Generic substitution is just the kind of safe but money-saving medicine that the NHS needs, argues Dr Andrew Perry. But Dr Peter Fellows disagrees, insisting that the policy would damage compliance and harm the pharmaceutical industry
Prozac, Lipitor and let’s not forget Viagra… brand names are there for one reason only, to sell, sell, sell.
Drug companies will pay marketing firms thousands of pounds to have a bunch of gurus sit in a room and come up with the next snazzy and snappy name, a name that will stick in our minds (especially if the name manages to get in the obligatory V or Z).
We all know that the mug sat on our desk would just not look the same if it was emblazoned with sildenafil or fluoxetine.
Brands surround us in everyday life but we all know that Sellotape merely represents many identical products which do exactly the same job, though no doubt the makers of Sellotape would like to have you believe otherwise!
Drug companies spend millions of pounds developing their drugs and are rightly safeguarded with patents to protect their molecule while they recoup their costs.
They may develop novel molecules and delivery methods and have a right to set their initial prices to continue their research and development. However, there should be no reason that once this time has passed that other producers should not manufacture and sell the same medicine.
The UK government’s view on this issue was only a matter of time in coming, with the realisation that our brand loyalty is costing the NHS dearly.
Ministers have spotted an opportunity to stop feeding the deep pockets of some drug firms and provide what the NHS really needs at the moment – economic medicine without causing harm.
It has realised that allowing pharmacists to safely substitute a branded prescription with a generic product will make huge financial savings for the cash poor organisation that it is.
So what are the problems with generics? Strict manufacture laws surely mean that these medicines are made to the same high standards and adhere to the molecular make-up of their original drug. Indeed a study published in JAMA in 2008 showed that no brand name cardiovascular drug was shown to be superior to a generic1.
The meta-analysis compared nine sub-classes of medications. With minimal levels of bio-equivalence required for manufacturers, inadequate therapy levels should not be a concern.
For some time now in Australia generic substitution by pharmacists has been commonplace. Patients here pay for the real cost of their medicine up to $33.30 (approximately £18.30) unless on a pension card, and consequently they are more aware themselves of the financial implications of treatment.
Following awareness campaigns, patients are proactive in asking their GP or pharmacist for the generic medication. But there is a sting in the tail.
As an incentive to reduce the country’s drugs cost the Australian government incentivises pharmacists with a reward of $1.50 (about 82 pence) each time they perform a cost-saving substitution.
This contentious practice and the apparent conflict of interest it causes is high on the agenda here and is a route I feel the UK should not follow.
This all said our prescription pads clearly have a box to be ticked if the GP does not wish for brand substitution to occur; an option I believe must remain and should be followed in the UK.
There are reported instances of confusion among patients and there are a few select drugs where we may believe that substitution is not in the best interests of the patient.
Finally we must ask ourselves why, when our (rep sponsored!) pen hits the pad, do we write down a trade-named medicine? Surely our basic pharmacological teaching is based around generic medicine names.
These names often serve to help us remember the class of drug we are prescribing, the beta blockers (olol) being a good example. We as GPs have a responsibility too; with legislation likely to be passed giving pharmacists the first bite at controlling drug costs, isn’t it about time that we started instead to prescribe generically from the very outset.
Dr Andrew Perry trained in Sheffield and worked as a GP in the UK, but is now medical director of the Redcliffe primary care superclinic in Australia
1 Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: A systematic review and meta-analysis. JAMA 2008; 300:2514-26
A consultation is underway on proposals to allow pharmacists to substitute initially 40 drugs for generics, unless actively blocked by the prescriber. That ultimately may well end freedom to prescribe as we think fit.
GPs already prescribe more drugs generically than anywhere in Europe.
But our duty is to prescribe cost-effectively, not cheaply.
Programmes such as Scriptswitch can be helpful, but this now recommends switching back from generics to brands in some cases – such as salbutamol to Ventolin. I doubt pharmacists will switch to a generic if dispensing profit drops.
Drug prices constantly change and our patients must not end up on a cost-based rollercoaster. Only drugs that are taken will work. Many are not taken.
Elderly patients often have memory loss and are easily confused. If patients receive regular medicines varying in colour, size, shape, taste, or form, inevitably it confuses them. They may choose not to take what they are unsure of.
Drug licences are brand-specific and are not transferable to generic forms.
As licences are very expensive to obtain, few generics are licensed. If there is then a problem, maybe years later, under Consumer Protection Law, unless the detail of the manufacturer and distributor can be obtained for 11 years after a prescription was dispensed, then responsibility reverts to the last identifiable point in the supply chain, quite possibly the GP.
Generic names identify a drug as one of a group with similar chemical names, which are often complex and difficult for even doctors to remember.
With a few exceptions, brand names are memorable. Generic names confuse patients, but also reception staff, who usually find the shorter brand-name has been written in clinical notes while a generic is in the prescribing list. Accurate records will be a problem if pharmacists can make voluntary generic substitution.
Although usually of minor clinical significance, base ingredients affect pharmacodynamics in subtle ways. One of my patients can only tolerate branded Eltroxin.
The classic case is that of old generic digoxin, when along came microfine Lanoxin, almost twice as potent. For some drugs base ingredients have serious effects and can affect absorption rates and potency by as much as 25%, especially with drugs such as calcium channel blockers, antiarrhythmics, anticonvulsants, and anti-diabetic drugs, not exclusively in slow release formulations. Side effects can vary according to base ingredients.
Patients can be intolerant to colorants or fillers. Preservatives can sensitise.
BNF advice is that modified-release preparations should only ever be prescribed by brand. The computer flags that up, but all too often advice is ignored.
Sudden switching to a generic can have catastrophic consequences and generate law suits, as recently happened in Stroud when a stable patient with epilepsy was switched to a generic anticonvulsant and promptly had a fit, ending a career, with loss of driving licence.
How will a doctor influence a switch? It seems a deliberate opt-out will be required, rather than an opt-in. A simple tick-box will not be permitted, and the proposal is that NGS (not for generic substitution) will have to be added to relevant prescriptions.
Time taken up would be better spent on properly checking prescriptions currently signed too hastily. GPs now have huge numbers of prescriptions to sign.
Pharmacists do not have medical skills. If doctors now have to consider whether a pharmacist’s substitute might be appropriate, mark a prescription to opt out and record their reasons it will add significantly to administration time.
Pressure from PCTs for 28-day prescribing already adds vastly to workload for reception staff, doctors, and dispensers, to say nothing of the inconvenience and time wasting for patients.
Pressures by Government for excessive generic prescribing are damaging our pharmaceutical industry and will force even more of it abroad.
Some 10% of the total workforce lost their jobs here in 2008, when much R&D and manufacturing was moved to the Far East. You will not have seen many reps recently.
Generic pressures here have been the major reason for parallel importing with the labelling problems that has brought.
Branded drugs were cheaper on the Continent until recently, so wholesalers could import at greater profit against the drug tariff.
That explained why new drugs were so expensive for the NHS.. Short-term profiteering on the back of a strong Euro has now reversed the situation, with many drugs becoming unavailable to NHS patients as they are exported for greater profit.
Longer patent periods for new drugs would protect our industry from a hostile Government, unfair competition and fake drugs. We must oppose attempts to increase generic prescription further, in what is a very controlled monopoly market.
When all of the disadvantages are accounted for, no money will be saved, but jobs, and the prestige of another sector of dwindling British industry, will be damaged, to say nothing of the vastly increased problems for patients and doctors.
Dr Peter Fellows is member (and former chair), of the GPC clinical and prescribing subcommittee, former member of the advisory council of the ABPI and a GP in Lydney Gloucestershire
A consultation is in progress on plans for generic substitution Yes No