Is it the same medicine, and will it do the same job?
A confident response can be supported with the professional knowledge and data the pharmacist has on bioequivalence
(see related article) and other information in this journal.
From the patient information leaflet...
'The medicine itself is not changing, only the brand. Medsafe, the agency that approves medication for use in
New Zealand, approved Loxamine after carefully considering clinical study data. To gain this approval, the new supplier
had to show that Loxamine delivers the same amount of the same medicine at the same rate as Aropax. This means you should
have the same clinical effect from taking Loxamine as you would from Aropax. If you notice any change you should discuss
this with your doctor.'
Will there be any side effects?
Understanding the potential for "new' side effects is key to an effective response to this question, and will require
a considered approach from the pharmacist. Some side effects are related to the dose of medicine and are increased if
the amount of medicine received is increased - others can occur when the dose of medicine received is suddenly reduced.
At the extremes of compliance with international standards of bioequivalence testing it is possible that content could
vary (0.8-1.25) compared with the reference product. At these extremes the appearance of discontinuation effects are unlikely
but there is a possibility of some dose related side effects. However, information received from Pacific Pharmaceuticals
shows that the results of the studies on Loxamine are well within the bioequivalence acceptance limits and that any variations
in the dose received compared with Aropax are very unlikely to be clinically significant. (For more information on bioequivalence
Consider the following...
The government agency Medsafe requires that Loxamine is tested to ensure that it is equivalent to Aropax and will give
the same therapeutic effect without increasing the chance of side effects.
However, equivalent does not mean identical and there will always be slight variations in the amount of medicine in
tablets due to manufacturing processes. This means that there are even slight variations in the amount of medicine between
individual tablets and different batches of the same brand. The testing that Medsafe requires on Loxamine means that any
variation in the amount of medicine between Loxamine and Aropax is very unlikely to be any different from variations between
different batches of Aropax.
It is very unlikely patients will experience any change in side effects with Loxamine but if they are concerned they
should be encouraged to discuss this with their pharmacist and doctor.
Other side effects may be due to fillers and colouring used to make the tablet rather than the active medicine. A comparison
of the excipients contained in Aropax and Loxamine can be found here.
Independent testing indicates that Aropax and Loxamine are very similar in taste.
There is no evidence that Loxamine is more likely to cause indigestion or is difficult to swallow. Some patients (even
adults) crush tablets to make them easier to swallow. In this case, point out that any difference in taste or texture
is likely to be due to different fillers which hold the tablet together and not a difference in the active medicine.
Do I have a choice?
From the patient information leaflet...
‘Loxamine will become available (fully subsidised) from 1 April 2007. The subsidy for Aropax will decrease from
1 June 2007, and be removed altogether from 1 September 2007. Your pharmacist will explain your options during this transition.’
There will be an expectation from the patient that the pharmacist will be fully informed of the options available to
them, so pharmacists will need to be prepared for this. Explaining the change has been initiated by PHARMAC, and clearly
outlining the cost implications should they choose to remain on Aropax will help the decision making process for the patient.
Patients can contact PHARMAC on 0800 66 00 50
People with mental illness experience a range of stigma and discrimination based on the attitudes and perceptions
of society. The lack of understanding with regard to mental illness and the resulting stigma attached to mental illness
is still evident in our communities despite programmes such as the 'Like Minds Like Mine' campaign.
"The stigma associated with taking medication is pretty hard, at the chemist we might wait till it is empty before
we get our script and asking questions is too much if there are other people in the chemist."