SINGAPORE: The Ministry of Health has alerted all hospitals to take immediate measures to ensure safety in the use of infusion pumps when administering drugs.
This follows a pharmaceutical error at KK Women’s and Children’s Hospital — where two cancer patients are now under observation, with one potentially in grave danger.
Mrs L K Ng, aged 51, and Mrs Yip Poh Hung, aged 44, were given chemotherapy drugs via an infusion pump — but settings on the pumps were inaccurate, despite two pharmacists checking to ensure accuracy before the infusion pumps were given to the women.
The ministry said it will share the findings and risk reduction strategies with other hospitals after KK Hospital completes its detailed root cause analysis.
If things go wrong, Mrs Yip Poh Hung’s organs could be damaged seriously. She is being given an antidote — Vistonuridine — specially flown in from the US. Although stable at the moment, she still needs to be observed carefully. She had consumed five days worth of cancer drugs in just five hours.
The hospital said the antidote being given to the patient is safe to use, even though the drug has not been approved for general use in Singapore. The drug has not even been approved by the FDA in the US. But the hospital is citing a recent study to vouch for its safety.
"They have tested this drug and out of the 17 patients, all actually recovered well. So that is why it is important to have this particular drug for our patient here," said Associate Professor Tan Kok Hian, director, Clinical Quality, KK Women’s & Children’s Hospital.
The hospital said her chances of full recovery are "very high".
Singapore’s Health Sciences Authority (HSA), which gave the last minute green light for the special use of the antidote in this instance, said: "Our regulatory framework has a system in place that allows HSA to consider special concession for clinicians to use unregistered medicinal products under exceptional medical circumstances, when there is no registered alternative available in Singapore.
"This is to ensure that patients are not denied access to critical treatments in the case of unmet medical needs." The HSA added that there have been past approvals granted in life or death situations where no alternative is available in Singapore.
Meanwhile, the pharmacists in question have been assigned "light duties", while they assist in investigations.
Hospital officials said they have apologised to the patients and their families. The hospital is also waiving current medical fees for the next cycle of chemotherapy treatment. As for further compensation, the hospital said the issue has not surfaced.
As a safeguard, the hospital has now decided to use only one type of infusion pump, so that the rate and calibration will be clearer and chances of error will be further diminished.
"We have a variety of pumps — the default rate is set at one rate and another pump is set at another rate. So sometimes if you are using the different pumps you should know the default rate and to set it accordingly. Unfortunately, it is very rare, there was an error and it wasn’t recognised," said Prof Tan.
"KK is also sorry about this incident and we take full responsibility for this error and we would also like to say sorry to the patients and their families who are involved," added Prof Tan.
Some patients, the hospital said, were concerned about their own medication after learning about the incident. However, doctors said the patients’ fears were assuaged and they were informed that the chances of such errors are extremely rare.
The hospital said investigations are ongoing.
(source: http://sg.news.yahoo.com/cna/20091113/tap-828-moh-alerts-hospitals-women-given-231650b.html )
My comments:
My prayers go to the affected patients and their families. I hope the patients can have a speedy recovery.
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