A sign of the digital times, or more red flags?
PRODUCT INSERT CHANGES
Australia’s Therapeutic Goods Administration (TGA) has long required that administered injectable medicine products include a hard copy of the product information (PI) in the packaging.
For more than 30 years, under the powers of Section 28(2B) of the Therapeutic Goods Act, the TGA has required a printed version of the PI (often referred to as the approved “labelling”) to be available as a package leaflet in the marketing of injectable products.
Of course, ask most people if they have ever seen or received any of these leaflets from their local GP, and you will get a confused look. Nonetheless, they were still available if requested (or demanded).
It was often a good tool used by the pro-choice movement to educate people on any risks that may be associated with any jab, the ingredients used in the injectable products, and more.
For healthcare professionals, their rationale was that leaflets provide them with immediate access to information relating to the correct administration of the product (i.e. routes of administration, reconstitution/dilution requirements, incompatibilities etc) and the safety profile associated with use.
But, after broad consultation last year, the TGA will drop the requirement for PI to be included in packaging for injectable products administered by healthcare professionals.
“From 1 September 2023, printed Product Information (PI) inserts won’t be required in the packaging of injectable medicines administered by health professionals.”
Yes, in response to ‘broad stakeholder consultation’ (you can fill in the blanks there), the TGA will cease mandatory requirements for package leaflets.
They say due to ‘the growth of the internet’ and ‘cloud-based software’, the original printed information should be entirely replaced by “electronic distribution channels”.
In other words, a doctor will tell you ‘go to the website and leave me alone’.
The specific conditions included in these new changes are:
- The change applies only to products administered by healthcare professionals. Products that are self-administered, or can be administered by healthcare practitioners or patients, are still required to include a package leaflet of the PI; and
- The TGA retains the authority to impose the PI package insert requirement where they consider it necessary for the ‘safe and effective’ use of a product.
They also say there will be advantages for production costs due to the dramatic reductions in physical resource requirements (paper), with ‘corresponding benefits’ to the ‘environmental footprint’.
Ah yes, we have to throw in the old ‘saving the planet’ green pitch as the cherry on top of the cake.
I have a hard enough time finding the correct FULL product pamphlets relating to vaccines, so we can imagine how many people (who may be less technological literate as myself) will be left in the dark.
What do they have to hide that they would be making these changes right now?
Ahead of universal mRNA vaccine trials, calls for new boosters, and more. Very interesting.
It also sounds familiar to everything else we have been witnessing over the past few years in the transition away from the physical, including cashless pushes, the end of land ownership papers and more.
And is a shady testament to changes they have been making in regards to the removal or changing to injectable product data and information.
The reason as to why these changes are a red flag all situate around the fact that the TGA and health official lackies have repeatedly covered up, altered, and downplayed injectable product data.
Just recently, the TGA announced that reports on myocarditis and pericarditis cases following mRNA-based COVID-19 vaccines are not necessary anymore and will no longer be provided.
Further hiding and downplaying the impacts of the biological injectables they let loose on us all.
The TGA, out ‘national drug authority’, says this is because ‘the rates have stabilised’, but they will ‘continue to monitor and review these adverse effects and will communicate any updated safety advice’.
Great, we’ll just leave it to you then! Sounds good!
We have also seen reporting on state levels experience the same type of ‘funny business’, including in NSW, where earlier this year the Health Department removed vaccine status from hospitalisation data.
This followed the overwhelming majority of patients being administered falling under the “vaccinated” category, and with the reasoning ‘well, everyone’s got one now, so we can’t really tell’, they removed it.
‘Can’t really tell’ is a classic theme for the NSW government.
Remember when they quietly announced one morning in 2021 that they would re-classify COVID death statistics to include ‘died with’, not just ‘died from’? The reasoning? They couldn’t determine differences!
Not to mention that over 90% of people who were hospitalised with ‘COVID-19’ had two or more co-morbidities recorded when they were checked in suffering from ‘the virus’.
Once again, as we have repeatedly witnessed over the past few years, health authorities are back again to make things just that little bit more difficult to determine, while covering their tracks even more.
What do you think about all of these changes?
Should doctors be required to provide a pamphlet to each individual physically?
Is the excuse for removal of adverse event data from reporting good enough?
Be sure to leave your thoughts down below!
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