[Unlicensed use of drugs: measures to minimize risks]. / Nicht-zugelassene Arzneimittel: Massnahmen zur Minimierung der Risiken.

INTRODUCTION: The use of unlicensed drugs is an unsettling issue in medical circles. "Dear Doctor Letters", batch recalls and important notifications about them are not provided systematically. Unlicensed use is, however, sometimes the only promising option for further medical treatment. Approaches to improve vigilance of pharmaceutical agents are available in many countries. An outline of legislation on and experiences with unlicensed use in selected industrial countries is reviewed in this article. Research data, documentation and assessment of the legal status of unlicensed drugs in selected industrial countries were obtained and compared to the situation in Germany. Expert interviews with specifically recruited representative samples from academic centers as well as regulatory and industrial sources, health technology assessments and health insurance data were analysed (N = 44, t = 20-120 min, transcribed verbatim). Approaches and limitations of licensing in different countries compared: Granting of a license has been an obligatory condition and there has been a duty of disclosure (sometimes with the right of prohibition) as well as reservations on the granting of permission. Central administration of data has made it possible to quantify and identify required drugs and ensure surveillance of their use. High administrative costs involved in giving notice of approval has caused delays in patient care. Procedures by which a medical doctor has to obtain permission affect physicians' freedom of action. Unlicensed and off-label use is variably regulated across the analysed settings. Legislation and regulation continue to be highly heterogeneous. Most promising approaches include the duty of disclosure, which allows quantification of use and surveillance of safety, including the right of recall while ensuring doctors' freedom to treat with medicinal products.

[Publication languages of Impact Factor journals and of medical bibliographic databanks (reprint)]. / Publikationssprachen der Impact Faktor-Zeitschriften und medizinischer Literaturdatenbanken (Nachdruck).

BACKGROUND AND OBJECTIVE: A preference for English-language sources during determination of Journal Impact Factors (IF) was discussed, IF being published in the annual Journal Citation Reports (JCR). The JCR are derived from data in Science Citation Index (SCI). The aim of this study was, therefore, (i) to review publication countries and languages in JCR, (ii) publication languages in SCI in comparison to further recognised medical bibliographic databanks. METHODS: Searching (i) countries and languages in JCR Science-Editions 1997 and 1998, (ii) language distributions in publication years 1995 - 2000 in bibliographic databanks SCI, MEDLINE (ME) and EMBASE (EM). RESULTS: (i) Almost 70 % journals in JCR 1997 and 1998 were published in USA, United Kingdom, or The Netherlands. Of two language options present, a number of English-classified journals contained > 90 % articles in other languages, whereas > 90 % publications in English could occur in Multi-Language (ML) journals, thereby complicating statistical comparisons. 83,9 % JCR-periodicals in 1997 and 85,6 % in 1998 were classified English. English/ML ratios increased exponentially with increasing IF. (ii) 95,5 % of the articles documented 1995 - 2000 in whole SCI and in our constructed SCI segment "Medicine and related areas" were written in English, compared to 88,5 % in ME and 89,8 % in EM. The SCI Medicine segment was 15 % more comprehensive than either MEDLINE or EMBASE. Highly significant differences of language distributions in SCI vs. MEDLINE and especially SCI vs. EMBASE were observed. Retrieval rates in SCI of German-, French-, Japanese- and Chinese-language medical papers published in 2000 were impressively augmented by EMBASE and MEDLINE. CONCLUSIONS: (i) Anglo-American publishers" countries and English-language journals prevail in JCR with respect to numbers and IF levels. Publication language English favours citation frequency. (ii) Of databanks studied, SCI shows a maximum preference for English-language sources, thereby causing an English Language Bias during IF derivation.

[Citation rates of medical German-language journals in English-language papers--do they correlate with the impact factor, and who cites? (reprint)]. / Wie häufig werden deutschsprachige Medizinzeitschriften in der englischsprachigen Literatur zitiert? (Nachdruck) - Korreliert diese Rate mit dem Impact-Faktor, und wer zitiert? -

BACKGROUND AND OBJECTIVE: Several publications are warning that the German language is no longer needed for transmission of scientific data. One of the causes may be the Impact Factor (IF), which appears to be derived predominantly from Anglo-American journals. The aim of this study was to check actual international attention paid to German-language journals, i. e. their citation frequencies in English-language papers. Are these citing rates in English-language articles correlated to the IF, and from where do citing articles originate? METHODS: Of 25 arbitrarily selected > 85 % German-language medical journals, IF as well as language distributions of citing articles were determined by searching publication years 1995 - 2000 in Science Citation Index (SCI). MEDLINE and EMBASE were used as supplementary retrieval systems. RESULTS: (i) The sample journals displayed an average IF = 0.357. A 99 % correlation (Pearson factor r = 0.987; n = 25) was observed between our "constructed" IF 2000 and IF published in Journal Citation Report 2000. This proves Stegmann's IF determination method to be valid. On the average, 53 % German-language and 45 % English-language articles between 1995 - 2000 cited the 1995 - 1999' contributions of the studied journals. No correlation was observed between IF vs. rates of citing articles in English (r < 0.1). 64 % of citing English-language articles showed corporate sources in Germany/Austria/Switzerland, and 13.5 % authors' institutions in USA. CONCLUSIONS: (i) An IF >/= 1 is, obviously, very hard to attain by German-language journals. ISI's differentiation between Citing vs. Cited-only Journals (the latter often serving as MEDLINE/EMBASE sources) during derivation of IF appears unjustified. (ii) English now serves as the predominant communication language in sciences in German-speaking countries, but has not supplanted the German language. Our study reveals remarkable international attention rates remaining.

[Publication languages of Impact Factor journals and of medical bibliographic databanks]. / Publikationssprachen der Impact Faktor-Zeitschriften und medizinischer Literaturdatenbanken.

BACKGROUND AND OBJECTIVE: A preference for English-language sources during determination of Journal Impact Factors (IF) was discussed, IF being published in the annual Journal Citation Reports (JCR). The JCR are derived from data in Science Citation Index (SCI). The aim of this study was, therefore, (i) to review publication countries and languages in JCR, (ii) publication languages in SCI in comparison to further recognised medical bibliographic databanks. METHODS: Searching (i) countries and languages in JCR Science-Editions 1997 and 1998, (ii) language distributions in publication years 1995 - 2000 in bibliographic databanks SCI, MEDLINE (ME) and EMBASE (EM). RESULTS: (i) Almost 70 % journals in JCR 1997 and 1998 were published in USA, United Kingdom, or The Netherlands. Of two language options present, a number of English-classified journals contained >90 % articles in other languages, whereas >90 % publications in English could occur in Multi-Language (ML) journals, thereby complicating statistical comparisons. 83,9 % JCR-periodicals in 1997 and 85,6 % in 1998 were classified English. English/ML ratios increased exponentially with increasing IF. (ii) 95,5 % of the articles documented 1995 - 2000 in whole SCI and in our constructed SCI segment >>Medicine and related areas<< were written in English, compared to 88,5 % in ME and 89,8 % in EM. The SCI Medicine segment was 15 % more comprehensive than either MEDLINE or EMBASE. Highly significant differences of language distributions in SCI vs. MEDLINE and especially SCI vs. EMBASE were observed. Retrieval rates in SCI of German-, French-, Japanese- and Chinese-language medical papers published in 2000 were impressively augmented by EMBASE and MEDLINE. CONCLUSIONS: (i) Anglo-American publishers' countries and English-language journals prevail in JCR with respect to numbers and IF levels. Publication language English favours citation frequency. (ii) Of databanks studied, SCI shows a maximum preference for English-language sources, thereby causing an English Language Bias during IF derivation.

[Citation rates of medical German-language journals in English-language papers - do they correlate with the Impact Factor, and who cites?]. / Wie häufig werden deutschsprachige Medizinzeitschriften in der englischsprachigen Literatur zitiert? - Korreliert diese Rate mit dem Impact-Faktor, und wer zitiert? -

BACKGROUND AND OBJECTIVE: Several publications are warning that the German language is no longer needed for transmission of scientific data. One of the causes may be the Impact Factor (IF), which appears to be derived predominantly from Anglo-American journals. The aim of this study was to check actual international attention paid to German-language journals, i. e. their citation frequencies in English-language papers. Are these citing rates in English-language articles correlated to the IF, and from where do citing articles originate? METHODS: Of 25 arbitrarily selected >85 % German-language medical journals, IF as well as language distributions of citing articles were determined by searching publication years 1995 - 2000 in Science Citation Index (SCI). MEDLINE and EMBASE were used as supplementary retrieval systems. RESULTS: (i) The sample journals displayed an average IF = 0.357. A 99 % correlation (Pearson factor r = 0.987; n = 25) was observed between our >> constructed<< IF 2000 and IF published in Journal Citation Report 2000. This proves Stegmann's IF determination method to be valid. On the average, 53 % German-language and 45 % English-language articles between 1995 - 2000 cited the 1995 - 1999' contributions of the studied journals. No correlation was observed between IF vs. rates of citing articles in English (r <0.1). 64 % of citing English-language articles showed corporate sources in Germany/ Austria/ Switzerland, and 13.5 % authors' institutions in USA. CONCLUSIONS: (i) An IF >/=1 is, obviously, very hard to attain by German-language journals. ISI's differentiation between Citing vs. Cited-only Journals (the latter often serving as MEDLINE/ EMBASE sources) during derivation of IF appears unjustified. (ii) English now serves as the predominant communication language in sciences in German-speaking countries, but has not supplanted the German language. Our study reveals remarkable international attention rates remaining.

[Not Available]. / Die deutsche Agentur für Health Technology Assessment (HTA) beim DIMDI (DAHTA@DIMDI).

With the Health Reform Act 2000 the assessment of medical procedures (Health Technology Assessment, HTA) was first applied to quality assurance in German public health. Since taking this step Germany belongs to the group of countries (Great Britain, Sweden, Australia, etc.) that employ HTA as an objective instrument to determine scientific grounds for political health decisions, for instance for decisions concerning absorption of costs or the development of a benefit catalogue. The German Agency for Health Technology Assessment was founded in September 2000 at the German Institute for Medical Documentation and Information (DAHTA@DIMDI) to fulfil the legal requirements. DAHTA set up and operates a databank-supported information system to supply HTA- relevant information. Additionally research assignments are commissioned for this area and quality standards determined. The goal is to create an up to date and objective information base for health politics and also for medical qualified personnel and consumers that considers the social, ethical, economical and legal results besides the efficacy and effectiveness of medical procedures.

[Medical-bioscientific databanks and the Impact Factor]. / Medizinisch-biowissenschaftliche Datenbanken und der Impact-Faktor.

BACKGROUND: Citation frequencies of medical journals are measured by the Journal Impact Factors (IF) published annually in the Journal Citation Report (JCR). Conclusions drawn from IF concerning the distribution of single journal articles are used worldwide for academic evaluation purposes. Because of this importance, IF are widely and controversially discussed, also regarding their derivation from a limited pool of databases (Science Citation Index, SCI). OBJECTIVE: To determine the comprehensiveness of IF's data basis by testing (i) SCI's sources, (ii) SCI's output. Are the IF sufficient for an objective evaluation of medical journals? METHODS: Comparative searches in 38 databases and their combinations (SCI; MEDLINE [ME]; EMBASE [EM]; BIOSIS Previews [BA] and other relevant systems). RESULTS: (i) Journals with higher IF (> or = 1) are almost completely retrievable in SCI (98%), but only approx. 60% in ME, EM, BA. (ii) Reverse: three samples of mainly German-language journals frequently indexed in SCI were represented in JCR by 90%; but only 23.5-57% of sample periodicals had an IF when indexed in ME, EM and BA, but not in SCI. (iii) Compiled average search results in the most productive databases in 18 biomedical queries, when titles were searched: SCI = 34%, ME = 27%, EM = 33%, BA = 25%; and, when combined: SCI + ME = 44%, SCI + ME + EM = 55%, SCI + ME + EM + BA = 65%, compared to the results in a 38-databases cluster. Costs increase in the order ME < EM < SCI < BA < Derwent, CAS. CONCLUSIONS: (i) The citation analyses presented in JCRs appear limited especially regarding German-language biomedical journals. Evaluation of publications based on IF therefore should be complemented by corrective measures. (ii) Single-database searches, including SCI, at best render orientating results; database combinations are recommended when higher completeness is required.

[Quality assurance of scientific information and databanks]. / Qualitätssicherung wissenschaftlicher Informationen in Datenbanken.

The situation in cases of fraud and scientific misconduct--either true or false--is reviewed and its reflection in databases illustrated by examples. Exemplary quality guidelines for these cases have been published by the US National Library of Medicine, one of the major medical database producers. However, no timely and consequent application was found in some cases studied. On the whole, results in the major worldwide medical/life sciences databases are still dissatifactory. The implicite meaning of database quality (as illustrated by cases of fraud) for the decision making process, and its results for patients too--is broached and has to be discussed in the future. Some proposals for quality improvement are submitted.

[The reaction of imidates with isocyanates]. / Zur Reaktion von Imidaten mit Isocyanaten.

Derivatives of isocyanates were prepared by reaction with imidates. Fragmentation reactions and behaviour in a simple biological test were examined.