Explore the vast range of titles available.

BackgroundPatient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk.ObjectiveTo test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard.DesignTwo-arm, multi-site patient-randomized pragmatic trial.ParticipantsEnglish- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications.InterventionA patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime).Main MeasuresDemonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months.Key ResultsA total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13–4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63–2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15–22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17–6.53).ConclusionsA simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens.Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849

Background The concept of pharmaceutical care is operationalized through pharmaceutical professional services, which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes. Objective The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a medication review with follow-up (MRF) service for older adults with polypharmacy in Spanish community pharmacies against the alternative of having their medication dispensed normally. Methods The study was designed as a cluster randomized controlled trial, and was carried out over a time horizon of 6 months. The target population was older adults with polypharmacy, defined as individuals taking five or more medicines per day. The study was conducted in 178 community pharmacies in Spain. Cost-utility analysis adopted a health service perspective. Costs were in euros at 2014 prices and the effectiveness of the intervention was estimated as quality-adjusted life-years (QALYs). In order to analyze the uncertainty of ICER results, we performed a non-parametric bootstrapping with 5000 replications. Results A total of 1403 older adults, aged between 65 and 94 years, were enrolled in the study: 688 in the intervention group (IG) and 715 in the control group (CG). By the end of the follow-up, both groups had reduced the mean number of prescribed medications they took, although this reduction was greater in the IG (0.28 ± 1.25 drugs; p  < 0.001) than in the CG (0.07 ± 0.95 drugs; p  = 0.063). Older adults in the IG saw their quality of life improved by 0.0528 ± 0.20 ( p  < 0.001). In contrast, the CG experienced a slight reduction in their quality of life: 0.0022 ± 0.24 ( p  = 0.815). The mean total cost was €977.57 ± 1455.88 for the IG and €1173.44 ± 3671.65 for the CG. In order to estimate the ICER, we used the costs adjusted for baseline medications and QALYs adjusted for baseline utility score, resulting in a mean incremental total cost of −€250.51 ± 148.61 (95 % CI −541.79 to 40.76) and a mean incremental QALY of 0.0156 ± 0.004 (95 % CI 0.008–0.023). Regarding the results from the cost-utility analysis, the MRF service emerged as the dominant strategy. Conclusion The MRF service is an effective intervention for optimizing prescribed medication and improving quality of life in older adults with polypharmacy in community pharmacies. The results from the cost-utility analysis suggest that the MRF service is cost effective.

People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring. Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care. Five UK private sector care homes. 41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine. Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step. Problems addressed and changes in medicines prescribed. Information was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site. Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22). The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines. ISRCTN 48133332.

There are only two countries in the world (the United States and New Zealand) that allow the pharmaceutical branch to advertise prescription medication directly to consumers. There is pressure on governments to allow direct-to-consumer advertising (DTCA) for prescription drugs elsewhere too. One argument the industry uses frequently is the claim that exposure to DCTA, through various methods and occasions, is supposed to improve customers' knowledge of a disease and treatment. This argument has been part of the health care community's wider discussion of whether DTCA of prescription drugs benefits the population's general interest or is only an attempt to increase the sales of the pharmaceutical branch. Belief in true learning by DTCA is rooted in concepts of empowered consumers and their autonomous and empowered decision-making. In this study, we tested the hypotheses that contact with DTCA increases recipients' literacy/knowledge, especially regarding the side effects of treatment (hypothesis 1), and empowerment (hypothesis 2). We further hypothesized that DTCA exposure would not increase depression knowledge (ie, about treatments, symptoms, and prevalence) (hypothesis 3). A snowball sample of 180 participants was randomly split into three experimental groups receiving (1) a traditional information sheet, (2) a DTCA video clip for an antidepressant prescription drug, or (3) both. The video was original material from the United States translated into Italian for the experiment. Dependent variables were measures of depression knowledge (regarding treatments, symptoms and prevalence, and antidepressant side effects), depression literacy, and empowerment. None of the experimental groups differed significantly from the others in the empowerment measure (hypothesis 2 not confirmed). Partial confirmation of hypothesis 1 was obtained. Lower values on the depression literacy scale were obtained when participants had been given the video compared to the sheet condition. However, the general depression knowledge and its subscale on side effects reached higher scores when participants were exposed to the DTCA, alone or in combination with the information sheet. Finally, participants showed lower scores on knowledge about treatment and symptoms or prevalence after watching the video compared to the sheet condition (hypothesis 3 confirmed). Symptoms and prevalence knowledge increased only when the video was presented in combination with the sheet. There is no evidence for an increase in empowerment following DTCA exposure. An increase in knowledge of the side effects of the medication was observed in the group exposed to the DTCA video. This was the only result that confirmed the hypothesis of the beneficial effect of DTCA videos on knowledge. Written information proved to be the most suitable way to convey knowledge on treatments and symptoms prevalence. Our findings support the necessity of studying health literacy and patient empowerment together and the consequences of such an increase in knowledge in terms of help-seeking behavior.

Purpose The feasibility of applying the Fit fOR The Aged (FORTA) list, a drug classification combining positive and negative labeling of drugs, should be studied in geriatric patients and medication quality and clinical endpoints measured. FORTA labels range from A (indispensable), B (beneficial), C (questionable) to D (avoid). Methods A prospective randomized controlled pilot trial was performed in hospitalized geriatric patients in whom the FORTA instrument or standard care was applied. Patients were randomly admitted to an intervention and a control ward. Changes of FORTA label distributions between admission and discharge, over- and under-prescription rates, clinical endpoints including the number of falls during the hospitalization, and Barthel Index (BI) at admission and discharge were measured. Results Polypharmacy persisted in both groups. At discharge, a higher rate of A drugs was prescribed in the intervention group (58 patients, median age 84 years) vs. standard care (56 patients, median age 83 years, p  < 0.02), and both over- and under-prescriptions were significantly lower in the FORTA than in the control group ( p  < 0.03). Two (3.4 %) intervention, but 12 (21.4 %) control, patients fell at least once ( p  < 0.001). The fall rate per 1,000 patient years was 1.5 ± 8.3 in the intervention and 10.6 ± 25.4 in the control group ( p  < 0.004). Conclusions This pilot study shows that the application of the FORTA list is feasible in geriatric patients. In this small study, the medication quality improved in the intervention group, but polypharmacy persisted in both groups. The fall rate was significantly lower in the intervention group. These encouraging results must be interpreted carefully.

Background A vigilant prescription of drugs during pregnancy can potentially safeguard the growing fetus from the deleterious effect of the drug while attempting to manage the mother’s health problems. There is a paucity of information about the drug utilization pattern in the area of investigation. Hence, this study was implemented to investigate the pattern of drug utilization and its associated factors among pregnant women in Adigrat general hospital, Northern Ethiopia. Methods An institution-based cross-sectional study was conducted among randomly selected 314 pregnant women who attended obstetrics-gynecology and antenatal care units of the hospital. Relevant data were retrieved from the pregnant women’s medical records and registration logbook. The drugs prescribed were categorized based on the United States Food and Drug Administration (US-FDA) fetal harm classification system. Data analysis was done using SPSS version 20 statistical software. Multivariate logistic regression was employed to analyze the association of the explanatory variables with the medication use, and p  < 0.05 was declared statistically significant. Results The overall prescribed drug use in this study was found to be 87.7%. A considerable percentage of the study participants (41.4%) were prescribed with supplemental drugs (iron folate being the most prescribed drug) followed by antibiotics (23.4%) and analgesics (9.2%). According to the US-FDA drug’s risk classification, 42.5, 37, 13, and 7% of the drugs prescribed were from categories A, B, C, and D or X respectively. Prescribed drug use was more likely among pregnant women who completed primary [AOR = 5.34, 95% CI (1.53–18.6)] and secondary education [AOR = 4.1, 95% CI (1.16–14)], who had a history of chronic illness [AOR = 7.9, 95% CI (3.14–19.94)] and among multigravida women [AOR = 2.9, 95% CI (1.57 5.45)]. Conclusions The finding of this study revealed that a substantial proportion of pregnant women received drugs with potential harm to the mother and fetus. Reasonably, notifying health practitioners to rely on up-to-date treatment guidelines strictly is highly demanded. Moreover, counseling and educating pregnant women on the safe and appropriate use of medications during pregnancy are crucial to mitigate the burden that the mother and the growing fetus could face.

Inaccurate medication records and poor medication adherence result in incomplete knowledge of therapy for patients. To study accuracy of medical records and patient adherence by measuring blood concentrations of medications. This cross-sectional study validated a serum-based liquid chromatography-tandem mass spectrometry assay to simultaneously quantify 263 medications used for acute and chronic conditions. The assay panel was applied to 3 clinical patient cohorts: residual serum from 1000 randomly selected samples sent for routine clinical chemistry testing between April 8 and October 6, 2015 (residuals cohort), 50 prospectively enrolled patients in a gastroenterology clinic between March 1 and March 15, 2016, who were prescribed more than 5 medications (gastroenterology care cohort), and a convenience cohort of 296 patients with hypertension who sought care in an emergency department (ED care cohort) between July 1, 2012, and April 25, 2013. Integrated data analysis of the cohorts was performed from August 22 to November 29, 2017. Medication serum concentrations, electronic health record medication lists, and predicted drug interactions. Of the 1346 total samples, 1000 came from the residuals cohort (640 women and 360 men; median age, 60 years [interquartile range (IQR), 44-71 years]), 50 from the gastroenterology care cohort (30 women and 20 men; median age, 66 years [IQR, 62-70 years]), and 296 from the ED care cohort (160 women and 136 men; median age, 59 years [IQR, 52-66 years]). Median medication adherence, defined as the subset of detected medications from the prescription record, was 83% (IQR, 50%-100%) in the residuals cohort, 100% (IQR, 84%-100%) in the gastroenterology care cohort, and 78% (IQR, 57%-100%) in the ED care cohort. Patients adherent to 1 medication were more often adherent to other medications. Among patients prescribed 3 medications or more, there were no significant associations between medication adherence and sex or number of prescribed medications, and there was a modest association between adherence and age. By comparing detected vs prescribed medications, we detected a median of 0 (IQR, 0-2) medications per patient that were not listed in the electronic health record in the residuals cohort, 1 (IQR, 0-2) medication per patient that was not listed in the electronic health record in the gastroenterology care cohort, and 1 (IQR, 0-2) medication per patient that was not listed in the electronic health record in the ED care cohort. A total of 435 patients (43.5%) in the residuals cohort had no discrepancy between the electronic health record and detected medication lists, 22 patients (44.0%) in the gastroenterology care cohort had no discrepancy between the electronic health record and detected medication lists, and 41 patients (13.9%) in the ED care cohort had no discrepancy between the electronic health record and detected medication lists. Half of adverse drug reaction alerts occurred among medications detected without prescription. Comprehensive medication monitoring offers promise to improve adherence, the accuracy of medical records, and the safety for patients with polypharmacy.

Background The use of Fall-Risk-Increasing-Drugs (FRIDs) has been associated with increased risk of falls and associated injuries. This study investigates the effect of withdrawal of FRIDs versus ‘care as usual’ on health-related quality of life (HRQoL), costs, and cost-utility in community-dwelling older fallers. Methods In a prospective multicenter randomized controlled trial FRIDs assessment combined with FRIDs-withdrawal or modification was compared with ‘care as usual’ in older persons, who visited the emergency department after experiencing a fall. For the calculation of costs the direct medical costs (intramural and extramural) and indirect costs (travel costs) were collected for a 12 month period. HRQoL was measured at baseline and at 12 months follow-up using the EuroQol-5D and Short Form-12 version 2. The change in EuroQol-5D and Short Form-12 scores over 12 months follow-up within the control and intervention groups was compared using the Wilcoxon Signed Rank test for continuous variables and the McNemar test for dichotomous variables. The change in scores between the control and intervention groups were compared using a two-way analysis of variance. Results We included 612 older persons who visited an emergency department because of a fall. The mean cost of the FRIDs intervention was €120 per patient. The total fall-related healthcare costs (without the intervention costs) did not differ significantly between the intervention group and the control group (€2204 versus €2285). However, the withdrawal of FRIDs reduced medication costs with a mean of €38 per participant. Furthermore, the control group had a greater decline in EuroQol-5D utility score during the 12-months follow-up than the intervention group ( p  = 0.02). The change in the Short Form-12 Physical Component Summary and Mental Component Summary scores did not differ significantly between the two groups. Conclusions Withdrawal of FRID’s in older persons who visited an emergency department due to a fall, did not lead to reduction of total health-care costs. However, the withdrawal of FRIDs reduced medication costs with a mean of €38 per participant in combination with less decline in HRQoL is an important result. Trial registration The trial is registered in the Netherlands Trial Register ( NTR1593 – October 1 st 2008).

Background Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. Methods The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. Discussion In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. Trial registration Current Controlled Trials ISRCTN42003273

Background Care transitions from hospital to community have been identified as risk points for the continuity of patient care. Without upstream information, the community pharmacist (CP) cannot ensure error-free drug dispensing. A hospital-to-community records transmission process would enable CPs to guarantee that all prescription drugs are ready to pick up at hospital discharge, and to improve their responses to patient health inquiries. Objective To evaluate the impact of a hospital-to-CP medication records scheme on post-discharge continuity of patient treatment. Setting A University Hospital Digestive Surgery Department. Method Prospective, single-center, randomized pilot study. Eligible adult Digestive Surgery department patients discharged home over a period of 4 months were included. The medication reconciliation procedure was the same in both arms of the study. For patients included in the intervention group, CPs were sent the discharge prescription, patient medication list, and clinical and biological data required for drug dispensing. At 7 ± 2 days post-discharge, the CPs were surveyed by questionnaire. Seamlessness of drug continuity, use of the discharge medication form, and CP satisfaction with the scheme were assessed. Main outcome measures Prevalence of medication shortages, i.e. CPs unable to supply the appropriate drugs at discharge, and CP satisfaction levels, analyzed using Chi squared test. Results 124 patients were included. Of 124 CPs surveyed, 104 returned a completed questionnaire. Analysis found medication shortage in 10 control-group patients and one intervention-group patient ( p  < 0.005), non-availability of the full prescription in 24 % of control-group patients and 6 % of intervention-group patients ( p  < 0.013). In terms of CP satisfaction, 96 % of the intervention-group CPs stated that they were satisfied with the new hospital-to-community liaison initiative, while just 24 % of control-group CPs were satisfied with the current level of hospital-to-community liaison. Mean hospital pharmacist time input required for this initiative was an estimated 21 min for the control group versus 35 min for the intervention group. Conclusion The results provide a strong rationale for embedding the process longer-term and extending it out to other healthcare services. A pre-project study is needed to define which service departments and patients groups should be given priority for this process initiative.