Fate of the most fundamental drug in clinical anaesthesia is now
at risk in Japan. Thiopental is now facing a decision to be
withdrawn from the market in Japan. This is not because of
serious side effects but because this drug is unacceptably cheap
to its Manufacturer, Tanabe Pharmaceutical Company in Osaka,
Japan.
Many clinical anaesthetists nationwide, have launched "Save
Ravonal (trade name of thiopental in Japan)" campaign on
their E-mail discussion list as well as on the Web sites.
However, their efforts have not yet succeeded to overturn the
Tanabe's decision to stop manufacturing and selling this one of
the most essential anaesthetic agents.
The Tanabe claim that their outdated factory producing Thiopental
is no more compatible with Japan's stringent industrial standard.
Moreover, because of low price of Thiopental, which had been set
by Japanese Health and Welfare Ministry, Tanabe cannot afford to
continue producing this drug without substantial profits for the
Company.
The other side of this story is: Propofol (Diprivan), another
intravenous anaesthetic, was finally introduced in late 1995 and
since then more and more anaesthetists here are becoming used to
this novel agent.
Cost containment in public heath care has become a serious issue
in Japan as in many other developed countries. At the present
time, the price of Thiopental 250 mg is roughly US$3.00, while
those of Diprivan 200 mg and 500 mg are approximately US$19.00
and $30.00, respectively.
If these expensive drugs are the only ones to survive while
cheaper ones are withdrawn from clinical practice, it will cause
the devastating effect on the cost of medical care in the nation.
Not only from clinical pharmacological point of view, we believe
that it is mandatory to preserve cheap, good drugs with a long
record of established safety and efficacy from the medical
economic viewpoint.
Moreover, quite a large number of surgeons here in Japan is
familiar with this intravenous anaesthetic. Chronic shortage of
anaesthetists has long been a problem in Japan. Not all National
Hospitals have their own Anaesthetic Departments. In those
unfortunate hospitals, surgeons are giving anaesthetics.
Consequently, in many Medical University Hospitals here, trainees
(residents) of surgical specialties (e.g., General Surgery,
Orthopaedics, ENT, OB-GYN, Urology) are required to rotate in
Anaesthetic Department for a couple of months to acquire basic
anaesthetic skills, not only the technique of tracheal intubation
but also maintenance of inhalation anaesthesia.
However, they are after all surgeons, not anaesthetists! They are
not really interested in the recent developments of new
anaesthetic agents nor say, how to give total intravenous
anaesthesia without using thiopental or inhalation agents, with
which they are quite familiar.
There has been a serious concern among Japanese anaesthetists
that if Thiopental is going to be withdrawn in the near future,
non-specialist anaesthetists inevitably start to use Propofol
instead of Thiopental, without thorough understanding of
pharmacological property of Propofol. If used improperly by
inexperienced personnel, we fear that the numbers of anaesthetic
mishap may sharply increase in this country.
Japan is one of the last countries in the world where
introduction of Diprivan is suspended for such a long time since
its first use in human patients in the UK in the 1980s. However,
it is very ironical if Japan will become the first country in the
world to discard thiopental, one of the most valuable and safest
anaesthetic drugs.
Much worse thing is that the story may not end with the
withdrawal of Thiopental. Other pharmaceutical companies in Japan
are now seriously considering to stop selling succinylcholine and
tetracaine. Unfortunately, we do not have good lternatives to
substitute these invaluable agents.
It seems that the drug armamentarium of Japanese anaesthetists
are getting smaller and smaller.
Although we Japanese anaesthetists are quite aware that this is
indeed our domestic problem, we need urgent, helpful suggestions
and advices from our international colleagues on the Net to
combat this "Thiopental Crisis".
Anybody who are interested in this matter, please also refer to
HomePage of Dokkyo Medical School at
http://dasnet02.dokkyomed.ac.jp/ (both in Japanese and English).
Any responses and comments on this list or personally will be
very much appreciated.
Shuya Kiyama
Department of Anaesthesia
Shizuoka Red Cross Hospital
8-2, Ohtemachi
Shizuoka 420 Japan