Public deliberation to assess patient views on biosimilar medication switching for the treatment of inflammatory bowel disease.

BACKGROUND: Biosimilars are highly similar, but not identical, versions of originator biologic medications. Switching patients to biosimilars presents an opportunity to mitigate rising drug costs and expand patient access to important biologic therapies. However, decreased patient acceptance and adherence to biosimilar medications have been reported, which can lead to loss of treatment response, adverse reactions, and inefficient resource utilization. Understanding patient perceptions of biosimilars and biosimilar switching is needed to inform patient-centered care strategies that promote efficient resource utilization. METHODS: We used democratic deliberation methods to solicit the informed and considered opinions of patients regarding biosimilar switching. Patients with inflammatory bowel disease (IBD; n = 29) from the Veterans Health Administration (VHA) participated in 5-hour deliberation sessions over two days. Following educational presentations with experts, participants engaged in facilitated small group discussions. Transcripts and facilitators' notes were used to identify key themes. Participants completed surveys pre- and post-deliberation to collect sociodemographic and clinical features as well as to assess IBD treatment knowledge and attitudes toward care and approaches to biosimilar switching. RESULTS: Five major themes emerged from the small group discussions in the context of biosimilar switching: 1) concerns about adverse consequences and unclear risk-benefit balance; (2) importance of communication and transparency; (3) desire for shared decision making and patient involvement in treatment decisions; (4) balancing cost-saving with competing priorities; and (5) advocating for individualized care and prioritization based on risk levels. These views led participants to favor approaches that prioritize switching the sickest patients last (i.e., those with poorly controlled disease) and that offer patients control and choices around biosimilar switching. Participants also expressed preferences for combining elements of different approaches to maximize fairness. CONCLUSIONS: Approaches to biosimilar switching should consider patients' desires for transparency and effective communication about biosimilar switching and engagement in their medical decision-making as part of patient-centered care. Incorporating patient preferences around biosimilar switching is critical when navigating the quality and affordability of care in resource constrained settings, both within the VHA and in other healthcare systems.

Switching antiepileptic drugs to once-daily dosing regimens in epilepsy patients.

BACKGROUND: Antiepileptic drug (AED) non-adherence is an important factor contributing to poor seizure control in patients with epilepsy. AIM: The aim of this study is to investigate seizure improvement after switching AEDs to once-daily dosing regimens in patients with drug-resistant epilepsy related to AED non-adherence. METHODS: We performed a 10-year retrospective analysis of drug-resistant epilepsy patients whom AED non-adherence attributed to drug resistance and switched AEDs to once-daily dosing regimens. Successful switching was defined by at least 70% reduction in seizure frequency without troublesome adverse events. RESULTS: Among 401 patients with drug-resistant epilepsy, 88 patients with AED non-adherence were switched to once-daily dosing regimens. Forty-six patients (52.3%) experienced successful seizure control following the switch. A higher chance of successful switch was found in patients without MRI abnormality (16/46 vs. 24/42; P = .04) and in patients who were switched to extended-release formulations or different AEDs with longer half-lives (33/46 vs. 19/42; P = .02). CONCLUSIONS: Our study shows that switching AEDs to once-daily dosing regimens was an effective therapeutic option in patients with poor seizure control related to AED non-adherence. Treatment with extended-release formulations or drugs with longer half-lives should be considered in these patients.

Patients' beliefs and behaviours are associated with perceptions of safety and concerns in a hypothetical biosimilar switch.

Although patient acceptance is important for biosimilar adoption and reducing healthcare costs, many patients perceive biosimilars to be unsafe and have concerns about switching. Studies show that patients' characteristics influence negative perceptions toward generic drugs, but little research has explored biosimilar acceptance. This study examines which demographic and psychological characteristics are associated with patients' safety perceptions and concerns about switching to biosimilars. Ninety-six patients taking bio-originators for rheumatic conditions (65% for rheumatoid arthritis) completed the Brief Illness Perceptions Questionnaire, Beliefs about Medicines Questionnaire and Perceived Sensitivity to Medicines Scale. Demographic factors, information seeking, concerns about switching and safety perceptions were also assessed. Pearson's correlations and hierarchical linear regressions were conducted to explore whether patient characteristics are associated with perceptions of biosimilars. Negative safety perceptions were associated with being female, short-term bio-originator use, illness beliefs, seeking health information online, high perceived sensitivity to medicines and negative beliefs about medicines. Only being female (ß = 0.24, P = 0.02) was independently associated. More concerns about switching were associated with being female, illness beliefs, high perceived sensitivity to medicines, information-seeking behaviours and preferring innovator drugs. Seeking health information online (ß = 0.20, P = 0.04), preferring innovator drugs (ß = 0.29, P = 0.004) and stronger emotional responses (ß = 0.26, P = 0.01) were independently associated. Perceived bio-originator effectiveness was inversely associated with preferring biosimilars (rs= - 0.33, P < 0.001). Patients who have stronger emotional responses to their condition, are females, seek health information online and prefer innovator drugs that have more negative perceptions about biosimilars. Experiences with bio-originators influence attitudes towards switching.

Exploring generic brittleness and the demographic factors for its susceptibility in patients with epilepsy.

PURPOSE: The purpose of this study was to provide an algorithm for generic brittleness and to elucidate the demographic factors that anticipate generic brittleness for patients with epilepsy. METHODS: This exploratory, observational, and nontherapeutic study was conducted in patients with epilepsy who were routinely followed at the University of Maryland epilepsy outpatient clinic in Baltimore, Maryland. Patients were taking at least one antiepileptic drug (AED) for treatment of epilepsy. Based on patient interview and medical history, 12 demographic factors were collected. Each patient was assessed to be either generic brittle (GB) or not GB. Demographic factors were subjected to binary logistical regression and other statistical tests, to elucidate determinants of GB status. RESULTS: N = 148 patients completed the study. An algorithm to define whether a patient was GB or not GB was devised. The two elements that defined GB status are as follows: patient opinion about generics and (if needed) whether patients were currently taking brand or generic of their most problematic AED. About 40% of patients were GB. From binary logistical regression, two demographic factors that contributed to patients being GB were whether a patient was currently taking a problem AED and total number of current medications for a patient, with odds ratios of 4.06 (95% confidence interval [CI] from 1.53 to 10.81) and 1.10 (95% CI from 1.003 to 1.21), respectively. Of the patients on a problem AED, 46.9% were GB, while only 18.2% of patients not currently on a problem AED were GB. The total number of current medications ranged from 1 to 22, with mode of four medications. From regression, for each additional medication that a patient took, the odds of being GB increased 1.10-fold. Although patient seizure and adverse event history was not employed to define GB status, being GB was associated with less seizure control and greater adverse events. CONCLUSIONS: An algorithm for generic brittleness was derived, and about 40% of patients were GB, usually due to prior history of a switch problem. Two demographic factors favored patients being GB: whether the patient was currently taking a problem AED and the total number of current medications.

Predictors of the effectiveness of an early medication change strategy in patients with major depressive disorder.

BACKGROUND: Patients with Major Depressive Disorder (MDD) who are non-improvers after two weeks of antidepressant treatment have a high risk of treatment failure. Recently, we did not find differences in outcomes in non-improvers randomized to an early medication change (EMC) strategy compared to treatment as usual (TAU). This secondary analysis investigated possible predictors of higher remission rates in the EMC strategy. METHODS: Of 192 non-improvers (i.e. decrease of ≤20% on the HAMD-17 depression scale) after a two-week treatment with escitalopram, n = 97 were randomized to EMC (immediate switch to high doses of venlafaxine XR) and n = 95 to TAU (continued escitalopram until day 28 with non-responders switched to venlafaxine XR). We first analyzed patient characteristics, psychopathological features and subtypes of MDD by logistic regression analyses as possible predictors of remission rates. In a second investigation, we analyzed the predictors, which showed a significant association in the first analysis before Bonferroni-Holm correction by chi-squared tests separated for treatment groups. All analyses were corrected by Bonferroni-Holm method. RESULTS: The first analyses yielded no statistically significant results after correction for multiple testing. In the second analyses, however, patients with prior medication at study entry showed higher remission rates in EMC than in TAU (24.2% versus 8.6%, p = 0.017; Bonferroni-Holm corrected significance level: p = 0.025.). Furthermore, patients with a recurrent course of MDD benefited less from treatment as usual (p = 0.009; Bonferroni-Holm corrected significance level: p = 0.025). Age, sex, age of onset, psychiatric or somatic comorbidities, and other subtypes of MDD did not predict remission rates. CONCLUSIONS: Although in our first analysis we found statistically non-significant results, the second analysis showed significant differences in remission rates between patients with or without previous medication and in patients with recurrent MDD or the first depressive episode. It would therefore be valuable to examine in larger and prospective studies whether remission rates can be increased by quick escalation of treatment in certain subgroups of patients. Promising subgroups to be tested are patients who were previously medicated, and who show a recurrent course of MDD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00974155 . Registered at the 10th of September 2009. Retrospectively registered.

Patient characteristics influence the choice of biological drug in RA, and will make non-TNFi biologics appear more harmful than TNFi biologics.

OBJECTIVES: With the wide range of biological disease-modifying anti-rheumatic drugs (bDMARDs) available for treating rheumatoid arthritis (RA), and limited evidence to guide the choice for individual patients, we wished to evaluate whether patient characteristics influence the choice of bDMARD in clinical practice, and to quantify the extent to which this would bias direct comparisons of treatment outcome. METHODS: Register-based study of all Swedish patients with RA initiating necrosis factor inhibitor (TNFi), rituximab, abatacept or tocilizumab in 2011-2015 as their first bDMARD (n=6481), or after switch from TNFi as first bDMARD (n=2829). Group differences in demographics, clinical characteristics and medical history were assessed in multivariable regression models. Predicted differences in safety and treatment outcomes were calculated as a function of patient characteristics, through regression modelling based on observed outcomes among patients with RA starting bDMARDs 2006-2010. RESULTS: Patients starting non-TNFi were older than those starting TNFi, had lower socioeconomic status, higher disease activity and higher burden of diseases including malignancy, serious infections and diabetes. Differences were most pronounced at first bDMARD initiation. These factors were linked to treatment outcome independent of therapy, yielding worse apparent safety and effectiveness for non-TNFi biologics, most extreme for rituximab. Standardising to the age/sex distribution of the TNFi group reduced differences considerably. CONCLUSIONS: There was significant channelling of older and less healthy patients with RA to non-TNFi bDMARDs, in particular as first bDMARD. Whether this channelling represents a maximised benefit/risk ratio is unclear. Unless differences in age, medical history and disease activity are accounted for, they will substantially confound non-randomised comparative studies of available bDMARDs' safety and effectiveness.

Patient preferences concerning the efficacy and side-effect profile of schizophrenia medications: a survey of patients living with schizophrenia.

BACKGROUND: Despite the availability of numerous antipsychotic medications, many patients with schizophrenia continue to experience side effects that contribute to the overall burden of the illness. The present survey of patients with schizophrenia and schizoaffective disorder aimed to assess patient attitudes toward antipsychotic treatment, and understand key factors about willingness to try a new medication. METHODS: A cross-sectional survey was administered to 250 patients with a primary clinical diagnosis of a schizophrenia spectrum disorder across five outpatient clinics in the United States. The survey included self-reported gender, age, weight, and height, and questions about the importance of efficacy and side effects on the decision to take a prescribed antipsychotic medication. RESULTS: Patients rated efficacy and side effects as important attributes of antipsychotic treatment, with 93.6% and 83.6% of patients listing these as "very" or the "most" important factors in taking prescribed medication. A total of 87.6% of respondents identified the ability to think more clearly as an important property of their medication. Patients identified weight gain, physical restlessness, and somnolence as important side effects of current treatments ("very" or "most" important by 61.6%, 60.8%, and 58.8%, respectively). When asked about willingness to change antipsychotic medication, anticipated weight gain had a negative influence on willingness to try the new treatment, with 22.0% declining to try a medication that would lead to weight gain of 2.7-4.5 kg (6-10 lb), 34.0% declining for anticipated weight gain of 5.0-9.1 kg (11-20 lb), and 52.4% declining for anticipated weight gain greater than 9 kg (20 lbs). CONCLUSION: Patients living with schizophrenia spectrum disorders are influenced by many factors when considering whether to take their medication, including efficacy and side effects. It is important for clinicians to assess specific patient concerns to develop a comprehensive treatment plan that maximizes adherence to the prescribed therapy.

Satisfaction and efficacy of switching from daily dipeptidyl peptidase-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes-Randomized controlled study.

We compared treatment satisfaction between daily dipeptidyl peptidase-4 (DPP-4) inhibitors and a weekly DPP-4 inhibitor in patients with type 2 diabetes. The study was a 12-week, open-label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes who had received daily DPP-4 inhibitors for more than 3 months. Patients were randomly assigned to a treatment cohort: (1) a group that continued taking daily DPP-4 inhibitors (daily group); or (2) a group that switched from daily DPP-4 inhibitors to a weekly DPP-4 inhibitor, trelagliptin (weekly group). The primary outcome was the change in treatment satisfaction levels from baseline to 12 weeks between the two groups, according to Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire scores. The changes in glycemic control and body weight were also assessed. Of 49 patients initially enrolled in the study, 47 completed the study. The change in DTSQ scores in the weekly group was not significantly different from that in the daily group. However, the improvements in total score and subscale domains 1 and 2 in the DTR-QOL analysis, which relate to burden on social/daily activities and anxiety/dissatisfaction with treatment, were significantly greater in the weekly group than the daily group (p = 0.048, 0.013 and 0.045, respectively). Mean changes in glycated hemoglobin levels and body weight were comparable between the groups. Switching from daily DPP-4 inhibitors to a weekly DPP-4 inhibitor, trelagliptin, could partially improve treatment satisfaction levels in patients with type 2 diabetes without affecting glycemic control.

Branded versus generic drug use in chronic disease management in Hong Kong-perspectives of health care professionals and the general public.

INTRODUCTION: The aim of the present study was to evaluate the understanding of generic substitution among health care professionals and members of the general public ("general public") in Hong Kong. METHODS: This cross-sectional descriptive study was performed by using a self-completed anonymous questionnaire from March 2015 to May 2017. The questionnaire included demographic data, knowledge of generic drugs, experiences of generic substitution, and views on policy. RESULTS: A total of 2106 general public, 73 doctors, 22 nurses, and 50 pharmacists responded the questionnaire. In all, 41.2% of the general public was aware that generic drugs have the same active ingredients. Although a majority of the health care professionals knew that generic drugs have the same active ingredients (doctors: 79.5%; nurses: 86.4%; pharmacists: 98.0%), many were unaware of bioequivalence (doctors: 37.0%; nurses: 18.2%; pharmacists: 50.0%). "Efficacy" was ranked as the primary concern among all groups; a substantial portion of respondents reported experiencing adverse drug reactions upon generic substitution (general public: 26.6%; doctors: 23.3%; nurses: 9.1%; pharmacists: 42.0%). At least half of the general public, nurses, and pharmacists considered that patients should be given a choice for generic substitution. However, fewer than one-fifth of doctors and nurses and approximately one-third of pharmacists considered that patient consent was needed prior to generic substitution, compared with approximately two-thirds of the general public. CONCLUSION: The knowledge and perception of generic substitution remains low, both in the general public and among health care professionals. This knowledge deficit could potentially lead to different perspectives among stakeholders regarding generic substitution.

Association between switching antiepileptic drug products and healthcare utilization: A systematic review.

AIMS: There is ongoing concern whether switching between different antiepileptic drug (AED) products may compromise patient care. We systematically reviewed changes in healthcare utilization following AED switch. METHODS: We searched MEDLINE and EMBASE databases (1980-October 2016) for studies that assessed the effect of AED switching in patients with epilepsy on outpatient visits, emergency room visits, hospitalization and hospital stay duration. RESULTS: A total of 14 articles met the inclusion criteria. All were retrospective studies. Four provided findings for specific AEDs only (lamotrigine, topiramate, phenytoin and divalproex), 9 presented pooled findings from multiple AEDs, and 1 study provided both specific (lamotrigine, topiramate, oxcarbazepine, and levetiracetam) and pooled findings. Three studies found an association between a switch of topiramate and an increase in healthcare utilization. Another three studies found that a brand-to-generic lamotrigine switch was not associated with an increased risk of emergently treated events (ambulance use, ER visits or hospitalization). The outcomes of the pooled AED switch studies were inconsistent; 5 studies reported an increased healthcare utilization while 5 studies did not. CONCLUSION: Studies that have examined the association between an AED switch and a change in healthcare utilization report conflicting findings. Factors that may explain these inconsistent outcomes include inter-study differences in the type of analysis undertaken (pooled vs individual AED data), the covariates used for data adjustment, and the type of switch examined. Future medical claim database studies employing a prospective design are encouraged to address these and other factors in order to enhance inter-study comparability and extrapolation of findings.

Patient emotions and perceptions of antiepileptic drug changes and titration during treatment for epilepsy.

OBJECTIVE: To investigate the impact of antiepileptic drug (AED) change and dose titration on the emotional well-being of patients with epilepsy. METHODS: Members of an online epilepsy community were invited to voluntarily participate in an online survey. The cross-sectional anonymous survey consisted of 31 multiple choice questions balanced in terms of variety and positivity/negativity of emotions concerning participants' most recent AED change. To substantiate survey results, spontaneous comments from epilepsy-related online forums and social media websites that mentioned participants' experiences with AED medication changes (termed passive listening statements) were analyzed and categorized by theme. RESULTS: All 345 survey participants (270 [78.3%] female; 172 [49.9%] were 26-45years old) self-reported an epilepsy/seizure diagnosis and were currently taking seizure medication; 263 (76.2%) were taking ≥2 AEDs and 301 (87.2%) had ≥1 seizure in the previous 18months. All participants reported a medication change within the previous 12months (dose increased [153 participants (44.3%)], medication added [105 (30.4%)], dose decreased [49 (14.2%)], medication removed [38 (11.0%)]). Improving seizure control (247 [71.6%]) and adverse events (109 [31.6%]) were the most common reasons for medication change. Primary emotions most associated (≥10% of participants) with an AED regimen change were (before medication change; during/after medication change) hopefulness (50 [14.5%]; 43 [12.5%]), uncertainty (50 [14.5%]; 69 [20.0%]), and anxiety (35 [10.1%]; 45 [13.0%]), and were largely due to concerns whether the change would work (212/345 [61.4%]; 180/345 [52.2%]). In the text analysis segment aimed at validating the survey, 230 participants' passive listening statements about medication titration were analyzed; additional seizure activity during dose titration (93 [40.4%]), adverse events during titration (71 [30.9%]), higher medication dosages (33 [14.3%]), and drug costs (25 [10.9%]) were the most commonly noted concerns. CONCLUSION: Although the emotional well-being of patients with epilepsy is complex, our study results suggest that participants report their emotional well-being as negatively affected by changes in AED regimen, with most patients reporting uncertainty regarding the outcome of such a change. Future research is warranted to explore approaches to alleviate patient concerns associated with AED medication changes.

Treatment satisfaction, adherence and behavioral assessment in patients de-escalating from natalizumab to interferon ß.

BACKGROUND: De-escalating natalizumab (NTZ) to interferon beta 1b (IFN B 1B) is a possible treatment option in multiple sclerosis (MS) patients interrupting NTZ because of increased risk of progressive multifocal leukoencephalopathy (PML). The aim of this study was to evaluate satisfaction and adherence to treatment, behavioral and fatigue changes in patients switched to IFN B 1B compared to continued NTZ treatment. METHODS: A 1 year, prospective, randomized, rater-blinded, parallel-group study. Nineteen relapsing remitting (RR) MS patients, randomly assigned to undergo either NTZ (n = 10) or IFN B 1B (n = 9) treatment, who had previously received NTZ for at least 12 months with disease stability and fearing or at risk for PML were included. Patients underwent behavioral and treatment assessments at baseline, after 24-week and 1 year follow-up. Behavioral assessment included measures of cognition, fatigue and quality of life. Treatment assessment included measures of satisfaction, persistence and adherence to treatment. Clinical-radiological disease activity and safety were also assessed. RESULTS: Baseline characteristics of patients were similar between groups except for Euro Quality Visual Analogue Scale, being higher in the NTZ group (p = 0.04). Within-group comparisons at the three time points, as well as interaction analysis of treatment effect over time did not show any statistically significant differences in behavioral or treatment assessments, but a coherent trend favoring NTZ over IFN B 1B. CONCLUSIONS: De-escalating NTZ to IFN B 1B is feasible and associated with overall good patient related outcome and persistently stable behavioral measures.

Patients' concern about their medicine after a generic switch: a combined cross-sectional questionnaire and register study.

PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence in treatment. We also included general beliefs about medicine (BMQ), views on generic medicine and confidence in the health-care system. The information about the patients' generic switch was obtained from a prescription database and not provided by the patients. Data were analysed using linear regression. RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0.28 95% CI: 0.20; 0.35). Patients having high confidence in the health-care system showed less concern (-0.16 95% CI: -0.27; -0.06). CONCLUSION: This study showed that for all three drug categories investigated, the patients who experienced a generic switch did not have more concerns about their index medicine than patients who did not switch.

"My doctor has changed my pills without telling me": impact of generic medication switches in stroke survivors.

Generic (i.e. non-branded medicine) and therapeutic (i.e. a less expensive drug from the same class) substitution of medication provides considerable financial savings, but may negatively impact on patients. We report secondary qualitative/quantitative analysis of stroke survivors from a pilot randomised controlled brief intervention to increase adherence to medication. Patients' experiences of medication changes were examined in conjunction with electronically-recorded medication adherence. Twenty-eight patients reported frequent medication changes (e.g. size/shape/colour/packaging) and two-thirds of these reported negative effects, resulting in, at least, confusion and, at worst, mistakes in medication-taking. Patients reporting a direct effect on their medication-taking (n = 6) demonstrated poorer objectively-measured adherence (i.e. % doses taken on schedule) than those reporting confusion [mean difference = 19.9, 95% CI (2.0, 37.8)] or no problems [mean difference = 20.6, 95% CI (1.6, 40.0)]. Changes to medication resulting from switching between generic brands can be associated with notable problems, including poorer medication adherence, for a significant minority.

Generic medicine substitution: a cross-sectional survey of the perception of pharmacists in North-Central, Nigeria.

OBJECTIVE: To investigate the views of pharmacists in North-Central Nigeria on generic medicines and generic substitution practices. SUBJECTS AND METHOD: A cross-sectional survey was conducted in 4 cities in North-Central Nigeria from April to June 2012 among 330 pharmacists in hospital and community pharmacy settings, recruited through a convenience sampling strategy. Data were collected using a prevalidated self-administered questionnaire and entered into SPSS version 16.0 software to generate descriptive statistics. Binary logistic regression was conducted to determine the demographic predictors of preference for generic substitution among respondents. RESULTS: The response rate was 46.7% (n = 154). Eighty-four (54.5%) respondents reported that generic medicines were not of equivalent quality to branded ones. There was no significant difference (p > 0.05) in the perception of respondents regarding the quality of imported generic medicines over locally manufactured ones. While 143 (92.9%) respondents supported generic substitution practices, 105 (68.2%) would prefer to recommend generic medicines over branded ones. Hospital pharmacists were more likely (OR = 2.6; 95% CI 1.2-5.8) than community pharmacists to recommend generic medicines. One hundred and fifty-three (99.4%) respondents would support the implementation of a future generic substitution right for pharmacists in Nigeria. CONCLUSION: The present study showed a high support for generic substitution and future generic substitution rights for pharmacists in Nigeria.

[Development of a questionnaire to identify patients' preference for a conventional or a direct oral anticoagulant]. / Entwicklung eines Fragebogens zur Identifikation der Präferenz von Patienten für ein konventionelles oder ein direktes orales Antikoagulanz.

BACKGROUND: Oral anticoagulant therapy is currently performed using vitamin K-dependent (VKA) or novel, non-vitamin-K-dependent (NOAC) anticoagulants. Patients can thus be involved into the decision process which type of anticoagulants to use. Preference of patients for a specific type of anticoagulants is included in several international guidelines for prophylaxis of embolic events in patients with atrial fibrillation. METHOD: Description of the development of a short questionnaire to identify this preference in patients treated with VKA. RESULTS: Using the questionnaires Freiburger personality inventory (FPI-R), health survey SF-12, State-Trait Anxiety Inventory (STAI) and a self-developed questionnaire on anticoagulant therapy, multiple regression analysis identified 7 items for the willingness of patients to change anticoagulation from VKA to NOAC with a probability of about 90%. CONCLUSION: Further investigations have to be performed to identify the preference of patients for anticoagulation with VKA using this short questionnaire.

The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects.

OBJECTIVE: Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. METHODS: Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting ß-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. RESULTS: The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). CONCLUSIONS: Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.

Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz.

Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects. The study aim was to assess the effect of switching zidovudine plus lamivudine twice-daily (Combivir, CBV) to once-daily tenofovir DF plus emtricitabine (Truvada, TVD), each plus efavirenz (EFZ), on adherence, beliefs about ART and quality of life (QoL). Subjects stable on CBV + EFV were randomised 1:1 to continue this regimen or switch to TVD + EFV. Adherence was measured using the Medication Adherence Self-Report Inventory at 4, 12, 24 and 48 weeks. Beliefs about ART (perceptions of necessity and concerns about adverse effects), treatment intrusiveness and QoL were measured by questionnaire at baseline 4, 12, 24 and 48 weeks. Viral load was assessed at each visit. Two hundred and thirty-four subjects initiated treatment. At week 48, the proportion of subjects reporting high adherence (≥95% taken as prescribed) was significantly greater in the TVD arm (p=0.049). Low adherence (reporting taking <95% as prescribed, discontinuing the study or having missing data) was associated with doubts about necessity (p=0.020), stronger concerns about adverse effects (p=0.010), greater treatment intrusiveness (p=0.010) and poorer mental health related QoL (p=0.008). At week 48, both concerns about ART (p=0.038) and treatment intrusiveness (p=0.004) were lower among those who switched to TVD. Furthermore, there was a decline in both concerns about ART (p=0.007) and treatment intrusiveness (p=0.057) over the 48 weeks among those who switched to TVD. There were no significant differences in necessity beliefs, QoL or viral load between randomised groups. Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.

Special challenges for drug adherence following generic substitution in Pakistani immigrants living in Norway.

PURPOSE: This study aims to explore how long-term drug users with a Pakistani background living in Oslo (Norway) perceive generic substitution and how generic substitution influences drug adherence in this population. METHODS: Personal interviews using a semi-structured questionnaire were carried out with 83 Pakistani immigrants (aged 40-80 years) who were using antihypertensives, antidiabetics, and/or cholesterol-lowering drugs. RESULTS: In all, 73% of the participants were using generic drugs at the time of the interview. Of these, 10% were erroneously using two equivalent generics at the same time. One quarter of the participants were of the opinion that cheaper generic drugs were counterfeit drugs. Two thirds had accepted generic substitution in the pharmacy whereas the remaining participants had either opposed or were unaware of the substitution. Of those who had accepted substitution, 27% claimed that the effect of the new drug was poorer and 20% reported more side-effects. Generic substitution had resulted in concerns about the therapy in 41% of the patients, and 26% thought it had become more demanding to keep track of their medication. Poor adherence tended to be most common among patients who were not fluent in Norwegian, patients who had concerns about medicine use, and patients who had accepted generic substitution in the pharmacy. CONCLUSION: This study shows that generic substitution may have a negative effect on drug adherence in Pakistani immigrants in Oslo (Norway) because of concerns and misconceptions, including confusion with regard to counterfeit drugs. Problems result primarily from inadequate information caused by language barriers but also from culturally conditioned views on encounters with the health care system.