Drug monitoring under fire
that consumers are provided with a way to seek help with, or report, adverse reactions to medicines’’.
Hotline manager and clinical pharmacist doctor Geraldine Moses said the hotline had probably received about 900 calls about Stilnox over a four-month period this year.
She said she was ‘‘ very grateful and very excited’’ at the extra funding. Although negotiations on the cost were still under way, the hotline had asked for $400,000 to fund the 12 months of operation, she said.
‘‘ It’s a short-term solution,’’ Moses said. ‘‘ We are going to be entering negotiations with the National Prescribing Service and the Therapeutic Goods Administration to see if we can come up with some sort of long-term solution. This gives us some breathingspace.’’
However, drug experts said Australia’s systems for detecting problems with drugs would remain sadly lacking, even after the hotline’s welcome reprieve.
Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, said much more rigorous surveillance of drugs was required after they were put on sale, including measures to force drug giants to conduct effective large-scale studies. ‘‘ It’s good the Government’s doing it (saving the hotline), but more needs to be done,’’ Harvey said. ‘‘ I certainly support what Geraldine Moses is doing. But you are still left with (a system of) spontaneous reporting, and we know that’s not good enough.
‘‘ There’s a move going on globally to get a much more rigorous post-marketing surveillance of drugs. Drug companies should be encouraged to do better studies, and to get good data, and you really need good population studies.’’
The February bulletin reporting the bizarre effects of Stilnox attracted massive media publicity, and further reports to the hotline spiked as a result. The TGA says that up until May 25 ADRAC had received 727 reports about Stilnox, with 208 reports concerning ‘‘ abnormal sleep-related event, sleep walking, and/or sleep talking’’ — with all but 24 of the latter category coming in after the February bulletin.
‘‘ This rapid increase in reported sideeffects following media attention on the issue of Stilnox is a phenomenon known as ‘ stimulated reporting’,’’ says a report on the TGA’s website. ‘‘ Regulators must interpret the results of stimulated reporting with great care as the effect of media attention may be to overestimate the number of adverse reactions related to a medicine.
‘‘ This in turn may result in an overestimate of the risk side of any risk-benefit analysis conducted by the regulator.’’
A spokesman for the drug industry umbrella group Medicines Australia said companies already had an obligation to report adverse efffects to the TGA.
‘‘ If the TGA had a concern they would work with the company to conduct postmarketing surveillance, and that process can be initiated by the company or by the TGA,’’ he said.
‘‘ Before medicines are allowed to be sold in Australia they have to have been through rigorous clinical trials to make sure the benefit outweighs the risk. These trials won’t necessarily pick up one-in-a-million sideeffects, but that’s why companies and the TGA continue to monitor medicines’ safety once medicines are in general use.
‘‘ The TGA is certainly moving towards requiring companies to have riskmanagement plans for new medicines when they evaluate these new medicines, and that’s being introduced now.’’
Point of sale: Keeping watch on side-effects should not end here, say authorities