Investigating maternal and neonatal health outcomes associated with continuing or ceasing dexamphetamine treatment for women with attention-deficit hyperactivity disorder during pregnancy: a retrospective cohort study.

PURPOSE: Attention-deficit hyperactivity disorder (ADHD) is becoming more commonly diagnosed in women, consequently, more women of reproductive age are taking ADHD medication, such as dexamphetamine. However, the safety associated with continuing or ceasing dexamphetamine during pregnancy is unclear. This study investigates outcomes associated with the continuation of dexamphetamine during pregnancy compared to those who ceased or were unexposed. METHODS: A population-based retrospective cohort of women from Western Australia who had been dispensed dexamphetamine during pregnancy and gave birth between 2003 and 2018. Women had either continued to take dexamphetamine throughout pregnancy (continuers, n = 547) or ceased dexamphetamine before the end of the second trimester (ceasers, n = 297). Additionally, a matched (1:1) comparison group of women who were dispensed an ADHD medication prior to pregnancy but not during pregnancy (unexposed) was included in the study (n = 844). Multivariable generalised linear models were used to compare maternal and neonatal health outcomes. RESULTS: Compared to continuers, ceasers had greater odds of threatened abortion (OR: 2.28; 95%CI: 1.00, 5.15; p = 0.049). The unexposed had some benefits compared to the continuers, which included lower risk of preeclampsia (OR: 0.58; 95%CI: 0.35, 0.97; p = 0.037), hypertension (OR: 0.32; 95%CI: 0.11, 0.93; p = 0.036), postpartum haemorrhage (OR: 0.57; 95%CI: 0.41, 0.80; p = 0.001), neonatal special care unit admittance (OR: 0.16; 95%CI: 0.12, 0.20; p < 0.001) and fetal distress (OR: 0.73; 95%CI: 0.54, 0.99; p = 0.042). CONCLUSION: Continuing dexamphetamine throughout pregnancy was not associated with an increase in adverse neonatal and maternal health outcomes compared to ceasing. Ceasing dexamphetamine during pregnancy was associated with increased odds of threatened abortion compared with continuing dexamphetamine. However, this is something that requires further investigation due to the small sample size, difficulties examining timing, and the inability to examine spontaneous abortions. The unexposed showed some benefits compared to the continuers, suggesting that where possible the cessation of dexamphetamine prior to pregnancy may be advisable.

Come back when you're infected: pharmacy access to sterile syringes in an Arizona Secret Shopper Study, 2023.

BACKGROUND: Pharmacies are critical healthcare partners in community efforts to eliminate bloodborne illnesses. Pharmacy sale of sterile syringes is central to this effort. METHODS: A mixed methods "secret shopper" syringe purchase study was conducted in the fall of 2022 with 38 community pharmacies in Maricopa and Pima Counties, Arizona. Pharmacies were geomapped to within 2 miles of areas identified as having a potentially high volume of illicit drug commerce. Daytime venue sampling was used whereby separate investigators with lived/living drug use experience attempted to purchase syringes without a prescription. Investigator response when prompted for purchase rationale was "to protect myself from HIV and hepatitis C." A 24-item instrument measured sales outcome, pharmacy staff interaction (hostile/neutral/friendly), and the buyer's subjective experience. RESULTS: Only 24.6% (n = 28) of 114 purchase attempts across the 38 pharmacies resulted in syringe sale. Less than one quarter (21.1%) of pharmacies always sold, while 44.7% never sold. Independent and food store pharmacies tended not to sell syringes. There emerged distinct pharmacy staff interactions characterized by body language, customer query, normalization or othering response, response to purchase request and closure. Pharmacy discretion and pharmacy policy not to sell syringes without a prescription limited sterile syringe access. Investigators reported frequent and adverse emotional impact due to pharmacy staff negative and stigmatizing interactions. CONCLUSIONS: Pharmacies miss opportunities to advance efforts to eliminate bloodborne infections by stringent no-sale policy and discretion about syringe sale. State regulatory policy facilitating pharmacy syringe sales, limiting pharmacist discretion for syringe sales, and targeting pharmacy-staff level education may help advance the achievement of public health goals to eliminate bloodborne infections in Arizona.

Insufficient Impact: Limited Implementation of Federal Regulatory Changes to Methadone and Buprenorphine Access in Arizona During COVID-19.

Introduction: This study examined the impact of federal regulatory changes on methadone and buprenorphine treatment during COVID-19 in Arizona. Methods: A cohort study of methadone and buprenorphine providers from September 14, 2021 to April 15, 2022 measured the proportion of 6 treatment accommodations implemented at 3 time periods: before COVID-19, during Arizona's COVID-19 shutdown, and at the time of the survey completion. Accommodations included (1) telehealth, (2) telehealth buprenorphine induction, (3) increased multiday dosing, (4) license reciprocity, (5) home medications delivery, and (6) off-site dispensing. A multilevel model assessed the association of treatment setting, rurality, and treatment with accommodation implementation time. Results: Over half (62.2%) of the 74-provider sample practiced in healthcare settings not primarily focused on addiction treatment, 19% practiced in methadone clinics, and 19% practiced in treatment clinics not offering methadone. Almost half (43%) were unaware of the regulatory changes allowing treatment accommodation. Telehealth was most frequently reported, increasing from 30% before COVID-19 to 80% at the time of the survey. Multiday dosing was the only accommodation substantially retracted after COVID-19 shutdown: from 41% to 23% at the time of the survey. Providers with higher patient limits were 2.5-3.2 times as likely to implement telehealth services, 4.4 times as likely to implement buprenorphine induction through telehealth, and 15.2-20.9 times as likely to implement license reciprocity as providers with lower patient limits. Providers of methadone implemented 12% more accommodations and maintained a higher average proportion of implemented accommodations during the COVID-19 shutdown period but were more likely to reduce the proportion of implemented accommodations (a 17-percentage point gap by the time of the survey). Conclusions: Federal regulatory changes are not sufficient to produce a substantive or sustained impact on provider accommodations, especially in methadone medical treatment settings. Practice change interventions specific to treatment settings should be implemented and studied for their impact.

Opportunities and Challenges: Hepatitis C Testing and Treatment Access Experiences Among People in Methadone and Buprenorphine Treatment During COVID-19, Arizona, 2021.

Introduction: The purpose of this study was to characterize hepatitis C virus screening and treatment access experiences among people in treatment for opioid use disorder in Arizona during COVID-19. Methods: Arizonans receiving treatment for opioid use disorder from methadone clinics and buprenorphine providers during COVID-19 were interviewed about hepatitis C virus testing, curative treatment, and knowledge about screening recommendations. Interviews were conducted with 121 people from August 4, 2021 to October 10, 2021. Qualitative data were coded using the categories of hepatitis C virus testing, knowledge of screening recommendations, diagnosis, and experiences seeking curative treatment. Data were also quantitated for bivariate testing with outcome variables of last hepatitis C virus test, diagnosis, and curative treatment process. Findings were arrayed along an adapted hepatitis C virus cascade framework to inform program and policy improvements. Results: Just over half of the sample reported ever having tested for hepatitis C virus (51.2%, n=62) and of this group, 58.1% were tested in the past 12 months. Among those who were ever tested, 54.8% reported a hepatitis C virus diagnosis and 16.1% reported either being in treatment or having been declared cured of the hepatitis C virus. Among those who were diagnosed with hepatitis C, 14.7% indicated that they unsuccessfully tried to access curative treatment and would not attempt to again. Reasons cited for not accessing or receiving curative treatment included beliefs about treatment safety, barriers created by access requirements, natural resolution of the infection, and issues with healthcare coverage and authorization. Conclusions: Structural barriers continue to prevent curative hepatitis C virus treatment access. Given that methadone and buprenorphine treatment providers serve patients who are largely undiagnosed or treated for hepatitis C virus, opportunities exist for them to screen their patients regularly and provide support for and/or navigation to hepatitis C virus curative treatment.

"As safe as possible": a qualitative study of opioid withdrawal and risk behavior among people who use illegal opioids.

BACKGROUND: Opioid withdrawal is a regular occurrence among many people who use illicit opioids (PWUIO) that has also been shown to increase their willingness to engage in risk-involved behavior. The proliferation of fentanyl in the illicit opioid market may have amplified this relationship, potentially putting PWUIO at greater risk of negative health outcomes. Understanding the relationship between withdrawal and risk-involved behavior may also have important implications for the ways that problematic drug use is conceptualized, particularly in disease models of addiction, which position risk behavior as evidence of pathology that helps to justify ontological distinctions between addicts and non-addicts. Examining withdrawal, and its role in PWUIO's willingness to engage in risk, may aid in the development of alternative theories of risk involvement and create discursive spaces for de-medicalizing and de-othering people who use illegal drugs. METHODS: This article is based on 32 semi-structured interviews with PWUIO in the New York City area who also reported recent withdrawal experience. Interviews were conducted remotely between April and August 2022 and recorded for later transcription. Data were then coded and analyzed based on a combination of inductive and deductive coding strategies and informed by the literature. RESULTS: Participants described a strong relationship between withdrawal and their willingness to engage in risk-involved behavior that was exacerbated by the proliferation of fentanyl. Yet, their descriptions did not align with narratives of risk as a product of bad decisions made by individuals. Rather, data demonstrated the substantial role of social and structural context, particularly drug policies like prohibition and criminalization, in the kinds of risks that PWUIO faced and their ability to respond to them. CONCLUSIONS: Withdrawal should be taken more seriously both from an ethical perspective and as an important catalyst of risk behavior. However, theories that position activities taken to avoid withdrawal as irrational and as evidence of pathology are poorly aligned with the complexity of PWUIO's actual lives. We recommend the use of less deterministic and less medicalized theories of risk that better account for differences between how people view the world, and for the role of socio-structural forces in the production of risk.

SI-CBPAR: Towards structural indicators of community-based participatory action research.

INTRODUCTION: Structural aspects of community-engaged research are not well measured yet have critical implications for community research empowerment. This is particularly so with people who use drugs. We introduce the Structural Indicators of Community-Based Participatory Action Research (SI-CBPAR) to measure structural indicators of community-research entity relationships. METHODS: A three-phased process of iterative development, feasibility and applicability assessment was used to examine the instrument with community-engaged studies as a first stage of instrument development. The development team included people with university, non-government organisation and lived/ing drug use experience. Four studies on the health of people who use drugs were reviewed for indicator evidence followed by iterative discussion about construct and item discrepancies. Indicators were measured for the degree to which they were observed using a three-point scale. RESULTS: All but two constructs were confirmed for meaning. Constructs of 'community' and 'coalition' required revision and explanation. The need for further exploration of power differentials between community and community-based organisations was identified. Indicator evidence was found for all six categories across studies. The instrument was deemed applicable and easy to use. It was observed that categories could apply to studies with various degrees of community engagement and to other research focal areas. DISCUSSION AND CONCLUSIONS: SI-CBPAR applicability testing and initial category confirmation indicate its potential utility for community research collaboratives. The next phase of development involves cognitive interviewing with researchers from across community engaged research orientations, and with communities engaged in research beyond drug user health.

Evaluation of the Grow Your Groceries Home Gardening Program in Chicago, Illinois.

COVID-19 exacerbated existing disparities in food security in Chicago. Home gardening can improve food security but there are often barriers to participation and the benefits are understudied. Chicago Grows Food (CGF) formed in 2020 to address food insecurity during COVID-19, and created the Grow Your Groceries (GYG) program to provide home gardening kits to families at risk of food insecurity in Chicago. A participatory program evaluation was conducted to better understand the experiences of and benefits to individuals participating in GYG. Program participants shared feedback via focus groups (n = 6) and surveys (n = 72). Qualitative data were analyzed using an iterative coding process. Quantitative data were analyzed using descriptive statistics. Most participants reported confidence in using a grow kit to grow food, increased healthy food consumption, easier access to healthy food, and high likelihood of growing food again. Additionally, participants described increased connections within their communities, increased interaction with their family, and personal growth as benefits of the program. These results demonstrate the benefits of a novel home gardening program that uses fabric grow bags to address food insecurity. A larger scale program evaluation is necessary to better understand the impacts of participating in this home gardening program.

Nothing really changed: Arizona patient experience of methadone and buprenorphine access during COVID.

OBJECTIVE: To understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic. METHODS: This community-based participatory and action research study involved one-hour, audio-recorded field interviews conducted with 131 people who used methadone and/or buprenorphine to address opioid use disorder at some point during COVID (January 1, 2020- March 31, 2021) in Arizona. Transcribed data were analyzed using a priori codes focused on federally recommended flexibilities governing MOUD access. Data were quantitated to investigate associations with COVID risk and services access. RESULTS: Telehealth was reported by 71.0% of participants, but the majority were required to come to the clinic to attend video appointments with an offsite provider. Risk for severe COVID outcomes was reported by 40.5% of the sample. Thirty-eight percent of the sample and 39.7% of methadone patients were required to be at the clinic daily to get medication and 47.6% were at high risk for COVID severe outcomes. About half (54.2%) of methadone patients indicated that some form of multi-day take home dosing was offered at their clinic, and 45.8% were offered an extra day or two of multi-day doses; but no participants received the federally allowed 14- or 28-day methadone take-home doses for unstable and stable patients respectively. All participants expressed that daily clinic visits interrupted their work and home lives and desired more take-home dosing and home delivery options. CONCLUSIONS: MOUD patients in Arizona were not offered many of the federally allowed flexibilities for access that were designed to reduce their need to be at the clinic. To understand the impact of these recommended treatment changes in Arizona, and other states where they were not well implemented, federal and state regulators must mandate these changes and support MOUD providers to implement them.

I don't even want to go to the doctor when I get sick now: Healthcare experiences and discrimination reported by people who use drugs, Arizona 2019.

BACKGROUND: People who use drugs experience severe health inequities created by structural and social barriers related to healthcare access. This includes stigma. OBJECTIVE: To characterize the experience of healthcare access among people who use drugs in Maricopa County, Arizona USA. METHODS: A 20-item guided survey with quantitative and qualitative items was fielded between October 23-November 5, 2019 among people who use drugs in community locations (public spaces, trap houses, drug copping areas). Surveys were administered face-to-face by community researchers with lived experiences. Survey recruitment included convenience sampling and social referral among respondents. Quantitative items were described and qualitative data were independently coded using an a priori coding scheme including reasons for healthcare seeking and healthcare-related stigma (anticipated, experienced, enacted). RESULTS: Over one-third (39.5%) of the185 person sample did not seek medical care in the past year. Of this group, 34.2% reported that they did not seek needed healthcare because they were afraid of being treated badly by medical providers for using drugs. The three major experiences reported by those seeking healthcare in the past year included 1) medical mistreatment (not addressing the primary medical complaint, providing wrong or inadequate treatment), 2) social mistreatment (disapproval, embarrassment, shaming) and 3) abusive behavior (verbal and physical) by healthcare providers. CONCLUSIONS: Efforts should create healthcare social and practice environments that assure appropriate and competent medical care and prohibit healthcare provider mistreatment of people who use drugs. Structural incentives such as healthcare finance, hospital accreditation and medical complaint registration should be considered.

Using progressive ratio schedules to evaluate tokens as generalized conditioned reinforcers.

The properties of operant reinforcers are dynamic and dependent on a number of variables, such as schedule and effort. There has been sparse research on the generalized conditioned properties of token reinforcement. We evaluated leisure items, edible items, and tokens using a progressive ratio schedule with three children with diagnoses of ASD and developmental delays. The highest break points occurred during the token reinforcement condition for two out of three participants, but response rates tended to be higher with edibles. We then evaluated the effects of presession access to edibles on the break points of edible items and tokens with two participants. Break points decreased only in the edible reinforcement condition, and the participants chose to work for leisure items rather than edibles when presession access to edibles was in place. These findings suggest that the tokens functioned as generalized conditioned reinforcers.

Strategies and therapeutic opportunities for the delivery of drugs to the esophagus.

Targeting of drugs and therapies locally to the esophagus is an important objective in the development of new and more effective dosage forms. Therapies that are retained within the oral cavity for both local and systemic action have been utilized for many years, although delivery to the esophagus has been far less reported. Esophageal disease states, including infections, motility disorders, gastric reflux, and cancers, would all benefit from localized drug delivery. Therefore, research in this area provides significant opportunities. The key limitation to effective drug delivery within the esophagus is sufficient retention at this site coupled with activity profiles to correspond with these retention times; therefore, a suitable formulation needs to provide the drug in a ready-to-work form at the site of action during the rapid transit through this organ. A successfully designed esophageal-targeted system can overcome these obstacles. This review presents a range of dosage form approaches for targeting the esophagus, including bioadhesive liquids and orally retained lozenges, chewing gums, gels, and films, as well as endoscopically delivered therapeutics. The techniques used to measure efficacy both in vitro and in vivo are also discussed. Drug delivery is a growing driver within the pharmaceutical industry and offers benefits both in terms of clinical efficacy, as well as in market positioning, as a means of extending a drug's exclusivity and profitability. Emerging systems that can be used to target the esophagus are reported within this review, as well as the potential of alternative formulations that offer benefits in this exciting area.