Sunday, July 25, 2010
Pharmaceutical-Technology.com features an excellent Q & A with several industry experts on the deadly global epidemic of counterfeit drugs.
The following are the ten questions and the responses from the July 20th Pharmaceutical-Technology.com Q & A:
As the number of counterfeit drugs on our streets continues to rise, Paul French asks Global Insight analysts Shuang Lewis and Denise Claux for the lowdown on the potentially deadly pills.
Research commissioned by the major drug companies suggests that the use of counterfeit drugs is on the rise. Would you agree?
Shuang Lewis: Yes, I'd agree that this is a trend we're seeing across many countries. The World Health Organisation (WHO) estimates that around 10% of drugs used worldwide are fake. The number varies from region to region but could be as high as 30% in Africa right now. And the signs are that the numbers are increasing year on year.
Denise Claux: In Brazil in 2008 the government seized 40t of counterfeit drugs coming into the country. In 2009 it was 333t. This to me shows two things – the problem is getting worse but also the authorities are getting better at finding these drugs as they come into the country.
Is it just a case of the major drugs companies, being concerned about protecting their patents from legitimate generic competitors, and wanting to sell more drugs by scaring people away from cheaper alternatives? Or is this a real problem?
Denise Claux: There is an issue with classification. For instance, a batch of generic Dutch drugs was recently confiscated on entry to Brazil because there was confusion between the two countries on what constituted a counterfeit drug. This kind of thing needs tightening up as statements about fake medicines create fear amongst patients. However, that's not to say there is no problem with counterfeit drugs. There is and it is very real.
So what sort of drugs are the counterfeit drugs mimicking? Is counterfeiting prevalent in a certain area of pharmaceuticals or all areas?
Shuang Lewis: Counterfeit drugs tend to be prevalent in therapeutic areas or at times of opportunity to cash in on lack of supply from legitimate sources.
For instance, during the swine flu pandemic, sales of fake medicines to combat it increased because there was a shortage of genuine Tamiflu available.
Weight loss is another area where counterfeit drugs capitalise on opportunity. Patients have to meet certain criteria in terms of their body mass index in regulated markets and if they can't get what they want, they can often find fake versions of what they're looking for elsewhere.
What about the geographical split? I heard that there's a lot of counterfeit anti-cancer and lifestyle drugs in the west whereas there's more anti-malaria and HIV fakes in developing countries like Africa? Is that right?
Denise Claux: I don't have any figures to prove that but it could well be a trend. Certain drugs are definitely more prevalent in some countries than others. For instance, erectile dysfunction drugs are the most commonly counterfeited drugs in Brazil. There are many factors behind this particular niche including availability and I guess social embarrassment. It's perhaps not the type of thing people want to go into chemists and ask for!
Do people take these medicines knowing they are counterfeit or do they believe them to be the real thing?
Shuang Lewis: It varies from case to case. Counterfeit drugs are often packaged up to look exactly like the drugs they're mimicking, so people would take them thinking they are legitimate drugs. In other cases people take counterfeit drugs knowingly because they are all they can afford or get hold of.
Why would people take these fake drugs instead of the real thing?
Denise Claux: The two main reasons are accessibility and cost. The price of medicinal drugs can be very high and sometimes the only way people can afford to take them is by getting them from the black market. If it's a choice of risking authenticity or not taking anything at all, of course people are going to be tempted into trying the drugs they can afford.
And if you're taking pills that have the wrong quantities of active ingredients inside, it can lead to health problems and even death.
Counterfeit drugs are so easy to get these days too. You can get hold of almost anything online, which can sometimes save people embarrassment if the drugs are for something they're not comfortable asking their pharmacist for. There's also a lot of unregistered pharmacies in places like Latin America, where fake drugs can be bought at knock-down prices.
So who’s producing these fake drugs and why?
Shuang Lewis: There are two types of counterfeit drugs – those with no actual medicine in and those that have the right ingredients but in the wrong quantities. Those with no active ingredients can be made by anyone, the others would probably need input from some kind of chemist but they’re all produced in factories that are not regulated.
Denise Claux: A lot of the counterfeit drugs in Western Europe are produced in factories in China and other developing markets and then smuggled across borders, just like cocaine and heroin.
What's the problem with taking counterfeit medicines? Aren't they just cheaper alternatives than the real thing?
Shuang Lewis: Some of the generic drugs can be cheaper alternatives to prescription drugs but most counterfeit medicines have significant health risks. If there is nothing actually in the tablets then by taking them, you're delaying the treatment you really need, which could be extremely harmful. And if you’re taking pills that have the wrong quantities of active ingredients inside, it can lead to health problems and even death.
So what's being done to counter the problem of counterfeit drugs?
Denise Claux: There are two levels of activity here. On a national level, governments like Bolivia are implementing national strategies and bringing in tougher penal codes for people caught making or selling counterfeit drugs. Brazil has also brought in a unique medicine identifying barcode to help them track the authenticity of drugs coming into the country.
The problem is that there's perhaps not enough being done yet on a regional level. The majority of counterfeit drugs in any given place come in from outside the country, but border patrols and customs officers are not yet proficient enough at detecting them.
Finally, what do you think the future holds for counterfeit drugs? Are they going to become increasingly prevalent or is it something that the authorities can get control of?
Denise Claux: It's a difficult trend to assess on a worldwide basis. Developing countries have different needs to the rest of the world but I think we could say that in the short-term, the number of counterfeit drugs available will continue to rise but as government initiatives to combat the problem begin to take effect, we could see an improvement in the longer term.
This Q & A had some interesting insight and statistics. Secure Pharma Chain believes, like these experts that the number of counterfeit drugs available world wide will continue to increase until regulatory authorities, the supply chain and consumers become more aware and take the necessary steps to eliminate and protect themselves from this potentially deadly criminal act.
To read the entire Pharmaceutical-Technology.com story, visit: http://www.pharmaceutical-technology.com/features/feature90441/?WT.mc_id=WN_Feat.
To learn about anti-counterfeiting solutions for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.