Adverse drug reaction reporting by patients in the Netherlands: Three years of experience

Drug Safety

Volumn 31, Issue 6, 2008, Pages 515-524

  De Langen, Joyce ^a   Van Hunsel, Florence ^a   Passier, Anneke ^a   De Jong Van Den Berg, Lolkje ^b   Van Grootheest, Kees ^a,b  

^a Netherlands Pharmacovigilance Centre Lareb   (Netherlands)

^b UNIVERSITY OF GRONINGEN   (Netherlands)

Author keywords

Adverse drug reactions; Adverse reaction monitoring; Pharmacovigilance

Indexed keywords

ANTICOAGULANT AGENT; BENZODIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; GLUCOCORTICOID; HYDROCORTISONE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LEVOTHYROXINE; OCTREOTIDE; PAROXETINE; PROTON PUMP INHIBITOR; SEROTONIN UPTAKE INHIBITOR;

ACROMEGALY; ADULT; AGED; ALOPECIA; ANGIONEUROTIC EDEMA; ARTHRALGIA; ARTICLE; DEPRESSION; DISEASE SEVERITY; DIZZINESS; DROWSINESS; DRUG SURVEILLANCE PROGRAM; DYSPNEA; EXPERIENCE; FATIGUE; HEADACHE; HEALTH CARE PERSONNEL; HEART PALPITATION; HUMAN; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MYALGIA; NAUSEA; NETHERLANDS; NORMAL HUMAN; PRIORITY JOURNAL; PRURITUS; PUBLICATION; RASH; RELIABILITY; SELF REPORT; SIDE EFFECT; WEIGHT GAIN;

ACROMEGALY; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTINEOPLASTIC AGENTS; DATA INTERPRETATION, STATISTICAL; FEMALE; HEADACHE; HUMANS; LEAST-SQUARES ANALYSIS; NETHERLANDS; OCTREOTIDE; PATIENTS; PHARMACISTS; PHYSICIANS; SLEEP STAGES; SUBSTANCE WITHDRAWAL SYNDROME;

EID: 43749091268     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831060-00006     Document Type: Article

References (26)

1. Mitchell AS, Henry DA, Hennrikus D, et al. Adverse drug reactions: can consumers provide early warning? Pharmacoepidemiol Drug Saf 1994; 3: 257-64
2. van Grootheest AC, van Puijenbroek EP, de Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 205-10
3. Morrison-Griffiths S, Walley TJ, Park BK, et al. Reporting of adverse drug reactions by nurses. Lancet 2003; 361: 1347-8
4. van Grootheest K, de Graaf L, de Jong-van den Berg LTW LTW. Consumer adverse drug reaction reporting: a new step in pharmacovigilance? Drug Saf 2003; 26: 211-7
5. BMA board of science. Reporting adverse drug reactions: a guide for healthcare professionals 2006 [online]. Available from URL: www.bma.org.uk/ap. nsf/content/AdverseDrugReactions [Accessed 2007 Sep 17]
6. Blenkinsopp A, Wilkie P, Wang M. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol 2006; 63: 148-56
7. van Grootheest AC, Passier JLM, van Puijenbroek EP. Direct reporting of side effects by the patient: favourable experience in the first year. Ned Tijdschr Geneesk 2005; 149: 529-33
8. Council for International Organizations of Medical Sciences. International reporting of adverse drug reactions. CIOMS working group report. Geneva: World Health Organisation, 1987
9. The ATC/DDD system 2007 [online]. Available from URL: http://www.whocc.no/atcddd/ [Accessed 2007 Sep 17]
10. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999; 20: 109-17
11. Brown EG. Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Drug Saf 2002; 25: 445-52
12. van Grootheest K, de Jong-van den Berg L. Patients' role in reporting adverse drug reactions. Expert Opin Drug Saf 2004; 3: 363-8
13. De Bruin ML, van Puijenbroek EP, Bracke M, et al. Pharmacogenetics of drug-induced arrhythmias: a feasibility study using spontaneous adverse drug reactions reporting data. Pharmacoepidemiol Drug Saf 2006 Feb; 15 (2): 99-105
14. de Jong-van den Berg LTW. Women and drug use. Pharm Weekbl 2001; 136: 1624-8
15. Medawar C, Herxheimer A, Bell A, et al. Paroxetine, panorama and user reporting of ADRs: consumer intelligence matters in clinical practice and post-marketing drug surveillance. Int J Risk Saf Med 2002; 13: 161-9
16. Golomb B, Evans M. Risk factors for rhabdomyolysis with simvastatin and atorvastatin. Drug Saf 2006; 29 (12): 1191-2
17. Passier JLM, Srivastava N, van Puijenbroek EP. Isotretinoin-induced inflammatory bowel disease. Neth J Med 2006; 64 (2): 52-4
18. Passier JLM. Lithium and hyperparathyroidism. Geneesmid-delenbulletin 2005; 39 (11): 131-2
19. van Grootheest AC, de Graaf L. Pergolide en gokverslaving. Geneesmiddelenbulletin 2006; 40 (8): 86-7
20. Dutch SPC. Permax® [online]. Available from URL: http://www.cbg-meb. nl/IB-teksten/h14587-h14588-h14589.pdf [Accessed 2000 Jan 2]
21. Dutch SPC. Sandostatin® [online]. Available from URL: http://www.cbg-meb.nl/IB-teksten/h12612-h12613-h12614-h1499-7.pdf [Accessed 2007 Oct 25]
22. US SPC. Sandostatin® [online]. Available from URL: http://www.fda.gov/cder/foi/label/2005/019667s050lbl.pdf [Accessed 2007 Oct 25]
23. May A, Lederbogen S, Diener HC. Octreotide dependency and headache: a case report. Cephalalgia 1994; 14 (4): 303-4
24. Donangelo I, Rodacki M, Peixoto MC, et al. Dependency and analgesia related to treatment with subcutaneous octreotide in patients with growth hormone-secreting tumors. Endocr Pract 2004; 10 (2): 107-11
25. Levy MJ, Goadsby PJ. Octreotide dependency: a cautionary tale [abstract]. Endocrine Abstracts 2004; 7: 110
26. Levy MJ, Matharu MS, Meeran K, et al. The clinical characteristics of headache in patients with pituitary tumours. Brain 2005; 128 (Pt 8): 1921-30