Introduction

When your doctor prescribes a generic drug, are you pleased, indifferent or affronted? Or are you perhaps uncertain and wondering what exactly generic means and how it will affect you?

Health authorities and insurers in many countries want to encourage physicians to prescribe generics because they are cheaper. Patients can benefit from that but also need to be assured that they are still getting the best medicine and not merely a cheaper form of second-class therapy.

What is a generic drug?

All drugs have a generic name. They can also have a brand name.

A generic name is that of the active drug substance. A brand name is the registered trademark under which the drug is being sold.

For example, Prozac is the brand of a drug whose generic name is fluoxetine. The generic name of Viagra is sildenafil. In most countries of the industrialised world, doctors may prescribe drugs either by their generic or their brand names.

As long as the active drug substance is protected by patents, only the patentee's own brand name or those that are licensed under agreements with the patentee may be used. Once the patent has expired, other companies may register the drug with health authorities and sell it under their own brand names or by its generic name. In the USA and the UK, most generics are unbranded, whereas in some other countries generics are commonly branded.

The doctor's choice: brand or generic?

New drugs are normally prescribed by their brand name. If the drug is covered by a patent, the pharmacist will also dispense the brand, even if the physician has actually prescribed the drug by its generic name: patented drugs are in effect single-source brands.

After patent expiry, generics can enter the market and compete with the original brand. Generics have no medical advantage over brands. Their only appeal is that they are cheaper. For branded drugs with high sales, many generic competitors will enter the market after patent expiry. Generics will offer a price advantage by undercutting not only the brand but also one another.

At this point, the question arises whether your doctor will continue to prescribe the original brand or switch to a generic version of the same drug.

Doctors' attitudes differ greatly from country to country. In some, the health authorities encourage doctors to prescribe generics; in others, they put obstacles in the way of generic entry into the market, for example by insisting on lengthy and costly registration procedures. Some health care payers put pressure on doctors (with incentives or penalties) to prescribe generically. Others take the decision out of the doctor's hands by allowing (or even requiring) the pharmacist to substitute a cheaper generic in place of the prescribed brand.

Generic substitution means that the pharmacist switches the physician's prescription by dispensing a generic instead of the prescribed brand. Depending on national or state regulations, the pharmacist may do so either with or even without the physician's prior consent. In some countries, patients may refuse a generic switch; in others, patients who insist on the prescribed brand may be asked to pay the price difference between it and an available generic.

The main reason why the authorities and health care payers support and encourage generic prescribing and dispensing is financial: generics save money.

In which countries are you most likely to receive a generic prescription?

The countries where more than one-third of all prescriptions are estimated to be generic are:

• USA
• Germany
• Canada
• UK
• Australia
• Netherlands
• New Zealand
• Denmark

In the retail pharmacy market of the USA, in 1998, generics were substituted for brands in 39% of all new prescriptions, and the generic volume of all prescriptions (new and refill) was over 41%¹. The fact that the cost of generics represented only about 10% of total drug sales by retail pharmacies in the USA shows the money-saving aspect of generic drug prescribing and dispensing quite clearly.

Are generics a form of 'second class' medicine?

That generics are a relatively cheap form of medicine is indisputable. Whether they always represent good medicine or the best medical value is more controversial. There are four main aspects to be considered:

1. Are generics safe?
2. Is their quality as good as that of the corresponding brand?
3. Is your doctor or pharmacist wise in switching your usual brand to a generic?
4. Are generics as effective as newer, medically innovative and more costly drugs that your doctor could prescribe for the same illness?

Provided you live in a country with strict regulatory control of medicines, the answer to the first two questions is "YES": generics are safe and their quality is not inferior. Unregulated Internet trading of prescription drugs from sources that are outside the grasp of national regulatory control could cast doubt on their safety and quality. However, that applies not only to generics but also to counterfeit brands. That said, generics from respectable suppliers are safe and of good quality.

The answer to Question 3 is less clear-cut. Doctors are sometimes reluctant to switch your prescription from a branded drug that 'works' and has never given you any trouble, to an equivalent generic, even though that generic is chemically and pharmacologically identical with the brand. The doctor may be quite happy to prescribe the generic to a new patient, but may be reluctant to switch existing patients on the principle "if it ain't broke..." - Why take a chance that you will come back and say "Doctor, I used to have the green tablet: this one is white, and it doesn't seem to work quite so well....?" The doctor will want you to stop worrying, even though you may just be imagining a problem. On the other hand, the doctor will also be under pressure not to exceed his budget for prescription drugs, or the pharmacist to substitute a generic for the brand. Finally, if you are a new in-patient in hospital, you will probably never be aware of the fact that, in many countries, hospital pharmacists regularly switch brands to generics according to hospital rules and budgets, because you may not have seen the prescription.

Undoubtedly, the trend in most countries is to increase generic prescribing and dispensing whenever possible, certainly for new patients but also increasingly by switching. Most patients will accept that this is a reasonable economy measure and that it will not harm them.

There are exceptional situations for some drugs where it is difficult or impossible to produce a generic that is in every respect identical with the original brand in terms of its availability within the body. That can lead to serious adverse reactions in some patients. Three old-established drugs where brands and generics are not regarded as automatically 'switchable' are digoxin, phenytoin and theophylline (Carlen², 1995).

There will also be a growing problem with many of the new biotechnology drugs that are not produced by chemical synthesis. For most, the generic question has not yet reached the prescribing stage because they are still patent-protected, and generics in the accepted sense are not available. During the next few years, however, experts in drug regulation will have to decide whether biotech-generics are or are not identical with the original brands. Regulatory approval of biotech-generics may well have to be delayed until these questions can be resolved and doctors as well as patients can be assured of the safety and efficacy of such 'generics'.

The fourth question is much the most difficult and the most important for you as a patient:

Are generics as effective as the newer, medically innovative and more costly drugs that your doctor could prescribe for the same illness?

This is where the conflict between the best medicine and saving money is sharp. New, innovative medicines have transformed drug therapy during the last sixty years. Not only have they helped to save lives, but they have also enormously helped patients (especially elderly patients) to live more comfortably with chronic conditions like heart disease, arthritis, ulcers and depression.

Such innovative drugs are not cheap and should not be expected to be cheap. They are the result of costly research and development with high risks of product failure before a new drug can be proven safe and effective and introduced as a prescription product in hospitals and/or for outpatients. Pharmaceutical patents were first introduced in the 19th Century in order to encourage this type of research and development by rewarding inventors and to stop the piracy of intellectual property.

Today's and tomorrow's problems can be stated very simply: Who is to pay for all this? The state? the insurer? the employer? the employee? or you - the patient - when you hand your prescription to the pharmacist?

The health care systems of various countries have tried to find different answers to the question 'Who Pays?', but there is general agreement that the health benefits that innovative drugs bring to medicine and patients need to be weighed against their cost and how that cost is to be shared.

That is where the conflict between prescribing cheap generics or costly innovative drugs comes to a head. The budget of health care payers will obviously benefit if old generics are prescribed and new medicines reserved only for exceptional cases. But will you, the patient, benefit? Will your health be maintained or improved as effectively with a generic that has been prescribed for the past 30 years as with the latest drug? That is not a conflict between brand and generic (as in Questions 1, 2 and 3, above) but between traditional and innovative remedies.

In the past, your problem as a patient was that you were not really in a position to judge whether your physician's prescribing choice was the best for you. The majority of older patients were brought up to accept the doctor's decision without question. They were not even told what drug was being prescribed, but handed a bottle labelled "The Medicine" - and that was that.

That was the past. Today, the situation is changing radically. There are self-help groups and patients' advocacy groups for most diseases in the USA and increasingly in Europe. There is the Internet. You can, if you wish, become fairly expert in the range of drugs that are available for the treatment of your illness. Above all, you can seek independent advice from advocacy groups whose pharmaceutical knowledge may be more up-to-date than that of physicians who have not taken refresher courses on Recent Advances in Pharmacology.

The idea is not that we should all become our own doctors or second-guess the professionals. It is simply that we have a right to understand whether we are being fobbed off with cheap, obsolete, second-class medicine or whether cheap happens also to be best - which in many cases it may well be.

Are generics a form of 'second class' medicine?

Generics are here to stay. Increasingly, your physician will prescribe them in place of the original brand, either willingly or under budgetary pressure from health care payers. How should patients react?

There is no simple, single answer. Common sense suggests that your attitude will be determined on the one hand by your circumstances, and on the other by your alertness. Circumstances will influence the policy of health care payers and how much you (as distinct from your insurer) will be expected to pay out of pocket if you opt for the brand instead of the generic.

Common sense will also help to convince you that, for the majority of older drugs in countries with strong regulatory control, generics will be as safe and as effective as brands. Moreover, common sense will scare you away from 'cowboy' generics obtainable from suspect sources (which may include unknown Internet suppliers in other countries).

Alertness is your greatest asset in making sure that cheap generics are not being prescribed in preference to better, costlier innovative drugs that would be more effective in maintaining or improving your health. There is no substitute for being vigilant and becoming more knowledgeable, or getting to know independent advisers who know about the 'latest and best' in a health care system that naturally gravitates towards the cheapest. Be alert!