Monday, 25 May 2015

Counterfeit medicines and drugs, a public health menance !

Fake medicines may contain toxic substances that include heavy metals (e.g. aresenic) and additives (e.g. steroids). – AFP

The drugs you are taking may be fake

Counterfeit drugs are a booming criminal industry with serious consequences for public health.

Many of us have a strong faith in the power of modern medicine.

We go to the doctor or pharmacist, get the prescribed pills, take them religiously and expect to be cured of whatever ails us.

Oftentimes, this faith is justified, but in an age where fake products abound, have you ever wondered about the authenticity and quality of the drugs that you are ingesting?

According to a 2013 Emerging Markets Health Network report, 3-5% of all medicines being circulated in Malaysia were fakes.

Health Minister Datuk Seri Dr S. Subramaniam has also been reported as saying that the ministry had seized some 33,704 unregistered products worth RM43.22mil last year alone.

While this is not high compared to other middle- and low-income countries – for example, the International Pharmaceutical Manufacturers Group in Indonesia estimates that about one-quarter of medicines on the Indonesian market are fake – it is certainly something to be worried about as it concerns our health.

University of Oxford’s Reader in Tropical Medicine, Prof Dr Paul Newton says that it is difficult to estimate the global size of the problem as there is not enough data.

According to him, there are very few studies, and very few of those are done in a scientifically-rigorous manner, adding that there are certainly hotspots of such problems around the world.

Pfizer Global Security director Mark Robinson shares that the pharmaceutical company sees the highest number of fake drug seizures in Asia, compared to the rest of the world.

But he adds: “That’s because we are targeting (illegal) labs, seizing the drugs before they reach the market.” He observes that in 60 countries around the world, patients went into a legitimate, licensed pharmacy and got counterfeit drugs.

In addition, he notes that the World Health Organisation (WHO) estimates that over half of those who buy drugs online from unverified websites receive counterfeit medicines.

Two types of fake

Fake drugs, also called poor quality drugs, can be divided into two types: counterfeit and substandard.

Prof Newton explains that counterfeit medicines are made by criminals with the intent to deceive patients and healthcare workers for monetary gain.

According to Robinson, these criminals include entrepreneurs, terrorist organisations, drug syndicates and weapons dealers.

 Brick dust, used to hold the fake pill together, as well as boric acid, leaded highway paint to provide the yellow colour, and floor wax to provide shine, were found to be used in the production of counterfeit mefenamic acid by an illegal lab in Colombia. - AFP

They do it, he says, because it is profitable, because they are pretty sure they won’t get caught, and because even if they do get caught, the penalties are very low compared to the amount of money they can make.

The danger of these drugs is that they can vary from not having any active pharmaceutical ingredient to containing toxic materials. (See What’s in your fake drug)

Active pharmaceutical ingredients are the chemical compounds that treat the medical condition.

Unlike counterfeit drugs, substandard drugs are made by the original or licensed manufacturer, but do not conform to the proper standard of quality.

They are “medicines with mistakes”, says Prof Newton.

These medicines occur due to errors in the factories. Sometimes, they can be small errors, and sometimes, they can be large errors, like using the wrong active ingredient, he says.

He opines that this problem is more likely to occur in low-income countries where there is a lack of drug regulation and quality control measures.

However, as with counterfeit drugs, it is difficult to estimate the size of this problem due to the lack of data.

“Not many people are actually looking (for this problem), so we might have an unpleasant surprise,” he says, adding that in terms of public health, substandard medicines are as dangerous as counterfeit drugs.

He adds that some companies are very active in ensuring that their products are good, but, like any human activity, some cut corners and skip the quality control.

Poor regulation

According to the WHO, only one-fifth of its member states have well-developed drug regulation; half have varying levels of regulation and enforcement; and the remaining 30% have either very limited or no drug regulation at all.

In Malaysia, Dr Subramaniam was reported as saying that online drug sales are a particularly hard area to enforce as the Customs Department does not screen packages valued below RM500, due to the very high number of such packages.

“We have asked the Customs Department to screen all packages, and they are trying to do it, but I think it is quite expensive to put such a system in place,” he said after opening the Access to Safe Medicines Training Conference organised by Mediharta Sdn Bhd in January.

Prof Newton was a speaker at the same conference, while Robinson was a speaker at the launch of Pfizer’s anti-counterfeit technology, Patient Authentication for Safety via SMS (PASS), in Malaysia.

According to Robinson, the top three drugs produced by Pfizer that are found to be counterfeited in Malaysia are erectile dysfunction drug, sildenafil; non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation, celecoxib; and hypertension drug, amlodipine.

He adds that it is not only branded drugs that are counterfeited, but also generic drugs that are no longer patented, like the NSAID mefenamic acid.

“People just want to use our good name (to sell fake drugs),” he says.

Prof Newton notes that antibiotics and cardiovascular drugs are also being increasingly counterfeited in South-East Asia.

He adds that it is not only drugs that are counterfeited, but also medical devices like cardiac stents, rapid diagnostic tests and insecticide-treated bed nets – a problem particularly rampant in Africa.



Bad effects

The effects of fake drugs can be felt both on the individual level, as well as on a wider scale. For the patient, taking counterfeit drugs can range from death to developing more serious health complications.

These health complications may be caused by the actual illness being untreated due to a lack of active ingredients in the counterfeit drug, or the drug containing either toxic ingredients or the wrong active ingredients.

The latter will also make it more complicated for doctors to treat the patients, as they might be confused by the incongruent symptoms.

Counterfeit or substandard drugs that contain less active ingredients than required can also cause drug resistance, particularly if they are antibiotics.

Prof Newton adds that consuming fake drugs also ends up incurring more expense on the patients’ part, as they don’t get better and keep on buying more medications.

Patients might also lose faith in the healthcare system, he says. “If you don’t trust the pharmaceutical companies or doctors, you won’t go back and might seek other alternatives.

He notes that fake drugs will also affect genuine pharmaceutical companies, as well as government healthcare systems and non-governmental organisations that inadvertently purchase these drugs.

Both Prof Newton and Robinson hope that governments around the world will take a stronger stance against counterfeit medicines, both in terms of enacting relevant legislation with much stronger penalties for those producing fake drugs, as well as in terms of enforcement.

Patients should also be more careful of what they consume.

For example, signs that a medicine could be fake include an excessively low price, flimsy or unprofessional packaging, and not requiring a doctor’s or pharmacist’s prescription for non-OTC (over the counter) drugs.

An example of the holographic security label for registered Malaysian drugs, which features the hibiscus symbol, serial number and the letters PBKD and DCA. All drug packaging must have this label. – Photo: Health Ministry
An example of the holographic security label for registered Malaysian drugs, which features the hibiscus symbol, serial number and the letters PBKD and DCA. All drug packaging must have this label. – Photo:
An example of the holographic security label for registered Malaysian drugs, which features the hibiscus symbol, serial number and the letters PBKD and DCA. All drug packaging must have this label. – Photo: Health Ministry

In Malaysia, registered drugs also have a holographic security sticker on their packaging.

Related:

The counterfeit menace - Health