Prescription Drug Abuse
Released: 2016-02-23T00:00:00

Summary:
An estimated 6.5 million individuals currently abuse prescription drugs in the United States. Unlike policy on street drugs, federal policy on prescription drug abuse is complicated by the need to maintain access to prescription controlled substances (PCS) for legitimate medical use. The federal government has several roles in reducing prescription drug abuse.
Coordination. The Office of National Drug Control Policy (ONDCP) coordinates and tracks prescription drug abuse reduction efforts and funding of multiple federal agencies.
Regulation. The primary federal statutes governing prescription drug regulation are the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly called the Controlled Substances Act (CSA).
Law Enforcement. Federal law enforcement, primarily the Drug Enforcement Administration (DEA), aims to prevent, detect, and investigate the diversion of prescription drugs while regulating the supply for legitimate medical, commercial, and scientific purposes.
Health. Federal agencies and programs involved in health may address prescription drug abuse through service delivery (e.g., the Veterans Health Administration), financing (e.g., Medicare), and research (e.g., the National Institute on Drug Abuse).
The federal government, state and local governments, and various private entities (e.g., pharmacies) are currently undertaking a range of approaches to reducing prescription drug abuse.
Scheduling of PCS. The scheduling status of a PCS (1) affects patient access to PCS (e.g., by limiting refills); (2) affects the degree of regulatory requirements (e.g., supply chain recordkeeping); and (3) determines the degree of criminal punishment for illegal traffickers.
Safe Storage and Disposal. DEA regulates storage of PCS by registered entities (e.g., pharmacies); provides registered entities with options for proper disposal of PCS; and sponsors National Prescription Drug Take-Back Days to assist citizens in safe disposal of PCS.
Focusing Law Enforcement. Federal law enforcement efforts may focus on geographic areas with higher rates of prescription drug abuse or on High Intensity Drug Trafficking Areas (HIDTA) that experience a higher volume of illicit trafficking of PCS.
Using Data to Identify Risk. Most states operate prescription drug monitoring programs—databases of prescriptions filled for PCS. Other public and private entities also have data that may be analyzed to identify high-risk behavior among prescribers, dispensers, or patients.
Awareness and Education. Efforts to increase awareness and education about prescription drug abuse may focus on health care providers, patients, or the general public.
Treatment. Some prescription drug abuse may be avoided in treating underlying conditions (e.g., pain) or may be treated with pharmacologic or non-pharmacologic interventions. New products may improve treatment for both underlying conditions and prescription drug abuse.

subsections: section_title: Background
paragraphs: Prescription drug abuse has been described as an epidemic, with an estimated 6.5 million current prescription drug abusers—including 4.3 million abusing prescription pain relievers (opioids). On average, 44 people die from an overdose of a prescription painkiller each day in the United States. While prescription painkillers are not the only prescription drugs of abuse (see text box), they are the most commonly abused and receive the most attention from federal policymakers.
Federal policy on PCS aims to balance the need to limit abuse of prescription controlled substances (PCS) with the need to maintain access to PCS for legitimate medical use. The federal government's approach to addressing prescription drug abuse has increasingly relied on coordination across agencies, including both law enforcement and health agencies.
This report begins with a summary of recent efforts to address prescription drug abuse—focused on prescription painkiller abuse. The remainder of the report is organized in two parts: (1) federal roles in reducing prescription drug abuse and (2) current approaches aimed at reducing prescription drug abuse. Federal roles include coordination across agencies; regulation of drugs; law enforcement activities; and health services, financing, and research. Approaches to reducing prescription drug abuse include scheduling of PCS; safe storage and disposal; focusing law enforcement; using data to identify risk; awareness and education; and treatment. 
section_title: Recent Efforts by Congress and the Administration
paragraphs: Congress has demonstrated an interest in addressing the problem of prescription drug abuse (and particularly prescription opioid abuse) by holding hearings and introducing legislation taking various approaches to the problem. For example, the Comprehensive Addiction and Recovery Act of 2015 ( H.R. 953 , S. 524 ) would primarily authorize the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and the White House Office of National Drug Control Policy (ONDCP) to administer grants and require HHS to convene task forces. In contrast, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 ( H.R. 471 , S. 483 ) would primarily amend current law regarding registration to distribute or dispense PCS and require an inter-departmental report to Congress. 
The Administration has also made efforts to address the problem, including an HHS opioid initiative and a Presidential Memorandum requiring federal agencies to provide training in opioid prescribing to employees who prescribe controlled substances and to identify and address barriers to accessing medication-assisted treatment for opioid addiction. 
Both Congress and the Administration have directed funds toward reducing opioid abuse and overdoses. The Consolidated Appropriations Act, 2016 ( P.L. 114-113 ) includes some funding for opioid-specific programs, most of which is identified in the explanatory statement accompanying the act. For example, the agreement provides $25 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) to expand prescription opioid and heroin abuse treatment services in high-risk communities. The President's Budget for FY2017 proposes both mandatory and discretionary funding for HHS to address prescription opioid and heroin abuse, with an emphasis on expanding the use of medication-assisted treatment.
section_title: Federal Roles in Reducing Prescription Drug Abuse
paragraphs: The federal government works to reduce prescription drug abuse in a variety of roles, including coordination across agencies; regulation of drugs; law enforcement activities; and health services, financing, and research. This section provides an overview of these roles, along with references to other CRS reports that address some of these roles in more detail. 
subsections: section_title: Coordination
paragraphs: Multiple federal agencies participate in the mission to reduce prescription drug abuse—the White House Office of National Drug Control Policy (ONDCP) coordinates and tracks these agencies' efforts and related federal funding. In its 2014 National Drug Control Strategy (the Strategy), ONDCP identifies three policy priorities where the Administration believes there can be substantial progress over the short term; these priorities include reducing prescription drug abuse. In its prescription drug abuse prevention plan, Epidemic: Responding to America's Prescription Drug Abuse Crisis (published in 2011), ONDCP outlined how the federal government intends to address prescription drug abuse. The plan expanded upon the Strategy's action items that specifically addressed demand reduction. Some action items included additional training and education for physicians and pharmacists, improved drug disposal programs, enhanced prescription drug monitoring programs (PDMPs), and improved cooperation and information sharing among PDMPs.
Coordinated efforts involve (1) educating parents, youth, patients, and health care providers; (2) tracking and monitoring of prescribing activity; (3) developing prescription drug disposal regulations and programs; and (4) taking enforcement action against pain clinics and prescribers who improperly prescribe and dispense narcotics. A number of federal agencies are directly involved in these efforts, including the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA); in addition, the federal government financially supports some state prescription drug abuse prevention efforts. State efforts include the operation of prescription drug monitoring programs and participation in drug task forces.
section_title: Regulation
paragraphs: The primary federal statutes governing the regulation of prescription drugs are the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly referred to as the Controlled Substances Act (CSA). 
subsections: section_title: Federal Food, Drug, and Cosmetic Act (FFDCA)
paragraphs: The FFDCA gives the Food and Drug Administration (FDA) responsibility for ensuring the safety and effectiveness of prescription and nonprescription drugs sold in the United States, among other things. An agency within the Department of Health and Human Services (HHS), FDA regulates the full life-cycle of a drug product, starting with initial clinical trials (and sometimes before that), through the approval process, and then for as long as the product remains on the U.S. market. FDA activities that apply to all drugs—such as drug approval, labeling, and postapproval surveillance—can be tailored to the challenges of regulating PCS, where the risk of addiction may pose a safety concern. Other FDA activities—namely the work of the Controlled Substances Staff—are focused specifically on curbing prescription drug abuse. (See text box.)
FDA reviews each new drug application submitted by a drug manufacturer with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to ensure the drug's identity, strength, quality, and purity. Reviewers can consider abuse potential (and possibly deterrence characteristics) within any of these elements. FDA approval of a drug for marketing may include specific conditions, such as restrictions on distribution, labeling disclosures, or postapproval studies that the manufacturer must conduct after marketing begins. 
FDA may require a risk evaluation and mitigation strategy (REMS) under specified conditions—including if it determines such a strategy is necessary to ensure that the benefits of a drug (e.g., pain relief) outweigh its risks (e.g., potential for abuse). A REMS may include drug safety information for patients and health care providers, as well as elements to assure safe use (ETASU). An ETASU is a restriction on distribution or use that is intended to (1) allow access to those who could benefit from the drug while minimizing their risk of adverse events, and (2) block access to those for whom the potential harm would outweigh potential benefit. By including these restrictions, FDA can approve a drug that it otherwise would have to keep off the market because of the risk it would pose. 
As part of the approval process, FDA reviews the manufacturer's labeling, which must begin with a highlights section that includes, if appropriate, black-box warnings (so called because they are bordered in black to signify their importance). Regulations specify other required elements of labeling, including risk of drug abuse and dependence. The Food and Drug Administration Amendments Act of 2007 (FDAAA) added authority for the agency to require a labeling change upon learning of new relevant safety information. In September 2013, FDA announced that it would use that new authority to require changes to the labeling of extended-release and long-acting opioids used to treat pain. 
FDA postmarket drug safety and effectiveness activities address aspects of drug production, distribution, and use. In addition to REMS and labeling requirements, FDA addresses product integrity and supply chain security, adverse event reporting, surveillance (including the Sentinel program), information dissemination, off-label use, direct-to-consumer advertising, and postmarket studies. The Secretary may require a study or a clinical trial involving a drug that is already on the market based on newly available information. In September 2013, FDA announced several studies it was directing the manufacturers of extended-release or long-acting opioid analgesic drugs to conduct.
FDA has a task force focused on combatting abuse of opioid pain relievers at various points throughout the drug life cycle described above. (See text box.)
In February 2016, FDA announced an opioids action plan, under which the agency will expand the use of expert advisory committees regarding approval of opioid products that do not have abuse-deterrent properties and pediatric opioid labeling; change labeling for immediate-release opioids; increasing manufacturers' postmarket data requirements; update an existing REMS; issue draft guidance on approval standards for general abuse-deterrent formulations; review options to increase access to naloxone (a drug that can reverse opioid overdose), support opioid prescribing guidelines, and "facilitate development of evidence and improved treatments;" and reassess the current risk-benefit framework for approval of opioids to incorporate public health effects of misuse.
For more information about FDA's role in drug safety and effectiveness—not limited to PCS—see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness , by [author name scrubbed].
section_title: Controlled Substances Act (CSA)
paragraphs: The CSA is designed to regulate and facilitate the use of controlled substances for legitimate medical, scientific, research, and industrial purposes and to prevent these substances from being diverted for illegal purposes. Most prescription drugs are not controlled substances and therefore are not regulated under the CSA . However, some prescription drugs—in particular those most susceptible to abuse such as powerful pain relievers —come within the purview of the CSA because they have a greater potential for abuse than other prescription drugs and may lead to physical and psychological dependence. 
The CSA assigns various plants, drugs, and chemicals to one of five schedules, ranging from Schedule I, which contains substances that have no currently accepted medical use in treatment and cannot safely be made available under prescription (such as heroin), to Schedules II, III, IV, and V, which include substances that have recognized medical uses and may be manufactured, distributed, and used in accordance with the CSA. The order of the schedules reflects substances that are progressively less dangerous and addictive. Schedule II includes the drugs morphine, codeine, OxyContin®, and Ritalin®. Schedule III includes ketamine, buprenorphine, and anabolic steroids, while Schedule IV includes Xanax® and Valium®. Schedule V includes, among other things, cough medicines that contain a limited amount of codeine (Robitussin AC®).
The CSA and its implementing regulations contain several provisions that specifically regulate the acts of prescribing and dispensing controlled substances. For example, it is unlawful for any person to prescribe or dispense controlled substances without having a current, valid DEA registration. No controlled substance that is a prescription drug (as determined under §503(b) of the Federal Food, Drug, and Cosmetic Act) assigned to Schedules II, III, IV, and V of the CSA may be dispensed without a prescription. A prescription for a controlled substance may be issued only for a "legitimate medical purpose" by a physician "acting in the usual course of his professional practice." The CSA authorizes the DEA Administrator to suspend or revoke a physician's prescription privileges upon a finding that the physician has "committed such acts as would render his registration ... inconsistent with the public interest."
The CSA aims to reduce the potential diversion of PCS out of legitimate distribution channels by imposing specific obligations on the following participants in the prescription drug delivery and supply chain:
Wholesale distributors of controlled substances who supply pharmacies with their drug inventories must proactively monitor and report to DEA any "suspicious orders of controlled substances." Physicians must abide by the federal regulatory requirement to write a controlled substance prescription only "for a legitimate medical purpose" and "in the usual course of [their] professional practice." Pharmacists are responsible for verifying the validity of prescriptions before dispensing controlled substance medication to patients (referred to as "ultimate users" under the CSA).
For more information about the CSA—not limited to PCS—see CRS Report RL34635, The Controlled Substances Act: Regulatory Requirements , by [author name scrubbed], and CRS Report R40548, Legal Issues Relating to the Disposal of Dispensed Controlled Substances , by [author name scrubbed].
subsections: section_title: Ryan Haight Online Pharmacy Consumer Protection Act
paragraphs: Although many online pharmacies are legitimate businesses that offer safe and convenient services similar to those provided by traditional neighborhood pharmacies and large chain drugstores, other online pharmacies—often referred to as "rogue sites"—engage in practices that are illegal, such as selling unapproved or counterfeit drugs or dispensing drugs without a prescription. These rogue sites are often difficult for law enforcement to shut down because they "have an extremely high turnover and may attempt to avoid detection by changing their Web names and addresses." They also often employ fake logos of government agencies or professional associations that make them appear to be legitimate or otherwise sanctioned by law.
In response to the problem of these rogue Internet websites that illegally sell and dispense PCS in violation of the CSA, the 110 th Congress passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (hereinafter called "Ryan Haight Act"), which amended the CSA to expressly regulate online pharmacies. The Ryan Haight Act added a new provision to the CSA that prohibits the delivery, distribution, or dispensing of controlled substances over the Internet without a "valid prescription." Only with respect to this new subsection of the CSA, a "valid prescription" is statutorily defined to mean a prescription that is issued for a legitimate medical purpose in the usual course of professional practice, by a practitioner who has conducted at least one medical evaluation of the patient in the physical presence of the practitioner. Although the Ryan Haight Act does not apply to the Internet sale of non-controlled pharmaceutical drugs, the vast majority of prescriptions sold by an online pharmacy involve controlled substances.
Under the Ryan Haight Act, pharmacies must be authorized by the DEA to deliver, distribute, or dispense controlled substances by means of the Internet. A registered online pharmacy must report to the DEA Administrator the total quantity of each controlled substance that the pharmacy has dispensed each month. In addition, online pharmacies must clearly display on their website homepage a statement that they comply with federal and state law concerning the delivery or sale of controlled substances, as well as post certain disclosure information such as the name and address of the pharmacy (as it appears on the pharmacy's DEA registration certificate), the pharmacy's telephone number and email address, a list of states in which the pharmacy is licensed to dispense controlled substance, and the identification and contact information of the pharmacist-in-charge. 
Finally, the Ryan Haight Act amended the CSA to authorize a state attorney general to bring a civil action in federal court against an online pharmacy for violations of the Ryan Haight Act, in order to stop the illegal conduct, enforce compliance with the law, or obtain damages, restitution, or other compensation that a court finds appropriate.
section_title: Secure and Responsible Drug Disposal Act of 2010
paragraphs: A possible approach to addressing the prescription drug abuse problem is to reduce the accessibility and availability of unused medications that accumulate in household medicine cabinets. Patients may want to get rid of their expired or unused drugs by giving them back to pharmacies or to their prescribing physicians. Yet, when Congress originally drafted the CSA, "it did not account for circumstances in which controlled substances were lawfully dispensed to and possessed by an ultimate user but not fully used." Thus, as originally enacted the CSA prohibited patients from transferring their unwanted, unused, or expired PCS to any another entity for disposal purposes, unless local law enforcement had obtained a waiver from DEA to take custody of the unused controlled substances from patients and destroy them.
To make it easier and more convenient for patients to dispose of unwanted controlled substances, the 111 th Congress enacted the Secure and Responsible Drug Disposal Act of 2010 (hereinafter called "Disposal Act"), which amended the CSA to allow a patient to deliver controlled substances to an entity that is authorized by federal law to dispose of them, providing that such disposal occurs in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances. These implementing regulations, published in the Federal Register on September 9, 2014, substantially expand the options available to patients for safe and secure disposal of their unwanted controlled substance medication. 
The regulations governing secure disposal of controlled substances allow three primary options for patient disposal of controlled substances. The first option is for federal, state, tribal, or local law enforcement agencies to conduct periodic drug "take-back" events to collect controlled substances from unwanted users; private entities or community groups may also partner with law enforcement to hold community take-back events. Second, DEA-registered manufacturers, distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, or retail pharmacies that wish to become collectors of unwanted controlled substances for disposal purposes must seek authorization from DEA to do so. Authorized collectors may then conduct "mail-back" programs that utilize the mail system for convenient transfer of the unwanted controlled substances, although the physical packages in which the drugs are shipped must comply with certain requirements (for example, tamper-resistance and tracking numbers) that DEA has specified. The third option permits law enforcement agencies or authorized collectors to manage, maintain, and empty secure collection receptacles at their DEA registered location. A long-term care facility may also dispose of controlled substances on behalf of its residents (or former residents) by using on-site collection receptacles that are installed, managed, and maintained by authorized retail pharmacies or hospitals/clinics with an on-site pharmacy. Finally, the regulations provide requirements that collectors must follow regarding methods of destroying controlled substances and destruction procedures, in order to render the collected controlled substances "non-retrievable."
section_title: Law Enforcement
paragraphs: Prescription drug abuse presents unique challenges to law enforcement because unlike illicit substances such as heroin, prescription drugs are often initially obtained through lawful channels and subsequently diverted from their lawful purpose. Federal law enforcement, primarily DEA, aims to prevent, detect, and investigate the diversion of prescription drugs while regulating the supply for legitimate medical, commercial, and scientific purposes. State governments, law enforcement agencies, and health departments also engage in diversion control efforts through the development and operation of prescription drug monitoring programs (PDMPs) among other activities.
DEA directly engages in diversion control. The mission of DEA's Office of Diversion Control is "to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs." In addition to diversion control activities, such as sponsoring National Prescription Drug Take-Back Days, the Office of Diversion Control also oversees registrations for those who seek to manufacture, import, export, sell, or dispense narcotics. DEA actions generally focus on doctors prescribing PCS or traffickers of PCS (rather than individuals using PCS); DEA lists 31 administrative actions against registrants (primarily doctors) in CY2013 and maintains a multi-year list of criminal cases against doctors.
section_title: Health
paragraphs: Federal agencies and programs that provide health care services may prescribe PCS for underlying conditions (e.g., pain, insomnia, or ADHD) and may treat patients for prescription drug abuse or related problems (e.g., overdose or withdrawal). Relevant federal agencies include the Department of Veterans Affairs (VA), the Department of Defense (DOD), the Indian Health Service (IHS) within the Department of Health and Human Services (HHS), the Bureau of Prisons (BOP) within Department of Justice (DOJ), and some smaller programs. Some agencies that deliver health care services also finance health care services and conduct research.
Federal agencies and programs may also support health care services by providing grants, reimbursing providers, or paying a portion of insurance premiums. In so doing, they may pay for the treatment of underlying conditions, prescription drug abuse, or related problems. Relevant federal programs include Medicare, the federal portion of Medicaid, grant programs within the Substance Abuse and Mental Health Services Administration (SAMHSA) and other agencies, and the Federal Employees Health Benefits Program (FEHBP). 
Federal agencies and programs may also conduct or support research activities relevant to prescription drug abuse, ranging from bench science conducted in laboratories to program evaluations conducted in the field. The National Institutes of Health (NIH) conducts and funds relevant research—primarily but not exclusively through the National Institute on Drug Abuse (NIDA). The Centers for Disease Control and Prevention (CDC) conducts public health surveillance (including, for example, deaths attributable to PCS overdoses) through the National Center for Health Statistics and provides information about PCS overdose through the National Center for Injury Prevention and Control. SAMHSA fields surveys about drug use that provide national statistics and also maintains a National Registry of Evidence-based Programs and Practices. FDA has required manufacturers of extended-release and long-acting opioid drugs to conduct specific postmarket studies within designated time periods. 
section_title: Current Approaches Aimed at Reducing Prescription Drug Abuse
paragraphs: The federal government, state and local governments, and various private entities (e.g., pharmacies) are currently undertaking a range of approaches to reducing prescription drug abuse. Such approaches may focus on health care professionals, law enforcement, or current or potential abusers. 
subsections: section_title: Scheduling of PCS
paragraphs: The particular scheduling status of a PCS has several significant consequences: (1) it directly affects patient access to the medication (in terms of the number of allowable refills and whether prescriptions must be written or may be conveyed over the telephone by the physician to the pharmacist); (2) it affects the degree of regulatory requirements that controlled substance handlers (manufacturers, distributors, pharmacies, and physicians) must follow (such as security restrictions and recordkeeping obligations); and (3) it determines the degree of criminal punishment for illegal traffickers of the controlled substance.
The CSA and its implementing regulations offer limitations on the prescribing and dispensing of a PCS that vary depending on the schedule in which the medication is placed. For example, no controlled substance listed in Schedule II may be dispensed to a patient by a pharmacist without a written prescription from a practitioner, except in certain cases where the practitioner administers the controlled substance directly to the patient. However, controlled substances in Schedules III-V may be dispensed by a pharmacy pursuant to either a written or oral prescription, including a facsimile of a written prescription; these substances may also be administered or dispensed directly by the practitioner in the course of his professional practice without a prescription. Pharmacists are prohibited from refilling prescriptions for Schedule II substances. Pharmacists may fill or refill prescriptions for controlled substances in Schedules III and IV up to five times within six months after the date on which the prescription was issued, unless the prescribing practitioner authorizes a renewal of the prescription.
The schedule status of a PCS also determines the nature and extent of federal regulatory requirements for lawful handlers of controlled substances. For example, manufacturers and distributors are required to store Schedule I and II substances in electronically monitored safes, steel cabinets, or vaults that meet or exceed certain specifications, while Schedule III, IV, or V substances may be stored in less secure enclosures. They must also receive a special order form from a purchaser prior to shipping Schedule I and II drugs. The form is preprinted by DEA with the name and address of the purchaser, and the drugs must be shipped by the supplier filling the order to the purchaser's registered location. DEA further monitors the distribution of controlled substances by requiring manufacturers and distributors of Schedule I and II drugs to file reports on acquisition and distribution of controlled substances through the Automated Reports and Consolidated Orders System (ARCOS). DEA also limits the quantity of Schedule I and II controlled substances which may be produced in a given calendar year.
Finally, the authorized criminal penalties and fines are greater for drug trafficking offenses involving Schedule I and II substances than for those in the other schedules.
The CSA provides both legislative and administrative mechanisms for substances to be added to a schedule; removed from the scheduling framework altogether; and rescheduled or transferred from one schedule to another. Congress may change the scheduling status of a drug or substance through legislation. For example, in the 113 th Congress, legislation has been introduced that would reschedule marijuana from its current placement in Schedule I to Schedule II, while another bill would direct the Attorney General to "issue a final order that removes marijuana in any form from all [CSA] schedules."
DEA, HHS, or (by petition) any interested person may initiate federal rulemaking proceedings to add, delete, or change the schedule of a drug or substance administratively. For example, DEA in 2009 requested from HHS an evaluation and recommendation concerning whether to reschedule hydrocodone combination products (HCPs) such as Vicodin® from Schedule III to Schedule II. In December 2013, HHS recommended to DEA that HCPs should be reclassified to the more restrictive Schedule II. On August 22, 2014, DEA published a final rule in the Federal Register that administratively reschedules HCPs from Schedule III to Schedule II, which subjects anyone who manufactures, distributes, or dispenses HCPs to the more stringent regulatory requirements and administrative, civil, and criminal sanctions that are applicable to Schedule II controlled substances.
section_title: Safe Storage and Disposal
paragraphs: Safe storage and proper disposal of medication are viewed as ways to prevent the diversion of prescription drugs. The federal government supports these prevention measures in several ways. DEA regulations require all applicants and registrants to comply with strict storage requirements for prescription medication. Also, as required under the Controlled Substances Act and DEA regulations, registrants have several options for proper disposal of medication. Congress may have an interest in monitoring the effectiveness of existing safe storage and disposal activities to determine whether additional legislative action (e.g., changes in authorizations or funding) is warranted.
subsections: section_title: Safe Storage: Security Requirements
paragraphs: For the purposes of ensuring the secure storage and distribution of controlled substances and listed chemicals, all applicants and registrants must generally "provide effective controls and procedures to guard against theft and diversion of controlled substances." DEA regulations further require all applicants and registrants to substantially comply with specific security standards for storage of controlled substances (and other specified chemicals). Applicants and registrants must also be prepared to make adjustments to their security systems in the event that a controlled substance is transferred to another schedule or removed from control under the CSA. 
DEA regulations also detail specific security requirements for the different types of applicants and registrants. Non-practitioners (i.e., manufacturers, distributors, and narcotic treatment programs) are required to store Schedule I and II substances in electronically monitored safes, steel cabinets, or vaults that meet or exceed certain specifications. Licensed practitioners must store controlled substances in a "securely locked, substantially constructed cabinet" and must notify DEA of the theft or significant loss of any controlled substances within one business day of discovering such loss or theft. Furthermore, all practitioners are prohibited from hiring employees who have been convicted of a drug-related felony or who have had a DEA registration denied or revoked. DEA regulations recommend that non-practitioners carefully screen individuals before hiring them as employees, to ensure that job applicants do not have convictions for crimes or have engaged in unauthorized use of controlled substances.
section_title: Safe Disposal: DEA Drug Take Back
paragraphs: To assist citizens in proper disposal, DEA has sponsored several different types of take-back programs, including the following: permanent locations where unused prescription drugs are collected; special one-day events in which patients can drop off unwanted drugs at pharmacies or hazardous waste collection sites; and mail-in/ship-back programs. As previously discussed, the Disposal of Controlled Substances final rule authorizes ultimate users to transfer unwanted drugs to authorized collectors for safe and secure disposal. 
Some local and state government agencies and grassroots organizations have established drug disposal programs (often referred to as pharmaceutical "take-back" programs) to facilitate the collection of unused, unwanted, or expired medications for incineration or other methods of destruction that comply with federal and state laws and regulations, including those relating to public health and the environment. 
section_title: Focusing Law Enforcement Efforts
paragraphs: Federal law enforcement efforts to combat prescription drug abuse may focus on specific geographic regions or on specific types of drugs, depending on how priorities are established. 
ONDCP analyzes geographic patterns of drug trafficking in High Intensity Drug Trafficking Areas (HIDTA). For example, a 2011 drug market analysis of the Rocky Mountain HIDTA shows that abuse of illegally diverted prescription drugs is "very high" in the region, and additionally this area has experienced increased overdose deaths. Using drug trafficking metrics is more consistent with federal law enforcement's emphasis on traffickers and prescribers than, for example, using drug abuse metrics. While geographic patterns of prescription drug abuse are available for analysis, the extent to which traffickers and prescribers are located in proximity to the individuals abusing prescription drugs is unclear.
Within the HIDTA Program, ONDCP funds the National Methamphetamine & Pharmaceuticals Initiative (NMPI), which targets specific types of drugs and chemicals. In addition to reducing the availability of methamphetamine and its precursor chemicals, NMPI aims "to reduce pharmaceutical drug crimes by utilizing best practices for investigations and intelligence collection and analysis." NMPI strategic priorities that support prescription drug abuse prevention include
[e]ffective pharmaceutical drug monitoring programs;
[t]raining to federal, state, local, and tribal personnel on methamphetamine and pharmaceutical drug crimes, trends, drug-endangered children, and best practice solutions; and 
[e]nhance parcel interdiction and investigations.
As part of this initiative, ONDCP also monitors pharmacy robberies, which may help identify trends in PCS diversion. 
section_title: Using Data to Identify Risk
paragraphs: Various data sources may support analyses that can identify high-risk behavior indicating potential PCS diversion and abuse among prescribers, dispensers, patients, and others. 
subsections: section_title: Prescription Drug Monitoring Programs (PDMPs)
paragraphs: Prescription drug monitoring programs (PDMPs) maintain statewide electronic databases of prescriptions dispensed for PCS. Analysis of information collected by PDMPs may help identify potential PCS diversion and abuse. Law enforcement uses of PDMP data include (but are not limited to) investigations of physicians who prescribe controlled substances for drug dealers or abusers, pharmacists who falsify records in order to sell controlled substances, and people who forge prescriptions. Public health uses of PDMP data include (but are not limited to) preventing dangerous combinations of medications when physicians check a patient's PDMP record prior to prescribing a PCS or other medication. Congress appropriates funds to support state PDMPs through DOJ-administered grants—and previously through HHS-administered grants as well. 
For more information about PDMPs, see CRS Report R42593, Prescription Drug Monitoring Programs , by [author name scrubbed], [author name scrubbed], and [author name scrubbed]. 
section_title: Other Data Sources
paragraphs: In addition to PDMPs, which were designed specifically to track PCS, various public and private entities have data potentially related to prescription drug abuse. For example, New York City's RxStat program combines multiple sources of health and crime data (including PDMP data) with sophisticated analytics to help target efforts to reduce prescription drug abuse. At the federal level, FDA (along with public and private partners) is building a national system of health care databases that FDA can search for adverse events possibly associated with its regulated products—including PCS. 
Medicare, Medicaid, and private health insurers have data about the medical care for which they pay. Analyses similar to those used to detect potential fraud may be applied to identify behavior potentially contributing to prescription drug abuse. For example, Iowa's Medicaid program refers members who receive prescriptions from multiple pharmacies or multiple prescribers (among other possible criteria) to a "lock-in" program, which limits them to one primary care physician, one pharmacy, one hospital, and one specialist. The Alliance to Prevent the Abuse of Medicines is reviewing legislative options for a similar program in Medicare, which would restrict certain beneficiaries to a single pharmacy and avoid disrupting access to needed medications. 
Pharmacies have data about prescriptions written by providers and filled by patients. For example, a large chain pharmacy identified high-risk prescribers and (after multiple attempts to contact them) stopped filling prescriptions for controlled substances written by those who were unable or unwilling to provide legitimate reasons for their high-risk prescribing patterns. 
Similarly, large health care service delivery systems have data about their patients' diagnoses and treatments, as well as providers' practice patterns.
section_title: Awareness and Education
paragraphs: ONDCP has described raising awareness through education as a "crucial first step in tackling the problem of prescription drug abuse." Efforts to increase awareness and education about prescription drug abuse may focus on health care providers, patients, or the general public. 
Although federal agencies do not generally regulate the practice of medicine, they may convene expert panels or encourage state-level activities to explore clinical decision support tools (e.g., electronic alerts or treatment guidelines). In conjunction with a REMS specifically for extended-release and long-acting opioid analgesics, FDA has published a "blueprint" for prescriber education and has established a searchable on-line repository for educational activities that comply with the REMS. The REMS also includes development of materials to educate patients when the prescription is written and when it is filled. SAMHSA offers reports, pamphlets, and continuing medical education about prescription drug abuse at no cost.
In addition to federal efforts, state or local governments and private entities may also engage in awareness and education activities. Several states have produced or sponsored Public Service Announcements to raise public awareness of prescription drug abuse. The Federation of State Medical Boards has published a model policy to encourage state medical boards to adopt guidelines for use of prescription pain relievers in treating chronic pain.
section_title: Treatment
paragraphs: Prescription drug abuse may be prevented in some cases through choices in treatment of underlying conditions (e.g., pain), and it may be treated effectively through pharmacologic or non-pharmacologic interventions. New products may be developed for treating both underlying conditions and prescription drug abuse. 
subsections: section_title: Treatment of Underlying Conditions
paragraphs: Decisions about how to treat underlying conditions (e.g., pain, ADHD, or insomnia) might be made with attention to minimizing the risk of prescription drug abuse. For example, alternatives to prescription medications—such as surgery or physical therapy instead of pain relievers—may be available for some conditions. VA and DOD have jointly issued clinical practice guidelines for treating chronic pain with prescription pain relievers, taking into account not only managing pain effectively but also limiting risk of abuse and monitoring for signs of abuse. As an example of a state-level effort, Ohio's guidelines for prescribing controlled substances in emergency departments and acute care facilities suggest limiting prescriptions to a three-day supply, thus putting less of the medication in circulation. 
section_title: Treatment of Prescription Drug Abuse
paragraphs: The National Institute on Drug Abuse (NIDA) recognizes both medications and behavioral treatments as effective approaches to treating drug abuse in general and prescription drug abuse in particular. Which treatment is effective—particularly among pharmacologic treatments—varies by the drug of abuse. Addiction to opioids (including prescription pain relievers) may be treated using medication-assisted treatment such as methadone, buprenorphine, and naltrexone. NIDA is funding research into medications to treat addiction to stimulants (e.g., Ritalin®); no medications are currently FDA-approved for this indication. The federal government may support treatment of prescription drug abuse through direct service delivery, financing or grant funding, and regulation of opioid treatment programs. 
For more information about medication-assisted treatment of opioid addiction, see CRS In Focus IF10219, Opioid Treatment Programs and Related Federal Regulations , by [author name scrubbed]. 
section_title: New Product Development
paragraphs: New pharmaceutical products may come in the form of new formulations of existing drugs (e.g., tamper-resistant or abuse-deterrent pain relievers), new drugs to treat underlying conditions (e.g., pain or insomnia) without addictive properties, or new drugs to treat addiction. 
Abuse-deterrent drug formulations include additional substances intended to make the primary drug less subject to abuse. An example is the combination of buprenorphine and naloxone, where the naloxone is meant to prevent the buprenorphine from taking effect if the drug is injected rather than dissolved under the tongue.
Tamper-resistant drug formulations are manufactured to prevent potential abusers from crushing them into a powder that can be snorted or dissolving them into a liquid that can be injected. An example is the reformulated version of extended release oxycodone, which is manufactured with a highly viscous (i.e., gooey) substance that prevents the pill from being crushed or dissolved.
NIDA has identified the "development of effective, nonaddicting pain medications [as] a public health priority." Non-pharmaceutical products or interventions may also be developed to treat underlying conditions such as pain, reducing the demand for PCS.