Feature

Q&A: Fake, substandard drugs place tens of thousands of kids in danger

Photo of Joel Breman
Joel G. Breman

According to a recently published review in the American Journal of Tropical Medicine and Hygiene, the use of poor-quality and fake drugs cost an economic toll of up to $200 billion every year. Researchers said fake or substandard medications are often given to children in low-income countries, where up to 155,000 deaths occur annually as a result of falsified antimalarial drugs.

Joel G. Breman, MD, senior scientist emeritus at the Fogarty International Center at the NIH and president-elect of the American Society of Tropical Medicine, and colleagues added that many organizations, including WHO, have become increasingly aware of this issue as the quantity of falsified and substandard drugs have increased in the marketplace.

Infectious Diseases in Children spoke with Breman to better understand who is behind the production of these drugs and why this is an area of global concern. – by Katherine Bortz

Q: How often are falsified or substandard drugs used to treat patients?

A: From the widespread presence of bad drugs and the frequency of illness in low-income countries, tens of thousands, hundreds of thousands of children are treated with bad products. It is not just children either. This is an international scandal. The numbers would mean that this is a very frequent occurrence.

Q: What kind of conditions are these fake drugs used for? Are some medications more prone to falsification?

A: The tropical countries seem to be targeted more than others, and the conditions are those that occur frequently with a high volume, including malaria, pneumonia or any disease that produces fever, chills or cough.

Photo of colorful pills 
Source: Shutterstock

Now, that does not mean that wealthier countries or adults are exempt. Drugs for conditions, such as hypertension, erectile dysfunction, other cardiovascular conditions and psychological problems, have all been found to be falsified or substandard when examined as well.

Q: What are some of the dangers related to taking medication s that are falsified or substandard?

A: Imagine yourself as a child aged younger than 5 years who has fever and chills and has been ravaged by billions of parasites — let’s say malaria. Let’s say you are treated with a falsified drug — a blank. In this case, the parasites can cause cerebral malaria, anemia, cognitive impairment and so many other problems. This could also be an issue for a pregnant woman with malaria, who would be at risk for having a small newborn.

Another problem is antimicrobial resistance that could occur, and that is also a very dangerous thing not just for the people who are exposed to these drugs, the direct community or the hospital and the clinic, but the wider community.

The third problem is the lack of confidence in the clinician and the health care system that could occur if patients are getting medicines that do not work.

Q: Is the creation of falsified or substandard drugs deliberate or a significant oversight?

A: There are a number of categories of falsified and substandard drugs. If a drug is falsified and has no pharmaceutical ingredient, that is intentional. That is criminal and would require apprehension, adjudication and punishment. Usually, organized bands or cartels or criminals are involved in the production of these drugs.

The falsified drugs are coming from criminals who are organized specifically to fake the drugs and make money. I would not even dignify where they make them by calling them labs, but they are made in unapproved facilities or rooms where conditions are unchecked.

More often than not, substandard drugs come from a bona fide drug company that, for whatever reason, does not have enough pharmaceutical ingredient or the medicine does not have the appropriate dissolution properties so that it is bioavailable to a patient.

These two categories are what we are most worried about.

Q: What is being done to limit how many of these drugs are produced and distributed, and how can we better protect children from these drugs?

A: We are not doing enough. WHO has established categories for falsified and substandard drugs and has started a surveillance program. This occurs mainly in Africa because that region has been the target of criminals. Countries passively report to WHO what is going on, which is the beginning of public awareness and attention.

One thing that could help is assisting countries in setting up legislation and other systems for good pharmaceutical governance so they can screen at customs and have an infrastructure to detect fakes that are coming across their borders.

The next thing we need is technology, such as high-performance liquid chromatography or mass spectrophotometry. These tools are very expensive and usually are in a reference laboratory. We do not have a simple, cheap, accurate point-of-care test for bad drugs for diseases like HIV and malaria that are right out in the field. There are hand-held devices and indicator strips to look at both the packaging and content of medicine. This is a big area of research.

An area that is not so far along is the consideration of policy changes. We do not yet have standards recognized for many of these drugs that countries should have so they can set goals. The Sustainable Development Goals established by the United Nations do not quantitate the essential drugs’ standards that each country should meet.

Lastly, our team has posited an international treaty so that the criminals are not just identified but apprehended and extradited.

For instance, we have treaties on hijacking airplanes, trafficking of women and children, counterfeiting money and transporting contraband tobacco, but we do not have a similar multilateral treaty for crimes involving medication. Right now, punishment is just a slap on the hand. There is sort of a haphazard way of passive reporting and sharing of information when fake drugs pop up, but we need to strengthen that system and add some other approaches in a more systematic way, both in technology and legislation.

Q: What is needed in the future to accomplish these goals?

A: I would say that the focus should be in the low- and middle-income countries, meaning that sampling methods for detecting these bad products should be taught and studies should be done in these countries by experts in chemistry, people who have experience. I would say that the organizations interested in this should go into the countries and work with them, not just have meeting after meeting telling the countries what to do. The countries should benefit from emerging technology. The laws in the countries and their systems should be strengthened so that they will have enough staff and other resources, equipment and start to define the quality of the drugs in their countries. Additionally, all this should be transparent so that if we find fake drugs in one country, others should know that it occurred.

I must say that the pharmaceutical industry has been marvelous in joining the effort to identify fake drugs. This is because their products have been faked, and criminals have inserted these fake products with a known company’s name into the supply chain. They do not want that to occur, and they have their own security mechanisms. They joined us on this study and have been helpful in introducing us to over 30 other pharmaceutical security groups.

Reference:

Nayyar GML, et al. Am J Trop Med Hyg. 2019;doi:10.4269/ajtmh.18-0981.

Disclosure: Breman reports no relevant financial disclosures.

Photo of Joel Breman
Joel G. Breman

According to a recently published review in the American Journal of Tropical Medicine and Hygiene, the use of poor-quality and fake drugs cost an economic toll of up to $200 billion every year. Researchers said fake or substandard medications are often given to children in low-income countries, where up to 155,000 deaths occur annually as a result of falsified antimalarial drugs.

Joel G. Breman, MD, senior scientist emeritus at the Fogarty International Center at the NIH and president-elect of the American Society of Tropical Medicine, and colleagues added that many organizations, including WHO, have become increasingly aware of this issue as the quantity of falsified and substandard drugs have increased in the marketplace.

Infectious Diseases in Children spoke with Breman to better understand who is behind the production of these drugs and why this is an area of global concern. – by Katherine Bortz

Q: How often are falsified or substandard drugs used to treat patients?

A: From the widespread presence of bad drugs and the frequency of illness in low-income countries, tens of thousands, hundreds of thousands of children are treated with bad products. It is not just children either. This is an international scandal. The numbers would mean that this is a very frequent occurrence.

Q: What kind of conditions are these fake drugs used for? Are some medications more prone to falsification?

A: The tropical countries seem to be targeted more than others, and the conditions are those that occur frequently with a high volume, including malaria, pneumonia or any disease that produces fever, chills or cough.

Photo of colorful pills 
Source: Shutterstock

Now, that does not mean that wealthier countries or adults are exempt. Drugs for conditions, such as hypertension, erectile dysfunction, other cardiovascular conditions and psychological problems, have all been found to be falsified or substandard when examined as well.

Q: What are some of the dangers related to taking medication s that are falsified or substandard?

A: Imagine yourself as a child aged younger than 5 years who has fever and chills and has been ravaged by billions of parasites — let’s say malaria. Let’s say you are treated with a falsified drug — a blank. In this case, the parasites can cause cerebral malaria, anemia, cognitive impairment and so many other problems. This could also be an issue for a pregnant woman with malaria, who would be at risk for having a small newborn.

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Another problem is antimicrobial resistance that could occur, and that is also a very dangerous thing not just for the people who are exposed to these drugs, the direct community or the hospital and the clinic, but the wider community.

The third problem is the lack of confidence in the clinician and the health care system that could occur if patients are getting medicines that do not work.

Q: Is the creation of falsified or substandard drugs deliberate or a significant oversight?

A: There are a number of categories of falsified and substandard drugs. If a drug is falsified and has no pharmaceutical ingredient, that is intentional. That is criminal and would require apprehension, adjudication and punishment. Usually, organized bands or cartels or criminals are involved in the production of these drugs.

The falsified drugs are coming from criminals who are organized specifically to fake the drugs and make money. I would not even dignify where they make them by calling them labs, but they are made in unapproved facilities or rooms where conditions are unchecked.

More often than not, substandard drugs come from a bona fide drug company that, for whatever reason, does not have enough pharmaceutical ingredient or the medicine does not have the appropriate dissolution properties so that it is bioavailable to a patient.

These two categories are what we are most worried about.

Q: What is being done to limit how many of these drugs are produced and distributed, and how can we better protect children from these drugs?

A: We are not doing enough. WHO has established categories for falsified and substandard drugs and has started a surveillance program. This occurs mainly in Africa because that region has been the target of criminals. Countries passively report to WHO what is going on, which is the beginning of public awareness and attention.

One thing that could help is assisting countries in setting up legislation and other systems for good pharmaceutical governance so they can screen at customs and have an infrastructure to detect fakes that are coming across their borders.

The next thing we need is technology, such as high-performance liquid chromatography or mass spectrophotometry. These tools are very expensive and usually are in a reference laboratory. We do not have a simple, cheap, accurate point-of-care test for bad drugs for diseases like HIV and malaria that are right out in the field. There are hand-held devices and indicator strips to look at both the packaging and content of medicine. This is a big area of research.

PAGE BREAK

An area that is not so far along is the consideration of policy changes. We do not yet have standards recognized for many of these drugs that countries should have so they can set goals. The Sustainable Development Goals established by the United Nations do not quantitate the essential drugs’ standards that each country should meet.

Lastly, our team has posited an international treaty so that the criminals are not just identified but apprehended and extradited.

For instance, we have treaties on hijacking airplanes, trafficking of women and children, counterfeiting money and transporting contraband tobacco, but we do not have a similar multilateral treaty for crimes involving medication. Right now, punishment is just a slap on the hand. There is sort of a haphazard way of passive reporting and sharing of information when fake drugs pop up, but we need to strengthen that system and add some other approaches in a more systematic way, both in technology and legislation.

Q: What is needed in the future to accomplish these goals?

A: I would say that the focus should be in the low- and middle-income countries, meaning that sampling methods for detecting these bad products should be taught and studies should be done in these countries by experts in chemistry, people who have experience. I would say that the organizations interested in this should go into the countries and work with them, not just have meeting after meeting telling the countries what to do. The countries should benefit from emerging technology. The laws in the countries and their systems should be strengthened so that they will have enough staff and other resources, equipment and start to define the quality of the drugs in their countries. Additionally, all this should be transparent so that if we find fake drugs in one country, others should know that it occurred.

I must say that the pharmaceutical industry has been marvelous in joining the effort to identify fake drugs. This is because their products have been faked, and criminals have inserted these fake products with a known company’s name into the supply chain. They do not want that to occur, and they have their own security mechanisms. They joined us on this study and have been helpful in introducing us to over 30 other pharmaceutical security groups.

Reference:

Nayyar GML, et al. Am J Trop Med Hyg. 2019;doi:10.4269/ajtmh.18-0981.

Disclosure: Breman reports no relevant financial disclosures.