Cost Savings and Waste Reduction Through Redispensing Unused Oral Anticancer Drugs: The ROAD Study.

Importance: New strategies targeting waste are required to improve financial and ecologic sustainability of expensive therapies, such as oral anticancer drugs, that frequently remain unused by patients. Redispensing unused oral anticancer drugs seems to be a promising strategy when drug quality is guaranteed. Objectives: To determine the waste reduction and net cost savings attained by redispensing oral anticancer drugs that go unused by patients compared with the standard practice of disposal. Design, Settings, and Participants: The ROAD study was a prospective single-group intervention conducted in the outpatient pharmacies of 4 hospitals in the Netherlands from February 1, 2021, to February 1, 2023, with 12-month follow-up of each patient. Patients with cancer and who had a prescription for an oral anticancer drug that could be stored at room temperature were included. Of 2426 eligible patients, 602 did not consent and 601 did not respond. Data analyses were performed from August 25, 2022, to April 19, 2023. Intervention: Participants received oral anticancer drugs for use at home in special packaging (ie, sealed packaging with time-temperature indicator), to be returned to the pharmacy should these remain unused. The pharmacy ensured quality of returned drugs based on authenticity, appearance, remaining shelf life and adequate storage temperature. Drugs fulfilling quality requirements were redispensed to other patients. Main Outcome and Measure: Total waste reduction and mean net annual cost savings per patient compared with the standard practice of disposal. Optimization of cost savings was explored by introducing variations in the quality assurance procedure and patient population. All analyses used the average exchange rate for 2021 €1 = US $1.18. Results: Of 1223 patients with cancer who consented, 1071 participated (median [IQR] age, 70 [62-75] years; 622 [58.1%] were male). In all, 171 patients (16.0%; 95% CI, 13.8%-18.3%) returned 335 unused oral anticancer drug packages. Of the returned drugs, 228 packages were redispensed, which reduced waste by 68.1% (95% CI, 67.7%-68.5%) compared with the standard practice (disposal). Redispensing unused oral anticancer drugs comprised 2.4% (95% CI, 2.2%-2.5%) of total drug costs, providing mean net annual cost savings of US $680 (95% CI, $524-$837) up to $1591 (95% CI, $1226-$2002) per participant. Conclusions and Relevance: The findings of this multicenter intervention study indicate that redispensing unused oral anticancer drugs is associated with waste reduction and cost savings, which in turn may improve the affordability and sustainability of cancer treatment. Trial Registration: World Health Organization International Clinical Trials Registry Platform Identifier: NL9208.

Implementing medication adherence interventions in four Dutch living labs; context matters.

BACKGROUND: Despite the abundant availability of effective medication adherence interventions, uptake of these interventions into routine care often lacks. Examples of effective medication adherence interventions include telephone counseling, consult preparation and the teach-back method. Assessing context is an important step in understanding implementation success of interventions, but context is often not reported or only moderately described. This study aims to describe context-specific characteristics in four living labs prior to the implementation of evidence-based interventions aiming to improve medication adherence. METHODS: A qualitative study was conducted within four living labs using individual interviews (n = 12) and focus groups (n = 4) with project leaders and involved healthcare providers. The four living labs are multidisciplinary collaboratives that are early adopters of medication adherence interventions in the Dutch primary care system. Context is defined as the environment or setting in which the proposed change is to be implemented. Interview topics to assess context were formulated based on the 'inner setting' and 'outer setting' domains of the Consolidated Framework for Implementation Research (CFIR). Interviews were recorded and transcribed verbatim. Transcripts were deductively analyzed. RESULTS: A total of 39 community pharmacists, pharmacy technicians, general practitioners and a home care employee participated in the (focus group) interviews. All four living labs proved to be pharmacy-driven and characterized by a high regard for innovation by staff members, a positive implementation climate, high levels of leadership engagement and high compatibility between the living labs and the interventions. Two living labs were larger in size and characterized by more formal communication. Two living labs were characterized by higher levels of cosmopolitanism which resulted in more adaptable interventions. Worries about external policy, most notably lack of reimbursement for sustainment and upscaling of the interventions, were shared among all living labs. CONCLUSIONS: Contextual characteristics of four living labs that are early adopters of medication adherence interventions provide detailed examples of a positive implementation setting. These can be used to inform dissemination of medication adherence interventions in settings less experienced in implementing medication adherence interventions.

Usability of an animated diabetes information tool for patients with different health literacy levels: a qualitative study.

OBJECTIVES: Most currently available medication self-management support tools do not meet the needs of patients with limited health literacy. Recently, tools that are better tailored to the needs of patients with limited health literacy have been developed. This study aimed to assess the usability of an animated diabetes information tool by patients with diabetes with limited and adequate health literacy levels. METHODS: Participants with limited and adequate health literacy levels were selected based on three health literacy questions in a screening interview, and asked to use the tool three times a week, after which individual semistructured interviews were conducted. The interview topics were based on the technology acceptance model (i.e. perceived ease of use, perceived usefulness, and intention to use). Twenty-five patients with diabetes were included in the study. KEY FINDINGS: All participants perceived the tool as easy to use due to a clear overview of topics and only personalized information being provided. Those with limited health literacy indicated that they had learned from the tool and had the intention to continue using it in the future. These participants also expressed the need for the tool to be more actively offered by healthcare professionals, while participants with adequate health literacy expressed the need for more in-depth information. CONCLUSION: The tailored self-management support tool was perceived as usable by all participants. To better serve them, the tool could be further improved by addressing the additional needs of people with limited as well as adequate health literacy.

Clarity and applicability of adverse drug reaction-related monitoring instructions in clinical practice guidelines for children and adolescents treated with antipsychotic drugs: a review of six clinical practice guidelines.

OBJECTIVES: Monitoring instructions related to adverse drug reactions (ADRs) are not always clearly described in clinical practice guidelines (CPGs) and not always easily applicable in daily clinical practice. The aim of this study was to assess the clarity of presentation and the applicability of ADR-related monitoring instructions in CPGs for children and adolescents treated with antipsychotic drugs. SETTING: Guidelines from different countries were selected, and monitoring instructions for 13 ADR-related parameters were assessed. PRIMARY AND SECONDARY OUTCOME MEASURES: To assess the clarity and the applicability of the sections concerning monitoring instructions in each CPG, the Appraisal of Guidelines for Research and Evaluation instrument was used. To assess the clarity and the applicability of the monitoring instructions for each ADR-related parameter, the Systematic Information for Monitoring score was used. RESULTS: Six CPGs were included. Overall, the presentation of the monitoring instructions in the different CPGs was clear; three CPGs scored >75%. All CPGs scored lower on applicability, as, for example, the barriers and facilitators were poorly described. The number of ADR-related parameters included in the CPGs varied between 8 and 13. Why and what to monitor was always described for each parameter. When to start monitoring was also often described (90.2%), but when to stop monitoring was less frequently described (37.4%). CONCLUSIONS: The CPGs differed on the parameters that needed to be monitored. Overall, the monitoring instructions were clearly presented, but improvement in their applicability is required. By improving the monitoring instructions, CPGs can provide better guidance on monitoring ADRs in daily clinical practice.

Monitoring of Adverse Drug Reaction-Related Parameters in Children, Youth, and Young Adults Prescribed Antipsychotic Drugs by General Practitioners.

Objective: The aim of the study was to assess monitoring of adverse drug reaction (ADR)-related parameters in children, youth, and young adults treated with second-generation antipsychotic drugs (SGAs) prescribed by general practitioners (GPs). Methods: This retrospective follow-up study included children, youth, and young adults aged 0 - 24 years, who had an initial prescription of an SGA recorded in the Clinical Practice Research Datalink between 2000 and 2017, and who were prescribed an SGA more than once for a duration of at least 6 months. It included an assessment of which ADR-related physical parameters (weight, height, body-mass index, waist circumference, pulse, blood pressure, and heart examination) and laboratory parameters (glucose, HbA1c, lipids, and prolactin) were monitored in children, youth, and young adults at least once every 6-month period, stratified by sex, age categories, and calendar years. Results: In total, 7006 patients were included and the mean duration of follow-up was 1.6 years. Monitoring frequencies of all parameters were below 25%. Blood pressure and weight were monitored in 23.6% and 23.4%, respectively, of all children, youth, and young adults during the first half year; waist circumference was monitored in 0.2%. Females were monitored more often than males, some differences between age categories were observed, and monitoring frequencies increased after 2000, but did not exceed 35% in any year. Conclusion: Monitoring frequencies of ADR-related parameters in children, youth, and young adults treated with SGAs prescribed by a GP were low. Monitoring in primary care should be improved to enable a better evaluation of the benefit-risk balance during antipsychotic drug therapy.

Medication self-management: Considerations and decisions by older people living at home.

BACKGROUND: Medication self-management is complicated for older people. Little is known about older persons' considerations and decisions concerning medication therapy at home. OBJECTIVE: (s): To explore how older people living at home self-manage their medication and what considerations and decisions underpin their medication self-management behavior. METHODS: Semi-structured interviews with consenting participants (living at home, aged ≥65, ≥5 different prescription medications daily) were recorded and transcribed with supporting photographs. Content was analyzed with a directed approach and presented according to three phases of medication self-management (initiation, execution, and discontinuation). RESULTS: Sixty people were interviewed. In the initiation phase, participants used different techniques to inform healthcare professionals and to fill and check prescriptions. Over-the-counter medication was seldom discussed, and potential interactions were unknown to the participants. Some participants decided to not start treatment after reading the patient information leaflets for fear of side effects. In the execution phase, participants had various methods for integrating the use of new and chronic medication in daily life. Usage problems were discussed with healthcare professionals, but side effects were not discussed, since the participants were not aware that the signs and symptoms of side effects could be medication-related. Furthermore, participants stored medication in various (sometimes incorrect) ways and devised their own systems for ordering and filling repeat prescriptions. In the discontinuation phase, some participants decided to stop or change doses by themselves (because of side effects, therapeutic effects, or a lack of effect). They also mentioned different considerations regarding medication disposal and disposed their medication (in)correctly, stored it for future use, or distributed it to others. CONCLUSIONS: Participants' considerations and decisions led to the following: problems in organizing medication intake, inadequate discussion of medication-related information with healthcare professionals, and incorrect and undesirable medication storage and disposal. There is a need for medication self-management observation, monitoring, and assistance by healthcare professionals.

Clozapine Treatment During Pregnancy and the Postpartum Period: A Systematic Literature Review.

Objective: The objective of this systematic review was to provide a critical appraisal of the evidence related to the safety of clozapine for schizophrenia during pregnancy and lactation.Data Sources: PubMed/MEDLINE, Embase, and the Cochrane Library were searched from inception through December 2020. Reference lists of included studies were hand-searched. The International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for unpublished trials, and PROSPERO was searched for unpublished reviews. The current marketing authorization holder of the originator brands Clozaril and Leponex was also contacted for pharmacovigilance data.Study Selection: Original reports published in English, German, French, or Dutch containing clinical and preclinical data were included if they provided data on maternal, fetal, and neonatal outcomes after clozapine exposure during pregnancy or lactation.Data Extraction: Two reviewers independently extracted relevant data.Results: A total of 860 records were identified, and the full texts of 117 articles were reviewed. Forty-two studies met the inclusion criteria. Data on perinatal clozapine exposure are of limited quality and quantity. Although clozapine demonstrates partial placental passage, data thus far do not support that clozapine is teratogenic; that it increases the risk of stillbirth, abortion, or fetal disorders; or that it increases the risk of delivery complications or premature birth. Information about clozapine exposure through breast milk is scarce, but based on its chemical properties, it is likely that clozapine enters the breast milk of nursing mothers taking clozapine.Conclusions: When weighing the risks and benefits of clozapine continuation during pregnancy and lactation versus switching to another antipsychotic, one should include severity of illness and treatment history but also be aware of the limitations of the available safety data regarding perinatal clozapine use, including the fact that there are few studies.

Home Care Patients' Experiences with Home Care Nurses' Support in Medication Adherence.

PURPOSE: To describe nurses' support interventions for medication adherence, and patients' experiences and desired improvements with this care. PATIENTS AND METHODS: A two-phase study was performed, including an analysis of questionnaire data and conducted interviews with members of the care panel of the Netherlands Patients Federation. The questionnaire assessed 14 types of interventions, satisfaction (score 0-10) with received interventions, needs, experiences, and desired improvements in nurses' support. Interviews further explored experiences and improvements. Data were analyzed using descriptive statistics and a thematic analysis approach. RESULTS: Fifty-nine participants completed the questionnaire, and 14 of the 59 participants were interviewed. The satisfaction score for interventions was 7.9 (IQR 7-9). The most common interventions were: "noticing when I don't take medication as prescribed" (n = 35), "helping me to find solutions to overcome problems with using medications" (n = 32), "helping me with taking medication" (n = 32), and "explaining the importance of taking medication at the right moment" (n = 32). Fifteen participants missed ≥1 of the 14 interventions. Most mentioned the following: "regularly asking about potential problems with medication use" (33%), "regularly discussing whether using medication is going well" (29%), and "explaining the importance of taking medication at the right moment" (27%). Twenty-two participants experienced the following as positive: improved self-management of adequate medication taking, a professional patient-nurse relationship to discuss adherence problems, and nurses' proactive attitude to arrange practical support for medication use. Thirteen patients experienced the following as negative: insufficient timing of home visits, rushed appearance of nurses, and insufficient expertise about side effects and taking medication. Suggested improvements included performing home visits on time, more time for providing support in medication use, and more expertise about side effects and administering medication. CONCLUSION: Overall, participants were satisfied, and few participants wanted more interventions. Nurses' support improved participants' self-management of medication taking and enabled patients to discuss their adherence problems. Adequately timed home visits, more time for support, and accurate medication-related knowledge are desired.

Implementation of an animated medication information tool in community pharmacies, with a special focus on patients with limited health literacy.

OBJECTIVES: The animated medication information tool 'Watchyourmeds' provides information in an accessible manner through animated videos and therefore appears to be especially suitable for people with limited health literacy. This study aimed to assess the implementation of this animated medication information tool in Dutch community pharmacies, with a special focus on patients with limited health literacy. METHODS: A cross-sectional survey based on the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was sent to approximately 75% of the ±1900 community pharmacies in the Netherlands through email newsletters of pharmacy networks. KEY FINDINGS: 140 pharmacists (⁓10%) completed the survey and 125 of them (89%) indicated that they offered the animated medication information tool to their patients. 108 pharmacists indicated that the tool was offered to all patients, not only to patients with limited health literacy. The distribution method was primarily passive (patients were given a leaflet and were not explicitly pointed to or informed about the tool). Two frequently cited motivations for offering the tool were that it complemented other sources of information and that the health insurer provided a financial incentive. The main reasons patients refused to use the tool were that they had no access to or no affinity for the required technology. CONCLUSIONS: This study demonstrated that the tool is used in community pharmacies and that it is offered to all patients, regardless of their presumed health literacy level. A more active method of offering the tool may be warranted to better reach patients with limited health literacy.

They promised this ten years ago. Effects of diabetes news characteristics on patients' perceptions and attitudes towards medical innovations and therapy adherence.

Patients have ever-increasing access to web-based news about hopeful scientific developments that may or may not cure them in the future. Science communication experts agree that the quality of news provision is not always guaranteed. However, literature does not clarify in what way users are actually affected by typical news characteristics such as the news object (described developmental phase of an innovation), the news source (degree of authority), and the news style (degree of language intensification). An online vignette experiment (N = 259) investigated causal relationships between characteristics of news about diabetes innovations and patients' perceptions of future success, their interest in the innovation, and attitudes regarding current therapy adherence. Findings show that descriptions of success in mice led to higher estimations of future success chances than earlier and later developmental phases. Furthermore, news from a nonauthoritative source led to an increased interest in the innovation, and a more negative attitude towards current lifestyle advice. Lastly, the intensification of the language used in news messages showed slight adverse effects on the readers' attitude. These findings, combined with their small effect sizes, support the optimistic view that diabetes patients are generally critical assessors of health news and that future research on this topic should focus on affected fragile subgroups.

Monitoring of Adverse Drug Reaction-Related Parameters in Children and Adolescents Treated With Antipsychotic Drugs in Psychiatric Outpatient Clinics.

Aim: To assess the frequency of monitoring of adverse drug reaction (ADR) related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics and the considerations when monitoring was not performed. Methods: This retrospective follow-up study included 100 randomly selected outpatients aged ≤18 years who had a first prescription of an antipsychotic drug recorded in the electronic medical records of psychiatric outpatient clinics between 2014 and 2017. They were followed for up to 3 years. This study assessed the frequency of monitoring for physical parameters (weight, height, body mass index, waist circumference, pulse, blood pressure, and an electrocardiogram) and laboratory parameters (glucose, lipids, and prolactin) before the first prescription of an antipsychotic drug as well as during its use. Monitoring frequencies were stratified by the patient characteristics (sex, age, cardiovascular risk factors, and use of other psychotropic drugs), and by location of antipsychotic drug initiation (psychiatric outpatient clinic or elsewhere). Additionally, this study assessed the considerations mentioned in the medical records for not monitoring ADR-related parameters. Results: Overall, physical parameters were monitored more frequently (weight: 85.9% during the first half-year) than laboratory parameters (glucose and cholesterol: both 23.5%). There were no significant differences in monitoring at least one physical as well as in monitoring at least one laboratory parameter during the baseline period and during the total follow-up of antipsychotic drug treatment between the patient characteristics. In total, 3% of the children and adolescents were never monitored for any physical parameter, and 54% were never monitored for any laboratory parameter. For a minority of the children (14.8%) who were never monitored for laboratory parameters, considerations were recorded in their medical records, including refusal by the child or parents and monitoring performed by the general practitioner or elsewhere. Conclusion: Monitoring frequencies of ADR-related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics varied and especially monitoring of laboratory parameters was infrequent. Considerations why monitoring was not performed were rarely recorded. The optimal method of monitoring and documentation thereof should become clear to optimize the benefit-risk balance of antipsychotic drug treatment for each child.

Long-term persistence and adherence with non-vitamin K oral anticoagulants in patients with atrial fibrillation and their associations with stroke risk.

AIMS: Studies on adherence and persistence with non-vitamin K oral anticoagulant (NOAC) treatment have relied on data from the early years of NOAC availability. We aimed to study long-term adherence and persistence with NOACs and their association with stroke risk. METHODS AND RESULTS: From the Stockholm Healthcare database, we included 21 028 atrial fibrillation patients claiming a first NOAC prescription from July 2011 until October 2018, with more than 1000 patients having more than 5 years of follow-up (median: 2.0, interquartile range: 1.0-3.2). Persistence rates, defined as continuing to claim NOAC prescriptions within a 90-day gap, decreased to 70% at the end of follow-up. However, 85% of the patients were treated at the end of the study due to reinitiations. Adherence, calculated as medication possession rate (MPR) in 3 and 6-month intervals among persistent users, remained stable at 90%, with 75% of patients having an MPR >95% throughout the study period. Using a case-control design, we calculated associations of persistence and adherence with stroke risk, adjusting for potential confounders. The outcome was a composite of ischaemic or unspecified stroke and transient ischaemic attack. Non-persistence and poor adherence were both associated with increased stroke risk [non-persistence adjusted odds ratio (aOR): 2.05; 95% confidence interval (CI): 1.49-2.82, 1% reduction MPR aOR: 1.03; CI: 1.01-1.05]. There was no association between non-persistence or poor adherence and the falsification endpoints; fractions and respiratory infections, indicating no 'healthy-adherer' effect. CONCLUSION: Persistence rates decreased slowly over time, but persistent patients had high adherence rates. Both non-persistence and poor adherence were associated with an increased stroke risk.

Psychotropic medication use in former ICU patients with mental health problems: A prospective observational follow-up study.

PURPOSE: To describe the extent to which patients with mental health problems after admission to an Intensive Care Unit (ICU) initiate and use psychotropic medication. METHODS: All adult patients who stayed in the ICU of the University Medical Center Utrecht for 48 h or more between 2013 and 2017, alive after 1 year and not admitted to the ICU with brain injury, were eligible. Questionnaires were used to identify mental health problems, depression, anxiety and posttraumatic stress disorder (PTSD) and psychotropic medication use. RESULTS: Of the 1328 former ICU patients, 24.3% (n = 323) had developed any of the mental health problems. Of this group, 29.7% (n = 96) used psychotropic medication one year after discharge versus the 10.6% (n = 107) of patients without these problems (OR 3.17, 95% CI 2.29-4.38). They were further 4.33 (95% CI 2.62-7.16) times more likely to initiate psychotropic medication (18.7% vs 4.8%) after ICU admission. Similar patterns were observed for individual groups of psychotropics: antidepressants, antipsychotics and benzodiazepines. DISCUSSION: Former ICU patients with mental health problems were almost four times more likely to use psychotropic medication than former ICU patients without these problems. Future research should investigate whether mental health problems are properly diagnosed and treated in former ICU patients.

Experiences with medical cannabis in the treatment of veterans with PTSD: Results from a focus group discussion.

Posttraumatic stress disorder (PTSD) is an often chronic condition for which currently available medications have limited efficacy. Medical cannabis is increasingly used to treat patients with PTSD; however, evidence for the efficacy and safety of cannabinoids is scarce. To learn more about patients' opinions on and experiences with medical cannabis, we organized a focus group discussion among military veterans (N = 7) with chronic PTSD who were treated with medical cannabis. Afterwards, some of their partners (N = 4) joined the group for an evaluation, during which they shared their perspective on their partner's use of medical cannabis. Both sessions were audio-recorded, transcribed verbatim, and analyzed by means of qualitative content analysis. Five overarching themes were identified. The first four themes related to the different phases of medical cannabis use - namely, 1) Consideration; 2) Initiation; 3) Usage; and 4) Discontinuation. The fifth theme related to several general aspects of medical cannabis use. Patients used medical cannabis to manage their symptoms and did not experience an urge to "get high." They used a variety of different cannabis strains and dosages and reported several therapeutic effects, including an increased quality of sleep. Furthermore, discussions about the experienced stigma surrounding cannabis generated insights with implications for the initiation of medical cannabis use. These results underscore the value of qualitative research in this field and are relevant for the design of future clinical trials on the use of medical cannabis for the treatment of PTSD.

Safety of clozapine use during pregnancy: Analysis of international pharmacovigilance data.

PURPOSE: Safety data on clozapine use during pregnancy are limited. The aim of this study was to determine disproportionality in case safety reports on adverse pregnancy outcomes between clozapine and other antipsychotics (OAP) used during pregnancy. METHODS: We included all reports of suspected adverse drug reactions (ADRs) to antipsychotics registered in the World Health Organization global individual case safety report (ICSR) database (VigiBase) in children younger than 2 years and women aged 12-45 years. A case/non-case approach was used to evaluate the association between several pregnancy-related ADRs and clozapine exposure during pregnancy, using 2×2 contingency tables to investigate disproportionality and Standard MedDRA Queries to select cases. Clozapine exposure was defined as all ICSR-ADR combinations with clozapine as (one of) the suspected drug(s). Non-exposure was defined as all ICSR-ADR combinations with OAP as (one of) the suspected drug(s). RESULTS: We identified 42 236 unique ICSR-ADR combinations related with clozapine exposure and 170 710 with OAP exposure. Of these, 494 and 4645 ICSR-ADR combinations involved adverse pregnancy outcomes related with clozapine exposure and OAP exposure respectively. Overall, no signal of disproportionate reporting associating clozapine with the studied adverse pregnancy outcomes was found compared with OAP exposure. CONCLUSION: Based on global pharmacovigilance data, we did not find any evidence that clozapine is less safe during pregnancy than OAP. Although this is not automatically equivalent to the relative safety of clozapine during pregnancy, these findings add to the convergence of proofs to allow final conclusions and decisions regarding the treatment of pregnant women with clozapine.

Medication self-management support for people with diabetes and low health literacy: A needs assessment.

INTRODUCTION: An adequate level of health literacy is regarded as a prerequisite for adequate medication self-management. Low health literacy skills are relatively more common in people with Diabetes Mellitus type 2. The aim of this study was to explore the needs regarding medication self-management of people with type 2 diabetes and low (functional, communicative and critical) health literacy, and their preferences for medication self-management support. MATERIALS AND METHODS: A two-stage qualitative needs assessment study was performed using in-depth individual interviews and focus groups. RESULTS: The participants preferred to be supported with reliable and easily understandable information, adequate interactive communication with health care professionals and fellow people with diabetes and tools for medication self-management support. DISCUSSION: Future interventions should be created in co-creation with people with low health literacy and fulfill the expressed needs on information, communication and tools to improve self-management.

Reporting Patterns of Sialorrhea Comparing Users of Clozapine to Users of Other Antipsychotics: A Disproportionality Analysis Using VigiBase.

BACKGROUND: Sialorrhea is a non-life-threatening, but potentially invalidating adverse drug reaction (ADR) in patients using clozapine. In light of the very serious ADRs (agranulocytosis and myocarditis), sialorrhea is at risk to be overlooked by health care professionals. In this study, the sialorrhea reporting patterns of clozapine compared with other antipsychotics were assessed by evaluating differences in relative reporting frequency and reporter type. METHODS: A case/noncase disproportionality analysis using data from VigiBase (1968-2016) was performed. Reports of antipsychotics with "salivary hypersecretion" as ADR were considered as cases, and those with ADRs other than salivary hypersecretion were defined as noncases. Relative reporting frequencies were expressed as reporting odds ratios (RORs), and multivariate logistic regression was performed with the drug-ADR pair as unit of analysis to estimate RORs with 95% confidence intervals (CIs). RESULTS: A total of 1,169,254 drug-ADR pairs from 425,304 unique Individual Case Safety Reports were identified. Sialorrhea was relatively more frequently reported in clozapine (n = 2732 [1.1%]) compared with other antipsychotics (n = 2911 [0.31%]; ROR, 3.60; 95% CI, 3.41-3.79) and was reported relatively more often by consumers (ROR, 19.8; 95% CI, 15.1-25.9) compared with health care professionals (ROR, 2.44; 95% CI, 2.27-2.63). CONCLUSIONS: Sialorrhea was reported almost 4 times more often with clozapine use than with other antipsychotic use and was reported 8 times more often by patients than by health care professionals. This provides a signal of disproportion in sialorrhea occurrence among clozapine compared with other antipsychotics and in light of the disproportionality between reporter and an underreporting by health care professionals, underlining the importance to incorporate sialorrhea into the shared decision process when commencing clozapine therapy.

Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial.

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients' self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X 2(1) = 0.58; p = 0.45), and the number of patients who logged on at least once (platform users) (X 2(1) = 0.46; p = 0.50). In addition, no differences were found between the groups in the type of users-patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X 2(1) = 0.56; p = 0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

Effects of the Proactive interdisciplinary self-management (PRISMA) program on self-reported and clinical outcomes in type 2 diabetes: a pragmatic randomized controlled trial.

BACKGROUND: Diabetes self-management education can be helpful for patients with type 2 diabetes in managing their condition. We aimed to study the effects of the group-based PRoactive Interdisciplinary Self-MAnagement (PRISMA) training program on self-reported and clinical outcomes in patients with type 2 diabetes treated in general practice. METHODS: Persons aged 18 years or older diagnosed with type 2 diabetes and treated in primary care were included. In a randomized controlled trial design (1:1), patients were followed for 6 months with an extension phase of 6 months. Block randomization was used. The patients with type 2 diabetes received either PRISMA in addition to usual care or usual care only. All patients completed a range of validated questionnaires (including knowledge, skills, and confidence for self-management [PAM], diabetes self-care behavior [SDSCA], health-related quality of life [EQ-5D], and emotional well-being [WHO-5]). In addition, clinical outcomes (HbA1c, body mass index, systolic blood pressure, and cholesterol levels) were collected during the routine diabetes checkups. RESULTS: Of the total sample (n = 193), 60.1% were men. The mean age was 69.9 years (SD = 9.1). No significant differences were found on self-reported outcomes between the groups at 0, 6, and 12 months. The clinical outcomes were not reported due to a large number of missing values. CONCLUSION: PRISMA did not improve self-reported outcomes in patients with type 2 diabetes treated in primary care. It was not possible to make a statement about the clinical effects. TRIAL REGISTRATION: date: 16/07/2014, number: NL4550 (https://www.trialregister.nl/trial/4550).