Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk.

Objective: To evaluate the accuracy of disease codes and free text in identifying upper gastrointestinal bleeding (UGIB) from electronic health-care records (EHRs).

Study Design And Setting: We conducted a validation study in four European electronic health-care record (EHR) databases such as Integrated Primary Care Information (IPCI), Health Search/CSD Patient Database (HSD), ARS, and Aarhus, in which we identified UGIB cases using free text or disease codes: (1) International Classification of Disease (ICD)-9 (HSD, ARS); (2) ICD-10 (Aarhus); and (3) International Classification of Primary Care (ICPC) (IPCI). From each database, we randomly selected and manually reviewed 200 cases to calculate positive predictive values (PPVs).

Parkinsonism and severe hypothyroidism in an elderly patient: a case of lithium toxicity due to pharmacological interactions.

What Is Known And Objective: Hypothyroidism is a common clinical side effect of lithium treatment, whereas parkinsonism is a very rare adverse event. A number of case series of clinical signs of reversible and permanent parkinsonism due to lithium toxicity have been previously published, but never in association with hypothyroidism. We describe a rare clinical case of concurrent reversible parkinsonism and severe hypothyroidism due to lithium toxicity.

New therapeutic strategies under development to halt the progression of renal failure.

Introduction: Chronic kidney disease (CKD) is a pathological condition associated with high morbidity and mortality. Accordingly, prevention of CKD onset and progression is mandatory. As pharmacological agents already used in clinical practice are not yet able to halt the progression of renal damage, new therapeutic strategies are being explored.

Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The exposure-adjusted self-controlled case series.

Most approaches used in postmarketing drug safety monitoring, including spontaneous reporting and statistical risk identification using electronic health care records, are primarily suited to pick up only acute adverse drug effects. With the availability of increasingly larger electronic health record and administrative claims databases comes the opportunity to monitor for potential adverse effects that occur only after prolonged exposure to a drug, but analysis methods are lacking. We propose an adaptation of the self-controlled case series design that uses the notion of accumulated exposure to capture long-term effects of drugs and evaluate extensions to correct for age and recurrent events.

Pulmonary sequestration: a (131)I whole body scintigraphy false-positive result.

A 35-year-old woman affected by a well-differentiated papillary thyroid carcinoma was referred to our hospital to perform a (131)Iodine ((131)I) whole body scintigraphy for restaging purpose. The patient had been previously treated with total thyroidectomy and three subsequent doses of (131)I for the ablation of a remnant jugular tissue and a suspected metastatic focus at the superior left hemi-thorax. In spite of the previous treatments with (131)I, planar and tomographic images showed the persistence of an area of increased uptake at the superior left hemi-thorax.

Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

A growing number of international initiatives (e.g. EU-ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety.

Restaging clear cell renal carcinoma with 18F-FDG PET/CT.

Aim: The aim of our retrospective study was to assess the usefulness of F-FDG PET/CT in the restaging of clear cell renal cell carcinoma (RCC) patients.

Patients And Methods: Sixty-nine patients (median age = 62 years; range = 36-86 years) affected by clear cell RCC (TNM at staging: T1, 42 patients; T2, 13 patients; T3, 11 patients; T4, 3 patients; Fuhrman grade: G2, 47 patients; G3, 20 patients; G4, 2 patients) underwent whole-body F-FDG PET/CT to restage the disease after nephrectomy for clinical or radiological suspicion of metastases. Areas of abnormal uptake at PET/CT were classified, taking the liver uptake as reference, as follows: 1 = faint uptake, lower than liver; 2 = moderate uptake, equal to liver; and 3 = high uptake, higher than liver.

The burden of nephrotoxic drug prescriptions in patients with chronic kidney disease: a retrospective population-based study in Southern Italy.

Background: The use of nephrotoxic drugs can further worsening renal function in chronic kidney disease (CKD) patients. It is therefore imperative to explore prescribing practices that can negatively affect CKD patients.

Aim: To analyze the use of nephrotoxic drugs in CKD patients in a general population of Southern Italy during the years 2006-2011.

Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network.

Background: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children.

Objectives: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) in children and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations.

Methods: We identified potential cases of ALI during exposure to any prescribed/dispensed drug for individuals <18 years old from the EU-ADR network, which includes seven databases from three countries, covering the years 1996-2010.

Changes in the prescribing pattern of antidepressant drugs in elderly patients: an Italian, nationwide, population-based study.

Background: Despite the high use of antidepressants (ADs) among the elderly, there is limited information about the prescribing pattern of these drugs in the Italian elderly population. The aim of this study was to analyze the trend in the use of ADs in the Italian elderly patients in the years 2003-2009, and specifically, to evaluate rates and predictors of AD treatment discontinuation in depressed older patients.

Methods: The nationwide general practice Health Search Database (HSD) was used to identify AD users aged 65 years old and over from 2003 to 2009.

Clinical and economic burden of adverse drug reactions.

Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs.

Lymphoscintigraphy in clinical routine practice: reproducibility and accuracy in melanoma patients with a long-term follow-up.

Introduction: The sentinel node status is the most important single factor determining overall survival for patients with localized melanoma. Preoperative lymphoscintigraphy (LS) is essential in locating the correct sentinel lymph node (SN) and the reproducibility of the method determines the accuracy of the sentinel node biopsy (SNB). This study aims at determining the reproducibility and accuracy of LS in routine clinical practice after long-term follow-up.

Effects of L'Aquila earthquake on the prescribing pattern of antidepressant and antipsychotic drugs.

Background: Natural disasters provoke an increase in mental and medical disorders in survivors. Monitoring drug prescription changes after natural disasters can provide an indirect evaluation of trauma impact in the population. Moreover, it could be useful to both identify risk categories that require special assistance and assess possible drug abuse or misuse.

Drug-induced acute myocardial infarction: identifying 'prime suspects' from electronic healthcare records-based surveillance system.

Background: Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in 'real-world' settings.

Objective: To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network.

Additional risk minimisation measures in the EU - are they eligible for assessment?

Purpose: "Additional" risk minimisation measures (aRMMs) can be necessary to optimise the benefit-risk balance of a drug. Evaluation of effectiveness of these measures has become mandatory with the new European Union (EU) pharmacovigilance legislation in force since July 2012. The aim of this study was to classify the aRMMs in the EU with a special emphasis on the possibilities to analyse the effectiveness of these aRMMs in existing electronic healthcare databases (EHDs).

High prevalence of poor quality drug prescribing in older individuals: a nationwide report from the Italian Medicines Agency (AIFA).

Background: Poor quality of drug prescribing in older persons is often associated with increased drug-related adverse events, hospitalization, and mortality. The present study describes a set of prescribing quality indicators developed by the Geriatrics Working Group of the Italian Medicines Agency (AIFA) and estimates their prevalence in the entire elderly (≥ 65 years) population in Italy.

Methods: We performed a cross-sectional study using 2011 data from the OsMed (Osservatorio dei Medicinali) database, which comprises all prescribed drugs that are reimbursed by the Italian National Healthcare System.

Growth hormone therapy and respiratory disorders: long-term follow-up in PWS children.

Context: Adenotonsillar tissue hypertrophy and obstructive sleep apnea have been reported during short-term GH treatment in children with Prader-Willi syndrome (PWS).

Objective: We conducted an observational study to evaluate the effects of long-term GH therapy on sleep-disordered breathing and adenotonsillar hypertrophy in children with PWS.

Design: This was a longitudinal observational study.

Identification of acute myocardial infarction from electronic healthcare records using different disease coding systems: a validation study in three European countries.

Objective: To evaluate positive predictive value (PPV) of different disease codes and free text in identifying acute myocardial infarction (AMI) from electronic healthcare records (EHRs).

Design: Validation study of cases of AMI identified from general practitioner records and hospital discharge diagnoses using free text and codes from the International Classification of Primary Care (ICPC), International Classification of Diseases 9th revision-clinical modification (ICD9-CM) and ICD-10th revision (ICD-10).

Setting: Population-based databases comprising routinely collected data from primary care in Italy and the Netherlands and from secondary care in Denmark from 1996 to 2009.

Evolving role of SPECT/CT in neuroendocrine tumors management: staging, treatment response, and follow-up.

The combined use of SPECT and CT strongly supports the molecular imaging of neuroendocrine tumors (NETs) with somatostatin receptor radiopharmaceuticals or with meta-iodobenzylguanidine. SPECT/CT fusion images provide potential attenuation correction, higher specificity, and accurate localization for the staging, evaluation of treatment response, and follow-up of NETs.

Cyclo-oxygenase-2 inhibitors or nonselective NSAIDs plus gastroprotective agents: what to prescribe in daily clinical practice?

Background: Two strategies for prevention of upper gastrointestinal (UGI) events for nonselective nonsteroidal anti-inflammatory drug (nsNSAID) users are replacement of the nsNSAID by a cyclo-oxygenase-2-selective inhibitor (coxib) or co-prescription of a gastroprotective agent (GPA).

Aim: To identify whether and in whom either of these strategies should be preferred in daily practice.

Methods: A nested case-control study was conducted using three European primary care databases.

Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries.

Background: Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and adolescents.

Objectives: (i) To assess the incidence of idiopathic acute liver injury (ALI) and its clinical features in children and adolescent outpatients; and (ii) to investigate the role of the drug as a potential cause of ALI which is considered idiopathic.

¹⁸F-FDG-PET/CT in malignant mesothelioma.

It is well known the useful role of ¹⁸F-FDG-PET/CT for differential diagnosis between benign and malignant disease, for staging, for monitoring response and for prognosis regarding mesothelioma. Recently, literature was enriched with new interesting studies regarding the potential applications of ¹⁸F-FDG-PET/CT in this field. The purpose of this review is to evaluate articles published on line (PubMed) from January 2011 until October 2012 in order to obtain an overview of recent progress of molecular imaging in malignant mesothelioma.