What is a medicine

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					New medicines – are they
always better?
New medicines may or may not suit you. Talk to your doctor or pharmacist about it.



The Australian Government approves             Scheme (PBS) if it is shown to be at least
many new prescription medicines each           as effective as existing medicines at an
year. It is easy to presume that each new      acceptable price. Visit www.pbs.gov.au
medicine is better than the existing one,      for more information.
but that is not always true. There are three
points to think about:                         A new prescription medicine does not
                                               have to be more effective. It has to be
    the government approval process            safe, and it has to be at least as effective
    the individual response to medicines       as existing medicines at an acceptable
                                               price.
    the knowledge gained after
    a medicine is approved.                    Individual responses differ

Government approves safety                     Everybody responds differently to
                                               medicines. A medicine that improves one
The government approves prescription
                                               person’s health might do little for someone
medicines through two stages.
                                               else. A medicine that causes serious
The Therapeutic Goods Administration           problems for one person might cause
approves a medicine if the manufacturer        no problems for someone else.
shows it to be safe and effective.
                                               Research using clinical trials shows what
It can then be sold in Australia. Visit
                                               happens if a large group of people take a
www.tga.gov.au for more information.
                                               medicine. For example, the research might
A medicine is approved for government          show that most people will feel better, or
subsidy under the Pharmaceutical Benefits      that some will have a minor adverse effect
                                               or a serious adverse effect. The research
                                               can not show what will happen to each
                                               individual person.
Knowledge gained after approval                   What does this mean for me?

When a new medicine is approved, it has           You should think about new medicines
been through a number of clinical trials          before automatically assuming they are
involving thousands of people. By the time        better. Many new medicines are described
these trials are finished, it is clear what the   as 'breakthroughs', but few are. Most add
main potential benefits and harms of the          to the range of medicines, but do not
medicine are. If the harms are too serious,       drastically change the way health
the medicine will not be approved.                problems are treated.

Often, once a medicine has been taken for         If you are taking a medicine and it does
a few years by people who are not taking          not agree with you, or you think you should
part in clinical trials, more is learnt. That     be feeling better than you are, or it is just
could mean more benefits or it could              not giving you the result you were looking
mean more harms are identified.                   for, talk to your doctor or pharmacist. You
                                                  could talk about adjusting your medicine or
For example, the medicine rofecoxib
                                                  trying a different medicine. Keep in mind
(brand name Vioxx) came on to the market
                                                  that all medicines have side effects as well
in 1999 as a treatment for pain in arthritis.
                                                  as benefits. If you wish, you could ask
At first, it seemed that it was similar to
                                                  what the research on the different
other arthritis medicines used for pain
                                                  medicines show.
relief, but with a lower chance of causing
stomach ulcers and stomach bleeding.              If you are taking a medicine that does
However, after five years, it became              agree with you, your health is good and
apparent that rofecoxib increased the risk        the medicine gives you the result you were
of heart attack and stroke for some people        after, then you should think carefully
taking it, and it was withdrawn from sale.        before changing to something different.

So while a new medicine has been passed
as safe, not everything is known about it.
It may cause problems that nobody could
have anticipated.



For more information
Contact the Medicines Line on 1300 888 763, or the National Prescribing Service at
www.nps.org.au, or the Consumers’ Health Forum of Australia at www.chf.org.au.
Published July 2007




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