Calls for drug monitoring to tighten
DRUG safety experts have called on the federal Government to tighten monitoring procedures that can detect harmful drug side-effects, saying existing methods remain relatively ineffectual.
More rigorous clinical studies and improved systems for picking up problems that only emerge after a new drug has appeared on the market should all be considered, they say amid claims that a recent controversy over a well-known brand of sleeping pill has exposed flaws in the current systems.
The criticism comes despite a move by the federal Government this week to intervene and save from closure a consumer medicines hotline which provides people with a means to report instances of suspected adverse events while taking drugs.
The Brisbane-based Adverse Medicine Events Line was to close at the end of this month when funding by its current sponsor, the pharmacy umbrella group the Pharmacy Guild, was to run out.
The hotline was mainly responsible for alerting Australia’s medicines regulator, the Therapeutic Goods Administration, to the full extent of the disturbing reactions to the sleeping pill Stilnox.
The TGA’s adverse events monitoring body, the Adverse Drug Reactions Advisory Committee, had put out a bulletin in 2002 saying it had received 72 reports of strange psychiatric effects in people taking the drug in the two years since its Australian release.
But it wasn’t until February this year that ADRAC warned of bizarre sleep-related effects’’ linked to Stilnox, prompted by 24 reports of such cases, many of them through the hotline.
The cases reported in the February bulletin — which preceded similar warnings in the US — including cases of patients eating from the fridge or driving cars while asleep. One patient put on 23 kilograms over seven months, and her bemused family only discovered why when she was found eating in front of an open refrigerator while asleep. Another patient woke with a paintbrush in her hand after painting the front door while asleep.
In this week’s announcement the Government said it had agreed to keep the service running for another 12 months, during which time longer-term funding options to keep it going indefinitely will be explored. The cost of the 12-month extension is not yet known.
In a statement, health minister Tony Abbott said the funding would ‘‘ ensure Continued inside, page 21