What do you think about Bravecto Injectable and this film?

RE: What do you think about Bravecto Injectable and this film?

scubamoo — Wed, 02 Oct 2024 18:58:38 GMT

Watched the briefing, concise basic information about the product. I will certainly be doing a bit more research on this although my practice is likely to use as they have preferred products.

One of my concerns would be side effects.

18gauge needle is pretty big but could use freeze spray to help with administration.

RE: What do you think about Bravecto Injectable and this film?

Helena Belcher — Wed, 02 Oct 2024 14:41:04 GMT

I think we would have clients interested for sure! But definitely agree that unfortunately the 60 seconds doesn’t provide enough information to myself (might be plenty for owners!)

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Wed, 02 Oct 2024 09:34:18 GMT

clare hawse £50 Amazon Voucher on its way to you for your contribution to this thread - have a nice day!

RE: What do you think about Bravecto Injectable and this film?

Georgie Hollis — Fri, 27 Sep 2024 12:19:21 GMT

I think this discussion is wonderful. These are proper, grown up conversations that are really valuable and help us understand the frustrations in practice and product development. Tessa and Louise what an absolutely shining example of the VN world you are!

So, despite the superficial and rude comment I made at the start, THANK YOU Arlo for stimulating discussion - that's exactly what you were aiming for!

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Fri, 27 Sep 2024 07:56:59 GMT

Hi Tessa,

Sorry for the delay coming back but yesterday was rather hectic!

I thought you might work in pharma ;) If you haven't already maybe contact BVNA and see if they would like a career talk for a future congress stream on VN career pathways/options - would make a difference from education and repping.

You make really good points and thank you for making these but it still doesn't remove the basic issue that when any new drug finally comes to market, by the very nature of some of the issues you outline, anything other than common adverse effects are unlikely to have been identified because the studies are not sufficiently powered to to detect this. This really is important information for a client to have and not find themselves just, for example, encouraged to switch because the vet group they are registered with is offered a better deal on a particular product.

My impression of the veterinary profession is that clients being given all the information needed for a client to have informed consent is not as common as might be liked, probably for many different reasons. I have been the other side of the counter as a client for most of my veterinary nursing career, either because I was working in non-clinical jobs or because I was working in A&E type settings so needed to go elsewhere for my dogs' primary health care needs. I would say that it is rare for the level of service you attribute to vets to be provided and I try not to rely on my vet (or nurse) alone to give me the clinical information that I require to make many of the decisions around the healthcare of my dogs unless I was in an emergency situation and did not have the luxury of time.

My impression is that ensuring there is informed consent before any decision is made is something that we tend to not be very good at as a profession and that may be due to a whole host of multifactorial considerations (before anyone thinks I am saying that vets and nurses are crap at their jobs). Plus, there are key areas in veterinary practice where a degree of flexible individual clinical decision making has been removed and replaced by commercial considerations e.g. preventative healthcare plans for cats, dogs, etc which risk dragging down vet/nurse clinical discussions with clients down to the lowest common denominator of just talking clients through what a plan can offer rather than a skilful detailed assessment of risks and needs linked to the evidence-base and client need. Again, not saying vets/nurses are crap at their job, but when you spread professionals skillsets as thinly as a the Margarine on a budget Just Cheese sarnie in order to have a very broad general practitioner that really can 'Jack of all Trades' (and JoaT are needed) there inevitably has to be a trade off in terms of breath versus depth of knowledge in a given area - and that has key repercussions for providing info needed for informed content - including, critically for this thread, around the potential uncertainties of risk profiling when using a relatively new product.

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Thu, 26 Sep 2024 11:51:07 GMT

[quote userid="7771" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178925#178925"]I think this should maybe have been a separate post now as we have turned the focus away from Arlo's educational video...oops :-)[/quote]

LOL - no, don't worry about that ... the point of the video is to stimulate discussion round the product.

RE: What do you think about Bravecto Injectable and this film?

tessa — Thu, 26 Sep 2024 11:42:45 GMT

Hi Louise

Yes I do work in drug safety (am a vet nurse but not with an 'R') and no I don't work or have any affiliation with MSD. My experience spans both clinical and post marketed having worked in pharma, CRO, biotech, consultancy etc...I did step away from animal health to human pharma some years ago now and I would love to go back to animal health to look at and maybe share some best practices from the human pharma side :-)

Clinical trials cannot cover every eventuality and that is why once they hit the market there is continuous monitoring to cover that and there are regulations in place to support that too. Drug companies are always looking for different indications or populations etc where the molecule may be of benefit or have a use and I guess that is what they looked at in the case of bravecto. Drug development costs are eye watering and I have worked in situations where a product was pulled from the stock exchange and the fall out from that which is sad as there were definitely benefits to some patients with rare/life impacting diseases who would have no other option.

I am sure that the vet does discuss the risk and benefit with a pets owner/carer so that they are able to make an informed choice. I mean I have no idea how much bravecto costs but I guess you will be paying for the convenience factor which may be a benefit to some pet owners but not all. Which brings us on to another product brought out in recent years Convenia, a product which had a longer lasting effect than the usual antibiotic...and I myself will opt for that any day over tableting a pet which will not take tablets (we've all been there right) lol and I do ask for it too! But obviously I have made that choice based on a risk and benefit and another pet owner may not choose for whatever reason.

Like you I don't think I would opt for Bravecto, I mean that 18G needle is the biggest stumbling block, but maybe some practices will offer to apply EMLA to soften the blow for the pet as this has been done for chips? It may also show that over time there is not enough uptake from pet owners and so that product may not remain on the market as the production costs etc will far exceed sales but only time will tell :-)

I think this should maybe have been a separate post now as we have turned the focus away from Arlo's educational video...oops :-)

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Thu, 26 Sep 2024 10:52:28 GMT

Hi, no I don't work in drug safety but have a good working knowledge of aspects of this through some of my other roles.

I am guessing from your comments that you did/do, though your profile is too scant to understand your background. Do you work for the company that owns or markets this product?

Your ongoing defence of clinical trials does not remove the basic concern that I am flagging here. Indeed, your last point supports it.

And my concern should be part of the discussions around prescribing a new product to a client and not just promote a new and jazzy product. It is a new product with a new USP in the market - but it is also now a new version of a product and therefore will have a less well understood safety profile across a heterogenous population of dogs and that is as important, if not important, to acknowledge alongside any USP that it confers.

RE: What do you think about Bravecto Injectable and this film?

tessa — Thu, 26 Sep 2024 10:38:36 GMT

As I said before where the regulators have concerns they may impose that PASS/PAES studies are performed post-authorisation and these again can take years.

Product labels do change in response to the emerging safety profile of a product. Rare adverse reactions/adverse events cannot always be seen in a clinical setting however they most likely have been considered in invitro studies. Medicinal products are taken on a risk/benefit basis.

In the case of a prophylactive medication a client may request it and the vets job is to advise based on the health status of their pet and the product label/safety profile. The decision is the clients to make. Where the risks outweigh the benefits the decision is clear (for most). You spoke about 'products sold to pet owners' however as can be seen flea medications have different prescribing categories and those molecules that have been on the market for many many years may be sold direct to a pet owner due to what is known about the safety profile. Newer molecules are only licenced under prescription so that use is a little more controlled (I hope thats the correct word).

:-) do you work in drug safety? :-)

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Thu, 26 Sep 2024 10:07:23 GMT

Absolutely but that doesn't alter the fact that one a new drug comes to market the initial individuals that the drug is used with are effectively guinea pigs for the less than commonly observed clinical side effect establishment. Product labels won't change that - until we have the those larger scale post-launch commercial trials (i.e. clients being prescribed a new product on a commercial basis) those cannot be established and therefore anyone who is one of the trail blazers for moving across to a new product is also one of those taking a disproportionate share of the risk that their animal might be the one that does have one (or more) of the less common side effects. As part of client informed consent it is important that they realise that. I am more risk adverse here with my animals' health and would not switch just on the basis of a selling point of a once a year dosing.

RE: What do you think about Bravecto Injectable and this film?

tessa — Thu, 26 Sep 2024 09:52:33 GMT

Clinical trial phases last years and one of the reasons pharmaceutical products are so expensive due to the investment made. Not every eventuality can be tested in clinical trials however they will have knowledge of interactions with certain drugs and whether the product has been tested in a certain population. This is why it is important that post marketing data is gathered and that people report those so that they are not just rumours based on hearsay and so that compounding factors may be considered. Product labels will indicate where they may not have data in some areas of use and if in doubt speak to the pharma company who may have some anecdotal data.

This situation is not unique to animal health but human pharma too and until a product is launched there may be surprises. Look at those products that may have been eg withdrawn from market or may also remain on the market under very strict risk management /additional monitoring measures. Thalidomaide & Valproate are 2 examples of such products that remain on the market today under very strict monitoring measures and very make for very interesting reading. Thalidomdie being also the key product which kick started pharmacovigilance/drug safety monitoring.

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Thu, 26 Sep 2024 09:38:50 GMT

[quote userid="7771" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178919#178919"]In pharma once a product receives marketing authorisation there is post-marketing data and that is under continuous review. Periodic reports are provided to the regulators at very specific timing intervals and according to regulation. In addition periodic signal detection/review is performed on an ongoing basis. These are regulated activities that the general public do not see but they are monitored by the regulators and performed by the pharma company. In addition upon receiving marketing approval if there are any areas which need more data the regulators may request that PASS/PAES studies are undertaken. This is why it is important that in practice people are aware of how and who to report any adverse events to whether they seem minor/insignificant as that is how the emerging safety profile is monitored once the product is out there in the real world. Unfortunately from experience adverse events are not often reported in vet practice unless they are considered really serious however they should all be reported however minor. A lot of this activity also drives the information which is shown on the product label (also known as the packaging insert that you receive with the product) and again that is under constant review and may change over time as the product experience increases.[/quote]

Thanks for this and I am already aware of this but that, by definition, needs to occur downwind of the potential adverse affect occurring because you cannot report what has not yet happened. Therefore, while it is of benefit to future dogs that haven't yet had the drug is it too late for those that have been administered it and had an adverse effect. That isn't a criticism of Bravecto per se by the way, just a recognition that this situation exists.

Smaller scale pre-launch clinical trials are generally too under powered to identify anything other than common side effects, and once a product moves into the post-launch phase and is being sold to pet owners to use it a population of dogs that, by nature of the situation is likely to be much more heterogenous vis a vis co-morbidities, etc then it is almost inevitable that, if you have any product that has an affect on any biological structure found in the mammalian species of interest, that there will be unexpected side effects, albeit more rarely occurring than those identified at the pre-commercial launch trial stage.

Hence, unless there are good quality clinical benefits to using a newer product (and I don't consider the increased convenience of dosing only once a year to be one) with a less established safety profile I would be hesitant to change from the status quo. I prefer my dogs to not be the post-launch guinea pigs where possible.

RE: What do you think about Bravecto Injectable and this film?

tessa — Thu, 26 Sep 2024 09:28:44 GMT

Hi Louise

In pharma once a product receives marketing authorisation there is post-marketing data and that is under continuous review. Periodic reports are provided to the regulators at very specific timing intervals and according to regulation. In addition periodic signal detection/review is performed on an ongoing basis. These are regulated activities that the general public do not see but they are monitored by the regulators and performed by the pharma company. In addition upon receiving marketing approval if there are any areas which need more data the regulators may request that PASS/PAES studies are undertaken. This is why it is important that in practice people are aware of how and who to report any adverse events to whether they seem minor/insignificant as that is how the emerging safety profile is monitored once the product is out there in the real world. Unfortunately from experience adverse events are not often reported in vet practice unless they are considered really serious however they should all be reported however minor. A lot of this activity also drives the information which is shown on the product label (also known as the packaging insert that you receive with the product) and again that is under constant review and may change over time as the product experience increases.

On the assumption that these cases happened in the UK? I hope that clare has reported those 2 serious cases to either the VMD or Pharma company (who are under an obligation to report to the VMD). I would expect that the pharma company & VMD would contact the vet practice and gather as much data as possible in order that a full assessment can be made as well as to look at any confounding factors.

If these 2 cases occurred outside of the UK they should still be reported to the pharma company and to the veterinary regulator who is responsible for veterinary medicines in that country.

:-)

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Thu, 26 Sep 2024 08:58:41 GMT

[quote userid="2100" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178917#178917"]

Louise Buckley said:
you have a bit of an issue if the chemical doesn't agree with the dog.

Hi Louise Buckley- yes .... but you've got a similar problem with most drugs to some degree or another! Normal Bravecto hangs around for 3 months. Program Injectable is 6 months. But even drugs that only hang around for hours are problematic if the dog has a reaction, surely?

[/quote]

Yes, you have but then that could also be seen as a wider argument to move away from such long lasting drugs that are only used for owner convenience, or a need for more extensive pre-launch testing before commercial launch. Clinical trials are designed to identify basically a) does the drug work, and b) are there any common side effects. It is likely that pre-launch clinical trials are relatively small scale and therefore underpowered to identify less common side effects. I wouldn't add my dog into what is effectively a post-launch larger scale clinical trial to identify rarer side effects. As there are alternatives with well established safety profiles that can achieve my dosing goals, I would prefer to use these. We only need to look at the growing body of anecdotal reports for Librela to see that, while it works well much of the time, when adverse effects occur they can be devastating and life ending for the dog. But we are in a catch 22 because that post-launch data is needed to also quantify these rarer effects [in the real world] or drug development can be too costly for a pet market.

This is quite a nice paper looking at drug half life and potential considerations associated with this. One draw back of a long half life is where an adverse reaction occurs. https://pubmed.ncbi.nlm.nih.gov/29112446/

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Thu, 26 Sep 2024 07:29:25 GMT

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178915#178915"] The 100million dog track record sounds good for the product but is that the track record for small regular doses ? As opposed to one large annual dose?[/quote]

clare hawse yes it is.

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178915#178915"]The dogs in question were perfectly healthy and the owner took the best care of them.[/quote]

Sure, all I am saying is that the safety profile of this drug is very good (dogs given 3x the dose and 5x the dose every 4 months for 6 doses only had treatment-site swellings that resolved over time). So whilst of course not ruling out a reaction, coincidence may be just as likely.

I have a daughter with a catastrophic form of intractable epilepsy, for which we have tried probably 20 drugs over the years. Almost without exception, we have seen what we thought were adverse reactions or positive effects which we would have sworn blind caused by the drug, but which later turned out to have a different cause. The thinking: "I gave the medication at 10:00am and saw a reaction soon after, therefore the reaction was caused by the drug" is a very hard one to shake.

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178915#178915"]Whilst you say that your short film was simply about the launch of a new product, it did have a 'sales pitch' feel about it and that is why I added my concerns. No offence intended![/quote]

None taken! And yes, others have remarked similarly, and it is something I shall bear in mind for future product briefings. I think it may be difficult to have that balance between being upbeat and succinct whilst not appearing promotional, but we'll see.

[quote userid="66257" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178911#178911"]you have a bit of an issue if the chemical doesn't agree with the dog.[/quote]

[quote userid="66257" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178911#178911"]What is the safety profile like for administration this way? Can we have links please to the clinical trial data?[/quote]

I don't think drug companies publish clinical trial safety data, but the safety profile info is published in the datasheet here (under clinical particulars/overdose): https://www.noahcompendium.co.uk/?id=-485826

RE: What do you think about Bravecto Injectable and this film?

tessa — Thu, 26 Sep 2024 06:40:21 GMT

Hi Clare I hope both of these cases have been reported to the VMD if not please do so asap

RE: What do you think about Bravecto Injectable and this film?

clare hawse — Thu, 26 Sep 2024 05:01:21 GMT

Hi Arlo, thank you for the reply. Just an update... one of the dogs has been euthanased and for the other, the vet is trying every possible avenue to save it but its not looking good. Will update. The 100million dog track record sounds good for the product but is that the track record for small regular doses ? As opposed to one large annual dose? The dogs in question were perfectly healthy and the owner took the best care of them. They both had the jab at the same time and very quickly developed neurological problems. I am waiting for genetic testing results and further information

Whilst you say that your short film was simply about the launch of a new product, it did have a 'sales pitch' feel about it and that is why I added my concerns. No offence intended!

RE: What do you think about Bravecto Injectable and this film?

Louise Buckley — Tue, 24 Sep 2024 18:07:06 GMT

I wouldn't personally touch for my own dogs, but I would want to know more about the studies undertaken to demonstrate efficacy and safety here if talking to clients about this. I can why a jab that could be given once a year might be attractive to some clients wanting a one stop shop visit with the vet (in which case nurses may be made fairly redundant from administering flea products for lots of clients), but, like others, I don't want something that will stick around in my dogs' systems for a year - you have a bit of an issue if the chemical doesn't agree with the dog. However, I still prefer to stick with fipronil, nitenpyram, etc where possible. Old products where generations of dogs have been tested on prior to my dogs receiving it! I have a relatively low risk almost closed population of dogs though so flea challenge isn't much of an issue for me.

What is the safety profile like for administration this way? Can we have links please to the clinical trial data?

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Tue, 24 Sep 2024 12:15:04 GMT

[quote userid="7771" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178907#178907"]how close to the line are they though in terms of advertising i wonder though and having to comply with abpi etc ...? [/quote]

A lot of people ask this, but they are not advertising or even close to advertising!

Advertising is paid for promotion by the manufacturer.

This is an editorial film I made as a publisher - not paid for by anyone.

Easiest comparison is ITV.

Obviously companies make adverts for their products which they pay to broadcast in the ad breaks. These are regulated.

Equally, ITV news might report some piece of news about the launch of a new product, and that is NOT an advert, and not regulated as one.

My product brief films are like the news.

RE: What do you think about Bravecto Injectable and this film?

tessa — Tue, 24 Sep 2024 11:46:41 GMT

i really like these, i like the style and they are short and snappy...

how close to the line are they though in terms of advertising i wonder though and having to comply with abpi etc ...?

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Tue, 24 Sep 2024 07:53:39 GMT

[quote userid="7771" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178901#178901"]nice to see you are jolly on camera, i enjoyed it :-)[/quote]

Thank you tessa - kind of you! For more jollyness, my weekend job is: @arlo.guthrie

On the whole, I'm quite pleased with how this video has gone. For sure things to learn and improve, but it does seem to have stimulated some useful discussion. Was discussing with my clinical ed last night and one thought is that we might expand this and do a daily short news film.

RE: What do you think about Bravecto Injectable and this film?

tessa — Mon, 23 Sep 2024 16:02:26 GMT

HI Arlo

I work in drug safety and that was my initial thought... once a product completes clinical trial phases we don't really know what will happen in real world as it won't have been tested in eg combination with concomitant medications or with all medical conditions (my experience in animal health was that clinical trials were not as in depth as in the human world) and well yes same as other an 18G needle...will stick with frontline lol

nice to see you are jolly on camera, i enjoyed it :-)

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Mon, 23 Sep 2024 08:38:12 GMT

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178899#178899"]Love that you are attempting to make videos more interesting but I think we need more information in the form of a caution.[/quote]

Interesting and useful feedback thank you.

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178899#178899"]this is a new product and yes it has been licensed but hasn't been in wide use and circulation yet.[/quote]

The active ingredient was first licensed in 2014 and has been in use for a decade, so whilst the injectable version is new, the active ingredient is very well known: 100 million doses delivered so far: https://www.msd-animal-health.com/2019/05/01/msd-animal-health-publishes-real-world-data-on-bravecto-fluralaner/

[quote userid="60743" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178899#178899"] I am aware of 2 dogs that had severe neurological reaction to this injection and were booked to be euth'd when I last spoke to owner. [/quote]

This raises a couple of points in my mind.

The first relates to your call for me to add more caution to my brief. The problem for me is that at the time of making a brief about a new product like this, I have no information to base caution upon, if that makes sense. All I have to go on is the safety data from trials (and perhaps more importantly, the 100 million dose track record of the product), neither of which suggest I should caution.

Now, as with any drug, there may be adverse effects reported, but obviously I will not be aware of those when making a film about the launch of a product.

The second is that you say you know of two dogs which had a severe neurological reaction. I think the danger of a statement like that is that it needs qualifying. What I mean is, is this a proven fact, or a working assumption?, because I can think of lots of situations where drugs have been credited with positive effect, or blamed for an adverse event, when in reality the drug and the supposed effect / event were completely unrelated. In fact, I helped with a book on that very subject!

RE: What do you think about Bravecto Injectable and this film?

clare hawse — Mon, 23 Sep 2024 08:16:35 GMT

Love that you are attempting to make videos more interesting but I think we need more information in the form of a caution.. this is a new product and yes it has been licensed but hasn't been in wide use and circulation yet. I am aware of 2 dogs that had severe neurological reaction to this injection and were booked to be euth'd when I last spoke to owner. Maybe a mention that it may not be safe for some dogs (MDR1)??

RE: What do you think about Bravecto Injectable and this film?

Arlo Guthrie — Mon, 23 Sep 2024 08:13:28 GMT

[quote userid="20886" url="~/f/clinical-discussions/32544/what-do-you-think-about-bravecto-injectable-and-this-film/178896#178896"]I'd be exchanging that for a smaller gauge needle. [/quote]

AliTee Hi, the product can only be given using an 18g needle, as the active ingredient won't pass through a smaller one.