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).

 





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