Exploration of the Misuse, Abuse, and Diversion of Gabapentin

Gabapentin is currently approved by the Food and Drug Administration (FDA) as an adjunctive anti-convulsant and an analgesic for post-herpetic neuralgia. Though gabapentin was initially presumed to have limited or no abuse potential, which may have contributed to its widespread off-label prescribing, there have been increasing anecdotal and published reports of its misuse by substance abusers in the community and penal system. However, to date, there has been limited systematic evaluation of the scope and risk of gabapentin misuse and its associated effects. This dissertation assesses the etiology and prevalence of gabapentin misuse, abuse, and diversion in a multi-faceted approach, namely by the individual, ecological, and pharmacoepidemiological factors associated with this phenomenon. Due to the importance of conducting theory-driven epidemiological research, this dissertation uses an adaptation of the Concurrent Triangulation Mixed Method Multilevel Theoretical Model to guide the study. Through qualitative analysis of focus group data in an existing cohort of opioid users, a systematic review of peer-reviewed published literature, and a pharmacovigilance assessment of adverse events reported to the FDA, this dissertation describes the present state of gabapentin misuse. Findings are important for providers and may help inform policy to establish for whom prescription of gabapentin is most appropriate

Pharmacy Staff Perspectives on Alcohol and Medication Interaction Prevention Among Older Rural Adults

Older adults are at high risk for alcohol and medication interactions (AMI). Pharmacies have the potential to act as ideal locations for AMI education, as pharmacy staff play an important role in the community. This study examined the perspectives of pharmacy staff on AMI prevention programming messaging, potential barriers to and facilitators of older adult participation in such programming, and dissemination methods for AMI prevention information. Flyers, telephone calls, and site visits were used to recruit 31 pharmacy staff members who participated in semistructured interviews. A content analysis of interview transcriptions was conducted to identify major themes, categories, and subcategories. The main categories identified for AMI prevention messaging were Informational, Health Significance, and Recommendations. Within barriers to participation, the main categories identified were Health Illiteracy, Personal Attitudes, and Feasibility. The main categories identified for program facilitators were Understanding, Beneficial Consequences, and Practicality. Multimethod dissemination strategies were commonly suggested. This study found positive pharmacy staff perspectives for the planning and implementation of AMI prevention programming, and future development and feasibility testing of such programming in the pharmacy setting is warranted

COVID-19 and Opioid Use in Appalachian Kentucky: Challenges and Silver Linings

Appalachian Kentucky is currently fighting two public health emergencies – COVID-19 and the opioid epidemic – leaving the area strapped for resources to care for these ongoing crises. During this time, people who use opioids (PWUO) have increased vulnerability to fatal overdoses and drug-related harms (e.g., HIV). Disruption of already limited services posed by COVID-19 could have an especially detrimental impact on the health of PWUO. Though the COVID-19 pandemic is jeopardizing hard-won progress in fighting the opioid epidemic, innovations in state policy and service delivery brought about by the pandemic may improve the health of PWUO long-term if they are retained

A Qualitative Descriptive Analysis of Erowid Gabapentinoid Forum Posts

Purpose/Background: With increased controls on opioid prescribing, the CDC has suggested prescribing gabapentinoids as a first-line alternative to opioids for pain. However, there have been an increasing number of reports of gabapentinoid misuse. Drug use forums are online spaces where individuals can anonymously post about their drug use experiences and may provide insight on gabapentinoid misuse. The purpose of this study was to extract and analyze posts from the drug use forum, Erowid, to examine reports of gabapentinoid misuse. Methods: Data for the study was drawn from 53 pregabalin forum posts and 89 gabapentin forum posts by unique usernames. In order to be considered for this analysis, the poster had to report recreational gabapentinoid use. Posts were thematically analyzed by gender, age, gabapentinoid source, concomitant substances, and subjective experiences. Results: Forum posts were created by 117 men, 19 women, and 6 users of undisclosed genders. The majority of forum posts were by 18-24 year olds. Erowid users reported obtaining gabapentinoids by stealing, misreporting symptoms to providers, and purchasing from a dealer. Erowid users reported taking gabapentinoids simultaneously with benzodiazepines, cocaine, alcohol, opiates, and heroin among a myriad of other drugs. Erowid users had varying subjective experiences while taking gabapentionoids, including: increased sociability, euphoria, hallucinations, dissociation, painlessness, and numbness. Conclusions: Erowid users who report gabapentinoid misuse report obtaining the gabapentinoids in various ways and mixing them with potentially harmful substances. Medical professionals should be aware of the abuse potential of gabapentinoids and their increasing popularity within the drug use community.https://ir.library.louisville.edu/uars/1013/thumbnail.jp

A Focus on Abuse/Misuse and Withdrawal Issues with Selective Serotonin Reuptake Inhibitors (SSRIs): Analysis of Both the European EMA and the US FAERS Pharmacovigilance Databases

© 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/)Despite increasing reports, antidepressant (AD) misuse and dependence remain underestimated issues, possibly due to limited epidemiological and pharmacovigilance evidence. Thus, here we aimed to determine available pharmacovigilance misuse/abuse/dependence/withdrawal signals relating to the Selective Serotonin Reuptake Inhibitors (SSRI) citalopram, escitalopram, paroxetine, fluoxetine, and sertraline. Both EudraVigilance (EV) and Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) datasets were analysed to identify AD misuse/abuse/dependence/withdrawal issues. A descriptive analysis was performed; moreover, pharmacovigilance measures, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), and the empirical Bayesian geometric mean (EBGM) were calculated. Both datasets showed increasing trends of yearly reporting and similar signals regarding abuse and dependence. From the EV, a total of 5335 individual ADR reports were analysed, of which 30% corresponded to paroxetine (n = 1,592), 27% citalopram (n = 1,419), 22% sertraline (n = 1,149), 14% fluoxetine (n = 771), and 8% escitalopram (n = 404). From FAERS, a total of 144,395 individual ADR reports were analysed, of which 27% were related to paroxetine, 27% sertraline, 18% citalopram, 16% fluoxetine, and 13% escitalopram. Comparing SSRIs, the EV misuse/abuse-related ADRs were mostly recorded for citalopram, fluoxetine, and sertraline; conversely, dependence was mostly associated with paroxetine, and withdrawal to escitalopram. Similarly, in the FAERS dataset, dependence/withdrawal-related signals were more frequently reported for paroxetine. Although SSRIs are considered non-addictive pharmacological agents, a range of proper withdrawal symptoms can occur well after discontinuation, especially with paroxetine. Prescribers should be aware of the potential for dependence and withdrawal associated with SSRIs.Peer reviewedFinal Published versio

Pharmacy Staff Perspectives on Alcohol and Medication Interaction Prevention Among Older Rural Adults

Older adults are at high risk for alcohol and medication interactions (AMI). Pharmacies have the potential to act as ideal locations for AMI education, as pharmacy staff play an important role in the community. This study examined the perspectives of pharmacy staff on AMI prevention programming messaging, potential barriers to and facilitators of older adult participation in such programming, and dissemination methods for AMI prevention information. Flyers, telephone calls, and site visits were used to recruit 31 pharmacy staff members who participated in semistructured interviews. A content analysis of interview transcriptions was conducted to identify major themes, categories, and subcategories. The main categories identified for AMI prevention messaging were Informational, Health Significance, and Recommendations. Within barriers to participation, the main categories identified were Health Illiteracy, Personal Attitudes, and Feasibility. The main categories identified for program facilitators were Understanding, Beneficial Consequences, and Practicality. Multimethod dissemination strategies were commonly suggested. This study found positive pharmacy staff perspectives for the planning and implementation of AMI prevention programming, and future development and feasibility testing of such programming in the pharmacy setting is warranted

Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS)

© 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).In the past twenty years, the consumption of opioid medications has reached significant proportions, leading to a rise in drug misuse and abuse and increased opioid dependence and related fatalities. Thus, the purpose of this study was to determine whether there are pharmacovigilance signals of abuse, misuse, and dependence and their nature for the following prescription opioids: codeine, dihydrocodeine, fentanyl, oxycodone, pentazocine, and tramadol. Both the pharmacovigilance datasets EudraVigilance (EV) and the FDA Adverse Events Reporting System (FAERS) were analyzed to identify and describe possible misuse-/abuse-/dependence-related issues. A descriptive analysis of the selected Adverse Drug Reactions (ADRs) was performed, and pharmacovigilance signal measures (i.e., reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean) were computed for preferred terms (PTs) of abuse, misuse, dependence, and withdrawal, as well as PTs eventually related to them (e.g., aggression). From 2003 to 2018, there was an increase in ADR reports for the selected opioids in both datasets. Overall, 16,506 and 130,293 individual ADRs for the selected opioids were submitted to EV and FAERS, respectively. Compared with other opioids, abuse concerns were mostly recorded in relation to fentanyl and oxycodone, while tramadol and oxycodone were more strongly associated with drug dependence and withdrawal. Benzodiazepines, antidepressants, other opioids, antihistamines, recreational drugs (e.g., cocaine and alcohol), and several new psychoactive substances, including mitragynine and cathinones, were the most commonly reported concomitant drugs. ADRs reports in pharmacovigilance databases confirmed the availability of data on the abuse and dependence of prescription opioids and should be considered a resource for monitoring and preventing such issues. Psychiatrists and clinicians prescribing opioids should be aware of their misuse and dependence liability and effects that may accompany their use, especially together with concomitant drugs.Peer reviewedFinal Published versio

Gabapentin Drug Misuse Signals: A Pharmacovigilance Assessment Using the FDA Adverse Event Reporting System

Background: Although there have been increasing reports of intentional gabapentin misuse, epidemiological evidence for the phenomenon is limited. The purpose of this study was to determine whether there are pharmacovigilance abuse signals for gabapentin.Methods: Using FDA Adverse Events Reporting System reports from January 1, 2005 to December 31, 2015, we calculated pharmacovigilance signal measures (i.e., reporting odds ratio, proportional reporting ratio, information component, and empirical Bayes geometric mean) for abuse-related adverse event (AR-AE)-gabapentin pairs. Loglinear modeling assessed the frequency of concurrent reporting of abuse-related and abusespecific AEs (AS-AEs) associated with gabapentin. Findings were compared to a positive (pregabalin) and negative (duloxetine) control.Results: From 2005-2015 there were 5,951,229 unique AE reports submitted to the FDA including 99,977 for gabapentin, 73,977 for duloxetine, and 97,813 for pregabalin. Significant drug-AR-AE pair signals involving gabapentin included: drug abuser, multiple drug overdose, and substance-induced psychotic disorder. Significant drug AR-AE signals involving gabapentin and pregabalin, but not duloxetine, were: ataxia, dependence, drug abuse, increased drug tolerance, and overdose. Compared to duloxetine, gabapentin had significantly greater odds of a coreport for an AS-AE with drug withdrawal syndrome (OR: 6.55), auditory hallucinations (OR: 4.57), delusions (OR: 2.36), euphoric mood (OR: 5.45), ataxia (OR: 2.85), drug abuser (OR: 3.01), aggression (OR: L98), psychotic disorder (OR: 1.96), and feeling abnormal (OR: 1.31).Conclusions: We identified abuse-related signals for gabapentin and highlighted several CNS effects that may be associated with its abuse. Gabapentin prescribers should be aware of the drug\u27s abuse liability and effects that may accompany its use

Pharmacy Staff Perspectives on Alcohol and Medication Interaction Prevention Among Older Rural Adults

Older adults are at high risk for alcohol and medication interactions (AMI). Pharmacies have the potential to act as ideal locations for AMI education, as pharmacy staff play an important role in the community. This study examined the perspectives of pharmacy staff on AMI prevention programming messaging, potential barriers to and facilitators of older adult participation in such programming, and dissemination methods for AMI prevention information. Flyers, telephone calls, and site visits were used to recruit 31 pharmacy staff members who participated in semistructured interviews. A content analysis of interview transcriptions was conducted to identify major themes, categories, and subcategories. The main categories identified for AMI prevention messaging were Informational, Health Significance, and Recommendations. Within barriers to participation, the main categories identified were Health Illiteracy, Personal Attitudes, and Feasibility. The main categories identified for program facilitators were Understanding, Beneficial Consequences, and Practicality. Multimethod dissemination strategies were commonly suggested. This study found positive pharmacy staff perspectives for the planning and implementation of AMI prevention programming, and future development and feasibility testing of such programming in the pharmacy setting is warranted

A Qualitative Analysis of Gabapentin Misuse and Diversion Among People Who Use Drugs in Appalachian Kentucky

Gabapentin, an anticonvulsant and analgesic for postherpetic neuralgia, has been thought to have no abuse potential despite numerous published reports to the contrary. Gabapentin has been linked with impaired driving and opioid use, highlighting the need to more fully understand its risk profile. Thirty-three individuals reporting recent nonmedical use of gabapentin were recruited from two ongoing longitudinal studies of drug users in Appalachian Kentucky to participate in focus groups. Four sessions were held (two in the community and two in jail settings), during which participants responded to questions regarding their personal experiences with gabapentin misuse. Focus group participants were similar to other gabapentin users in the larger cohort studies with respect to demographics and drug use behaviors. Overall, the sample reported having initiated gabapentin more than 10 years earlier after having it prescribed for a legitimate, though generally off-label, medical indication (e.g., pain, anxiety, opioid detoxification). Participants reported use of gabapentin in combination with buprenorphine, other opioids, cocaine, and caffeine to produce sought-after central nervous system effects (e.g., muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high”). Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in the community, particularly over the last 2 years. Gabapentin was a prominent drug of abuse in two cohorts of the primarily opioid-using individuals. Providers should be aware of gabapentin’s abuse potential, and a reexamination of the need for scheduling is warranted