PMID- 19079413
OWN - NLM
STAT- MEDLINE
DCOM- 20090114
LR  - 20131121
IS  - 0807-7096 (Electronic)
IS  - 0029-2001 (Linking)
VI  - 128
IP  - 23
DP  - 2008 Dec 4
TI  - [Adverse events related to substitution of generic products in Norway 2005].
PG  - 2696-700
AB  - BACKGROUND: The Norwegian Medicines Agency has since 2003 encouraged health 
      professionals to report adverse events (AEs) related to generic substitution 
      through the spontaneous reporting system. Goals of this study were to evaluate 
      the quality of these reported AEs and to assess whether there were signals of 
      altered efficacy or AEs related to substitution of such products. MATERIAL AND 
      METHODS: The World Health Organisation's (WHO) tool for documentation grading was 
      used to evaluate the AE reports. Signals of AEs were identified based on WHO's 
      signal definition. RESULTS: 423 spontaneous reports concerning substitution of 
      generic products were identified; 232 (55 %) of these reached documentation grade 
      1?-?3 and could be used to detect signals of AEs. The AEs were mostly common 
      symptoms that also appear in the general population not treated with drugs. Only 
      two of the 423 reports were classified as serious AEs. Signals of dizziness and 
      muscle pain were identified after substitution of the original product Norvasc 
      with the generic product Amlodipin Ratiopharm. Amlodipine was the substance 
      associated with most AE reports; i.e. 79 (19 %) reports. INTERPRETATION: About 
      half the spontaneous reports regarding substitution of generic products could be 
      used for signal detection. The substitution of generics does not seem to 
      represent a safety problem.
FAU - Reppe, Linda Amundstuen
AU  - Reppe LA
AD  - RELIS Midt-Norge Avd. for klinisk farmakologi St. Olavs Hospital 7006 Trondheim. 
      linda.reppe@legemidler.no
FAU - Stenberg-Nilsen, Hanne
AU  - Stenberg-Nilsen H
FAU - Harg, Pernille
AU  - Harg P
FAU - Hegge, Anne Bee
AU  - Hegge AB
FAU - Lillefloth, Anna Karine
AU  - Lillefloth AK
FAU - Buajordet, Ingebjorg
AU  - Buajordet I
LA  - nor
PT  - English Abstract
PT  - Journal Article
TT  - Bivirkninger ved generisk bytte i Norge i 2005.
PL  - Norway
TA  - Tidsskr Nor Laegeforen
JT  - Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny 
      raekke
JID - 0413423
RN  - 0 (Drugs, Generic)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems/standards
MH  - Documentation/standards
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Drugs, Generic/*adverse effects
MH  - Humans
MH  - Norway
MH  - Product Surveillance, Postmarketing/standards
MH  - Quality Assurance, Health Care
EDAT- 2008/12/17 09:00
MHDA- 2009/01/15 09:00
CRDT- 2008/12/17 09:00
PHST- 2008/12/17 09:00 [entrez]
PHST- 2008/12/17 09:00 [pubmed]
PHST- 2009/01/15 09:00 [medline]
AID - 1773811 [pii]
PST - ppublish
SO  - Tidsskr Nor Laegeforen. 2008 Dec 4;128(23):2696-700.