Data Sheets in every box.....

RE: Data Sheets in every box.....

Rob Loxley — Thu, 03 Jan 2019 08:45:17 GMT

[quote user="Judith Archbold"]The whole thing is bonkers because most clients won‘t read them[/quote]

But if some clients do read them and therefore notice the odd, rare side effect maybe it's not entirely bonkers?

I think the onus should be on drug manufacturers to help in supplying copies of datasheets, especially where drugs are supplied in bulk packages. Either with the bulk package - as many currently do - or as separate pads - as some do.

RE: Data Sheets in every box.....

Martin Atkinson — Thu, 03 Jan 2019 08:40:22 GMT

[quote user="bob lehner"]''If a product is placed into a container which hasn’t been authorised as part of the MA (for example tablets being supplied in a standard bottle with a child resistant closure) sufficient written information must still be provided to make sure the product is used safely.''[/quote]That doesn't say that we have to provide a data sheet with all the potential side effects for the intended patient. All my labels say 'For animal treatment only', 'Keep out of the reach of children', and where appropriate such as cytotoxic drugs or Felimazole for example', 'Do not break tablets, wear gloves when handling'.

RE: Data Sheets in every box.....

Bob Russell — Wed, 02 Jan 2019 16:15:00 GMT

Just tried to download a datasheet from the ~VMD website for prednisolone but it is six pages long and reducing font size just makes the printing on the six pages smaller!

Pretty useless really!

RE: Data Sheets in every box.....

Nicola Cole — Wed, 02 Jan 2019 15:54:49 GMT

[quote user="Martin Atkinson"]

As regards human medication the pharmacist certainly doesn't provide a copy of the data sheet with my regular tablets they dispense out of the original packaging.

[/quote]

Same here with a recent medication that wasn’t in original packaging-hence my question as was curious as to why I’d received no data sheet on it (nor verbal warning about side effects!)

RE: Data Sheets in every box.....

bob lehner — Wed, 02 Jan 2019 15:53:39 GMT

[quote user="Martin Atkinson"]In answer to the question - nothing. I wasn't even aware we were supposed to, it certainly wasn't mentioned at my last VMD visit.[/quote]

VMD Guidance Notes on the Retail of Veterinary Medicines:

''If a product is placed into a container which hasn’t been authorised as part of the MA (for example tablets being supplied in a standard bottle with a child resistant closure) sufficient written information must still be provided to make sure the product is used safely.''

RE: Data Sheets in every box.....

Anthony Todd — Wed, 02 Jan 2019 14:52:49 GMT

[quote user="Andrea Tarr"]The advantage of written information, given with a medicine, is that it can be read after leaving the practice, when questions and uncertainties can arise (e.g. if an adverse effect has appeared)[/quote]

Can someone just tell me what was wrong with dinovets' instruction, oft repeated twice and by the receptionist on the way out to "ring us with any problems or questions".

I wonder if anyone has bothered to enquire from recipients ever or at all........

I would capitulate totally if someone would quote some problems with dinovets' old system as above but it seems that this is something someone thought is a good idea based on sweet FA and a lot of time on their hands.

I bet clients still ring just as often with questions that are clearly covered in the copious newspaper supplied with every few tablets!

RE: Data Sheets in every box.....

Judith Archbold — Wed, 02 Jan 2019 14:30:47 GMT

10.1.21 of the PSS modules indicates we are expected to either supply an SPC with each medication or to explain everything on the label ...which is not possible.

The whole thing is bonkers because most clients won‘t read them. I always explain what the medication and what it does and the main potential side- effects in a consult anyway.

RE: Data Sheets in every box.....

Martin Atkinson — Wed, 02 Jan 2019 14:14:37 GMT

[quote user="Judith Archbold"]What is everyone currently doing re regs to give out data sheets with every dispensed medication?[/quote]In answer to the question - nothing. I wasn't even aware we were supposed to, it certainly wasn't mentioned at my last VMD visit.

As regards human medication the pharmacist certainly doesn't provide a copy of the data sheet with my regular tablets they dispense out of the original packaging.

With drugs I consider there is a high risk of complications a warning is printed on the label i.e NSAIDs say: 'Stop if not eating, vomiting or severe diarrhoea especially with blood occurs and advise us immediately'.

RE: Data Sheets in every box.....

Anthony Todd — Tue, 01 Jan 2019 10:11:11 GMT

PS. Ironically i didn't read or quote the vital post-script advising calling the vet, and I suspect some clients wouldn't have got that far either....

Ass covering by documentary overload I think.

RE: Data Sheets in every box.....

Anthony Todd — Tue, 01 Jan 2019 09:48:32 GMT

[quote user="Neil Wheadon"]

They aren't hypothetical, they happen

Powerful drugs can have powerful side effects, you've contradicted yourself

[/quote]

Well, not at all; see below

We seemed to cover everything by advising simply "any problems or questions at all, just ring the surgery". Common sense, as I said

But, using your advice and copious documents:

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

Patient gets these signs I [as the vet] would like to know, and pronto!

Your client, reading the copious advice; not a problem just a rare side effect; stop the drug and all will be well, don't want to bother my vet over Xmas, after all he gave me all the written advice I should ever need....

[er, except the bit that may turn out to be disastrous......]

RE: Data Sheets in every box.....

Evelyn Barbour-Hill — Mon, 31 Dec 2018 20:04:12 GMT

[quote user="Bob Russell"]They did find a bottle of Vomend that had been opened without the box being marked as such [/quote]

There is no law that says you MUST write a date on the bottle when you open it.

[quote user="Bob Russell"]we have a lot of bloo*y awful Amazon Basics paper so we need to print lots to get rid of it![/quote]

You could cut out the middleman, as it were, and put it in the recycling bin yourself.

RE: Data Sheets in every box.....

Evelyn Barbour-Hill — Mon, 31 Dec 2018 19:41:52 GMT

[quote user="Beats"] I can't imagine prescribing a medicine and then not actually handing it to the owner myself with whatever instructions I think are sensible. I wouldn't prescribe metacam without showing the owner how to draw up the correct amount[/quote]

Seconded.

RE: Data Sheets in every box.....

Andrea Tarr — Mon, 31 Dec 2018 17:10:34 GMT

You're right about eMC- not everything is there (some Teva drugs- but not the huge range of generics). MHRA only has nationally authorised medicines. So between the two it should be possible to find most.

[quote user="Beats"]I can't imagine prescribing a medicine and then not actually handing it to the owner myself with whatever instructions I think are sensible. I wouldn't prescribe metacam without showing the owner how to draw up the correct amount - visually demonstrating is much more important than including a package leaflet in my opinion.[/quote]

Some people get a better understanding about medication if they are given both written and verbal instructions, rather than verbal alone. People might forget what they're told. The advantage of written information, given with a medicine, is that it can be read after leaving the practice, when questions and uncertainties can arise (e.g. if an adverse effect has appeared)

RE: Data Sheets in every box.....

Neil Wheadon — Mon, 31 Dec 2018 13:03:55 GMT

[quote user="Minnie"]My question is why aren't the manufacturers supplying more data sheets when it is patently obvious that a box of 240 tablets ,to use one example, is not going to be dispensed to a single person? Out of interest how are the online pharmacies handling this?[/quote]

OK It's a tangent, but has anyone done a script for 239 tablets? Maybe if we all started doing this....

Neil

RE: Data Sheets in every box.....

Bob Russell — Mon, 31 Dec 2018 12:25:53 GMT

There are really only a handful of products that do not come ready equipped with data sheets. These tend to be the preds, furosemide etc etc. Newer ones usually have them included.

We were marked down in our last inspection for a small number of issues. Not one of them appear to be enshrined in law.

We have made adjustments but at our next inspection I will be asking where the law says we have been in the wrong.

Such a shame we had a total jobsworth this time. The previous inspector was really helpful and we managed to streamline a few things following his suggestions. This time was unhelpful, petty and pretty much a waste of my time and money.

I still cannot see where in law it states we must record how much propofol goes into the syringe as well as the volume administered. All propofol goes into the operating theatre and either goes into the patient or waste.

If this is required then we really need to record every drug in the same way as controlled drugs. The PMS keeps a tally of medication received and medication administered just not that bit that stays in the syringe. This makes general practice using multidose bottles almost impossible to administer.

They did find a bottle of Vomend that had been opened without the box being marked as such so we assumed it was a new bottle!

Back to the original subject - we have a lot of bloo*y awful Amazon Basics paper so we need to print lots to get rid of it!

A happy and prosperous New Year to all!!

RE: Data Sheets in every box.....

Neil Wheadon — Mon, 31 Dec 2018 11:59:45 GMT

[quote user="Anthony Todd"]Dinovets seemed to be able to practice using some pretty powerful drugs without warning clients of any of the hyperthetical risks but just using common sense experience and reason.[/quote]

They aren't hypothetical, they happen

Powerful drugs can have powerful side effects, you've contradicted yourself

[quote user="Anthony Todd"]Is it just ass covering by the manufacturer and indirectly the vet or doctor, although most of the warnings aren't health threatening?[/quote]

Look at Metacam,

From NOAH

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

By supplying the data sheet the client is informed, that's the first step surely in avoiding problems?

In a way it avoids a lot of time being wasted going through all the side effects and hand on heart does any vet know them all?

[quote user="Anthony Todd"]And modvets just blindly worry about printing all this guff......[/quote]

Akin to the vascular consultant who we chatted with last week. We are moving away from a position where consultants are seen as gods, people are questioning which is a good thing. Society has moved and so should we

Happy New Year

Neil

RE: Data Sheets in every box.....

Michael Woodhouse — Mon, 31 Dec 2018 09:57:27 GMT

[quote user="Beats"]I would challenge an intelligent owner (or non-vet/medical-spouse) to get from that URL to, say, the Onsior product leaflet for a dog and find what the timings of the recommended liver enzyme tests were. I would then ask them if, as busy intelligent people, they would have given up and just phoned you to ask had it not been set as a challenge of their intelligence.[/quote]

I agree and I think the idea is daft, but it's a way of ticking a box. Do you really think that if labels didn't say "for animal treatment only and keep out of the reach of children" everyone would be feeding their kids Milbemax?

RE: Data Sheets in every box.....

Anthony Todd — Mon, 31 Dec 2018 09:39:25 GMT

[quote user="bob lehner"]VMD have decreed fairly recently:[/quote] and the rest.

I am amazed that the profession accepts this, and without a murmur.

Dinovets seemed to be able to practice using some pretty powerful drugs without warning clients of any of the hyperthetical risks but just using common sense experience and reason.

Why the apparent sudden need to flood every client [and the same in human medicine, although it is in the box in most languages....].

Is it just ass covering by the manufacturer and indirectly the vet or doctor, although most of the warnings aren't health threatening?

Have there been a flood of serious, unmentioned side effects from a drug already in use for yonks?

Who or what or why is this driving force for total information for everyone with everything?

Will we soon be handed a comprehensive sheet of all the conceivable side-effects of a slice of bread?

Where did all this come from?

And modvets just blindly worry about printing all this guff......

RE: Data Sheets in every box.....

Beats — Mon, 31 Dec 2018 00:00:12 GMT

[quote user="Andrea Tarr"]This is usually easy to do because human medicine PILs are available on the electronic medicine compendium (eMC)[/quote]

eMC doesn't have all the PILs. Notably TEVA drugs seem conspicuous by absence often (or is that just me)?

For clomipramine, if you used eMC, you could print only the Mylan one, and it comes out at 10 pages! (https://www.medicines.org.uk/emc/files/pil.2552.pdf )

TEVA UK one available at:

http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1544764243662.pdf

(along with all others other than EU authorised...)

I appreciate as not trying to print PILs this doesn't really matter, but if searching for available drugs surely just using eMC is a bit like using NOAH? While MRHA is equivalent to VMD?

[quote user="Andrea Tarr"]although this often means giving the patient several A4 sheets.[/quote]

Have you ever seen a local community pharmacist do this?

[quote user="Andrea Tarr"]but the leaflets themselves are not fit for purpose.[/quote]

amen. although I'll confess that modern ones are superior to older ones.

[quote user="Andrea Tarr"]vets bear the full burden of communication[/quote]

I'm personally happy with this. I can't imagine prescribing a medicine and then not actually handing it to the owner myself with whatever instructions I think are sensible. I wouldn't prescribe metacam without showing the owner how to draw up the correct amount - visually demonstrating is much more important than including a package leaflet in my opinion.

[quote user="Andrea Tarr"]The veterinary profession should demand better help and support from the regulator and drug companies, in the form of client-friendly package ieaflets (and these should be readily available online when copies are needed).[/quote]

I would settle for making drug trial data publically available for licensing trials.

RE: Data Sheets in every box.....

Andrea Tarr — Sun, 30 Dec 2018 22:56:51 GMT

Yes - the law requires that a patient information leaflet (PIL) is provided. Most human medicines are now available as patient packs which include a PIL. But if a medicine is repackaged - either because it's dispensed from a bulk pack or because only part of a patient pack is dispensed, a PIL must be provided. This is usually easy to do because human medicine PILs are available on the electronic medicine compendium (eMC) and can be printed - although this often means giving the patient several A4 sheets.

For veterinary medicines, not only is there the problem of not being able to get hold of copies of package leaflets, but the leaflets themselves are not fit for purpose. Human PILs have to be prepared according to legibility and layout criteria and have to be tested with target patient groups. Veterinary medicine package leaflets are the same as SPCs but with a few phrases added (such as about disposal). This means they contain overwhelming detail in highly technical language, small typeface and an unhelpful layout.

For pet owners, information provision on medicines is poor. It means that vets bear the full burden of communication. The veterinary profession should demand better help and support from the regulator and drug companies, in the form of client-friendly package ieaflets (and these should be readily available online when copies are needed).

https://www.veterinaryprescriber.org/free-articles/the-dogs-blog-no-9-medicines-information-for-pet-owners-is-stuck-in-the-dark-ages

https://www.veterinaryprescriber.org/subscribers-content/what-pet-owners-need-to-know-about-medicines

RE: Data Sheets in every box.....

Beats — Sun, 30 Dec 2018 21:46:14 GMT

[quote user="Nicola M"]Do human pharmacists have to put data sheets in?[/quote]

I'm sure they do (patient-information-leaflet, PIL) in dispensing community pharmacies.

http://psnc.org.uk/birmingham-lpc/wp-content/uploads/sites/9/2013/07/LPCnewsletter-JULY-2014.pdf

RE: Data Sheets in every box.....

Nicola Cole — Sun, 30 Dec 2018 21:24:35 GMT

Do human pharmacists have to put data sheets in?

RE: Data Sheets in every box.....

Beats — Sun, 30 Dec 2018 20:51:21 GMT

[quote user="Michael Woodhouse"]

[quote user="bob lehner"]You can also direct clients to access the information on our Product information database: https://www.vmd.defra.gov.uk/ProductInformationDatabase/[/quote]

Think I'm just going to set up the PMS to print that on all labels and put a sign in reception that a full copy is available on request if required. Think that should cover me.

[/quote]

I would challenge an intelligent owner (or non-vet/medical-spouse) to get from that URL to, say, the Onsior product leaflet for a dog and find what the timings of the recommended liver enzyme tests were. I would then ask them if, as busy intelligent people, they would have given up and just phoned you to ask had it not been set as a challenge of their intelligence.

(Of course if you tell them what they need to know and write down any instructions they might need to remember then it doesn't really matter, does it?)

On the occasions that I feel the need to provide a link on the label for the purpose to cover myself, where I work can't print very much and I don't like to reduce my actual instructions to facilitate a lengthy URL. In the case of onsior, as an example, I would do so as: https://tinyurl.com/ybqllb52, pp40-43.

RE: Data Sheets in every box.....

Silvia Maldonado — Sun, 30 Dec 2018 20:23:29 GMT

Very useful info, Bob. Thanks

RE: Data Sheets in every box.....

Michael Woodhouse — Sun, 30 Dec 2018 18:21:35 GMT

[quote user="bob lehner"]You can also direct clients to access the information on our Product information database: https://www.vmd.defra.gov.uk/ProductInformationDatabase/[/quote]

Think I'm just going to set up the PMS to print that on all labels and put a sign in reception that a full copy is available on request if required. Think that should cover me.