Published by Computachem Services

P.O Box 297.
Alstonville. 2477
NSW Australia

Phone:
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By universal agreement of just about everyone in the profession, 2003 so far has been the worst year anyone can recall for product shortages and discontinuations.
The shortages have affected products from across the spectrum, and a fair proportion of them have been off-patent medications.
It seems to be an industry-wide trend and many pharmacists are asking for answers.
While shortages can easily be explained in letters from a product manager at the manufacturer, it is less easily explained at the patient/pharmacist interface.

It is an interesting exercise to measure the real costs of a product shortage.
* patient may go without medication
* pharmacist time is used chasing up the item or alternatives
* doctor's time may is used deciding on alternatives
* a considerable amount of stress may occur for all involved.

Currently the time available to pharmacists and GPs is very limited and needs to be focused on core activities, yet this can only occur when an efficient backbone exists.

As identified during the Pan recall, there is a major supply chain inefficiency from the lack of a unified product identification system.
Pat Gallagher and Neil Johnston have written at length in this publication in the past about the need for this system.

It needs to be asked if the just-in-time supply chain systems in place are adequately buffered against problems, given the events of the past months.

It is easy in retail pharmacies to fall into the trap of relying on the same-day/next-day delivery patterns of the major wholesalers to trim shelf holdings to the bare minimum.
But some buffer is required against shortages, and thus high velocity items are nearly always kept in larger quantities.

New products are continually emerging from the R+D pipelines at Big Pharma and these require a place in the production schedule.
Manufacturers are faced with the choice of reducing/eliminating production of less profitable lines to make room, or undertake major capital expansion.
Commercial reality dictates that the former is usually a more economical option.
Lower production of a popular item will of course reduce buffer capacity and increase the chances of shortages.

Mysoline is set to be discontinued in the UK in around six months (despite specialists generally advising a 12-18 months tapering period for most patients) because the 10,000 or so patients taking the drug are considered to be too small a population to warrant continuing production.
Reuters Medical News reported last week that the same manufacturer is about to spend over US$1 billion to launch a new medication in the US.
Given the potential profitability of the new medication you probably can't blame AstraZeneca for backing it with a lot of cash.

Off-patent, low-margin items will continue to have their production squeezed in favour of higher-margin patented medicines, and thus it will fall upon niche manufacturers and importers to fill the gap.
Inevitably, this will cause prices to increase for these medicines.
It may be time to look at a PBS-funded initiative to ensure that cost-effective medicines can remain on the market at a reasonable price, particularly when there is a risk of their production being compromised.
Pharmalab has returned hydrochlorothiazide and benztropine to the market, similarly Link has returned Nardil and other products to the market, but prices invariably rise due to their small scale.
The growth of these niche companies should be encouraged to enable them to compete with larger manufacturers, and to encourage the larger manufacturers to farm more products out if they are no longer interested in their manufacture.
What is not profitable for them could well be for a smaller company.