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A PAMPHLET produced by a pharmaceutical company may perpetuate the misconception that generic drugs are not as effective as branded drugs, according to a leading pharmacologist.
The pamphlet, produced by Nycomed and distributed to general practices, listed various reasons why consumers should be cautious when choosing generic drugs.
“You could find yourself substituting the tried and trusted brand prescribed by your doctor with a generic copy at no cost saving at all”, the pamphlet said.
It stated that generics were not always cheaper than the original drug, that the variety of names and packages used by generics could cause confusion, and that the different inactive ingredients used in generics could cause allergic reactions.
Professor Ric Day, professor of clinical pharmacology at the University of NSW, said the pamphlet may lead consumers to believe that generics are not as good as the original drug.
“For generic medicines, their performance is the same — and that’s the one thing that’s being undermined to an extent … there’s clearly a self-interest at play here”, he said.
He said although allergic reactions to inactive ingredients were likely to be “vanishingly rare”, they were possible.
However, Professor Day said the pamphlet did highlight the important issue of potential patient confusion due to the multiple bioequivalent drugs available.
Professor Day coauthored a paper in the latest MJA which said that the proliferation of generics led to increasing brand substitution, which raised the potential for confusion and medication misadventure. (1)
For example, although only eight different ACE inhibitors were used in Australia, 81 different brands were available.
“Consumer confusion and adherence problems are related not only to names but also shape, colour, taste, packaging and excipients”, the authors wrote.
Despite this, Professor Day told MJA InSight that generic drugs did save the government money, and their responsible use should be encouraged.
The authors called for an urgent change to drug labelling to reduce the risk of confusion and duplicate prescriptions.
“We call on the responsible authorities, as a matter of urgency, to amend Australian and New Zealand labelling laws to ensure the active ingredient or generic name is displayed more prominently and in a larger font than the brand name on all pharmaceutical labels”, the authors wrote.
Dr Jenny Martin, an associate professor of clinical pharmacology at the University of Queensland and Princess Alexandra Hospital, said the labelling suggestion could contribute towards patient safety, although she expected there would be resistance from industry.
“Some negotiation with industry would need to occur to ensure this was successfully implemented”, she said.
Dr Martin said the price of generic drugs was often similar to the branded drug, as stated in the Nycomed pamphlet. She said Australian consumers paid substantially more for generics than consumers in the UK or New Zealand and only a minimal amount of the cost benefit seemed to be passed on to consumers or the government.
Both Dr Martin and Professor Day said they regularly saw patients who were unwittingly taking multiple brands of the same medication.
Professor Day recommended that health professionals regularly review their patients’ medication, particularly with older patients, or those taking multiple medications.
“Ask patients to bring all their medication in, or book a home medicine review”, Professor Day said.
He also suggested that doctors improve their communication with patients to ensure patients know more about their medicines.
“The more patients understand what their medicines are for, which ones they are taking, what the proper names for them are, the safer everyone will be”, he said.
Nycomed did not return MJA InSight’s request for comment.
– Sophie McNamara
1. MJA 2011; 195 (11/12): 650-651
Posted 12 December 2011
As a general physician, I ask patients to bring in ALL their medications when they come – only way to be “sure” what they’re taking.
Over the years, I’ve found that referral letters, other specialists’ letters, hospital admission notes and discharge summaries are usually wrong when listing medications and doses. The sources of error are numerous, and relatively easy to track down from out-of-date lists on practice software, to out-of-date labels on boxes and bottles not checked with the patient, to the patient stating they are on the “same as last time” when they’re not.
I’m surprised this issue has not been systematically studied since it’s at the heart of what we do.
I’ve found that sticking to brands (original or generic) avoids confusion.
To clarify the allowable degree of variation between brands. The 20% relates to a 90% confidence interval of a bioequivalence parameter (AUC). The actual degree of variability is about 10%, so with the possible exception of those few drugs with narrow therapeutic indexes, the two brands should be able to be readily interchanged with no difference in response to the active ingredient.
Absolutely lets have generic names dominant on packaging. The multitude of brand names only serves the needs of the pharma companies, be they originators or generic manufacturers. We need to shift patients thinking towards generic names, not for the primary purpose of saving (in some cases) them and the government money, but for safety… it’s even a problem with common OTCs, panadol v panamax etc.
What we also need though is a system that mandates that generics are cheaper to the patient and government, there are far too many examples of where there is no advantage to the patient. But lets not forget that there are examples of where generics can be vastly more affordable to patients, in my area perindopril is around $10 per month less to patients than coversyl and that has a big influence on compliance.
Acentuate the GENERIC name and educate patient to Drug Name not brand… had patient taking Frusemide, Lasix and Uremide each morning… another Lactose intolerant had very bad experience with a generic substitute.
No brand names for generics wouldn’t help those patients whom I stabilise on a specific generic for economic reasons, and then get to stick to that one so I can control dose. No name means they won’t be able to tell one from another at the pharmacy and the variance between generics will cause problems with dosage again.
Generic drugs are brought out for the profitability of the manufacturer only. No development costs. Cheapest excipients. Then they charge minimally below the originator brand (or the same).
It’s a con.
Not all patients complain of side effects they didn’t get originally, but too many to be dismissive of them. “Vanishingly rare” indeed!
I like the suggestion of no brand name at all for generics.
I agree with Prof Day that a major problem with generic substitution is the possibility of confusion and medication misadventure. However, I’d go even further. I would mandate that generic companies be allowed to call their version of the drug by the chemical name only and not be able to have a new brand name. In brackets after the chemical name it would need to be stated that this preparation is equivalent to the original brand name, with which both patient and doctor would be more familiar. I certainly cannot (and don’t want to) remember 81 different brand names for 8 ACE inhibitors.
When I last checked: Generics were allowed a variation of +/- 20%.
There is considerable variance in effect clinically.
The law says the TGA MAY test new products – not WILL.
(Read budgetary pressure here – I’ve talked to someone on the TGA committee.)
Patients do have allergic reaction to some excipients and not others.
So, I prescribe by brand – whether it is a flagship brand or a specific generic – and encourage patients to stick to that brand regardless of pressure from the pharmacist.
Then we know what is going on.
So, I want the brand name prominent – not the one that looks like a meaningless long string of letters to the patient…