European Journal of Clinical Pharmacology
Sources of information used by regulatory agencies on the generation of drug
safety alerts
Carlos Alves1,2,3, Ana Filipa Macedo3, Francisco Batel Marques1,2
1. Centre for Health Technology Assessment and Drug Research (CHAD), AIBILI,
Coimbra, Portugal.
2. School of Pharmacy, University of Coimbra, Coimbra, Portugal.
3. Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal.
Carlos Alves: PharmD. PhD candidate at School of Pharmacy, University of Coimbra,
Coimbra, Portugal, and at CICS-UBI – Health Sciences Research Centre, University of
Beira Interior, Covilhã, Portugal. Assistant Investigator at Centre for Health Technology
Assessment and Drug Research (CHAD), AIBILI, Coimbra, Portugal.
Ana F. Macedo: PharmD, PhD. Professor at Faculty of Health Sciences, University of
Beira Interior, Covilhã, Portugal.
Francisco Batel-Marques: PharmD, PhD. Professor at School of Pharmacy, University
of Coimbra, Coimbra, Portugal. Director of Centre for Health Technology Assessment
and Drug Research (CHAD), AIBILI, Coimbra, Portugal
Corresponding author:
Carlos Miguel Costa Alves
Centre for Health Technology Assessment and Drug Research (CHAD),
AIBILI – Association for Innovation and Biomedical Research on Light and Image
Azinhaga de Santa Comba,
Celas,
3000-548 Coimbra,
Portugal
E-mail: carlosmiguel.costaalves@gmail.com
Telephone number: (+351) 239 480 100
Fax number: (+351) 239 480 117
Supplemental File 1 – Worldwide most consumed drug classes in ambulatory care
from 2010 until September 2012
ATC 2nd level
Worldwide Ambulatory setting
Units*
September 2012
Units*
Year 2011
Units*
Year 2010
TOTAL
86.705.920
85.303.455
81.295.783
J1 (SYSTEMIC ANTIBACTERIALS)
7.338.442
7.202.647
7.058.254
N2 (ANALGESICS)
6.341.166
6.267.979
6.040.099
A2 (A-ACID A-FLAT A-ULCERANT)
5.399.376
5.217.473
4.763.242
R5 (COUGH,COLD PREPARATIONS)
4.750.842
4.867.359
4.628.154
M1 (ANTIRHEUMATIC SYSTEM)
3.931.491
3.920.386
3.756.272
A11 (VITAMINS)
3.824.783
3.714.156
3.614.190
A10 (DRUGS USED IN DIABETES)
3.005.279
2.865.126
2.569.084
R3 (ANTI-ASTHMA & COPD PROD)
2.743.511
2.772.934
2.606.099
C9 (RENIN-ANGIOTEN SYS AGENT)
2.502.718
2.428.457
2.242.174
A7 (A-DIAR ORAL ELEC+A-INFLA)
2.339.231
2.222.082
2.128.853
N5 (PSYCHOLEPTICS)
2.112.611
2.152.871
2.130.181
H2 (SYSTEMIC CORTICOSTEROIDS)
1.953.957
1.927.224
1.859.051
S1 (OPHTHALMOLOGICALS)
1.941.345
1.917.163
1.894.804
D7 (TOPICAL CORTICOSTEROIDS)
1.660.655
1.589.325
1.476.307
A3 (GAST-INTEST DISORD DRUG)
1.557.979
1.570.617
1.474.761
R6 (ANTIHISTAMINES SYSTEMIC)
1.429.452
1.419.120
1.349.397
R1 (NASAL PREPARATIONS)
1.405.983
1.389.094
1.332.254
C8 (CALCIUM ANTAGONISTS)
1.401.255
1.371.635
1.307.215
N6 (PSYCHOANALEPTICS)
1.374.850
1.342.811
1.261.624
B1 (ANTITHROMBOTIC AGENTS)
1.355.129
1.342.219
1.274.782
C7 (BETA BLOCKING AGENTS)
1.352.113
1.317.395
1.238.400
C10 (LIP.REG./ANTI-ATH. PREPS)
1.336.965
1.305.105
1.218.968
P1 (ANTIPROTOZOALS & ANTHELMIN)
1.268.085
1.275.381
1.278.451
G3 (SEX HORMONES-SYSTEMIC)
1.235.709
1.216.392
1.162.638
N3 (ANTI-EPILEPTICS)
1.188.892
1.128.611
1.029.457
M2 (ANTIRHEUMATICS TOPICAL)
1.017.346
984.034
942.144
B3 (ANTIANAEMICS)
1.002.198
987.989
937.067
906.938
880.395
822.031
V6 (GENERAL NUTRIENTS)
* Thousands of units.