Generic substitution – cost saver or resource drainer?
Posted 5th November 2009 in Articles, General | 4 comments
Leslie Galloway
Ethical Medicines Industry Group (EMIG)
In the UK, the 2009 Pharmaceutical Price Regulation Scheme (PPRS) settlement included a proposal by the Association of the British Pharmaceutical Industry (ABPI) for the introduction of generic substitution (GS) from 2010.
In this context, the term “generic substitution” refers to the practice of allowing a pharmacist to override the doctor’s decision to write a prescription for either the branded or generic form of a drug. In other words, where the doctor has written a prescription for the branded drug, the pharmacist could instead dispense the equivalent generic without consulting either the patient or the doctor. Currently, this practice is not permitted by UK law, except in emergency cases.
So, if it came into law dispensing of cheaper generics drugs should increase, which on face value would seem to be beneficial.
Why is it therefore that so many people and organisations are opposed to generic substitution when, in theory, this should be a useful cost saving measure for the National Health Service (NHS)?
“Why is it therefore that so many people and organisations are opposed to generic substitution…?”
Let’s look at the facts from some differing perspectives.
National Health Service (NHS) Financial Perspective
Currently, 84% of all prescriptions are written generically and a further circa 15% must be filled with a brand for clinical reasons e.g. patients with epilepsy to name but one of many patient types.
That leaves just 1% of the total volume of prescriptions and many, having been off-patent for a long time, will have been subject to numerous PPRS price cuts, making them already low in price.
What would happen to the many branded products that are priced below the generic Drug Tariff and are already saving the NHS money?
What would be the implementation costs to the NHS?
EMIG believes generic substitution would be an enormous resource outlay for very little reward for the NHS.
“What would be the implementation costs to the NHS?”
Patients’ Perspective
Elderly patients, and particularly those with sight problems, are at risk. They may have been used to taking the same product for a number of years and could suddenly be faced with a generic from a different manufacturer every month, depending on where the prescription is sourced. This has enormous safety implications, not only because of the likely difference in appearance, but also because of the certain difference in bioavailability.
In the case of topical medicines for treating skin disease, it is well established that the excipients in the formulation may have a significant effect on the safety and efficacy of a topical formulation.
If a product has a narrow therapeutic window, substitution of the doctor’s prescription for a particular brand may have serious implications. For example, lithium carbonate has a narrow therapeutic index and the blood levels of lithium need to be maintained within a certain range. If the blood levels are too low the product may not be effective, and if blood levels are too high, serious and sometimes irreversible toxicity can occur.
Modified release preparations containing the same active ingredient may have different release characteristics which may alter the effect of the medicine in an individual patient. If a patient is established, for example, on a specific brand of modified release diltiazem, it could be detrimental to the patient if this product was substituted for a generic.
Doctors’ Perspective
The culture in UK prescribing is one of prescribing generically, so when a doctor writes a brand for a patient, surely that doctor is already making a conscious decision that the brand is more appropriate for the patient.
Why, then, is there a need for further expensive control of a doctor’s prescribing?
“…who is liable in cases where the pharmacist substitutes and the patient experiences an untoward event…?”
How would the doctor feel if a retail pharmacist substitutes a more expensive and profitable generic for a low cost brand and pushes up the GP’s costs? In fact, the doctor would be unaware until the Primary Care Trust (PCT) pointed out the increase in the cost of their prescribing.
Finally, who is liable in cases where the pharmacist substitutes and the patient experiences an untoward event. The doctor or the pharmacist?
Industry Perspective
Some people say that innovation is ‘the only game in town’. It’s worth remembering that pharma small and medium enterprises (SMEs) produce 40% of the branded products in the UK and those brands reflect only 10% of the drugs bill. That’s because these companies focus on improving older off-patent products.
This is true “Incremental Innovation” – the development and improvement of existing formulations, delivery technologies and flavours of out of patent products. Generic Substitution would deter further development work on existing molecules and a significant section of the UK pharma industry is dedicated to Incremental Innovation. Those same companies invest in important patient initiatives and co-operation with PCTs – who will replace that investment?
Where generic supply is unpredictable, product forecasting for the manufacturer would be very challenging indeed, leading on one hand to either expensive over stocking of product with a limited shelf life, or a shortage on the other.
EMIG continues to urge the Department of Health (DH) to reconsider whether this policy should be implemented. It is vital that the DH takes all of these issues into account and consults the wide range of stakeholders affected by this issue.
About the author:
Leslie Galloway is Chairman of the Ethical Medicines Industry Group (EMIG), based in the UK.
For enquiries regarding this article he can be contacted on leslie.galloway@emig.org.uk.
About EMIG
The Ethical Medicines Industry Group (EMIG) was established in 1985 as the forum for small to medium-sized pharmaceutical companies operating in the UK. EMIG has grown substantially in recent years and now represents over 60 member companies. EMIG’s membership uniquely reflects the various stages of pharmaceutical company development in the UK, from start-ups whose prime focus is R&D, to highly developed businesses delivering essential products to patients while continuing to invest heavily in the fight against disease. For more details please visit http://www.emig.org.uk.
Please let EMIG know your views – do you agree with generic substitution?
6th November 2009, 16:59
NO. I am responding as a drug safety physician, ex-clinician, and patient. The generic drugs are not always equivalent in effectiveness or safety to the brand name drugs, just as the brand name drugs are marketed as if there are significant differences among them. The physician should make the sole determination on substitution based on the individual patient's clinical presentation, history, and response. There are well-known clinical and anecdotal questions on the comparative effectiveness and safety of generic products in important therapeutic areas - e.g., hypnotics, antidepressants, and classic drugs with direct organ effects, such as diuretics and digoxin.
Will pharmacists be allowed to substitute in most cases, anyway? YES. This is a financial and not a clinical question, since medicine is a business.
Michael Joseph
6th November 2009, 17:58
Absolutely, UK pharmacists are trained in clinical pharmacy and pharmacology and know when it is and is not appropriate to substitute. They are specialists in medicines and guardians of both the patient and of the public purse.
The use of the words 'retail pharmacist' in the article does community pharmacists a disservice. Our pharmacists practice clinical pharmacy on the High Street and are not simply shopkeepers. Many of them are running clinics and prescribing in their own right.
The article infers that pharmacists would substitute in inappropriate circumstances e.g. lithium and modified release meds, also in a situation where the patient would become confused. Pharmacists are fully aware of these situations, are responsible clinicians and will not substitute if it will adversely affect the patient. Many times they will have suggested that a brand should be prescribed when a prescriber has inappropriately prescribed a generic.
Pharmacists have been practising generic substitution in UK hospitals for at least 30 years, possibly longer.
In primary care it is different and until now pharmacists have needed to contact the GP to arrange generic substitution. GPs will find the legislation change of great benefit as it will result in lower prescribing costs and fewer telephone interruptions. I would expect the pharmacists to discuss the principles of the proposed change in legislation with their local prescribers and come to some form of local understanding.
GPs already employ pharmacists to assist them to prescribe generically, and some have software installed on their prescribing systems that offer generic substitute suggestions for manual or automatic switching.
This merely increases the tools at their disposal
7th November 2009, 12:52
I'm struggling to understand something here...
If the majority of medicines prescribed in the UK are written as generic - which I understand to be the case - then the potential for cost-savings by empowering the pharmacist to make generic substitution would appear to be very small. Correct?
So, what advantages does this change of legislation offer? I can not see much of an advantage either in cost savings or interruptions to the GP as most practices conform to a PCT formulary in any case. As Pauline has already pointed out, many GP's employ (or work closely with) pharmacists to assist their prescribing and generic substitution is already well entrenched.
On those rare occasions when a prescription is written for a branded product I would imagine there is very good reason why a GP has specified that, as most computer systems default to the generic equivalent, so, it's actually more hassle for a GP to try and prescribe the branded version. So, it appears to me that this new legislation is actually giving licence to pharmacists to change prescriptions that have been written as branded for specific reasons. I'm not sure that's a good thing - and obviously up until now it's been illegal to do so - which further reinforces the concern.
My youngest child suffers with asthma. He's been on a branded product for several years. Recently his branded product was switched to the generic equivalent. He's since developed mouth ulcers while on treatment. We've never had this problem before but it became so bad that he was refusing his inhaler, it is most certainly linked to his medication - and specifically, we think, to his change of medication.
So, if we now go back to our GP and demand the branded version, the GP will be powerless to prevent the pharmacist dispensing whatever generic he can get the best deal on? And some of you are saying this is a good thing?
Hmm!
8th November 2009, 23:34
Whilst I would like to see Pharmacists having this right, I feel it should only be with the agreement of the patient. I would be happy for some of my meds to be switched to Generics but some of them I would strongly object to being switched. Apart from any active ingredients there are varying other components of such tablets, capsules, caplets, etc., there are also different presentations with differing oesophageal transit times, different storage requirements (which can be of importance to travellers etc) and other factors. Such differences should be explained to a patient and they should have the right to decline a Pharmacist's offer of substitution.
