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Table 1 Description of the reporting of adverse reactions from the randomized primary healthcare units in 2008

From: Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study

 

Control units

(n = 74)

Intervention units

(n = 77)

P-value

Total number of reports

52

79

 

Number of reporting units (% of all units)

30 (40.5%)

37 (48.1%)

 

Mean number of reports per unit (± SD)**

0.70 ± 1.21

1.03 ± 2.46

0.34

Total number of high quality reports (% of all reports)*

15 (29%)

37 (48%)

 

Serious

4

12

 

Unexpected

13

20

 

New drug and not

common ADR*

4

7

 

Mean number of high quality reports per unit (± SD)

0.20 ± 0.57

0.47 ± 0.94

0.048

  1. *A high quality report was defined as a report concerning an ADR which should be reported according to Swedish regulations, that is, an ADR which was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the SPC.
  2. **Mean ± SD is presented although the non-parametric Mann Whitney test was used for comparisons between randomization groups, since median (interquartile range) would provide limited information.
  3. ADR, adverse drug reaction; SD, standard deviation; SPC, summary of product characteristics