Adverse reactions (part 1)

Re: Do you report adverse reactions to VMD?

Arlo Guthrie — Fri, 05 Feb 2010 10:30:28 GMT

Sorry everyone, we've been tinkering with the questions on that originally appeared on this thread, which renders previous votes void.

I've copied the poll over to a new thread now (the only way to reset the votes).

http://www.vetsurgeon.org/forums/t/4227.aspx

If you voted on the last poll, could you vote again on the new one!

Please don't reply to this thread, and instead take up where we left off on the new thread.

Re: Do you report adverse reactions to VMD?

Mike Martin — Fri, 05 Feb 2010 09:44:41 GMT

So everyone is refreshed with the comprehensive nature of what an adverse reaction is, here is a precise from the VMD website:

Suspected Adverse Reaction (SAR) is a harmful and unintended reaction to a veterinary medicine when administered to an animal (including birds, fish and bees) at its normal dosage. This is an adverse reaction which is fatal, life threatening, disabling, incapacitating or which results in permanent or prolonged signs.
Unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics. This includes a Lack of expected efficacy that might involve a veterinary immunological breakdown eg a vaccine breakdown or a veterinary pharmaceutical product and includes drug resistance.
Adverse reactions to people, due a veterinary medicines/product.

I must confess a wee bit of skepticism that anyone could have truely reported every adverse reaction that have ever seen (or even recognised), when you consider all the above.

An example of lack of efficacy..........in my opinion Hypercard (diltiazem) lacks efficacy in the treatment of Hypertrophic Cardiomyopathy in Cats (maybe I can't say that here?). But I've not reported it because it is something that would be difficult to prove without rigorous clinical trials.

But I am impressed that people are reporting. Are you in the minority or majority? Will this poll determine that?

Re: Do you report adverse reactions to VMD?

Arlo Guthrie — Thu, 04 Feb 2010 23:01:02 GMT

Poll added - votes anonymous

Re: Do you report adverse reactions to VMD?

J G Wray — Thu, 04 Feb 2010 22:37:41 GMT

***Typo**** *Typo****

I wrote:

[quote user="Jonathan Wray"]This is a problem for VDS [/quote]

This should of course read

This is a problem for VMD. The VDS might not cover this, but could probably advise.

Re: Do you report adverse reactions to VMD?

J G Wray — Thu, 04 Feb 2010 22:34:33 GMT

It's SARSS and there's a legal problem with it.

You use the yellow form MLA252A. It says "In confidence" on it

http://www.vmd.gov.uk/General/Adverse/mal252.pdf

The Yellow form does not necessarily contain any owner information

VMD receive the form and turn the information over to the manufacturer referred to on the yellow form as the Marketing Authorisation Holder.

The Company then takes up the investigation

Beware, this is the point at which you need to have explicit informed consent from the owners to divulge details of the use of this drug to the company. This information which relates to a service provided as well as a product supplied for use/used on the owner's property (animal) may be Data Protection Act protected material. Check your practice's DPA registration form and exemptions.

Think of this another way. How would you like your contact details divulged by a third party to a multinational organisation without being asked? Or, how many of you give your client details to drug companies unless you have a specific exemption in your DPA registration document and state this in your Terms and Conditions?

This is a problem for VDS which they know about and rely on the companies' ethical policies in respect of dealing with vets and their clients. However, they haven't checked any of these. They have a gentlemans agreement between themselves and the companies, but , ooops, forgot to include the other stakeholder in the equation, the vet in this agreement.

If you are divulging client details which are DPA protected and please distinguish these from animal details which are not DPA protected, because animals can't own their own data, then consider what you will do if a client doesn't want the details of a SARSS passed on and complains.

Then, by extension lots of SARSS is exactly the sort of thing which generates a product recall when vets are asked to list all the clients whose animals are supplied with a drug. How does anyone propose they get consent from hundreds of clients for a product recall?

VMD's answer is that DPA is overruled because there is a public interest. They haven't asked the Information Commissioner, and won't specify what the threshold for public interest is, but who cares? Well, vets will if clients take umbrage.....

Regs

JGW

PS VMD do know about this problem and are happy for vets to take the risk, because it ain't their problem.

Re: Do you report adverse reactions to VMD?

Stephen Courtney — Thu, 04 Feb 2010 22:13:39 GMT

I report all adverse reactions now, but until a couple of years ago it rarely crossed my mind.

Re: Do you report adverse reactions to VMD?

Julian Earl — Thu, 04 Feb 2010 21:59:37 GMT

Yes, always, even the trivial; in fact I was once complimented by the VMD for my enthusiasm.

Why so? Because I believe we need to know true risks, not just what data sheets say... or perhaps I am just overly cynical.

Re: Do you report adverse reactions to VMD?

Noweia — Thu, 04 Feb 2010 19:38:02 GMT

I report any reactions I can clearly put down to a specific drug, which usually turns out to be vaccines. i use the forms in the back of the formulary and have done so twice in the last month or so.

Re: Do you report adverse reactions to VMD?

listhestar — Thu, 04 Feb 2010 19:05:59 GMT

Yeh I think that covers most options I can think of.

lisa

Re: Do you report adverse reactions to VMD?

Arlo Guthrie — Thu, 04 Feb 2010 18:37:59 GMT

Good idea. What do you think is the right question / answer?

Something like:

Do you report SAR's to the VMD?:

a) Always, whenever I encounter them
b) Only with regard to severe SARs
c) Only with regard to drugs that are new to the market
d) b AND c above
e) Rarely
f) Never