The Cascade and it's purpose.

RE: The Cascade and it's purpose.

Anthony Todd — Fri, 29 Dec 2017 09:53:45 GMT

[quote user="Michael Woodhouse"]

Norbrook was traditionally generic only. They brought out:

Pour on and injectable ivermectin/closantal

Pour on Levamisole

Liquid thiamazole with variable dosing for cats

[/quote]

Nit-picking I know, but these were only changes in formulation of an existing drug; easier to do and probably not challenged by the original drug developer, as it would increase their sales volume by sales, or licensing, to Norbrook.

PS Levamisole, and, I think, Ivermectin were discovered by Janssen [and, for those interested, Levamisole gives a positive reading when you're tested for cocaine.......]

RE: The Cascade and it's purpose.

Michael Woodhouse — Fri, 29 Dec 2017 01:11:02 GMT

[quote user="Anthony Todd"]That's the theory; so we shall see how many new drugs are developed by the copy-cat generic re-labellers, and how many are developed by the same companies that developed all the new veterinary drugs in the last 30 years.[/quote]

Norbrook was traditionally generic only. They brought out:

Pour on and injectable ivermectin/closantal

Pour on Levamisole

Liquid thiamazole with variable dosing for cats

All as unique products. Without the income from generics this wouldn't be possible. They've done a lot to make many other products very affordable and with a vet licence. Sure there are other examples I'm unaware of

RE: The Cascade and it's purpose.

Anthony Todd — Thu, 28 Dec 2017 19:42:42 GMT

Easy, if someone had the time and effort.

How many new drugs have been developed by the generic piggy backers and how many by manufacturers that have always developed new drugs?

RE: The Cascade and it's purpose.

Martin Atkinson — Thu, 28 Dec 2017 17:13:30 GMT

[quote user="Gillian Mostyn"]The fact that drug companies have been able to see the economic benefits of it does not indicate a fault with the cascade..[/quote]No but it does indicate a cynical manipulation of the system as a back door through the cascade to maximise profit with minimum investment.

[quote user="Gillian Mostyn"]As Michael has said, due the the cascade, there will be profit in the development of veterinary specific medicines in the future, [/quote]I'm not sure this is the case, there are plenty of new medicines which I am prepared to pay for because I appreciate that the drug companies have to recoup their R&D costs and invest for future R&D. However, it appears to me that most of the companies producing veterinary specific versions of human generics are not large pharmaceutical companies and have no intention/do not have the resources to develop new drugs.

[quote user="Gillian Mostyn"]Without the cascade, we'd be stuck using generics in human-friendly form and doses.[/quote]I agree to some extent with this and again I'm prepared to pay extra for animal friendly doses but not when someone just chucks out the same drug in the same strength as a human generic - that is purely profiteering.

RE: The Cascade and it's purpose.

Bob Russell — Thu, 28 Dec 2017 15:02:15 GMT

[quote user="Richard Carter"]

but all the arguments here still assume the UK drug industry is working in isolation which 'needs protecting' - most drugs now manufactured in India, USA and other countries (had one batch recently all labelled in Greek?) with equally rigorous testing and innovation and concern for safety so there could definitely be more open competition, less of monopoly status, more freedom to try other products - remember the colleague who was done for importing gentamycin registered for horses from Ireland (EU country as well) to use in horses in UK? Not quite cascade, legally didn't have a SIP but certainly not dangerous. Time to stop treating highly trained and qualified vets like idiots who apparently intentionally inflict unsafe practices on their patients and clients.

Gets everyone upset, stressed and suppresses freedom of thought and the option of trying a similar medicine based on intelligence looking at a case in front of you over rules.

[/quote]

I think this is precisely what the VMD is doing. The legislation is clear cut but the will to interpret it harshly or sympathetically is in the hands of VMD staff.

I harp on about Prof Dean but he really promoted the letter of the law without any flexibility. I consider his behaviour to be bullying and showing contempt for the professionalism of practising vets. The fact that there have been no prosecutions suggest the VMD are behaving in a more balanced and sensible way.

I have reported prescription medicines available without prescription on the internet and found them really helpful!

I would support action against a veterinary surgeon illegally importing medication from overseas. He or she should know better otherwise what signal does it send to those non-vets choosing to risk the wild west of the internet in order to get cheap medicines?

RE: The Cascade and it's purpose.

Rob Loxley — Thu, 28 Dec 2017 14:57:18 GMT

[quote user="Anthony Todd"]Will the BSAVA Small Animal Formulary need to be edited so that "generic" drugs recommended are only those with a VMD licence?[/quote]

It already flags the difference between licensed and unlicensed drugs?

RE: The Cascade and it's purpose.

Anthony Todd — Thu, 28 Dec 2017 14:47:02 GMT

Will the BSAVA Small Animal Formulary need to be edited so that "generic" drugs recommended are only those with a VMD licence?

RE: The Cascade and it's purpose.

Richard Carter — Thu, 28 Dec 2017 14:34:48 GMT

Gets everyone upset, stressed and suppresses freedom of thought and the option of trying a similar medicine based on intelligence looking at a case in front of you over rules.

RE: The Cascade and it's purpose.

Anthony Todd — Thu, 28 Dec 2017 14:02:49 GMT

[quote user="Gillian Mostyn"]As Michael has said, due the the cascade, there will be profit in the development of veterinary specific medicines in the future[/quote]

That's the theory; so we shall see how many new drugs are developed by the copy-cat generic re-labellers, and how many are developed by the same companies that developed all the new veterinary drugs in the last 30 years.

RE: The Cascade and it's purpose.

Gillian Mostyn — Thu, 28 Dec 2017 13:40:07 GMT

I am not a dinovet (I think) but I do remember during work experience counting out vitamin pills from a large tub into little pots, which were then dispensed to anything with diarrhoea. No proper labelling, no justification for use and I'm sure a healthy profit margin.

I also remember making up bottles of propylene glycol plus other questionable ingredients, dispensed out for 'ear canker'.

The cascade has its faults, but in my opinion the benefits outweigh them. Vets should be using properly tested, licensed and labelled medicines. The fact that drug companies have been able to see the economic benefits of it does not indicate a fault with the cascade...it simply indicates a lack of veterinary specific medicines.

As Michael has said, due the the cascade, there will be profit in the development of veterinary specific medicines in the future, and competition and higher production quantities will even out some of the 'unfair' prices. Without the cascade, we'd be stuck using generics in human-friendly form and doses.

RE: The Cascade and it's purpose.

Iain Richards — Thu, 28 Dec 2017 11:51:14 GMT

Heart Tonic and Stimulant Tablets. There's a blast from the past. I do wish I could return to those simpler days, you know the ones, when firing cured strained tendons, when a mix of clamla/B12/laurabolin in the same syringe cured cats with renal failure, when you could buy a bottle of chloramphenicol and steroid in the same bottle that cured everything....

RE: The Cascade and it's purpose.

bob lehner — Thu, 28 Dec 2017 11:08:10 GMT

[quote user="grumpyoldman"]Now we have ridiculous PSS inspectors telling you not to use Sevo because its not licensed in cats and go back 10 years to Iso[/quote]

Bit harsh - don't shoot the messenger - PSS assessors don't make the rules - they are just there to tell you what the rules are - and more importantly to try and keep you out of trouble if/when things go wrong.

The Sevo thing has now been resolved as it is now licensed for use in cats as well - but it was rather surprising how many practices using Sevo were blissfully unaware that formerly it was only licensed for use in dogs - something the marketing company conveniently forgot to tell practices when trying to wean them away from Iso.

If the worst had happened and a cat had died under Sevo - and the practice had not advised the owner in advance that it was unlicensed and therefore being used under the cascade (even tho' there is a perfectly acceptable alternative licensed product), and had not advised on any potential side effects, then it would be difficult for the VDS, or anyone else to defend in court.

RE: The Cascade and it's purpose.

Anthony Todd — Wed, 27 Dec 2017 20:54:08 GMT

[quote user="Michael Woodhouse"]When Phenoleptil was launched (I can remember) the price was less than the human generic we were using before from the wholesaler by quite a margin. Tablet sizes better. Back up if problems. Dispensing envelopes etc.[/quote]

Well not in our dogs' case and, come on, "back up if problems, what back up exactly?

"Dispensing envelopes"; mmmm child proof, dog proof?? [i dispensed in envelopes back in the day; er, not now!

Not too many advantages that I can see!

We constantly compared prices and human generics won every time.

RE: The Cascade and it's purpose.

Michael Woodhouse — Wed, 27 Dec 2017 20:24:50 GMT

[quote user="Anthony Todd"]Sorry I have to requote our 2 alsations, both epileptic, well controlled on generic human phenobarb but were put down because the owner couldn't afford the very expensive vPOM which, the law says, must be prescribed!![/quote]

When Phenoleptil was launched (I can remember) the price was less than the human generic we were using before from the wholesaler by quite a margin. Tablet sizes better. Back up if problems. Dispensing envelopes etc.

[quote user="Anthony Todd"]Where would Dechra and many others be without human generics???[/quote]

My dog's on Vetoryl, that wouldn't be so readily available in the number of dog friendly sizes if relying on human generics (do they still use it in people?). Heaps of client information, technical back up. Methadone in convenient vet multi use bottles, less wastage. I think it's 'worth' paying a little more on other licensed vet generics with these benefits to us and our patients.

RE: The Cascade and it's purpose.

Anthony Todd — Wed, 27 Dec 2017 18:51:27 GMT

Er, Autumn 2017????

Who were the stakeholders? Um er, let me guess.....

RE: The Cascade and it's purpose.

Rob Loxley — Wed, 27 Dec 2017 18:46:54 GMT

[quote user="Martin Atkinson"]So will this legislation be repealed when we leave the EU? If so it will be probably the only good thing to come out of Brexit![/quote]

Have your say with the VMD:

"1.3 EU Exit stakeholder workshops – Autumn 2017

We are organising workshops for each of our stakeholder groups to discuss the implications of the UK’s exit from the EU.

Topics could include:

Prescribing cascade
Pharmacovigilance
Joint labelling
Residues surveillance plan (samples)
Ongoing applications at time of EU exit
Inspection of non-UK based manufacturers

Our aim is to listen to our stakeholders to understand what you consider to be the key risks and opportunities from leaving the EU and to plan for the future.

In order for us to gauge attendance levels, please express your interest by emailing events@vmd.defra.gsi.gov.uk and include any topics, in order of preference, that you would like to be discussed on the day. You will receive further information by email."

RE: The Cascade and it's purpose.

Martin Atkinson — Wed, 27 Dec 2017 18:44:45 GMT

[quote user="Bob Russell"]At least buprenorphine is now available in small single dose vials plus it does not sting![/quote]I agree with everything else you've said in the post but was this not always thus? I've only just discovered Buprenorphine multi-dose vials!

RE: The Cascade and it's purpose.

Anthony Todd — Wed, 27 Dec 2017 18:42:51 GMT

[quote user="robloxley"]I would not move a patient stable on a human generic onto a new, possibly not (according to everything we are told about the differences between human and animal medicines ) 'equivalent' animal version if it came out.[/quote]

Alleylooyah!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Why risk patient health by changing to a VPOM, by licence not testing, drug.

RE: The Cascade and it's purpose.

Rob Loxley — Wed, 27 Dec 2017 18:31:28 GMT

[quote user="Anthony Todd"]How did the profession allow the drug companies to secure regulation prohibiting the use of generic drugs, which had been safely used for many years, on many animals by many vets and require us to use exactly the same drug but with vastly inflated prices just because it had gone through a "veterinary" licencing process?[/quote]

The pharmaceutical lobby is rich and powerful?

[quote user="Bob Russell"]Patients on a generic would not automatically be moved onto a licenced version just because it becomes available! [/quote]

I would not move a patient stable on a human generic onto a new, possibly not (according to everything we are told about the differences between human and animal medicines ) 'equivalent' animal version if it came out. We have cats that were on amlodipine before Amodip that are on the human one still; new cases go on Amodip. I'm quite happy to justify that.

RE: The Cascade and it's purpose.

Anthony Todd — Wed, 27 Dec 2017 17:41:14 GMT

[quote user="Bob Russell"]Patients on a generic would not automatically be moved onto a licenced version just because it becomes available! [/quote]

Sorry I have to requote our 2 alsations, both epileptic, well controlled on generic human phenobarb but were put down because the owner couldn't afford the very expensive vPOM which, the law says, must be prescribed!!

Come on you guys, the cascade is total bulldust! How can a drug, like phenobrbitone used on humans, and sadly, our esteemed editor's daughter, not be safe for a couple of alsatians!!!

I can't believe all vet's on here aren't sort of squirming, to say nothing of the VMD!!

They could have so easily got round it, as they did back in the day with "Heart Tonic and Stimulant Tablets", and given these generics "Licences of Right" ie they had been known and used for a long time, and therefore would be safe and useful for vet.medicine.

Oh no!! Profit again...........

Where would Dechra and many others be without human generics???

RE: The Cascade and it's purpose.

Bob Russell — Wed, 27 Dec 2017 17:05:52 GMT

Cephalexin and Oxytetracycline are the two I can think of. A myriad of others where there is no licenced option. Did not know there was a licenced diazepam!

We are generally pretty good at following cascade as a principle and offering human drugs to save money is rare and specific.

That said, I do not live in fear of cascade, I understand its main purpose and principle. Not dissimilar to a speed limit!!

I do not approve of companies licencing old drugs and selling at a major premium. Patients on a generic would not automatically be moved onto a licenced version just because it becomes available!

RE: The Cascade and it's purpose.

Anthony Todd — Wed, 27 Dec 2017 15:56:42 GMT

[quote user="Bob Russell"]We have a number of generics on our shelf and could justify each and every one of them when we had our last inspection.[/quote]

When you say "generics" do you mean copy-cat human generics like pred or phenobarb or do you mean the human generic bought from a medical supplier, ie human Pred 5mg or phenobarb in various tablet strengths?

RE: The Cascade and it's purpose.

Bob Russell — Wed, 27 Dec 2017 15:37:59 GMT

I am struggling to work out why so many vets seem to live in fear of cascade. In general it makes good sense most of the time and it is clear that following the departure of Prof Dean a much more reasonable attitude is being taken by the VMD.

We have a number of generics on our shelf and could justify each and every one of them when we had our last inspection.

The only ones I might hide would be oxytetracycline which we buy in 28's rather than have a pot of a thousand waiting to go out of date. That is grossly wasteful!

Prof Dean made no effort to keep the profession on his side but somewhere on my old computer is a copy of a letter written to the Veterinary Record suggesting cost may be an acceptable defence when the alternative is a welfare problem. Not a clear OK but enough to show some common sense can be shown.

I am not sure who is pushing the issue of cascade so aggressively. It does not appear to be the VMD. They seem to be happy to let sleeping dogs lie! Is it the universities that are still taking Prof Deans approach?

I don't see cascade as a big deal and certainly understand the significant costs of producing niche products such as apomorphine.

I would like the 28 days broaching rule to be scrapped and replaced with a combination of smaller bottles and more vigorous testing to see how long these products remain safe under good clinical standard conditions.

At least buprenorphine is now available in small single dose vials plus it does not sting!

RE: The Cascade and it's purpose.

Dinu Catilina — Wed, 27 Dec 2017 13:18:33 GMT

[quote user="Martin Atkinson"]So will this legislation be repealed when we leave the EU? If so it will be probably the only good thing to come out of Brexit![/quote]

The cascade is not really a big deal in the rest of EU, it's the UK where it's being pushed more aggressively.

RE: The Cascade and it's purpose.

Martin Atkinson — Wed, 27 Dec 2017 12:43:12 GMT

[quote user="Gillian Mostyn"]What do you do when you have your VMD inspection?[/quote]Hide them out the back?

[quote user="Edward Jones"]Affordability is not defendable. [/quote]

[quote user="Edward Jones"]I think this is entirely the point. It should be okay to use the cascade on financial grounds, so long as the client has given informed consent on this basis.[/quote]

It may not be defendable to the VMD/RCVS but I'm pretty sure that it would be to a court of appeal if one was deprived of ones living/right to trade with the defence that Tiddles would have died because Mrs Jones couldn't afford the licenced drug. Probably why AFAIA no SA vet has yet been prosecuted/disciplined for not following the cascade. It would be difficult to prove that one was dispensing generics with the intention solely of making a huge profit rather than for some higher altruistic purpose. Heck, I make a far bigger profit from a licenced medicine that I ever would from a generic equivalent.

[quote user="Iain Richards"]EU requirements for residues was the big driver of the cascade, until they remembered about pet species.[/quote]So will this legislation be repealed when we leave the EU? If so it will be probably the only good thing to come out of Brexit!