Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry.

PURPOSE: The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et al. PDS 2012; 21[7]:677-689). Due to the broader and evolving scope of pharmacoepidemiology, ISPE considers it important to proactively identify, update and expand the list of core competencies to inform curricula of education programs; thus, better positioning pharmacoepidemiologists across academic, government (including regulatory), and industry positions. The aim of this project was to update the list of core competencies in pharmacoepidemiology. METHODS: To ensure applicability of findings to multiple areas, a working group was established consisting of ISPE members with positions in academia, industry, government, and other settings. All competencies outlined by Jones et al. were extracted from the initial manuscript and presented to the working group for review. Expert-based judgments were collated and used to identify consensus. It was noted that some competencies could contribute to multiple groups and could be directly or indirectly related to a group. RESULTS: Five core domains were proposed: (1) Epidemiology, (2) Clinical Pharmacology, (3) Regulatory Science, (4) Statistics and data science, and (5) Communication and other professional skills. In total, 55 individual competencies were proposed, of which 25 were new competencies. No competencies from the original work were dropped but aggregation or amendments were made where considered necessary. CONCLUSIONS: While many core competencies in pharmacoepidemiology have remained the same over the past 10 years, there have also been several updates to reflect new and emerging concepts in the field.

Prescription Opioid Use Among a Community Sample of Older and Younger Women.

Background: Women bear a heavier burden of the consequences related to prescription opioid use compared to their male counterparts; however, there has been little attention in the literature regarding prescription opioid use among women. We aimed to examine risk factors for prescription opioid use among women. Methods: Demographics, health status, and substance use data, including prescription opioid use, were collected through a community engagement program, HealthStreet, during a health needs assessment. Women older than 18 years were classified by opioid use: past 30-day, lifetime, but not past 30-day, or no lifetime prescription opioid use. Descriptive statistics and chi-square tests were calculated, and multinomial logistic regression was used to calculate adjusted odds ratios (aORs; confidence interval [CI]). Results: Among 5,549 women assessed, 15% reported past 30-day use and 41% reported lifetime use of prescription opioids. While prescription sedative use was the strongest risk factor for past 30-day use among younger women (aOR = 4.84; 95% CI, 3.59-6.51), past 6-month doctor visits was the strongest risk factor for past 30-day use among older women (aOR = 4.15; 95% CI, 2.62-6.60). Conclusions: We found higher rates of prescription opioid use in this community sample of women compared to national rates. Risk factors for recent prescription opioid use (past 30-day use) differed among older and younger women. Clinicians should be more vigilant about prescribing opioids as the medical profile for women may change through age, especially the co-prescribing of opioids and sedatives.

Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?

In the current era of the COVID-19 pandemic, the world has never been more interested in the process of vaccine development. While researchers across the globe race to find an effective yet safe vaccine to protect populations from the newly emergent SARS-CoV-2 virus, more than one-third of the world has been subjected to either full or partial lockdown measures. With communities having felt the burden of prolonged isolation, finding a safe and efficacious vaccine will yield direct beneficial effects on protecting against COVID-19 morbidity and mortality and help relieve the psychological and economic load on communities living with COVID-19. There is hope that with the extraordinary efforts of scientists a vaccine will become available. However, given the global public health crisis, development of a COVID-19 vaccine will need to be fast tracked through the usual prelicensing development stages and introduced with limited clinical trial data compared with those vaccines that are developed conventionally over more than a decade. In this scenario, surveillance of the vaccine in the real world becomes even more paramount. This responsibility falls to observational researchers who can provide an essential safety net by continuing to monitor the effectiveness and safety of a COVID-19 vaccine after licensing. Postauthorisation observational studies for safety and effectiveness are complementary to prelaunch clinical trials and not a replacement. In this paper, we highlight the importance of postmarketing studies for future newly licensed COVID-19 vaccines and the key epidemiological considerations.

A Systematic Review of Flurbiprofen 8.75 mg Dose and Risk of Haemorrhagic Events.

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are known to be associated with an increased risk of bleeding. The NSAID, flurbiprofen, in the form of 8.75 mg lozenge or oromucosal spray is indicated for the symptomatic relief of sore throat. Despite the low dose as compared to alternative flurbiprofen preparations, concerns have been raised regarding its safety in terms of haemorrhagic events. This systematic review was conducted to identify existing evidence on the risk of haemorrhagic events with flurbiprofen 8.75 mg dose (any formulation), particularly where this may be due to potential interactions with other medicinal products. The systematic review examined studies reporting haemorrhagic events in patients receiving flurbiprofen 8.75 mg dose. Six individual electronic databases were searched up to 28th April 2020. Records were initially screened for relevance followed by further review of potentially eligible studies. Data extraction was performed for eligible studies and risk of bias in studies was assessed. The search strategy identified 1093 individual records. Of these, 1038 records were excluded after initial review; the majority of these records related to flurbiprofen in alternative formulations with alternative doses (e.g., eye drops, skin patches, oral tablets) thus were not considered relevant for further review. The 55 remaining records related to flurbiprofen 8.75 mg dose (any formulation) or flurbiprofen lozenge/oromucosal spray where the dose was not specified. After further review, 52 of these records were not considered eligible. Thus, only three records were included in this systematic review. The three studies reported a total of five haemorrhagic events in patients taking flurbiprofen 8.75 mg lozenge; the corresponding risk in each of the studies was 8.33, 1.98 and 1.96%. Where possible, comparison of flurbiprofen 8.75 mg lozenge to placebo produced risk ratios of 0.96 (95% CI 0.07, 13.25) and 2.00 (95% CI 0.10, 118.0). This systematic review found limited evidence on the risk of haemorrhagic events with flurbiprofen when used at a dose of 8.75 mg. Counts were low across all studies and results comparing flurbiprofen and placebo treatment arms were non-significant. However, scarcity of studies and low certainty of evidence for the outcome of haemorrhagic events limits the conclusions of this systematic review.

Opioids in the United Kingdom: safety and surveillance during COVID-19.

PURPOSE OF REVIEW: Opioid use is prevalent in the United Kingdom and prior to the COVID-19 pandemic it had been recognized that the safety of opioids was an important issue to be monitored by the UK medicines regulatory agency. With the emergence of COVID-19, this requirement has been even greater. This review was undertaken to determine the impact of the pandemic on safety and surveillance of opioids in the United Kingdom. RECENT FINDINGS: During the COVID-19 pandemic, the surveillance of opioids in the United Kingdom continued, although primary research was often conducted with data prior to the pandemic. Of those studies that were conducted while the pandemic was ongoing, access to opioids (or opioid substitution therapy) and the subsequent effect on patient safety was the main theme. SUMMARY: In the United Kingdom, changes in accessibility to the healthcare system and how healthcare providers operated during the COVID-19 pandemic may have had unintended consequences on use and safety of opioids, due to the shift in focus to preventing COVID-19 from overwhelming the healthcare system. The findings from this review support the need to continue surveillance in the United Kingdom, including the impact of the COVID-19 pandemic on opioid utilization and safety.

The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology.

In pharmacoepidemiology, comparison studies can provide a useful estimate of the level of increased or decreased risk of specific events with a medication (through a measure of effect). A key focus of pharmacoepidemiological studies is the safety and effectiveness of medicines in their real-world use, and adequate comparisons of effect estimates are critical. However, consideration of guidelines, pharmacoeconomic assessments, and policies for reimbursement have made comparisons in pharmacoepidemiological studies far more difficult to conduct in recent years. Where certain subject characteristics influence the probability of being exposed to a treatment, this can introduce issues of selection bias and confounding. Methodologies are available to minimise selection bias (through case-only and randomised study designs) and deal with confounding (such as regression modelling or propensity score matching methods), however these each have their own limitations. Where prescribing guidelines are present, conducting comparisons in pharmacoepidemiology produces many challenges and not all of these can be easily overcome. Patient channelling can be more frequent with adherence to clinical guidelines compared with when prescribing decisions by doctors are based predominantly on their clinical judgement. Use of a contextual cohort could be considered as an option to characterise the adoption of new medications into clinical practice and describe the prevalence of clinical characteristics and risk factors in the two cohorts, rather than compare event rates and produce an estimate of effect.

Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study.

OBJECTIVES: To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales. DESIGN: An observational cohort study using the technique of Specialist Cohort Event Monitoring. SETTING: The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales. PARTICIPANTS: 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016. INTERVENTIONS: Non-interventional postauthorisation safety study of rivaroxaban. PRIMARY AND SECONDARY OUTCOME MEASURES: (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds. RESULTS: Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years. CONCLUSIONS: In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979).

Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study.

INTRODUCTION: Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice. METHODS AND RESULTS: The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA2DS2-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years. CONCLUSION: In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice.

Age of First Use of Prescription Opioids and Prescription Opioid Non-Medical Use among Older Adolescents.

BACKGROUND: Non-medical use (NMU) of prescription opioids is of concern due to the opioid epidemic in the United States. Objective: We examined sex differences in the effect of age of first use of prescription opioids on prescription opioid NMU among 17- and 18-year olds. Methods: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) recruited youth 10-18 years from 10 United States cities between 2008 and 2011 (n = 11,048). The cross-sectional survey included questions on past 30 day prescription opioid use (10,965 provided responses; 278 age 17 to 18 years who used opioids in past 30 days), with NMU defined as non-oral use and/or use of someone else's opioids. Nonparametric survival analysis with lifetable estimates was used to examine age at first use. Binomial logistic regression was conducted predicting any NMU, adjusted for covariates. Results: Among 278 youth 17 to 18 years, a significant difference in age of first use between those with MU only and any NMU (p < .0001) was observed. Each one year increase in age resulted in a 33% decrease in the odds of any prescription opioid NMU compared to MU only, after controlling for covariates (Odds Ratio = 0.67, 95% Confidence Interval: 0.47,0.96). Sex differences in age at first use were not observed. Conclusions: Risk of past 30 day prescription opioid NMU decreased by a third for each one year increase in age of first use, after adjustment for other covariates. Use of prescription opioids in young adolescents may need to be limited where possible and researched further.

Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England.

BACKGROUND: This study was designed to monitor the short-term (up to 12 weeks) use and safety of quetiapine (Seroquel) extended release (XL) and quetiapine immediate release (IR) prescribed to patients with a clinical diagnosis of schizophrenia, and/or manic episodes associated with bipolar disorder by psychiatrists under normal conditions of use. METHODS: A Specialist Cohort Event Monitoring (SCEM) study was conducted in England February 2010-April 2013. This observational cohort study recruited patients prescribed quetiapine XL within the secondary care setting by psychiatrists. A reference cohort of quetiapine IR users was also recruited. Baseline and 12 week observational data were collected from psychiatrists who abstracted information from medical records onto bespoke questionnaires. Data were collected on demographics, indication, past medical history, prescribing information and events of interest. Summary descriptive statistics were calculated. RESULTS: The final cohort consisted of 869 eligible patients; 646 XL users and 223 IR users. The majority of XL and IR users were female (56.2% and 55.6%, respectively), with a median age of 40 (interquartile range [IQR]: 29, 49) and 39 (IQR: 28, 50) years, respectively. The most frequent indication for treatment was Manic episodes associated with Bipolar Affective disorder (53.4% XL and 49.8% IR). Median index dose was 200 mg/day (IQR: 100, 300) for XL users and 50 mg/day (IQR: 50, 100) for IR users, while median final maintenance dose was 400mg/day (IQR: 250, 600) and 300 mg/day (IQR: 100, 400), respectively. The most frequently reported event of interest in both cohorts was sedation (n = 151, 23.9% XL cohort and n = 49, 23.0% IR cohort). CONCLUSION: Utilisation of quetiapine XL appeared to be in line with prescribing guidelines in terms of dose, and commonly reported events of interest were in concordance with the known safety profile. Overall, this SCEM study provided important information on the safety and utilisation of quetiapine XL in the secondary care setting in England.

Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment.

INTRODUCTION AND OBJECTIVE: COVID-19 is an ongoing, global public health crisis for which safe and effective treatments need to be identified. The benefit-risk balance for the use of lopinavir-ritonavir in COVID-19 needs to be monitored on an ongoing basis, therefore a systematic benefit-risk assessment was designed and conducted. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation; although initially this evaluation is likely to contain limited information, it is required because of the urgent unmet public need. Importantly, it allows additional data to be incorporated as they become available, and re-evaluation of the benefit-risk profile. METHODS: A systematic benefit-risk assessment was conducted using the Benefit-Risk Action Team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in severe COVID-19 compared to standard of care, placebo or other treatments. A literature search was conducted in PubMed and Embase to identify peer-reviewed papers reporting clinical outcomes. Two clinicians constructed a value tree and ranked key benefits and risks in order of considered clinical importance. RESULTS: We screened 143 papers from PubMed and 264 papers from Embase for lopinavir-ritonavir; seven papers were included in the final benefit-risk assessment. In comparison to standard of care, data for several key benefits and risks were identified for lopinavir-ritonavir. Time to clinical improvement was not significantly different for lopinavir-ritonavir in comparison to standard of care (hazard ratio 1.31, 95% confidence interval 0.95-1.80). From one study, there were fewer cases of acute respiratory distress syndrome with lopinavir-ritonavir compared with standard of care (13% vs 27%). There also appeared to be fewer serious adverse events with lopinavir-ritonavir (20%) vs standard of care (32%). Limited data were available for comparison of lopinavir-ritonavir to other treatments. CONCLUSIONS: Based on currently available data, there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute respiratory distress syndrome with lopinavir-ritonavir in one study. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available.

Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment.

INTRODUCTION: There is a need to identify effective, safe treatments for COVID-19 (coronavirus disease) rapidly, given the current, ongoing pandemic. A systematic benefit-risk assessment was designed and conducted to examine the benefit-risk profile of remdesivir in COVID-19 patients compared with standard of care, placebo or other treatments. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation, which starts with inevitably limited information (to meet the urgent unmet public health need worldwide), then update the benefit-risk evaluation as more data become available. METHODS: The Benefit-Risk Action Team (BRAT) framework was used to assess the overall benefit-risk of the use of remdesivir as a treatment for COVID-19 compared with standard of care, placebo or other treatments. We searched PubMed, Google Scholar and government agency websites to identify literature reporting clinical outcomes in patients taking remdesivir for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. RESULTS: Using the BRAT method, several key benefits and risks for use of remdesivir in COVID-19 compared with placebo have been identified. In one trial, the benefit of time to clinical improvement was not statistically significant (21 vs 23 days, HR 1.23, 95% CI 0.87-1.75), although the study was underpowered. In another trial, a shorter time to recovery in patients treated with remdesivir was observed (11 vs 15 days), with non-significant reduced mortality risk (8% vs 12%). Risk data were only available from one trial. This trial reported fewer serious adverse events in patients taking remdesivir (18%) compared with the placebo group (26%); however, more patients in the remdesivir group discontinued treatment as a result of an adverse event compared with those patients receiving placebo (12% vs 5%). CONCLUSIONS: Preliminary clinical trial results suggest that there may be a favourable benefit-risk profile for remdesivir compared with placebo in severe COVID-19 infection and further data on benefits would strengthen this evaluation. There is limited safety data for remdesivir, which should be obtained in further studies. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit-risk assessment.

Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management.

BACKGROUND: Prior to approval in the European Union, a systematic benefit-risk assessment was required to compare buprenorphine implant to sublingual buprenorphine as part of the license application to the European Medicines Agency. OBJECTIVE: The Benefit-Risk Action Team framework was used to describe the overall benefit-risk of buprenorphine implant in comparison to sublingual buprenorphine. STUDY SELECTION/METHODS: A value tree of key benefits and risks related to the implant formulation of buprenorphine was constructed. Risk differences (RD) or reporting ORs (ROR) and corresponding 95% CIs were calculated for each outcome, along with the number needed to treat and number needed to harm. Swing weighting was assigned to outcomes and the weighted net clinical benefit (wNCB) was calculated. FINDINGS: Key benefits assessed: reduced risk of illicit opioid use (RD=0.09, 95% CI 0.01 to 0.17), reduced risk of misuse and diversion (ROR=0.13, 95% CI 0.02 to 0.94), improved compliance and convenience (RD=0.20) and quality of life measures (RD=0.03). Key risks assessed: clinically significant implant breakage (RD=0.01, 95% CI 0.00 to 0.01), migration/missing implant (RD=0.01, 95% CI 0.00 to 0.02), infection at insertion/removal site (RD=0.08, 95% CI 0.03 to 0.12) and implant-related allergic reaction (RD=0.07, 95% CI 0.03 to 0.11). The wNCB for buprenorphine implant was 4.96, which suggests a favourable benefit-risk profile. CONCLUSIONS: The benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting.

Sex differences in peer and parental risk factors for non-medical use of prescription opioids in youth.

Background: Prescription opioid non-medical use (NMU) and its associated consequences have been of concern in the US in recent years.Objective: We examined peer influence and parental guidance, in addition to peer and parental sources of alcohol, on patterns of prescription opioid use, including NMU, among males and females separately. We hypothesized that peer influence and parental guidance would have a differential influence for males and females.Methods: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) recruited youth 10-18 years from 10 US cities between 2008 and 2011 (n = 11,048). The cross-sectional survey included questions on past 30-day prescription opioid use (10,965 provided responses), with NMU defined as non-oral use and/or use of someone else's opioids. Multinomial logistic regression was conducted, examining medical use only and NMU in the past 30 days.Results: Among the 10,965 youth, 3.1% (n = 345) reported past 30-day NMU. Obtaining alcohol from parents was associated with increased odds of past 30-day NMU among males (OR = 2.49, 95%CI: 1.54,4.03) only. For each additional close friend who used other substances, odds of past 30-day NMU increased among males (OR = 1.23, 95%CI: 1.11,1.37) and females (OR = 1.15, 95%CI: 1.04,1.27). Increased number of close friends was associated with decreased odds of past 30-day NMU among males (OR = 0.87, 95%CI: 0.78,0.97) and females (OR = 0.86, 95%CI: 0.77,0.96).Conclusions: Peer and parental risk factors for prescription opioid NMU were identified among youth, although not all differed by sex. An increased number of close friends was a protective factor against prescription opioid NMU for both males and females.

If kids ruled the world, how would they stop non-medical use of prescription drugs?

PURPOSE: We examined ideas about how youth would mitigate non-medical use of prescription medications among their peers. DESIGN/METHODOLOGY/APPROACH: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) interviewed 11,048 youth10-18 years of age between 2008 and 2011 from entertainment venues of 10 US urban, suburban, and rural areas. Using a mixed-methods approach, participants completed a survey culminating in open ended questions asking: 1) How should kids your age be told about prescription drugs and their effects?; 2) If you ran the world, how would you stop kids from taking other people's prescription medicines?; 3)Why do people use prescription stimulants without a prescription? Responses from a random sample of 900 children were analyzed using qualitative thematic analyses. FINDINGS: The random sample of 900 youth (52% female, 40% white, with a mean age was 15.1 years) believed they should be educated about prescription drugs and their negative effects at schools, at home by parents, through the media, and health professionals. Youth would stop kids from using other people's prescription drugs through more stringent laws that restricted use, and education about negative consequences of use. Peer pressure was the most common reason youth gave for using other's pills, though some reported using for curiosity. ORIGINALITY/VALUE: This analysis shows the importance of considering youth's opinions on non-medical use of prescription medications, which are often overlooked. Studies should disseminate this data from youth to stop the illicit use of prescription drugs among teens and youth.

A Longitudinal Analysis of the Substance Abuse, Violence, and HIV/AIDS (SAVA) Syndemic among Women in the Criminal Justice System.

Using data from a randomized controlled trial of 319 women mainly recruited from a Municipal Drug Court System in St. Louis, MO, this study evaluates substance use, victimization, and HIV/AIDS risk behaviors over time. The results indicated that, for all participants, the likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk decreased by 46% by the eight-month follow-up; however, results did not differ significantly by intervention group. Women who were sexually abused as a child, had 4+ arrests, or believed they had sexual and drug-using behaviors that need changing at baseline were more likely to experience these issues over time.

Power of the Peer and Parent: Gender Differences, Norms, and Nonmedical Prescription Opioid Use Among Adolescents in South Central Kentucky.

This study examined risk factors of nonmedical prescription opioid use (NMPOU) among adolescents and how risk factors differ by gender. In the fall of 2017, adolescents attending 6th through 12th grades across 44 schools in 10 south central Kentucky counties were invited to participate in an anonymous, school-based survey. A total of 11,761 adolescents completed the survey. Logistic regression was conducted to examine the association between NMPOU and constructs of the Theory of Reasoned Action (i.e., attitudes and subjective norms), descriptive norms (i.e., peer use), and parental control of prescription medications in the home. There were 297 (2.7%) adolescents who reported NMPOU in the past 12 months. In the adjusted multivariate logistic regression model, for both males and females, the adolescents who perceived that more of their peers engaged in NMPOU were significantly more likely to endorse NMPOU, whereas male and female adolescents who perceived their peers disapproved of use were significantly less likely to report NMPOU. Parent disapproval was significantly associated with decreased NMPOU for females only. Moderated regression analyses revealed that gender moderated the relationship between parental disapproval and NMPOU. We found that during adolescence, NMPOU is influenced by peer norms for both genders and parental norms for females. These results indicate that prevention efforts should focus on changing adolescents' peer and parental norms related to NMPOU.

Sex differences in patterns of prescription opioid non-medical use among 10-18 year olds in the US.

BACKGROUND: Non-medical use (NMU) of prescription opioids is a public health concern and sex differences in prevalence of NMU have been observed previously. Little is known about how youth are obtaining and using these drugs. While any regular use could be problematic, NMU is particularly concerning. More information is needed on NMU patterns among youth and how these patterns might differ by sex. METHODS: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) recruited youth 10-18 years of age from 10 US metropolitan areas from 2008 to 2011 with a final sample of 11,048 youth. The cross-sectional survey included questions on past 30 day use of prescription opioids (10,965 provided responses), with NMU defined as non-oral use and/or use of someone else's opioids. NMU through use of a patient's own prescription orally for a reason other than prescribed could not be identified, though this is usually contained within the standard definition of NMU. RESULTS: Among the 10,965 youth, past 30 day prevalence of NMU of prescription opioids was 3.1% (n = 345) with 59.7% (n = 206) using someone else's opioids only, 5.2% (n = 18) having non-oral use only and 35.1% (n = 121) having both. In total, seven sources and three routes of administration were assessed. The most common source among males was someone from school (n = 111, 60.0%), with no highly prevalent second source. Among females, there were two prevalent sources of prescription opioids; a parent (n = 59,41.6%) and someone from school (n = 53,37.3%). For non-oral use, snorting prescription opioids was more frequent among males compared to females (n = 85, 31.8% and n = 44, 17.1%; p < .01). CONCLUSIONS: Based on these findings, to combat the current opioid crisis, implementation of strategies to prevent youth from sharing opioids, especially with friends from school, should be considered and tested.

One Step at a Time: A Latent Transitional Analysis on Changes in Substance Use, Exposure to Violence, and HIV/AIDS Risk Behaviors among Female Offenders.

The aim of this analysis is to identify latent subgroups of women based on substance use, exposure to violence, and risky sexual behaviors and quantify discrete stages of behavior change over time. Data comes from 317 women recruited from a Municipal Drug Court System in the Midwest. All participants were interviewed regarding their substance use and sexual behaviors, as well as their exposure to violence at baseline, a 4th-month follow-up, and an 8th-month follow-up. A latent transitional analysis (LTA), a longitudinal extension of a latent class analysis (LCA), was used to quantify discrete stages of behavior change. The results of our analyses revealed 4 distinct behavioral profiles in our sample: 1) women with high probabilities of risky sexual behaviors, exposure to violence, and crack/cocaine use, 2) women with a high probability of exposure to violence, and moderate sexual risk taking, 3) women characterized solely by a high probability of crack/cocaine use, 4) women with low probabilities of all factors. The proportion of women in latent statuses characterized by a high probability of crack/cocaine use did not substantially decrease over time. Women who experienced child sexual abuse, had a greater number of lifetime arrests, were older, and believed they had risky drug using behavior that needed changing at baseline were significantly more likely to be in higher-risk latent statuses. Targeted interventions tailored to crack/cocaine users, as well as a wide-spread need for trauma-informed interventions among females involved in the criminal justice system, are needed.