Dear Mr James

This is a request for information pursuant to the Official Information Act.
Thank you for your recent replies. In order to understand some of the information, I have some further questions please. Recent OIA materials have informed
-reports associated with death of the consumer are never identified in SMARS and were not identified in the COVID-19 vaccine safety reports for privacy.
-reports where death is the only reported reaction are not included in the line listing;

OIA response H2023031262 refers to caveat text. Can you please confirm that this refers to the following text on the link below:-

‘any report where it is considered the patient may be identifiable (eg due to the rareness of the condition).’
https://www.medsafe.govt.nz/Projects/B1/...

Can you please answer the question that remains unanswered in OIA response H2023032008 and confirm whether or not the aggregated material from the Covid 19 Medsafe Safety Reports includes AEFI-A numbers not included in the line listings because they are associated with a report of death or otherwise.

I understand reports cannot be removed from the system they can only be made invalid and that criteria for a valid report are:-
1. one patient identifier (eg, name, initials, gender, date of birth, age)
2. suspect medicine(s)
3. suspected reaction(s)
4. reporter details.

What mechanism is used to remove reports of where death is the only reported reaction and reported terms of death from line listings? Is it a manual or automated process? If automated please provide the date at which it became automated.

If an assessment number is missing from a line listing can there be other reasons for that other than the report being marked invalid or it being associated with a report where death is the only reported reaction?

What is the treatment for an update made to an existing report where death is the only reported reaction in the update? Is this report then removed from the line listing?

In H2023032008 it is stated that with regard to safety reports

‘counts may change due to receipt of additional information. This may mean some reports are determined to be invalid or incorrect when further information is made available..the information may change over time, due to quality control procedures and/or receipt of further information’.

There are AEFI-A numbers that were included in Safety Report 46 that are not included in the line listing posted 28/8/23. Can you please supply the suite of all reasons these AEFI-A numbers have not been included ie not satisfying the criteria for a valid report, duplicate reports etc.

As the vast majority are very early reports it is unlikely they have been omitted post December 2022 due to being invalid - this would be fairly belated wouldn't it? If a further report was made with updated symptoms and given another assessment number rather than an update to intial report, which report would be retained - the earlier with update information or the later including the prior information? Or are they both retained and linked somehow?

In addition to direct contact with the reporter or patient what are the different specific processes whereby updated information can be received and what systems or procedures are used?

Furthermore, allowing for the omitted reports there are 355 more AEFI-A numbers in the line listing posted 28/8/23 than in Safety Report 46 yet there are in the realm of 13,000 less lines in the line listing posted 28/8/23. In addition there are duplicate rows in the line listing posted 28/8/23 and there do not seem to be duplicate rows in report 46. Can you please provide explanation as to what has caused this unusual presentation? Please include any communications, procedure or policy documents or reports that reference the reason for this or provide explanation partial or full.

I appreciate your assistance with this. There may be process/procedure documentation that cover answers to some of these questions. I do wonder whether CARM (now moved to within Medsafe I understand?) has been adequately resourced to manage 240k line entries. I understand there has been introduction of new IT systems too within this tumultuous time. Are you able to provide me with the org structure of CARM as it was for 2021-23 and the org structure of whatever replacement structure now sits within Medsafe (if that is correct).

Yours sincerely,

Catherine Jamieson

Dear OIA Requests,

Please supply the answers to these questions.

Yours sincerely,

Catherine Jamieson