Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions.

The spontaneous reporting system (srs) is the most important early warning system of adverse drug reactions. As there is serious under-reporting we studied the respective knowledge and attitudes of two samples of physicians in Germany. Five hundred randomly sampled physicians and 815 physicians who had actually reported an ADR were included; the response rate to the mail questionnaire was 51.4 and 43.9%, respectively; 61.3% said to have reported at least one case in their life. As many as 75-85% of physicians said never to have sent an ADR report to the governmental or professional reporting systems. Reporting to pharmaceutical companies, on the other hand, has been substantially better. Sixty-eight and two-tenths percent indicated to have suspected an ADR without reporting it. Major reasons for not reporting were: ADR well known (75.6%), too trivial (71.1%), causality uncertain (66.3%). The ADR with the highest probability of being reported were serious unknown adverse reactions of a new drug (81.1%) or an established drug (72.9%) and serious known reactions to a new drug (65.2%). Almost 20% of the physicians admitted to not know the spontaneous reporting system and 30% to not know how to report; 54% would rather report an ADR if therapeutic advice was offered. The results indicate that the traditional ways of advertising the srs and communicating with physicians could be improved. Proactive services and professional marketing of srs are needed to reduce underreporting.

[Manifestation and prevention of adverse drug reactions (ADR) in the pharmacotherapy of cardiovascular diseases]. / Manifestation und Präventionsmöglichkeiten unerwünschter Arzneimittelwirkungen (UAW) in der Pharmakotherapie von Herz-Kreislauf-Erkrankungen.

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. ADR leading to hospital admission were registered and reported. Especially ADR caused by cardiovascular drugs and all factors, which could have been important for their occurrence were analyzed. RESULTS: 559 of 2270 (24.6%) registered ADR cases were related to cardiovascular drugs. The drugs most frequently related to ADR were angiotensin inhibitors (17.9%), digitalis (17.3%), calcium channel blockers (13.9%), beta blockers (12.8%), and diuretics (12.2%). The most often observed ADR were arrhythmias (27.1%), syncopes and blood pressure dysregulations (25.1%), gastrointestinal symptoms (12.4%), and metabolic disorders (10.2%). 72% of patients were older than 65 years. Older patients were on a significantly higher number of drugs (6.2 +/- 2.4 vs 5.5 +/- 3.2; p < 0.001) than the younger ones. Furthermore, they were hospitalized significantly longer (13.2 +/- 9.9 vs 15.3 +/- 9.3 days; p < 0.01). Eleven patients (2%) died because of ADR due to cardiovascular drugs. CONCLUSIONS: Cardiovascular drugs are frequently used. They are prescribed mainly to older patients. Often observed ADR can be prevented effectively by considering their indication, by a clear definition of the therapeutic target, by a dose adjustment to the individual clinical parameters of the patient and by regular control investigations. The large number of drug-induced rhythm disorders--in particular bradycardia--show that extraordinary attention should be paid to rhythm-affecting drugs. The detailed instruction of the patient about therapeutic aims, risks and a concrete guideline for the therapy/drug handling is generally necessary.

Adverse drug reaction monitoring--cost and benefit considerations. Part II: cost and preventability of adverse drug reactions leading to hospital admission.

Although adverse drug reactions (ADR) are common, there is little knowledge on their direct, indirect and intangible costs. Our study is focused on the direct costs caused by ADR leading to hospital admission. The objective is to quantify the achievable financial benefits if avoidable ADRs were actually prevented by appropriate measures. A literature search on two subjects was done, first on length of stay (LOS) of hospital admissions due to ADR as a proxy measure for direct costs and second on their preventability. Thirteen studies on the length of stay of hospital admissions due to ADR, published between 1975 and 1996, were identified. The median LOS is 8.7 days (lower quartile=8.0 days; upper quartile=12.3 days). Assuming 4.5 million admissions to departments of internal medicine in Germany with a cost of DM 465 per hospital day and a median proportion of 5.8% of medical hospital admission to be due to ADR this yields direct costs of 1050 million DM per year in Germany. A cost table for other regions is provided. Preventability of ADR was the subject of 14 publications that revealed about 30% of all ADRs to be preventable. With regard to Germany this means that 350 million DM per year could be saved by preventing adverse drug reactions. These conservative estimates-no indirect and intangible costs, no ADRs that occur during hospital stay, no ADRs in outpatient care are included-show a considerable economic burden of ADRs. As about 30% of these ADRs are considered avoidable policy-makers are asked to invest more into ADR monitoring and preventive measures. Their benefit would surmount costs and at the same time increase the quality of care.