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 Sponsor: Phone: |
Deletion from market: 02 Apr 2020 |
Status: Patient impact: Availability: Reason: TGA Management Actions: |
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.
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.
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
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.
