[A new joint approach to drug management: clinical pharmacy services and risk management unit].

INTRODUCTION: According to the "To Err is Human" report, medication-related errors are common in medicine and may have several and different effects. Clinical Pharmacy is a leading worldwide established pharmacy service which has been improving the quality of care for the last 30 years. The accumulated experience shows improved quality of care, improved patient safety and economic benefit. These understandings led to the definition and expansion of the Clinical Pharmacist Intervention Program and a joint project with the Risk Management Unit was created. METHODS: A characterization process was conducted, parameters were defined for monitoring and surveillance and interventions were devised. The relevant data requiring pharmacist intervention was defined (e.g., dose adjustments, contraindications, side-effects); a report was devised, based on the patient's electronic medical record; daily follow-up included analysis, stratification, quantification and understanding of the different types of pharmacist interventions. The pharmacist interventions were summed up and assessed for performance and quality control. RESULTS: Between March 2013 and February 2014 the medical records of 14,499 patients were examined in our hospital Only in 16% of the records an active pharmacist intervention was performed, according to the parameters defined. Interventions for potentially high risk events such as therapeutic duplication, drug administration in spite of contraindication and in spite of documented allergy were very rare, less than 2% of all the pharmacist interventions. DISCUSSION AND CONCLUSIONS: This joint venture, which is based on an existing platform, reflects an up-to-date view of an important facet of the clinical work performed at the hospital, helps identify trends, potential failures and vulnerabilities with regard to medication treatment and allows the formulation of intervention programs to improve the quality and safety of drug therapy.

The advantage of specific intravenous immunoglobulin (sIVIG) on regular IVIG: experience of the last decade.

During the last decade it has been shown that some components of intravenous immunoglobulin (IVIG) are responsible for their broadly therapeutic application. Currently, such specific subfractions are defined as specific IVIG (sIVIG) and are affinity-purified from commercial IVIGs that target specific antigens/antibodies related to a specific autoimmune disease. A remarkable example of the therapeutic potential of sIVIG is the proven enhanced anti-inflammatory potency of sialylated and recombinant sialylated IVIG obtained from total IVIG. In other experimental models, it has also been demonstrated that sIVIG work in many other contrivances, such as revealing anti-idiotypic networks blocking pathogenic antibodies ameliorating disease activity. sIVIG has also been shown to exert its action by modulating specific receptors expressed on immune cells in both inflammatory and autoimmune diseases. Indeed, sIVIG has emerged as a novel approach to treat different immune-mediated conditions in a more accurate antigen-specific manner. Herein we review experimental evidence supporting sIVIG-efficacy in treating autoimmune diseases and inflammation.

Clinical application of static fluorescence-based cytometry, Cellscan, in cutaneous adverse drug reaction.

The aim of the present study was to evaluate the effectiveness of Cellscan in identifying culprit drugs causing cutaneous adverse drug reaction. It was a prospective study with 3 months follow up conducted at the Departments of Dermatology, Internal Medicine and Dermatology Outpatient Clinic, Chaim Sheba Medical Center, Tel Hashomer, Israel. The study included 36 patients with cutaneous reaction suspected to be secondary to drugs, treated with a total number of 148 drugs. All patients and drugs were classified to three probability groups according to accepted clinical criteria. The effectiveness of the Cellscan test in identifying the culprit drug was addressed according to the clinical probability for cutaneous drug reaction, the drug class and the type of rash. Data analysis according to the clinical probability for cutaneous drug reaction revealed that patients in the moderate and high probability groups had a high test sensitivity of 77.7% and 83.3% with specificity of 71% and 63%, respectively, in identifying the culprit drug. Classifying the data according to drug classes, revealed that for the antibiotic and cardiovascular drug classes the sensitivity of the test was 100% and 92% with specificity of 83.3% and 55.5%, respectively, in identifying the culprit drug. Finally, the classification of patients according to the type of rash revealed a high evaluating accuracy for culprit drugs in maculopapular rashes with sensitivity and specificity of 90% and 60.4%, respectively. The results of this study imply that the Cellscan test is it a good practical tool for identifying the culprit drug in cutaneous adverse drug reaction.

Autoimmunity to protective molecules: is it the perpetuum mobile (vicious cycle) of autoimmune rheumatic diseases?

Apoptotic defects and impaired clearance of cellular debris are considered key events in the development of autoimmunity, as they can contribute to autoantigen overload and might be involved in the initiation of an autoimmune response. The C1q protein and mannose-binding lectin are activators of the complement system. The pentraxins are a group of highly conserved proteins including the short pentraxins, C-reactive protein and serum amyloid P, and the long pentraxin family member, pentraxin 3, all of which are involved in innate immunity and in acute-phase responses. In addition to their role in innate immunity and inflammation, each of these proteins participates in the removal of damaged and apoptotic cells. In this article, we discuss the clinical significance of different levels of these proteins, their role in the induction of or protection against autoimmunity, and the presence of specific autoantibodies against them in various autoimmune diseases.

Thrombocytopenic conditions-autoimmunity and hypercoagulability: commonalities and differences in ITP, TTP, HIT, and APS.

Immune thrombocytopenia purpura (ITP), thrombotic thrombocytopenia purpura (TTP), heparin-induced thrombocytopenia (HIT), and antiphospholipid syndrome (APS) are clinical conditions associated with significant morbidity and mortality. These well-defined clinical syndromes have in common several properties: (1) their pathogenesis is immune mediated, specifically by autoantibodies; (2) thrombocytopenia is a hallmark in these four conditions; (3) except for the case of ITP, platelet and endothelial cell activation occurs in TTP, HIT, and APS, resulting in a prothrombotic state and an increased risk of thrombosis. Although these four immune-mediated syndromes are well-defined diseases, several case reports and studies have documented the association of two diseases in the same patient, illustrating the concept of the kaleidoscope of autoimmunity.

Protective molecules--C-reactive protein (CRP), serum amyloid P (SAP), pentraxin3 (PTX3), mannose-binding lectin (MBL), and apolipoprotein A1 (Apo A1), and their autoantibodies: prevalence and clinical significance in autoimmunity.

Apoptotic defects and impaired clearance of cellular debris are considered key events in the development of autoimmunity, as they can contribute to autoantigen overload, and may initiate an autoimmune response. The pentraxins are a group of highly conserved proteins including the short pentraxins, C-reactive protein (CRP) and serum amyloid-P (SAP), and the long pentraxin-3 (PTX3), which are all involved in innate immunity and in acute-phase responses. Mannan-binding lectin (MBL) is an activator of the complement system, and Apolipoprotein A-1 (Apo A-1) is pivotal in the cholesterol homeostasis and has anti-inflammatory properties. In addition to their role in innate immunity and inflammation, each of these five proteins participates in the removal of damaged and apoptotic cells. In this review, we discuss the clinical significance of different levels of these proteins, their role in the induction or protection from autoimmunity, and the presence of specific autoantibodies against them in the different autoimmune diseases.

A novel system to diagnose cutaneous adverse drug reactions employing the cellscan--comparison with histamine releasing test and Inf-gamma Releasing Test.

BACKGROUND: There are several mechanisms to describe allergic drug reactions yet the methods to diagnose them are limited. OBJECTIVE: To compare several conventional clinical and laboratory methods to diagnose skin reactions to drugs to a new method of diagnosing drug reactions by the CellScan system. METHODS: The study entailed 21 patients who were diagnosed as suffering from drug eruptions, and 105 healthy controls with no history of drug allergy. The drugs were classified into two groups according to suspicion of causing drug allergy: high and low. Most of the patients were on more than one drug, leading to 41 patient-drug interactions (assays). Histamine releasing test (HRT), interferon (INF)-gamma releasing test and CellScan examination were performed on lymphocytes of the patients and controls. RESULTS: The HRTwas interpreted as positive in 9 out of 18 (50%) patients and in 13 out of 35 (37%) assays. Based on the INF-gamma releasing test, positive results were observed in 16 out of 21 (76%) patients and in 24 out of 41 (59%) assays. In the CellScan test (CST), positive results were observed in 17 out of 21 (81%) patients and in 29 out of 41 (71%) assays. The rate of identifying the drug for eruption in the high suspicion level drugs was 9 out of 22 (41%) assays in the HRT, 20 out of 24 (83%) assays in the INF-gamma releasing test, and 21 out of 24 (87%) studies with the CellScan method. The rate of determining of the drug that caused the eruption in the low suspicion level drugs was 4 out of 13 (31 %) in the HRT, 4 out of 17 (24%) assays in the INF-gamma releasing test, and 8 out of 17 (47%) analyses in the CST. When examined in the CellScan, 99 out of 105 (94%) controls were interpreted as negative. CONCLUSION: This preliminary study indicates that the CellScan seems to be an easy and promising method for the detection of drugs responsible for adverse skin reactions. In contrast to the HRT and to the Interferon-gamma secretion test, the CellScan method is characterized by its ability to track and monitor the reaction of individual cells. By measuring the kinetic parameters of selected cells before and after adding the suspected drug, we were able to identify the culprit drug. The CellScan method had the highest sensitivity, and the interferon-gamma secretion test had the highest specificity for detection of the culprit drug. In contrast, the analysis of 105 normal control sera disclosed a high specificity of 94% for the CellScan method.