National outpatient medication utilization for opioid and alcohol use disorders from 2014 to 2016.

BACKGROUND AND AIMS: Research has recommended a combination of pharmacotherapy and behavioral therapy to treat opioid use disorder (OUD) or alcohol use disorder (AUD). The objective of this study was to estimate the prevalence of U.S. outpatient visits in which patients had a documented OUD or AUD and in what proportion of these visits the patient was receiving medication for OUD (MOUD) or AUD (MAUD), alone or in combination with behavioral therapy. DESIGN: Cross-sectional analysis of the National Ambulatory Medical Care Survey (NAMCS) from 2014 to 2016. SETTING: NAMCS provides national estimates based on the latest census data, for all U.S. outpatient medical visits. PARTICIPANTS/CASES: All visits involving patients aged ≥18 years with an OUD or AUD diagnosis. MEASUREMENT: Medications for OUD included buprenorphine, buprenorphine/naloxone, or naltrexone; medications for AUD included acamprosate, disulfiram, or naltrexone. We defined behavioral therapy as provision of psychosocial therapy, mental health counseling, or stress management. We also compared annualized data between 2014 and 2016 using the Chi-square test. FINDINGS: From 2014 to 2016, NAMCS recorded nearly 2.3 billion adult outpatient visits, including 17.1 million and 21.7 million visits involving patients with an OUD or AUD diagnosis, respectively. From 2014 to 2016, a decreased prevalence of annual visits involved AUD (11.7 vs. 9.9/1000, P < 0.0001), while those for OUD increased (9.3 vs. 13.3/1000, P < 0.0001). Among office visits with an OUD diagnosis, a MOUD was documented in 14.2 million (83.1%) visits and behavioral therapy was provided in 4.4 million (25.6%). Among office visits with an AUD diagnosis, an MAUD was documented in approximately 800,000 (3.6%) and behavioral therapy in 5.4 million (24.8%). CONCLUSION: These data highlight an opportunity to increase the use of MAUD and offer behavioral therapy to those with OUD and/or AUD.

Receipt of Substance Use Counseling Among Ambulatory Patients Prescribed Opioids in the United States.

BACKGROUND: As opioid-related overdose deaths climb in the U.S., risk reduction measures are increasingly important. One such measure recommended involves provision of proactive substance use counseling regarding the risks of opioid analgesics. This is particularly important in patients at increased risk of overdose, such as those with substance use disorders (SUD) or those receiving concomitant medications that further increase the overdose risk (eg, benzodiazepines, gabapentinoids, or Z-hypnotics). However, previous research regarding the likelihood that such counseling is provided during outpatient prescriber visits is lacking. OBJECTIVES: To determine the percentage of U.S. ambulatory care visits in which patients taking prescription opioids received substance use counseling, and whether counseling was more common in patients with concomitant GABAergic medication(s) (benzodiazepine, gabapentinoid or Z-hypnotic) or substance use disorder (SUD) diagnosis. METHODS: A cross-sectional analysis was conducted of all patients aged ⩾18 years identified as having a prescription opioid on their medication list within the 2014-2015 National Ambulatory Medical Care Survey data. RESULTS: Among 162.7 million visits in which patients were taking opioid medication(s), substance use counseling was provided in 2.4%. During visits for patients receiving opioid(s) plus GABAergic(s), substance use counseling was marginally more common (3.1% versus 2.0%, P < .0001). Substance use counseling was also more common among visits for patients taking opioid(s) with SUD (18.9% versus 1.5%, P < .0001). Among visits in which a patient was diagnosed with SUD and taking opioid(s) plus GABAergic(s), counseling was more common (23.1% versus 1.4%, P < .0001) compared to patients taking opioid(s) plus GABAergic(s) without SUD. CONCLUSIONS: Among national ambulatory care visits in the United States, substance use counseling is provided infrequently for patients taking opioids, even when significant risk factors are present. Increasing patient education may help reduce opioid-related overdose mortality.

Consideration of Aggressive and Strategic Approaches to Address Declining Enrollment in US Pharmacy Schools.

Members from Cohort 13 of the Academic Leadership Fellows Program (ALFP) 2016-2017 were challenged to present a debate on the topic: "In Turbulent Times, Pharmacy Education Leaders Must Take Aggressive Action to Prevent Further Declines in Enrollment" at the American Association of Colleges of Pharmacy INfluence 2017 meeting in Rio Grande, Puerto Rico. This paper is the result of thoughtful insights emerging from this debate. We present a discussion of the question of whether pharmacy education leaders must take aggressive action or strategic approaches to prevent further declines in enrollment. There are many thoughts regarding current declines in enrollment. Some educators contend that a more aggressive approach is needed while others argue that, while aggressive actions might lead to short-term gains, a more viable approach involves strategic actions targeting the underlying causes for decreasing enrollment. This paper explores themes of enrollment challenges, current and future workforce needs, and financial issues for both pharmacy programs and students. In summation, both aggressive actions and a strategic, sustainable approach are urgently needed to address declining enrollment.

Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: An analysis of the Food And Drug Administration Adverse Events Reporting System (FAERS).

BACKGROUND: Reports of gabapentinoid (gabapentin and pregabalin) misuse have increased in recent years. Pharmacovigilance data from the Food and Drug Administration Adverse Event Reporting System (FAERS) provides a useful examination of adverse drug event (ADE) reporting for safety signal detection. OBJECTIVE: This study was conducted to analyze epidemiological information on the nature and extent of gabapentin/pregabalin abuse utilizing the FAERS database. METHODS: A query was designed utilizing SafeRx, an indexed, searchable database of FAERS data from October 2012-December 2016. All-cause and abuse-related (including abuse/misuse/dependence/overdose events) ADE reports for gabapentin and pregabalin were isolated, as well as limited demographic data. The proportional reporting ratio (PRR) was calculated to compare signal detection. RESULTS: A total of 10,038 all-cause ADEs were reported to FAERS for gabapentin, including 576 (5.7%) abuse-related events. For pregabalin, 571 all-cause ADEs were identified, including 58 (10.2%) related to abuse. Compared to all-cause ADEs, those involved in abuse-related events were younger and more likely to be male. The PRR of pregabalin versus gabapentin abuse-related events was 1.77. CONCLUSION: Though not traditionally thought of as drugs of abuse, over 600 cases of gabapentinoid abuse were reported in the time frame analyzed, prompting the need for further study and regulatory investigation.

Gabapentin for Off-Label Use: Evidence-Based or Cause for Concern?

Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. With concerns for safety mounting, it is prudent to examine the efficacy of gabapentin across its many uses to understand the risk-benefit balance. Reviews on off-label indications such as migraine, fibromyalgia, mental illness, and substance dependence have found modest to no effect on relevant clinical outcomes. This high-quality evidence has often been overshadowed by uncontrolled studies and limited case reports. Furthermore, the involvement of gabapentin in questionable marketing schemes further calls its use into question. Overall, clinicians should exercise rigorous appraisal of the available evidence for a given indication, and researchers should conduct larger, higher-quality studies to better assess the efficacy of gabapentin for many of its off-label uses.

Predictors of Gabapentin Overuse With or Without Concomitant Opioids in a Commercially Insured U.S. Population.

OBJECTIVE: Research suggests the medical consequences of gabapentin overuse depend on whether gabapentin is abused alone or with opioids to potentiate an opioid "high." The objective of this study was to assess predictors of gabapentin overuse with or without concomitant opioids. METHODS: Data were obtained from the Truven Health MarketScan® Commercial Claims and Encounters database for 2013 through 2015. Eligibility criteria were gabapentin utilization, with or without opioids, for 120 days or longer throughout a 12-month observation period. Cohort identification was based on patterns of overuse exceeding thresholds of 3600 mg of gabapentin and/or 50 morphine-mg equivalents of opioids; sustained overuse was defined as three or more quarters exceeding threshold. Diagnostic predictors were measured in the 6 months pretreatment in inpatient (IP) or emergency department (ED) settings. Indications were measured in IP, ED, or ambulatory settings. Logistic regression analyses adjusted for age, sex, indication, use of benzodiazepine or z-hypnotics (i.e., zaleplon, zolpidem, eszopiclone) during gabapentin treatment, pretreatment ED/IP use, and pretreatment diagnoses of anxiety or depression. RESULTS: Criteria for sustained overuse were met by 2.0% of 44,148 patients treated with gabapentin without opioids and by 11.7% of 15,335 patients treated with concomitant gabapentin-opioid. The top three predictors of sustained overuse for gabapentin-only patients were insomnia (7.0%), euphoria (4.5%), and bipolar disorder (4.5%), and were detoxification (35.6%), altered mental status (26.3%), and addiction (21.6%) for gabapentin-opioid patients. In adjusted analyses, concomitant opioid use multiplied the odds of sustained misuse by 6.32 (95% confidence interval [CI] = 5.80-6.89) and the interaction of addiction with opioid use by 1.88 (95% CI = 1.32-2.66). Among gabapentin-only patients, sustained misuse was predicted by a history of anxiety (odds ratio = 1.56, 95% CI = 1.02-2.38) but not by a history of addiction. CONCLUSIONS: The likelihood of gabapentin overuse alone is low but significantly increases with concomitant opioid use, especially when coupled with a history of addiction. History of addiction does not appear to increase risk of gabapentin misuse among those with gabapentin alone.

Partners in Public Health: Public Health Collaborations With Schools of Pharmacy, 2015.

To collect data on public health collaborations with schools of pharmacy, we sent a short electronic survey to accredited and preaccredited pharmacy programs in 2015. We categorized public health collaborations as working or partnering with local and/or state public health departments, local and/or state public health organizations, academic schools or programs of public health, and other public health collaborations. Of 134 schools, 65 responded (49% response rate). Forty-six (71%) responding institutions indicated collaborations with local and/or state public health departments, 34 (52%) with schools or programs of public health, and 24 (37%) with local and/or state public health organizations. Common themes of collaborations included educational programs, community outreach, research, and teaching in areas such as tobacco control, emergency preparedness, chronic disease, drug abuse, immunizations, and medication therapy management. Interdisciplinary public health collaborations with schools of pharmacy provide additional resources for ensuring the health of communities and expose student pharmacists to opportunities to use their training and abilities to affect public health. Examples of these partnerships may stimulate additional ideas for possible collaborations between public health organizations and schools of pharmacy.

Current Practices in Global/International Advanced Pharmacy Practice Experiences: Preceptor and Student Considerations.

The objective of this article is to describe the key areas of consideration for global/international advanced pharmacy practice experience (G/I APPE) preceptors, students and learning objectives. At the 2013 Annual Meeting of the American Association of Colleges of Pharmacy (AACP), the GPE SIG prepared and presented an initial report on the G/IAPPE initiatives. Round table discussions were conducted at the 2014 AACP Annual Meeting to document GPE SIG member input on key areas in the report. Literature search of PubMed, Google Scholar and EMBASE with keywords was conducted to expand this report. In this paper, considerations related to preceptors and students and learning outcomes are described. Preceptors for G/I APPEs may vary based on the learning outcomes of the experience. Student learning outcomes for G/I APPEs may vary based on the type of experiential site. Recommendations and future directions for development of G/IAPPEs are presented. Development of a successful G/I APPE requires significant planning and consideration of appropriate qualifications for preceptors and students.

Prescription Monitoring Program Trends Among Individuals Arrested in Maine for Trafficking Prescription Drugs in 2014.

OBJECTIVE: To evaluate controlled substance prescribing trends available in the Maine Prescription Monitoring Program (PMP) among individuals arrested for prescription drug "trafficking." The demographic characteristics of the individuals who had matching prescription records in the PMP within 90 days of the arrest were identified. STUDY DESIGN: A population-based, retrospective cohort study using data from the Maine Diversion Alert Program (DAP) and the Maine PMP. The study population consisted of persons arrested for trafficking prescription drugs in Maine during the 2014 calendar year from January 1 to December 31. RESULTS: There were 594 trafficking arrests reported by the Maine DAP in 2014. The study population consisted of the 235 persons (40%) with arrests involving controlled prescription medications. The mean age of these persons was 33 years (range 18-77 yrs), and 156 (66%) were male. Arrests involved 154 prescription opioids (65%), seven stimulants (3%), seven benzodiazepines (3%), and 77 unspecified controlled prescription drugs (33%). A minority of individuals (n=57, 24%) had a prescription record in the PMP that matched the substance involved in the arrest. Only one person with matching PMP and arrest records utilized ≥ 5 prescribers, while none used ≥ 5 pharmacies within 90 days before the arrest. Payment methods for matching prescriptions were commercial insurance (n=28, 49%), Medicaid (n=19, 33%), Medicare (n=5, 9%), and cash (n=5, 9%). CONCLUSIONS: The majority (76%) of persons arrested for prescription drug trafficking did not have PMP records and did not directly obtain the diverted medication from a licensed pharmacy. Traditional red flags, like cash payment and using multiple prescribers or pharmacies, were uncommon. Therefore, arrest records for diversion and PMPs are distinct and complementary tools for identifying individuals at risk for substance misuse.

Inside Maine's Medicine Cabinet: Findings From the Drug Enforcement Administration's Medication Take-Back Events.

Objectives. We evaluated the quantity and type of medications obtained in unused-medications return programs and the proportion of medication waste. Methods. We analyzed data collected in 11 Maine cities in 2011 to 2013 during 6 Drug Enforcement Administration (DEA) national medication take-back events. Pharmacy doctoral student volunteers collected data under the supervision of law enforcement, independent of the DEA. Data entry into the Pharmaceutical Collection Monitoring System, through its interface with Micromedex, allowed for analysis of medication classification, controlled substance category, therapeutic class, and percentage of medication waste (units returned/units dispensed). Results. Medication take-back events resulted in return of 13 599 individual medications from 1049 participants. We cataloged 553 019 units (capsules, tablets, milliliters, patches, or grams), representing 69.7% medication waste. Noncontrolled prescription medications accounted for 56.4% of returns, followed by over-the-counter medications (31.4%) and controlled prescription medications (9.1%). Conclusions. The significant quantities of medications, including controlled substances, returned and high degree of medication waste emphasize the need for medication collection programs to further public health research and improve health in our communities.

Metformin and breast cancer risk: a meta-analysis and critical literature review.

Observational studies have suggested that metformin decreases the incidence of several common cancers. However, findings regarding breast cancer have been mixed. In order to explore this issue, a systematic literature review and meta-analysis were performed with a focus on potential biases. We conducted a comprehensive literature search for all pertinent studies addressing metformin use and breast cancer risk by searching PubMed, Cochrane Library, and Scopus (which includes Embase, ISI Web of Science) using the Mesh terms: "metformin" or "biguanides" or "diabetes mellitus, type 2/therapy" and "cancer" or "neoplasms." When multiple hazard ratios (HR) or odds ratio (OR) were reported, the most adjusted estimate was used in the base-case analysis. We pooled the adjusted HR and performed sensitivity analyses on duration of metformin use (> or ≤3 years use), study quality (assessed using the GRADE system), and initial observation year of the cohort (before vs after 1997). From a total of 443 citations, 18 full-text articles were considered, and seven independent studies were included. All were observational (four cohort and three case control). Our combined OR of all seven studies was 0.83 (0.71-0.97). Stronger associations were found when analyses were limited to studies estimating the impact of longer metformin use (OR = 0.75. 95 % CI 0.62, 0.91) or among studies that began observing their cohort before 1997 (OR = 0.68. 95 % CI 0.55-0.084). Stratification according to study quality did not affect the combined OR but higher quality studies had smaller CI and achieved statistical significance. Interpretation is limited by the observational nature of reports and different comparison groups. Our analyses support a protective effect of metformin on breast cancer risk among postmenopausal women with diabetes. Clinical trials are needed for definitive determination of the role of metformin in breast cancer risk reduction.

Medical student and senior participants' perceptions of a mentoring program designed to enhance geriatric medical education.

In 2000, the Senior Mentor Program was implemented as an innovative, instructional method in the University of South Carolina's medical school curriculum designed to enhance and strengthen student training in geriatrics. This study qualitatively analyzed second- year medical students' and senior participants' perceptions of and attitudes towards the Senior Mentor Program as an effective learning modality. A total of 36 second-year students from two consecutive classes (2002-2003) and 42 senior mentors at USC's School of Medicine participated in five and seven separate focus group interviews, respectively. The group discussions were transcribed and a content analysis performed using NVivo. The coding scheme and analyses were driven by the data collected and recurrent themes were examined across all focus groups. Overall, student and senior mentor participants viewed the program positively. Thematic comparisons by participant type indicate a shared view that the mentoring relationship has a far-reaching, educational, professional, and personal impact. Both students and seniors agreed that myths and stereotypes about aging were dispelled and students indicated that a close, caring relationship with an older person will change they way they practice. A longitudinal mentoring program that pairs students with community-dwelling seniors can be a valuable addition to traditional geriatric curricular activities designed to increase students' skills and compassion for caring for older adults.