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Keep the mandatory drug labels clear and comprehensive

The New Straits Times, March 3, 2002

By Dzulkifli Abdul Razak

THE announcement that the Ministry of Health is to ensure the safety of health products by enforcing compulsory labelling from July 1, cannot have come at a better time (NST, Feb 11). This is indeed an important step towards making the drug registration process in this country more effective for consumers.

As it stands today, it is not easy to recognise if a particular health product is in fact registered. One way is to look for four letters (PBKD, which stands for Drug Control Authority in Bahasa Malaysia) followed by six digits and ending with yet another alphabet: A,T or X. Another is to look for "MAL" (for Malaysia) followed by eight digits. But the two systems existing side by side can only confuse the consumer further.

In addition, on all packaging containing drugs, there are already other alpha-numeric codes, for example, the batch or lot identification, the expiry dates and so on. To the uninformed all these are just too confusing, especially when one is ill and more interested in getting well as fast as possible. The only numbers of interest at that stage are the ones on the medical bill! So if all registered health products carry a clear endorsement such as Diluluskan oleh Kementerian Kesihatan Malaysia (approved by the Health Ministry of Malaysia) the consumer is better informed of product quality, safety and efficacy. 

These are three key characteristics foremost for any approved product; although for some the last remains a moot point, as in the case of traditional products. But making labelling mandatory for importers, manufacturers and distributors is definitely a plus for consumer protection.

In other words, unapproved health products will stand out like sore thumbs in the market place. But this is precisely where it can get tricky. What if unapproved products too carry such labels in an attempt to hoodwink the public? What assurance does the public have about the authenticity of the label, let alone the product? Already, there have been cases where consumers are hard pressed to distinguish, for example, a popular brand of painkiller from the fake one. Even health professionals and manufacturers cannot do so for certain casually.

The latter in fact have to resort to a secret marking, visible only via a special ultra-violet device, to confirm the status of the product, such is the sophistication of health product piracy today! This is just one example. There are plenty more. We have not even gone into the complicated means of how fakes are purveyed to the public away from the eyes and reach of the enforcement agencies. One extreme is the Internet, and the other is the much touted multi-level marketing strategies so prevalent today. Mandatory labelling, therefore, is only one of the many safeguards that need to be in place.

But labelling too has many facets before quality health care could be assured. The cliche "good medicines can be badly used" sums up the larger concern about the question of safe or quality use of medicines. In other words, quality products (albeit with mandatory labelling) can be poorly used, especially when the other dimension of labelling with respect to their use is ignored.

Foremost are labels giving users clear directions on when to use the product, and when not to use it. Included too how to use, manage or avoid unwarranted side-effects. More fundamental than this is the name of the product, in generic terms and the brand name, if appropriate, and at once what the drug is used for as well as how it works for the intended purpose.

At least all these should also be made mandatory because they are the basic information needed to optimise drug use.

In fact, such are the requirements each time drugs are professionally dispensed over the counter. The products are accompanied by information on the labels, some mandatory while others are situational.

But in all cases they must be complete, accurate and properly attached so that it will stay in place for as long as the medicine is required for use.

Sad to say, however, these "best practices" are still not in the mainstream in our healthcare setting. Too often important information about drugs is missing as consumers abdicate their responsibility to the persons in white coats who may not even be qualified professionally.

In other words, the proposed mandatory labelling is just one strategy to promote awareness but clearly falls short of the larger aim to educate and commit.

It is a point that cannot be over-emphasised. To educate is an integral part of labelling per se, since it has been demonstrated that many patients do not even read labels properly, or do not understand the message, sometimes creating unnecessary risks instead. In many instances, the labels are totally absent, something that is not unfamiliar to Malaysians.

Therefore, in the light of the mandatory labelling announced last month, it is timely to adopt a more comprehensive labelling strategy, especially in relation to use of the drug.

Unless this is done, the ministry's labelling requirement, will be no more effective than the warning on cigarette boxes — nice to see, but with no significant impact on health. 

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