Sunday, May 19, 2013

USP chemical and "DRUG"

During my first few years of work, it would take 15-20 minutes for a brain scan and 40+ minutes for an abdominal scan. The duration and length of the examination is a pain in the ass for the medical staff. I had seen senior physician, utilizing chloral hydrate for pediatric sedation during the examination. It does not work always but yet, I knew it is quite safe for use in the setting.
Later in my practice, I had never had the chance to use the drug, partial due to improvement of the scan machine which reduce the exmination time to less than 2 minutes for brain.
Lately, my boss had told me that the chloral hydrate is available in our pharmacy and in case I need it, I could call the pharmacy.
Last night I had this 2 years old boy who presented with seizure for the 1st time. I had ordered a brain CT but the child was quite irritable and the parents and I shared the same opinion that the child would not be able to hold still for the needed 2 minutes. Thence I ordered a chloral hydrate and later the pharmacy had called me up for a discussion.
I had visited the pharmacy and the pharmacist had shown me that bottle. He had told me that this might not be “pharmacy grade” chloral hydrate and asked me to reconsider my order. I complied with his call and later did a check over the net.
Well, there is currently no approved chloral hydrate in the market. All the 3 suppliers did not renew the drug license few years ago and there is no approved “chloral hydrate” to be use on human currently in Taiwan. According to the label, the chemical was manufactured by WS Simpson Ltd and I ran a check over the net and found that the company produced dye and reagent. Although the label did revealed the word “USP” but there was no such chemical in the online catalog.
If the drug is USP grade, that means it is suitable to be use in human however since the chemical is not approved by the local FDA, thence it would be a violation to use it as a drug and if any side effect was noted, the prescript physician would be held fully responsible for the event.
I am still thinking of how to bring this issue to  boss…..

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