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Consuelo Pedrós

Publications and source records attributed to Consuelo Pedrós.

9 recordsLinked to original sources
PubMed2003

Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads.

BACKGROUND: The effectiveness of voluntary reporting systems in pharmacovigilance highly depends on the number of assembled reports. AIM: The aim of this study was to measure the effect of the periodical distribution of a bulletin on drug safety issues and of including yellow cards in prescription pads on the rate of adverse drug reaction (ADR) reporting. STUDY DESIGN AND METHODS: The Catalan Centre of Pharmacovigilance began its activities at the end of 1982. Since 1985, an ADR bulletin (ADRB) has been mailed approximately quarterly to all physicians in its catchment area, with one yellow card enclosed. Additionally, from 1991-1994, a yellow card was included in the prescription pads of the Catalan Health Service. Time series methodology, with adjustment of the monthly number of reports to an Auto-Regressive Integrated Moving Average (ARIMA) model, was used to evaluate the effect of these two measures. RESULTS: From January 1983-October 1995, 6240 spontaneous ADR reports were received, and 41 issues of the ADRB were sent out. Initially, the mean monthly spontaneous ADR reporting rate was 34.4 (SD = 14.1; n = 106 months). After the inclusion of yellow cards in prescription pads, the mean monthly spontaneous ADR reporting rate increased to 53.9 (SD = 14.4; n = 48 months). According to an ARIMA model, when a bulletin was send out (MONTH1), a mean increase of 9.4 reports was produced in that month, plus 12.3 additional reports in the following month (MONTH2), and 6.3 in the second month after sending the ADRB (MONTH3). A yellow card in the prescription pads elicits a monthly mean increase of 19.8 in the number of reports. CONCLUSIONS: The present study suggests that ADRBs elicit a temporal increase of the ADR reporting rate. Including a yellow card in prescription pads was followed by an even greater increase in the reporting rate, possibly because it guarantees that yellow cards are available at the workplace.

Adverse Drug Reaction Reporting Systems↗
PubMed2002

[First spontaneous reports of adverse reactions to the new selective COX-2 non-steroidal anti-inflammatory drugs].

BACKGROUND: [corrected] The new selective cyclooxygenase 2 non-steroidal anti-inflammatory drugs (NSAIDs) have been associated with a lower incidence of adverse gastrointestinal effects. MATERIAL AND METHOD: The first Yellow Cards received at the Catalan Centre of Pharmacovigilance reporting adverse effects of rofecoxib and celecoxib were reviewed and compared to those attributed to non-selective NSAIDs. RESULTS: Most frequent adverse effects of rofecoxib were gastrointestinal and cardiovascular; those of celecoxib were mostly cutaneous and gastrointestinal; and those of non-selective NSAIDs were gastrointestinal and neuropsychiatric. CONCLUSIONS: Rofecoxib and celecoxib are not devoid of gastrointestinal toxicity; they may also induce cardiovascular adverse effects.

Adult↗
PubMed2002

Case-population studies in pharmacoepidemiology.

The case-population approach aims at providing a risk estimate by comparing the incidence of the disease of interest among those exposed to the drug under study with the incidence among the non-exposed. For that purpose, the cases with the disease of interest have to be ascertained independently of the exposure status. Their rate and pattern of exposure have to be ascertained by interview with a structured questionnaire. Information on the patterns and the prevalence of drug consumption is needed in order to estimate the rate of exposure, and drug consumption statistics can be used to this end. In this paper, we review the main characteristics of studies using this approach or a similar one, and studies where series of cases exposed to the drug of interest were compared with drug consumption statistics. We looked at selected basic methodological requirements. Most of the studies reviewed suffer from incomplete case ascertainment, inaccurate definition of the disease of interest, incomplete information on exposures and other risk factors, and/or limited control of potential confounding, among other limitations. All the reviewed studies had several limitations regarding the estimation of the population at risk. The methods used in case-population studies should be clearly described, particularly with respect to the identification of the cases (numerator) and the estimation of the consumption prevalence (denominator). Case-population studies can give approximate risk estimates, but the method should be validated by comparing its results with those of case-control studies.

Case-Control Studies↗
PubMed2002

Therapeutic ineffectiveness: heads or tails?

Reporting of therapeutic ineffectiveness through adverse drug reaction spontaneous reporting systems has been proposed by some authors. In the WHO Adverse Reactions Terminology (WHO-ART) and Medical Dictionary for Regulatory Activities (MedDRA) terminology, the term therapeutic ineffectiveness includes drug interactions, resistance, tolerance and tachyphylaxis, as well as pharmaceutical defects such as substandard, adulterated, and counterfeit drugs. Under certain circumstances, reporting therapeutic ineffectiveness may contribute to identifying pharmaceutical defects. However, the best approach to avoid their occurrence would be implementing good manufacturing practices and strengthening quality control activities. This would prevent the misuse of spontaneous reporting of adverse drug reactions (e.g. when reporting of therapeutic ineffectiveness is 'suggested' by interested parties, especially when a generic product has been substituted for a branded original product).

Adverse Drug Reaction Reporting Systems↗