Classification of ADRs: a proposal for harmonization and differentiation based on the experience of the Comprehensive Hospital Drug Monitoring Bern/St. Gallen, 1974-1993.

The present paper deals with the classification of adverse drug reactions (ADRs) according to today's largely accepted pathomechanisms. The classification system applied, relies primarily on the proposals of Rawlins and Thomson with type A ('augmented') and B ('bizarre') reactions. In the database of the Comprehensive Hospital Drug Monitoring (CHDM) Bern/St.

Incidence of lethal adverse drug reactions in the comprehensive hospital drug monitoring, a 20-year survey, 1974-1993, based on the data of Berne/St. Gallen.

Objectives: Realising the limitations of spontaneous drug monitoring systems concerning the epidemiological aspects, a comprehensive program was founded. It was based on previous publications from the US, Canada and Northern Ireland, mainly those of the BCDSP (Boston Collaborative Drug Surveillance Programme).

Methods: Drug monitoring was carried out by a group of physicians which included the medical head of each of the divisions of internal medicine, a statistician and an informatician.

[Parenteral iron therapy: problems and possible solutions].

To investigate whether there are differences in the frequency of ADRs (adverse drug reactions) to parenteral iron preparations, we compared the results of 4 different data collections which contain observations in particular on i.m. or i.

Comprehensive hospital drug monitoring (CHDM): adverse skin reactions, a 20-year survey.

Studies on the epidemiology of common adverse cutaneous drug reactions have rarely been reported, since they can only be successfully conducted in clinics of internal medicine employing consultant dermatologists and having a comprehensive or intensive system of monitoring. Between 1974 and 1993, the adverse skin reactions occurring in divisions of general internal medicine of three different hospitals were monitored by a computerized comprehensive system. The "drug-monitoring patient" was defined as the recipient of at least one drug during hospitalization.

Drug-induced attack of bronchial asthma in inpatients: a 20-year survey of the Comprehensive Hospital Drug Monitoring Programme on adverse drug reactions, Berne/St. Gallen.

Epidemiological aspects of attacks of bronchial asthma related to drugs are prospectively studied in inpatients of three teaching hospitals in the Comprehensive Hospital Drug Monitoring (CHDM)-programme. Results are based on 34,840 individual patients (among 48,005 consecutive admissions) in the years 1974-1993. Between 1974 and 1993, every patient admitted to any of the three medical clinics in the CHDM programme was monitored for any suspicion of an adverse drug reaction (ADR); every drug exposure period during hospital stay was registered.

[Heparin-induced thrombocytopenia. Results from the Comprehensive Hospital Drug Monitoring (CHDM) Bern/St. Gallen].

Of 23,520 consecutive hospitalizations from 1980-1988 (corresponding to 16,628 individual patients) in three departments of general internal medicine, 8261 were treated with heparin. All observations of patients displaying a probable, possible or questionable relationship of thrombocytopenia to heparin (administered i.v.

[Frequency of antibiotics-associated colitis in hospitalized patients in 1974-1991 in "Comprehensive Hospital Drug Monitoring", Bern/St. Gallen].

In 3 divisions of internal medicine of teaching hospitals of the Comprehensive Hospital Drug Monitoring (CHDM) Foundation Bern/St Gallen, 42,920 patients consecutively admitted between 1974-1991 were investigated for adverse drug reactions. Of these 16,150 patients (38%) had received at least one systemically administered antibacterial drug during the hospital stay. Antibiotic-associated colitis included the following diagnoses: pseudomembranous colitis, hemorrhagic colitis and milder forms of colitis.

Diuretic-related hypokalaemia: the role of diuretics, potassium supplements, glucocorticoids and beta 2-adrenoceptor agonists. Results from the comprehensive hospital drug monitoring programme, berne (CHDM).

All 5,047 consecutive inpatients admitted to the Internal Medicine Division of a teaching hospital (Zieglerspital, Berne) between 1982 and 1985 were registered in accordance with the CHDM (Comprehensive Hospital Drug Monitoring) questionnaire of adverse drug reactions (ADRs). Of them, 2,439 were treated with at least one potassium losing diuretic. The hospital records of the patients were reviewed with particular regard to serum potassium levels, and on the basis of this evaluation, the patients were assigned to four different diuretic treatment groups, and the incidence of hypokalaemia related to diuretic treatment was estimated.

[Incidence of drug side effects by symptoms and syndromes. From the experiences of the Comprehensive Hospital Drug Monitoring and the Swiss Drug Side Effect Center. As an example: allergic and pseudo-allergic reactions with mild analgesics and NSAID].

From 1974 to 1989, 37,392 patients were admitted to the divisions of general internal medicine of the CHDM hospitals. 19,082 of them were treated with a minor analgesic or an NSAID. In 95 of the exposed patients, an allergic or a pseudoallergic reaction to one or two of these drugs was observed.

[Palpable purpura].

Non-thrombocytopenic palpable purpura is a characteristic lesion of cutaneous leukocytoclastic vasculitis. In association with manifestations in the gastrointestinal tract, kidney and/or joints, it forms the clinical entity of Henoch-Schönlein purpura. Among 27,510 inpatients in the years 1974 to 1989 from the CHDM Berne/St.

Treatment of streptococcal endocarditis with a single daily dose of ceftriaxone sodium for 4 weeks. Efficacy and outpatient treatment feasibility.

Unlabelled: OBJECTIVE--To evaluate the efficacy and safety of ceftriaxone sodium in the treatment of streptococcal endocarditis. DESIGN--An open, multicenter, noncomparative study with a follow-up of patients for 4 months to 5 years. SETTING--Internal medicine wards and outpatient clinics of hospitals of various sizes in three European countries.

Risk factors for adverse drug reactions communication of the CHDM.

In the CHDM (Comprehensive Hospital Drug Monitoring for Adverse Drug Reactions, Bern/St. Gallen), the data of the 34,838 computer registered patient admissions 1974-1988 were available for evaluation. We summarize the results of three different studies: 1.

[Hyperkalemia with potassium-sparing and potassium-losing diuretics. Results from the Comprehensive Hospital Drug Monitoring Bern (CHDM)].

Of 5047 in-patients in the Division of Internal Medicine, Zieglerspital Bern (regional/teaching hospital), admitted from 1982 to 1985, 2412 were treated with at least one diuretic. The hospital records of these patients were reviewed with regard in particular to serum potassium and creatinine values as well as potassium supplementation. On the basis of this evaluation the patients were assigned to 6 different treatment groups and the relative occurrence rate of hyperkalemia probably related to drug treatment was determined.

[Acute severe dyspnea as a side effect of drugs. Report from the CHDM (Comprehensive Hospital Drug Monitoring)].

This "syndrome" has been observed in 4 of 23,935 in-patients registered in the years 1974-1987 in the Comprehensive Hospital Drug Monitoring (Bern/St. Gallen), with 6 reactions. Signs of an attack of bronchial asthma, laryngeal or pulmonary edema or a (heart-)circulatory event were not observed.

Risk of acute upper gastrointestinal bleeding in patients with ulcerative disease and treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Results from the Comprehensive Hospital Drug Monitoring Berne (CHDM).

The hospital prevalence rate for upper gastrointestinal ulcerative disease in 28,531 inpatients consecutively admitted in two teaching hospitals in the Comprehensive Hospital Drug Monitoring (CHDM) in Berne, from 1974 to 1985, was 2.2% (1.8% for gastric or duodenal ulcer, and 0.

Time pattern of allergic reactions to drugs.

Generalized, allergic reactions to drugs show time patterns different from those based on pharmacological concepts. We distinguish three types of reactions: acute reactions (reaction time (RT): 0-60 minutes), subacute reactions (RT: 1-24 hours) and reactions of the latent type (RT: 1 day to several weeks). In this study, allergic reactions in the strict sense are supplemented by reactions considered to be based on intolerance or idiosyncrasy to aspirin, pyrazolones, paracetamol, NSAIDs, quinidine, iodine-containing contrast media and some as yet not understood reactions to local anaesthetics.

Risk factors for adverse drug reactions--epidemiological approaches.

Age by itself is not an important risk factor for ADRs. Age-related changes are the consequence of a number of individual factors, for example morbidity associated with polypharmacy, decline in renal or liver function in the elderly, hypoalbuminaemia, reduced body weight, etc. The relationship between gastrointestinal bleeding and non-steroidal anti-inflammatory drugs can be assessed globally in large cohort studies with access to computerized data, but complete accuracy requires access to the original patient records.

[Side-effects of frequently administered hypnotics and sedatives as well as of anxiolytics. Results from a Comprehensive Hospital Drug Monitoring (CHDM) program].

The occurrence and age distribution of patients with adverse drug reactions (ADR) were studied on the basis of a total of 17,653 admissions to the medical divisions of the Zieglerspital Bern and the Anna-Seiler-Haus, Inselspital Bern, during the period 1976-1982. Among this population 12,424 patients (70.4%) happened to have been treated with hypnotics, sedatives or anxiolytics.