OBJECTIVES

To compare the product information published by the EMA and the FDA in the form of the EU SmPC and the US PI, respectively, and to identify the information being conveyed to the HCPs.

METHODS

Descriptive analysis of the product information published by the EMA and the FDA was done to assess the difference between the EU SmPC and the USPI. Ten out of 138 drugs acting on the CNS were chosen due to availability of SmPCs and Physician’s Labeling Rule Format USPI, for consistent comparison.

RESULTS

Ten drugs, which fulfilled the criteria for inclusion in this study, were: pregabalin, levetiracetam, levodopa/carbidopa, pramipexole, duloxetine, loxapine, aripiprazole, olanzapine, rivastigmine and memantine. For each drug, the following characteristics were extracted and analysed from the product information: indication, dosage, clinical trials, primary endpoint, adverse drug reaction, black box warning and the presentation/order of information.

Overall, 82.9% of prominent distinctions were identified between the two product label formats. For indication, the most prominent distinctions were identified in the number of approved indications (60%); for dosage, it was in the dosing regimen (60%); and for clinical trials, the distinction was in the number of trials described and presentation of overall trial data (70%). The choice of primary endpoints were also prominently different for 90% of the drugs. For adverse drug reactions, black box warnings and order of information, the details regarding all drugs (100%) were prominently different.

CONCLUSIONS

Publicly available drug product documents have the potential to be valuable and vital sources of safety information. The reason for the differences between the USPI and the EU SmPC could be the different regulatory requirements for both authorities. The prominent distinctions may influence how HCPs interpret product information in different regions. Considering global drug safety, all the stakeholders, including the regulators, need to work together to harmonise these product labels.