That is why there is a patent which gives a temporary monopoly so that the comapny can recoup the money it invested in the research and in getting a product to the pharmacy shelves.

I do however beleive that after the patent expires, patients have a right to have their medicine at a better price. It is also a means of social justice otherwise medicines would only be available for people who can afford them even in the western world.

What about writing something about MUMN

[Daphne – I’ve set it aside for Sunday.]

If two drugs are bioequivalent, then they should have the same therapeutic effect and basically can be considered the same drug.

There are only two potential problems:

1. A large portion of the drug (i.e. oral drug) are excipients, basically inactive substances usually used to bulk up the drug (e.g. a 50 microgram dose is usually too small to packed into a tablet, so an inert compound is added to make it larger). There are persons that can be either allergic or intolerant to some e.g. gluten in wheat starch. So whilst the bioequivalence is the same, one drug might produce an allergic reaction whilst the other no.

2. Bioequivalence is taken with a confidence interval of 90% that is one can have a difference of +/-10%. Whilst this is acceptable in most cases e.g. antibiotics in some e.g. epileptic drugs, lithium (used in manic depressive disorders) and anticoagulants, the difference between the therapeutic dose and the toxic dose can be less than 10% and thus there is the risk of either an over or under dose. That is why in these cases it is recommended not to change brands – so it is not the same as saying not to use generics but to use the same brand of generics.

So I cannot see how a generic which has been deemed as bioequivalent can have a different rate of absorption.

In this dossier the manufacturer has to demonstrate quality safety and efficacy. Quality and safety standards are the same be it for branded products as well as generic drugs. the story is a bit different with regards to efficacy whereby branded drug manufacturers submit the clinical trial data while generic manufacturers submit a bioequivalnce study to demonstrate that the generic product is bioequivalent to the branded one.

While it is granted that a doctor should be left free to choose between a generic and a branded product; IT IS VERY SORRY AND MISCHIEVOUS TO CAST DOUBTS OVER THE QUALITY OF GENERIC DRUGS given the present scenario that generics all originate from the EU.

I hope that this is a genuine misconception and not fuelled by someone to please originator companies.

[Daphne – This is not something I know much about, so I’ll leave you to thrash it out between you.]

If a doctor prescribes the drug with its generic name, then the pharmacist is free to dispense any brand – hence whilst the doctor is stil liable (he is the one who has prescribed the generic drug) whilst the pharmacist is not liable at all.

@ Moggy – agreed 100% on the need to keep complete records – unfortunately most doctors do not.

@ Sybil – to be fair, a copy of the prescription, together with some proof of the item dispensed, should also be kept by the pharmacist, so that he/she can be covered. I think that prescriptions should be written on a three copy basis – one to be kept by the doctor, the other by the pharmacist and a third would be the patient’s copy. The pharmacist should then put in both copies (his and the patient’s) in a system where the brand name of the drug and maybe even the lot number, is clearly printed on both his and the patient’s copy. I have seen this system at work in Finland (in this case they even go a step further, the doctor asks you for your preferred pharmacy, and the prescription is sent through the system to the pharmacy and one fidns the medicien ready and packed when he/she goes to pick it up).