Pharmaceutical risk management in Turkey: the first national overview.

Risk management plans and actions aim to limit the known risks of drugs and provide valuable data to evaluate actual risks and pre-disposing factors for adverse drug reactions. In this study, it is aimed to evaluate and summarize the risk management actions in Turkey between 2005 and 2013 for the first time. The drugs monitored with a risk management plan and actions taken are evaluated by examining the records of the Turkish Pharmaceuticals and Medical Devices Agency retrospectively. Various risk management actions such as provision of information, summary of product characteristics and patient information leaflets, direct communication with healthcare professionals, patient and physician brochures, change of the legal status of the drug, education of doctors and pharmacists, control of number and validity of prescriptions, using informed consent forms, using "drug safety surveillance form" for the TNF blockers (firstly on the world), using web-based monitoring system, web-based prescription and web-based adverse reaction monitoring system were used for safe use of drugs during and after authorization in Turkey. Although, most of the actions are similar to those of international health authorities, the remaining are specific to the conditions of Turkey such as "drug safety surveillance form" for the TNF blockers.

Association between troponin T and ICU mortality, a changing trend.

BACKGROUND: Initially elevated levels of troponin predict adverse outcomes in patients admitted to the intensive care unit (ICU). No research team has investigated the changes in concentration of cardiac troponin T (cTnT) during ICU stay and their association with patient outcome. OBJECTIVE: We investigated whether the change in cTnT levels during ICU stay could predict outcomes (death or survival). METHODS: In this cohort study, all patients admitted to the medical ICU (10 beds) from January to July 2008 were enrolled. Troponin levels were evaluated within the first 24 hours of ICU admission and on the fourth, seventh and 10th days after admission. RESULTS: The study population (135 patients) had a mean age of 60.9 ± 21.5 years. The outcome was significantly different with regard to normal or elevated cTnT concentrations on the first and seventh days of follow up (p = 0.03 and 0.023, respectively). This difference was non-significant for cTnT levels on the fourth and 10th days after admission (p = 0.69 and 0.78, respectively). The change in cTnT levels was not significantly different between the deceased and discharged patients (p = 0.4). CONCLUSION: Changes in cTnT levels during ICU stay did not show a significant trend (power: 0.26). Patients whose cTnT levels were increased on the first and seventh days of ICU stay had a worse survival, which could be associated with cardiac events on admission or at specific times during the stay in ICU.

Isochromosome 7q: the primary cytogenetic abnormality in hepatosplenic gammadelta T cell lymphoma.

Malignant lymphomas often have complex, nonrandom chromosomal abnormalities. Hepatosplenic gammadelta T cell lymphoma (gammadelta TCL) is an unusual post-thymic T cell lymphoma that primarily involves liver and spleen, often in young adult males. Few cases have had cytogenetic analysis. We report a consistent isochromosome 7q [i(7q)] abnormality in three cases of hepatosplenic gammadelta TCL, one with i(7q) as the sole abnormality at presentation. Three patients, 15-, 37- and 65-year-old males, presented with hepatosplenomegaly and fevers. Histopathologic, immunophenotypic, and molecular genetic studies supported the diagnosis. Spleen, liver, and bone marrow contained sinusoidal infiltrates of atypical lymphoid cells of T cell immunophenotype. PCR performed on two cases demonstrated clonal T cell receptor gamma gene rearrangements. Cytogenetic analysis of bone marrow showed i(7q) as the sole abnormality at presentation in one case. The second case showed i(7q) in addition to two normal chromosomes 7, and other structural and numerical abnormalities. The third case showed i(7q) and a deletion in the long arm of chromosome 11. These findings support the proposal that i(7q) represents the primary nonrandom cytogenetic abnormality in hepatosplenic gammadelta TCL, and plays a role in its pathogenesis.

Synovial sarcoma of the heart. Correlation with cytogenetic findings.

A primary sarcoma of the heart was submitted to cytogenetic studies, which showed a translocation t(X;18)(p11;q11.2). The translocation between X and 18 is a characteristic one in synovial sarcoma of the lower extremities. As the histological appearance was not helpful for further classification of this primary sarcoma, karyotypic analysis proved useful in confirming diagnosis of synovial sarcoma, which, to our knowledge, is an uncommon neoplasm in the heart.

Translocation (1;17) in accelerating and blast phases of chronic myelogenous leukemia.

A translocation (1;17)(p11;q11) has been observed in two chronic myelogenous leukemia (CML) patients studied during the accelerated or acute stages of their diseases. In a review of the literature, four additional cases of t(1;17)(p11;q11) were identified, suggesting that this marker may be specific for the terminal phase of CML.

Increased numbers of marrow basophils may be associated with a t(6;9) in ANLL.

We have characterized another subset of acute nonlymphocytic leukemia (ANLL) based on the cytogenetic and morphologic findings in a group of nine patients. Five patients had chromosomal analyses performed at the University of Chicago, two patients were studied at the All-Union Cancer Research Center in Moscow, and one patient each was studied at the University of Maryland and at Fairfax Hospital in Fairfax, Virginia. All nine patients had a reciprocal translocation involving the short arm of chromosome 6 and the long arm of chromosome 9 [t(6;9)(p23;q34)]. The patients, four males and five females, ranged in age from 5 to 51 years; the median age of 38 years is lower than that typically seen in ANLL. Only two of eight treated patients entered a complete remission. Classification of bone marrow morphology according to FAB Cooperative Group criteria revealed AML-M1 in one patient, AML-M2 in four, and AMMoL-M4 in three. One patient had refractory anemia with excess blasts (RAEB) which evolved to AML-M2. All bone marrow specimens showed severe myelodysplasia, with Auer rods present in seven of the nine cases. Of note was the particular prominence of bone marrow basophils (greater than 1%) in eight of the nine (89%) patients. Among 160 evaluable patients with ANLL de novo seen at the University of Chicago whose cells lacked a t(6;9), only five (3%) had greater than 1% basophils in the marrow aspirates. It is of interest that the breakpoint in 9q involves the same chromosomal band as that in the t(9;22) observed in chronic myelogenous leukemia (CML), in which increased basophils are a prominent feature. Thus, the association of the t(6;9) with increased bone marrow basophils in ANLL may provide additional insight into the chromosomal location of genes regulating the production and/or maturation of basophils.

Translocation (6;9)(p23;q34) in acute nonlymphocytic leukemia.

A consistent chromosomal abnormality t(6;9)(p23;q34) was demonstrated in the bone marrow or unstimulated peripheral blood cultures of two patients with acute nonlymphocytic leukemia (ANLL). Only two additional cases with ANLL and a similar cytogenetic finding have been reported, indicating that this translocation may represent another chromosomal abnormality specifically associated with ANLL.