Tuesday, September 01, 2009


Sunday STAR August 30, 2009

Stretching the healthcare dollar


Last week, we discussed the issues concerning the choice between generic and branded drugs. Now, we look at whether switching to generic drugs will boost our healthcare budget.

ONE of the main reasons for the push to use generic drugs is cost. It is often claimed (but not well substantiated by data) that drug cost forms a substantial part of our healthcare budget.

In researching this article, I discovered that in 2005, we spent about 8% to 10% of our healthcare budget (at that time the healthcare budget was about RM7.8bil) on medicines and drugs.

There are important and sometimes crucial differences between generic drugs and branded ones.

This is similar the world over. For example, according to the National Health Expenditure Report 2004, the US spent about 11 cents for every healthcare dollar (11%) on drugs in 2002. In fact, drug expenditure is much less than administrative expenditure.

Despite worldwide data to the contrary, many countries are embarking on a policy of using generic drugs in the treatment of diseases whenever possible.

I suppose they wish to cut down drug cost from 10% to 5% of the healthcare budget, but at what cost to the patient?

Would a better strategy be to try and reduce administrative expenditure by greater use of digital technology and computerisation, and also streamlining administrative procedures?


As the subhead implies, this is the policy to use generic drugs as a substitute for branded ones. This can take one of two forms.

Firstly, the healthcare governing body can mandate that their healthcare facilities only stock generic drugs. Doctors are asked to prescribe the proper drugs using the generic (pharmacological) name and the healthcare facility will then buy the generic (copy) version of that prescribed drug.

For example, in the treatment of dyslipidaemia, the doctor may prescribe the branded drug simvastatin (Zocor). The healthcare facility may carry a generic drug called covastin. So the patient treated in that healthcare facility will get covastin.

In this case, the patients who go to that healthcare facility know that he/she will be getting a generic drug. This is commonly done in general hospitals.

The second form of substitution, which is more subtle, is the replacement of drugs (substituting with a generic) by the pharmacy. For example, the patient with dyslipidaemia is prescribed simvastatin (Zocor) by his doctor. He goes and buys the drug from the pharmacy. That pharmacy carries the generic covastin, and dispenses that to the patient, without the doctor’s permission.

Strictly speaking, this is unethical. The doctor should be contacted first and his permission sought in generic substitution. But this is not often done.

Potential dangers of generic substitution

Is it wrong to substitute generic drugs for branded ones? The advantage is obvious. There is usually cost savings. But there are also potential dangers, which is why a list of drugs that should not be substituted by generics is necessary.

There are some drugs that should not be substituted. For one, drugs with low “therapeutic index” should not be substituted.

Therapeutic index refers to the drug dosage difference between the effective dose of the drug and the dangerous dose of the drug. The wider the therapeutic index, the safer the drug, as the difference between the drug’s effective dose and toxic dose is wide.

This means that for a generic drug with a low therapeutic index to substitute for a branded one, a delicate balance has to be maintained. If the effective dose of the drug is not achieved and maintained constantly, the patient could suffer a relapse instantly.

This is particularly true with generic substitution of anti-epileptic drugs and anti-psychotic drugs.

There have been many reports from the US, Canada, Germany, Austria, Switzerland and others, of patients who suffered relapses when they received generic forms of their anti-epileptic drugs, and who again came under control when they were given the branded product.

One study in the US found that a certain form of generic diphenylhydantoin (a drug widely used to control seizures/fits), had a bio-equivalence 31% lower than the branded one.

I feel that drugs for fits should not be substituted.

Clearly, reducing healthcare costs and stretching the health dollar may have to come from other measures, like trimming administrative “fat” and “leakage.”

Personally, I am very concerned about generic drug substitution of vital drugs, especially cardiac drugs, where one or two doses missed could have a catastrophic effect.

Let me give you an example. In interventional cardiology, we implant drug-eluting stents (DES), which mandates the use of dual anti-platelet therapy to prevent acute clotting of the DES, especially in the first three to six months (with most FDA-approved DES). The usual dual anti-platelet therapy is aspirin (there are many generic forms) and clopidogrel (brand name Plavix).

There are many studies to show that acute clotting of a recently implanted DES may result in an acute heart attack, from which a patient may die.

It is also well documented that one of the commonnest causes of acute DES clotting is the avoidance of Plavix. (These studies were done by reputable cardiac institutions.)

Generic substitution of drugs for the control of hypertension in a high risk population may result in stroke. On the other hand, generic substitution for vitamins and other OTC products should be much less dangerous.

Taking cognizance of this, the Ministry of Health, Pharmacy division, asked the Federation of Private Medical Practitioners’ Associations of Malaysia to come up with a list of drugs that should not be substituted at the last Malaysian National Medicine Policy workshop.

Is generic substitution good for the patient?

I believe that the choice of whether to use a generic or branded drug lies with the patient. For those who are happy to carry on using generics, do so by all means.

The purpose of my sharing with you is, as always, to give you an informed choice. The next time your doctor writes a prescription for you, I hope that you can also ask him a few questions for clarification.

There are important and sometimes crucial differences between generic drugs and branded ones. Substitution should not be taken lightly.

We are all for saving on healthcare costs, but they should not come at the expense of a person’s health and life. After all, we are here to help a patient live longer, and better.

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