Emerging Therapeutics, Technologies, and Drug Development Strategies to Address Patient Nonadherence and Improve Tuberculosis Treatment.

Imperfect medication adherence remains the biggest predictor of treatment failure for patients with tuberculosis. Missed doses during treatment lead to relapse, tuberculosis resistance, and further spread of disease. Understanding individual patient phenotypes, population pharmacokinetics, resistance development, drug distribution to tuberculosis lesions, and pharmacodynamics at the site of infection is necessary to fully measure the impact of adherence on patient outcomes. To decrease the impact of expected variabilityin drug intake on tuberculosis outcomes, an improvement in patient adherence and new forgiving regimens that protect against missed doses are needed. In this review, we summarize emerging technologies to improve medication adherence in clinical practice and provide suggestions on how digital adherence technologies can be incorporated in clinical trials and practice and the drug development pipeline that will lead to more forgiving regimens and benefit patients suffering from tuberculosis.

Patient Centricity Driving Formulation Innovation: Improvements in Patient Care Facilitated by Novel Therapeutics and Drug Delivery Technologies.

Innovative formulation technologies can play a crucial role in transforming a novel molecule to a medicine that significantly enhances patients' lives. Improved mechanistic understanding of diseases has inspired researchers to expand the druggable space using new therapeutic modalities such as interfering RNA, protein degraders, and novel formats of monoclonal antibodies. Sophisticated formulation strategies are needed to deliver the drugs to their sites of action and to achieve patient centricity, exemplified by messenger RNA vaccines and oral peptides. Moreover, access to medical information via digital platforms has resulted in better-informed patient groups that are requesting consideration of their needs during drug development. This request is consistent with health authority efforts to upgrade their regulations to advance age-appropriate product development for patients. This review describes formulation innovations contributingto improvements in patient care: convenience of administration, preferred route of administration, reducing dosing burden, and achieving targeted delivery of new modalities.

Medication adherence in patients with type 2 diabetes after disability onset: a difference-in-differences analysis using nationwide data.

BACKGROUND: Effectively managing the coexistence of both diabetes and disability necessitates substantial effort. Whether disability onset affects adherence to type 2 diabetes medication remains unclear. This study investigated whether disability onset reduces such adherence and whether any reduction varies by disability type. METHODS: This study used the National Disability Registry and National Health Insurance Research Database from Taiwan to identify patients with type 2 diabetes who subsequently developed a disability from 2013 to 2020; these patients were matched with patients with type 2 diabetes without disability onset during the study period. Type 2 diabetes medication adherence was measured using the medication possession ratio (MPR). A difference-in-differences analysis was performed to determine the effect of disability onset on the MPR. RESULTS: The difference-in-differences analysis revealed that disability onset caused a reduction of 5.76% in the 1-year MPR (P < 0.001) and 13.21% in the 2-year MPR (P < 0.001). Among all disability types, organ disabilities, multiple disabilities, rare diseases, and a persistent vegetative state exhibited the largest reductions in 2-year MPR. CONCLUSIONS: Policies aimed at improving medication adherence in individuals with disabilities should consider not only the specific disability type but also the distinct challenges and barriers these patients encounter in maintaining medication adherence.

Medication non-adherence and self-inflicted violence behaviors among 185,800 patients with schizophrenia in the community: a 12-year cohort study.

BACKGROUND: Despite the importance of medication adherence in treatment effectiveness, little is known about the association between medication non-adherence and self-inflicted violence behaviors. We aimed to assess whether medication non-adherence increased the risk of self-inflicted violence behaviors among schizophrenics in communities (hypothesis 1) and whether the dose-response relationship existed (hypothesis 2). METHODS: This 12-year cohort study in western China recruited 292,667 community-dwelling schizophrenics. The proportion of regular medication (PRM) was calculated by dividing the time of "regular adherence" by the total time of antipsychotic treatment during follow-up period as an indicator of medication adherence. For hypothesis 1, medication adherence was designated as a binary variable with a threshold of 0.8 (PRM); for hypothesis 2, medication adherence was specified as five-category and continuous variables, respectively. Inverse probability weighting and mixed effects Cox proportional hazards models were conducted for confounders control and survival analyses. RESULTS: One hundred eighty-five thousand eight hundred participants were eligible for the final analyses, with a mean age of 47.49 years (SD 14.55 years), of whom 53.6% were female. For hypothesis 1, the medication non-adherence group (PRM < 0.8) had a lower risk of suicide (HR, 0.527, 95% CI, 0.447-0.620), an increased risk of NSSI (HR, 1.229, 95% CI, 1.088-1.388), and non-significant risk of attempted suicide compared with adherence group (PRM ≥ 0.8). For hypothesis 2, the lowest medication adherence (PRM < 0.2) was associated with increased risks of suicide attempt (HR, 1.614, 95% CI, 1.412-1.845), NSSI (HR, 1.873, 95% CI, 1.649-2.126), and a decreased risk of suicide (HR, 0.593, 95% CI, 0.490-0.719). The other non-adherence groups had lower risks for all three self-inflicted violence behaviors. The associations between medication adherence in continuous-variable and three outcomes were consistent with the categorical medication adherence results. CONCLUSIONS: Almost no medication taken as prescribed was associated with an increased risk of suicide attempt and NSSI. However, medication adherence did not appear to prevent completed suicide. Besides, patients with moderate adherence had a lower incidence of suicide attempt and NSSI. These findings highlight the need for a more detailed portrayal of medication adherence and the need to be vigilant for suicide intent in schizophrenics with good medication adherence who may be overlooked previously.

Lost in Translation: Why Are Rates of Hypertension Control Getting Worse Over Time?

Treatment of hypertension to decrease rates of cardiovascular disease is the most well studied and most broadly applicable treatment in cardiovascular prevention. Blood pressure can be measured anywhere, not just in a physician's office; medications are readily available, inexpensive, and have highly favorable benefit/harm ratios with relatively minimal side effects; and stepped medication regimens can be prescribed in algorithmic fashion by a variety of practitioners. Yet overall hypertension control rates in the United States have never exceeded 60%, and the last 5-10 years have seen decreased, rather than increased, rates of control. Here, I describe the scale of this massive failure to deliver on the promise of preventive hypertension care; outline the populations most affected and the contemporaneous events that have impacted hypertension control; discuss the disparate paths of hypertension science and health care delivery; and highlight novel interventions, approaches, and future opportunities to bend the curve back toward improvements in hypertension control.

Barriers and Unmet Educational Needs Regarding Implementation of Medication Adherence Management Across Europe: Insights from COST Action ENABLE.

BACKGROUND: Medication adherence is essential for the achievement of therapeutic goals. Yet, the World Health Organization estimates that 50% of patients are nonadherent to medication and this has been associated with 125 billion euros and 200,000 deaths in Europe annually. OBJECTIVE: This study aimed to unravel barriers and unmet training needs regarding medication adherence management across Europe. DESIGN: A cross-sectional study was conducted through an online survey. The final survey contained 19 close-ended questions. PARTICIPANTS: The survey content was informed by 140 global medication adherence experts from clinical, academic, governmental, and patient associations. The final survey targeted healthcare professionals (HCPs) across 39 European countries. MAIN MEASURES: Our measures were barriers and unmet training needs for the management of medication adherence across Europe. KEY RESULTS: In total, 2875 HCPs (pharmacists, 40%; physicians, 37%; nurses, 17%) from 37 countries participated. The largest barriers to adequate medication adherence management were lack of patient awareness (66%), lack of HCP time (44%), lack of electronic solutions (e.g., access to integrated databases and uniformity of data available) (42%), and lack of collaboration and communication between HCPs (41%). Almost all HCPs pointed out the need for educational training on medication adherence management. CONCLUSIONS: These findings highlight the importance of addressing medication adherence barriers at different levels, from patient awareness to health system technology and to fostering collaboration between HCPs. To optimize patient and economic outcomes from prescribed medication, prerequisites include adequate HCP training as well as further development of digital solutions and shared health data infrastructures across Europe.

Patient experiences: a qualitative systematic review of chemotherapy adherence.

Adherence to chemotherapy treatment is recognized as a crucial health concern, especially in managing cancer patients. Chemotherapy presents challenges for patients, as it can lead to potential side effects that may adversely affect their mobility and overall function. Patients may sometimes neglect to communicate these side effects to health professionals, which can impact treatment management and leave their unresolved needs unaddressed. However, there is limited understanding of how patients' experiences contribute to improving adherence to chemotherapy treatment and the provision of appropriate support. Therefore, gaining insights into patients' experiences is crucial for enhancing the accompaniment and support provided during chemotherapy.This review synthesizes qualitative literature on chemotherapy adherence within the context of patients' experiences. Data were collected from Medline, Web of Science, CINAHL, PsychINFO, Embase, Scopus, and the Cochrane Library, systematically searched from 2006 to 2023. Keywords and MeSH terms were utilized to identify relevant research published in English. Thirteen articles were included in this review. Five key themes were synthesized from the findings, including positive outlook, receiving support, side effects, concerns about efficacy, and unmet information needs. The review underscores the importance for healthcare providers, particularly nurses, to focus on providing comprehensive information about chemotherapy treatment to patients. Adopting recommended strategies may assist patients in clinical practice settings in enhancing adherence to chemotherapy treatment and improving health outcomes for individuals living with cancer.

Can Smartphone Notifications Help With Gout Management? A Feasibility Study.

OBJECTIVE: This feasibility study aimed to assess the acceptability of using smartphone notifications to modify the medication beliefs of people with gout. We evaluated the feasibility and acceptability of a smartphone application using the Technology Acceptance Model. We explored adherence rate differences and outcomes between the intervention and control groups. METHODS: Fifty-two patients with gout who were prescribed allopurinol were randomly assigned to either active control (n = 24) or intervention group (n = 28). Over 3 months, both groups used the study app on their smartphones. The active control group received notifications about general health advice, whereas the intervention group received adherence-targeted notifications. The feasibility and acceptability of the smartphone app was measured through semistructured interviews. Adherence rate was assessed through serum urate levels and missed doses at 3 timepoints: baseline, 3 months (post intervention), and 6 months (follow-up). RESULTS: The smartphone app demonstrated high feasibility, with strong participant retention and compliance. The participants expressed high levels of satisfaction with the app's user-friendliness and content, highlighting its acceptability. Both groups showed a significant reduction in missed doses over time (P < 0.05), but no significant differences in serum urate levels were found between the groups. Patients who received adherence-targeted notifications reported finding it more convenient to take allopurinol and expressed higher overall treatment satisfaction throughout the study. CONCLUSION: Adherence-targeted notifications have the potential to be an effective and scalable approach to supporting medication adherence in patients with gout. Further research is needed with larger samples to refine the components of the intervention and explore its optimal implementation.

Factors Influencing Medication Adherence Among Adults Living with Diabetes and Comorbidities: a Qualitative Systematic Review.

PURPOSE OF REVIEW: Medication adherence plays an important role in improving health outcomes related to diabetes and comorbidity. The potential factors influencing medication adherence and how they contribute to health behaviors have not been synthesized to date. This review synthesized qualitative studies that identified factors influencing medication adherence among adults living with diabetes and comorbidity. RECENT FINDINGS: Twenty-eight findings were extracted and synthesized into four themes: perceived support, lack of knowledge, medication issues, and the importance of routine. The findings highlight the factors that support medication adherence and areas that can be targeted to support and promote medication adherence. The findings also support the potential role of healthcare providers in supporting people living with diabetes and comorbidity to adhere to and maintain medication regimes. Several factors were identified that are amenable to intervention within the clinical practice setting and have the potential to enhance medication adherence and improve health outcomes for people living with diabetes and comorbidities. The development of acceptable and effective interventions could have a positive effect on medication adherence and health outcomes.

Sodium phenylbutyrate-taurursodiol access, adherence and adverse event in patients with amyotrophic lateral sclerosis: Experience at one center in the United States.

INTRODUCTION/AIMS: Sodium phenylbutyrate-taurursodiol (PB-TURSO) was recently approved for treating amyotrophic lateral sclerosis (ALS). Third-party payors' coverage policies are evolving, and adverse events are just being fully assessed. The goals of this study were to evaluate patients' experiences in obtaining and continuing PB-TURSO and assess adverse events and medication adherence. METHODS: Medical records of 109 ALS patients who were considered PB-TURSO candidates by the treating physician at a tertiary ALS clinic from October 2022 to May 2023 were reviewed. Data was recorded for demographics, clinical, and insurance information. A survey was e-mailed to patients asking about out-of-pocket expenses for PB-TURSO, financial assistance, medication start and (if applicable) stop dates, and reasons for discontinuation. RESULTS: Insurance information was available for 91 patients [57 males (62%); mean age 64.8 years (range 25.7-88)]. Of 79 who applied for insurance approval, 71 (90%) were approved; however, 19 required 1-3 appeals. Among 73 patients with available data about medication status, 54 started PB-TURSO and 19 did not, most commonly due to personal choice or out-of-pocket expenses. About 44% of patients (24/54) stopped taking PB-TURSO, primarily due to adverse events. Monthly out-of-pocket expenses varied from $0 to $3500 and 36 patients qualified for financial assistance. Administrative and nursing staff devoted 7.2 hours/week to the insurance authorization process. DISCUSSION: Most patients received insurance approval for PB-TURSO, but one-fourth required appeals. Some out-of-pocket costs were very high. Investment of staff time was substantial. These findings have implications for insurance coverage of, and adherence to, future ALS treatments.

A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.

OBJECTIVE: Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to identify factors that enable adherence to immunosuppressive medications among patients with SLE from racial and ethnic minority groups. METHODS: Using a qualitative descriptive study design, we conducted in-depth interviews with purposefully selected (1) patients with SLE from racial and ethnic minority groups who were taking immunosuppressants and (2) lupus providers and staff. We focused on adherence facilitators, asking patients to describe approaches supporting adherence and for overcoming common adherence challenges and providers and staff to describe actions they can take to foster patient adherence. We used applied thematic analysis and categorized themes using the Capability, Opportunity, Motivation, Behavior (COM-B) model. RESULTS: We interviewed 12 patients (4 adherent and 8 nonadherent based on medication possession ratio) and 12 providers and staff. Although each patient described a unique set of facilitators, patients most often described social support, physical well-being, reminders, and ability to acquire medications as facilitators. Providers also commonly mentioned reminders and easy medication access as facilitators as well as patient education/communication and empowerment. CONCLUSION: Using an established behavioral change model, we categorized a breadth of adherence facilitators within each domain of the COM-B model while highlighting patients' individual approaches. Our findings suggest that an optimal adherence intervention may require a multi-modal and individually tailored approach including components from each behavioral domain-ensuring medication access (Capability) and utilizing reminders and social support (Opportunity), while coupled with internal motivation through improved communication and empowerment (Motivation).

Evaluation of health literacy and its association with medication adherence and quality of life in childhood-onset systemic lupus erythematosus.

OBJECTIVE: Little is known about health literacy in childhood-onset systemic lupus erythematosus (cSLE) and how health literacy relates to medication adherence and psychosocial outcomes in this high-risk population. The objective of this study was to evaluate health literacy in adolescents and young adults with cSLE and its association with medication adherence and quality of life. METHODS: Youth 10-24 years with cSLE (n = 48) completed the Brief Healthy Literacy Screen (BHLS) and the Newest Vital Sign (NVS) to assess health literacy. Participants also completed validated measures of medication adherence and quality of life. Descriptive analyses were used to determine levels of health literacy. Bivariate correlations were used to evaluate associations between measures of health literacy with adherence and quality of life. A multivariable regression analyses was used to determine if health literacy was a significant predictor of adherence or quality of life, after adjusting for age, sex, race, and household income. RESULTS: Inadequate health literacy was common in this population, with 67% of youth categorized as having inadequate health literacy by the BHLS and 42% by the NVS. Higher medication adherence was associated with a higher BHLS score (r=.36, p = .017). BHLS was also significantly associated with better quality of life (r = 0.31, p = .034). CONCLUSION: Inadequate health literacy is prevalent among youth with cSLE. Higher health literacy is associated with higher medication adherence and better quality of life, suggesting that attention to health literacy could improve outcomes for this vulnerable population.

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. METHODS: This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. RESULTS: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). CONCLUSIONS: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. TRIAL REGISTRATION: ISRCTN12027752.

Systematic Review Examining the Behavior Change Techniques in Medication Adherence Intervention Studies Among People With Type 2 Diabetes.

BACKGROUND: Although previous systematic reviews have studied medication adherence interventions among people with Type 2 diabetes (PwT2D), no intervention has been found to improve medication adherence consistently. Furthermore, inconsistent and poor reporting of intervention description has made understanding, replication, and evaluation of intervention challenging. PURPOSE: We aimed to identify the behavior change techniques (BCTs) and characteristics of successful medication adherence interventions among PwT2D. METHODS: A systematic search was conducted on Medline, Embase, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus. Studies were included if they were randomized controlled trials with BCT-codable interventions designed to influence adherence to anti-diabetic medication for PwT2D aged 18 years old and above and have medication adherence measure as an outcome. RESULTS: Fifty-five studies were included. Successful interventions tend to target medication adherence only, involve pharmacists as the interventionist, contain "Credible source" (BCT 9.1), "Instruction on how to perform the behaviour" (BCT 4.1), "Social support (practical)" (BCT 3.2), "Action planning" (BCT 1.4), and/ or "Information about health consequences" (BCT 5.1). Very few interventions described its context, used theory, examined adherence outcomes during the follow-up period after an intervention has ended, or were tailored to address specific barriers of medication adherence. CONCLUSION: We identified specific BCTs and characteristics that are commonly reported in successful medication adherence interventions, which can facilitate the development of future interventions. Our review highlighted the need to consider and clearly describe different dimensions of context, theory, fidelity, and tailoring in an intervention.

Medication is the mainstay treatment for diabetes. However, the use of anti-diabetic oral medications and/or injections may be intrusive, inconvenient, and complicated, leading to poor medication adherence, which occurs in about 50% of patients. Medication adherence is the extent to which a person's medication-taking behavior corresponds with agreed recommendations from a healthcare provider and is associated with suboptimal health outcomes and increased healthcare expenditure. Interventions to improve adherence have not been consistently effective or well described, which makes it difficult to ascertain what works best. In this study, we aimed to identify the behavior change techniques (BCTs) and characteristics of successful medication adherence interventions among adults with Type 2 diabetes. BCTs are active ingredients in an intervention that regulate medication adherence and have standardized definitions. After searching 7 databases systematically, we analyzed 55 studies published in January 2018­March 2022. We found that the more effective interventions were those which had a sole focus on medication adherence, involved pharmacists, and contained specific BCTs, namely "Credible source," "Instruction on how to perform the behaviour," "Social support (practical)," "Action planning," and/or "information about health consequences." These specific BCTs and characteristics can be considered in future interventions for improving medication adherence.

The Association Between Social Isolation and Medication Adherence Among Chinese Older Adults With Chronic Diseases: Serial Mediation of Social Support and Loneliness.

BACKGROUND: Medication adherence is essential for chronic disease management among older adults. Previous studies have shown significant links among social isolation, social support, loneliness, and medication adherence, yet most were based on cross-sectional designs. PURPOSE: We conducted a longitudinal cohort study among Chinese older adults with chronic diseases to explore the mediating effects of social support and loneliness in the association between social isolation and medication adherence. METHODS: This study followed a cohort of 797 older adults with chronic diseases in China from 2022 to 2023. The serial mediation model was examined via bootstrapping techniques to evaluate the mediating effect of social support and loneliness in the association between social isolation and medication adherence. RESULTS: From baseline to follow-up, there were significant decreases in social support (from 26.6 ± 6.2 to 23.5 ± 6.7) and medication adherence (from 6.7 ± 1.2 to 6.0 ± 1.5) and significant increases in social isolation (from 1.8 ± 1.3 to 2.5 ± 1.4) and loneliness (13.2 ± 4.1 to 23.5 ± 6.7), all with p < .001. A serial mediation model was confirmed, where social support and loneliness serially and partially mediated the association between social isolation and medication adherence (total effect c = -0.216, 95% CI = -0.296 to -0.136; direct effect c' = -0.094, 95% CI = -0.171 to -0.017; total indirect effect ab = -0.122, 95% CI = -0.179 to -0.070). CONCLUSIONS: Our findings yield critical insights into the relationship between social isolation and medication adherence through various mediating mechanisms. These findings hold significant implications for devising psychosocial interventions to enhance medication adherence among older adults with chronic diseases, underscoring the pivotal role of bolstering social support and alleviating loneliness.

This study investigated the relationship between social isolation, medication adherence, and psychosocial factors (social support and loneliness) in Chinese older adults with chronic diseases. We observed decreases in social support and medication adherence and increases in social isolation and loneliness from baseline to follow-up. The findings revealed that social support and loneliness sequentially and partially mediated the association between social isolation and medication adherence. These results highlight the importance of psychosocial interventions to improve medication adherence among older adults by enhancing social support and addressing feelings of loneliness. This study contributes to our understanding of the complex factors influencing medication adherence in this population and offers insights for designing effective interventions.

Effectiveness of motivational interviewing on medication adherence for the prevention of recurrent stroke or transient ischemic attack: Systematic review of randomized controlled trials.

BACKGROUND AND PURPOSE: This systematic review examines the effectiveness of motivational interviewing (MI) on medication adherence for preventing recurrent stroke and transient ischemic attack (TIA). METHODS: MEDLINE (via PubMed), CINAHL, PsycINFO, CENTRAL, and ClinicalTrials.gov were searched from inception to 12 June 2023. Randomized controlled trials comparing MI with usual care or interventions without MI in participants with any stroke type were identified and summarized descriptively. Primary outcome was medication adherence. Secondary outcomes were quality of life (QoL) and different clinical outcomes. We assessed risk of bias with RoB 2 (revised Cochrane risk-of-bias tool) and intervention complexity with the iCAT_SR (intervention Complexity Assessment Tool for Systematic Reviews). RESULTS: We screened 691 records for eligibility and included four studies published in five articles. The studies included a total of 2751 participants, and three were multicentric. Three studies had a high risk of bias, and interventions varied in complexity. Two studies found significantly improved medication adherence, one at 9 (96.9% vs. 88.2%, risk ratio = 1.098, 95% confidence interval = 1.03-1.17) and one at 12 months (97.0% vs. 95.0%, p = 0.026), but not at other time points, whereas two other studies reported no significant changes. No significant differences were found in QoL or clinical outcomes. CONCLUSIONS: Evidence on MI appears inconclusive for improving medication adherence for recurrent stroke and TIA prevention, with no benefits on QoL and clinical outcomes. There is a need for robustly designed studies and process evaluations of MI as a complex intervention for people with stroke. REGISTRATION: PROSPERO (CRD42023433284).

Determinants of adherence to post-stroke/transient ischemic attack secondary prevention medications: A cohort study.

BACKGROUND: Adherence to post-stroke secondary prevention medications mitigates recurrence risk. This study aimed to measure adherence to secondary prevention medications during 3 years post-ischemic stroke/transient ischemic attack, using prescription and dispensing data, and identify factors associated with suboptimal adherence. METHODS: This multicenter, prospective, cohort study involved patients from the STROKE 69 cohort, which included all consecutive patients with suspected acute stroke admitted between November 2015 and December 2016 to any emergency department or stroke center in the Rhône area in France. Prescription data for antihypertensive agents, antidiabetic agents, lipid-lowering drugs, and antithrombotics were collected. Dispensing data were provided by the French regional reimbursement database. Adherence was calculated using the continuous medication acquisition index. Associations between suboptimal adherence and potential influencing factors across the World Health Organization's five dimensions were explored through univariate and multivariate analyses. RESULTS: From 1512 eligible patients, 365 were included. Optimal adherence to overall treatment (≥90%) was observed in 61%, 62%, and 65% of patients in the first, second, and third years, respectively. Education level (high school diploma or higher: OR = 3.24, 95% CI [1.49; 7.36]) and depression (Hospital Anxiety and Depression Scale-Depression scores 8-10: OR = 1.90, 95% CI [1.05; 3.44]) were significantly associated with suboptimal adherence. CONCLUSIONS: Overall adherence to secondary prevention medications was fairly good. Having an initial diagnosis of transient ischemic attack, a high level of education, or depression was associated with increased odds of suboptimal adherence, while having a history of heart rhythm disorder was associated with lower odds.

Pan-European survey on medication adherence management by healthcare professionals.

AIMS: While medication adherence (MA) is a key prerequisite for achieving optimal clinical and economic outcomes, nonadherence is highly prevalent. Assessing how healthcare professionals (HCPs) in Europe manage MA, focusing on measurement, reporting and interventions, is the subject of this study. METHODS: A cross-sectional study was conducted among 40 European countries and quantitative analysis was conducted via an online survey. The multi-language online survey was created using Webropol 3.0 survey and reporting tool. Descriptive statistics and chi-squared tests were applied. RESULTS: In total, 2875 HCPs (pharmacists: 39.9%; physicians: 36.7%; nurses: 16.4%) from 37 European countries participated. The most used methods for MA assessment were direct communication with patients (86.4%) and referring to personal patient records (56.7%) (P < 0.0001). Physicians (74.9%) and nurses (58.8%) were more aware of problems related to MA in contrast to pharmacists (48.6%) (P < 0.001). Almost all HCPs (92.6%) indicated that MA-enhancing interventions involved mainly direct communication with nonadherent patients (93.3%) and their caregivers (55.7%). Medication review and related optimization of therapy were mainly performed in Western European countries (46.8%). Technological solutions were ranked as one of the less applied approaches (10-15%) (P < 0.001). CONCLUSIONS: HCPs in all European regions recognize MA management as an integral element of overall patient-centred care. More efforts are needed to ensure timely, adequate and relevant MA assessment, reporting and improvement and involvement of all HCPs, especially among pharmacists who were generally less aware of MA issues. Promotion and use of digital technological solutions should be the focus of current and future clinical practice to optimize MA management processes.

Medication adherence to inflammatory bowel disease medications in Aotearoa New Zealand and correlation with health outcomes: A nationwide database analysis.

AIMS: Inflammatory bowel disease (IBD) management entails long-term medication therapy. Worse disease outcomes and reduced quality of life might arise from poor medication adherence (MA). This study is the first to investigate patients with IBD's adherence across Aotearoa New Zealand and its relationship with disease outcomes. METHODS: Dispensing claims data (Pharmaceutical Collection) were used to calculate (3- and 5-year) adherence, using daily polypharmacy possession ratio. Using hospitalization data (National Minimum Dataset), the relationship between adherence and the numbers of hospitalizations and corticosteroid dispensings was investigated. RESULTS: In total, 4654 patients (53% female; 55% Crohn's disease [CD], 45% ulcerative colitis [UC]; median age-at-first-dispensing, 43 years) and 3148 patients (54% female; 55% CD, 44% UC; median age-at-first-dispensing, 44 years) were in the 3- and 5-year cohorts, respectively. The 3- and 5-year cohorts had mean 4.6 and 4.2 IBD-related hospitalizations and 6.9 and 9.2 corticosteroid dispensings, respectively. Average adherence estimates were 77.4% (95% confidence interval: 76.9-78.0%) and 74.9% (95% confidence interval: 74.1-75.6%; 3 and 5 years), while 54% and 51% of patients, respectively, had good adherence (MA ≥ 80%). There was no correlation between adherence and the numbers of hospitalizations (Pearson's R = -.0007; P = .65 and R = -.04; P = .02 [3 and 5 years]) and corticosteroid dispensings (R = .08; P = <.0001 and R = .08; P = <.0001, respectively). CONCLUSION: MA of Aotearoa New Zealand patients with IBD is moderately high but just over half of patients meet the adherent threshold. There was no correlation between adherence and hospitalizations or corticosteroid dispensings; hence, research into longitudinal adherence patterns and associated factors is needed.

The impacts of undetected nonadherence in phase II, III and post-marketing clinical trials: An overview.

AIMS: This research aims to provide an overview of the consequences of undiagnosed nonadherence (noninitiation, suboptimal implementation, nonpersistence) in randomized clinical trials (RCTs). METHODS: This research was conducted by combining a literature review and qualitative semistructured interviews with key opinion leaders. Based on this groundwork, the consequences of undiagnosed nonadherence in RCTs were summarized and reported in a figure. This study focused on phases II, III and post-marketing in ambulatory settings across a variety of therapeutic areas and indications. RESULTS: Various consequences of nonadherence in RCTs were investigated. In phase II, drug efficacy may be underestimated, variability in the outcomes may be high and a distorted picture of side effects could be reported, resulting in an uncertain impression of the investigational product's profile and complicating decision-making. The sponsor may need to increase the sample size of the upcoming phase III study to improve its power, representing additional costs, or even terminate the study. In phase III, similar phenomena may be observed, making demonstration of efficacy to the regulatory bodies more difficult. Lastly, after commercialization, a distortion in pharmacometrics may occur: the drug may underperform, prescriptions may be refilled less often than expected or extra expenses may be incurred by the payers. This can result in post-marketing dose reduction, new competitors coming into the market and, eventually, product withdrawal. CONCLUSIONS: This research highlighted the many potential adverse consequences of undiagnosed nonadherence in RCTs, including additional costs. Collecting accurate data appeared to be crucial for decision-making throughout the drug development process.