28 days then discard rule

Re: 28 days then discard rule

Anthony Todd — Thu, 18 Nov 2010 14:04:16 GMT

[quote user="Peter Ding"]it is not illegal for a vet to use an injectable on day 32 after opening.[/quote]

Can you quote me chapter and verse on this because, although I am confident of my common sense and duty of care, I'd hate one of mine to be made the example.

Certainly there is wide extrapolation when it comes to "animals under our care" as an arbitrary period. usually 6 or 12 months is quoted as "The Law" when, of course, its no such thing.

Re: 28 days then discard rule

Peter Ding — Thu, 18 Nov 2010 11:29:03 GMT

..the extrapolation was referred to on a website but actually occurs in real life Jonathon, Some vets appear to anticipate that any deviation from a practice standard or guideline will be automatically penalised in law. I would suggest it all depends on circumstance....it is not illegal for a vet to use an injectable on day 32 after opening.

Re: 28 days then discard rule

J G Wray — Wed, 17 Nov 2010 15:32:24 GMT

[quote user="Martin Atkinson"]I'm struggling to understand what some nut-job who went round murdering his patients has to do with legislation on using a multi-use bottle after 28 days. Can someone oblige?[/quote]

Happy to oblige. It doesn't. It was my answer to a question about why some people extrapolate on a website where extrapolation is tolerated. Ironic huh?

JGW

Re: 28 days then discard rule

Mark Holmes — Wed, 17 Nov 2010 14:12:04 GMT

[quote user="Martin Atkinson"]Isn't the danger just the opposite that they'll see us as soft targets? Like the taxman who found something trivial to keep his bosses happy but in his excitement left bigger stones unturned[/quote]

I guess it might, but surely lots of beaurocrats, each trying to be enthusiastic, career minded and and concientous are inherently more likely to meddle than a handful, each of them stressed, over worked and disillusioned.

Re: 28 days then discard rule

Martin Atkinson — Wed, 17 Nov 2010 13:18:33 GMT

[quote user="Mark Holmes"]

It occurred to me that one of the benefits of underfunded public services is that the staff that are left are too busy to worry about meaningless anomilies. They are too busy to worry about having to justify their jobs and will therefore leave us all alone.

[/quote]

Isn't the danger just the opposite that they'll see us as soft targets? Like the taxman who found something trivial to keep his bosses happy but in his excitement left bigger stones unturned.

Re: 28 days then discard rule

Malcolm Ness — Wed, 17 Nov 2010 12:02:34 GMT

[quote user="Mark Holmes"]. " it doesn't matter nobody will care"[/quote]

Anybody that believes anything that a civil servant says, but doesn't commit to paper needs their head read!!!

Re: 28 days then discard rule

Mark Holmes — Wed, 17 Nov 2010 10:49:44 GMT

[quote user="Peter Ding"]

By that do you mean media driven paranoia, extrapolating ad absurdam?

I was actually referring to what goes on in a person's head when they decide to apply a "standard" or "guideline"unthinkingly to the detriment of the individual case. Rather than assessing the risk themselves and making a judgement. Is it because we seek greater insulation from perhaps unfounded fears of litigation?

[/quote]

Absolutely this has always been my problem with rules, they get appleid without thought often to the detriment of the situation. I have recently had experience of the future though, it looks promising.

I had cause to approach DEFRA regarding a small paperwork anomily, from a practical point of view it was meaningless but it is the sort of thing thta might have been a headache. However thanks to government cuts, the office is under some strain and is short of staff. Their approach was... " it doesn't matter nobody will care"

Re: 28 days then discard rule

Martin Atkinson — Wed, 17 Nov 2010 10:36:48 GMT

[quote user="Jonathan Wray"]

Shipman

JGW

[/quote]

I'm struggling to understand what some nut-job who went round murdering his patients has to do with legislation on using a multi-use bottle after 28 days. Can someone oblige?

Re: 28 days then discard rule

Bob Russell — Wed, 17 Nov 2010 09:17:33 GMT

So far only seen the negatives from Steve Dean - 'you cannot do that, or that, or that'. I have obviously missed the positives.

Re: 28 days then discard rule

J G Wray — Wed, 17 Nov 2010 09:10:08 GMT

[quote user="Peter Ding"]By that do you mean media driven paranoia, extrapolating ad absurdam?[/quote]

To some degree, but in Shipman's case responsibility and accountability wound up on the doorstep of bureaucrats, something which is , of course, unfamiliar and intolerable, ergo rules ostensibly to protect the public.

[quote user="Peter Ding"]Is it because we seek greater insulation from perhaps unfounded fears of litigation?[/quote]

It is not the fashion or will of politicians of any hue to allow professionals their head, because of Shipman etc. Therefore regulation and the law is constructed in a manner which makes taking a risk in clinical decisions, not worth the risk in personal terms.

Having said that and to borrow from another thread, the AMI inspection we had yesterday went well because we conform and on matters where we are helping ourselves to improve on conformity and can justify our view, the inspector was prepared to be flexible.

So, as I see it we get better regulation from these organisations if we lead rather than baulk and where there are silly anomalies we, through BVA, should encourage VMD to take common sense up with European authorities. Steve Dean, a positive advocate for common sense and a friend of the profession, ain't going to be there forever. Shame on those who have indentified him as a negative.

JGW

Re: 28 days then discard rule

Peter Ding — Wed, 17 Nov 2010 08:29:51 GMT

By that do you mean media driven paranoia, extrapolating ad absurdam?

Re: 28 days then discard rule

J G Wray — Wed, 17 Nov 2010 07:11:30 GMT

[quote user="Peter Ding"]Why do some people create "rules" where only "standards" and "guidelines" exist?[/quote]

Shipman

JGW

Re: 28 days then discard rule

Anthony Todd — Wed, 17 Nov 2010 04:12:16 GMT

[quote user="Jonathan Wray"] "..more driven by finances than anything else at present..."[/quote]

Sure, and why not? When the "drive" is against unnecessary cost , actually pure waste, with no scientific evidence, no record of problems, no valid reason apart from the human rule of discarding an open vial, with no preservative, after 28 days against the knowledge that the injection has been given for umpteen years with no adverse effects and continuing efficiency for months after broaching.

When you think about it would you like to have an injection of anything which has been in an open container for 28 days???

I'll bet doctors apply common sense and discard it well before then, probably after they have drawn up the single dose.

Just another example of professionals using common sense and not following bureaucracy!

Re: 28 days then discard rule

Peter Ding — Tue, 16 Nov 2010 18:00:02 GMT

Why do some people create "rules" where only "standards" and "guidelines" exist?

In my view such things should be on a "best endeavour" basis and should certainly not compromise animal welfare by making some important treatments unavailable or uneconomic. Alizin being a possible case in point.

Re: 28 days then discard rule

J G Wray — Wed, 10 Nov 2010 14:06:00 GMT

[quote user="Emily Nightingale"]Thanks for asking me what I think though Mr. Wray.[/quote]

No problem.

[quote user="Emily Nightingale"]We have been using little white stickers for "date of opening" on all injectables[/quote]

Hmm. Do they obscure any label detail? We have been putting on use by dates in pen. That way the calculation is made once when broached, rather than every time a product is picked up.

[quote user="Emily Nightingale"]

Now I actually have to think of an answer !!

1) Follow the rules 100% (My employer who is obv more driven by finances than anything else at present may disagree but on the whole we do try to stick to the rules)

[/quote]

"..more driven by finances than anything else at present..." It's nice to be in a postion of absence of responsibility for a larger picture. I'm also glad your employer is enlightened enough not to mind you telling us what drives them currently and speculating on their point of view on a list like this.

You have asked them haven't you?

JGW

Re: 28 days then discard rule

Clive Ansell — Wed, 10 Nov 2010 12:49:20 GMT

I begin a new locum position next Monday, if there bottles of unlabelled and undated injectables should I refuse to use them and throw them away because I cannot be sure they are with their 28 day breach date limit ?????

Not practical, unworkable, and unenforceable.

Re: 28 days then discard rule

Anthony Todd — Wed, 10 Nov 2010 12:05:02 GMT

[quote user="Martin Atkinson"]If we agree that the 28 day rule is just another example of bureaucracy gone mad and arbitrarily applied[/quote]

Does anyone not agree that this is so.

Why then are all of the posters just meekly trying to follow the regulation?

There has been no evidence produced whatsoever that any injectable becomes unsafe after 28 days with the sensible but infrequent recommendation of a shorter discard date for some injectables where this has been shown, by testing or experiment, to be necessary.

I'm not sure that using 4 year old insulin would be something I would do, except in an emergency, and I'm sure there would be some deterioration demonstrated but it gives some idea of where discard dates may be after trials and data collection.

As I have said before, noone has shown that there is a problem, noone has produced any evidence of deterioration after 28 days yet all us sensible scientifically aware vets blindly just accept this and throw common sense, our training and our scientific reason out the window 'cos it is a regulation.

Exasperating!!

[I was tempted to use an imoticon, whatever that is]

Re: 28 days then discard rule

Martin Atkinson — Wed, 10 Nov 2010 10:49:04 GMT

If we agree that the 28 day rule is just another example of bureaucracy gone mad and arbitrarily applied, then we as intelligent people can apply common sense in an arbitrary manner and use our own judgement. Challenge the VMD to make a test case if they wish and see if any sane judge or jury would think there was any sense in assuming a product is any less effective on day 29 than day 27 and if they would condemn our motivation for trying to save clients money by using perfectly safe and effective products for longer. I have used soluble insulin that was 4 years out of date - let alone past 28 days since opening (not with intent I add, it was all I had in an emergency) and it worked perfectly well in a patient in DKA. If something as supposedly as fragile as insulin is safe and effective that long after opening then surely all the other products metioned previously in this thread and more can survive as well.

Re: 28 days then discard rule

Bob Russell — Wed, 10 Nov 2010 10:48:06 GMT

We comply as best we can. Only one bottle of each drug is open at a time. Otherwise no comment

Re: 28 days then discard rule

bob lehner — Wed, 10 Nov 2010 10:17:49 GMT

[quote user="Clive Ansell"]

Of all of the practices I know, none of them write a date or stick a label on a new bottle or vial when opening. How do you all know when you reach the 28 day deadline?

What is the punishment, if any, for breaking this rule? is it the responsibility of individual vets or practice owners?

[/quote]

1. Without labelling the bottle on first broaching it you can't know when the deadline is reached.

2. Apart from just being a law-abiding MRCVS, I guess the only realistic way you would run into trouble by not discarding appropriately would be if the animal threw an adverse reaction to the product. If you then reported this as a SAR and it came to light that the bottle was beyond the due discard date, then the manufacturer would probably not support you - and if (perhaps a bit unlikely, but possible) the owner/owner's lawyer became aware of this, then you would be in a sticky situation and I would hazard a guess that your professional indemnity insurer might not be too happy.

I suppose also if you had a VMD inspection and they saw unlabelled bottles they could take action against you - and a PSS inspection would require you to rectify the situation.

I think it is the responsibility of the practice owner to ensure that everyone is aware of the rules and to set up the appriopriate protocols for labelling - but ultimately it is the responsibility of the individual v.s. to comply.

Having said that, compliance with the rule is clearly a problem. Best practice is, as others have pointed out, to keep tight control of stock, don't have more than one open bottle of any product in circulation, don't duplicate similar products, buy the smallest bottle-size available, use oral preparations where possible etc. However it doesn't get round the problem of injectable products which you do need, but use infrequently.

The profession needs to lean on the pharmaceutical companies to produce smaller volume products - but of course it is not really in their interests to do so.

Re: 28 days then discard rule

Clive Ansell — Wed, 10 Nov 2010 08:09:59 GMT

Of all of the practices I know, none of them write a date or stick a label on a new bottle or vial when opening. How do you all know when you reach the 28 day deadline?

What is the punishment, if any, for breaking this rule? is it the responsibility of individual vets or practice owners?

Re: 28 days then discard rule

Emily Nightingale — Wed, 10 Nov 2010 08:02:40 GMT

Dear Mr. Wray,

Oh bless you. =) Thank you for so cleverly turning my own question back around on me Now I actually have to think of an answer !!

1) Follow the rules 100% (My employer who is obv more driven by finances than anything else at present may disagree but on the whole we do try to stick to the rules)

2) We do only keep 1 bottle of the injectables open on the go, apart from Metacam (ops+cons+2 branch surgeries). The question arose with what to do with <2kg cats that require NSAIDS- In the end we decided to circulate 1 open bottle of Rimadyl between branch surgeries and swap over with the one on ops when it gets to 7-14 days from opening so ops can use it up. Alizin can be circulated too, as usually the appointments are booked in advance and therefore we can bring a couple of bottles along to each branch and then back to main hosp as required.

We have been using little white stickers for "date of opening" on all injectables (Bar Pentoject- see previous thread) in line with keeping up to practice standards.So all in all, we are doing what we can to stick to the rules.

The Panomec from 10-08-08 is going in the bin and a new one will be ordered. =D

Thanks for asking me what I think though Mr. Wray.

Yours, in gratitude, Miss Nightingale DVM MRCVS.

Re: 28 days then discard rule

J G Wray — Wed, 10 Nov 2010 07:25:20 GMT

[quote user="Emily Nightingale"]What, in reality, do you think we should do? Stick to the rules, or bend them, or break them?[/quote]

Dear Ms Nightingale,

Never mind what anyone else thinks, what do you think and what do you want to do? You are a MRCVS, an adult, capable of free thought and, I would speculate capable of idnignation if anyone suggested, never mind told you how to work, so what do you think should happen?

JGW

Re: 28 days then discard rule

Michael Woodhouse — Tue, 09 Nov 2010 22:34:56 GMT

[quote user="Mark Hedberg"]

Interesting, I would have thought injectable fluoroquinolones would move rather well. (Just a random musing, really...)

[/quote]

Personally use them as little as possible. Also only do a little small animal work, mainly large animal practice.

Re: 28 days then discard rule

Laurence Webb — Tue, 09 Nov 2010 22:30:32 GMT

We're pretty good (but not perfect!) about not using drugs after the 28 days have elapsed despite being a small practice (2 vets) so our drug turnover is less that it would be in a larger place. It does have an effect on our pricing and drug choice thought.

Drug mark-ups vary between regularly used drugs that are always used before the 28 days are up and those that aren't. Some drugs have higher that normal mark-ups so that we can discard unused stuff without losing out. On some injectables I've introduced a minimum charge so that, even if you just inject a fraction of a ml clients are charged for a minimum of (eg) 5ml. On some drugs this extends to charging for a whole bottle, such as Alizin, but at a smaller mark-up, if an.

Drug choice has also been influenced by the day rule. We use Marbocyl instead of Baytril as Marbocyl injection comes in 20ml bottles whilst Baytril is 50ml. We stopped stocking Tardak as it was being used so infrequently that it was never used up and it was prohibitive to charge clients for a whole bottle, even if just at cost price, so we use Ypozane and Suprelorin instead.

It's not perfect and there are still drugs that are difficult to work out a price that covers our costs (and you'd hope to make a profit!) without being unaffordable to clients. Panomec is a good example. £50 per injection anyone?

The other thing we avoid is multiple bottles of 1 drug on the go at once. We have 1 bottle of Metacam for the consulting room and 1 for operating as it gets used up so rapidly, but otherwise we only have 1 bottle of anything open at once. I worked at a practice where 1 single vet branch had 8 (I counted them once) bottles of ketamine open at once. Doubt many of them were used within the 28 days. Don't recall a ketamine drug register either!