Intravenous Drug Research Articles

Considerations on the sustainability of hypercholesterolemia treatment in the context of new drugs on the market: data from Campania, Italy.

Hypercholesterolemia is a major risk factor in the development of cardiovascular diseases. Statins have been the primary treatment for reducing LDL cholesterol for years; however, adverse events related to their use have led to the development of alternative therapies, such as ezetimibe, bempedoic acid, and PCSK9 inhibitors, including alirocumab, evolocumab, and inclisiran. The study is aimed at comparing the consumption and costs of lipid-lowering drugs in the first half of 2023 (21,446,011.54 DDD and 10,974,495.47 €) and 2024 (19,493,540.71 DDD and 12,260,634.95 €) to assess the economic impact of new therapies in the management of dyslipidemia and adherence to guidelines. Dispensing data, without access to patient data, were collected from private community pharmacies and hospital and district pharmacies. Drug consumption was measured using the ATC classification system and the defined daily dose (DDD). The study revealed a trend toward a reduction in the use of traditional statin monotherapy and an increase in more recent and combined therapies. Statins showed a significant reduction from 42% in the first half of 2023 to 30% in the first half of 2024. Combined therapies, such as statins with ezetimibe, showed no change in trend, maintaining a 17% share in both periods. New therapies, such as PCSK9 inhibitors, demonstrated an increase from 33% in the first half of 2023 to 40% in the first half of 2024, while bempedoic acid, either as monotherapy or in combination with ezetimibe, remained below 2%. In recent years, the treatment of dyslipidemia has seen the introduction of many therapeutic alternatives. Bempedoic acid, recently introduced and less expensive, when used as an adjunct therapy with statins and ezetimibe, could reduce side effects and improve therapeutic efficacy without immediately resorting to higher-cost injectable drugs such as evolocumab, alirocumab, and inclisiran. Monitoring prescription trends and costs is essential to maintain the sustainability of the healthcare system, enabling investments in innovation and effective therapies without waste.

Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services

Monoclonal antibodies (mAbs) constitute a new form of immunotherapy that has shown great success in long-term tumour control. These injectable drugs are managed and compounded by the Pharmacy Intravenous Admixture Services (PIVAS) staff in a specified sterile environment. This study utilized failure mode and effect analysis (FMEA) as a risk management tool to manage mAb drugs within the PIVAS. The nine-member multidisciplinary team mapped the processes; evaluated the severity, occurrence, and detection of each subprocess; and calculated the risk priority number (RPN). Further corrective actions were taken for high-risk steps, followed by re-evaluation and scoring to achieve a low-risk process. We identified seven major processes and twenty-eight subprocesses involved in the management of mAb drugs in PIVAS. A total of thirteen high-risk failure modes with an assigned RPN 1 were selected. This selection represents the first calculated RPN values, resulting in a total score of 3375. After a first round of evaluation and implementation of corrective actions, the RPN 2 score decreased to 464. Following a second round of the FMEA process, the RPN 3 score was further reduced to 51. Through refinement, we successfully mitigated the occurrence of high-risk failure modes of mAb drugs in PIVAS. These efforts are aimed at enhancing the safety and efficacy of mAb drugs, ultimately ensuring patient safety.

Infective Endocarditis in People Who Inject Drugs – a Five-Year Follow-up: “I´ve Seen the Needle and the Damage Done”

Abstract Background Infective endocarditis (IE) among people who inject drugs (PWID) has been associated with better short-term outcome. Long-term outcome of PWID with IE is poorly known. Methods PWID with IE and non-PWID adults with community-acquired IE who were diagnosed and treated in Southern Finland between 2013-2017 and who survived the initial IE episode were included in this retrospective population-based study. All patients were followed for five years. Data on drug use, receipt of medications for opioid use therapy (MOUD), survival, and subsequent IE episode during follow-up were collected. Results Seventy-five PWID with IE and 98 patients with community-acquired IE were included. Buprenorphine and amphetamine (or other stimulant) were the most used substances amongst PWID. Sixteen PWID received MOUD before onset of IE and 33 received MOUD at the time of discharge. Most PWID (86%) received addiction specialist consultation during the hospitalization. Fifteen patients in PWID-IE group experienced a new IE episode in 5-year-follow-up and five patients in non-PWID-IE group (OR 4.65, P=0.003). One-year all-cause mortality in PWID-IE was 4.0% (n=3/75) and in non-PWID-IE 4.1% (n=4/98). Five-year all-cause mortality was 18.7% (n=14/75) in PWID-IE and 13.3% (n=13/98) in non-PWID-IE (P=0.399). In multivariate analysis of whole group, injection drug use (OR 12.2), female gender (OR 2.62) and higher age-adjusted comorbidity index were independent factors associated with death during five-year follow-up. Conclusion Long-term survival of PWID with IE is poor and they are at increased risk of a new IE episode compared to non-PWID with community-acquired IE. More efforts in the treatment of addiction are needed.

PrEP Awareness, Interest, and Use among Women Who Inject Drugs in Seattle, Washington: A Mixed Methods Study.

Women who inject drugs (WWID) are disproportionately affected by HIV and experience multiple barriers to PrEP use. We conducted a mixed methods study to assess PrEP awareness, interest, and use, and determinants of PrEP utilization among WWID at three community sites in Seattle, Washington from March-May 2023. Participants were ≥ 18 years old, spoke English, identified as women, had a history of injecting drugs, and self-reported a negative or unknown HIV status. We describe survey participant characteristics (n = 30) by PrEP candidacy based on behaviors associated with HIV acquisition. We concurrently recruited 16 WWID for semi-structured interviews, which were analyzed using the Rapid Assessment Process. Survey and interview data were triangulated to enhance interpretations. Among 30 WWID, 25 (83%) were PrEP candidates, of whom 19 (76%) had heard about PrEP; only 2 (8%) were currently using PrEP. Among PrEP candidates, 13 (57%) reported interest in daily oral PrEP and almost half (n = 12, 48%) reported interest in injectable PrEP. Qualitative data revealed cursory PrEP knowledge and a strong interest in daily oral and injectable PrEP among those who perceived they were at risk for HIV. Several barriers to PrEP use were noted including housing instability, adherence challenges, limited perceived risk, and competing priorities like safety and substance use. While most WWID were aware of PrEP, qualitative data suggested significant misconceptions about PrEP, and many described complex, intersecting barriers to use. Our findings highlight the need for increased low-barrier, population-specific interventions to improve uptake and sustained use of PrEP among WWID.

Cognitive function among people with severe substance use.

Studies report a high variability of cognitive impairment in people who use drugs, ranging from 20% to 80%. Most research focus on individuals who use drugs who are either admitted to treatment facilities or incarcerated and being abstinent from substances. The present study aimed to assess cognitive function among populations with ongoing, severe, habitual substance use, mimicking a real-world day-to-day situation. Cross-sectional design with 171 participants (70.2% male) with severe substance use, recruited from two sites in Oslo, Norway. All participants were screened for cognitive function using the Montreal Cognitive Assessment (MoCA). A cutoff of < 26 points was used to classify possible cognitive impairment. Participants also provided information on their alcohol and substance use, as well as demographic data. 74.9% of the participants scored below the MoCA cutoff for possible cognitive impairment. We did not find any associations between scoring below the MoCA cutoff <26 and the substance use variables (substance use, number of substances used, history of overdoses, injection drug use, and past substance use treatment). A high proportion of people with severe substance use may experience a functional cognitive impairment. This study provides novel insights into cognitive function within a population actively engaged in habitual substance use, offering a real-world perspective with high external validity. This knowledge is highly relevant for service providers who aim to deliver tailored follow-up services to this population outside of traditional treatment settings.

An Adapted Friendship Bench Counseling Intervention (FB) to Improve Mental Health and HIV Care Engagement Outcomes Among People Living with HIV (PWH) Who Inject Drugs in Hanoi, Vietnam: Results from the VITAL Pilot Randomized Controlled Trial.

Common mental disorders (CMDs) are prevalent among people living with HIV (PWH) and cause morbidity, jeopardize HIV care engagement, and worsen HIV outcomes. In Vietnam, PWH who inject drugs are at high risk for poor HIV and CMD outcomes. However, few evidence-based interventions are available to address this population. We conducted a three-arm individually randomized pilot trial assigning 75 PWH with opiate use disorder and a CMD from methadone maintenance treatment clinics to either FB by a professional counselor, FB by a peer counselor, or enhanced usual care. Primary outcomes were feasibility, acceptability, and fidelity of FB; we also assessed preliminary indicators of CMD improvement and HIV care engagement. Feasibility was high, with 99% retention at 6weeks and 96% retention at 6months. 100% of patients receiving FB attended all 6 weekly sessions. Acceptability of FB was high for participants in both the professional and peer counselor groups. Providers were highly satisfied with the FB experience. Fidelity was adequate: 72% of professional counselors met or exceeded fidelity expectations, while 44% of peer counselors did. Preliminary indicators of effectiveness for CMDs were promising. Participants in the professional counselor arm had the greatest improvement as measured by CMD symptom improvement and CMD response rates at most follow-up visits. The adapted FB intervention should be scaled up and evaluated in a larger, fully powered randomized controlled trial to evaluate its efficacy in improving CMDs and HIV engagement for PWH and CMDs at greatest risk of poor HIV and CMD outcomes.Clinical Trial Number: NCT04790201 registered 3/10/2021.

AI-Driven Innovation in Skin Kinetics for Transdermal Drug Delivery: Overcoming Barriers and Enhancing Precision

Transdermal drug delivery systems (TDDS) offer an alternative to conventional oral and injectable drug administration by bypassing the gastrointestinal tract and liver metabolism, improving bioavailability, and minimizing systemic side effects. However, widespread adoption of TDDS is limited by challenges such as the skin’s permeability barrier, particularly the stratum corneum, and the need for optimized formulations. Factors like skin type, hydration levels, and age further complicate the development of universally effective solutions. Advances in artificial intelligence (AI) address these challenges through predictive modeling and personalized medicine approaches. Machine learning models trained on extensive molecular datasets predict skin permeability and accelerate the selection of suitable drug candidates. AI-driven algorithms optimize formulations, including penetration enhancers and advanced delivery technologies like microneedles and liposomes, while ensuring safety and efficacy. Personalized TDDS design tailors drug delivery to individual patient profiles, enhancing therapeutic precision. Innovative systems, such as sensor-integrated patches, dynamically adjust drug release based on real-time feedback, ensuring optimal outcomes. AI also streamlines the pharmaceutical process, from disease diagnosis to the prediction of drug distribution in skin layers, enabling efficient formulation development. This review highlights AI’s transformative role in TDDS, including applications of models such as Deep Neural Networks (DNN), Artificial Neural Networks (ANN), BioSIM, COMSOL, K-Nearest Neighbors (KNN), and Set Covering Machine (SVM). These technologies revolutionize TDDS for both skin and non-skin diseases, demonstrating AI’s potential to overcome existing barriers and improve patient care through innovative drug delivery solutions.

Intersecting Structural and Psychosocial Conditions: Investigating Injection Drug Use and HIV Among Transgender Women.

Transgender women continue to face a significant burden of health disparities with HIV infection as a critical public health concern. Substance use is higher among transgender women than among cisgender women. However, little is known about transgender women who inject drugs and risk for HIV in the United States. The objectives were to explore HIV prevalence, injection-related behaviors, and HIV prevention and care outcomes among transgender women who inject drugs and to compare transgender women with a general sample of persons who inject drugs. Participants from the National HIV Behavioral Surveillance were recruited through respondent-driven sampling, interviewed, and tested for HIV infection in 2019-2020. Log-linked Poisson regression models were used to test for associations between injection drug use and selected characteristics. Among 1561 transgender women, 7% injected drugs in the past 12 months. HIV prevalence was higher among transgender women who inject (adjusted prevalence ratio = 1.5, 95% confidence interval: 1.2 to 1.8) than among those who do not. Multiple psychosocial conditions were associated with injection drug use. Among transgender women with HIV, those who inject were less likely to take antiretroviral therapy (adjusted prevalence ratio = 0.8, 95% confidence interval: 0.7 to 1.0) than those who do not. Methamphetamine was the most commonly injected drug (67%); most accessed a syringe services program (66%). Transgender women who inject have substantial challenges related to health outcomes including high HIV prevalence and exposure to psychosocial conditions, such as homelessness, incarceration, and exchange sex, that may exacerbate risks associated with injection drug use. This population may benefit from increased access to nonjudgmental and culturally competent harm reduction services.

Factors associated with emergency department methicillin-resistant Staphylococcus aureus coverage in patients with skin and soft tissue infections in an urban, tertiary care emergency department.

Skin and soft tissue infections (SSTIs) are common and contribute significantly to morbidity and healthcare costs in emergency departments (EDs). The rise of antimicrobial resistance, particularly due to community-acquired methicillin-resistant Staphylococcus aureus (MRSA), complicates treatment decisions. Objective physical examination findings suggesting need for empiric MRSA coverage are sometimes ignored. Improving initial antimicrobial selection in the ED, especially regarding MRSA, could enhance antimicrobial stewardship. We conducted a retrospective review of patient records for those who presented with SSTIs to an urban tertiary care ED between January 1, 2017, to December 31, 2019. Patients admitted during their initial visit were excluded. Data collected included demographics, vital signs, and laboratory results. Logistic regression was used to assess factors associated with the decision to provide MRSA coverage at presentation, reporting odds ratios with 95% confidence intervals. Among 1675 patients, 42.2% received empiric MRSA coverage. Factors associated with MRSA coverage included male gender, white race, intravenous drug use, immunocompromised status, systemic symptoms, tachycardia, presence of abscess, and surgical consultation. After adjusting for confounders, male gender, history of intravenous drug use, immunocompromised status, systemic symptoms, tachycardia, surgical consultation, and recent antibiotic use remained significantly associated. Several factors, not always aligned with clinical guidelines, influenced the decision to initiate MRSA coverage in the ED. Understanding these determinants may improve antimicrobial stewardship and reduce costs. Future research should focus on patient outcomes based on methicillin-sensitive S. aureus (MSSA) versus MRSA coverage decisions and educational initiatives to improve guideline compliance.

Association between homelessness and PrEP uptake among men who have sex with men: Results from the American Men's Internet Survey, 2017-2021.

Gay, bisexual, and other men who have sex with men (GBMSM) are disproportionately affected by housing insecurity across the US. This study examined the association between homelessness and uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among GBMSM in the United States and investigated the modifying effect of injection drug use. 47,750 cisgender GBMSM who participated in the American Men's Internet Survey from 2017 to 2021 and who self-reported not living with HIV were included in this secondary, cross-sectional analysis. Homelessness was defined as living on the street, a shelter, a Single Room Occupancy hotel, or a car in the past 12 months. Associations between sociodemographic characteristics and homelessness were tested using chi-squared tests. Weighted univariable and multivariable Poisson regression models with robust variance estimation assessed associations between homelessness and PrEP uptake; weights were constructed based on race/ethnicity and region. 8304(17.4%) participants reported PrEP uptake in the last 12 months. Those experiencing homelessness were more likely to be younger, Black, uninsured, living in the US South, and report lifetime injection drug use. Homelessness was independently negatively associated with PrEP uptake (aPR=0.85; 95%CI: 0.75, 0.95). Homelessness was negatively associated with PrEP uptake in those not reporting injection drug use (aPR=0.77; 95%CI: 0.67, 0.90). However, homelessness was not associated with PrEP uptake in those reporting injection drug use. Homelessness was associated with lower PrEP uptake among GBMSM. Outreach and peer-based interventions tailored specifically to homeless GBMSM are needed given the disproportionate need. Future research on the impact of macro-level systems of inequality and individuals with marginalized identities are needed to unpack intersectional vulnerabilities.

HBV and HCV testing outcomes among marginalized communities in Italy, 2019–2024: a prospective study

The health of the marginalized populations is crucial for public health and inequalities. The World Health Organization (WHO) Global Hepatitis Report 2024 stated that over 304 million people were living with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) infection in 2022. We performed HBV/HCV screenings among marginalized communities to reveal hidden infections and link-to-care positive participants. From January 2019 to May 2024, finger-prick tests were used to conduct on-site screenings at non-profit organizations in Tuscany, Italy. Positive participants were referred to the closest outpatient clinic. Eighty/1812 (4.4%) participants were Hepatitis B surface Antigen (HBsAg)+, mostly men (p<0.001) and non-Italian natives compared to those HBsAg- (p<0.001). Fifty-two/1812 (2.9%) were anti-HCV+ with a higher proportion of Italians (p<0.001) and lower education level (p<0.01) compared to the anti-HCV-. Intravenous drug use was an independent factor for being anti-HCV+ (p<0.0001). Among the HBsAg+individuals, 66.3% (53/80) were linked and 90.4% (48/53) retained in care (treated/monitored). Of the anti-HCV participants requiring clinical evaluation, 37.8% (14/37) were linked to care, and all the 11/14 (88.6%) viremic patients were successfully treated. We found higher HBV/HCV positivity compared to national prevalences. Participation and linkage to care were successful. The young mean age (33.6yrs) of HBsAg+individuals, primarily from regions with low vaccinal adherence, indicated geographical origin as a key risk factor. HCV positivity was associated with extreme marginality. The results stress the need to implement marginalized groups screening to target HBV/HCV hidden infections, reducing disparities in healthcare and advancing towards the WHO 2030 elimination goal. Gilead Sciences; Fondazione Cassa di Risparmio di Pistoia e Pescia; Regione Toscana.

The role of virtual wards in maternity in the United Kingdom.

Virtual wards are an initiative which aims to provide hospital care from the comfort of the patient's own home. Monitoring and additional services, such as intravenous drugs and fluids and blood tests can be undertaken through this system. Although virtual wards have been used in the UK since 2005 in specialties such as General Medicine, General Surgery and Paediatrics, their use in maternity has been more limited. This article aims to review their current use in the UK and beyond as well as to discuss some of the advantages and challenges they may pose to a maternity population.

Evaluation of a Smartphone Application to Reduce Overdose Risk: Results From a Pilot Clinical Trial With People Who Inject Drugs

Evaluation of a Smartphone Application to Reduce Overdose Risk: Results From a Pilot Clinical Trial With People Who Inject Drugs

Patterns of Polysubstance Use Among People who Inject Drugs Using the National HIV Behavioral Surveillance System: A Latent Class Analysis

Patterns of Polysubstance Use Among People who Inject Drugs Using the National HIV Behavioral Surveillance System: A Latent Class Analysis

Establishing the Preliminary Feasibility of a Mobile Phone-based Intervention for People Who Inject Drugs

Establishing the Preliminary Feasibility of a Mobile Phone-based Intervention for People Who Inject Drugs

Ethical Considerations for Using Biometric Enrollment Technology With Persons who Injection Drugs in Ciudad Juárez, Mexico

Ethical Considerations for Using Biometric Enrollment Technology With Persons who Injection Drugs in Ciudad Juárez, Mexico

Factors Associated With Carrying Naloxone Among People who Inject Drugs in New York City: A Mixed-Methods Analysis

Factors Associated With Carrying Naloxone Among People who Inject Drugs in New York City: A Mixed-Methods Analysis

Accuracy and precision of 3 multidose vial tracking methods to inform controlled drug tracking in practice.

To evaluate the precision and accuracy of 3 common methods (method 1, actual draws of the volume remaining; method 2, weight tracking of the volume remaining and/or the volume removed; and method 3, discrepancy percentage at the end of each vial) for monitoring volumes in vials of injectable controlled drugs. For methods 1 and 2, doses were drawn from a vial containing a known amount of sterile water. For method 1, after each dose was removed, the remaining quantity of liquid was withdrawn, measured, and reinjected into the vial. The estimated and actual hub loss were calculated. For method 2, the syringe with the needle attached was weighed immediately prior to each draw and reweighed after the draw. The vial was weighed after each draw and compared to the expected weight of 1 g/mL. For method 3, the total discrepancy volume per vial was determined for vials used from January 1, 2022, through March 31, 2023. The discrepancy percentage between the calculated amount remaining and 0 mL was determined for each vial. Accuracy and precision were determined for each method. Method 2 was more accurate than method 1. Precision was equal for methods 1 and 2, with method 3 having the lowest precision. Methods 1 and 2 have accuracy and precision sufficient to justify their use in practice. Method 3 is not sufficiently precise to be used alone. The method(s) chosen should be based on accuracy and precision as well as the pros and cons of each method.

Drug Use-Related Discrimination in Healthcare Settings and Subsequent Emergency Department Utilization in a Prospective Cohort Study of People With a History of Injection Drug Use

Drug Use-Related Discrimination in Healthcare Settings and Subsequent Emergency Department Utilization in a Prospective Cohort Study of People With a History of Injection Drug Use

Development and Validation of a Hepatitis C Risky Injection Behaviours Index in a Cohort of People who Inject Drugs Located in Montréal, Canada

Development and Validation of a Hepatitis C Risky Injection Behaviours Index in a Cohort of People who Inject Drugs Located in Montréal, Canada