Thursday, 08 October 2015 10:31

Testing Provisions Patient Safety

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So what is this image? It is a patient safety check. Each coloured line represents a single patient's self imported Sofosbuvir being tested against a reference standard. Yes it's just lines but for each chemical there is a unique NMR signature represented by the spikes in those lines, but let's rewind.....

Back in February when patient zero asked me to help them personally import Hepatitis C medication the conversation went like this:

  • Have you heard about the new DAA medications that cure Hep C?
  • No, I thought the cure was worse than the disease, but it sounds interesting I'll look into it.
  • Ok, so there is a cure, but it's not available (I had some Indian doctor friends check)
  • Ok, so now it is available but it's the wrong treatment for you
  • Ok, so you've found a supplier in China that makes what you need...
  • Ok, so here's the deal:
    • I will prescribe it so you can import it
    • It comes to me first
    • I will arrange to get it tested for you
    • If it passes testing you can take it, if not I will bin it
    • Ok?
  • Yes

So the medication arrived, it did pass testing, patient zero took it and at 4 weeks the pathology company rang up to say:

  • We think there is a problem with patient zero
  • I thought OMG, I've killed him, he's in liver failure, I'm going to be in so much trouble, but said...
  • Ok, so what's the problem?
  • We think you've switched the blood samples because he used to have Hep C and terrible liver function tests but....
    • Now his viral load is zero and his liver function is normal
  • Hallelujah
  • Yeah, no worries, that's expected, he's on treatment
  • Oh, we don't see many of these...

 So patient zero was really supposed to be a one off and was in fact sworn to secrecy, something he honoured.

The problem was I had asked some expert doctors for their opinion, and when patient zero hit VL=0 they started sending me patients who faced the options of parallel import, interferon or death.

So one patient became several, and several became more. With each passing week more people saying "I'm better" and the validation of VL=0.

While the initial testing was robust the lab that did it was careful to inform us that they were not NATA accredited to do testing, so with that in mind we went in search of a NATA accredited lab.

These APIs have also been cross checked in Australia by the NMI (National Measurement Institute) which is NATA (National Association of Testing Authorities) accredited to perform testing. Only the Department of Defense and NMI have NATA accreditation to perform this testing.

Australian NMI NATA Certification Sofosbuvir

Australian NMI NATA Certification Ledipasvir

Australian NMI NATA Certification Daclatasvir

If you happen to be a laboratory looking for real NMR data in multiple solvents, 1H, 13C, 2D, here it all is in one place:

NMR Spectra of Sofosbuvir

NMR Spectra of Ledipasvir

NMR Spectra of Daclatasvir

 

Read 4294967295 times Last modified on Thursday, 12 November 2015 09:18