Guidance by physicians and pharmacists during antidepressant therapy: patients' needs and suggestions for improvement.

BACKGROUND: Guidance of patients treated with antidepressants is paramount for successful therapy. The aim was to assess patients' needs and suggestions for improvement of guidance by physicians and pharmacists during second generation antidepressant (SGA) therapy. METHODS: Five focus group discussions were held with a total of 34 patients using an SGA. The discussions were conducted flexibly and responsively using a semi-structured topic list. All focus group discussions were video-recorded and transcripts were analyzed using ATLAS.ti for coding, thematic and open analysis. RESULTS: Participants stated they were in need of better guidance. They suggested improving content of information during decisional moments, patient-health care professional communication and communication between health care professionals, and finally, organization of guidance. Barriers to achieving improved guidance were cited. CONCLUSIONS: Content, communication and organization of guidance are pivotal for achieving optimal guidance. Participants mentioned their current experienced guidance had limitations and brought up solutions for improvement. A next step would be to discuss the suggested solutions with health care professionals to assess their views and to discuss the possibility for implementation. After implementation, future studies could be aimed at determination of its impact on patients' treatment efficacy, quality of life, treatment satisfaction and healthcare costs.

Medication Discontinuation in Patients After Discharge From a Psychiatric Hospital.

BACKGROUND: Patients discharged from psychiatric hospitals may be at risk for intentional or unintentional discontinuation of their medication. OBJECTIVE: To describe and assess the discontinuation of, and changes to, psychiatric and/or somatic medication in patients after discharge from psychiatric hospitals. METHODS: A retrospective follow-up study was conducted in patients discharged from 4 psychiatric hospitals in The Netherlands between 2006 and 2009. Patients' medication use during the last 2 days of hospitalization was compared with medication dispensed during the 3 months following discharge. Changes in psychiatric and somatic medication were investigated and defined as medication discontinuation, start, or switch. Patients were classified as continuing users, when there were no changes to the medication after discharge. Relative risks with 95% confidence intervals to measure differences in discontinuation were estimated using Cox regression analysis. RESULTS: This study included 1324 patients, 69.8% of whom discontinued medication, and 9.7% switched one or more medications. Nearly half (47.4%) of all patients started a medication other than that dispensed during the last 2 days of hospitalization, and 13.7% of all patients experienced no changes to their medication regimen. Approximately 40% of the patients discontinued one or more medications for chronic conditions. From these, 68% discontinued psychiatric medications and 49.4% discontinued somatic medications. A quarter (25.2%) of the 644 patients discontinued using antipsychotics. More than a quarter (28.4%) of the 292 patients using medications for cardiovascular problems discontinued. Patients using as-needed medication prior to discharge were more likely to discontinue their medication (relative risk = 1.85; 95% confidence interval = 1.55-2.20). CONCLUSIONS: Discharge from a psychiatric hospital led to medication discontinuation in approximately 70% of all patients. Approximately 40% of the patients discontinued medications for chronic conditions. Discontinuation of somatic medication was more frequent than discontinuation of psychiatric medication, and risk of discontinuation was lower for patients with depressive and anxiety disorders. Although medication discontinuation can be deliberate it is alarming that a quarter of our patients using antipsychotics and cardiovascular medications discontinued their use, both of which are meant for chronic conditions.

Discontinuation of somatic medication during psychiatric hospitalization.

BACKGROUND: Psychiatric hospitalization can increase the risk of discontinuation of pharmacotherapy, which may negatively influence patients' health. OBJECTIVE: To investigate the association between psychiatric hospitalization and discontinuation of somatic medication. METHODS: A retrospective crossover study was performed in patients admitted to a psychiatric hospital (index date), who had got somatic medication dispensed during the 3 months prior to hospitalization. Discontinuation of somatic medication was investigated at the following time points: index date and 3, 6, and 9 months before the index date. Relative risks (RR) with 95% confidence intervals (95% CIs) of discontinuing somatic medication at the index date versus the time points before the index date were estimated using Cox regression. RESULTS: In all, 471 hospitalized patients were included in the study; 38.9% of the patients were discontinuers on the index date. RR for discontinuation of ≥1 somatic medication was 1.88 (95% CI=1.55-2.27) at the index date compared with the other time points and highest for patients<45 years (RR=2.83; 95% CI=1.92-4.18). CONCLUSIONS: Psychiatric hospitalization was associated with an almost doubled risk of discontinuation of somatic medication. Future studies should address the influence of discontinuation of care on patients' health.

Topical diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure: a double-blind randomized clinical trial.

OBJECTIVE: A double-blind randomized clinical trial to compare topical diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. BACKGROUND: Chronic anal fissures remain a challenging condition. Topical diltiazem and BTA are promising agents in the treatment of anal fissure. As to date diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. METHODS: One hundred thirty-four patients were randomized to receive either diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. RESULTS: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the diltiazem group, and this difference was statistically significant (P = 0.012). CONCLUSIONS: BTA yields higher healing rates in the short term, though after 3 months diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.

Preventable hospital admissions related to medication (HARM): cost analysis of the HARM study.

OBJECTIVE: Adverse drug events (ADEs) can cause serious harm to patients and can lead to hospitalization or even death. ADEs are a burden not only to patients and their relatives, but also to society and have the potential to involve high costs. To provide more information on the economic burden of preventable adverse drug events of outpatients, we performed a cost study on the data collected in the Hospital Admissions Related to Medication (HARM) study. In this study we examined the frequency, preventability, and risk factors for hospital admissions related to medication. METHODS: The average costs for a preventable medication-related hospital admission were calculated by summing the direct medical costs and the production losses of all the preventable admissions, taking into account the different types of hospitals (academic and general) and the age of the admitted patients. RESULTS: The average medical costs for one preventable medication-related hospital admission were €5461. The average production loss costs for one admission were €1712 for a person younger than 65 years of age. Combining the medical costs and the costs of production losses resulted in average costs of €6009 for one, potentially preventable, medication-related hospital admission for all ages. CONCLUSIONS: The costs of potentially preventable hospital admissions related to medication are considerable. Therefore, patient safety interventions to prevent ADEs and hospital admissions may be cost-effective or even cost saving.

Effect of reimbursement restriction policy on the use of benzodiazepines in the Netherlands: an interrupted time series analysis.

OBJECTIVES: Use of benzodiazepines has health risks. Reimbursement was restricted in the Netherlands from January 2009 onwards with the goal to reduce chronic use and healthcare expenditures. The aim of this study is to assess the initial and long-term effects of this policy on benzodiazepine use. DESIGN: Interrupted time series analysis, segmented regression models, Kaplan-Meier survival analysis and Cox proportional hazards analysis. SETTING: A 10% random sample of benzodiazepine dispensings by outpatient pharmacies between January 2002 and August 2015 were obtained from the PHARMO database. This database covered a catchment area representing about 3.6 million residents in 2015. PARTICIPANTS: 2 500 800 benzodiazepine prescriptions from 128 603 patients were included. INTERVENTION: Reimbursement restriction policy from January 2009 onwards. OUTCOME MEASURES: Changes in: the volume of dispensed prescriptions and doses, the incidence, prevalence of incidental, regular and chronic use and discontinuation rates of benzodiazepines. RESULTS: The volume of dispensed prescriptions and doses decreased by 12.5% (95% CI 9.0% to 15.9%) and 15.1% (95% CI 11.4% to 17.3%) respectively in January 2009 compared with December 2008. A clear initial effect on the overall incidence (-14.7%; 95% CI -19.8% to 9.6%) and the prevalence of incidental (-17.8%; 95% CI -23.9% to 11.7%), regular (-20.0%; 95% CI -26.1% to 13.9%) and chronic (-16.0%; 95% CI -23.1% to 8.9%) use was observed. A statistically significant reduction in the monthly trend per 1000 medication users was observed for the overall incidence (-0.017; 95% CI -0.031 to 0.003) and the prevalence of incidental (-3.624; 95% CI -4.996 to 2.252) but not for regular (-0.304; 95% CI -1.204 to 0.596) and chronic (0.136; 95% CI -0.858 to 1.130) use. Patients who started treatment before policy had a slightly higher probability of discontinuation (HR=1.013; 95% CI 1.004 to 1.022). CONCLUSIONS: The reimbursement policy had a significant initial effect on the volume, incidence and prevalence of benzodiazepine use. In addition, there is a statistically significant reduction in the monthly trend of overall incidence and of the prevalence of incidental use. No statistically significant reduction in the monthly trend of chronic use, the main purpose of the reimbursement restriction, could be demonstrated.

Predicting rehospitalization in patients treated with antipsychotics: a prospective observational study.

BACKGROUND: Prediction of rehospitalization in patients treated with antipsychotics is important for identifying patients in need of additional support to prevent hospitalization. Our aim was to identify factors that predict rehospitalization in patients treated with antipsychotics at discharge from a psychiatric hospital. METHODS: Adult patients suffering from schizophrenia, psychotic or bipolar I disorders who had been hospitalized in a psychiatric hospital for ⩾7 days and were treated with oral antipsychotics at discharge were included. The main outcome was rehospitalization within 6 months after discharge. A prediction model for rehospitalization was constructed including: patient/disease and medication characteristics, patients' beliefs about medicines, and healthcare-professional-rated assessment for all patients. The patients were stratified by diagnosis (schizophrenia and nonschizophrenia). Area under the receiver operating characteristic curve (AUCROC) was also assessed. RESULTS: A total of 87 patients were included and 33.3% of them were rehospitalized within 6 months after discharge. The variables that predicted rehospitalization were duration of hospitalization, patients' attitude towards medicine use, and healthcare-professional-rated assessment with an AUCROC of 0.82. Rehospitalization for patients with schizophrenia could be predicted (AUCROC = 0.71) by the Global Assessment of Functioning score, age, and harm score. Rehospitalization was predicted (AUCROC = 0.73) for nonschizophrenia patients with, for example rehospitalization predicted by the nurse. CONCLUSIONS: Rehospitalization was predicted by a combination of variables from the patient/disease and medication characteristics, patients' attitude towards medicine use, and healthcare-professional-rated assessment. These variables can be assessed relatively easily at discharge to predict rehospitalization within 6 months.

Instructions for clinical and biomarker monitoring in the Summary of Product Characteristics (SmPC) for psychotropic drugs: Overview and applicability in clinical practice.

The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. The present study evaluated which monitoring instructions are given in the SmPCs, and assessed whether instructions are informative enough to be applicable in clinical practice. Monitoring instructions were collected from complete SmPCs for psychotropic drugs (n=70). Reasons and requirements for monitoring were assessed and somatic parameters were distinguished from non-somatic parameters. Instructions were evaluated using the Systematic Information for Monitoring (SIM) score and considered applicable when a SIM score of ⩾ 3 was found. An average of 3.3 (range 0-13) instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. Overall, an average SIM score of 2.0 (SD=1.7) was found (out of a maximum possible score of 6). In conclusion, prescribing of psychotropic drugs is accompanied by diverse instructions aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice.

Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands.

BACKGROUND: Medication-related problems that lead to hospitalization have been the subject of many studies, many of which were limited to 1 hospital or lacked patient follow-up. Furthermore, little information exists on potential risk factors associated with preventable medication-related hospitalizations. METHODS: A prospective multicenter study was conducted to determine the frequency and patient outcomes of medication-related hospital admissions. A case-control design was used to determine risk factors for potentially preventable admissions. All unplanned admissions in 21 hospitals were assessed during 40 days. Controls were patients admitted for elective surgery. Cases and controls were followed up until hospital discharge. The frequency of medication-related hospital admissions, potential preventability, and outcomes were assessed. For potentially preventable medication-related admissions, risk factors were identified in the case-control study. RESULTS: Almost 13,000 unplanned admissions were screened, of which 714 (5.6%) were medication related. Almost half (46.5%) of these admissions were potentially preventable, resulting in 332 case patients matched with 332 controls. Outcomes were favorable in most patients. The main determinants of preventable medication-related hospital admissions were impaired cognition (odds ratio, 11.9; 95% confidence interval, 3.9-36.3), 4 or more comorbidities (8.1; 3.1-21.7), dependent living situation (3.0; 1.4-6.5), impaired renal function (2.6; 1.6-4.2), nonadherence to medication regimen (2.3; 1.4-3.8), and polypharmacy (2.7; 1.6-4.4). CONCLUSIONS: Adverse drug events are an important cause of hospitalizations, and almost half are potentially preventable. The identified risk factors provide a starting point for preventing medication-related hospital admissions.