Preventable ADRs leading to hospitalization - results of a long-term prospective safety study with 6,427 ADR cases focusing on elderly patients.

Background: Studies evaluating the impact of age and potentially inappropriate medication (PIM) on avoidable adverse drug reactions (ADRs) are scarce.

Methods: In this prospective, multi-center, long-term (8.5 years) observational study, we analysed ADRs leading to hospitalization in departments of internal medicine.

Self-medication with over-the-counter and prescribed drugs causing adverse-drug-reaction-related hospital admissions: results of a prospective, long-term multi-centre study.

Background: Self-medication, including both the use of over-the-counter (OTC) drugs and the use of formerly prescribed drugs taken without a current physician's recommendation, is a public health concern; however, little data exist regarding the actual risk.

Objective: We aimed to analyse self-medication-related adverse drug reactions (ADRs) leading to hospitalisation.

Methods: In a multi-centre, observational study covering a hospital catchment area of approximately 500,000 inhabitants, we analysed self-medication-related ADRs leading to hospital admissions in internal medicine departments.

Bleeding complications and liver injuries during phenprocoumon treatment: a multicentre prospective observational study in internal medicine departments.

Background: Even after the recent approval of newer oral anticoagulants for clinical use, the vitamin K antagonist phenprocoumon remains an important treatment option for many patients. In order to quantify the hitherto "accepted" risks of phenprocoumon treatment, we analyzed adverse drug reactions (ADRs) that led to hospitalization on the internal medicine wards of four German pharmacovigilance centers.

Methods: We prospectively analyzed ADRs leading to hospitalization on the internal medicine wards of the hospitals belonging to the German Network of Regional Pharmacovigilance Centers (Rostock, Greifswald, Jena, and the Sophien- und Hufeland-Klinikum in Weimar) in the years 2000 to 2008.

Magnetic Active Agent Release System (MAARS): evaluation of a new way for a reproducible, externally controlled drug release into the small intestine.

Human absorption studies are used to test new drug candidates for their bioavailability in different regions of the gastrointestinal tract. In order to replace invasive techniques (e.g.

Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations.

Purpose: German hospital reimbursement modalities changed as a result of the introduction of Diagnosis Related Groups (DRG) in 2004. Therefore, no data on the direct costs of adverse drug reactions (ADRs) resulting in admissions to departments of internal medicine are available. The objective was to quantify the ADR-related economic burden (direct costs) of hospitalizations in internal medicine wards in Germany.

[Adverse drug reactions and interactions - cause of admission to hospital and after discharge].

Adverse drug reactions (ADRs) and interactions not only cause hospitalisation but also occur during the hospital stay itself. There, they contribute significantly to patient morbidity and mortality and furthermore create considerable additional costs for the healthcare systems. The majority of ADRs are dose-dependent and commonly found also for long-established and well known drugs.

Excessive medical information increase in package inserts.

Objectives: Package inserts are the most frequent source of patient information about medicines aside from doctors and pharmacists.

Materials And Methods: A representative selection of 271 German package inserts available in 2005 was investigated, using 152 validated quality criteria and by measuring 242 further values.

Results: A significant increase in package insert texts over recent years was found; standing at an average of 2,005 words.

Phenotyping with sulfasalazine - time dependence and relation to NAT2 pharmacogenetics.

Objective: N-acetyltransferase 2 (NAT2) genotype-phenotype relation with sulfasalazine as probe drug by means of detailed genotype analysis and kinetic data evaluation.

Background: Though phenotype analysis of sulfasalazine metabolism has been described before, genotype investigations in this regard are scarce. The influence of different single point mutations on the metabolism of the sulfasalazine metabolite sulfapyridine (SP) should give more insight into the functionality of different alleles especially with those still under discussion.

[Analysis of hospital admissions associated with digitalis glycosides].

Background: Although the value of digitalis glycosides in the treatment of heart failure is limited, approximately 255 million DDDs of digitalis glycosides (DGs) were prescribed in Germany in 2004.

Method: The authors analyzed data from adverse drug reactions (ADRs) resulting in hospitalization in the four German Pharmacovigilance Centers (PVCs) associated with DGs between 2000 and 2004. All patients with an at least "probable" ADR were included.

Inappropriate dosage instructions in package inserts.

Objective: Regardless of all efforts by the supervisory authority and the manufacturers to ensure that package inserts are patient-oriented, they are still under discussion. The survey package insert test (PAINT) aimed to examine the availability and comprehensibility of the information contained on five package inserts and five model versions for the same drugs.

Methods: A questionnaire containing 15 questions referring to the package insert contents was developed for a written survey.

Pharmacokinetics of oxaliplatin and non-hematological toxicity in metastatic gastrointestinal cancer patients treated with chronomodulated oxaliplatin, 5-FU and sodium folinate in a pilot investigation.

Objective: To analyze in a pilot study the association between the pharmacokinetics of chronomodulated administered oxaliplatin and non-hematological toxicity in patients with metastatic gastrointestinal cancer.

Methods: 16 patients received a 4-day chemotherapeutic regimen consisting of a 12-h chronomodulated infusion of oxaliplatin (25 mg/m2) followed by a 12-h chronomodulated infusion of 5-fluorouracil (750 mg/m2) and sodium folinate (150 mg/m2) daily. Plasma pharmacokinetics of oxaliplatin, measured as ultrafiltrable platinum, were determined.

Chronomodulated chemotherapy with oxaliplatin, 5-FU and sodium folinate in metastatic gastrointestinal cancer patients: original analysis of non-hematological toxicity and patient characteristics in a pilot investigation.

Objective: Several clinical trials have demonstrated that oxaliplatin is a useful agent in combination with 5-fluorouracil (5-FU) and folinic acid (FA) for the treatment of patients with colorectal carcinoma. The aims of this pilot study were to evaluate non-hematological toxicity and patient characteristics in gastrointestinal cancer patients treated with chronomodulated chemotherapy consisting of oxaliplatin, 5-FU and sodium folinate.

Methods: Patients with metastatic gastrointestinal cancer received a chronomodulated regimen with oxaliplatin (25 mg/m2), 5-FU (750 mg/m2) and sodium folinate (150 mg/m2).

Analysis of German package inserts.

Objective: Package inserts have an important impact on patients compliance and thus on the effectiveness of drug use. Despite efforts of the European or national regulatory authorities and manufacturers to improve the readability and comprehensiveness of package inserts, they are still the subject of critical discussion.

Material And Methods: 68 German package inserts were chosen for a detailed analysis of their quality and suitability based on a set of 104 quality criteria developed prior to the survey.

Drug-induced gastrointestinal disorders in surgical patients admitted to the University Hospital, Jena, Germany.

The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs). Particularly important among these are serious ADRs that require hospital admission. Such cases often include patients with gastrointestinal ADRs and many reports have been published on drug-induced gastrointestinal bleeding and ulcers.

Adverse drug reaction monitoring in Jena. Relevance of polymorphic drug metabolizing enzymes for inducing adverse drug reactions.

Inter-subject variability in therapeutic drug response and drug toxicity is a major problem in clinical practice. In this field genetic polymorphisms of drug metabolizing enzymes play an important role. In a multicenter study supported by the German Federal Institute for Drugs and Medical Devices (BfArM, Z 12.

[Severe electrolyte imbalance and edema in therapy with rosiglitazone].

Case Report: A case of a 49-year-old male with preexisting liver damage is reported. The patient was admitted to hospital with severe electrolyte disorder and face edema after therapy first with 4 mg for 2 months and later for 5 months with 8 mg rosiglitazone. The initial electrolyte values were: sodium 110 mmol/l, potassium 3.

Assessment of ADRs associated with lipid-lowering agents recorded in the Department of Internal Medicine, University Hospital, Jena.

Drug-related illness is an important cause of admission to hospital. Little information is available regarding the frequency of ADRs caused by antilipidemic agents classified as HMG-CoA reductase inhibitors (statins). Treatment with statins has been associated with the occurrence of myopathy or liver toxicity in case reports.

Documentation and evaluation of adverse drug reactions (ADR)--contribution from a poison information center.

The Department of Clinical Pharmacology in Jena is a pharmacovigilance center in a study on intensified spontaneous adverse drug reaction reporting. Physicians specialized in clinical pharmacology screen admissions to the Department of Internal Medicine for possible adverse drug reactions. Because of the collaboration between the Pharmacology Department and the nearby Poison Information Center (PIC) in Erfurt the question occurred whether the latter might contribute to adverse drug reaction monitoring.

[Manifestation and prevention of adverse drug reactions (ADR) in the pharmacotherapy of cardiovascular diseases].

Objectives: Cardiovascular drugs are the most often prescribed drug class in Germany. The objective of this study is to analyze the adverse drug reaction (ADR) profiles of these drugs and to identify some targets for prevention of ADR.

Method: Since 1997 specially trained medical staff members of five Pharmacovigilance Centers in Germany prospectively screened all hospital admissions at the departments of internal medicine of five large teaching hospitals.

Adverse drug reaction monitoring--digitoxin overdosage in the elderly.

Drug-related illness is an everlasting universal problem and also an important cause of admissions to hospitals. Adverse reactions are still grossly underreported by medical professions. Little information is available regarding the frequency or type of ADRs managed in hospitals.

First results from an intensified monitoring system to estimate drug related hospital admissions.

Aims: An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications.

Methods: Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment.

[Rhabdomyolysis as a rare complication of theophylline poisoning].

Case Report: A case of a 73-year-old male with theophylline overdose complicated by rhabdomyolysis is reported. After uncontrolled self-medication with an unknown number of theophylline slow release 350 mg tablets and furosemide 40 mg tablets he was admitted with unspecific clinical signs like tachyarrhythmia, vomiting and restlessness. Maximum theophylline concentration was 66.

Can oral contraceptive steroids influence the elimination of nifedipine and its primary pryidine metabolite in humans?

Objective: To investigate the influence of oral contraceptives on cytochrome P450 3A4 (P450NF) activity.

Methods: In 23 healthy women, the pharmacokinetics of nifedipine and its main metabolite dehydronifedipine in plasma were assessed after a single oral dose, prior to and after intake of one of two oral contraceptive formulations, one containing 2 mg dienogest and 0.03 mg ethinylestradiol (group A) and the other containing 0.