Prescription opioid abuse: pharmacists' perspective and response.

Opioid medication abuse and overdose are major concerns for public health, and a number of responses to address these issues have taken place across the US. Pharmacists and the pharmacy profession have made important contributions as a part of the response to this national crisis. This article provides a brief review of the antecedents, driving forces, and health status of patients involved in the opioid medication and overdose epidemic. This review further discusses pharmacy-based actions that have been undertaken to address this issue, including prescription drug monitoring, take-back, and naloxone training/distribution programs. This review likewise examines current efforts underway in the field to educate practitioners and needed future steps that must be taken by pharmacists in order to continue the profession's pivotal role in working toward resolving this national public health problem. In particular, evidence and arguments are presented for proactively identifying and intervening with patients who abuse and/or are at risk for overdose. Continued and active engagement by pharmacists in these efforts has the potential to result in important reductions in opioid medication abuse and overdose and improvements for patient's health.

Introduction

Trends in the nonmedical use of prescription opioids (NMPO), related health problems, and opioid medication overdose mortality in the US have reached epidemic proportions.1 These challenges currently facing the nation require a multifaceted approach to achieve resolution. A number of policy- and clinical-level actions have been employed to combat this issue. The pharmacy profession has been an integral part in taking both direct and indirect steps to confront NMPO and overdose. This article provides a brief review of the opioid medication epidemic, pharmacy-based efforts to address this issue, and needed future steps that must be taken by pharmacists and the pharmacy profession must act upon as they continue to play a pivotal role working toward resolving this national public health crisis. We recognize that within the empirical literature, there are a number of conceptual/operational definitions and behaviors that characterize problematic consumption of opioid medications.2,3 In this review, we categorize these definitions and behaviors as NMPO for the purpose of simplicity.

Opioid medication epidemic and epidemiology

Opioids are one of the primary drugs of abuse in the world.4 An estimated 26–36 million individuals use opioids illicitly internationally, with approximately one-half to one-third of illicit opioid use being nonheroin consumption.4 The US is the largest consumer of prescription opioid medication compared to every other nation in the world.5 Data indicate that Americans consume >80% of the world’s prescription opioids, regardless of the fact that the US comprises <5% of the world’s population.6 Opioid medication sales in the US have increased 150% between 1997 and 2007, with the average milligrams of opioids used per person increasing at the same time >400%.7 A large contributor to this rapid uptake in opioid medication consumption was the inclusion of pain as the “fifth vital sign” during the 1990s.8 The inclusion of pain as the fifth vital sign stemmed from the American Pain Society’s efforts to elevate awareness among health care professionals regarding pain treatment and was intended to improve attention to pain management nationally.8 During this same time in the US, opioid pain medications, such as OxyContin, were heavily marketed for nonmalignant pain.9 This marketing campaign included claims by manufacturers that there was little risk of addiction to opioid analgesics.9 Moreover, targeted sales marketing accompanied by large cash bonuses to pharmaceutical sales representatives occurred for promoting and increasing the distribution of these medications, particularly OxyContin.9 Despite claims of limited risk for addiction, an additional instrumental factor motivating this epidemic is the abuse liability of opioid medications. Users of opioid pain medications report that these drugs can produce a heroin-like euphoria or “high”. In addition to psychoactive properties, street values for these medications approximate or are greater than heroin.10 Regular consumption of these medications can produce physical dependence. Consequently, withdrawal symptomology, which includes vomiting, diarrhea, nausea, chills, cramps, and increased blood pressure, can increase the likelihood for continued consumption.11

The total number of persons in 2012 who reported NMPO was 4.9 million, second to only those using marijuana at 18.9 million.12 Among those with NMPO, 2.1 million individuals were diagnosed as having abused or were dependent on opioid pain medications.12 Annual societal costs in the US stemming from NMPO have been calculated to be ~$56 billion.13 Half of those reporting NMPO obtain medications from friends or relatives who had the prescriptions under their possession.12 Additionally, one-fifth of individuals engaged in NMPO obtain opioid medications through “shopping” behaviors,12 wherein patients visit multiple doctors and pharmacies seeking prescriptions and fills.14,15

New trends in street opioid use indicate unintended consequences in addressing NMPO. Emerging research points to NMPO as a likely starting point for heroin use. In a study from 2002 to 2011, heroin use reported by respondents in the previous 12 months was 19 times greater for those who had previously engaged in NMPO.16 This transition from NMPO to heroin use has been consistently documented across a number of studies, and while all patients who engage in NMPO do not initiate heroin use, evidence supports this graduated trend in substance use serverity.17,18

Individuals engaged in NMPO have been noted to suffer from a number of health comorbidities. In specific terms, those engaged in NMPO are more likely to have additional mental and behavioral health conditions,19–22 including posttraumatic stress, mood, anxiety, personality,19,21,23–25 and substance use disorders.19–22,26,27 Common comorbid health problems among those engaged in NMPO include pain conditions,20,22,25,28,29 hepatitis,19,26 and overall poorer health.21,29 Heavy users of prescription opioid medications have also been found to have disproportionately higher rates of HIV infection,30 immunosuppression,31 hypertension, stomach ulcers, and urination/bladder problems.29 Another aspect of chronic and heavy opioid usage is structural and functional changes in regions of the brain that can impact regulation of affect, impulse control, and reward and motivational functions.32 The most detrimental consequence of the NMPO epidemic has been the associated overdose deaths, which increased fourfold from 1999 to 2008,33 with 44 individuals per day currently dying of fatal overdoses.34 Altogether, deaths in 2010 involving prescription opioid painkillers (N=16,651) accounted for 45% of all illicit and prescription drug overdose deaths combined.35 Given the impact of NMPO in the US, a broad-based concerted response is necessary.

Efforts to address NMPO and overdose

Prescription drug monitoring programs

Responses to the national NMPO epidemic in the US have spanned the continuum of social and health care arenas and include, for example, activities of law enforcement,36 government,17 pharmaceutical companies,37,38 and clinical health care providers.39 One of the furthest reaching efforts in the US has been a policy solution designed to impact prescribing and patient access to medications. Prescription drug monitoring programs (PDMPs) are large scale data collection, reporting efforts implemented by states to supply prescribers and pharmacists with information regarding prescribing patterns and medication fills in order to help identify drug-seeking patients or those with inappropriate prescriptions.40 With the exception of Missouri, PDMPs have been implemented in varying degrees in each of the US states.41

Possessing data indicating questionable drug-seeking and/or use patterns among patients, prescribers, and pharmacists can assist in the better management of writing and filling prescriptions for those who might be engaged in NMPO.40,41 The effectiveness of PDMPs, however, has been evaluated in empirical studies and has shown mixed outcomes, underutilization,40 and limited effectiveness in reducing consumption and overdose deaths.42 Furthermore, PDMPs have also been noted to operate within limited environments for patient identification and data sharing.43 Research data likewise show that PDMPs have limited use among some practitioners primarily because of time restraints, difficulty in accessing and navigating systems, and beliefs that using the system will not change patients’ behaviors.44 Evidence also exists showing that pharmacists feel discomfort in assuming a “policing” role, wherein they are expected to monitor and confront patients.45–47 In addition, what is not apparent in the literature regarding PDMP is their effects on NMPO among patients for actual improvement in health.

Potentially valuable additions to PDMPs would ideally include more extensive data collection related to patients’ demographic and health information within these systems in order to provide richer profiles of patients’ health, medication usage, and demographic characteristics. For instance, connecting these programs with patient’s health information collected in electronic health records could add valuable information regarding patient’s risk for NPMO. Additionally, linking narcotic medication prescriptions in PDMPs with other medications filled by patients could yield important results for pharmacists to know if patients have concomitant fills for mental health medications, muscle relaxants, or benzodiazepines. Similarly, improvements could result from linking these systems with prescription dispensing software to better integrate PDMP processes into the established pharmacy workflow.

While possessing information regarding patient’s medication use is valuable for pharmacists, PDMPs could be further enhanced if they were to also produce tips or guidance for intervention purposes. For example, if a patient is seeking an early refill, pharmacists would not only be alerted to such behaviors by the PDMP system but also ideally could be given action steps for initiating a targeted medication therapy management (MTM) session.48 This session would be aimed at helping patients increase adherence to their prescribed medication regimen. Such targeted MTM sessions have demonstrated efficacy for the improvement of medication adherence and health problems, including alcohol problems and bone density screening and education.48–51 Furthermore, pharmacists presented with at-risk patients could also be instructed from within the system to not only consult pre-scribers of the medications being filled, but instructions could also be given to pharmacists to refer patients (including the system providing up-to-date contact information) to additional needed health services, such as mental health counseling, health coaching, and social work services available from insurers.45

Take-back programs

Other efforts to reduce NMPO that have involved pharmacy are drug take-back programs across the US.52–54 These programs typically operate in conjunction with local law enforcement entities and involve widespread advertising in target areas. These efforts solicit individuals to “drop off ” unused or excess medications without punitive or legal repercussions. Medications are dropped off by community members to law enforcement officials in pharmacy parking lots or are deposited in secure, unmanned containers within commercial pharmacy settings. Given that patients who receive medications may discard drugs (eg, in the trash and sewer) or retain them after discontinuing use,52 take-back programs are designed to prevent inappropriate disposal for environmental protection and to prevent used medications from being stolen or consumed by those to whom they were not prescribed. This is especially valuable given that, as mentioned earlier, a large portion of medication diversion occurs from friends or relatives who had the prescriptions under their possession.12

Community members generally have encouraging views of take-back programs,54 and those who have participated in these events have also reported positive experiences when dropping off medications.52,54 These programs have reported limited success for addressing NMPO in that they have been documented to have taken-back mostly nonnarcotic drugs.53,55 Measurement of outcomes from take-back programs regarding impact on individuals has also been narrow in terms of the impact on patient-level and health improvements or reductions in overdose within communities. More detailed research on these programs and their impact on NMPO are needed.

While the anonymity and ease of take-back programs is certainly beneficial, the high number of individuals utilizing this resource could be viewed as an opportunity for patient screening, intervention, and possible referral to ancillary health services. Take-back programs occurring within community pharmacy locations could be an excellent venue for pharmacists and/or pharmacy staff members to attempt engaging patients regarding their health to assess for NMPO or explore with patients’ additional health problems that could put them at-risk for future issues with their opioid medications. If patients are identified as at-risk or engaged in NMPO, pharmacists could work to assist these individuals to receive appropriate information to safeguard their health or resources to receive additional health services.

Naloxone training and distribution

Another major effort targeting this national epidemic focuses specifically on addressing overdose. Rapidly escalating overdose deaths has called national attention to the need for effective approaches to reach individuals at-risk of overdose from illicit heroin use and NMPO.56 While overdose previously has been in large part associated with injection drug use, trends over the past decade regarding NMPO indicate overdose risk is not restricted to heroin users. Overdose risk is particularly pertinent to those who consume high doses of opioids for pain management and/or those who mix opioid medications with other psychoactive substances.57,58 Given these issues, there has been a growing body of evidence to support community-level approaches to prevent opioid overdose deaths through various harm reduction strategies. Such efforts have focused training on how to respond effectively to opioid overdose through community-based overdose education and naloxone distribution (OEND) programs. OEND programs have concentrated their efforts on individuals using opioid medications and bystanders who are at an increased likelihood to witness an opioid overdose.59 The content of OEND programs has mainly centered on how to respond appropriately to overdose including the emergency administration of Naloxone, an opioid antidote to revive individuals experiencing an overdose.60

Naloxone is not considered a controlled substance as it has no potential for abuse, and it has been employed by medical professionals in the US for >40 years as the best-practice for opioid overdose resuscitation.61 In the early 1990s, health professionals first called for the provision of naloxone outside of inpatient settings.59 The first programs in the US to dispense naloxone for fatal overdose prevention were in the early 1990s, and by the mid-2000s, OEND programs were scattered across the US.62 As of June 2014, 644 community-based OEND programs were in operation in the US, and participants reported reversing >26,463 overdose events.63 Research data support the effectiveness of OEND. An analysis of OEND programs conducted between 2006 and 2009 in Massachusetts communities with high opioid overdose rates demonstrated a significant reduction in overdose mortality within those communities that implemented these programs.64 Furthermore, researchers have determined that naloxone distribution programs are cost effective.65

Despite these advancements in having patient access to naloxone, the US Food and Drug Administration has expressed minimal interest in supporting these efforts.59 As an alternative, a number of states have adapted Collaborative Pharmacy Practice Agreements (CPAs). CPAs for naloxone involve prescribers authorizing pharmacists to dispense naloxone to patients in the pharmacy setting without patients needing to visit prescribers in person.59 CPAs utilize pharmacists as drug therapy experts and ultimately are intended to improve the efficiency and quality of patient care.59 As of 2014, collaborative practice authority existed in 48 states. However, wide variation exists between states regarding regulations of what authority can be delegated from prescribers to pharmacists under these agreements.59 In addition to CPAs, other states (such as California, New Mexico, and Vermont) have adopted statewide protocols for naloxone prescribing in pharmacies.66 These dispensing protocols are between the state and pharmacists and are employed when states have significant interest in improving public health via pharmacist prescribing. While naloxone distribution is not necessarily a sole solution to NMPO and related overdose, it is a crucial adjunct to other measures for addressing this national problem.67

Response of professional pharmacy organizations

One of the key national pharmacy organizations supporting naloxone distribution and education has been the American Pharmacist Association (APhA).68 Specifically, APhA policy statements express support for educating pharmacists and student pharmacists regarding the appropriate use of overdose reversal agents, the passage of federal and state laws that permit pharmacists to provide overdose reversal agents, and the role of pharmacists in directing and managing dosing, therapy, and education to patients regarding the appropriate and effective use of overdose reversal agents.69 Such support for naloxone education and distribution has been critical in the field as it recognizes that NMPO is an issue that has a serious impact on health professions across the continuum of care.

Complementary to naloxone overdose prevention, APhA policy also supports pharmacists taking on the role of health care providers by proactively screening and assessing patients’ for possible NMPO and diversion.69 APhA policy likewise promotes the need for a national PDMP to promote and sustain proactive clinical practices, such as universal patient monitoring.70 In the recent US White House meeting on addressing NMPO and the opioid overdose epidemic, APhA leadership pledged the development and publication of an online educational resource center for pharmacists and pharmacy technicians regarding NMPO.71 Such a resource for the pharmacy profession will potentially fill an important gap in information and has the capability of providing help for pharmacy professionals to more actively take on and address this issue. However, while developing such resources is an important aspect of a solution, APhA should dedicate resources to evaluate actual changes in practice behaviors of those professionals who utilize this online training resource.

The American Society of Health-System Pharmacists (ASHP) is likewise making significant efforts to address NMPO and overdose in the US. ASHP recommends that pharmacists proactively engage in prevention, education, and assistance to patients efforts to address NMPO and its consequences.72 Examples of prevention efforts recommended to health system pharmacists include collaborating with other health care professions to develop prevention programs, advocating and participating with public leaders to prevent NMPO, and working to discourage prescribing practices associated with behaviors indicative of abuse.72 Additionally, ASHP recommends that pharmacists provide information to patients and other health care professionals pertaining to substance use disorders, the effects of mood altering drugs, and safe storage/disposal of medications. Recommendations for educational efforts likewise include efforts to develop curricula for delivery in pharmacy training programs and university settings to assist the next generation of pharmacists to appropriately confront this issue.72 In terms of assistance to patients, ASHP encourages the active identification of patients engaged in NMPO and providing necessary referrals to treatment. Additionally, ASHP directs health-system pharmacists to remain vigilant in efforts to be gatekeepers of medications that may be the target of diversion or abuse.72 It comes as no surprise that ASHP was also a key contributor to federal efforts in strategizing the national response to NMPO and overdose by committing to the education of the organization’s members on this issue.71

Education and training programs

Previous research has indicated that pharmacists who feel awkward or unconfident in their abilities to communicate with patients about NMPO are less likely to screen patients.73,74 Furthermore, pharmacists who report having little training in NMPO are less likely to discuss misuse with patients.74,75 Research has also shown that communicative, task-specific-efficacy beliefs, and participation in NMPO specific continuing education are significantly associated with addiction treatment information provision to pharmacy patients.76 Based on these facts, it is critical that student pharmacists and pharmacists participate in education, training, continuing education, and/or board certification relevant to substance use disorders, risk minimization with opioid therapy, law update and overview of prescription drug abuse, drug diversion, new drugs of abuse, and pain management. Such training has the capacity to advance pharmacists’ active involvement in prevention, education, and assistance of patients engaged in NMPO and/or who suffer from other substance use disorders. Pharmacy schools and colleges must take the opportunity to further integrate education and practice opportunities around substance use disorders.76,77

Pharmacists are trained during their didactic curriculum and experiential learning to identify appropriate pharmacotherapy for patients, assess medication use outcomes, and ensure the safety and effectiveness of the medication-use system. During their education, student pharmacists are introduced to substance use disorders. Although each pharmacy school has a unique curriculum, the Accreditation Council for Pharmacy Education requires specific elements of the didactic doctor of pharmacy curriculum that are viewed as central to a contemporary high-quality pharmacy education, which includes both pharmacology and toxicology.78 Pharmacology introduces the knowledge of pharmacodynamics, which involves how drugs work in the body, mechanisms of therapeutic and adverse drug reactions and interactions, and the application of these principles to therapeutic decision making. Toxicology expands this medication knowledge by educating students on pharmacodynamics, mechanisms, prevention, and treatment of the toxic effects of drugs. Student pharmacists in many programs in the US have the opportunity to take elective coursework concerning addiction, wellness and prevention, as well as advanced pharmacy practice experiences utilizing community substance use disorder resources.77 Given the importance of training pharmacists regarding substance use disorders, the American Association of Colleges of Pharmacy has proposed curricular guidelines on substance use disorders that would allow future pharmacists entering the profession to have the training and ability to effectively pursue a role in substance abuse.77 With this breadth of knowledge, pharmacists entering practice have the education and training to serve in leadership and service roles in substance use disorder prevention and education and the ability to assist in a variety of patient care, employee health, and community activities involving addiction.78

Beyond the doctor of pharmacy education, pharmacists and student pharmacists have resources to aid in their education and training on NMPO and substance use disorders. One significant opportunity is provided by the APhA foundation in collaboration with the Ohio State University College of Pharmacy and the Cardinal Health Foundation. These entities have developed the Generation Rx program, an educational program that increases public awareness of NMPO and encourages health care providers, community leaders, parents, teens, and college students to actively work toward prevention.79 Generation Rx strives to increase awareness among pharmacists and student pharmacists with respect to the opportunity to serve as educators and to provide information and resources regarding the prevention of prescription medication abuse, delivery of materials necessary to effectively implement prescription abuse programs, and promotion of the pharmacy profession and its role in community health.80 Generation Rx similarly provides pharmacists with materials and knowledge to address substance abuse issues in a variety of areas of practice; including educational settings, among patients across the lifespan, and within the workplace.80

An additional training opportunity on addiction is provided through the APhA Institute on Alcoholism and Drug Dependencies. The institute has a long-standing history of providing education to pharmacists and student pharmacists regarding substance use disorders. The annual institute is delivered via seminar, wherein participants receive information regarding addiction and obtain practical experience in managing substance use disorder-related problems as they impact the pharmacy profession. Seminars follow a disease model pedagogy by explaining the pharmacology and pathophysiology of addiction, providing training with respect to the design of intervention strategies and techniques to provide care to patients in need, and aiding in the development of pharmacy-based strategies to assist patients to maintain substance use recovery.78

Behavioral efforts

As gaps in substance abuse training programs are identified, education and resources can further be developed to allow pharmacists to incorporate patient care and patient outcomes surrounding substance use disorders into practice. One immediate opportunity for pharmacists to address NMPO exists within community pharmacy practice. In the US, community pharmacies are abundant, with >60,000 community pharmacies, employing >170,000 pharmacists.81 Until the recent past, the dominant role of the community pharmacist has been in dispensing medications. However, the role of the pharmacist has been rapidly expanding to include a patient-centered focus and patient-centered outcomes. Central among the activities of this evolving focus are health education/promotion, supporting patients in achieving optimal medication adherence, and screening and monitoring patient health.82 Given these trends, pharmacists are continually increasing patient engagement and adapting their practice environments to meet the various needs of their patients. An innovative example of this is community pharmacies developing and utilizing private rooms for consultation in order to interact one-on-one regarding sensitive matters pertaining to the patient’s heath.83–85

Such adaptation and evolution creates a distinct opportunity for community pharmacies to become a venue for the identification of patients at-risk or engaged in NMPO. Foundational clinical evidence has established that screening patients in community pharmacy for the risk of developing and/or current NMPO appears to have strong feasibility.86 Recent findings show that screening patients filling opioid medications with a computer tablet-based health screening survey was not only acceptable to patients, but such a protocol is not disruptive to pharmacy workflow as patients respond to screening questionnaires while they wait for medications to be processed and filled.86 Furthermore, the majority of patients (~80%) reported being comfortable if pharmacists engaged them in conversations about their pain medication consumption if pharmacists had any specific concerns.86

Unfortunately, there is a gap within the field of pharmacy with respect to evidence-based patient care services that have been tested and have demonstrated efficacy and/or effectiveness for NMPO. The protocols that do exist in the field either are not opioid medication specific or have not been tested to this point in a clinical setting. In terms of existing models that are not opioid medication specific, MTM is an evidence-based intervention that can be delivered in community pharmacy setting. MTM involves brief sessions wherein medications are reviewed by pharmacists to assist patients resolve challenges related to adherence. A core goal of MTM is to empower patients in the active management of their medications.87,88 MTM services are currently considered an evidence-based practice that are reimbursed by Medicare and some private insurers.89 Other modalities employed in the field are motivational interviewing-based interventions. These approaches train pharmacists and other health care professionals to provide brief interventions that focus on helping patients increase their adherence to various medications.90–94 Models, such as MTM and motivational interviewing-based interventions, have many important components that possess the capacity for helping patients with NMPO.

In terms of protocols that have yet not been tested within clinical settings, a recently published model within the pharmacy practice literature is designed to address NMPO and more severe levels of opioid addiction that may present at community pharmacy settings.45 This model recommends that within the community pharmacy setting, all patients filling opioid pain medications be screened for NMPO and other health problems that would increase patients’ risk for NMPO, such as mental, behavioral, and physical health conditions. For those who do not screen positive for NMPO or for other health risk factors, pharmacists are encouraged to continue to follow-up with those individuals during subsequent prescription fill visits in order to continuously monitor patient health.45 For patients who screen positive for conditions that increase their risk for developing NMPO, the model instructs that within an MTM framework, patients receive information and prevention messaging.45 Similarly, patients with health risks that increase chances for future NMPO would be referred back to their primary care physician or health insurance plans to initiate interdisciplinary care to ensure the conditions that increase risk for NMPO are properly managed/treated. For patients who screen positive for NMPO or more severe levels of opioid addiction, these individuals would receive brief adherence interventions and be trained by pharmacists in naloxone administration for fatal overdose prevention.45 Those patients with more severe levels of addiction would also receive referrals to primary or specialty care to be assessed for the need of agonist maintenance therapy.45

Currently, results of a pharmacist-led patient care protocol for NMPO have not been reported in the empirical literature. It is, therefore, paramount that clinical pharmacists and health services researchers collaborate to design and execute such studies. Information generated by these endeavors has the capacity to be transformative to professional pharmacy practice in how patients with NMPO or opioid medication addiction are treated within community pharmacy settings.

Conclusion

NMPO and opioid medication overdose are complex national public health issues that require multifaceted and broad-based efforts to effectively achieve appropriate management of access to these medications while providing patients with effective pain management.95 A number of pharmacy-based and related efforts have taken place in the US to confront this issue. National organizations that represent pharmacy practitioners have undertaken important efforts to increase pharmacist presence and influence among other health and governmental entities working toward resolution of NMPO, and pharmacy training and education programs have greatly augmented their efforts to equip those currently practicing and the next generation of pharmacists to effectively deal with this issue. Significant opportunities are available to pharmacists working in the community setting to identify patients with NMPO or with heighted risk for overdose; nevertheless, additional research must take place in order to establish evidence-based patient care protocols for national dissemination. As pharmacists and the pharmacy profession continue to lead in resolving this national issue, patient and public health will be improved.