Questions arising from OIA response H2023031262
Catherine Jamieson made this Official Information request to Ministry of Health
Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: Catherine Jamieson
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
From: OIA Requests
Kia ora Catherine
Thank you for your request for official information. The reference number
for your request is: H2023032533
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
If you have any queries, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
------------------- Original Message -------------------
From: Catherine Jamieson <[FOI #24490 email]>;
Received: Fri Oct 20 2023 16:09:00 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Questions arising from OIA
response H2023031262
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).’
[6]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
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From: Catherine Jamieson
Dear OIA Requests,
Please supply the answers to these questions.
Yours sincerely,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine
This request was consolidated with another similar request and responded
to under reference H2023032271. The response to this request was provided
to you on 6 November 2023. The response letter has been reattached for
your convinience.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at:
[email address] or by calling 0800 802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
--------------------------------------------------------------------------
From: Catherine Jamieson <[FYI request #24490 email]>
Sent: Tuesday, 20 February 2024 06:46
To: OIA Requests <[email address]>
Subject: Re: Acknowledgement of your request for official information ref:
H2023032533 CRM:0261834
Dear OIA Requests,
Please supply the answers to these questions.
Yours sincerely,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine
Thank you for your request for official information. The reference number
for your request is: H2023032533
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]https://aus01.safelinks.protection.outlo...
If you have any queries, please feel free to contact the OIA Services
Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so
that
these can be taken into account.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FYI request #24490 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[3]https://aus01.safelinks.protection.outlo...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
3. https://fyi.org.nz/help/officers
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