Eliminating the Harms of Counterfeit and Substandard Medicines in Anesthesia

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Jason Nickerson
Jason Nickerson is a respiratory therapist and PhD candidate in Population Health at the University of Ottawa. His research examines how to evaluate the availability of essential health resources and services during humanitarian crises (who is doing what, where?), and he has a particular interest in surgical care provided in low- and middle-income countries by humanitarian agencies. Jason blogs about the role of surgery in global health, public health research methods in crises, and interesting topics in population health.
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This post was originally published on Views From Beyond the OR.

Poor-quality medicines are found all over the world, and can be of poor quality for a variety of reasons: they might be made with poor-quality chemicals, they may contain toxic substances instead of the proper active ingredients, they may contain inactive or ineffective preparations, or they might be deliberately mislabeled. The World Health Organization calls them spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines.

In cases of deliberate counterfeiting, the products are intended to look like genuine medicines, leaving healthcare workers uncertain as to which drugs are real (and could therefore help) and which drugs are counterfeit (and could cause harm).

In anesthesia, the stakes are high: many of the drugs that are used are given by injection, either into the veins or into the spine. When the drugs that are injected are compromised or contaminated, this could mean that bacteria or toxic substances are being injected directly into the body, causing immediate and severe harm. Anecdotally, we have heard stories of harm being caused in this way, such as pregnant women in Rwanda who received injections of contaminated spinal anesthetics for a caesarean section and became paralyzed. Several other similar stories have emerged as we have begun to talk about these issues.

Regrettably, however, there have been no major studies of anesthetic drugs in low- and middle-income countries that might help us to identify the sources of these problems. Our colleagues are thus left to hope for the best, knowing that the drugs they are using might be of poor quality and, as a result, might cause harm when they administer them.

We want to fix this. Counterfeit medicines are a huge problem around the world that we don’t know enough about, and worse – don’t yet know how to fix. We want to work with our colleagues in Zambia to try and tackle this problem and improve safe surgery and anesthesia. So, we have applied for funding from Grand Challenges Canada to do exactly this. But, we need help to vote for our project and make sure that we get the funding to support our work against counterfeit anesthetics. We need you to register and vote for our project on the Grand Challenges Canada website.

Our proposal is straightforward: We want to figure out the cause of poor-quality anesthetics in public hospitals and see if we can use existing technologies at the point-of-care to identify medicines that are likely to cause harm.

How will we do this?

We want to use an existing device called the TruScan to test medicines in public hospitals in Zambia for their authenticity. The TruScan is a handheld Raman spectrometer (for the science fans, here’s the Wikipedia page) that allows the user to essentially point-and-shoot at a drug, through the packaging, to determine its authenticity as compared to the device’s database. Basically, a front-line health worker can hold a vial up to the device and have it tell them if it is authentic, or not.

Because we don’t know much about why injectable anesthetic drugs are of poor-quality, we need to validate the use of this device in the field before we can say that this is an effective way of preventing harmful drugs from reaching patients. There are a range of other problems that we hope to be able to detect and eliminate – bacterial or fungal contamination, for example – that might not be responsive to this approach. That’s why every drug that we test at the point of care will also be tested in a lab in Canada, to make sure we haven’t missed anything. Once we know and understand the issues, we can figure out how to go about solving them.

What do we hope will come from this project?

We hope that we will be able to show that handheld devices like the TruScan can be used by front-line health workers to identify poor-quality medicines before they are delivered to patients. If our project is a success and we have a high rate of detection, we think that this could save lives and provide us with enough evidence to support integrating this kind of device into other health facilities where we know poor quality medicines are a problem. By empowering local health workers, particularly anesthesiologists, we hope to be able to show that better control of the drug supply chain can be attained by local staff.

If our project is a success, then this gives us solid evidence to support scaling up this kind of intervention. Furthermore, it also will provide us with valuable information on the drug supply in anesthesia: something that we know relatively little about in low- and middle-income countries. Of course, preventing counterfeiting at the source is always preferable, and there are a number of initiatives doing just that, which compliment the work that we are undertaking (like mPedigree or Sproxil.

How can you help?

First, watch our Grand Challenges Canada video, register, and VOTE for us.

Second, share our video with your friends and colleagues and encourage them to do the same.

Surgical care is an integral component of a strong, functioning health system. Regrettably, millions of people are denied access to safe surgical care around the world. There is a growing momentum to strengthen the quality of surgical care available, and ensuring access to safe and effective anesthetics is a critical component of these initiatives. But, we need to know more about what the problems in the anesthetic supply chain are and how to fix them. This project is an important part of this work and we hope that you will support us.

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