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Pharmacists’ role in addressing opioid abuse, addiction, and diversion American Pharmacists Association
Abstract
Received May 21, 2013, and in revised form September 3, 2013. Accepted for publication September 18, 2013.
Objective: To review the scope of the problem of opioid misuse; explore pharmacists’ roles and responsibilities regarding opioid use; discuss existing laws, guidelines, and regulations governing opioid management; identify potential patient and practice management strategies to address opioid abuse; and disseminate leader insights on these issues.
Correspondence: James A. Owen, BSPharm, PharmD, BCPS, Associate Vice President, Professional Practice, American Pharmacists Association, 2215 Constitution Ave., NW, Washington DC 20037. E-mail: [email protected]
Data sources: Information presented at a conference convened by the American Pharmacists Association (Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion; held November 15, 2012) and discussed in conference workgroups , as well as related information from the literature. Summary: Opioid misuse, abuse, and diversion has grown dramatically since the early 1990s and affects public health considerably. In 2011, more individuals died from drug overdoses than from motor vehicle accidents. Strategies are available that pharmacists can use to reduce the likelihood of opioid misuse, abuse, and diversion while minimizing the impact on legitimate pain management efforts. These strategies and tools can be used to support (1) the assessment of prescriptions that are presented for opioid medications, (2) the management of patients receiving opioids, and (3) follow-up options when misuse, abuse, or diversion has been identified. Conclusion: Implementation of systems and processes that support pharmacist management of opioid-related issues under financially viable business models would create a number of opportunities to improve patient care.
This publication was prepared by Judy Crespi Lofton, MS, Medical Writer and Consultant, Schwenksville, PA, in conjunction with staff from the American Pharmacists Association. Disclosure: Ms. Crespi Lofton and APhA staff declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: The American Pharmacists Association meeting, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion, and this article were supported by Purdue Pharma LP, Teva Pharmaceutical Industries Ltd., Endo Pharmaceuticals, and Mallinckrodt, The Pharmaceuticals business of Covidien. Published online early at www.japha.org on November 20, 2013.
Keywords: Addiction, laws and regulations, medication therapy management, opioids, pain management, pharmacists, pharmacy. J Am Pharm Assoc. 2014;54:e5–e15. doi: 10.1331/JAPhA.2014.13101
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Issues for pharmacists managing opioids Although opioids are widely regarded as the most effective agents for treating many types of pain, they also have the potential to be misused and abused. These features make the management of opioids complex. When dispensing opioids, pharmacists have a responsibility to ensure that patients in pain receive appropriately prescribed opioids. This responsibility must be balanced with the responsibility not to permit the misuse or diversion of controlled substances by patients or other individuals. Definitions related to the use of opioids can be found in Table 1.1,2 Pharmacists’ responsibilities regarding opioids often can conflict with each other. Dispensing opioids without carefully assessing each prescription may increase misuse and diversion. On the other hand, efforts to reduce misuse and diversion may result in denying legitimate patients medications or result in the creation of additional barriers for pain patients. Pharmacists must manage these responsibilities within an environment of potential regulatory scrutiny if they inadvertently dispense medications to diverters or abusers. Thus, it is imperative that pharmacists carefully balance these two responsibilities in their practice.
At a Glance Synopsis: The misuse, abuse, and diversion of opioids have increased dramatically since the early 1990s, resulting in a considerable impact on public health. Participants at a conference convened by the American Pharmacists Association discussed a number of tools and strategies that can help address opioid abuse, addiction, and diversion and benefit public health. To address this critical issue, pharmacists can support (1) the assessment of prescriptions that are presented for opioid medications, (2) the management of patients receiving opioids, and (3) follow-up options when misuse, abuse, or diversion has been identified. Analysis: Ensuring access to opioids for patients who have a legitimate need while working to prevent misuse, abuse, and diversion is a complex balancing act for pharmacists. In addition to complying with federal and state regulations governing controlled substances, pharmacists must exercise diligence and careful judgment. They must assess the appropriateness of opioid prescriptions, weigh the risks and benefits of opioids for individual patients, and attempt to discern whether patients are presenting legitimate prescriptions. Pharmacists also must consider the importance of their own physical safety and security when working with controlled substances.
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Guidance and tools are available that may help pharmacists achieve a balance between patient care and management of opioids. These include federal and state laws, state practice standards, and store-level policies. However, current evidence suggests that achieving an appropriate balance is a struggle for pharmacists.3
Pharmacists’ role in addressing opioid abuse, addiction, and diversion To engage national leaders in a discussion about opioid abuse, addiction, and diversion and to explore strategies that pharmacists could use to balance their responsibilities related to opioids, the American Pharmacists Association (APhA) convened a conference, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion, on November 15, 2012. The conference was attended by subject matter experts and pharmacy thought leaders. Conference participants (Table 2) heard a series of presentations related to opioid misuse and abuse and to opioid management laws, regulations, guidelines, and tools. The presentations were followed by facilitated workgroup sessions and group discussion focused on tools and strategies that can be used to address opioidrelated issues in pharmacy practice. This article presents information from conference presentations and discussions. Supporting information from the literature is provided in the appendices. This article should not be considered a set of best practice recommendations. Rather, it reports on the collective dialogue among pharmacy thought leaders and is intended to provide information for pharmacists, pharmacies, and other stakeholders who grapple with this issue.
Issues surrounding opioid misuse and management strategies Conference presentations focused on a variety of issues, including data regarding use and abuse of opioids, federal oversight of opioid use, state-level regulation of opioids, and guidance from professional societies. Data regarding use and abuse of opioids The conference began with a look at data that quantify the current problem of opioid misuse and abuse. A dramatic increase in the misuse and abuse of opioids occurred in the previous decade, creating a public health issue that has been called an epidemic. In 2011, 6.1 million Americans reported current nonmedical use of prescription drugs.4 The cost of prescription drug abuse was $55.7 billion in 2007, including $24.7 billion in direct health care costs.5 Along with the rise in misuse and abuse of opioids, the number of drug overdose deaths in the United States rose dramatically through the 1990s and 2000s. In 2010, more people in the United States died from drug overdoses than from motor vehicle accidents (Figure 1).6,7 Journal of the American Pharmacists Association
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Table 1. Definitions related to the use of opioids Term Abuse
Definition Self-administration of medications to alter one’s state of consciousness (i.e., “get high”). This is an intentional, maladaptive pattern of use of a medication (whether legitimately prescribed or not) leading to major impairment or distress (e.g., repeated failure to fulfill role obligations, recurrent use in situations in which it is physically hazardous, multiple legal problems, recurrent social and interpersonal problems) occurring during a 12-month period. Addiction is a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Redirection of a prescription drug from its lawful purpose to illicit use; can be done with criminal intent. The intentional or unintentional use of a prescribed medication in a manner that is contrary to directions, regardless of whether a harmful outcome occurs. Physical dependence is a state of adaptation that often includes tolerance and is manifested by a drug class–specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Patients with pseudoaddiction exhibit behaviors of addiction (frequently asking for more analgesics or higher doses) that resolve when pain is adequately treated. Patients often are coined as “drug seeking.” The cause is inadequate analgesic management, and the treatment for pseudoaddiction is adequate analgesic management. Pseudoaddiction results in a crisis of mistrust between the patient and staff and threatens the ability to provide analgesic management. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.
Addiction
Diversion Misuse Physical dependence
Pseudoaddiction
Tolerance Source: References 1 and 2.
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Figure 1. U.S. overdose death rate trends: 1980–2010 Source: References 6 and 7.
Prescription drugs, particularly opioids, are the primary cause of these deaths (Figure 2). Of the more than 38,300 drug overdose deaths in 2010 (including medications and illicit drugs), approximately 16,700 involved opioid painkillers (compared with 4,200 for cocaine and 3,000 for heroin).6,7 The increase in opioid misuse and abuse also has been accompanied by an increase in heroin use. Injection drug users have reported that prescription opioid use Journal of the American Pharmacists Association
predated their heroin use and that tolerance motivated them to try heroin.8 The average number of heroin users, the number of individuals who started using heroin, and the number of individuals seeking treatment for heroin use increased dramatically from the early 2000s to 2011.9,10 In addition to preventing drug use escalation by individuals who are misusing opioids, preventing new individuals from initiating opioid misuse is critical. j apha.org
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Table 2. Participants in the APhA conference, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion Jennifer Adams, PharmD Senior Director, Strategic Academic Partnerships, American Association of Colleges of Pharmacy, Alexandria, VA Bona Benjamin, BSPharma Director, Medication-Use Quality Improvement, Coordinator, Drug Resources Center, American Society of Health-System Pharmacists, Bethesda, MD Heather Bonome, PharmD Clinical Account Executive, Express Scripts, Washington, DC Marcie Bough, PharmDb Senior Director, Government Affairs, American Pharmacists Association, Washington, DC Mary Jo Carden, BSPharm, JDa Director of Regulatory Affairs, Academy of Managed Care Pharmacy, Alexandria, VA Bethany DiPaula, PharmD, BCCP Associate Professor, School of Pharmacy, University of Maryland, Baltimore Carolyn Ha, PharmD Director, Professional Affairs, National Community Pharmacists Association, Alexandria, VA Michael Jackson, BSPharm Executive Vice President and Chief Executive Officer, Florida Pharmacy Association, Tallahassee Kathleen Jaeger, BSPharm, JD Senior Vice President, Pharmacy Care and Patient Advocacy, President, NACDS Foundation, National Association of Chain Drug Stores, Alexandria, VA Lloyd Jessen, BSPharm, JDa Executive Director, Iowa Board of Pharmacy, Des Moines Nik Johnson, CPhT Pharmacy Affairs Program Manager, Academy of Managed Care Pharmacy, Alexandria, VA LCDR Christopher M. Jones, PharmD, MPHa Acting Team Lead, Prescription Drug Overdose Team, Division of Unintentional Injury, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Chamblee, GA Regina LaBelle, JDa Chief of Staff, White House Office of National Drug Control Policy, Washington, DC Claudia Manzo, PharmD Director of the Division of Risk Management, Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD Meagan McCrane Health and Wellness Department, Food Marketing Institute, Arlington, VA Suzanne Amato Nesbit, PharmD, CPE Clinical Pharmacy Specialist, Pain Management, Research Associate, Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, MD James A. Owen, PharmD, BCPSb Senior Director, Professional Practice, American Pharmacists Association, Washington, DC Tasha Polster, BSPharm Director of Pharmaceutical Integrity, Walgreens Company, Deerfield, IL e8 JAPhA | 5 4 : 1 | JAN/F EB 2014
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Table 2 continued Jeff Porter, BSPharm Pharmacy Merchandiser–Kroger Pharmacy Delta Division, Kroger Pharmacy, Memphis, TN Rebecca Snead, BSPharm Executive Vice President and Chief Executive Officer, National Alliance of State Pharmacy Associations, Richmond, VA Lisa Strucko, PharmD Director of Pharmacy, Leesburg Pharmacy, Leesburg, VA Lorinda Tisdell Executive Director, Pharmacy Operations, Walgreens Company, Deerfield, IL Peter Van Pelt, BSPharmb Associate Director, Corporate Alliances, American Pharmacists Association, Washington, DC C. Edwin Webb, PharmD, MPH Associate Executive Director, Director, Government and Professional Affairs, American College of Clinical Pharmacy, Washington, DC Moderator: Harry Hagel, BSPharm Independent Consultant, Austin, TX Presenter. Small-group facilitator.
a
b
As shown in Figure 3, the majority of those who report misuse of opioids obtain the medications from a friend or relative.11 Often the medication is offered for free; in other cases, individuals take it without asking. Particularly for recent initiates, the percentage who pay for the opioid from a friend or dealer or via the Internet is rather small. Thus, strategies that prevent inappropriate sharing of medications are critical to prevent the initiation of opioid misuse. These data have supported the implementation of strategies to address the problem of opioid use and abuse, some of which are discussed in the following sections. More recent data suggest that these strategies have resulted in some progress, with the national rate of past-year nonmedical use of prescription pain relievers among those 12 years or older dropping from 4.9% in 2009–10 to 4.6% in 2011.12 Federal oversight of opioid use On a national level, several government organizations are involved in regulating the use of opioids, including the White House Office of National Drug Control Policy, Drug Enforcement Administration (DEA), and Food and Drug Administration (FDA). During the invitational conference, information about the use of risk evaluation and mitigation strategies (REMSs) was presented. Information regarding other select programs, requirements and initiatives can be found in Appendices 1 and 2. FDA’s role in opioid regulation: REMSs. FDA has begun to address the management of opioids through various tools, including the use of REMSs. A 2007 law directed FDA to develop REMSs to manage risks when needed to ensure that the benefits of a medication outJournal of the American Pharmacists Association
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Figure 2. Overdose deaths for specific drugs: 1999-2010 Source: Reference 6 and 7.
Figure 3. Source of prescription pain relievers Source: Reference 11. Journal of the American Pharmacists Association
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weigh its risks, and FDA has applied this law to address risk management for opioids.13 A REMS can include communication tools and elements to ensure safe use, such as requiring specific training for health professionals, restricted distribution, patient registries, and/or other patient monitoring. In April 2009, FDA announced that it was exploring the development of a single shared-system REMS for long-acting (LA)/extended-release (ER) opioids.13 Although improper use of any opioid can result in serious consequences, FDA focused on LA/ER opioid products because if used improperly, they can result in even greater risk than an immediate-release opioid product. The increased risk occurs because the amount of opioid contained in an LA/ER tablet often is much greater than the amount of opioid contained in an immediate-release product and can take much longer to be cleared out of the body.14 In April 2011, FDA announced the specific elements of the LA/ER REMS: All manufacturers of LA/ER opioids must ensure that training is provided to prescribers of these medications and develop information that prescribers can use when counseling patients about the risks and benefits of opioid use. (Of note, pharmacists are absent from the REMS program.15) The list of opioid products that are required to have a REMS can be found at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm. Prescriber education includes information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, prescribers will receive training to recognize evidence of and potential for opioid misuse, abuse, and addiction.14 The REMS will include education materials that prescribers can provide to patients on how to use and store these products safely. Prescribers will be educated to properly counsel patients on safe use and the responsibilities associated with using these products, and patients will receive Medication Guides when they pick up their prescriptions. (Medication Guides are designed to provide information in patient-friendly language about the medication’s risks and how to use the medication safely.14) FDA is implementing the REMS in a stepwise fashion to minimize the impact and burden on the health care system and patients. The plan for assessment of the LA/ER REMS includes a goal of having 80,000 active prescribers trained within the first 2 years of the program, 160,000 active prescribers within 3 years, and 192,000 active prescribers within 4 years. In addition, patients’ and health care providers’ understanding of the risks of the medications will be evaluated. Drug use will be monitored, and the surveillance plan will include monitoring for misuse, abuse, overdose, addiction, and e10 JAPhA | 5 4:1 | JAN/F EB 2014
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death, with information specifically tracked to different risk groups, settings, and medications. At this time, the education program is voluntary for health care providers. FDA is working with lawmakers with the goal of adding an education requirement to the DEA licensure process. If such a requirement is implemented, it would be mandatory for licensure and would circumvent the need to create a separate registration system.14 Other FDA efforts to reduce the misuse and abuse of opioids include the development of abuse-resistant formulations, stimulating the development of physician– patient agreements (Appendix 3), and efforts to educate patients to properly dispose of unused medications. An overview of FDA’s activities to address the misuse and abuse of opioids can be found at www.fda.gov/Drugs/ DrugSafety/InformationbyDrugClass/ucm337852. htm. Additional information about opioids can be found at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm. State-level regulation of opioids On a state level, opioids are regulated through a variety of laws, including state practice acts and the more recent implementation of prescription drug monitoring programs (PDMPs). States may exercise stricter, but not less stringent, regulations than federal regulations. For example, states may require patients to present identification when picking up medications in a specific schedule and/or may require pharmacist to review a PDMP in certain situations. States regulate the practices of medicine and pharmacy through their health care practice acts and have been responsible for establishing whether the use of a medication constitutes a legitimate medical practice. The National Association of Boards of Pharmacy has issued a model state pharmacy act that covers a wide range of issues related to the practice of pharmacy. Several state practice acts have provisions that are relevant to the use of opioids. For example, the model act and many state acts call for pharmacists to work to optimize patient outcomes, which may be particularly relevant for patients with undertreated pain. Some state practice acts have requirements for when pharmacists should review PDMPs. In addition, many state boards have policy statements on pain management. The Pain and Policy Studies Group at the University of Wisconsin maintains a database of laws, regulations and other policies for pain management for all states except Illinois and Indiana. The database can be accessed at www.painpolicy.wisc.edu/database-statutes-regulations-other-policies-pain-management. PDMPs. PDMPs are statewide electronic databases that collect data about the prescribing and dispensing of scheduled substances. PDMPs are used as a tool to help prevent drug abuse and diversion while supportJournal of the American Pharmacists Association
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ing legitimate access to controlled substances. Health care providers can use PDMPs to ensure that patients are not “doctor shopping” (i.e., obtaining prescriptions for controlled substances from multiple prescribers and pharmacies). The specific requirements and features of each PDMP vary from state to state. As of November 2012, 49 states had legislation authorizing a PDMP and 42 states had operational systems. The National Alliance for Model State Drug Laws (www.namsdl.org) provides links to each state’s statutes and regulations regarding PDMPs. The Prescription Drug Monitoring Program Center of Excellence released a report on PDMP best practices in September 2012. Selected features and activities of PDMPs that were listed as best practices in the report include16: ❚❚ Allowing prescribers and dispensers access to the database. ❚❚ Allowing database access to regulatory boards, state Medicaid and public health agencies, medical examiners, and law enforcement (under appropriate circumstances). ❚❚ Providing real-time data and access. ❚❚ Sharing data with other states. ❚❚ Integrating with other health information technology to improve use among health care providers. According to DEA, PDMPs can deter would-be diverters, and states that have implemented such programs have reported decreases in abuse and diversion of the monitored drugs. Pharmacists in states that use these programs have reported increased levels of confidence in dispensing controlled substances.17 States with PDMPs have been found to have lower substance abuse treatment rates for opioids. An analysis of poison control center data from 2003 to 2009 found that states with PDMPs had lower annual increases in opioid misuse/abuse than other states.18 In another study of emergency department prescribing, implementing a PDMP resulted in modifications to opioid prescribing. After review of the PDMP data, providers changed the clinical management for patients with nontraumatic pain in 41% of cases. In cases of altered management, the majority (61%) resulted in fewer or no opioid medications prescribed than originally planned, whereas 39% resulted in more opioid medication than previously planned.19 These data support the conclusion that PDMPs can reduce misuse and increase prescriber comfort levels for legitimate patients. Guidance from professional societies Few legal or regulatory consequences exist for refusing to dispense legitimate prescriptions. A legitimate patient who is denied treatment can file a complaint with the store’s management or with the state board of pharmacy, and prescribers may become frustrated and send their patients elsewhere. To ensure balance, pharmacists Journal of the American Pharmacists Association
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must consider their ethical obligations to resolve patients’ drug therapy problems and ensure that patients receive appropriate therapy. Professional pharmacy associations, including APhA and the American Society of Health-System Pharmacists (ASHP), provide guidance to address this issue. For example, several aspects of APhA’s Code of Ethics for Pharmacists are relevant to the management of opioids (Table 3).20 The code of ethics calls upon pharmacists to provide the best possible care to patients, treat patients with “a caring attitude and compassionate spirit,” and act in the best interest of patients. The code also acknowledges that pharmacists must balance the needs of individual patients (e.g., those with a legitimate need for opioids) with those of broader public health objectives (e.g., need to prevent opioid misuse and abuse). ASHP has developed a position statement on pharmacists’ role in substance abuse prevention, education, and assistance.21 According to this statement, pharmacists have a unique specialized body of knowledge, skills, and responsibilities for assuming an important role in substance abuse prevention, education, and assistance. This statement identifies key organizational and societal roles of health system pharmacists and defines a list of activities for pharmacists to address the problem of substance abuse.
Approaches for pharmacist management of opioid risks The legal and regulatory opioid management framework and guidance from professional societies discussed by the conference presenters provided tools and strategies to support pharmacists as they work to balance their opioid-related roles. During the subsequent workgroup discussions, participants explored how these and other tools and strategies could be used to address three issues that arise when managing opioids in pharmacy practice: (1) identifying potential opioid misuse or abuse, (2) policies and procedures to manage risk of opioid misuse, (3) strategies to use when misuse, abuse, and/or diversion of opioids are confirmed. Highlights of group discussions are presented here but are not intended to represent best practice recommendations. Identifying potential opioid misuse or abuse A key issue in preventing the misuse and abuse of opioids is evaluating patients and prescriptions for potential opioid misuse or abuse. Conference participants were asked to list signs that could potentially suggest that a prescription is fraudulent. Participants noted that identifying patients who are dishonest and seeking opioids for abuse or diversion is difficult. Participants noted the importance of consistently applying criteria for assessing legitimacy of prescriptions, so that disparities based on race/ethnicity, socioeconomic status, or j apha.org
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Table 3. Selected provisions from the Code of Ethics for Pharmacists Selected provision Preamble
I. A pharmacist respects the covenantal relationship between the patient and pharmacist. II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. IV. A pharmacist acts with honesty and integrity in professional relationships. VII. A pharmacist serves individual, community, and societal needs.
Details “Pharmacists are health professionals who assist individuals in making the best use of medications. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are established to guide pharmacists in relationships with patients, health professionals, and society.” “Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust.” “A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.” “A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients.” “The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly.”
Adopted by the membership of the American Pharmacists Association, October 27, 1994. Source: Reference 20.
other factors do not inadvertently lead to disparities in the treatment of patients. According to workgroup participants, when presented with a prescription for an opioid, potential red flags that something is amiss include the following: ❚❚ Modification of the prescription ❚❚ Dosage that seems inappropriate ❚❚ Filling the prescription too frequently ❚❚ Multiple prescribers ❚❚ A prescription that appears inconsistent with the patient’s demeanor ❚❚ A prescription that is outside the scope of practice of the prescriber ❚❚ Patient’s physical appearance suggests drug misuse or abuse (e.g., injection marks, dilated pupils) ❚❚ Patient paying cash for an opioid prescription ❚❚ Patient’s only prescription is an opioid or the only one he or she is adherent to is an opioid ❚❚ Patient presents with several prescriptions for a cocktail of drugs that does not make therapeutic sense Participants also noted that if an illicit prescription appears to be legitimate and is filled, it is likely that many other purported patients will present with identical prescriptions within a short period of time. The sudden appearance of multiple very similar prescriptions from the same prescriber is a clear indicator that something is amiss and should be reported to law enforcement. Other resources for identifying patient and prescription red flags are available to support pharmacists when they are evaluating patients and prescriptions for potential opioid misuse or abuse. These resources include the DEA and VIGIL (verification, identification, generalization, interpretation, and legalization), which prese12 JAPhA | 5 4:1 | JAN/F EB 2014
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ent strategies that align with those proposed during the meeting (Appendices 4 and 5). Pharmacists need to be thoughtful regarding which red flags would trigger a concern and be mindful that a red flag is merely a trigger for further investigation and not a clear indicator of wrong doing. In general, a single instance of a red flag (e.g., request for an early refill) may be due to a legitimate reason; however, a consistent pattern (e.g., repeated early refill requests) is more of a concern. Participants noted that context is critical and that additional caution may be necessary for a new patient compared with one with whom the pharmacist has a relationship. Some stores have specific policies regarding actions to take if red flags are identified. The group stressed that pharmacists are ethically obligated to perform due diligence when assessing concerns. When in doubt, pharmacists should seek outside verification. Collaborating with other health care providers is essential. However, participants acknowledged that time limitations make it challenging to perform due diligence when assessing the validity of a prescription. The group also indicated that more widespread implementation of electronic health records, including electronic prescribing and PDMPs, are improving the ability of pharmacists to distinguish legitimate prescriptions from illicit ones. They recommended that pharmacists should use these resources whenever possible and within the parameters and capabilities at their disposal. Use of PDMP data during the dispensing process can be used to identify potential misuse or increase pharmacists’ level of comfort regarding a patient. However, participants noted that depending on how they are designed, use of PDMPs can be cumbersome and inefficient. Further, often no clear guidance exists regarding Journal of the American Pharmacists Association
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when pharmacists should query the PDMP system. Efforts are under way to integrate PDMPs into the workflow process. Developing electronic health record systems that are accessible to pharmacists, interoperable with both dispensing systems and PDMP systems, and allow PDMP data to automatically be presented to the pharmacist during the dispensing process would address many of these barriers. Another important issue raised by the group was lack of clarity on interpreting data found in a PDMP. No specific threshold exists above which it is clear that a patient is “doctor shopping.” For example, it may be reasonable for a patient to visit several prescribers, including specialists, within the span of a few months, particularly if they are seeking a diagnosis or have uncontrolled pain. They noted that if the PDMP reveals several prescribers, discussing this finding with the patient to assess whether a legitimate explanation exists is important. Further, pharmacists should assess whether the prescribers are aware of each other. Managing the risk of opioid misuse Workgroup participants were asked to consider strategies that could be used to manage risk related to opioids. Discussions included legislative and regulatory strategies, health care provider strategies, store-level strategies, and patient-level strategies. Legislative and regulatory strategies addressing opioids. The group noted that prescribing standards are in development in some states. However, when additional state regulations exist, pharmacists have the added burden of determining whether physicians comply with state regulations, yet pharmacists are not compensated for their time for this activity. In addition, the group reported that the recent implementation of the REMS for LA/ER opioids has heightened awareness of issues surrounding opioid misuse and the importance of patient and provider education. Health care provider–level strategies. In addition to the education provided as a component of the LA/ER opioid REMS, participants called for greater education for a variety of groups, including physicians and patients, to inform them about the activities that pharmacists engage in to validate prescriptions. The group felt that if others are aware of pharmacists’ responsibilities and activities for managing opioids, they may be less frustrated by questions they receive from pharmacists. Additional training of all health care providers, including pharmacists, will help support appropriate management of situations related to opioids, such as undertreated pain and misuse/abuse/addiction. The group also noted that in addition to the need to prevent opioid misuse, data on drug overdoses point to a need for overdose prevention and education. The National Drug Control Strategy supports overdose training and emergency intervention, such as having first Journal of the American Pharmacists Association
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responders carry naloxone. Health care providers can inform patients who use opioids about the potential for, signs of, and interventions to use in case of overdose. Pharmacy-level strategies. Participants recommended that pharmacies should establish policies related to the dispensing of opioids that address a variety of situations, including when a PDMP should be queried, how questionable situations should be managed, and other situations that relate to opioids. They proposed that opioid-related policies can be developed as part of larger quality management programs run by the pharmacy. Clearly stated policies can help alleviate concerns that pharmacists have regarding appropriate actions to take in a variety of ambiguous situations and can help to ensure consistency and prevent bias. The group commented that many pharmacies have policies that prevent pharmacists from describing controlled substance inventory levels over the phone. However, this creates a barrier for legitimate patients who must travel from store to store to find a medication and is an issue especially for patients with transportation challenges. The group proposed that in select cases where a relationship exists between the prescriber and the pharmacist, it may be appropriate to have a physician call a pharmacy to check stock on behalf of a patient. This may be particularly reasonable in cases where the medication in question is affected by a supply shortage. Patient-level strategies. Participants noted that, as the “gatekeepers” to opioid medications, pharmacists make the final determination whether to dispense an opioid and must carefully assess each prescription that is presented. After an initial assessment and opioid prescription, pharmacists can play an important role in the ongoing monitoring of patients to assess whether opioids have had an overall positive or negative effect—a role that is often unfilled in today’s health care system. The group recommended a number of tools that can be used to assess patient risk for opioid misuse (Appendix 6). They also noted that carefully discussing all issues relating to a patient’s pain management is complex and may be best performed in the context of a medication therapy management (MTM) visit. Participants recommended the use of MTM interventions that allow for initial and ongoing patient assessment and monitoring. They group also noted that pharmacists who provide MTM services to patients with pain will be more familiar with patients’ diagnoses, indications for treatment, treatment goals, and responses to therapy. They will be better able to work with patients to optimize treatment and manage any adverse events that arise, including misuse and issues such as constipation. They proposed that structured opioid education, such as that called for in REMSs, could be delivered in the context of MTM services for patients receiving opioid therapy, particularly for those with chronic pain. Participants noted that provision of MTM services j apha.org
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to patients receiving opioids would be an excellent strategy to support more widespread and thorough opioid risk assessments. An MTM encounter would allow for more in-depth patient assessment, ongoing monitoring, and relationship building that are necessary for preventing and managing misuse of opioids. MTM visits also would allow pharmacists to administer screening tools, allot time for interfacing with PDMP programs, and support collaboration with other members of the health care team. In addition, for patients in recovery from opioid addiction who have severe painful conditions and require opioid treatment, MTM encounters would allow for the type of close monitoring necessary to appropriately manage the patient. Available data support the observations of the conference participants. Provision of pain care services by pharmacists has been found to improve opioid prescribing, documentation, and monitoring so that practices are aligned with chronic nonmalignant pain management guidelines.22 Further, current evidence suggests that not all primary care providers perform adequate opioid risk assessments and that pharmacists can play an important role filling this gap.23 The group called for increased third-party reimbursement for MTM services to make this strategy viable in greater numbers of practice settings. Finally, participants noted that in addition to monitoring patient use of opioids to ensure that patients are not misusing or abusing the medications themselves, clinicians must warn against diversion of the medications. Participants indicated that patient education also must focus on the risks associated with sharing medications. Patients should be educated not to share their medications and to store them in a secure location, possibly a locked safe. In addition, pharmacists should verify that patients are prescribed an appropriate amount of medication for their condition, in order to reduce the likelihood of leftover medication that could be diverted. Strategies to address confirmed misuse, abuse, diversion Conference participants were asked to consider the actions that pharmacists should take in the event of confirmed misuse of opioid medications when not medically indicated, addiction to opioid medications, or diversion of opioids. Participants reported that if misuse of an opioid is identified, pharmacists should consider the possibility of pseudoaddiction, assess whether patients are receiving proper pain management, and follow-up with prescribers as appropriate to address patient needs. If the evidence the pharmacist is able to gather is suggestive of misuse or abuse of the medication, the pharmacist should refuse the prescription and indicate the problem in the PDMP (where available). Participants disagreed regarding how to handle hardcopies of fraudulent prescriptions. An industry standard for e14 JAPhA | 5 4:1 | JAN/F EB 2014
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handling fraudulent prescriptions does not appear to exist; however, some pharmacies have policies in place. Some participants reported that they would return the prescription to the patient and call neighboring pharmacies to inform them of their concerns about the patient. Some reported that they would document on the back of the prescription their reasons for not filling it. Others reported keeping the hardcopy prescription. If opioid addiction is identified, participants felt that patients should be referred to addiction treatment resources. However, depending on a patient’s disposition, the pharmacist may choose to call emergency medical services, law enforcement, or store management. Participants noted that physical safety is paramount and that pharmacists should provide the requested opioids if physically threatened. Participants called for pharmacy management to develop standard policies and procedures to follow in various situations. Regardless of the action taken, pharmacists should document all interactions and referrals. If the pharmacist determines that an individual is attempting to divert medications (i.e., obtain medications with the intent of giving or selling them to other individuals), they should notify the prescriber, as well as local law enforcement and the local DEA office. They also can place an alert in the PDMP. To minimize personal and professional risk, participants stressed the importance of maintaining objectivity and professionalism when communicating with patients, particularly when abuse/addiction/diversion is suspected. Performing due diligence to find out all the information needed to make an informed decision and working with the entire health care team are important. In addition, the actions taken and rationale supporting pharmacists’ decisions should be documented carefully. Pharmacists should familiarize themselves with resources to refer patients to if misuse, abuse, or addiction is suspected. Each pharmacy or pharmacist should develop a list of local providers for referrals, including addiction-related treatment centers and resources and a list of physicians who provide good pain management. Participants felt that ethically, it is important not to lie to patients about the stock of a controlled substance. If the pharmacist has a reason not to fill the prescription, he or she should tell the patient (assuming that the pharmacist does not feel that his or her personal safety would be threatened by doing so). If concerns exist about misuse or abuse, then the pharmacist should give the patient information about treatment options. If, on the other hand, an explanation does exist, the honest information gives the patient the opportunity to explain him or herself. However, if a pharmacist concludes that a prescription is not legitimate but does not feel safe confronting the patient, he or she may tell the patient that the pharmacy is out of stock.
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Conclusion Ensuring access to opioids for patients who have a legitimate need while working to prevent misuse, abuse, and diversion is a complex balancing act for pharmacists. In addition to complying with federal and state regulations governing controlled substances, pharmacists must exercise diligence and careful judgment. They must assess the appropriateness of opioid prescriptions, weigh the risks and benefits of opioids for individual patients, and attempt to discern whether patients are presenting legitimate prescriptions. Finally, pharmacists must consider the importance of their own physical safety and security when working with controlled substances. Although eliminating misuse, abuse, and diversion of opioids may not be possible, conference participants felt that pharmacists’ use of a number of tools and strategies would improve patient management and benefit public health. If they have access to necessary tools and resources, pharmacists can assess the likelihood that prescriptions are legitimate and manage risks associated with opioids. Tools and resources that could improve pharmacists’ ability to achieve balance in managing opioids include efficient access to electronic health records that include PDMPs, access to local pain management and addiction specialists, and integration in new payment models for pharmacist services. Implementing systems and processes that support pharmacist management of opioid-related issues under financially viable business models would create a number of opportunities to improve patient care. References 1. American Academy of Pain Medicine, American Pain Society, American Society of Addiction Medicine. Definitions related to the use of opioids for the treatment of pain: consensus statement. www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policystatements/2011/12/15/definitions-related-to-the-use-of-opioids-forthe-treatment-of-pain-consensus-statement. Accessed May 21, 2013. 2. American College of Preventive Medicine. Use, abuse, misuse, and disposal of prescription pain medication clinical reference. www.acpm. org/?UseAbuseRxClinRef. Accessed May 21, 2013. 3. Crespi-Lofton J. Early refills are opportunity to improve patient care. Pharmacy Today. 2011;17(12)58–60. 4. Substance Abuse and Mental Health Services Administration. Results from the 2011 National Survey on Drug Use and Health: past year initiates of specific illicit drugs among persons aged 12 or older: 2011. www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresults2011. htm#5.2. Accessed May 21, 2013. 5. Birnbaum HG, White AG, Schiller M, et al. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12(4):657–67. 6. National Center for Health Statistics. Drug poisoning deaths in the United States, 1980–2008. www.cdc.gov/nchs/data/databriefs/db81.htm. Accessed May 21, 2013. 7. National Center for Health Statistics. CDC WONDER database: multiple cause of death 2000-2010. http://wonder.cdc.gov. Accessed May 1, 2012. Journal of the American Pharmacists Association
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8. Lankenau SE, Teti M, Silva K, et al. Initiation into prescription opioid misuse amongst young injection drug users Int J Drug Policy. 2012;23(1):37–44. 9. Substance Abuse and Mental Health Services Administration. Results from the 2011 National Survey on Drug Use and Health: discussion of trends in marijuana, prescription drug, heroin, and other substance use among youths and young adults. www.samhsa.gov/data/ NSDUH/2k11Results/NSDUHresults2011.htm#Ch8. Accessed December 26, 2012. 10. Banta-Green CJ. Adolescent abuse of pharmaceutical opioids raises questions about prescribing and prevention. Arch Pediatr Adolesc Med. 2012;166(9):865–6. 11. Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: national findings. http://oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf. Accessed November 6, 2013. 12. Substance Abuse and Mental Health Services Administration. State estimates of nonmedical use of prescription pain relievers. www.samhsa. gov/data/2k12/NSDUH115/sr115-nonmedical-use-pain-relievers.htm. Accessed January 19, 2013. 13. Food and Drug Administration. Risk evaluation and mitigation strategies for certain opioid drugs; notice of public meeting. Fed Regist. 2009;74(200):17967–70. 14. Food and Drug Administration. Questions and answers: FDA requires a risk evaluation and mitigation strategy (REMS) for long-acting and extended-release opioids. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251752.htm. Accessed June 25, 2012. 15. Matthews ML. Class-wide REMS for extended-release and longacting opioids: potential impact on pharmacies. J Am Pharm Assoc. 2013;53(1):e1–7. 16. Clark T, Eadie J, Knue P, et al. Prescription drug monitoring programs: an assessment of the evidence for best practices. www.pdmpexcellence.org/sites/all/pdfs/Brandeis_PDMP_Report.pdf. Accessed December 19, 2012. 17. Department of Justice, Drug Enforcement Administration, Office of Diversion Control, National Alliance for Model State Drug Laws. Diversion and abuse of prescription drugs: a closer look at state prescription monitoring programs. Washington, DC: Drug Enforcement Administration; 2000. 18. Reifler LM, Droz D, Bailey JE, et al. Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Med. 2012;13(3):434–42. 19. Baehren DF, Marco CA, Droz DE, et al. A statewide prescription monitoring program affects emergency department prescribing behaviors. Ann Emerg Med. 2010;56(1):19-23.e1-3. 20. American Pharmacists Association. Code of Ethics for Pharmacists. www.pharmacist.com/code-ethics. Accessed May 21, 2013. 21. American Society of Health-System Pharmacists. ASHP statement on the pharmacist’s role in substance abuse prevention, education, and assistance. Am J Health Syst Pharm. 2003;60(19):1995–8. 22. Li RM, Franks RH, Dimmitt SG, Wilson GR. Ideas and innovations: inclusion of pharmacists in chronic pain management services in a primary care practice. J Opioid Manag. 2011;7(6):484–7. 23. Salinas GD, Susalka D, Burton BS, et al. Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: a national multifaceted assessment of physicians, pharmacists, and their patients. J Opioid Manag. 2012;8(5):273–84.
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Pharmacists’ role in addressing opioid abuse, addiction, and diversion American Pharmacists Association
Abstract
Received May 21, 2013, and in revised form September 3, 2013. Accepted for publication September 18, 2013.
Objective: To review the scope of the problem of opioid misuse; explore pharmacists’ roles and responsibilities regarding opioid use; discuss existing laws, guidelines, and regulations governing opioid management; identify potential patient and practice management strategies to address opioid abuse; and disseminate leader insights on these issues.
Correspondence: James A. Owen, BSPharm, PharmD, BCPS, Associate Vice President, Professional Practice, American Pharmacists Association, 2215 Constitution Ave., NW, Washington DC 20037. E-mail: [email protected]
Data sources: Information presented at a conference convened by the American Pharmacists Association (Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion; held November 15, 2012) and discussed in conference workgroups , as well as related information from the literature. Summary: Opioid misuse, abuse, and diversion has grown dramatically since the early 1990s and affects public health considerably. In 2011, more individuals died from drug overdoses than from motor vehicle accidents. Strategies are available that pharmacists can use to reduce the likelihood of opioid misuse, abuse, and diversion while minimizing the impact on legitimate pain management efforts. These strategies and tools can be used to support (1) the assessment of prescriptions that are presented for opioid medications, (2) the management of patients receiving opioids, and (3) follow-up options when misuse, abuse, or diversion has been identified. Conclusion: Implementation of systems and processes that support pharmacist management of opioid-related issues under financially viable business models would create a number of opportunities to improve patient care.
This publication was prepared by Judy Crespi Lofton, MS, Medical Writer and Consultant, Schwenksville, PA, in conjunction with staff from the American Pharmacists Association. Disclosure: Ms. Crespi Lofton and APhA staff declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: The American Pharmacists Association meeting, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion, and this article were supported by Purdue Pharma LP, Teva Pharmaceutical Industries Ltd., Endo Pharmaceuticals, and Mallinckrodt, The Pharmaceuticals business of Covidien. Published online early at www.japha.org on November 20, 2013.
Keywords: Addiction, laws and regulations, medication therapy management, opioids, pain management, pharmacists, pharmacy. J Am Pharm Assoc. 2014;54:e5–e15. doi: 10.1331/JAPhA.2014.13101
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Issues for pharmacists managing opioids Although opioids are widely regarded as the most effective agents for treating many types of pain, they also have the potential to be misused and abused. These features make the management of opioids complex. When dispensing opioids, pharmacists have a responsibility to ensure that patients in pain receive appropriately prescribed opioids. This responsibility must be balanced with the responsibility not to permit the misuse or diversion of controlled substances by patients or other individuals. Definitions related to the use of opioids can be found in Table 1.1,2 Pharmacists’ responsibilities regarding opioids often can conflict with each other. Dispensing opioids without carefully assessing each prescription may increase misuse and diversion. On the other hand, efforts to reduce misuse and diversion may result in denying legitimate patients medications or result in the creation of additional barriers for pain patients. Pharmacists must manage these responsibilities within an environment of potential regulatory scrutiny if they inadvertently dispense medications to diverters or abusers. Thus, it is imperative that pharmacists carefully balance these two responsibilities in their practice.
At a Glance Synopsis: The misuse, abuse, and diversion of opioids have increased dramatically since the early 1990s, resulting in a considerable impact on public health. Participants at a conference convened by the American Pharmacists Association discussed a number of tools and strategies that can help address opioid abuse, addiction, and diversion and benefit public health. To address this critical issue, pharmacists can support (1) the assessment of prescriptions that are presented for opioid medications, (2) the management of patients receiving opioids, and (3) follow-up options when misuse, abuse, or diversion has been identified. Analysis: Ensuring access to opioids for patients who have a legitimate need while working to prevent misuse, abuse, and diversion is a complex balancing act for pharmacists. In addition to complying with federal and state regulations governing controlled substances, pharmacists must exercise diligence and careful judgment. They must assess the appropriateness of opioid prescriptions, weigh the risks and benefits of opioids for individual patients, and attempt to discern whether patients are presenting legitimate prescriptions. Pharmacists also must consider the importance of their own physical safety and security when working with controlled substances.
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Guidance and tools are available that may help pharmacists achieve a balance between patient care and management of opioids. These include federal and state laws, state practice standards, and store-level policies. However, current evidence suggests that achieving an appropriate balance is a struggle for pharmacists.3
Pharmacists’ role in addressing opioid abuse, addiction, and diversion To engage national leaders in a discussion about opioid abuse, addiction, and diversion and to explore strategies that pharmacists could use to balance their responsibilities related to opioids, the American Pharmacists Association (APhA) convened a conference, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion, on November 15, 2012. The conference was attended by subject matter experts and pharmacy thought leaders. Conference participants (Table 2) heard a series of presentations related to opioid misuse and abuse and to opioid management laws, regulations, guidelines, and tools. The presentations were followed by facilitated workgroup sessions and group discussion focused on tools and strategies that can be used to address opioidrelated issues in pharmacy practice. This article presents information from conference presentations and discussions. Supporting information from the literature is provided in the appendices. This article should not be considered a set of best practice recommendations. Rather, it reports on the collective dialogue among pharmacy thought leaders and is intended to provide information for pharmacists, pharmacies, and other stakeholders who grapple with this issue.
Issues surrounding opioid misuse and management strategies Conference presentations focused on a variety of issues, including data regarding use and abuse of opioids, federal oversight of opioid use, state-level regulation of opioids, and guidance from professional societies. Data regarding use and abuse of opioids The conference began with a look at data that quantify the current problem of opioid misuse and abuse. A dramatic increase in the misuse and abuse of opioids occurred in the previous decade, creating a public health issue that has been called an epidemic. In 2011, 6.1 million Americans reported current nonmedical use of prescription drugs.4 The cost of prescription drug abuse was $55.7 billion in 2007, including $24.7 billion in direct health care costs.5 Along with the rise in misuse and abuse of opioids, the number of drug overdose deaths in the United States rose dramatically through the 1990s and 2000s. In 2010, more people in the United States died from drug overdoses than from motor vehicle accidents (Figure 1).6,7 Journal of the American Pharmacists Association
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Table 1. Definitions related to the use of opioids Term Abuse
Definition Self-administration of medications to alter one’s state of consciousness (i.e., “get high”). This is an intentional, maladaptive pattern of use of a medication (whether legitimately prescribed or not) leading to major impairment or distress (e.g., repeated failure to fulfill role obligations, recurrent use in situations in which it is physically hazardous, multiple legal problems, recurrent social and interpersonal problems) occurring during a 12-month period. Addiction is a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Redirection of a prescription drug from its lawful purpose to illicit use; can be done with criminal intent. The intentional or unintentional use of a prescribed medication in a manner that is contrary to directions, regardless of whether a harmful outcome occurs. Physical dependence is a state of adaptation that often includes tolerance and is manifested by a drug class–specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Patients with pseudoaddiction exhibit behaviors of addiction (frequently asking for more analgesics or higher doses) that resolve when pain is adequately treated. Patients often are coined as “drug seeking.” The cause is inadequate analgesic management, and the treatment for pseudoaddiction is adequate analgesic management. Pseudoaddiction results in a crisis of mistrust between the patient and staff and threatens the ability to provide analgesic management. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.
Addiction
Diversion Misuse Physical dependence
Pseudoaddiction
Tolerance Source: References 1 and 2.
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Motor vehicle traffic
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Deaths per 100,000 population
20
15
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1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010
Figure 1. U.S. overdose death rate trends: 1980–2010 Source: References 6 and 7.
Prescription drugs, particularly opioids, are the primary cause of these deaths (Figure 2). Of the more than 38,300 drug overdose deaths in 2010 (including medications and illicit drugs), approximately 16,700 involved opioid painkillers (compared with 4,200 for cocaine and 3,000 for heroin).6,7 The increase in opioid misuse and abuse also has been accompanied by an increase in heroin use. Injection drug users have reported that prescription opioid use Journal of the American Pharmacists Association
predated their heroin use and that tolerance motivated them to try heroin.8 The average number of heroin users, the number of individuals who started using heroin, and the number of individuals seeking treatment for heroin use increased dramatically from the early 2000s to 2011.9,10 In addition to preventing drug use escalation by individuals who are misusing opioids, preventing new individuals from initiating opioid misuse is critical. j apha.org
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Table 2. Participants in the APhA conference, Pharmacists’ Role in Addressing Opioid Abuse, Addiction, and Diversion Jennifer Adams, PharmD Senior Director, Strategic Academic Partnerships, American Association of Colleges of Pharmacy, Alexandria, VA Bona Benjamin, BSPharma Director, Medication-Use Quality Improvement, Coordinator, Drug Resources Center, American Society of Health-System Pharmacists, Bethesda, MD Heather Bonome, PharmD Clinical Account Executive, Express Scripts, Washington, DC Marcie Bough, PharmDb Senior Director, Government Affairs, American Pharmacists Association, Washington, DC Mary Jo Carden, BSPharm, JDa Director of Regulatory Affairs, Academy of Managed Care Pharmacy, Alexandria, VA Bethany DiPaula, PharmD, BCCP Associate Professor, School of Pharmacy, University of Maryland, Baltimore Carolyn Ha, PharmD Director, Professional Affairs, National Community Pharmacists Association, Alexandria, VA Michael Jackson, BSPharm Executive Vice President and Chief Executive Officer, Florida Pharmacy Association, Tallahassee Kathleen Jaeger, BSPharm, JD Senior Vice President, Pharmacy Care and Patient Advocacy, President, NACDS Foundation, National Association of Chain Drug Stores, Alexandria, VA Lloyd Jessen, BSPharm, JDa Executive Director, Iowa Board of Pharmacy, Des Moines Nik Johnson, CPhT Pharmacy Affairs Program Manager, Academy of Managed Care Pharmacy, Alexandria, VA LCDR Christopher M. Jones, PharmD, MPHa Acting Team Lead, Prescription Drug Overdose Team, Division of Unintentional Injury, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Chamblee, GA Regina LaBelle, JDa Chief of Staff, White House Office of National Drug Control Policy, Washington, DC Claudia Manzo, PharmD Director of the Division of Risk Management, Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD Meagan McCrane Health and Wellness Department, Food Marketing Institute, Arlington, VA Suzanne Amato Nesbit, PharmD, CPE Clinical Pharmacy Specialist, Pain Management, Research Associate, Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, MD James A. Owen, PharmD, BCPSb Senior Director, Professional Practice, American Pharmacists Association, Washington, DC Tasha Polster, BSPharm Director of Pharmaceutical Integrity, Walgreens Company, Deerfield, IL e8 JAPhA | 5 4 : 1 | JAN/F EB 2014
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Table 2 continued Jeff Porter, BSPharm Pharmacy Merchandiser–Kroger Pharmacy Delta Division, Kroger Pharmacy, Memphis, TN Rebecca Snead, BSPharm Executive Vice President and Chief Executive Officer, National Alliance of State Pharmacy Associations, Richmond, VA Lisa Strucko, PharmD Director of Pharmacy, Leesburg Pharmacy, Leesburg, VA Lorinda Tisdell Executive Director, Pharmacy Operations, Walgreens Company, Deerfield, IL Peter Van Pelt, BSPharmb Associate Director, Corporate Alliances, American Pharmacists Association, Washington, DC C. Edwin Webb, PharmD, MPH Associate Executive Director, Director, Government and Professional Affairs, American College of Clinical Pharmacy, Washington, DC Moderator: Harry Hagel, BSPharm Independent Consultant, Austin, TX Presenter. Small-group facilitator.
a
b
As shown in Figure 3, the majority of those who report misuse of opioids obtain the medications from a friend or relative.11 Often the medication is offered for free; in other cases, individuals take it without asking. Particularly for recent initiates, the percentage who pay for the opioid from a friend or dealer or via the Internet is rather small. Thus, strategies that prevent inappropriate sharing of medications are critical to prevent the initiation of opioid misuse. These data have supported the implementation of strategies to address the problem of opioid use and abuse, some of which are discussed in the following sections. More recent data suggest that these strategies have resulted in some progress, with the national rate of past-year nonmedical use of prescription pain relievers among those 12 years or older dropping from 4.9% in 2009–10 to 4.6% in 2011.12 Federal oversight of opioid use On a national level, several government organizations are involved in regulating the use of opioids, including the White House Office of National Drug Control Policy, Drug Enforcement Administration (DEA), and Food and Drug Administration (FDA). During the invitational conference, information about the use of risk evaluation and mitigation strategies (REMSs) was presented. Information regarding other select programs, requirements and initiatives can be found in Appendices 1 and 2. FDA’s role in opioid regulation: REMSs. FDA has begun to address the management of opioids through various tools, including the use of REMSs. A 2007 law directed FDA to develop REMSs to manage risks when needed to ensure that the benefits of a medication outJournal of the American Pharmacists Association
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Figure 2. Overdose deaths for specific drugs: 1999-2010 Source: Reference 6 and 7.
Figure 3. Source of prescription pain relievers Source: Reference 11. Journal of the American Pharmacists Association
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weigh its risks, and FDA has applied this law to address risk management for opioids.13 A REMS can include communication tools and elements to ensure safe use, such as requiring specific training for health professionals, restricted distribution, patient registries, and/or other patient monitoring. In April 2009, FDA announced that it was exploring the development of a single shared-system REMS for long-acting (LA)/extended-release (ER) opioids.13 Although improper use of any opioid can result in serious consequences, FDA focused on LA/ER opioid products because if used improperly, they can result in even greater risk than an immediate-release opioid product. The increased risk occurs because the amount of opioid contained in an LA/ER tablet often is much greater than the amount of opioid contained in an immediate-release product and can take much longer to be cleared out of the body.14 In April 2011, FDA announced the specific elements of the LA/ER REMS: All manufacturers of LA/ER opioids must ensure that training is provided to prescribers of these medications and develop information that prescribers can use when counseling patients about the risks and benefits of opioid use. (Of note, pharmacists are absent from the REMS program.15) The list of opioid products that are required to have a REMS can be found at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm. Prescriber education includes information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, prescribers will receive training to recognize evidence of and potential for opioid misuse, abuse, and addiction.14 The REMS will include education materials that prescribers can provide to patients on how to use and store these products safely. Prescribers will be educated to properly counsel patients on safe use and the responsibilities associated with using these products, and patients will receive Medication Guides when they pick up their prescriptions. (Medication Guides are designed to provide information in patient-friendly language about the medication’s risks and how to use the medication safely.14) FDA is implementing the REMS in a stepwise fashion to minimize the impact and burden on the health care system and patients. The plan for assessment of the LA/ER REMS includes a goal of having 80,000 active prescribers trained within the first 2 years of the program, 160,000 active prescribers within 3 years, and 192,000 active prescribers within 4 years. In addition, patients’ and health care providers’ understanding of the risks of the medications will be evaluated. Drug use will be monitored, and the surveillance plan will include monitoring for misuse, abuse, overdose, addiction, and e10 JAPhA | 5 4:1 | JAN/F EB 2014
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death, with information specifically tracked to different risk groups, settings, and medications. At this time, the education program is voluntary for health care providers. FDA is working with lawmakers with the goal of adding an education requirement to the DEA licensure process. If such a requirement is implemented, it would be mandatory for licensure and would circumvent the need to create a separate registration system.14 Other FDA efforts to reduce the misuse and abuse of opioids include the development of abuse-resistant formulations, stimulating the development of physician– patient agreements (Appendix 3), and efforts to educate patients to properly dispose of unused medications. An overview of FDA’s activities to address the misuse and abuse of opioids can be found at www.fda.gov/Drugs/ DrugSafety/InformationbyDrugClass/ucm337852. htm. Additional information about opioids can be found at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm. State-level regulation of opioids On a state level, opioids are regulated through a variety of laws, including state practice acts and the more recent implementation of prescription drug monitoring programs (PDMPs). States may exercise stricter, but not less stringent, regulations than federal regulations. For example, states may require patients to present identification when picking up medications in a specific schedule and/or may require pharmacist to review a PDMP in certain situations. States regulate the practices of medicine and pharmacy through their health care practice acts and have been responsible for establishing whether the use of a medication constitutes a legitimate medical practice. The National Association of Boards of Pharmacy has issued a model state pharmacy act that covers a wide range of issues related to the practice of pharmacy. Several state practice acts have provisions that are relevant to the use of opioids. For example, the model act and many state acts call for pharmacists to work to optimize patient outcomes, which may be particularly relevant for patients with undertreated pain. Some state practice acts have requirements for when pharmacists should review PDMPs. In addition, many state boards have policy statements on pain management. The Pain and Policy Studies Group at the University of Wisconsin maintains a database of laws, regulations and other policies for pain management for all states except Illinois and Indiana. The database can be accessed at www.painpolicy.wisc.edu/database-statutes-regulations-other-policies-pain-management. PDMPs. PDMPs are statewide electronic databases that collect data about the prescribing and dispensing of scheduled substances. PDMPs are used as a tool to help prevent drug abuse and diversion while supportJournal of the American Pharmacists Association
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ing legitimate access to controlled substances. Health care providers can use PDMPs to ensure that patients are not “doctor shopping” (i.e., obtaining prescriptions for controlled substances from multiple prescribers and pharmacies). The specific requirements and features of each PDMP vary from state to state. As of November 2012, 49 states had legislation authorizing a PDMP and 42 states had operational systems. The National Alliance for Model State Drug Laws (www.namsdl.org) provides links to each state’s statutes and regulations regarding PDMPs. The Prescription Drug Monitoring Program Center of Excellence released a report on PDMP best practices in September 2012. Selected features and activities of PDMPs that were listed as best practices in the report include16: ❚❚ Allowing prescribers and dispensers access to the database. ❚❚ Allowing database access to regulatory boards, state Medicaid and public health agencies, medical examiners, and law enforcement (under appropriate circumstances). ❚❚ Providing real-time data and access. ❚❚ Sharing data with other states. ❚❚ Integrating with other health information technology to improve use among health care providers. According to DEA, PDMPs can deter would-be diverters, and states that have implemented such programs have reported decreases in abuse and diversion of the monitored drugs. Pharmacists in states that use these programs have reported increased levels of confidence in dispensing controlled substances.17 States with PDMPs have been found to have lower substance abuse treatment rates for opioids. An analysis of poison control center data from 2003 to 2009 found that states with PDMPs had lower annual increases in opioid misuse/abuse than other states.18 In another study of emergency department prescribing, implementing a PDMP resulted in modifications to opioid prescribing. After review of the PDMP data, providers changed the clinical management for patients with nontraumatic pain in 41% of cases. In cases of altered management, the majority (61%) resulted in fewer or no opioid medications prescribed than originally planned, whereas 39% resulted in more opioid medication than previously planned.19 These data support the conclusion that PDMPs can reduce misuse and increase prescriber comfort levels for legitimate patients. Guidance from professional societies Few legal or regulatory consequences exist for refusing to dispense legitimate prescriptions. A legitimate patient who is denied treatment can file a complaint with the store’s management or with the state board of pharmacy, and prescribers may become frustrated and send their patients elsewhere. To ensure balance, pharmacists Journal of the American Pharmacists Association
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must consider their ethical obligations to resolve patients’ drug therapy problems and ensure that patients receive appropriate therapy. Professional pharmacy associations, including APhA and the American Society of Health-System Pharmacists (ASHP), provide guidance to address this issue. For example, several aspects of APhA’s Code of Ethics for Pharmacists are relevant to the management of opioids (Table 3).20 The code of ethics calls upon pharmacists to provide the best possible care to patients, treat patients with “a caring attitude and compassionate spirit,” and act in the best interest of patients. The code also acknowledges that pharmacists must balance the needs of individual patients (e.g., those with a legitimate need for opioids) with those of broader public health objectives (e.g., need to prevent opioid misuse and abuse). ASHP has developed a position statement on pharmacists’ role in substance abuse prevention, education, and assistance.21 According to this statement, pharmacists have a unique specialized body of knowledge, skills, and responsibilities for assuming an important role in substance abuse prevention, education, and assistance. This statement identifies key organizational and societal roles of health system pharmacists and defines a list of activities for pharmacists to address the problem of substance abuse.
Approaches for pharmacist management of opioid risks The legal and regulatory opioid management framework and guidance from professional societies discussed by the conference presenters provided tools and strategies to support pharmacists as they work to balance their opioid-related roles. During the subsequent workgroup discussions, participants explored how these and other tools and strategies could be used to address three issues that arise when managing opioids in pharmacy practice: (1) identifying potential opioid misuse or abuse, (2) policies and procedures to manage risk of opioid misuse, (3) strategies to use when misuse, abuse, and/or diversion of opioids are confirmed. Highlights of group discussions are presented here but are not intended to represent best practice recommendations. Identifying potential opioid misuse or abuse A key issue in preventing the misuse and abuse of opioids is evaluating patients and prescriptions for potential opioid misuse or abuse. Conference participants were asked to list signs that could potentially suggest that a prescription is fraudulent. Participants noted that identifying patients who are dishonest and seeking opioids for abuse or diversion is difficult. Participants noted the importance of consistently applying criteria for assessing legitimacy of prescriptions, so that disparities based on race/ethnicity, socioeconomic status, or j apha.org
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Table 3. Selected provisions from the Code of Ethics for Pharmacists Selected provision Preamble
I. A pharmacist respects the covenantal relationship between the patient and pharmacist. II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. IV. A pharmacist acts with honesty and integrity in professional relationships. VII. A pharmacist serves individual, community, and societal needs.
Details “Pharmacists are health professionals who assist individuals in making the best use of medications. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are established to guide pharmacists in relationships with patients, health professionals, and society.” “Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust.” “A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.” “A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients.” “The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly.”
Adopted by the membership of the American Pharmacists Association, October 27, 1994. Source: Reference 20.
other factors do not inadvertently lead to disparities in the treatment of patients. According to workgroup participants, when presented with a prescription for an opioid, potential red flags that something is amiss include the following: ❚❚ Modification of the prescription ❚❚ Dosage that seems inappropriate ❚❚ Filling the prescription too frequently ❚❚ Multiple prescribers ❚❚ A prescription that appears inconsistent with the patient’s demeanor ❚❚ A prescription that is outside the scope of practice of the prescriber ❚❚ Patient’s physical appearance suggests drug misuse or abuse (e.g., injection marks, dilated pupils) ❚❚ Patient paying cash for an opioid prescription ❚❚ Patient’s only prescription is an opioid or the only one he or she is adherent to is an opioid ❚❚ Patient presents with several prescriptions for a cocktail of drugs that does not make therapeutic sense Participants also noted that if an illicit prescription appears to be legitimate and is filled, it is likely that many other purported patients will present with identical prescriptions within a short period of time. The sudden appearance of multiple very similar prescriptions from the same prescriber is a clear indicator that something is amiss and should be reported to law enforcement. Other resources for identifying patient and prescription red flags are available to support pharmacists when they are evaluating patients and prescriptions for potential opioid misuse or abuse. These resources include the DEA and VIGIL (verification, identification, generalization, interpretation, and legalization), which prese12 JAPhA | 5 4:1 | JAN/F EB 2014
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ent strategies that align with those proposed during the meeting (Appendices 4 and 5). Pharmacists need to be thoughtful regarding which red flags would trigger a concern and be mindful that a red flag is merely a trigger for further investigation and not a clear indicator of wrong doing. In general, a single instance of a red flag (e.g., request for an early refill) may be due to a legitimate reason; however, a consistent pattern (e.g., repeated early refill requests) is more of a concern. Participants noted that context is critical and that additional caution may be necessary for a new patient compared with one with whom the pharmacist has a relationship. Some stores have specific policies regarding actions to take if red flags are identified. The group stressed that pharmacists are ethically obligated to perform due diligence when assessing concerns. When in doubt, pharmacists should seek outside verification. Collaborating with other health care providers is essential. However, participants acknowledged that time limitations make it challenging to perform due diligence when assessing the validity of a prescription. The group also indicated that more widespread implementation of electronic health records, including electronic prescribing and PDMPs, are improving the ability of pharmacists to distinguish legitimate prescriptions from illicit ones. They recommended that pharmacists should use these resources whenever possible and within the parameters and capabilities at their disposal. Use of PDMP data during the dispensing process can be used to identify potential misuse or increase pharmacists’ level of comfort regarding a patient. However, participants noted that depending on how they are designed, use of PDMPs can be cumbersome and inefficient. Further, often no clear guidance exists regarding Journal of the American Pharmacists Association
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when pharmacists should query the PDMP system. Efforts are under way to integrate PDMPs into the workflow process. Developing electronic health record systems that are accessible to pharmacists, interoperable with both dispensing systems and PDMP systems, and allow PDMP data to automatically be presented to the pharmacist during the dispensing process would address many of these barriers. Another important issue raised by the group was lack of clarity on interpreting data found in a PDMP. No specific threshold exists above which it is clear that a patient is “doctor shopping.” For example, it may be reasonable for a patient to visit several prescribers, including specialists, within the span of a few months, particularly if they are seeking a diagnosis or have uncontrolled pain. They noted that if the PDMP reveals several prescribers, discussing this finding with the patient to assess whether a legitimate explanation exists is important. Further, pharmacists should assess whether the prescribers are aware of each other. Managing the risk of opioid misuse Workgroup participants were asked to consider strategies that could be used to manage risk related to opioids. Discussions included legislative and regulatory strategies, health care provider strategies, store-level strategies, and patient-level strategies. Legislative and regulatory strategies addressing opioids. The group noted that prescribing standards are in development in some states. However, when additional state regulations exist, pharmacists have the added burden of determining whether physicians comply with state regulations, yet pharmacists are not compensated for their time for this activity. In addition, the group reported that the recent implementation of the REMS for LA/ER opioids has heightened awareness of issues surrounding opioid misuse and the importance of patient and provider education. Health care provider–level strategies. In addition to the education provided as a component of the LA/ER opioid REMS, participants called for greater education for a variety of groups, including physicians and patients, to inform them about the activities that pharmacists engage in to validate prescriptions. The group felt that if others are aware of pharmacists’ responsibilities and activities for managing opioids, they may be less frustrated by questions they receive from pharmacists. Additional training of all health care providers, including pharmacists, will help support appropriate management of situations related to opioids, such as undertreated pain and misuse/abuse/addiction. The group also noted that in addition to the need to prevent opioid misuse, data on drug overdoses point to a need for overdose prevention and education. The National Drug Control Strategy supports overdose training and emergency intervention, such as having first Journal of the American Pharmacists Association
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responders carry naloxone. Health care providers can inform patients who use opioids about the potential for, signs of, and interventions to use in case of overdose. Pharmacy-level strategies. Participants recommended that pharmacies should establish policies related to the dispensing of opioids that address a variety of situations, including when a PDMP should be queried, how questionable situations should be managed, and other situations that relate to opioids. They proposed that opioid-related policies can be developed as part of larger quality management programs run by the pharmacy. Clearly stated policies can help alleviate concerns that pharmacists have regarding appropriate actions to take in a variety of ambiguous situations and can help to ensure consistency and prevent bias. The group commented that many pharmacies have policies that prevent pharmacists from describing controlled substance inventory levels over the phone. However, this creates a barrier for legitimate patients who must travel from store to store to find a medication and is an issue especially for patients with transportation challenges. The group proposed that in select cases where a relationship exists between the prescriber and the pharmacist, it may be appropriate to have a physician call a pharmacy to check stock on behalf of a patient. This may be particularly reasonable in cases where the medication in question is affected by a supply shortage. Patient-level strategies. Participants noted that, as the “gatekeepers” to opioid medications, pharmacists make the final determination whether to dispense an opioid and must carefully assess each prescription that is presented. After an initial assessment and opioid prescription, pharmacists can play an important role in the ongoing monitoring of patients to assess whether opioids have had an overall positive or negative effect—a role that is often unfilled in today’s health care system. The group recommended a number of tools that can be used to assess patient risk for opioid misuse (Appendix 6). They also noted that carefully discussing all issues relating to a patient’s pain management is complex and may be best performed in the context of a medication therapy management (MTM) visit. Participants recommended the use of MTM interventions that allow for initial and ongoing patient assessment and monitoring. They group also noted that pharmacists who provide MTM services to patients with pain will be more familiar with patients’ diagnoses, indications for treatment, treatment goals, and responses to therapy. They will be better able to work with patients to optimize treatment and manage any adverse events that arise, including misuse and issues such as constipation. They proposed that structured opioid education, such as that called for in REMSs, could be delivered in the context of MTM services for patients receiving opioid therapy, particularly for those with chronic pain. Participants noted that provision of MTM services j apha.org
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to patients receiving opioids would be an excellent strategy to support more widespread and thorough opioid risk assessments. An MTM encounter would allow for more in-depth patient assessment, ongoing monitoring, and relationship building that are necessary for preventing and managing misuse of opioids. MTM visits also would allow pharmacists to administer screening tools, allot time for interfacing with PDMP programs, and support collaboration with other members of the health care team. In addition, for patients in recovery from opioid addiction who have severe painful conditions and require opioid treatment, MTM encounters would allow for the type of close monitoring necessary to appropriately manage the patient. Available data support the observations of the conference participants. Provision of pain care services by pharmacists has been found to improve opioid prescribing, documentation, and monitoring so that practices are aligned with chronic nonmalignant pain management guidelines.22 Further, current evidence suggests that not all primary care providers perform adequate opioid risk assessments and that pharmacists can play an important role filling this gap.23 The group called for increased third-party reimbursement for MTM services to make this strategy viable in greater numbers of practice settings. Finally, participants noted that in addition to monitoring patient use of opioids to ensure that patients are not misusing or abusing the medications themselves, clinicians must warn against diversion of the medications. Participants indicated that patient education also must focus on the risks associated with sharing medications. Patients should be educated not to share their medications and to store them in a secure location, possibly a locked safe. In addition, pharmacists should verify that patients are prescribed an appropriate amount of medication for their condition, in order to reduce the likelihood of leftover medication that could be diverted. Strategies to address confirmed misuse, abuse, diversion Conference participants were asked to consider the actions that pharmacists should take in the event of confirmed misuse of opioid medications when not medically indicated, addiction to opioid medications, or diversion of opioids. Participants reported that if misuse of an opioid is identified, pharmacists should consider the possibility of pseudoaddiction, assess whether patients are receiving proper pain management, and follow-up with prescribers as appropriate to address patient needs. If the evidence the pharmacist is able to gather is suggestive of misuse or abuse of the medication, the pharmacist should refuse the prescription and indicate the problem in the PDMP (where available). Participants disagreed regarding how to handle hardcopies of fraudulent prescriptions. An industry standard for e14 JAPhA | 5 4:1 | JAN/F EB 2014
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handling fraudulent prescriptions does not appear to exist; however, some pharmacies have policies in place. Some participants reported that they would return the prescription to the patient and call neighboring pharmacies to inform them of their concerns about the patient. Some reported that they would document on the back of the prescription their reasons for not filling it. Others reported keeping the hardcopy prescription. If opioid addiction is identified, participants felt that patients should be referred to addiction treatment resources. However, depending on a patient’s disposition, the pharmacist may choose to call emergency medical services, law enforcement, or store management. Participants noted that physical safety is paramount and that pharmacists should provide the requested opioids if physically threatened. Participants called for pharmacy management to develop standard policies and procedures to follow in various situations. Regardless of the action taken, pharmacists should document all interactions and referrals. If the pharmacist determines that an individual is attempting to divert medications (i.e., obtain medications with the intent of giving or selling them to other individuals), they should notify the prescriber, as well as local law enforcement and the local DEA office. They also can place an alert in the PDMP. To minimize personal and professional risk, participants stressed the importance of maintaining objectivity and professionalism when communicating with patients, particularly when abuse/addiction/diversion is suspected. Performing due diligence to find out all the information needed to make an informed decision and working with the entire health care team are important. In addition, the actions taken and rationale supporting pharmacists’ decisions should be documented carefully. Pharmacists should familiarize themselves with resources to refer patients to if misuse, abuse, or addiction is suspected. Each pharmacy or pharmacist should develop a list of local providers for referrals, including addiction-related treatment centers and resources and a list of physicians who provide good pain management. Participants felt that ethically, it is important not to lie to patients about the stock of a controlled substance. If the pharmacist has a reason not to fill the prescription, he or she should tell the patient (assuming that the pharmacist does not feel that his or her personal safety would be threatened by doing so). If concerns exist about misuse or abuse, then the pharmacist should give the patient information about treatment options. If, on the other hand, an explanation does exist, the honest information gives the patient the opportunity to explain him or herself. However, if a pharmacist concludes that a prescription is not legitimate but does not feel safe confronting the patient, he or she may tell the patient that the pharmacy is out of stock.
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Conclusion Ensuring access to opioids for patients who have a legitimate need while working to prevent misuse, abuse, and diversion is a complex balancing act for pharmacists. In addition to complying with federal and state regulations governing controlled substances, pharmacists must exercise diligence and careful judgment. They must assess the appropriateness of opioid prescriptions, weigh the risks and benefits of opioids for individual patients, and attempt to discern whether patients are presenting legitimate prescriptions. Finally, pharmacists must consider the importance of their own physical safety and security when working with controlled substances. Although eliminating misuse, abuse, and diversion of opioids may not be possible, conference participants felt that pharmacists’ use of a number of tools and strategies would improve patient management and benefit public health. If they have access to necessary tools and resources, pharmacists can assess the likelihood that prescriptions are legitimate and manage risks associated with opioids. Tools and resources that could improve pharmacists’ ability to achieve balance in managing opioids include efficient access to electronic health records that include PDMPs, access to local pain management and addiction specialists, and integration in new payment models for pharmacist services. Implementing systems and processes that support pharmacist management of opioid-related issues under financially viable business models would create a number of opportunities to improve patient care. References 1. American Academy of Pain Medicine, American Pain Society, American Society of Addiction Medicine. Definitions related to the use of opioids for the treatment of pain: consensus statement. www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policystatements/2011/12/15/definitions-related-to-the-use-of-opioids-forthe-treatment-of-pain-consensus-statement. Accessed May 21, 2013. 2. American College of Preventive Medicine. Use, abuse, misuse, and disposal of prescription pain medication clinical reference. www.acpm. org/?UseAbuseRxClinRef. Accessed May 21, 2013. 3. Crespi-Lofton J. Early refills are opportunity to improve patient care. Pharmacy Today. 2011;17(12)58–60. 4. Substance Abuse and Mental Health Services Administration. Results from the 2011 National Survey on Drug Use and Health: past year initiates of specific illicit drugs among persons aged 12 or older: 2011. www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresults2011. htm#5.2. Accessed May 21, 2013. 5. Birnbaum HG, White AG, Schiller M, et al. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12(4):657–67. 6. National Center for Health Statistics. Drug poisoning deaths in the United States, 1980–2008. www.cdc.gov/nchs/data/databriefs/db81.htm. Accessed May 21, 2013. 7. National Center for Health Statistics. CDC WONDER database: multiple cause of death 2000-2010. http://wonder.cdc.gov. Accessed May 1, 2012. Journal of the American Pharmacists Association
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8. Lankenau SE, Teti M, Silva K, et al. Initiation into prescription opioid misuse amongst young injection drug users Int J Drug Policy. 2012;23(1):37–44. 9. Substance Abuse and Mental Health Services Administration. Results from the 2011 National Survey on Drug Use and Health: discussion of trends in marijuana, prescription drug, heroin, and other substance use among youths and young adults. www.samhsa.gov/data/ NSDUH/2k11Results/NSDUHresults2011.htm#Ch8. Accessed December 26, 2012. 10. Banta-Green CJ. Adolescent abuse of pharmaceutical opioids raises questions about prescribing and prevention. Arch Pediatr Adolesc Med. 2012;166(9):865–6. 11. Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: national findings. http://oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf. Accessed November 6, 2013. 12. Substance Abuse and Mental Health Services Administration. State estimates of nonmedical use of prescription pain relievers. www.samhsa. gov/data/2k12/NSDUH115/sr115-nonmedical-use-pain-relievers.htm. Accessed January 19, 2013. 13. Food and Drug Administration. Risk evaluation and mitigation strategies for certain opioid drugs; notice of public meeting. Fed Regist. 2009;74(200):17967–70. 14. Food and Drug Administration. Questions and answers: FDA requires a risk evaluation and mitigation strategy (REMS) for long-acting and extended-release opioids. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251752.htm. Accessed June 25, 2012. 15. Matthews ML. Class-wide REMS for extended-release and longacting opioids: potential impact on pharmacies. J Am Pharm Assoc. 2013;53(1):e1–7. 16. Clark T, Eadie J, Knue P, et al. Prescription drug monitoring programs: an assessment of the evidence for best practices. www.pdmpexcellence.org/sites/all/pdfs/Brandeis_PDMP_Report.pdf. Accessed December 19, 2012. 17. Department of Justice, Drug Enforcement Administration, Office of Diversion Control, National Alliance for Model State Drug Laws. Diversion and abuse of prescription drugs: a closer look at state prescription monitoring programs. Washington, DC: Drug Enforcement Administration; 2000. 18. Reifler LM, Droz D, Bailey JE, et al. Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Med. 2012;13(3):434–42. 19. Baehren DF, Marco CA, Droz DE, et al. A statewide prescription monitoring program affects emergency department prescribing behaviors. Ann Emerg Med. 2010;56(1):19-23.e1-3. 20. American Pharmacists Association. Code of Ethics for Pharmacists. www.pharmacist.com/code-ethics. Accessed May 21, 2013. 21. American Society of Health-System Pharmacists. ASHP statement on the pharmacist’s role in substance abuse prevention, education, and assistance. Am J Health Syst Pharm. 2003;60(19):1995–8. 22. Li RM, Franks RH, Dimmitt SG, Wilson GR. Ideas and innovations: inclusion of pharmacists in chronic pain management services in a primary care practice. J Opioid Manag. 2011;7(6):484–7. 23. Salinas GD, Susalka D, Burton BS, et al. Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: a national multifaceted assessment of physicians, pharmacists, and their patients. J Opioid Manag. 2012;8(5):273–84.
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