Assessment of the quality of sample labelling for clinical research
Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals we...
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| Format: | Article |
| Language: | English |
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Elsevier
2016-03-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/9753.pdf |
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| author | Pablo Pérez-Huertas María Tordera-Baviera Concepción Martínez-Nieto Natalia Benito-Zazo Ana García-Robles José Luis Poveda-Andrés |
| author_facet | Pablo Pérez-Huertas María Tordera-Baviera Concepción Martínez-Nieto Natalia Benito-Zazo Ana García-Robles José Luis Poveda-Andrés |
| author_sort | Pablo Pérez-Huertas |
| collection | DOAJ |
| description | Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors. |
| format | Article |
| id | doaj-art-5a6050cf643245b1b11071c73e41e1a5 |
| institution | Kabale University |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2016-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-5a6050cf643245b1b11071c73e41e1a52025-01-02T16:24:44ZengElsevierFarmacia Hospitalaria1130-63432171-86952016-03-01402788910.7399/fh.2016.40.2.9753Assessment of the quality of sample labelling for clinical researchPablo Pérez-Huertas0María Tordera-Baviera1Concepción Martínez-Nieto2Natalia Benito-Zazo3Ana García-Robles4José Luis Poveda-Andrés5Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.Pharmacy Service, Hospital Universitario de la Princesa, Madrid.Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.http://www.aulamedica.es/fh/pdf/9753.pdfDrug labelling; Clinical trialsMedical errors |
| spellingShingle | Pablo Pérez-Huertas María Tordera-Baviera Concepción Martínez-Nieto Natalia Benito-Zazo Ana García-Robles José Luis Poveda-Andrés Assessment of the quality of sample labelling for clinical research Farmacia Hospitalaria Drug labelling ; Clinical trials Medical errors |
| title | Assessment of the quality of sample labelling for clinical research |
| title_full | Assessment of the quality of sample labelling for clinical research |
| title_fullStr | Assessment of the quality of sample labelling for clinical research |
| title_full_unstemmed | Assessment of the quality of sample labelling for clinical research |
| title_short | Assessment of the quality of sample labelling for clinical research |
| title_sort | assessment of the quality of sample labelling for clinical research |
| topic | Drug labelling ; Clinical trials Medical errors |
| url | http://www.aulamedica.es/fh/pdf/9753.pdf |
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