The Medicines Control Council (MCC) recommends that substitution should not occur when prescribing and dispensing medicines which:
a) Have a narrow therapeutic range;
b) Have been known to show erratic intra- and inter-patient responses;
c) Are contained in dosage forms that are likely to give rise to a clinically significant bioavailability problem, e.g. extended or delayed release preparations, as well as those known to be super bioavailable*;
d) Are intended for the critically ill and/or geriatric and paediatric patients.
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In terms of the above-mentioned factors, the following medicines have, on occasion, been known to present bioequivalence problems and should ideally not be interchanged
with a generic:
Alendronate tablets or capsules
Atenolol tablets or capules
Carbamazepine tablets
Chlorpromazine tablets
Dexamethasone tablets
Diethystilboestrol tablets
Digoxin tablets
Disulfiram tablets
Ethinyl Oestradiol tablets
Fluoxymesterone tablets
Furosemide tablets
Glibenclamide tablets
Hydralazine, hydrochlorothiazide and Reserpine combination tablets
Non-inclusion of any particular medicine does not necessarily mean it is substitutable. The list is periodically reviewed, and alterations are made at the discretion and recommendation of the MCC.
References:
United States Food and Drug Administration. Generic drugs: what you need to know. [online] 2002 [cited 2007 Jul 09]. Available at: http://www.fda.gov/fdac/features/2002/502_generic.html
United States Food and Drug Administration. Savings from generic drugs purchased at retail pharmacies. [online] 2004 [cited 2007 Jul 09]. Available at http://www.fda.gov/cder/consumerinfo/savingsfromgenericdrugs.htm
United States Food and Drug Adminstration: Office of Generic Drugs. [online] 2007 [cited 2007 Jul 09]. Available at: http://www.fda.gov/cder/ogd/
SA Medicines Control Council. Guidelines on generic substitution. Government Gazette 2003;25145:183-5.
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