Kasem Akhras

1993 Bibliography: A 32-Year Literature Review on the Value and Acceptance of Ambulatory Care Provided by Pharmacists

OBJECTIVE: To review the published literature on the value and acceptance of pharmaceutical services provided by pharmacists in ambulatory care settings. DATA SOURCES AND METHODS: Articles published between 1960 and 1992. A MEDLINE search of the English-language literature was conducted using the terms pharmacists, services, and ambulatory settings. Studies were selected for inclusion if they addressed services provided by pharmacists in ambulatory settings and dealt with the cost of patient care, quality of care, or attitudinal surveys. Original research reports were summarized according to objectives, sample size, duration of study, methods, and findings. Summaries were categorized according to reported positive impact, negative impact, or investigational reports with no outcome. RESULTS: One hundred seventy articles were identified; 104 of them reported research data and were summarized. The 1970s was the most prolific decade for publication of articles reporting positive, negative, or no impact, which numbered 47, 20, and 37, respectively. Positive correlation was found among studies conducted according to predetermined protocol and reporting positive impact. Moreover, academic interest in pharmacy varied for the different decades. CONCLUSIONS: Collectively, this article provides references of the published reports on pharmacy professional services in ambulatory care settings, and a summary of the articles reporting research data. Additional and more focused research on pharmaceutical services in the community is needed. Emphasis is required on practicing pharmacists attitudes toward nondispensing, patient-oriented pharmaceutical services; the impact of educational changes on the practice of pharmacy and consumers attitudes and willingness to pay for services; and the link between patient outcome and pharmaceutical services.

Severity assessment of skin and soft tissue infections: cohort study of management and outcomes for hospitalized patients

BACKGROUNDnSkin and soft tissue infections (SSTIs) are caused by bacterial invasion of the skin and underlying soft tissues and can present with a wide spectrum of signs, symptoms and illness severity. They are a common indication for antimicrobial therapy. However, there are few data on treatment outcomes or the validity of clinical severity scores.nnnMETHODSnTwo hundred and five adult patients admitted to Ninewells Hospital, Scotland in 2005, and treated with antibiotics for SSTI, were identified. They were stratified into four classes of severity (class IV = most severe) based on sepsis, co-morbidity and their standardized early warning score (SEWS). Empirical antimicrobial therapy by severity class was compared with the recommendations of a UK guideline.nnnRESULTSnThirty-five different empirical antimicrobial regimens were prescribed. Overall, 43% of patients were over-treated, this being particularly common in the lowest severity class I (65% patients). Thirty-day mortality was 9% (18/205) and 17 patients (8%) died during their index admission. Mortality (30 day) and inadequate therapy increased with severity class: I, no sepsis or co-morbidity (45% patients, 1% mortality, 14% therapy inadequate); II, significant co-morbidity but no sepsis (32% patients, 11% mortality, 39% therapy inadequate); III, sepsis but SEWS <4 (17% of patients, 17% mortality, 39% therapy inadequate); and IV, sepsis plus SEWS ≥ 4 (6% of patients, 33% mortality, 92% therapy inadequate).nnnCONCLUSIONSnSSTI in hospital is associated with significant mortality. Choice of empirical therapy is not evidence based, with significant under-treatment of severely ill patients.

Clinical and resource-use outcomes of risperidone long-acting injection in recent and long-term diagnosed schizophrenia patients: results from a multinational electronic registry

ABSTRACT Background: Non-adherence to pharmacological treatment leading to frequent relapses and rehospitalizations is a major issue of concern among schizophrenia patients, especially those who are recently diagnosed. Risperidone long-acting injection (RLAI) has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy. Objective: To determine clinical outcomes and hospitalizations before and after the initiation of RLAI among schizophrenia patients with recent (≤2 years) diagnosis relative to those who had long-term (> 2 years) diagnosis. Research design and methods: The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is an observational study of patients with schizophrenia who start treatment with RLAI. Data were recorded at baseline, retrospectively for the 12 months prior to baseline, and prospectively every 3 months for 24 months. Data on patients with a defined length of diagnosis were pooled from eight countries. Main outcome measures: Clinical Global Impression of Illness Severity (CGI-S), Global Assessment of Functioning (GAF) scores, and hospitalization data were key outcomes. Results: The magnitude of improvement in CGI-S scores was greater in the recent versus long-term diagnosis group [Δ −1.48 vs. Δ −0.95 (12 months); Δ −1.6 vs. Δ −1.09 (24 months)]. There were parallel improvements in GAF scores [Δ 19.4 vs. Δ 13.7 (12 months); Δ 22.3 vs. Δ 16.8 (24 months)]. The decline in the proportion of patients hospitalized from the retrospective to the prospective period was greater in the recent versus long-term diagnosis group (Δ −36.0 vs. Δ −19%, respectively) at 12 months. This was also true for the number of hospital stays (Δ −0.6 vs. Δ −0.3, respectively) and length of stay (days) (Δ −20.9 vs. Δ −6.9, respectively) at 12 months. Common adverse events in both groups included psychiatric, gastrointestinal, musculoskeletal and reproductive system and breast disorders. Conclusions: Treatment with RLAI is associated with improved outcomes in recently diagnosed and chronic patients. However, the magnitude of improvement was higher in recently diagnosed patients.

Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries

Abstract Objective: To assess treatment retention on risperidone long-acting injection (RLAI) and outcomes in schizophrenia patients for whom 24 months of follow-up data in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) were available. Research design and methods: e-STAR is an ongoing, international, multicenter, prospective, observational registry assessing use of antipsychotics in patients with schizophrenia or schizoaffective disorder in a normal clinical practice setting. Parameters were assessed prior to and post-initiation of RLAI. Data presented are from six European countries that enrolled patients in e-STAR after they initiated treatment with RLAI. Main outcome measures: Clinical and demographic information were collected at baseline and treatment-related data, including RLAI discontinuation, psychiatric hospitalization and medication utilization, were collected prospectively every 3 months. Data collection continued for 24 months, even for patients who discontinued RLAI therapy. Hospitalization and medication utilization were also collected retrospectively by chart review for the 12-month period prior to RLAI initiation. Results: A total of 1659 patients (mean age, 39.2; 18.3% inpatients) completed the study. Twenty-four months after initiating therapy (initial RLAI doseu2009=u200933.6u2009mg) 85% of patients (nu2009=u20091410) remained on RLAI (completers) while 15% discontinued therapy. The main reasons for discontinuation were insufficient response (28.5%), patient/family choice (26.1%), adverse events (9.6%) and unacceptable tolerability (6.0%). At baseline, compared to completers, discontinuers were younger (37.4 vs. 39.6 years, pu2009=u20090.01), had schizophrenia for a shorter time (10.2 vs. 11.9 years, pu2009=u20090.02), had lower Global Assessment of Functioning (GAF) scores (43.5 vs. 48.0, pu2009=u20090.0001), higher utilization of benzodiazepines (56.5 vs. 43.3%) and more initiated therapy as inpatients (30 vs. 16%). With RLAI therapy GAF scores improved significantly (pu2009<u20090.001) for both groups but the 24-month value for discontinuers was lower than that of completers (55.4 vs. 67.2). Compared to the pre-RLAI initiation period, at 12 months post-initiation completers had greater reductions than discontinuers in the percent of patients hospitalized (66.2% reduction vs. 29.2%) and in the length (68% reduction vs. 0%) and number (80.0 vs. 14.3%) of hospital stays, differences that remained at 24 months. The most common adverse events while patients were taking RLAI were nervous system disorders (6.8%), psychiatric disorders (5.6%), weight increase (3.2%), reproductive system and breast disorders (2.5%) and gastrointestinal disorders (2.1%). Conclusions: These observational data confirm that RLAI is an effective treatment in schizophrenia and high levels of adherence to therapy offers an opportunity for effective long-term disease management and significant sustained decreases in hospitalization.

Burden of schizophrenia in recently diagnosed patients: healthcare utilisation and cost perspective

Abstract Background: Inpatient care to manage relapse of patients with schizophrenia contributes greatly to the overall financial burden of treatment. The present study explores to what extent this is influenced by duration of illness. Methods: Medical and pharmaceutical claims data for patients diagnosed with schizophrenia (ICD-9 295.xx) were obtained from the PharMetrics Integrated Database, a large, regionally representative US insurance claims database, for the period 1998–2007. Recently diagnosed (nu2009=u2009970) and chronic patients (nu2009=u20092996) were distinguished based on ICD-9 295.xx classification, age and claims history relative to the first year (recently diagnosed) and the third year onwards (chronic) after the first index schizophrenia event. Results: The medical resource use and costs during the year following the index schizophrenia event differed significantly between cohorts. A higher proportion of recently diagnosed patients were hospitalised compared with chronic patients (22.3% vs 12.4%; pu2009<u20090.0001), spending a greater mean number of days in hospital (5.1 days vs 3.0 days; pu2009=u20090.0065) as well as making more frequent use of emergency room (ER) resources during this time. The mean annual healthcare costs of recently diagnosed patients were also greater (

Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium

20,654 vs

The attributable clinical and economic burden of skin and skin structure infections in hospitalized patients: a matched cohort study

15,489; pu2009<u20090.0001) with inpatient costs making up a higher proportion of total costs (62.9%) compared with chronic patients (38.5%). Conclusions: There is a considerably higher overall economic burden in the year following their first schizophrenia event in the treatment of recently diagnosed schizophrenia patients compared with chronic patients. Since hospitalisations and ER visits are the most significant components contributing to this finding, efforts that focus on measures to reduce the risk of relapse, particularly amongst recently diagnosed patients, such as improved adherence programs, may lead to better clinical and economic outcomes in the management of schizophrenia. Limitations: Only commercially insured patients and direct medical costs were included, therefore, results may underestimate the economic burden of schizophrenia.

Comparisons of Hypertension-Related Costs from Multinational Clinical Studies

BackgroundBecause wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries.MethodsThis was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods.ResultsThe initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P < 0.001 at all post-baseline visits). The mean improvement was approximately 1 point on the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, respectively, had ≥1 post-baseline visit and were included in the analysis of psychiatric hospitalization rates. Hospitalization rates decreased significantly in all countries regardless of hospitalization status at RLAT initiation (P < 0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the analysis was limited to outpatients only.ConclusionsRLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.

Outcomes and management costs in patients hospitalized for skin and skin-structure infections

We estimated the incremental clinical and economic burden of skin and skin structure infections (SSSI) in hospitalized patients using a matched cohort study design. Cases with SSSI as secondary diagnosis were matched with up to 4 randomly selected non-SSSI controls by age, gender, admission date, and ICD-9 code of principal diagnosis. Among the 1 472 965 hospitalizations episodes, 23 026 had SSSI as their secondary diagnosis. Matching was successful in 22 551 (98%) cases. Compared with controls (n = 87 811), the cases had an average mean unadjusted length of hospital stay (LOS) of 5 days longer and excess hospital charges over

Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia

21 000 and higher mortality rate (5.4% versus 3.5%). Adjusted estimates from regression models revealed that SSSI incurred on average 3.81 additional days and