I am interested in the variability of the quality and content of
medicines data sheets (PI or MSDS) between countries and between
different drugs (especially generics) marketed in the same country.
For example Voltaren injection has a comprehensive insert that warns
against injection in to the thigh and prolonged use - to avoid
injection site reactions that can be very severe. In contrast, some
diclofenac injection products (especially generics in developing
countries) carry no such warnings.
Shouln't we be adopting a standard datasheet, at least for ADRs?
Does anyone have any similar anecdotes or concerns, or know if any
studies have been done in this area ?
[The moderator agrees with Dave but have for years been pessimistic about the
possibility to make this an international standard. At least it will have to be
done by someone else than the pharmaceutical industry. In Europe, it is not
even possible to harmonise the patented product and the generics mainly because
of the industry's resistance.]