Last updated on: 02/11/2017
1. Contact details
Name of data sourceBIFAP
Name under which the data source should be displayed in the inventory (e.g short name if one exists)BIFAP
Name of organisation
1) Department/research groupPharmacoepidemiology and Pharmacovigilance
2) Organisation/affiliationSpanish Agency of medicines and medical devices
Administrative Contact
Title Dr
Last name Macia
First name Miguel-Angel
Address line 1Parque Empresarial "Las Mercedes"
Address line 2C/Campezo 1 edificio 8
Address line 3
CityMadrid
Postcode28022
CountrySpain
Scientific Contact
Title Dr
Last name Montero
First name Dolores
Address line 1Parque Empresarial "Las Mercedes"
Address line 2C/Campezo 1 edificio 8
Address line 3
CityMadrid
Postcode28022
CountrySpain
Alternative Contact
Title Dr
Last name Macia
First name Miguel-Angel
Address line 1Parque Empresarial "Las Mercedes"
Address line 2C/Campezo 1 edificio 8
Address line 3
CityMadrid
Postcode28022
CountrySpain
2. Description/category
Routine primary care electronic patient registry
3.1 Coverage of licensed medicinal products
Licensed Medicinal Product
Comments
Community / general practice data
Vaccines
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? ICPC
4. Coverage of events
Event
Dictionary
Dictionary details
Symptoms/signs
Yes
ICPC
Diagnosis in primary care
Yes
ICPC
Specialist diagnosis
No
As registered by the GP either coded or in free text fields
Discharge diagnosis
No
As registered by the GP either coded or in free text fields
Laboratory values
No
Included in a structured way in a subset of patients
Death
No
5. Year of establishment
2003
6. Geographical origin of data
EEA/EFTA countries
Spain
7. Demographical extent of data collection
Regional sub-set :
Participating GPs of 10 Autonomous regions in Spain
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
23,751,452
10 a. Total (cumulative) number of persons with actual data
8,077,841
10 b. Number of persons with active data collection in past calendar year
4,605,469
11. Possibility to obtain additional information on the patient
a) Clinical information from treating physician?
Yes
b) Questionnaire data from the patient?
No
c) Genetic information or samples?
No
12. Possibility of links to other sources of data
No
13. Written policy governing data access
No
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
de Abajo FJ, Gil MJ, García Poza P, Bryant V, Oliva B, Timoner J, García-Rodríguez LA. Risk of nonfatal acute myocardial infarction associated with non-steroidal antiinflammatory drugs, non-narcotic analgesics and other drugs used in osteoarthritis: a nested case-control study. Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1128-38https://doi.org/10.1002/pds.3617
Martin E, de Abajo FJ, Gil M. Risk of toxic epidermal necrolysis and Steven-Johnson syndrome associated with benzodiazepines: a population-based cohort study. Eur J Clin Pharmacol. 2015 Jun;71(6):759-66https://doi.org/10.1007/s00228-015-1850-y
Huerta C, Abbing-Karahagopian V, Requena G, Oliva B, Alvarez Y, Gardarsdottir H, Miret M, Schneider C, Gil M, Souverein PC, De Bruin ML, Slattery J, De Groot MC, Hesse U, Rottenkolber M, Schmiedl S, Montero D, Bate A, Ruigomez A, García-Rodríguez LA, Johansson S, de Vries F, Schlienger RG, Reynolds RF, Klungel OH, de Abajo FJ. Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven European electronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project. Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:56-65.https://doi.org/10.1002/pds.3825
Saiz LC, Garjón J, Gorricho J, Erviti J, Gil-García MJ, Martín-Merino E. Epidemiol Infect. 2017 Oct;145(14):3056-3064. doi: 10.1017/S0950268817001868. Epub 2017 Aug 31.https://doi.org/10.1017/S0950268817001868
Martín-Merino E, Huerta-Álvarez C, Prieto-Alhambra D, Álvarez-Gutiérrez A, Montero-Corominas D. Secular trends of use of anti-osteoporotic treatments in Spain: A population-based cohort study including over 1.5million people and more than 12years of follow-up. Bone. 2017 Dec 1;105:292–8.https://doi.org/10.1016/j.bone.2017.08.031
