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Highlights 2015


Reports The Netherlands Pharmacovigilance Centre Lareb is the reporting and knowledge centre for adverse drug reactions of medicines and vaccines. Analysing reported ADRs generates new knowledge. Lareb shares this knowledge with health care professionals and patients. Increase in reports 2014 21.713 2015 24.167

Increase in reports in 3 years

+11%

2012 14.202 2015 24.167

+70%

Number of reports 2001-2015 25000

20000

15000

10000

5000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015


Vaccines Adverse events following immunisation were reported 2.000 times.

Reported AEFIs

2.000 C B

Reports per vaccine A National Immunisation Programme (NIP) 76% B Influenza C Other

16% 8% A


Reporters Number of reports per group 2001-2015 8000

Patients

7000

6000

5000

4000

3000 Medical specialists 2000

1000

Pharmacists Nurses** General practitioners Other HCPs Public health specialists* Hospital pharmacists

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 *since 2010 registered as separate category **since 2015 registered as separate category


The number of reports by patients increased from 4.393 in 2014 to 8.010 in 2015 (82%). The number of reports by health care professionals also increased (39%).

Patients 2014 4.393 2015 8.010

Health Care Professionals

+82%

2014 4.730 2015 6.571

+39%

Number of reports by Health Care Professionals – top 3

2.308 1.833 871

*including hospital pharmacists

General practitioners

Pharmacists*

Medical specialists


Lareb Intensive Monitoring Lareb monitors the safety of some drugs with Lareb Intensive Monitoring (LIM ). When starting taking these drugs, patients are actively asked if they experience any adverse drug reaction. The main goal is to get more insight into the frequency, type and timing of adverse drug reactions. In 2015 2.033 users of 18 drugs were monitored by LIM, such as the new antidiabetic drugs and new oral anticoagulants. The number of new inclusions was 575. Also 1.475 patients were monitored by LIM following influenza vaccination.

Monitored by LIM Drugs

Participants

18 Vaccine

2.033 Participants

1

1.475


Signals Based on these analyses, 39 signals were detected. 1. Overview of reports of injection site inflammation after Prevenar13® administered to a selected population of elderly 2. Terbinafine and erectile dysfunction 3. Overview of reports on novel anticoagulants 4. Commissie Praktijk: dabigatran en oesophagitis 5. Overview: Off-label use alpha-reductase inhibitors in women 6. Dimethylfumarate and progressive multifocal leukoencephalopathy 7. Overview reports on clioquinol 8. Tramadol and hiccups 9. Isotretinoine and anal fissure 10. Desloratadine and abnormal behaviour 11. Update of Overview of Dutch cases of narcolepsy associated with Pandemrix® 12. Fluconazole and fixed eruption - Update 13. Lamotrigine and alopecia 14. Triptans and post-traumatic pain 15. Overview mirabegron 16. Overview reports on narcolepsy for Focetria® 17. Tramadol and anorgasmia 18. Isotretinoine and erectile dysfunction 19. Noscapine and angioedema 20. Overview novel antidiabetic drugs 21. Azathioprine and photosensitivity reaction an update 22. Overview reports on oxaliplatine 23. ACE-inhibitors and psoriasis

24. Domperidone and cardiac ADRs and fatal outcomes 25. Hydrocorticone with antibacterials and dizziness 26. Paracetamol and flucloxacilline interaction and metabolic acidosis 27. Anaphylactic reaction after switch from Ferinject® to Monofer® and Diafer® 28. Proton Pump Inhibitors and gastric polyps 29. Cisplatine and peripheral arterial thrombosis 30. Infant immunization and petechiae and discoloured leg syndrome 31. Omeprazole and erectile dysfunction 32. Nadroparine and headache 33. Commissie Praktijk: Melding na substitutie salmeterol/fluticason poederinhalator & Meldingen verminderde effectiviteit salbutamol aerosol Sandoz® 34. Decreased effectivity revised formulation salbutamol aerosol from Sandoz® 35. Eindanalyse Prevenar13® 36. Long-lasting and unexplained symptoms following vaccination with Cervarix®: overview of reports received after media attention 37. Loop diuretics and additive drug interaction with PPIs causing hypomagnesiemia 38. Analyse van meldingen na HPV-vaccinatie, 1ste overzicht 39. VWA: Hop en soja bevattende fytopreparaten en postmenopauzale bloedingen


Knowledge centre (Inter)national publications

68 TV/Radio broadcasts

10

Publications lay press

40 Newsletter subscribers

9.119

Lareb was regularly in the news. For example, the news items were about aggression after the use of SSRIs, adverse events after package change of Thyrax速 and long-lasting adverse drug reactions following immunization with Cervarix速. Information requests

1.888 Presentations

40

Lectures

45 Congres booths

7


Teratology Information Service (TIS) TIS is Lareb’s knowledge centre for medication use during pregnancy and lactation.

Telephone consults by TIS

Web service users

2.224

64.004

Who called TIS A Midwives

36%

B Gynaecologists

20%

C Pharmacists

14%

D General practitioners

12%

E Other physicians

6%

F Public

5%

G Psychiatrics

3%

H Other HCPs

3%

I Other

1%

F

I G H

E

A

D

C B


Goudsbloemvallei 7 5237 MH ‘s-Hertogenbosch Tel. +31 (0)73-6469700 Fax +31 (0)73-6426136 The Netherlands info@lareb.nl www.lareb.nl

Highlights 2015 International  

Highlights 2015 Netherlands Pharmacovigilance Centre Lareb

Highlights 2015 International  

Highlights 2015 Netherlands Pharmacovigilance Centre Lareb

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