Posted by: Fatima Sabir24 APR 2011
Generic or branded….should be an easy decision right? Or is it?
How many times have you advised a customer that instead of picking up a packet of Nurofen that they should instead chose ibuprofen because they have the same active ingredient but most importantly it is CHEAPER. Ok I’ve just done it the once and the reply I got was ‘nothing works for my headache but Nurofen’….is this really true or just a placebo? Is society becoming more selective with medical treatments; edging towards the one with the big name? Is there a formation of designer drugs? Is Nurofen the Louis Vuitton handbag, quality at its best, whilst a generic branded ibuprofen is just a Primark clutch with a very low expiry date? Between me and you, it’s best getting the Louis V, but choosing generic or branded is a very debatable issue.
As pharmacy students we are trained to provide excellent medical advice; advising patients on which drug is best suited for them in terms of tolerability, toxicity levels and more importantly efficacy. As well as putting patient’s health first, it is also important to consider NHS economic pressures. The Food and Drug Administration (FDA) clearly states that when a generic drug is approved, it has undergone rigorous testing procedures. Such testing is meant to ensure that the generic drugs have the same active ingredients, strength, dosage form and bioequivalence as the brand or reference product. Sounds pretty acceptable to me; which is why I steer clear away from Anadin, and have no problem popping back a couple of good old generic paracetamol tablets.
But what makes me nervous is when a newly generic drug with narrow therapeutic index (NTI) comes around the block. Although generic drugs have the same active ingredients to their brand name equals, variability in inactive materials is acceptable according to the FDA. Is it this gap that causes the potential difference? And with the absence of clinical trials, can generic drugs be completely safe as outlined by the FDA? According to G. Kramer et al (2007) generic substitution in patients with epilepsy can be problematic, thus such replacements cannot be made.
In contrast, Kesselheim et al (2008) indicated that cardiovascular generic drugs have the same efficacy and safety to their brand-name counterparts. They conclude that generic substitutions can be readily made, and with the cardiovascular drugs industry being so big, such potential savings should be celebrated.
Branded drugs and generic drugs both have their niche in the medical world. It is the job of health care professionals to remain informed on current issues, so that they are able to identify when it is necessary to suggest only branded and when generic is a more than acceptable alternative. Generic substitution is encouraged as a cost-containment strategy for the management of health care recourses. However, both their positive and negative attributes should be considered and the usage of the yellow card scheme should always being place.