MAOIs – International shortage

by Dr Ken Gillman

Nardil shortage overview

The situation in different countries around the world is very different for all sorts of reasons so remember that these comments are international and may not always apply to particular localities.

It is likely that much of the comment here applies not just to Nardil, but also to many other less-used out of patent drugs of all kinds, not just psychotropics.  Thus, this is an illustration of the old quotation from John Donne ‘No man is an island…’.  Everyone is in this together.

This problem is likely to affect everybody everywhere, sooner or later, just like the Covid virus.

I have received information from all sorts of people all over the world and will try to condense here my deductions and thoughts about what is going on.

International Supply news

Australia

https://www.tga.gov.au/sites/default/files/phenelzine-nardil-discontinuation.pdf

The statement by the TGA and the college would have to be regarded as somewhat unsatisfactory and the advice given falls a little short of state of the art knowledge.  They say ‘for or advice on individual cases, please contact your local hospital pharmacy team or a psychiatrist experienced in the use of MAOIs’ — few if any hospital pharmacists would be competent to give advice on this subject; there are lamentably few psychiatric specialists with appropriate experience.  Unless the college provide a list of their specialists members who have such experience this comment could be regarded as facile.

The fact that the Australian College of Psychiatry has not produced a list of specialists who are willing and able to advise in this context is regrettable.  My website attempts to maintain a list of Australian specialists who participate in my international MAOI and expert group, but it is a short list.

The TGA cannot be accused of being flexible, proactive, or helpful in this context — It is clear that there is an adequate world supply of the active pharmaceutical ingredient, phenelzine sulphate (see above), there is in adequate supply in both North America and Europe, so it is difficult to understand why the TGA cannot allow & subsidise import of these supplies.  Even if individual patients managed to get a supply under Section 19A of the Therapeutic Goods Act 1989, because the government decline to subsidise the cost, even though this is the same drug has been subsidised for 50 years, the average patient will be unable to afford the cost.  A percentage of these patients are going to be disadvantaged and not fully functional, so negotiating this obstacle course will be impossible, even I would find it difficult, and most ordinary doctors who are unfamiliar with it, and overburdened with work in the current circumstances, are probably going to throw their hands up in despair and give up.

There are clearly Legal, ethical, and moral issues involved here.  It is obviously not right that they can suddenly declare that they will not subsidise an available supply of a drug which has for decades been an essential drug to maintain wellness in a considerable number of highly vulnerable and extremely ill patients.

I have communicated with the Link (who have until now be in the Australia New Zealand importer) to see if they can expedite a resupply.

Link (A Clinigen Company) t. +61 2 8401 9777 medinfo@linkhealthcare.com.au

Individuals can import up to 3 months for personal use (with a prescription) under the Special Access Scheme for TGA contact – ph 1800 020 653. Click here for more information about special access scheme

Product details Supply Impact Dates Further Details

NARDIL phenelzine 15mg (as sulfate) tablet bottle
AUST R: 93600
Active ingredients:
phenelzine sulfate

Sponsor:
Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Phone:
1800 181 060

Deletion from market:
02 Apr 2020

Status:
Discontinued

Patient impact:
Medium

Availability:
Unavailable

Reason:
Manufacturing

TGA Management Actions:
An unregistered product has been approved for supply under Section 19A. For details about ordering and supply please contact the approval holder – Medsurge Healthcare Pty Ltd (Ph. 1300 788 261).

 

U.K

Seigfried produce the API (active pharmaceutical ingredient) and their director Andrew Lamb says:

  • we currently have no intention to stop manufacture of this API and will continue to supply into existing markets as long as our customers’ demand remains, .. Depending on the market demand, we will produce Phenelzine Sulfate every 12-18 months. … We will work proactively with Kyowa Kirin and with their nominated Contract Manufacturer(s) to supply API from the 2020 campaign and to plan the next production campaign after 2020.
  • there are a very large number of factors which influence the overall cost of a drug dose, including economy of scale, process complexity, raw materials costs, storage and distribution costs, R&D costs, etc.
  • I am confident that our partners are ready to resupply the UK market as soon as possible (initially from material transferred from Recipharm and then from the new Siegfried supply). I am also sure that each party is in contact with the right people to allow timely planning for future supply beyond this year.

Kyowa Kirin U.K. were using a contractor, Recipharm U.K., to manufacture* Nardil brand and their source of the API was from Siegfried CH . 

*In the sense I think ‘manufacture’ means to make it up into tablets with the appropriate colourings and excipients, but I’m willing to be corrected on this detail

Recipharm seems to have been ‘closed down’ by the U.K. MHRA due to cross contamination.  Kyowa Kirin U.K. are as far as I understand it a mere intermediary in this process since they don’t produce the API and they contract out the production of the tablets.

Phenelzine (Nardil®)15mg tablets updated memo click here

Possible importers:

Importer Contact details 
Alium Medical Tel: 020 8238 6770
Email: enquiries@aliummedical.com
Chemys Limited Tel: 02085008497
Email: orders@chemys.co.uk
Clinigen Group PLC Tel: 01932 824100
Email: ukcustomerservice@clinigengroup.com
Durbin PLC Tel: 0208 869 6555
Email: Imports@durbin.co.uk
Ethigen Ltd Tel: 0800 019 7100
Email: specials@ethigen.co.uk
Mawdsley-Brooks & Co Tel: 01302 553000
Email: customerservices@mawdsleys.co.uk
Target Healthcare UK Limited Tel: 08456 180036
Email: specials@target-healthcare.co.uk
Thistle Pharma Limited Tel: 0800 169 9765
Email: contactus@thistlepharma.com
WEP Clinical Tel: 0208 004 8185
Email: info@wepclinical.com

(Sourced from Pharmacy Business https://www.pharmacy.biz/nardil-15mg-tablets-likely-to-remain-out-of-stock-this-year/)

U.S.A

Far as I can ascertain there has been no major supply issue in the USA even if some people have had difficulty getting supplies at one time or another there has still been supply available somewhere. The information below has been received from the FDA.

Labeling for most FDA approved drugs may often be found on CDER’s page at DRUGS @ FDA:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

‘We take concerns about drug treatments for depression and other psychiatric conditions very seriously.

FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage. However, as a regulatory agency, FDA cannot require firms to increase production or to continue making a particular product or active pharmaceutical ingredient (API) if they are not willing to do so. Please understand that this is because FDA does not have control over firms’ business decisions.

As noted by FDA’s Drug Shortages Staff in an email to Mr. Johnston, in the U.S., phenelzine supply is currently available from an approved manufacturer, Lupin Pharmaceuticals. If your patients or anyone you know is having issues with obtaining supply of phenelzine, please contactDrugShortages@fda.hhs.gov

Individuals in the U.S. who contact you to FDA (drugshortages@fda.hhs.gov or druginfo@fda.hhs.gov) and we can try to determine if there are supply issues in the United States. 

In terms of inspections: as noted on the COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process page, most foreign and domestic surveillance facility inspections are currently postponed.  Only inspections deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

This is available through the GoodRX app instructions below:

GoodRX is not an app in the Apple store, but it is accessible through a website:

Prescription Prices, Coupons & Pharmacy Information – GoodRx

Canada

Nardil is currently unavailable in Canada. It has been in shortage since 2019, and has been on back-order for several months. The date of resupply has been delayed three times. Erfa Canada 2012 Inc. is the distributor of Nardil in Canada. They have stated that Nardil will be available sometime in July 2020.

 https://eci2012.net/

Belgium

Belgium has own online supply channel

Denmark

We have 1,500 packs of Marplan that can be initially shipped: Each containing 56 tablets (10 mg). 

The issue is that we are only in a position to deliver packs with Danish text. 

Although we do have full English translation of both Label, SPC and the Patient Insert Leaflet.   

 Another good news is that we are now 99% sure that Medilink is in a position to deliver a second round of Marplan by end of August.  From August Medilink would be in position to deliver whatever demand needed. 

Therefore, the 1,500 packs would correspond to 500-700 patients, that can be treated with an MAO-inhibitor right now. 

www.medilink.dk

Italy

No MAOis available.

It is possible to import TCP from Germany via Switzerland but it is very expensive (about 250 dollars/month for 30 mg/day dosage).

Spain

No MAOis available.

Expensive and long import procedures required

India

India based Lupin. They continue listing Phenelzine on their website. They inherited Phenelzine after buying Somerset Pharmaceuticals (the developer of EMSAM) which had  bought Nardil from Pfizer.

http://www.lupinpharmaceuticals.com/productlist.htm#product_p

I started taking Nardil when I was 27, and it was life-changing

At age 16 I found it difficult to attend school. I ruled out university when I finished. At around 26 I was still in the same cafe job I had had when I left school. I told myself I would end my life at 30 were I still in the same circumstances. Life is hard to enjoy when you are scared of human interaction.

I started taking Nardil when I was 27, and it was life-changing. The symptoms of social anxiety quickly disappeared, and I began to ENJOY the company of others. It is remarkable how much your life changes when you are able to truly connect with other people. So much of what makes us happy and content with our lives comes from human interaction. Perhaps it sounds cheesy but I really didn’t know how lonely I was until I wasn’t.

My newfound comfort with human interaction meant the future no longer looked grim. I enrolled into university and was two years into a law degree when I was no longer able to find any Nardil.

It has been around 6 weeks since I stopped taking Nardil (I stopped because I couldn’t get more, not of my own volition). I have been unable to study, my moods are too volatile. On a few occasions I’ve cried hysterically for entire Zoom sessions for no reason at all. Consequently I failed two units this semester. I still have to pay for them.

Aside from these withdrawal symptoms that could have been better managed had there been better communication about the discontinuation of Nardil, I’m also scared the social anxiety symptoms I had previously will return. I have tried CBT, and various other AD medications including Parnate in the past so I’m not really sure what will happen to me now. I hope I can still finish uni.

Whatever happens, I’m grateful for the past few years I was on Nardil. I’ve met so many people and done so many things I didn’t think I was capable of doing.

Doctors who have been unwilling to prescribe MAOIs, have been brainwashed

The doctors who have been unwilling to prescribe MAOIs, who have been brainwashed by the lie that “MAOIs are dangerous,” are to blame for this. Instead of prescribing an extremely effective MAOI like Nardil, the damn fools will go and prescribe an SSRI + atypical antispychotic + a mood stabilzer + a benzo, etc etc….and even after all these meds, the patient is still ill and only needed an MAOI. SSRI monotherapy works for people with only “situational depression”, a type of depression that can actually be treated without medication.

People on Nardil very often have no other recourse

As with many others, prior to Nardil I tried SSRIs, TCAs, mood stabilizers, atypicals, etc. These medications helped hardly at all, in fact some exacerbated the symptoms. In contrast, Nardil is truly amazing, completely eradicated depressive symptoms, and almost all anxiety symptoms. Nardil allows for full functioning, that is, to actually participate fully in life, rather than being almost completely housebound due to severe, intractable anxiety and depression.

Nardil was a last resort!

It took six long years of trying almost every drug available at the time, numerous hospitalisations, two courses of ECT and two suicide attempts before my psychiatrist gave me Nardil (Phenelzine) and he said at the time it was a last resort! I have now taken it for the last 35 years and it has given me a good life and a lovely family, neither of which I would have had without it.

The anxiety I experience every day about the next bottle being my last is absolute torture. I really don’t see much of a future for myself if I can no longer get it!

Nardil literally SAVES LIVES

Nardil has changed my life immensely, it has allowed me to function well when no other medication (SSRI, SNRI, TCA, atypical antispychotic, psychotherapy even Parnate) has allowed me too. Before Nardil I was hospitalized and was a burden on everyone around me.

I am in a constant state of fear now, I have reduced to a sub-therapeutic dose of 30mg, and my symptoms have returned- severe anxiety, anhedonia, suicidal ideation, etc. Without this medication, I will not be able to function. Period. The supply needs to be reinstated because this medication is immensely helpful (and under-prescribed) and it literally SAVES LIVES.

Nardil helped me tremendously

Nardil helped me tremendously in managing my panic disorder, social phobia & GAD. I’ve never felt better in my entire life. It improved my mood, concentration and my overall mental health.

The shortage has severely impacted my physical and mental state, as my original symptoms has returned and are worsening.

Obviously this is not acceptable and supplies should be reinstated quickly

 

With nardil my life is transformed to one worth living

Without Nardil I’m reduced to bed in non stop agony unable to function, self care, get dressed or stay on top of these things. I don’t have any quality of life. With nardil my life is transformed to one worth living.

The shortages have worsened my condition and had a directly bad impact on my state.

It’s been non stop stress and my next step is unfortunately suicide.

Useful links to Nardil information for patients:

Sign the end Nardil shortage petition created by a passionate and driven patient who is reliant on Nardil along with over 1900 other people who NEED Nardil to function.

End the shortage of the MAOI anti-depressant Nardil (phenelzine Sulfate)

or more Nardil patient support  go to nardil.org

This site includes useful support groups such as below and more success stories and information.

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