Which do you think are the most unfair cascade drugs?

RE: Which do you think are the most unfair cascade drugs?

Evelyn Barbour-Hill — Mon, 21 Oct 2024 00:00:15 GMT

[quote userid="3169" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245721#245721"]Legally the 32p paracetamol only licenced for humans so was never 'legal' for people to give them to pets. I remember a pharmacist telling me years ago that if someone goes in for cough medicine for their dog (even if the vet sent them) they were not allowed to supply for that purpose.[/quote]

Ah,but if the veterinary surgeon issues a prescription for the paracetamol. that was legal. Still is as far as i know. As long s the veterinary surgeon has a reason for prescribing paracetamol rather than Pardale-V. You don't wish the dog to be given codeine, that's your reason.

Somebody's going to shoot me down now.

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Wed, 16 Oct 2024 21:51:57 GMT

[quote userid="3169" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245721#245721"]was never 'legal' for people to give them to pets[/quote]

It's also true that the amended Veterinary Medicines Regulations doesn't change the VMD guidance relating to medicines commonly found around the home,

'quote

Medicines commonly found around the home

In exceptional emergency circumstances, you may judge there is a need to alleviate a pet’s discomfort until a home visit can be made or the animal brought to the surgery.

You could recommend that an animal owner use a human medicine that they already have in their possession, such as antihistamine tablets. This does not mean a pet owner should be encouraged to go into a pharmacy and ask for a human medicine for their pet.

RE: Which do you think are the most unfair cascade drugs?

Michael Woodhouse — Wed, 16 Oct 2024 21:47:42 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245719#245719"]

Licenced vet drug Pardale-V (paracetamol and codeine) for 5 days £30

Packet of paracetamol from tesco £0.32p

[/quote]

I agree that elements of the cascade are wrong, but you will never convince me it's a good/sensible idea to suggest that the owner goes away and sources a medicine and administers it at the correct dose and frequency. The simple safety check that the pack size is checked, the dose written on the label etc are essential safeguards IMO. I think it should be perfectly legal to prescribe/supply human paracetamol (although when we couldn't get Pardale it never worked quite as well in a number of patients, despite people claim codeine does nothing in dogs), but rightly illegal to send the owner to the shop.

Legally the 32p paracetamol only licenced for humans so was never 'legal' for people to give them to pets. I remember a pharmacist telling me years ago that if someone goes in for cough medicine for their dog (even if the vet sent them) they were not allowed to supply for that purpose.

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Wed, 16 Oct 2024 21:25:29 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245719#245719"]criminal in that I commiting an offence[/quote]

But if owner wants to put down the dog because it's too expensive that's fine

RE: Which do you think are the most unfair cascade drugs?

Clive Ansell — Wed, 16 Oct 2024 20:55:38 GMT

[quote userid="2100" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245597#245597"]To make it an actual offence to whisper to someone that they could just pop down to boots and by some paracetamol is frankly ridiculous.[/quote]

Yep.

Hot off the RCVS press this week

"New offence relating to misuse of the cascade

Veterinary surgeons and veterinary nurses (and any person) must not promote or facilitate any purported use of the cascade which is not in accordance with the VMRs, and to do so is now an offence in England, Wales, and Scotland."

I had a large dog this morning, minor post op infection of a castration wound. The usual Metacam we prescribe doesn't suit him, and we don't need hard core analgesics here, so paracetamol would be a safe and adequate choice for a few days while it heals.

But - - - If I tell the owner, or even just suggest it is OK, to buy paracetamol from a high street chemist, I am now a criminal in that I commiting an offence.

Licenced vet drug Pardale-V (paracetamol and codeine) for 5 days £30

Packet of paracetamol from tesco £0.32p

If I sniff really hard there is a distinct rodent type odour about. Nothing more than a cartel or legalised protection racket.

Needs to be put before a judge, through the courts.

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Wed, 16 Oct 2024 20:21:35 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245717#245717"]Guess it would cure the constipation though? [/quote]

absolutely and it could be signed on the fly

RE: Which do you think are the most unfair cascade drugs?

Clive Ansell — Wed, 16 Oct 2024 19:17:45 GMT

[quote userid="4103" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245716#245716"]

Clive Ansell said:
harm has been caused to an animal patient

If a shipping container full of lactulose sol.120ml bottles is inadvertently falling from a certain height onto a pug, it will cause a great damage I suppose

[/quote]

It is only licenced for oral dosing, so that would be off label and would need a disclaimer signing by the client.

Guess it would cure the constipation though?

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Wed, 16 Oct 2024 18:34:43 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245714#245714"]harm has been caused to an animal patient[/quote]

If a shipping container full of lactulose sol.120ml bottles is inadvertently falling from a certain height onto a pug, it will cause a great damage I suppose

RE: Which do you think are the most unfair cascade drugs?

Clive Ansell — Wed, 16 Oct 2024 13:50:32 GMT

[quote userid="4103" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245713#245713"]I'm not talking about assumptions of course[/quote][quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245698#245698"]I'm only saying you can't make assumptions about the characteristics of absorption of human formulations in animals.[/quote]

I agree we cannot assume, but we are capable of using our thorough training and experience to reach an informed decision as to whether or not prescribing a human generic drug is appropriate on a case by case basis.

Don't forget, as already been pointed out, that drugs for human use been subjected to safety and efficacy in laboratory animals.

Is anyone aware of a single case anywhere, that harm has been caused to an animal patient, as a result of being prescribed or given a human generic drug?

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Wed, 16 Oct 2024 11:24:16 GMT

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245698#245698"]you can't make assumptions[/quote]

I'm not talking about assumptions of course, I'm talking about a comparison of all vet medicines to the corresponding human medicines, that in most of the cases came before the vet licensing, and a comparison of all excipients or substances other than the active ingredient contained and a detailed discussion about the active ingredient in term of chemical formula needed for a specific animal. This is to select the right one among the many available in the human field for the same active igredient. As a matter of fact in the old days when there were no or very few vet medicines like vaccines or mostly for large animals, this is what you had to consider. It's also true that for xylitol you have also to consider human sweets containing it, and the toxic dose of it. Example products include candies, baked goods, peanut butter, pudding snacks...

RE: Which do you think are the most unfair cascade drugs?

Andrea Tarr — Tue, 15 Oct 2024 14:51:24 GMT

I don't know of any among the generics that have been discussed here. I'm only saying you can't make assumptions about the characteristics of absorption of human formulations in animals.There are obvious examples such as liquids containing xylitol and modified-release formulations of tramadol (dogs don't absorb the products as well as humans, and it could potentially cause an overdose if they chew on the m/r tablets or capsules).

RE: Which do you think are the most unfair cascade drugs?

Cinzia Gandini — Sun, 13 Oct 2024 17:01:59 GMT

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245598#245598"]a drug formulated for absorption in humans will be absorbed in the same way in another species[/quote]

Can you post some, more than one of course, examples of human drugs composition vs vet med composition and point out the adverse effects of the formulations

RE: Which do you think are the most unfair cascade drugs?

Clive Ansell — Sat, 12 Oct 2024 13:45:00 GMT

Lactulose is the one that annoys me the most - marketed as Laxatract by Dechra. It's just a sugar for christ's sake.

Nothing more than a legalised criminal drug cartel.

RE: Which do you think are the most unfair cascade drugs?

Marianne Thomas — Fri, 11 Oct 2024 09:21:03 GMT

I agree furosemide is particularly galling.

I actually love some of the licensed products- the flavour on metrobactin I genuinely think helps patient compliance, for example.

But I would welcome a common sense discussion & review of the cascade. If the human product is at an appropriate dose, and the vet is familiar with the safety of the excipients, then maybe we can leave the clinical decision to the clinician, eh?

RE: Which do you think are the most unfair cascade drugs?

Richard Carter — Sat, 05 Oct 2024 12:02:32 GMT

The reading of the new regulations was introduced by Lord Trees before Lords on behalf of vmd and defra and the ENTIRE discussion referred to drugs in food producing animals and the reason an impact study was not needed was that the anticipated impact on the industry would be less than £5 million.. probably the earnings of one NSAIDs?

Stitched up by our own side

RE: Which do you think are the most unfair cascade drugs?

David Mills — Fri, 04 Oct 2024 16:48:23 GMT

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245598#245598"]there might be an increased risk of harm[/quote]

I always fin this difficult to understand given that dogs are used as toxicity models for humans (however accurate these models might be) - so there is data out there. How accessible it is I don't know.

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245598#245598"]You can't assume that a drug formulated for absorption in humans will be absorbed in the same way in another species.[/quote]

I think the inductive step that you can, given the similarities in biology and the above point about drug development and testing, is more justified than assuming that you can't.

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245598#245598"]Without knowing the pharmacokinetic data for the formulation you can't be certain[/quote]

How much does formulation change significantly between pre-clinical and during clinical human drug trials?

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245598#245598"] Other considerations are the possibility of unsuitable excipients in human formulations and the lack of animal-appropriate client information, and there's product liability, which would presumably shift to the vet[/quote]

Responsibility is one the vet anyway, so I don't see this as burdensome.

BSAVA leaflets have information for clients.

Informed consent (and clinical experience on which recommendations are made) negates much of the above anyway. I can't remember a client every asking for a vet licensed product over a generic human one

RE: Which do you think are the most unfair cascade drugs?

Andrea Tarr — Fri, 04 Oct 2024 16:01:58 GMT

It's the potential for adverse effects that needs to be balanced against the likelihood of benefit. In the case of human formulations there might be an increased risk of harm, but there is the possibility of a lack of benefit. Because the formulation is important. You can't assume that a drug formulated for absorption in humans will be absorbed in the same way in another species. Without knowing the pharmacokinetic data for the formulation you can't be certain. Other considerations are the possibility of unsuitable excipients in human formulations and the lack of animal-appropriate client information, and there's product liability, which would presumably shift to the vet. On the other hand cost can impact on welfare, so the risks might be justified.

RE: Which do you think are the most unfair cascade drugs?

Arlo Guthrie — Fri, 04 Oct 2024 15:31:09 GMT

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245590#245590"]Logically, the medicine authorised for species and indication should offer the best benefit/risk balance (and this also applies to the veterinary authorised drugs previously available only as human generics).[/quote]

Andrea Tarr, but ...

To my mind, if you are going to create a law to protect something, you first really need to show evidence that harm was being caused.

I am not aware of harm being caused by the prescription of cheaper human-licensed forms of veterinary drugs (such as those listed by David Mills).

And if there WAS harm being caused by the prescription of human use amlodipine, furosemide, lactulose, fluoxetine or liquid paraffin, the question then is ...

Does it actually cause more harm by requiring vets to prescribe the vet-licensed versions at AT LEAST double the cost (but usually many times more than that), than is caused by using human-licensed versions.

I do 'get' the principle behind cascade, but it needs to be balanced with pragmatism, surely.

There needs to be some recognition here that we are protecting the welfare of animals, not humans, and that should be considered when lawmakers weigh up the risks.

Vets should be free to prescribe cheaper human use drugs when the alternative is that the client cannot afford to treat the animal at all. Or, frankly, if the benefits of the vet licensed one do not outweigh the human version.

To make it an actual offence to whisper to someone that they could just pop down to boots and by some paracetamol is frankly ridiculous.

RE: Which do you think are the most unfair cascade drugs?

Andrea Tarr — Fri, 04 Oct 2024 13:30:50 GMT

I'm not confusing cascade and protocols. NICE guidance applies to NHS practice. Guidance on prescribing off-label/unlicensed medicines comes from the GMChttps://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines. It's guidance - not law. Medicines legislation was originally designed to ensure that only products that have been assessed by a regulatory agency, and are of acceptable quality of manufacture, efficacy in the proposed indications, and safety, can be sold, supplied, or exported. The VMR has evolved to affect prescribing decisions in a way that, as you say, seems more in the interests of industry. Prescribing should be based on evidence.

RE: Which do you think are the most unfair cascade drugs?

David Mills — Fri, 04 Oct 2024 11:35:22 GMT

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245590#245590"]The cascade is logical and in the interests of welfare[/quote]

That may be its intention - but the road to hell is paved with such. The practical effects of it are illogical - there are doubtless more examples but Hypercard for feline HCM? No evidence of efficacy. Cefovecin for UTIs, skin? Poor use of abx. The fluoroquinolones - awful what they are licensed for. Some weasly worded data sheets putting use under the vet's discretion? Metoclopramide in cats - demonstrably useless (they don't have the receptors).

It is interesting that it sees to be an EU instrument. If we are the safeguarders or animal welfare via the cascade - why aren't there welfare issues in (much bigger) areas that don't have it?

It is an overbearing piece of legislation that was largely lobbied for by pharma. And guess what it has been abused by those same lobbyists with the trend for "retro-licensing".

I have no issue with genuinely new products being under patent - and patent laws are more than adequate to safeguard pharma's investment in R&D. If your product is good, and genuinely improves the welfare of patients (e.g. pimobendan) it will be used regardless of the cascade. What the cascade does is it allows shitty behaviour from pharma then straightjackets vets into using products that are vastly inflated in price compared to human generics. I posted a price comparison for meloxicam which is something like 20-40x more expensive with a vet licence cf human generic.

You often hear the "it means more R&D" argument - but I'm unconvinced as it is all shrouded in mystery as to how much is pumped back in - I suspect a very diluted amount.

[quote userid="13407" url="~/f/non-clinical-questions/31029/which-do-you-think-are-the-most-unfair-cascade-drugs/245590#245590"]octors are expected to follow the same cascade order (of course without the drugs authorised for other species, and they don't need to resort to cascade prescribing as much because there are many more authorised medicines)[/quote]

You're confusing cascade with protocols. Doctors are expected to follow protocols as set out by NICE - taking into account efficacy, cost, availability etc. As you say they have far more drugs with a higher evidence base.

The cascade by contrast is like hobbling a clinician with pin prick of questionable evidence that serves no-one but pharma.

RE: Which do you think are the most unfair cascade drugs?

Andrea Tarr — Fri, 04 Oct 2024 10:43:48 GMT

That's correct. But the RCVS interpretation of the new clause in the VMR sounds like more policing of vets' prescribing. I don't think that's the intention.

The cascade is logical and in the interests of welfare - the chosen treatment should be the one that offers most benefit and least risk. Doctors are expected to follow the same cascade order (of course without the drugs authorised for other species, and they don't need to resort to cascade prescribing as much because there are many more authorised medicines). Logically, the medicine authorised for species and indication should offer the best benefit/risk balance (and this also applies to the veterinary authorised drugs previously available only as human generics). The regulator has already broadly assessed the benefit/risk for authorised medicines, but only the vet can make the ultimate decision knowing the characteristics of the patient. The vet also takes on more risk by prescribing a medicine outside its authorised uses.

But there are problems with the rigid application of the cascade because it assumes that companies have kept their products up-to-date with the evidence (not always the case). E.g. prescribing Pardale V (paracetamol + codeine) when paracetamol is indicated. Pardale V is an illogical combination for dogs. In my opinion it should not be on the market.

In asking my question about annoying generics (sorry I didn't thank the people who responded, @Arlo the function at the bottom of the message doesn't work for me for some reason), I was thinking about it all from a different angle. An argument for not using human generics to save money is that it helps support the veterinary pharmaceutical industry. I haven't yet looked at the cost differential between veterinary and human generics, or the evidence presented to support applications. Some look like easy pickings, with no new clinical evidence, and authorisation based on historical use. Is what is being charged justified and what is industry is doing in return? E.g. why isn't there a veterinary authorised paracetamol?

RE: Which do you think are the most unfair cascade drugs?

Arlo Guthrie — Fri, 04 Oct 2024 08:21:41 GMT

But Andrea Tarr, my understanding is that prescribing a human licensed medication in preference to a vet-licensed one is 'not in accordance with this Schedule' - even if it is done because the owner cannot afford medication, and the alternative is that the animal is untreated.

If that is NOT the case, then I think this is a reasonably widespread misunderstanding - I have already had a number of members of the profession stick their hand up and say they are frustrated by not being able to offer cheaper human use alternatives.

RE: Which do you think are the most unfair cascade drugs?

Andrea Tarr — Fri, 04 Oct 2024 08:02:15 GMT

The proposed new wording (there's no published version of the new regulations yet) in the VMR relating to the Misuse of the cascade was "A person must not encourage or facilitate use of the cascade which is not in accordance with this Schedule".. I believe this is more directed at people promoting the use of unlicensed medicines (specials - which cannot legally be advertised), not individual vets prescribing human licensed medicines.

RE: Which do you think are the most unfair cascade drugs?

Arlo Guthrie — Thu, 03 Oct 2024 18:55:03 GMT

Thank you for that list David Mills, which provided inspiration for my latest news bulletin:
https://www.instagram.com/reel/DArAR7htj_e

RE: Which do you think are the most unfair cascade drugs?

David Mills — Sun, 15 Sep 2024 21:54:41 GMT

The cascade is an anti competitive pro-pharma nonsense based on whiff wharf nonsense about safety and efficacy. It is total and utter bollocks. Look at places where it isn't a thing - such as litigious heavy US - are there animals keeling over from using human paracetamol? Of course there isn't because the drug has been tested on animals up to and including toxic dosing.

Copied and pasted from another thread but these are the drugs that come to mind.

Fraudulent post hoc licensing of these drugs is stain on the companies doing it, the govt allowing it, and the whole profession.

Amlodopine

Ampicillin (?)

Apomorphine

Atropine

Diazepam

Erythromycin

Fentanyl

Fluoxetine

Frusemide (tabs)

Hydrocortisone

Lactulose

Methadone

Metronidazole (tabs)

Metoclopramide (liquid, tabs, injection)

Midazolam

Mirtazapine

Liquid paraffin

Spironolactone

Tramadol

Trimeth-suplhonamides (oral liquid)