Psycho-Babble Social Thread 1108912

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phenelzine

Posted by paulb on March 8, 2020, at 11:28:21

Hello
i wanted to post a medication about the medication phenelzine. Does anyone know why the formulation of phenelzine may have changed. I am from england and when i was on phenelzine i had to keep mine in the fridge. Also does any one know why phenelzine like other maoi type medications know why they may be very popular for people with social anxiety disorder.

 

Re: phenelzine paulb

Posted by alexandra_k on March 8, 2020, at 15:01:13

In reply to phenelzine, posted by paulb on March 8, 2020, at 11:28:21

I had a bit of a look online to see what I could find / figure out.

I didn't find much.

I would be looking into who is manufacturing the tablets and what the manufacturers instructions say, specifically, about storage of the product.

It might be that different manufacturers have different formulas or the formula from the same manufacturer has changed. For example, some formulations might avoid fillers that are known allergens but a result might be a product less stable at room temperature.

On the other hand, it could be that there isn't a change to the product, so much as a change in our knowledge about it. For example, it might be that the product is more widely distributed (e.g., to tropical countries) so they have updated the information to provide a more predictably stable temperature for storage.

It might be that they have lengthened the expiry date on the product by way of requiring refrigeration.

Don't know.

 

Re: phenelzine

Posted by alexandra_k on March 8, 2020, at 15:18:03

In reply to Re: phenelzine paulb, posted by alexandra_k on March 8, 2020, at 15:01:13

It looks like the manufacturer of Nardil is not producing it anymore / not producing enough of it to meet supply anymore. Or... The UK NHS has decided to go with cheaper generic imports, or something, so limiting supply of Nardil. I found these:

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https://www.medicines.org.uk/emc/files/pil.228.pdf

> Store the tablets in a refrigerator between 2C and 8C. Tablets in use may be stored at normal room temperature (below 25C) for short periods (e.g. when travelling or at work).

> Each tablet contains 15 mg of the active substance phenelzine (in the form of phenelzinesulfate).The other ingredients are:mannitol, povidone, magnesium stearate, maize starch, hydroxypropylcellulose (E463), hypromellose (E464), talc, polyvinylacetatephthalate, stearic acid, sunset yellow (E110), erythrosine (E127) and titanium dioxide (E171)

2 listed manufacturers, updated 02/2017
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https://www.pfizer.com/files/products/uspi_nardil.pdf

> Storage:Store between 15 - 30C (59 - 86F)

> Each NARDIL film-coated tablet for oral administration contains phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, USP; magnesium stearate, NF; isopropyl alcohol, USP; purified water, USP; opadry orange Y30-13242A.

> Revised Feb 2009.

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https://www.sps.nhs.uk/articles/shortage-of-phenelzine-15mg-tablets-nardil/

> Shortage of phenelzine 15mg tablets (Nardil)

> Published 12th July 2019, updated 26th February 2020 London and South East Regional Medicines Information

> Kyowa Kirin are the sole supplier of phenelzine tablets in the UK. They are out of stock due to manufacturing issues, with no confirmed resupply date. Phenelzine tends to only be used in difficult to treat patients and many of these have been stabilised on this treatment for a long time. Given the difficulties in withdrawing treatment and initiating new treatments in patients stabilized on phenelzine it would seem advisable to maintain them on this treatment using unlicensed imports should they run out of supply. If there is potential for a patient maintained on phenelzine to run out of supply during this shortage, they should be urgently referred back to mental health specialist for advice on ongoing clinical management.

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https://psnc.org.uk/our-news/shortage-notice-nardil-phenelzine-sulfate-15mg-tablets/Shortage Notice: Nardil (phenelzine sulfate) 15mg tablets

> October 11, 2019

> Kyowa Kirin, the sole manufacturers of Nardil (phenelzine sulfate) 15mg tablets, are currently experiencing temporary disruptions.

> Kyowa Kirin, the main supplier of Nardil (phenelzine sulfate) 15mg tablets have advised a delayed resupply date of March 2020. Supplies are available from specialist importers on an unlicensed basis, and these companies listed below have advised they can continue to source unlicensed imports from abroad but the list is not exhaustive...

_____________________________________


 

Re: phenelzine

Posted by alexandra_k on March 8, 2020, at 15:26:51

In reply to Re: phenelzine, posted by alexandra_k on March 8, 2020, at 15:18:03

If I was a person who had been on Nardil for many years with good result and I was finding that the non-Nardil version wasn't suiting me so well (insofar as it was possible for me to keep track of that)...

Then I would see about contacting the supplier or about having my Doctor contact the supplier on my behalf (or similar). To see if it is possible to get hold of the original.

I don't know what the issue is - if it is still being manufacturerd, but not enough to meet supply. Or if the issue is cost, or whatever.

Sometimes medication decisions are made on the basis of what is most effective in *populations*. Which is of no comfort whatsoever if one is in fact a genuine outlier.

It might be that you can make a good case for why you are one of the people who should be allowed to continue taking Nardil. If it is indeed effective for you.

One of the things they seem concerned with is placebo.

It might potentially come down to cost savings for the NHS only. I don't know.

 

Re: phenelzine

Posted by alexandra_k on March 8, 2020, at 17:24:40

In reply to Re: phenelzine, posted by alexandra_k on March 8, 2020, at 15:26:51

Okay, so...

I really don't know very much about anything very much at all...

But my understanding of MAOI inhibitors was that they were a drug that worked very well indeed for some people. But not for ALL people. Because the drug seemed to work very well indeed for SOME people there was a tendancy to want to more widely prescribe it.

I heard that the real push towards curbing MAOI prescriptions was because of the number of people that would not / could not stick to the diet. And so, on a population level, prescribing the drug (over-prescribing the drug) did a buch more harm than good as people developed symptoms of toxic interactions.

There is also a push for there to be continuing cost savings. Instead of paying a fair price and keeping on paying the fair price people (particularly those working in charge of public health systems) continually try and drive down the bottom line. If they can get the 'same drug' (in some sense) more cheaply, then they feel that they are obliged to do this.

So manufacturing gets pushed off-shore. Often quality control isn't as good. We know this from food production and production of every other thing. Of course production of pharmaceuticals is going to go the same way. Cheap fillers. Not heating things to quite the temperatures they were supposed to be heated to. Whatever cost cutting corners that can be cut. NOt paying the wokers. Paying workers who are sick to turn up to work and produce medications. You get the idea. Not testing the quality control to make sure doses are standardised properly. Substituting in cheaper stabilisers and the like.

The thing about population health is that they always say that particular individuals can't have what they want / need because 'what if everybody wanted / needed the same thing - there isn't enough to go around. Only, it isn't the case that everybody wants / needs Nardil. They say individuals are supposed to take a hit for the good of the team. Only, what seems to happen actually as a matter of fact in practice is that every member of the team, the overall team as well, all of the people individually and as a group are actually expected to take a hit so the people in charge of the individuals and the group can further f*ck over both the indivduals and the group for their own petty whims and desires.

Only garbage falls out of their mouths. I called them on it: They don't talk to me, anymore.

What I mean to say: The manufacturer of Nardil is Canadian. They speak English in Canada. Try and write to the manufacturer and say Nardil has helped you (if it has) and you want to stay on it (if you do) and you are interested in continuing your supply of Nardil. Is there any way they can work with you to figure out what would be a fair price for you to continue taking that product? Figure out if it is worth it to you / what it is worth to you. See about it, I mean to say.

I suppose that is why National Health Systems like this whole idea of 'placebo'. If they can convince themselves that a medication isn't effective (if they can undermine efficacy by sourcing contaminated products more cheaply) then they can convince themselvs that they can have further pay rises for themselves instead of funding the product for the people it actually helps.

_______________

It has been interesting to read of the different States response to CoronaVirus in the US. It has been interesting to read of what is 'publically' available in different states. It is good for the US to be presenting itself in that way.

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Trump said everyone would get tested... Eventually...

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It's kind of... Beyond that.

My understanding of these kinds of tests is that people with the virus will test negative, and people without the virus will test positive. The test only tells you what was found in the patient and immediately after the test was taken who knows what will be found there now.

People will have the virus but the virus won't replicate in them in a manner that causes serious threat to them. They will be okay. And of course people die of other things, but the virus may be found in them on autopsy.

I don't know how many people of what ages typically die for each month of the year... I don't know if there is a change in the pattern globally or not. I don't know if we are simply blaming Coronavirus for the deaths that would have bene attiribued to other causes, before, is what I mean.

__________________

So... What's left? What else is there?

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When did you last hear people saying about washing your hands?
About cleaning doorknobs?
About coughing into your elbow or shoulder and not your hands?
When did you last hear about keeping space between people (in lecture theatres and the like)?
When were you told to be mindful of touching your face from a health point of view?

Things are moving to people being allowed to work from home instead of being herded / forced into overcrowded communal spaces with people who don't know basic hygeine.

Education is moving to online. Studying for online exainations.

That will be objectively graded? One can only hope.

____________________

Brown. Those kids who were picked from High School to do an undergraduate Degree (largely ungraded) and then on to Medicine.

They have to sit the Step Exams.

They do.

Of course they have every advantage in terms of being taught how to as for informed consent and do a good physical examination. And high quality caring lecturers teaching... Chemistry and Biochemistry and Cell Biology and Ethics and History and Sociology and... All the things. Management. All the things.

But then they sit the exams.

And probably do badly and get to work in their parents clinic or whatever. But yeah.

It seems fairer to me then what we try and persuade ourself / convince ourself if good and proper and just, here.


 

Re: phenelzine paulb

Posted by beckett2 on March 9, 2020, at 17:56:11

In reply to phenelzine, posted by paulb on March 8, 2020, at 11:28:21

Hi, you might ask this question at the Med forum.

 

Re: phenelzine

Posted by alexandra_k on March 13, 2020, at 18:50:54

In reply to Re: phenelzine paulb, posted by beckett2 on March 9, 2020, at 17:56:11

People did ask a similar question over on the Meds forum. Seems Nardil wasn't the original (I was thinking that it was) to find the original manufacturer / recipe for the medication that some people were, in fact, stabilised on, over a number of years, you have to go back, back, back, further than that.

I don't know what happened. If it was greed to push the prices up. If it was desire to curb availability to prevent toxicity (e.g., more similar to my understanding of the reduction and cessatoin of supply of barbiturates).

I don't know if it would be possible to get the manufacturer manufacturing them, again, or how much it would cost to have them produced. Presumably it's old technology. Presumably manufacturing technology isn't the problem.

So... What is the problem? The manufacturer would be the people I would write to to know why they ceased production and what (if anything) can be done to have it resumed.

Maybe it is stockpiled somewhere... Who knows.

 

Re: phenelzine

Posted by alexandra_k on March 16, 2020, at 6:51:12

In reply to phenelzine, posted by paulb on March 8, 2020, at 11:28:21

https://fyi.org.nz/request/11020/response/41166/attach/3/2019%2010%2014%20all%20documents%20combined%20redactions%20saved.pdf

 

Re: phenelzine

Posted by alexandra_k on March 17, 2020, at 7:49:52

In reply to Re: phenelzine, posted by alexandra_k on March 16, 2020, at 6:51:12

It is a very long document -- but I think it purports to answer your questions.

It addresses the shortage in supply. Manufactuers recall. They found that over 50 per cent of the sample tested wasn't dissolving the way it was supposed to after 9 months storage. They thought that may affect bio availability in people so they recalled that particular shipment.

It led to a global shortage.

NZ was provided with a number of alternative sources for supply. That was redacted. So we can't see the various costings for the various products.

There was information, though, about the difference between the one that was recalled and the replacement from Canada.

It is hard to know if the drug company was trying to extort more money for production of something. Or if they simply needed more money to produce it. Or if the government could have agreed to pay more money for, basically, the same formula. Or a better formula. But went with the cheapest option...

Even if we had the redacted information I guess you would need to look at where the difference in cost actually would go to see if it was justified or whatever.

Anyway... There we go. Nardil. Huh.


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