Longitudinal monitoring of the safety of drugs by using a web-based system: The case of pregabalin

Pharmacoepidemiology and Drug Safety

Volumn 20, Issue 6, 2011, Pages 591-597

  Härmark, Linda ^a   van Puijenbroek, Eugene ^b   van Grootheest, Kees ^a  

^a UNIVERSITY OF GRONINGEN   (Netherlands)

^b Netherlands Pharmacovigilance Centre Lareb's Hertogenbosch   (Netherlands)

Author keywords

Intensive monitoring; Longitudinal data collection; Pharmacovigilance; Pregabalin

Indexed keywords

PREGABALIN;

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; DIZZINESS; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUNK SENSATION; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; NETHERLANDS; NEUROLOGIC DISEASE; NEUROPATHIC PAIN; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUESTIONNAIRE; SIDE EFFECT; SOMNOLENCE; WEIGHT GAIN;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; ANTICONVULSANTS; CHILD; DATA COLLECTION; DRUG MONITORING; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; INTERNET; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; NETHERLANDS; QUESTIONNAIRES; TIME FACTORS; YOUNG ADULT;

EID: 79959543811     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2135     Document Type: Article

References (22)

1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005; 353(5): 487-497.
2. Kwara A, Herold JS, Machan JT, et al. Factors associated with failure to complete isoniazid treatment for latent tuberculosis infection in Rhode Island. Chest 2008; 133(4): 862-868.
3. Baldessarini RJ, Perry R, Pike J. Factors associated with treatment nonadherence among US bipolar disorder patients. Hum Psychopharmacol 2008; 23(2): 95-105.
4. Kane SV, Brixner D, Rubin DT, et al. The challenge of compliance and persistence: focus on ulcerative colitis. J Manag Care Pharm 2008; 14(1 Suppl A): s2-s12.
5. van Grootheest K, Olsson S, Couper M, et al. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13(7): 457-464.
6. de Langen J, van Hunsel F, Passier A, et al. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf 2008; 31(6): 515-524.
7. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf 2009; 32(11): 1067-1074.
8. Harrison-Woolrych M, Coulter DM. PEM in New Zealand. In Pharmacovigilance, Mann R, Andrews E (eds). John Wiley and Sons, Ltd: Chichester, 2007; pp. 317-332.
9. Shakir SAW. PEM in the UK. In Pharmacovigilance, Mann R, Andrews E (eds). John Wiley and Sons, Ltd: Chichester, 2007; pp. 307-316.
10. SPC Lyrica®. EMA, London. [13 August 2009].
11. 2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res 2007; 73(2): 137-150.
12. Härmark L, Kabel JS, van Puijenbroek EP, et al. Web-based intensive monitoring, a new patient based tool for early signal detection. Drug Saf 2006; 29(10): 911-1010.
13. Oosterhuis I, Härmark L, van Puijenbroek EP, et al. Lareb Intensive Monitoring: an interim analysis. Drug Saf 2007; 30(10): 919-990.
14. Van Grootheest AC, Härmark L, Oosterhuis I, et al. Lareb Intensive Monitoring, a web based system for monitoring ADRs in the postmarketing phase. Pharmacoepidemiol Drug Saf 2007; 16: S252-S253.
15. Härmark L, van Puijenbroek E, Straus S, et al. Intensive monitoring of pregabalin: results from an observational, web-based, prospective cohort study in the Netherlands using patients as a source of information. Drug Saf 2011; 34(3): 221-231.
16. Council for International Organisations of Medical Sciences. International Reporting of Adverse Drug Reactions. CIOMS Working Group Report. World Health Organisation: Geneva, 1987.
17. MedDRA and MSSO. [19 August 2010].
18. Z-Index. [19 August 2010]
19. The Council of the European Communities. Regulation (EEC) No 2309/93. Version date: 22 July 1993. [19 August 2010]
20. Meyboom RH, Lindquist M, Egberts AC. An ABC of drug-related problems. Drug Saf 2000; 22(6):415-423.
21. Raine JM. Risk management-a European regulatory view. In Pharmacovigilance, Mann R, Andrews E (eds). John Wiley and Sons, Ltd: Chichester, 2007; pp. 553-558.
22. Centraal Bureau voor de Statistiek. Mediaproducten steeds meer via Internet. Version date: 28 August 2008. [29 November 2010]