Last updated on: 08/11/2019
1. Contact details
Name of data sourcePharmacovigilance Program from Laboratory Signals at La Paz University Hospital
Name under which the data source should be displayed in the inventory (e.g short name if one exists)PPLS-LPUH
Name of organisation
1) Department/research groupClinical Pharmacology Department
2) Organisation/affiliationHospital La Paz, School of Medicine, UAM
Administrative Contact
Title Dr
Last name Ramirez
First name Elena
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario la Paz
Address line 3Paseo de la Castellana, 261
CityMADRID
Postcode28046
CountrySpain
Scientific Contact
Title Dr
Last name Ramirez
First name Elena
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario la Paz
Address line 3Paseo de la Castellana 261
CityMADRID
Postcode28046
CountrySpain
Alternative Contact
Title Professor
Last name Frias
First name Jesus
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario la Paz
Address line 3Paseo de la Castellana 261
CityMADRID
Postcode28046
CountrySpain
2. Description/category
Prospective studies database
3.1 Coverage of licensed medicinal products
Licensed Medicinal Product
Comments
Hospital data
3.2 ATC code (5th level)
Yes
3.3 Other product dictionaries
No
3.4 Recording of indication for use
Yes
Is a coding dictionary being used? International Classification of Diseases, Ninth Revision, Clinical Modification codes
4. Coverage of events
Event
Dictionary
Dictionary details
Adverse events (for pharmacovigilance databases)
Yes
International Classification of Diseases, Ninth Revision, Clinical Modification codes
Laboratory values
Yes
WHO Toxicity Grading Scale or CDER-PhRMA-AASLD as appropriate
5. Year of establishment
2007
6. Geographical origin of data
EEA/EFTA countries
Spain
7. Demographical extent of data collection
Regional sub-set :
Hospital La Paz
8. Age groups
17 years and under [Paediatrics]
preterm newborn infants
term newborn infants (0 to 27 days)
infants and toddlers (28 days to 23 months)
children (2 to 11 years)
adolescents (12 to 17 years)
18 to 45 years
46 to 64 years
65 years and over
65 to 75 years
76 years and over
9. Size of the source/catchment population
5,500,000
10 a. Total (cumulative) number of persons with actual data
30,089
10 b. Number of persons with active data collection in past calendar year
4,401
11. Possibility to obtain additional information on the patient
a) Clinical information from treating physician?
Yes
b) Questionnaire data from the patient?
Yes
c) Genetic information or samples?
Yes
12. Possibility of links to other sources of data
Yes :
Electronic Prescriptions
13. Written policy governing data access
Yes
14. Committee to evaluate requests for data access
Yes
15. Charge/fee for data access
No
16. Selected publications of the last 5 calendar years using data from this data source
ReferenceLink to web-publication
Nicolás Medrano-Casique, Hoi Y Tong, Alberto M Borobia, Antonio J Carcas, Jesús Frías, Elena Ramírez. NON-CHEMOTHERAPY-INDUCED AGRANULOCYTOSIS DETECTED BY A PROSPECTIVE PHARMACOVIGILANCE PROGRAM IN A TERTIARY HOSPITAL. Basic Clin Pharmacol Toxicol 2015; 117: 399-408.
Ramírez E, Rodríguez A, Queiruga J, García I, Díaz L, Martínez L, Muñoz R, Muñoz M, Tong HY, Martínez JC, Borobia AM, Carcas AJ, Frías J. Severe Hyponatremia Is Often Drug Induced: 10-Year Results of a Prospective Pharmacovigilance Program. Clin Pharmacol Ther. 2019 Jun 27. doi:
10.1002/cpt.1562.
Ramírez E, Rossignoli T, Campos AJ, Muñoz R, Zegarra C, Tong H, Medrano N, Borobia AM, Carcas AJ, Frías J. Drug-induced life-threatening potassium disturbances detected by a pharmacovigilance program from laboratory signals. Eur J Clin Pharmacol 2013; 69:97-110
Ramirez E, Carcas AJ, Borobia AM, Lei SH, Fudio S, Frias J. A Pharmacovigilance Program from Laboratory Signals for the detection and reporting of serious adverse drug reaction in hospitalized patients. Clin Pharmacol Ther 2010; 87: 74-86
Ramírez E, Medrano-Casique N, Tong HY, Bellón T, Cabañas R, Fiandor A,
González-Ramos J, Herranz P, Trigo E, Muñoz M, Borobia AM, Carcas AJ, Frías J.
Eosinophilic drug reactions detected by a prospective pharmacovigilance programme
in a tertiary hospital. Br J Clin Pharmacol 2017;83:400-415.
