From Dr P. Tooley, MRCGP
SIR,—I was interested to read the article by Ian Wong regarding pharmacovigilance resources in the United Kingdom (PJ, August 21, p285). However, I think he has missed two very important points.
He fails to mention that there is a need to involve the pharmaceutical company. It should not be left to discover problems indirectly, but should receive these reports at the same time they are sent to the authorities. The company can then perform its own investigation and signal generation. It is important also to remember that the Medicines Control Agency only supplies the pharmaceutical industry with anonymised information, with therefore no chance of follow up.
The second factor that was missed is the requirement to inform other regulatory authorities throughout the world. The pharmaceutical industry has a duty not only to report serious adverse reactions to their local authority, but circulate these for submission to other bodies (eg, the United States Food and Drug Administration).
Finally, while I agree that the MCA should receive many more reports, what it asks for are serious adverse reactions (after the black triangle is removed), not each and every one. That might lead to system overload.
Peter Tooley
Consultant in Pharmaceutical Medicine, Vale, Guernsey