Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form

Journal of Pharmacology and Pharmacotherapeutics

Volumn 3, Issue 3, 2012, Pages 228-232

  Singh, Anshi ^a   Bhatt, Parloop ^b  

^a Care Institute of Medical Sciences   (India)

^b L M COLLEGE OF PHARMACY   (India)

Author keywords

Causality assessment; generic form; pharmacovigilance

Indexed keywords

CAUSAL ATTRIBUTION; CLINICAL EVALUATION; DRUG INFORMATION; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; HEALTH BEHAVIOR; INFORMATION DISSEMINATION; MANDATORY REPORTING; MEDICAL HISTORY; POLYPHARMACY; REVIEW;

EID: 84865060586     PISSN: 0976500X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0976-500X.99417     Document Type: Review

References (19)

1. Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm 1993;28:1199-204,240. (Pubitemid 24004261)
2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients-a meta-analysis of prospective studies. JAMA 1998;279:1200-5. (Pubitemid 28193431)
3. WHO Collaborating centre for international drug monitoring, the uppsala monitoring centre. Adverse reactions and adverse reaction monitoring training course. Available from: http://www.who-umc.org/DynPage. aspx?id = 13140andmn = 1514#6 [Last accessed on 2011 Aug 14].
4. Olsson S. The need for a generic form for spontaneous reporting of drug related problems Pharm Newslett 2007;1:7-9.
5. National Administration of Drugs, Food and Medical Technology (ANMAT), Adverse Drug Reaction reporting form, Argentina. Available from: http://www.anmat.gov.ar. [Last accessed on 2010 Dec 22].
6. National Health Surveillance Agency (Anvisa), Adverse Drug Reaction reporting form, Brazil. Available from: http://www.portal.anvisa.gov.br. [Last accessed on 2010 Dec 22].
7. Therapeutics Goods Administration, Adverse Drug Reaction Reporting Form, Australia. Available from: http://www.tga.gov.au. [Last accessed on 2010 Dec 22].
8. Medicines and Medical Devices Safety Authority (Medsafe), New Zealand. Available from: https://www.nzphvc-01.otago.ac.nz. [Last accessed on 2010 Dec 22].
9. U.S. Food and Drug Administration. Adverse Drug Reaction Reporting Form, United States of America. Available from: http://www.fda.gov/medwatch. [Last accessed on 2010 Dec 22].
10. Health Canada. Adverse Drug Reaction Reporting Form, Canada. Available from: http://www.hc-sc.gc.ca. [Last accessed on 2010 Dec 22].
11. Central Drugs Standard Control Organization. Adverse Drug Reaction Reporting Form, India. Available from: http://www.cdsco.nic.in [Last accessed on 2010 Dec 22].
12. National Pharmaceutical Control Bureau. Adverse Drug Reaction Reporting Form, Malaysia. Available from: http://www.bpfk.gov.my. [Last accessed on 2010 Dec 22].
13. Health Sciences Authority (HSA). Adverse Drug Reaction Reporting Form, Singapore. Available from: http://www.hsa.gov.sg. [Last accessed on 2010 Dec 22].
14. The Medicines and Healthcare Products Regulatory Agency (MHRA). Adverse Drug Reaction Reporting Form, United Kingdom. Available from: http://www.mhra.gov.uk. [Last accessed on 2010 Dec 22].
15. Medical Products Agency (MPA). Adverse Drug Reaction Reporting Form, Sweden. Available from: http://www.lakemedelsverket.se. [Last accessed on 2010 Dec 22].
16. Pharmacy and Poisons Board Kenya Adverse Drug Reaction Reporting Form, Kenya. Available from: http://www.pharmacyboardkenya.org. [Last accessed on 2010 Dec 22].
17. Health Kwazulu-Natal. Adverse Drug Reaction Reporting Form, South Africa. Available from: http://www.kznhealth.gov.za. [Last accessed on 2010 Dec 22].
18. McDowell SE, Coleman JJ, Ferner RE. Systematic review and metaanalysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine. BMJ 2006;332:1177-81.
19. ICH Topic E 2 A. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Available from: www.ema.europa.eu/pdfs/human/ ich/037795en.pdf. [Last accessed on 2011 Aug 14].