MANILA, Philippines — Ernie (not his real name) had a clear plan: He would commit suicide by overdosing on sedatives. But hours after his attempt, nothing happened. Laboratory tests later explained why—what he consumed were counterfeit drugs.

Cases like Ernie’s are rare and isolated, according to the Food and Drug Administration (FDA), the state agency tasked to ensure safety, efficacy, and quality of foods, drugs, and cosmetics being sold to the public.

FDA Director Suzette Lazo said most cases brought to their attention every day are heartbreaking ones. They are stories of unwitting patients regularly taking medicines that do not cure them or, worse, can kill them.

While Lazo said the spread of counterfeit drugs is a huge problem in the Philippines, but statistics are difficult to put together. Most cases are not reported.

According to the World Health Organization (WHO), Asia has the biggest trade in counterfeit drugs. A 2005 US FDA study estimates that worldwide sales of fake drugs exceed $ 3.5 billion a year.

‘We are all victims’ 

Crooks counterfeit both branded and generic products, and do it several ways. According to Republic Act 8203, the law prohibiting counterfeit drugs, products are considered counterfeit when they are substandard, meaning they have the correct ingredients but not the right amount; when they are outright spurious; or when they are falsely packaged.

Lazo said counterfeiters’ targets are usually hypertensives, anti-lipid, sildenafil citrate, steroid preparations, and antibiotics.

“We are all victims of counterfeit drugs. The industry is a victim because they are cheated of the market that rightfully belongs to them. But it is the patient that suffers from the scourge of counterfeit drugs,” Lazo told the Bulletin.

Treatment failure can lead to complications and heavier financial burden for patients and their families, she added.

Vigilance is vital. Lazo said the public should participate more in government efforts to crack down on the drug counterfeiting industry and help save lives.

Lazo told the story of a nurse who, while doing her rounds, noticed the unusual color of the liquid that was being prepared to be injected into a patient. A nurse for several years, she was aware of the right color of the liquid and the packaging of the vial.

Suspecting that something was odd about the medicine, she alerted the authorities. Test results revealed that the vial contained a counterfeit medicine.

Telltale signs 

How can ordinary citizens tell if drugs are counterfeit? Lazo gave three general pointers:

Their labels are poor imitation of the original.

Tablets have irregular color.

There are solid particles in suspensions, syrups, or injectables.

Lazo also said the practice of recycling vials of antibiotics in the local market has been documented. She said a telltale sign that an antibiotic vial was possibly recycled is the presence of a punctured hole in the container.

Counterfeiters have been improving on their techniques. Some counterfeits now very closely resemble the original labels or packaging, as they bear FDA registration numbers.

“The most difficult to spot are higher quality counterfeit drugs that have labels grossly indistinguishable from the original ones, and whose contents may even contain the actual ingredients,” said Lazo.

RA 8203 provides for administrative and criminal sanctions and penalties of imprisonment and fines from P100,000 up to P5 million. But it's a long battle that requires public cooperation.

Lazo said the public should be actively reporting patients’ adverse reaction to drugs or treatment failures. Their reports will allow the agency to test the reported products.

“If you have pneumonia, that should be cured. If you found something that does not work, you should report it. The problem is, many do not report, so it’s difficult to know. Even adverse effects should be reported,” Lazo said.

The practice of reporting every treatment failure is called “pharmacovigilance,” she said.

Anyone can file a complaint with the FDA. With a complaint to act on, the government agency can investi-gate, punish, and close the business of counterfeiters. Without complainants, Lazo said, their job becomes more difficult.

The WHO is also calling for international collaboration—between legislative bodies, enforcement agencies, and the courts—to defeat drug counterfeiters.

“Most countries have mechanisms in place, enabling regulatory authorities to take measures against substandard medicines and their manufacturers, but, as counterfeiters usually work in unauthorized set-tings, within international networks and with the intention of hiding their identity, such law enforcement mea-sures taken by national and regional regulatory procedures may be only partially successful,” WHO said in its February 2011 study on counterfeit medical products.

Lazo said the FDA is stepping up. The agency is set to submit a proposal to the World Intellectual Property Office (WIPO) to help the Philippine government in crafting a study on the extent of the problem of counterfeit drugs in the local market.