Thursday, June 15, 2006

Fake drugs could kill

The Inquirer is one of the institutions behind the current campaign against fake drugs. It is not every day that this paper joins a campaign. We’re quite choosy, you see.

Counterfeit drugs could kill. This was the title of the first part of the three-part series I wrote some years ago. At that time the Philippines landed on the list of proliferators of fake drugs released by the Drug Information Association that was meeting in Canada. Another concern at that time was adverse drug reaction (ADR). For while even genuine drugs could cause ADR, how much more the fake ones whose components only the fakers know about?

Listed as an ADR is ``failure of efficacy’’ or Type F. This is what sends patients asking, ``Why is the drug not working?’’ Therapeutic failure could be due to a drug that has little or nothing in it. In other words, some illegal manufacturers could have tampered with a brand’s contents and unless the doctor and patient get the drug tested, they have no way of knowing the cause of the problem.

A change of prescription could be the next option and if the new drug is not fake, it could work. That is, if it is not too late and the patient has not crossed the bridge of no return.

There has been a debate on whether or not brand names of drugs that have been counterfeited should be published so that the public may know. (I did provide a list.) Legit drug companies whose brands have been counterfeited could raise a howl and say they are getting a double whammy because sales of even the genuine items could suffer because consumers will stay away. That is the short-term adverse effect.

But there is a positive long-term effect. Exposing the counterfeit could put the evildoers’ work on hold. The informed public would pay more attention to what they are buying. In the end, the genuine drug makers would profit from this kind of vigilance.

Fake drugs are not like fake signature jeans or watches that could serve their purpose in much the same way as the original, and they’re even cheaper. Fake drugs sell like the genuine ones but they have reduced or no efficacy. Worse, they endanger lives.

According to R.A. 8203 or The Special Law on Counterfeit Drugs, counterfeit medicines refer to

1) the drug itself, or the container or labeling thereof or any part of such drug, container, or labeling bearing, without authorization, the trademark, trade name or other identification mark, or imprint or any likeness to that which is owned or registered in the Bureau of Patent;

2) a drug product refilled in containers by unauthorized persons if the legitimate labels are used;

3) an unregistered imported drug product, except drugs bought in the country for personal use as confirmed and justified by accompanying medical records;

4) drugs that contain no amount of, or a different active ingredient, or less than 80 percent of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or less of efficacy due to expiration.

The first two would seem like stealing of intellectual property, much like faking signature jeans. Not that this crime should be condoned but if it were merely brand stealing but the essence of the product is as good as the genuine one (much like a fake Rolex would tell the same time as the genuine one) the poor would probably go for the fakes.

A pedicab driver/handyman told me the other day that he buys the medicine of his wife (whom I know and who’s recuperating from a stroke) tingi, that is, two pieces at most. After a long day’s work, he passes by a drugstore to buy ``dalawang piraso lang.’’ What if he learns about cheaper ones sold somewhere?

Number 4 (less than 80 percent active ingredient) is the one that could be life-threatening.

The Bureau of Food and Drugs has initiated once again a nationwide campaign against counterfeit drugs. There have been buy-bust operations and closure orders of drugstore selling fakes. How long will this zeal last?

I’ve been seeing TV info-ads on counterfeit drugs and how citizens could help curb the illegal activities the past weeks. Alas, the words and numbers on screen go so fast one wonders whether the viewers could catch them at all. So here is the toll-free hotline that you can call to report a counterfeit or a counterfeiter: 1-800-10-FAKEMED.

The Coalition Against Counterfeit Medicines is among those behind the awareness campaign. It encourages people to be more vigilant so that drug stores would sell only the real thing. It calls on the government to enforce the laws, and on lawmakers to even tighten the laws against counterfeiters.

The 12 members of the coalition are the Departments of Health, Justice, and Trade and Industry, Philippine Medical Association, Drugstores Association of the Philippines, Mercury Drug Corporation, Watson’s, Zuellig Pharma, Pfizer, Philippine Pharmaceutical Association, GMA-7 and the Philippine Daily Inquirer.

How to tell a fake? A suspected counterfeit has these tell-take signs: the appearance of the packaging or the medicine itself is different from the registered product. The printing on the packaging is somewhat blurred or of poor quality. There is no expiration date, lot or batch numbers. In some cases lot or batch numbers are excessively repeated. The brand name is larger than the generic name. The authenticity indicators such as holograms and tamper-evident seals are not always reliable as the counterfeiters can replicate these.

I just hope the campaign to separate the genuine branded drugs from the fakes does not kill the generic drugs and their manufacturers. I hope it does not put fear and doubt in the hearts of generic drug users who cannot afford the brand names.