ZIFFPAGE TITLEBy Deborah Gage | Posted 2005-12-06 Print
The drug maker's best-seller has some nasty side effects. A voice recognition system helps patients, doctors and pharmacists manage the risk.Can't Track Everything'">
'Can't Track Everything'
What has happened with thalidomide since the FDA approved it shows how hard it can be for companies and government organizations to manage risk, even when they have made what appear to be the best-laid plans.
One consultant suggests that even though risks are never static, few companies have processes in place that can prepare them for every problem.
"The business owner says, 'I can't track everything,'" says Jeff Weber, the managing director of Protiviti, a subsidiary of Robert Half International that advises companies on how to identify and keep reassessing business and technology risks. "But do you [just] assess the risk that hits you in the head?"
S.T.E.P.S. is a fairly straightforward system. It is part of a class of systems called performance-linked access that are mandated by the FDA to control dangerous drugs.
Celgene provides doctors with software to generate forms and an education kit that includes pictures of babies deformed by thalidomide. Before prescribing any drug, the doctor must show the patient the pictures to emphasize the dangers of taking thalidomide, and female patients of childbearing age must have had a pregnancy test and been using two forms of contraception for a month.
The patient signs the consent form, and doctor and patient each call the IVR to answer questions on such things as how much of the drug has been prescribed and whether pregnancy tests, if applicable, are negative. If their answers are inconsistent, someone from Celgene intervenes.
If the answers are consistent, Celgene's system generates an authorization number for the doctor to write on the patient's prescription. The patient then carries the prescription to the pharmacist, who calls the system to see if the authorization number is valid. If so, Celgene's system checks that the amount being confirmed is in line with authorized prescriptions to prevent unauthorized orders of the drug. Pills are shipped in blister packsmolded plastic sealed to backing that can't be cut, so the patient can't share medication. Before each renewal, the patient must again visit the doctor, have another pregnancy test and call the IVR to answer questions on safe behavior, such as whether she has used two forms of contraception while taking Thalomid.
S.T.E.P.S. works for what it does. A more useful system, however, would track all side effects of the drug in real time, over the Web, so doctors could immediately assess whether patients should receive it, according to Dr. Richard Gliklich, CEO of Outcome Sciences, a Cambridge, Mass.-based consultant for companies that have had drugs or devices approved by the FDA. Such a system could be linked with online prescribing, which could happen in the background.
But those systems don't exist today. One reason is that technical standards like HL7, which determines how these systems would swap data, are still being defined. "Right now, if the FDA mandates a performance-linked access system [like S.T.E.P.S.] to a drug, it's not the best news for the pharma company," Gliklich says. He expects a big improvement in such systems by 2010.
As of late November, Celgene was trying to convince the FDA to approve what the company says is the first of several successors to Thalomida chemical analog called Revlimid that Celgene says won't cause birth defects.
Mercedes Benegbi, executive director of the Thalidomide Victims Association of Canada, says Celgene promised the victims' group in 1997 that it would develop a drug like Revlimid and take Thalomid off the market. In return, the group agreed not to oppose Celgene when the company asked the FDA to approve thalidomide, she says.
"We asked Celgene to be honest, and we trust that all the information they provide to us is true," says Benegbi, who was born with defects caused by thalidomide.
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