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With great power comes great responsibility

-Spiderman!

To redact a digital document you need to understand a few things:

1) Digital documents can consist of layers so although what you see looks like you scribbled over the top of something it could be that you scribbled on a new layer – as a result the old layer still exists intact, and although the visual representation might look like what’s underneath is hidden, to a computer it is still their plain as day.

2) With all digital documents there is METADATA http://soft-xpansion.eu/files/cc/Metadata.pdf – so if you create a document on your device, chances are details about you were automatically added into this metadata and will still be there even if you made the entire content of the document blank. You can use this tool to read it:

http://www.extractmetadata.com/

For example if you download and check this document http://fixhepc.com/images/coa/NMR-spectra-of-sofosbuvir.pdf

You will see

Result

Mimetype application/pdf
Title Reports template
Author name National Measurement Institute
Created by software Microsoft® Word 2010
Produced by software Microsoft® Word 2010
Page count 24
Format PDF 1.5
Creation date 20150925095622+10'00'
Modification date 20150925095622+10'00'
Mimetype application/pdf

If you check some of the other documents here: http://fixhepc.com/blog/item/16-testing-provisions-patient-safety.html

You will find for example this for the document: http://fixhepc.com/images/coa/NMI-NATA-Sofosbuvir-Certification.pdf

Result

Mimetype application/pdf
Title Analysis report template
Subject Steroid RMs analysed by GC-FID
Author name PSRM-NARL
Created by software Microsoft® Word 2010
Produced by software Microsoft® Word 2010
Page count 3
Format PDF 1.5
Creation date 20151007171208+11'00'
Modification date 20151007171208+11'00'
Mimetype application/pdf

Which tells us that NMI used a Template and that it was probably a document called “Steroid RMs analysed by GC-FID”.

3) Ever wonder how the “Undo” button works?

The undo button on (say) word works like this. For each change a “note” is added saying “user changed this”.

The version you see represents the original + all the changes you have made since the last “Save As”.

So if you send a Word document that has not had a “Save As” for a while the recipient will be able to use the back button to read previous versions.

“Save As” flattens the document – combining all the changes into one fresh document that has the “Undo” button disabled simply because all the changes got incorporated and the change notes were deleted.

Graphics programs that have layers have a function called “Flatten” then adds all the layers together to produce a single image, however Graphics Program, Word Doc, or PDF there will still be Metadata in there.

Please take steps to protect your privacy. Although there is nothing to be ashamed of for having contracted an infectious disease, if you don’t want to have people find out your name make sure it’s not there to be found…..

No I could not prescribe it (on the PBS). I could prescribe it privately but it costs $14,000

The PBS listing is here: http://www.pbs.gov.au/medicine/item/10197q-10200w

It’s an authority item. Click on the red “Authority Required” and you will see the requirements to qualify for it are:

Chronic genotype 1 hepatitis C infection

Clinical criteria:

Patient must have compensated liver disease,

AND

Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,

AND

The treatment must be in combination with peginterferon alfa and ribavirin,

AND

The treatment must be limited to a maximum duration of 12 weeks,

AND

The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.

Population criteria:

Patient must be aged 18 years or older,

AND

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Treatment criteria:

Must be treated in an accredited treatment centre.

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient’s medical records.

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient’s medical records.

Authority Required
Chronic genotype 1 hepatitis C infection

Clinical criteria:

Patient must have compensated liver disease,

AND

Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C,

AND

The treatment must be in combination with peginterferon alfa and ribavirin,

AND

The treatment must be limited to a maximum duration of 12 weeks,

AND

The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.

Population criteria:

Patient must be 18 years or older,

AND

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Treatment criteria:

Must be treated in an accredited treatment centre.

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient’s medical records.

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient’s medical records.

So it you wanted to have Interferon and Riba as well, and you were being treated in an accredited treatment centre (read Liver Clinic) it can be prescribed.

The 4 °C (fridge temp) is only required for a few medications. Thyroxine is an example. Sofosbuvir, Ledipasvir and Daclatasvir are, according to the manufacturers, fine at room temperature.

The original manufacturers of Sofosbuvir, Ledipasvir, Daclatasvir say this in their CMI:

Keep HARVONI tablets in a cool, dry place where it stays below 30°C

Store DAKLINZA tablets in a cool dry place where the temperature stays below 30°C.

More or less all medications say something like this.

For reference:

Sofosbuvir: Melting point. 95-100 ºC
Ledipasvir: Melting Point: 186 – 190ºC
Daclatasvir: Melting Point: 166-172°C

So you could almost certainly store them at > 30 °C but if you follow the < 30 °C recommendations everything should be fine.

You could send it to:

Dr Greg Tarrant
Senior Synthesis Chemist, Chemical Reference Materials
Ph: +61 2 9449 0180 | Fax: +61 2 9449 0292
greg.tarrant@measurement.gov.au
National Measurement Institute
105 Delhi Rd, North Ryde, NSW 2113, Australia

Normally it would be:

Dr Stephen Davies
Team Leader, Chemical Reference Materials
Ph: +61 2 9449 0183 | Fax: +61 2 9449 0292
stephen.davies@measurement.gov.au
National Measurement Institute
105 Delhi Rd, North Ryde, NSW 2113, Australia

But he is away for 3 weeks.

The National Measurement Institute did our testing.