Media attention and the influence on the reporting odds ratio in disproportionality analysis: an example of patient reporting of statins.
OBJECTIVE
To study the influence of media attention about statins and ADRs on the level of disproportionality, expressed as the reporting odds ratio (ROR) for statins in the Lareb database, based on patients' reports.


METHODS
Patient reports about statins, before and after the broadcast of a consumer programme about statins, were compared. In order to calculate the correlation between the ROR for patient-statin reports between the period before and after the broadcast a Pearson correlation-coefficient (r) was calculated. The type of reported ADRs associated with statins before and after the broadcast was compared both on the level of system organ class (SOC) and preferred terms (PT).


RESULTS
Pearson's Correlation-coefficient for the comparison of RORs before and after the broadcast was 0.83. In respect to specific ADRs, no differences were found in reporting on SOC level before and after the broadcast, except for the SOC Musculoskeletal and connective tissue disorders. For ADRs that were specifically mentioned during the broadcast, no differences were found except for an increased number of myalgia and arthralgia reports.


CONCLUSIONS
Our study demonstrates that media attention does not necessarily influence the relative reporting by patients expressed as RORs in the national ADR database. On SOC level only in Musculoskeletal and connective tissue disorders the relative reporting increased. For myalgia and arthralgia, there was a proportional increase of reporting within the statin class but not for the other ADRs that were explicitly mentioned in the TV programme about statins.
van Hunsel
Florence
F
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl
van Puijenbroek
Eugène
E
de Jong-van den Berg
Lolkje
L
van Grootheest
Kees
K
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000706:statistics & numerical data*; D003256:Community Participation / Q000706:statistics & numerical data*; D016208:Databases, Factual; D016903:Drug Monitoring; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008402:Mass Media; D009426:Netherlands; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors