A need to intensify drug surveillance in Germany

Kapp, Joachim Friedrich; Zentgraf, R.; Widmer, A.; Schöpf, Erwin

doi:10.1007/bf01744267

Cited by 3 publications

(2 citation statements)

References 14 publications

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“…For middle age patients, metabolichutritional events were the second most common reported complaints for France. (19)(20)(21)(22)(23)(24)(25)(26)(27). In addition, the level of socialized medicine practices in these countries may also have an impact on the frequency as well as the type of events reported (28).…”

Section: Resultsmentioning

confidence: 99%

Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting

Wu¹,

Fung

Hornbuckle

et al. 1999

Drug Information J

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A study was conducted to explore the potenticil diflerence in geographic' mid cross-culturul variution in safee udverse drug reuction reporting. Attempts n'ere made in the study design to minimize genetic dflerences, market representution. age. and gender CIS confounding fiictors in affecting the findings. Six thousand spontaneous reports from five countries ( Frunce, Germany, United Kingdom, United Stutes, and Canudu) were randomly generated from our spontaneous safety dutabase which covered u 15-year reporting period (March 1. I983 to December 31, 1997). The reports were then reviewed and compared ugainst each cvuntrv for severul factors of interest. Despite some limitations, there are interesting observations from the current study that are worth further review. For example, German reporis seem more likely to be serious. related to death und lifethreatenin.? events. and muy nrirrrmt more attention. The Cunudirm and American reports hod the highest numbers in the catego? of luck of drug eflect. When .further analyzed using continent ruther than coutitty u s a base. Europe was consistently higher in terms of number qf serious reports. deatidlife-threatening events. and cases qf overdose. The current study is limited to our experience and ,further research by other investigators to confirm these findings is wurranted.

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Section: Resultsmentioning

confidence: 99%

Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting

Wu¹,

Fung

Hornbuckle

et al. 1999

Drug Information J

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“…Another example of active surveillance comes in the form of monitoring patients during their stay in hospital. Hospital monitoring of adverse reactions in patients undergoing treatment were reported in Germany, Mexico and India (Kapp et al 1991, Juarez & Olguin 2007and Khairnar & Gade 2011. Hospital monitoring schemes involved; increasing awareness of both doctors and patients about Pharmacovigilance and potential adverse reactions, and improving methods for validation of adverse events (Kapp et al 1991), such as better expert review systems for reviewing adverse reaction reports.…”

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confidence: 99%

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

ltd¹

2015

EFSA Supporting Publications

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Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified (GM) food and feed legalised the requirement for a Post-Market Monitoring (PMM) plan if the outcome of the risk assessment identifies a need to do so. This report provided a systematic review of existing monitoring programmes for food, feed, human and animal health and an inventory of data collection sources that may be useful for PMM of GM food and feed. Under the legislative requirements PMM should confirm that specific recommendations of use are followed by the consumer/animal owner, qualify the predicted consumption of GM food and feed and further characterise any intended or unintended effects highlighted during the pre-market risk assessment. The largest barriers to conducting PMM of GM food and feed in the EU were found to be the 'unrecognisable' nature of GM traits further down the food and feed supply chain after processing, and the lack of appropriate consumption data at the branded/product level. EU legislation on traceability and labelling of GMOs requires products to carry a 'unique identifier', however, this information is lost once the product is further processed to become a product 'produced from a GMO'. Consumption data held at a product level by retailers or market research agencies was shown to be more useful for PMM of GM food or feed than that held at the national level by public bodies. The project concludes that several changes would be required in order to conduct comprehensive PMM of GM food and feed in the EU, namely; greater detail on traceability requirements of GMOs, a database of which food and feed products contain which GM traits at specific quantities, consumption data at the branded/product level and a system for reporting the relevance and intensity of effects and unintended effects.

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European postmarketing surveillance of ramipril in hypertension

Lawson¹,

Bridgman²,

Böck³

et al. 1995

Eur J Clin Pharmacol

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A prospective observational cohort study of the angiotensin inhibitor, ramipril, was undertaken in four countries within the European Community-Netherlands, United Kingdom, Germany and Belgium. A total of 10,377 consecutive patients with essential hypertension were recruited to the study with the aim of follow-up for one year. Overall 37% of doctors who agreed to participate in the study actually enrolled at least one patient. One third of the doctors who enrolled patients in the study entered two thirds of patients studied. Some 15% of participating males and 27% of females were aged over 70 years. Newly diagnosed hypertensives comprised 22% of the study cohort, the proportion being highest in UK and Netherlands, whereas 53% were established hypertensives of two or more years' duration, the proportion being highest in Germany and Belgium. There were substantial differences among the participating countries in the concurrent treatment these patients were receiving for hypertension, with two or more co-therapies being most frequent in Germany and Belgium. There were also substantial differences in co-therapies for concurrent diseases among the participating countries, reflecting both standard therapeutic practices in local areas and differences in marketing of drugs in the different countries. This report describes the initial findings of this multinational study and emphasises the need to consider several major potentially confounding variables in the analysis of the outcome events both in this study and in other collaborative observational international monitoring schemes for adverse drug reactions.

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A need to intensify drug surveillance in Germany

Cited by 3 publications

References 14 publications

Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting

Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

European postmarketing surveillance of ramipril in hypertension

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