| 7 February 2012
OIA REPLY! : REPORTED DEATHS FROM ADVERSE REACTIONS TO MEDICINES/VACCINES/NATURAL PRODUCTS/ DIETARY SUPPLEMENTS
Here you go!
(Attached)
How many adverse reactions and deaths are actually reported – if reporting is NOT mandatory?
Interesting how there were 1524 reported deaths from adverse reactions to pharmaceutical drugs in 1998 – but there are apparently far less now?
http://www.scoop.co.nz/stories/GE0610/S00037.htm
Natural medicines – the safest way to avoid death
Thursday, 12 October 2006, 3:20 pm
Press Release: Coroner’s Council
12 October 2006
Natural medicines – the safest way to avoid death
A report just released by the Acting Chair of the Coroner’s Council has shown natural medicines have the lowest fatality rate of all medical treatments in this country.
Despite extensive research, coroner Dr Wallace Bain found no deaths have occurred in this country due to natural medicines such as vitamins, minerals and herbal products.
Dr Bain, who is also a trained pharmacist and lawyer, undertook the study in light of growing opposition to new legislation that will see New Zealand’s natural health industry come under Australian laws.
The safety of natural products is often sited as a reason for the need for such a move.
The Labour government plans that the Australia New Zealand Therapeutic Products Authority (ANZTPA) will soon replace the current Medsafe agency as part of a `trans-Tasman harmonisation’ push. Opponents fear this move will decimate New Zealand’s natural health industry as has already occurred in Australia.
At present lack of support from New Zealand First, the Maori and Green parties is the only thing stopping the legislation coming into effect.
Says Dr Bain: “In my capacity as Acting Chair of the Coroner’s Council, I enquired of all Coroners as to whether or not from a search of their Coronial findings they could find any instances where there had been a problem with any of these natural products.
“They were asked to provide any information from inquests where these products had been involved whether or not a death had resulted. At the same time the Coronial records held by the Ministry of Justice in Wellington were searched at my request by ministry staff.”
Dr Bain’s study returned a finding of zero deaths from natural remedies.
His only findings were:
- A three-year-old child who choked to death on a vitamin tablet in 2003 that was too large for the child to swallow
- A woman who terminated her third pregnancy after a scan showed the foetus had spina bifida. The woman had been taking 300mg of folic acid a day rather than the recommended 800mg per day
- A man who died from non-viral hepatitis of unknown origin who also had a pre-existing prostrate cancer condition. The man had been taking an Indian herbal product K4. The Corner’s report said despite no certainty of a link with the herbal product, the remedy such be banned until more was known about its effects on liver toxicity
- Some ongoing inquests into party pills
In contrast, deaths in 1998 (the last year of detailed official statistics available) caused by adverse reactions to pharmaceutical drugs killed 1524 New Zealanders and deaths associated with medical injury (mistakes by doctors and medical staff) killed 4222 New Zealanders.
Says Dr Bain: “A recent Australian study shows that 1 in 10 patients presenting to a general practitioner had an adverse pharmaceutical drug event in the preceding six months with 50% of those being in the moderate to severe range and 8% requiring hospitalisation.
“A New Zealand study reported in July of 2006 and referred to Parliament’s Health Committee pointed to previous research suggesting problems such as hospital acquired infection, drug error and staff mistakes are costing this country around $870 million a year. This prompted the Health Minister to ensure that District Health Boards gave priority to reducing such adverse events – most clearly identified as being drug induced.”
Also in Dr Bain’s report is mention of a US study that puts complications resulting from medication errors in American hospitals at $US1.5 billion dollars per year. Studies also show that prescription drug errors double a person’s risk of dying in hospital. Another study put the cost of a single adverse drug event to a hospital in the US at $US2,500.
“The estimate of costs incurred by US hospitals as a result of drug-related injury or death was put at $US76.6 billion which was three times the cost of all diabetes care in the United States,” says Dr Bain.
“What is ironic here is that what is being held out as a justification for high regulation and compliance in the area of complementary medicines and natural products in New Zealand is public safety and risk. Despite a diligent search of Coronial records and the literature, no instances have been found to demonstrate that in fact these products have any serious public health issue or risk.
“The problem is clearly with prescription and other drugs,” says Dr Bain. “The Coronial and literature searches in so far as natural products are concerned and linkages to public safety and risk can be described legally as De minimis no curat lex. That is – of minimal risk importance.
“The law does not and should not concern itself with such trifles.”
Dr Bain’s report has been sent to Annette King.
cheers!
Penny
On Tue, Feb 7, 2012 at 1:05 PM, CARM – Centre For Adverse Reactions Monitoring <carmnz@otago.ac.nz> wrote:
Dear Penny
Attached is a file with two tables covering the years 2006 to 2011.
Reports
The first table shows the total number of REPORTS received per year by CARM and these have been shown in three categories -:
MEDICINES – This includes all therapeutic regulated medicines and ‘Over The Counter’ products such as paracetamol
VACCINES - All vaccines administered in New Zealand
CAMs – Complementary and Alternative Medicines which includes ‘Natural Products’, ‘Herbal remedies’, Health Food products
Causal Deaths
The second table shows the number of cases per year where the patient died and the death has been assessed as ‘related to the adverse reaction’ or ‘the medicine may be contributory’. These are the two groupings used to indicate a ‘Causal’ association between the death and the medicine.
If you need any clarification, my contact details are below.
Regards
Janelle
Janelle Ashton
Manager Information Systems
NZ Pharmacovigilance Centre
DDI: +64-3-4799043
FAX: +64-3-4797150
Email: Janelle.ashton@otago.ac.nz
From: Penny Bright [mailto:waterpressure@gmail.com]
Sent: Thursday, 19 January 2012 6:11 p.m.
To: CARM – Centre For Adverse Reactions Monitoring
Cc: Penny Bright
Subject: Re: OIA REQUEST: REPORTED DEATHS FROM ADVERSE REACTIONS TO MEDICINES/VACCINES/NATURAL PRODUCTS/ DIETARY SUPPLEMENTS
19 January 2012
Hi Janelle,
“Can you confirm that the number of deaths assessed as related to the medicinal product groups you have listed, from 2005 to 2011, presented on a year by year basis, will meet your requirements.”
That will be fine .
Thanks!
Penny Bright
Ph: (09) 8469 825
021 211 4 127
On Thu, Jan 19, 2012 at 5:41 PM, CARM – Centre For Adverse Reactions Monitoring <carmnz@otago.ac.nz> wrote:
Dear Penny
This is acknowledgement of receipt of your email.
I have had a brief discussion with our Director today when he returned from leave and he advised me that you had also left a message on his phone.
We are going to discuss further tomorrow as I am not sure if your phone message came before or after your discussion with myself.
Looking at the detail you have requested, I will be able to provide the data from 2005 reasonably quickly but going back to 1999 to collate will take a bit of time and as I indicated on the phone, while this is not a major issue, it would have to wait till mid February when I have finished the reports required by the Ministry for the Medicines Adverse Reaction Committee meeting.
Can you confirm that the number of deaths assessed as related to the medicinal product groups you have listed, from 2005 to 2011, presented on a year by year basis, will meet your requirements.
Thank you
Regards
Janelle
Janelle Ashton
Manager Information Systems
NZ Pharmacovigilance Centre
P O Box 913
DUNEDIN, NZ 9054
DDI: +64-3-4799043
FAX: +64-3-4797150
Email: Janelle.ashton@otago.ac.nz
From: Penny Bright [mailto:waterpressure@gmail.com]
Sent: Thursday, 12 January 2012 4:15 p.m.
To: CARM – Centre For Adverse Reactions Monitoring
Cc: Penny Bright
Subject: OIA REQUEST: REPORTED DEATHS FROM ADVERSE REACTIONS TO MEDICINES/VACCINES/NATURAL PRODUCTS/ DIETARY SUPPLEMENTS
12 January 2012
Junelle Ashton
Manager
Information Services (?)
CARM
OIA REQUEST: REPORTED DEATHS FROM ADVERSE REACTIONS TO MEDICINES/VACCINES/NATURAL PRODUCTS/ DIETARY SUPPLEMENTS
Hi Junelle,
Thanks for your helpful and informative phone discussion today.
As discussed, I am requesting the following information:
REPORTED DEATHS FROM ADVERSE REACTIONS TO MEDICINES/ VACCINES/ NATURAL PRODUCTS/ DIETARY SUPPLEMENTS, on an annual basis.
It would be GREAT to have these figures on an annual basis from 1999, but I do understand that is probably a lot of work.
However, in order to send this information in the form of a submission on the Food Bill, if necessary directly to the Minister Kate Wilkinson, I would like to be able to compare reported deaths from food-bourne illnesses to reported deaths from adverse reactions to medicines, vaccines, natural products and dietary supplements?
Given that there are Annual Reports on food bourne illnesses from 2005, (including reported deaths) it would be REALLY helpful to have the comparable figures of reported deaths from adverse reactions to medicines, vaccines, natural products and dietary supplements from 2005 on an annual basis?
Hopefully that won’t be so much work!
There is a lot of public interest in this matter.
( http://www.petitiononline.co.nz/signatures/oppose-the-new-zealand-government-food-bill-160-2/1301 )
Thanks!
Kind regards,
Penny Bright
Ph (09) 846 9825
021 211 4 127
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