Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA.

Objectives: US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed independently by the Advisory Committee of Drug Registration (ACDR).

Increasing adverse drug reaction reporting-How can we do better?

Adverse drug reactions (ADRs) are associated with morbidity and mortality worldwide. Although national systems for reporting ADRs exist there is a low reporting rate. The aim of the current study was to evaluate an intervention plan for improving ADRs reporting among medical professionals (physicians and nurses).

The effect of an intervention program on the knowledge and attitudes among medical staff regarding adverse drug reaction reporting.

Purpose: Adverse drug reactions (ADRs) are a growing important public health problem; however, underreporting of ADRs is very common. The aim of the current study was to explore the effect of an intervention program on the knowledge and attitudes among physicians and nurses regarding ADRs reporting.

Methods: A multicentre study consisted of three phases: filling out a questionnaire; an intervention program; filling out the same questionnaire again.

Medications and glucose-6-phosphate dehydrogenase deficiency: an evidence-based review.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common human enzyme defect and one of the most common genetic disorders worldwide, with an estimated 400 million people worldwide carrying a mutation in the G6PD gene that causes deficiency of the enzyme. Although drug-induced haemolysis is considered the most common adverse clinical consequence of G6PD deficiency, significant confusion exists regarding which drugs can cause haemolytic anaemia in patients with G6PD deficiency. In the absence of consensus among physicians, patients are subject to conflicting advice, causing uncertainty and distress.

Appropriate antibiotic prescribing pattern in hospitalized children.

This study analyzes prospectively the antibiotic prescription habits in terms of appropriateness of use and cost pattern effects in the paediatric wards of two different university hospital patient set-ups. Data on demographics, discharge diagnosis, antibiotic utilization and costs were collected prospectively from the children's individual electronic charts at Rambam Health Care Campus (R) and Kaplan Medical Centre (K) in Israel. A total of 505 and 497 children from R and K units, respectively, were screened.

Cigarette smoking and infection.

Background: Infectious diseases may rival cancer, heart disease, and chronic lung disease as sources of morbidity and mortality from smoking. We reviewed mechanisms by which smoking increases the risk of infection and the epidemiology of smoking-related infection, and delineated implications of this increased risk of infection among cigarette smokers.

Methods: The MEDLINE database was searched for articles on the mechanisms and epidemiology of smoking-related infectious diseases.

High fasting glucose levels as a predictor of worse clinical outcome in patients with coronary artery disease: results from the Bezafibrate Infarction Prevention (BIP) study.

Background: A high fasting glucose level may be a marker not only for microvascular complications, but also for macrovascular complications. We evaluated the clinical significance of a high fasting glucose level (> or =110 mg/dL), detected either at baseline or during follow-up, in the Bezafibrate Infarction Prevention (BIP) study.

Methods: The BIP study was a secondary prevention prospective double-blind study comparing bezafibrate to placebo.

[Drug related taste disturbances: emphasis on the elderly].

Background: Taste disturbances are common among the elderly due to physiologic changes, diseases, and medications. As many as 11% of elderly persons using multiple drugs report taste aberrations. The main danger of taste decline and disturbance in the old is food-anhedonia, causing loss of body weight via decreased calorie and nutrient intake.