain management in general, and opioid analgesia in particular, has influenced the practice of pain medicine over the last several decades.
Keywords
diversion, federal law, litigation cases, opioid analgesics, professional standards, state policies
The legal and regulatory landscape of pain management has, perhaps unsurprisingly, continued to be shaped (critics might say distorted) by what can plausibly be characterized as “the politics of pain.” Over the last decade there has been the convergence of two “perfect storms” in the domain of pain management. According to an Institute of Medicine report, there continue to be many patients in the health care system who do not receive adequate pain relief. Yet there is also compelling evidence that there has been a substantial increase in recent years in deaths from prescription drug overdose. Physicians who care for patients with pain have vociferously expressed their concerns that, in attempting to fulfill their professional responsibility to patients, these laws and litigation (civil, criminal, and administrative) place them between the proverbial “rock and a hard place” or “damned if they do and damned if they don’t.” A gulf between practice standards (established by laws, clinical practice guidelines, and legal determinations) and actual clinical practice continues to persist, perhaps due, in part, to the fact that most pain management is provided by primary care physicians rather than pain medicine specialists who are primarily involved in formulating such standards. In this chapter, we provide an overview of the policy and legal environment that informs pain care.
Laws and Policies Affecting Pain Management
Legislative bodies typically create laws (i.e., statutes) that are broad and general, and depend on the relevant regulatory agency to interpret and implement the laws. For medicine, the legislature grants authority to the state medical board to operationalize and uphold its laws through regulation. Such professional boards generally have updated their pain management policies in reaction to changing professional standards. Alternatively, pain-related statutes do not as consistently keep pace with advances in medical and scientific understanding.
The purpose of this section is to review relevant legislative and regulatory policies governing the treatment of pain, including opioid analgesics. Of course, a variety of therapeutic modalities (both pharmacological and nonpharmacological) are required for a comprehensive approach to pain management for cancer, HIV/AIDS, or other more chronic conditions, including interventional techniques, nerve blocks, acupuncture, psychological interventions, and nonopioid analgesics. Many of these treatments are discussed throughout this textbook. However, practitioners generally do not receive training in legal and regulatory issues related to opioid prescribing, and are not familiar with the federal and state laws that govern their practice. Nevertheless, they are increasingly being called on to have knowledge of the policies under which they practice.
Federal Controlled Substances Laws
Controlled substances laws govern the distribution of prescription medications that have an abuse liability (i.e., that fulfill the potential to produce psychological or physical dependence), and which the Food and Drug Administration (FDA) have approved for medical use. The federal Controlled Substances Act (CSA) is the principal drug control law in the United States, and establishes a closed distribution system to minimize the substances’ trafficking, abuse, and diversion.
The CSA is designed to prohibit the nonmedical use of controlled substances and establishes criminal penalties for their illicit possession, manufacture, and distribution, while at the same time recognizing that they have a useful and legitimate medical purpose, and that they are necessary for public health. “Controlled substances” status of any medication is not meant to diminish its medical usefulness or create the perception that practitioners should avoid its use when it is clinically justified. The legislative history, as well as the language contained in the CSA itself (which is implemented through its related regulations called the Code of Federal Regulations [CFR]), makes it clear that efforts to prevent drug abuse and diversion should not interfere with legitimate medical practice and appropriate patient care. This position conforms to a long-standing medico-legal principle, referred to as “Balance,” which was established by the Single Convention on Narcotic Drugs of 1961.
The CSA specifies five classification schedules for controlled substances, each carrying different penalties for unlawful uses. Both a drug’s medical usefulness and abuse liability form the basis for the decision to assign it to a particular schedule. Schedule I controlled substances (e.g., heroin, LSD, and ecstasy) have no currently accepted medical use, no accepted safety for use under medical supervision, and a high potential for abuse, and are available only for scientific research. Controlled substances that have an FDA-approved medical use are placed in Schedules II through V according to the potential for abuse ( Box 45.1 ). For example, on October 6, 2014, hydrocodone-combination products were reclassified from Schedule III to Schedule II of the CSA. As a result, Schedule II now contains single-entity hydrocodone products as well as those of hydrocodone combined with acetaminophen, aspirin, or ibuprofen. Under federal law, the Drug Enforcement Administration (DEA) is the primary federal agency responsible for enforcing the CSA and, thus, has regulatory authority over controlled substances in every schedule.
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Schedule II medications have the highest potential for abuse, and include opioids such as codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, and oxycodone.
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Schedule III medications have a lower abuse potential than Schedule II drugs, and include opioids such as dihydrocodeine combinations with aspirin and paracetamol, and codeine combinations with aspirin or acetaminophen.
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Schedule IV medications have a lower abuse potential relative to drugs in Schedule III, and include opioids such as dextropropoxyphene, pentazocine, and tramadol.
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Schedule V medications have a lower abuse potential compared to drugs in Schedule IV and include compounds or preparations containing limited quantities of opioids such as codeine or opium, which may be used for over-the-counter preparations to treat cough or diarrhea, respectively.
Licensed practitioners must be registered with the DEA to prescribe, dispense, and administer controlled substances. To minimize harm to patients and to protect the public health, conditions of registration involve, among other things, adhering to statutes and regulations that limit medication availability to legitimate medical uses and patients ; incorporating into practice safeguards against diversion ; and reporting to the DEA the medication amounts that are lost or stolen. Prescriptions for controlled substances must be issued only for legitimate medical purposes and in the usual course of professional practice. Prescriptions for Schedule II medications may not be refilled, while five refills are permitted for medications in Schedules III and IV. Federal law allows oral authorization of prescriptions for Schedule II controlled substances in medical emergencies if certain requirements are met. It is also possible under federal law to partially dispense or fax prescriptions under specific circumstances. Importantly, in 2010 the DEA issued an interim final rule, including a request for comment, to revise the CFR to provide practitioners with the option of electronically writing prescriptions for controlled substances. The regulation became effective on June 1, 2010. According to the DEA, the new regulations:
“…will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.” (p. 16236)
Federal law was also recently developed in recognition of the need for more controlled substance disposal options, as a means to reduce the volume of unused medications and, ultimately, curtail opportunities for diversion. The CFR was changed, effective October 9, 2014, to permit certain DEA-registrants to become “collectors” of controlled substances for the purpose of destruction using a number of specified methods. Under the new regulations, manufacturers, distributors, reverse distributors, opioid treatment programs (OTPs), hospitals/clinics with on-site pharmacies, and retail pharmacies can volunteer to be registered as a collector. In addition, a registered hospital/clinic with an on-site pharmacy or a retail pharmacy can be a collector to maintain a medication drop box at long-term care facilities (LTCFs), to dispose of medications from residents of those LTCFs. The regulation also permits law enforcement to voluntarily conduct collection activities for controlled substances through a variety of methods (e.g., take-back events and mail-back programs). Importantly, however, practitioners cannot be designated as a collector and, therefore, have no more disposal opportunities than previously (e.g., medication transfer to a reverse distributor or delivery to a DEA agent). It would be beneficial for practitioners to at least have access to a current list of volunteer collectors so that they could inform their patients about a greater array of disposal options, to reduce the volume of unused medications possibly entering into the illicit market.
In addition to these policy developments, other provisions demonstrate that federal drug control laws are not intended to interfere with medical practice or limit the availability of controlled medications for patient care.
Assuring Medication Availability
The CSA authorizes the DEA to establish production quotas for a number of opioids and other controlled substances as a means to curtail diversion resulting from excessive unused supplies. Such quotas, however, are meant to maintain sufficient supplies for accommodating all medical and scientific needs. Although a recent US Government Accountability Office (GAO) report has identified a notable increase in shortages of controlled medications in recent years, officials from the DEA and the FDA are now working to update a shared memorandum of understanding to prevent future shortages.
Medical Practice Is Not Regulated
The authorization to regulate medical practice belongs to the states and underlies the medical practice acts that are designed to protect the public health and safety. Thus, the CSA provides no authority for the DEA to define or regulate medical practice. The DEA’s enforcement authority is intended to relate to clinicians involved in unlawful distribution of controlled substances that is outside legitimate health care practice (i.e., behaviors that are clearly criminal).
Treating Addiction Versus Treating Pain
Under federal law, it is unlawful for a practitioner to administer or dispense (but not prescribe) methadone or administer or dispense (including prescribe) buprenorphine to treat addiction unless separately registered by the federal government as an OTP for the purpose of maintenance or detoxification of opioid addiction, and is in compliance with regulations governing such treatment. However, methadone, a Schedule II medication approved for the purpose of addiction treatment, can be prescribed as an analgesic according to the same laws for prescribing any other Schedule II opioid. In addition, the CSA and the CFR place no prohibitions on the use of opioids to treat pain in a patient who has a history of substance use or a current addictive disease, although such practices may be addressed in state law. Critically, determining the legitimacy of a particular prescribing practice must be based on the purpose of the prescribing and not solely the type of patient being treated.
Prescription Amount and Duration
Federal laws do not set limits on the amount or duration of medication that a practitioner can prescribe, administer, or dispense at one time. Importantly, the DEA clarified that this standard did not change when the CFR was amended to allow practitioners to issue multiple prescriptions of a Schedule II controlled substance, each issued on the same date and filled sequentially (called a “prescription series”). With the CFR amendment, the DEA’s stated intent was to permit health care professionals to better manage chronic pain in stable patients while exercising improved control over potential medication abuse and diversion, which is consistent with the principle of balance.
State Controlled Substances and Health Care Laws
Both federal and state laws govern the prescribing, dispensing, and administering of controlled substances. However, only states have the authority to regulate health care practice, including medical, pharmacy, and nursing practice, and such regulatory policies can be used to address concerns that professionals hold about investigation or sanction for prescribing pain medications. Unlike federal law, state laws generally do not recognize that controlled medications are important to public health. Some state laws also consign more frequent restrictions than do federal laws regarding the prescribing and dispensing of opioids, which ultimately can hinder medical decision making that should be based both on the expertise of the practitioner and the individual patient needs. The messages and requirements contained in state policies that govern health care practice, including opioid prescribing, has been shown to influence clinical care decisions. As a result, state policy content must be considered a necessary part of a multifaceted plan to improve pain and symptom management, while at the same time stemming prescription medication abuse and diversion.
Evaluating the Quality of State Pain Policy
Since the early 2000s, a criteria-based policy research methodology has existed to evaluate and promote more balanced state drug control and health care regulatory policies related to pain management, including for palliative care and end-of-life care. As indicated earlier, balanced state policies maintain drug controls and avoid undue restrictions to appropriate health care practice and patient care, and will support pain treatment, including the use of controlled substances when warranted, as an essential part of quality medical practice. Although separate efforts are necessary to assess the presence and effectiveness of current state-level drug control frameworks to minimize abuse and diversion, the purpose of this evaluation has been to characterize pain-related issues covered in state policies.
The evaluation uses 16 criteria from two categories: (1) positive provisions—policy language that can enhance pain relief; and (2) negative provisions—language that can impede pain relief. Periodic reports have been developed containing a complete description of the criteria, the evaluation methodology, and the identified policy language from all states (including the District of Columbia) that satisfies each criterion. State policy evaluations have been conducted periodically since 2000. The findings presented in Table 45.1 represent policies in effect by the end of 2015, which is the most recent year to date for which policies were evaluated.
| Positive Provisions: Criteria That Identify Policy Language With the Potential to Enhance Pain Management | |
| 1. | Controlled substances are recognized as necessary for the public health (in 4 states) |
| 2. | Pain management is recognized as part of general medical practice (in 45 states) |
| 3. | Medical use of opioids is recognized as legitimate professional practice (in 51 a states) |
| 4. | Pain management is encouraged (in 40 states) |
| 5. | Practitioners’ concerns about regulatory scrutiny are addressed (in 39 states) |
| 6. | Prescription amount alone is recognized as insufficient to determine the legitimacy of prescribing (in 32 states) |
| 7. | Physical dependence or analgesic tolerance are not confused with “addiction” (in 38 states) |
| 8. | Other provisions that may enhance pain management Category A: Issues related to health care professionals (in 47 states) Category B: Issues related to patients (in 44 states) Category C: Regulatory or policy issues (in 50 states) |
| Negative Provisions: Criteria That Identify Policy Language With the Potential to Impede Pain Management | |
| 9. | Opioids are relegated as only a treatment of last resort (in 0 states) |
| 10. | Medical use of opioids is implied to be outside legitimate professional practice (in 6 states) |
| 11. | Physical dependence or analgesic tolerance are confused with “addiction” (in 12 states) |
| 12. | Medical decisions are restricted Category A: Restrictions based on patient characteristics (in 5 states) Category B: Mandated consultation (in 7 states) Category C: Restrictions regarding quantity prescribed or dispensed (in 1 state) Category D: Undue prescription limitations (in 2 states) |
| 13. | Length of prescription validity is restricted (in 2 states) |
| 14. | Practitioners are subject to additional prescription requirements (in 6 states) |
| 15. | Other provisions that may impede pain management (in 0 states) |
| 16. | Provisions that are ambiguous Category A: Arbitrary standards for legitimate prescribing (in 14 states) Category B: Unclear intent leading to possible misinterpretation (in 14 states) Category C: Conflicting (or inconsistent) policies or provisions (in 5 states) |
Overall, policy language that promotes the concept of appropriate pain management and that maintains patient access to pain care opportunities is common in policies from state regulatory agencies, rather than from legislative drug control statutes. A state’s drug control laws often focus on the abuse potential of controlled medications to the exclusion of recognizing their public health and medical benefit when used as directed for legitimate purposes, unlike more positive provisions contained in federal law (see, e.g., Refs. and ). It has been, and continues to be, possible to adopt state policies designed to prevent drug abuse and the transfer of medications to an illicit distribution system without creating additional requirements that unduly restrict health care decision making, that conform to and do not conflict with current standards of professional practice, and that eschew imposing excessive burdens on patients. Indeed, many of the policy actions identified in these reports reinforce state governments’ willingness to work collaboratively to avoid unduly restricting access to controlled medications for the people who need them while taking precautions against activities that could contribute to patient or public harm. Such an approach corresponds to the continued call from international and national authoritative bodies (representing legal, regulatory, and health care communities) to reduce the misuse, abuse, and diversion of prescription medications, while at the same time addressing inadequate treatment for debilitating pain (see, e.g., Refs. ).
Grading the Quality of State Pain Policy
Findings from each criteria-based evaluation of state pain policy also has served as the basis for a methodology to quantify a state’s policy based on its quality, creating a single metric that can then be used to compare all states and track policy change over time. In the last report, grades (ranging from A to F) were calculated for the state policies in effect in 2015. A higher grade means a state’s policies has many positives and few negatives and is, therefore, more balanced in relation to appropriate pain management. An “A” is achieved only if a state has a high number of positive provisions and no instances of unduly restrictive or ambiguous language. A lower grade is associated with the presence of provisions that contradict current medical knowledge, are inconsistent with policy guidance recommendations from authoritative sources, or fail to communicate the appropriate messages about pain management to professionals, patients, and the public. An “F” results when a state has abundant negative provisions and no positive language.
The grades, and the methodology used to calculate them, are contained in a recent report that is available at www.acscan.org/painreportcard . In the aggregate, the last decade was a time of notable improvement in the quality of many states’ drug control and professional practice policies. This policy change seems to represent continued progress in response to evolving national and state acknowledgment that adopting positive policies governing health care practice and patient care is part of improving pain treatment for patients with cancer, HIV/AIDS, and other diseases or conditions. By and large, states avoided adopting new policies that could impede pain management and the medical use of controlled substances when clinically justified. Members of government and regulatory agencies, as well as health care professionals, are in a position to continue seeking policy approaches that eschew undue restrictions on medical decision making or unintentional consequences on pain treatment.
Much of the improvement in the quality of state pain policies results from individual health care regulatory boards taking advantage of the Federation of State Medical Boards’ (the Federation’s) policy templates to promote consistency in state medical board policy. Throughout the templates, the importance of documenting various aspects of treatment is mentioned. These templates also encourage safe and effective pain relief, perpetuate the message that pain management and the appropriate use of controlled substances is an accepted part of professional practice, and reassure clinicians that they have nothing to fear from their licensing agency if reasonable professional practices are followed when using controlled substances for patient care. In addition, the policies promote the assessment of both potential benefits and risks when considering opioid treatment, especially for patients with more chronic conditions. Patient risk assessment, as well as the periodic monitoring for adverse events and the manifestation of abuse-, addiction-, and diversion-related behaviors, have been an explicit component of the Federation’s templates since their inception ; in fact, the clinical need for risk stratification strategies was emphasized even more in the most recent policy issued in 2013. Importantly, health care regulatory boards (e.g., medical, osteopathic, pharmacy, and nursing) in many states have worked together to adopt joint guidelines for pain management, palliative care, or end-of-life care. Such policies tend to emphasize the value of an integrative and multidisciplinary approach to treating pain; they recognize that the goal of pain treatment should include improvements in patient functioning and quality of life; and they assure that a broader variety of health care practitioners should not fear disciplinary action from their licensing board for practice that generally conforms to the included treatment standards.
Given this notable regulatory progress, most states now can focus on maintaining policy improvement and consider efforts to remove long-outdated restrictive or ambiguous language from law, some of which has been present for almost 40 years. This is especially the case with drug control laws that contain outdated definitions of “drug-dependent person” (or “narcotic-dependent person,” “addict,” “active addiction,” “narcotic addict,” or “habitué”) that are based on the concept of physical dependence and developing a withdrawal syndrome. Such definitions should be abrogated because they can legally classify any patient who is taking an opioid to treat pain as an addict. Repeal from law of archaic restrictive language has received less attention compared to the work of professional licensing boards to adopt positive policy. Although states must be allowed to vary in their approaches to public policy, the creation of undue restrictions is not obligatory in laws designed to control drug diversion or regulate professional practice. Avoiding such language ensures that patient care decisions requiring medical judgment are not overly limited by governmental laws.
The Importance of Practitioners in Improving State Policy
Inadequately treated pain is a multifactorial phenomenon and, as such, focusing solely on changing state policy is likely insufficient to guarantee better patient access to appropriate pain relief and symptom control. Addressing this single factor, however, often remains a necessary activity to attain a supportive professional practice and a regulatory environment for the appropriate treatment of pain. Adoption of state policies also requires broad dissemination and communication to relevant practitioners to help enhance compliance to the policy recommendations or requirements, since an evaluation of practice generally involves a determination regarding adherence to applicable policy.
Improving state policies covering pain-related issues requires a strategic approach, often beginning simply by determining the types of policies in need of improvement. For example, revising statutory law requires legislative activity, whereas changing regulatory policy involves engaging with the relevant health care administrative agency, such as the medical, pharmacy, or nursing board. Health care practitioners increasingly have assumed a leadership role in collaborating with legislators or members of administrative agencies to help construct state policy that avoids undue restrictions, recognizes the professional obligation to treat pain, and promotes effective patient pain care. This activity has been accomplished when practitioners have acted alone, in conjunction with a state pain initiative or other organization, or as a member of a legislatively created advisory committee.
Other Important Policies to Consider
Although the aforementioned policy evaluation reports synthesize the content of numerous state-level statutes and regulatory policies governing drug control and medical and pharmacy practice, as well as nursing practice for certain years, various other policy types fall outside the scope of the research but may nevertheless affect pain care. Such unevaluated policies include physician assistants practice, controlled substances scheduling, advance directives or living wills, workers’ compensation, institutional (including chain pharmacies) policies, and program grants to state agencies. Especially important also are the multitude of federal and state laws establishing standards for reimbursement of therapeutic interventions, covering such areas as prior authorization, drug formularies, medication synchronization, and abuse-deterrent formulations for opioid medications. Efforts to understand the positive and negative aspects of these policies, as well as the impact of such policy content on professional practice and patient care, are warranted. In addition, it is often important to be aware of the content of statutes being proposed in the state legislature but which have not yet become laws (i.e., bills). Some recent bills have been designed with the objective of improving public health and safety by reducing prescription medication abuse and diversion, but may inadvertently establish barriers to the availability of medications needed by people who use them therapeutically for pain relief and to maintain quality of life (see http://sppan.aapainmanage.org/legislation ). Coordinated responses to introduced legislative bills, and to proposed regulatory policies whenever possible, provide opportunities to make policy makers aware of potential unintended consequences. Engagement with legislators and regulators during policy development can effectively reduce the prospect of future policy impediments.
One of the most prevalent policies recently promoted to reduce opioid-related overdoses and other harmful consequences is dosing thresholds based on daily cumulative morphine milligram equivalence (MME) amounts. At this time, most of the thresholds are limited to the treatment of patients with chronic noncancer pain. These thresholds have been described as “a precautionary signal to get the prescriber to press pause before moving forward with dose escalation.” When the dosage threshold is met or exceeded, prescribers are then recommended to obtain an expert consultation (see, e.g., Ref. ). Beginning in 2007 in Washington, with a recommended 120 MME threshold established in clinical practice guidelines, some states (including Washington) eventually established such amounts in law (see, e.g., Ref. ). Now that these dosage amounts are imposed by laws, there is a legal liability established for failing to comply with the requirements. This concern is especially relevant in a state like Maine, which, in 2016, adopted a 100 MME amount for treating chronic pain that, for all intents and purposes, cannot be exceeded.
In addition to the dosing equivalence threshold itself, the American Academy of Pain Management (now the Academy of Integrative Pain Management) has identified a number of provisions from the Washington policy, and therefore contained in similar policies adopted subsequently by other states, which could create ambiguity for practitioners attempting to follow the rules. Such provisions include (1) the use of a written prescriber/patient agreement for those judged to be at a high risk of substance abuse, have a history of substance abuse, or have psychiatric comorbidities; (2) the requirement of certain prescribers to obtain a consultation with a “pain management specialist” under certain circumstances, including exceeding the dosing threshold; and (3) the establishment of qualifications for prescribers who can serve as adequately prepared specialist consultants. It is possible, though, that practitioner confusion may relate more to an inaccurate understanding of the legal requirements, rather than to the requirements themselves. Indeed, policy can become a barrier to practice due equally to misunderstandings about policy requirements as from perceptions of legal liability based on actual policy content.
A recent commentary by Ziegler, however, has identified substantive concerns related to policies establishing dosage thresholds, such as the emphasis on potential harms only at higher dosage levels, the neglect of other factors contributing to harms, the errors in morphine equivalent conversions, and the lack of pain management specialists required for consultation. Given these considerations, there is a clear need to thoroughly assess the various reasons for practitioners’ concerns to determine appropriate next steps. This is especially feasible now since some of these policies have been in effect for a few years. Ultimately, the question remains: Will identified practitioner concerns be better addressed through changes (by any extent) to the laws or other regulatory policies, enhanced resources to aid implementation, or improving practitioners’ knowledge about the policy standards and promoting their clinical utility, or by a combination of approaches?
The Importance of Considering Diversion
Along with policy efforts to enhance benefits and minimize harms for pain treatments, drug control measures must be in place to reduce the potential for transferring prescription medications into illicit channels. Despite the preponderance of legislative and regulatory requirements governing the closed distribution of controlled medications, it remains possible for opioid analgesics to be diverted from all levels of the distribution system. Once diverted, they can become illegally available for sale and nonmedical use, which may result in harmful consequences, such as overdose and death. Indeed, using controlled medications without a valid prescription issued by a properly licensed practitioner for a legitimate medical purpose, or in ways that are contraindicated, compounds the risk of harmful effects.
To this end, health care professionals who prescribe opioid medications have a responsibility to protect public safety by avoiding unintentionally contributing to abuse and diversion. Some practitioners may prescribe or dispense more dosage units than medically necessary, which often remain unused and become susceptible to theft or perhaps accidental use by others. When such prescribing reaches a level or pattern considered “excessive,” it can further be designated as “unprofessional conduct” and make the practitioner vulnerable to license revocation or other civil penalties under law (see, e.g., Ref. ).
Patients receiving prescription-only controlled medications also share responsibilities under law, which has yet received little attention up to this time. Prescription labeling includes a warning for patients that it is a violation of law to transfer the medications prescribed for them to any other person. More generally, it is illegal under federal and state laws for any person to possess controlled substances, including opioid analgesics, without a valid prescription, as well as to acquire these medications by theft, fraud, or misrepresentation. Even when opioids are prescribed legitimately, but then are not stored securely in the patient’s home, they become susceptible to diversion through loss or theft. As a result, when attempting to mitigate diversion, learning that a person acquired an opioid from peers or family, for example, remains insufficient. Further investigation is necessary to determine the circumstances through which the opioid became available for nonmedical uses (e.g., through a dispensed prescription, through a forged prescription, or when medication is lost or stolen).
Since opioid medications are diverted from throughout the entire medication distribution system, including before they are prescribed, there are many potential sources feeding their use for illicit purposes. Examples of such activities include:
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Criminal diversions of large quantities are reported by manufacturers, distributors, and pharmacies
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Often involving armed robberies and night break-ins
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Criminal activities by organizations and individuals, including some patients, to obtain opioid analgesics unlawfully
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Thefts, including employee pilferage, occur from pharmacy supplies in nursing homes and hospitals
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Fraud and misrepresentation, such as “doctor shopping” or prescription form theft, forgery, or alteration
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“Script doctors” and “Pill Mills,” which are illegal activities by rogue physicians who still have the necessary authority to prescribe, or to purchase and dispense, controlled substances
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Misuse of Medicare and Medicaid drug coverage.
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It is essential, therefore, that efforts to reduce nonmedical drug use and diversion should include, but must be more comprehensive than, focusing on prescribing and dispensing practices and patient access.
As of today, little empirical evidence exists about the degree to which these numerous possible diversion sources play a role in prescription medication-related abuse, addiction, overdose, and death. However, an appreciation for the multiple determinants of diversion substantiates the benefit of a broad, multifaceted, approach to effectively address the nonmedical use of opioid analgesics. Such an approach is exemplified at a federal level by the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan, which was published in April 2011 and has been updated annually. The ONDCP’s Plan is a multiagency collaboration of federal, state, and local enforcement activities to enhance practitioner and public awareness about the risks and benefits of prescription medications; investigate the production of analgesics with less or no abuse liability; reduce pill mills, doctor-shopping or pharmacy-hopping; and reduce the volume of unused medications. The ONDCP’s collaborative and systematic strategy is auspicious, because it seeks to more comprehensively address the multiple means by which prescription medications can become available for illicit use, including through the practitioner/patient relationship. Such an approach, as well as broad policy initiatives now underway in some states, appropriately focuses on the intricate nature of the national public health problem of nonmedical drug use.
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