Treatment Patterns Of Antiepileptic Drugs In Patients With Potential Refractory Epilepsy In The Texas Medicaid Program

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Objectives: To identify predictors of sleep disturbance in persons with cancer, and compare with predictors of hypnotic use in the same population.  Methods: Data were originally collected in a study of cancer symptoms and practice patterns. Subjects were 3,106 adults (aged ≥ 18 years) receiving treatment for solid tumors (breast, colorectal, lung, or prostate), and their treating clinicians. Baseline demographic, clinical, and treatment data were collected, along with severity ratings (evaluated by both patients and clinicians) for a broad range of cancer symptoms. Clinicians and patients reevaluated symptoms approximately four weeks later. Scores for sleep disturbance severity (from 0= ’not present’ to 10= ’as bad as you can imagine’) were only available for 2,379 subjects. Linear regression determined predictors for sleep disturbance severity, while logistic regression determined predictors for hypnotic use (‘yes/no’; benzodiazepines [BZDs] or BZD receptor agonists [BzRAs]).  Results: Among 2,379 subjects, 62.8% reported some degree of disturbed sleep, and 23.54% reported hypnotic use (Χ 2[10]= 581.49, p< 0001). Significant predictors of sleep disturbance were: age (p< 0.001), recent employment change (p< 0.001), history of depression (p< 0.001), cancer type (p= 0.002), functional status (p< 0.001), psychological distress (p< 0.001), prior number of treatment regimens (p< 0.004), and type of pain treatment (p< 0.001). Significant predictors of hypnotic use were: race (p< 0.001), recent employment change (p< 0.001), history of depression (p< 0.001), clinical stage of cancer (p< 0.001), type of pain treatment (p< 0.006), and sleep disturbance severity (p< 0.001). Notably, odds of hypnotic use were not higher among patients for whom clinicians determined disturbed sleep to be a priority concern (by impact on quality of life).  Conclusions: Predictors and prevalence of hypnotic use are not entirely consistent with predictors and prevalence of sleep disturbance in persons with cancer, suggesting a need to investigate further the determinants of shared decision-making in this context, including possible racial disparities and the influence of prescribers’ attitudes regarding hypnotic use. PND69 Treatment Patterns Of Antiepileptic Drugs In Patients With Potential Refractory Epilepsy In The Texas Medicaid Program Gupte-Singh K, Wilson JP, Barner JC, Hovinga CA, Rascati KL, Richards KM The University of Texas at Austin, College of Pharmacy, Austin, TX, USA

Objectives: Antiepileptic drug (AED) monotherapy is usually effective in half of the patients with epilepsy, while one-third of patients are refractory. This study compared medication treatment patterns (adherence, persistence, addition, switching) associated with refractory and non-refractory epilepsy.  Methods: Texas Medicaid prescription and medical claims from 09/01/07-12/31/13 were analyzed over a 30-month study period. Patients eligible for the study: 1) were 18-62 years of age at index, 2) had an AED claim during the identification period (03/01/08-12/31/11) with no 6-month baseline AED use, and 3) had evidence of epilepsy diagnosis during the study period. Based on AED use in the identification period, patients were categorized as “refractory” (≥ 3AEDs) and “non-refractory” (< 3AEDs). The index date was the date of the first AED claim. Patients in both cohorts were matched 1:1 using propensity scoring and compared for adherence (proportion of days covered≥ 80%) and persistence, and a subgroup of the matched cohorts on ≥ 2 AEDs were compared for addition (Yes/No) and switching (Yes/No) using multivariate conditional regression models.  Results: Of the 10,599 eligible patients, 2,798(26.4%) refractory patients were matched to non-refractory patients. The matched cohorts (n= 5,596) had a mean adherence and persistence of 82.8%(±23.4%) and 311.5(±102.5) days, respectively. Among those patients on ≥ 2 AEDs (n= 5,414), 90.1% added, while 19.6% switched an AED. Compared to patients with non-refractory epilepsy, refractory patients were 3.6 times more likely to adhere to AEDs (OR= 3.553;95% CI= 3.060-4.125;p< 0.0001) and had a 34.7% lower hazard rate of AED discontinuation (HR= 0.653;95% CI= 0.608-0.702;p< 0.0001). Also, refractory patients were 3.7 times more likely to add (OR= 3.723;95% CI= 2.902-4.776;p< 0.0001) and 3.6 times more likely to switch an AED (OR= 3.591;95% CI= 3.010-4.284;p< 0.0001).  Conclusions: More than 25% of Texas Medicaid epileptic patients in the study were refractory. These patients were more likely to be AED adherent than their non-refractory counterparts, although they were also more likely to add and switch AEDs.

RESEARCH POSTER PRESENTATIONS – SESSION II

RESEARCH ON METHODS STUDIES RESEARCH ON METHODS – Clinical Outcomes Methods PRM1 Incidence of Prescribing Errors in Hospitalized Patients in Saudi Arabia Mahmoud MA1, Aljadhey H2, Hassali MA1 Sains Malaysia, Penang, Malaysia, 2King Saud University, Riyadh, Saudi Arabia

1Universiti

Objectives: The aim of this study was to determine the incidence of prescribing errors using a validated definition and assess their severity and identify contributing factors.  Methods: This was a 4 month retrospective chart review study. Patients admitted to medical, surgical and intensive care units (ICU) and aged 12 years or older were included in the study. The main study outcomes were the percentage of medication orders and hospital admissions with prescribing errors; and the types of prescribing errors. The secondary study outcomes were the severity of prescribing errors determined by two independent reviewers using the National Coordination Council for Medication Errors Reporting and Prevention (NCC MERP) index and patient’s related factors associated with prescribing errors.  Results: A total of 691 prescribing errors were identified in 2,033 patients’ files. The incidence of prescribing errors was 3.6 (95% CI, 3.3 - 3.9) per 100 prescriptions, 33.9 (95% CI, 31.5 - 36.6) per 100 admissions and 76.5 (95% CI, 70.9 - 82.3) per 1000 patients days. The most commonly identified prescribing errors type was dosing errors (127; 18.4%) with 74 overdoses and 53 under doses. Antibiotic (230; 33.3%) was the most common drug class involved with prescribing errors. Out of the identified prescribing errors

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20 (2.9%) were judged to be actual, 330(47.8%) potential and 341(49.3%) prescribing errors with no harm. Prescribing errors were significantly most common in surgical unit compared to the other study units (P< 0.001) with small effect size (Eta =  0.089) and (Carmer’s v =  0.089). There was a significant differences in the mean length of hospital stay between those who had prescribing errors 5.42 (±6.26) days and those who didn’t 4.04 (±4.01) days (p< 0.001).  Conclusions: The study has identified important prescribing errors and their associated factors and based on these findings strategies to prevent future errors should be developed. PRM2 Cross-Cultural Validation of Four Commonly used Symptoms Based Questionnaires to Assess Neuropathic Pain in Patients with Chronic Pain Gudala K1, Bansal D2, Ghai B3 1National Institute of Pharmaceutical Education and Research, Mohali, India, 2National Institute of Pharmaceuitical Education and Research, Mohali, India, 3Postgraduate Institute of Medical Education and Research, Chandigarh, India

Objectives: There is a lack of reliable method of diagnosis of neuropathic pain (NP) in clinical practice. However symptoms based questionnaires including the self-reported version of Douleur Neuropathique 4 (S-DN4), ID Pain, Short form of Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) and PainDETECT questionnaire (PDQ) were showed promising in many countries. However there is no Hindi version of these scales to use in Indian patient. So this study aims to translate or/and cross-culturally validate above said four commonly used questionnaires to assess NP in patients with chronic pain.  Methods: The present study is performed in two phases; (a) translation of three questionnaires (S-DN4 was already translated in to Hindi by MAPI) (b) cross-cultural validation of the translated questionnaires. Process of translation was undertaken using the methodology recommended by the ISPOR for the translation and validation of PROMs. Reliability, validity and testretest reliability of translated questionnaires was assessed in patients with chronic pain.  Results: Three scales were successfully translated in to Hindi language. Cross-cultural validation was done in 155 patients with chronic pain, of which 55% (85) patients found to have NP component. Hindi version of all four questionnaires had good reliability (Cronbach’s alpha >  0.6). Sensitivity and specificity values of the Hindi versions of all questionnaires were acceptable (> 80%). Area under the curve of all questionnaires studied was significantly high (> 0.9).  Conclusions: The Hindi version of four commonly used symptoms based questionnaire was successfully translated in to Hindi language and validated in patients with chronic pain to assess NP for use in Indian patients. PRM3 Do Accepted Techniques for Indirect Comparative Effectiveness Reflect the need for Individualized Patient Care in Heterogeneous Populations? The Case of Brivaracetam Versus Adjunctive Antiepileptic Medications for the Treatment of Adult Patients with Focal Seizures Borghs S1, Harvey RC2, Srivastava K3, Townsend R4, Charokopou M4 Pharma, Slough, UK, 2BresMed Health Solutions LTD, Sheffield, UK, 3BresMed Health Solutions, Panjim, India, 4UCB Pharma, Brussels, Belgium

1UCB

Objectives: Despite the number of available antiepileptic treatments, 30% of patients remain uncontrolled, with clinical practice and guidelines suggesting an individualized treatment choice algorithm. Published indirect comparisons have failed to show differences between the available treatments, possibly due to reliance on registration studies conducted over several decades and the heterogeneity of the epilepsy trial population. In this analysis, we have applied generally accepted comparative effectiveness techniques to a new market entrant, brivaracetam, thereby addressing healthcare decision-makers’ needs.  Methods: A systematic review collated data from all published randomized controlled trials comparing antiepileptic regimens (AEDs). After study selection and bias assessment, a Bayesian network meta-analysis (NMA) was performed. Outcomes considered were those favored by regulators and payers: seizure freedom, ≥ 50% seizure frequency reduction, rates of discontinuation and serious adverse events.  Results: Out of the 275 publication records identified, 65 were eligible for inclusion in the NMA analyzing 5 interventions. Given the overlap in 95% credible intervals (CI) between treatments, this analysis shows that no treatment is consistently better than another. Scenario analyses considering different doses and treatment periods provided consistent results. Odds ratios (ORs) of brivaracetam versus placebo for seizure freedom and 50% seizure frequency reduction were estimated at 8.7 (95%CI: 1.35; 36.51) and 2.24 (95%CI: 1.60; 3.07), respectively. Brivaracetam had the lowest risk of discontinuation [OR:2.33; (95%CI: 0.74; 5,72)]) and serious adverse events [(OR:0.78; 95%CI: 0.25; 1.91)].  Conclusions: Results revealed relative equivalence of brivaracetam to the studied interventions; an expected observation in line with previously conducted research for AEDs applying similar techniques. Evidence based on generally accepted comparative effectiveness methods is widely used by decision-makers; however, these methods do not adequately address unobserved confounding factors (which cannot be controlled for by the standard NMA methods), and do not currently address the disparity between efficacy and effectiveness, or recognize the need for individualized treatment. PRM4 Assesment of the Medical and Social Benefits of Incretin-Based Therapy Petrova G, Zaharieva S, Carukciev D Medical University - Sofia, Sofia, Bulgaria

Objectives: To evaluate the medical and social benefits of newly introduced incretins.  Methods: The diabetes registry was reviewed for one-year period about the changes in the HbA1c, BMI, body weight, and systolic blood pressure for 300 patients on incretin based therapy. Patients treated with GLP agonists are divided on two subgroups – with primary HbA1C level above 6.5%, and below 6.5%. Patients on