The public health implications of unsafe drugs

WHO/TDR/Crump

St Peter's TB Clinic, Addis Ababa: A handful of DOTS drugs given to an outpatient attending the clinic

Article Highlights

  • Counterfeit drugs take lives, waste money and make precious cures useless

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  • Self-treating patients have little chance of recognizing that a drug is of poor quality before the damage is done

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  • Faulty drugs directly or indirectly cause thousands of deaths every year

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Ineffective drugs take lives, waste money and make precious cures useless. Drugs have been recycled after their expiry date; they have been contaminated with fatal toxins; they have been made too weak or with no active ingredient at all. 

New ways to falsify medicines are invented every week to squeeze out more profits. Often, the victims are the world’s poorest people: the rural and sometimes urban poor struggle to afford treatments for deadly diseases such as malaria, tuberculosis, and bacterial infections, only to find out that the medicines it cost so much of their meager resources  to purchase are useless or even fatal. 

Medicines may not cure as expected for several reasons. For the majority of the world’s population this is exacerbated because they so often diagnose and treat themselves because doctors are scarce and expensive, especially in the vast rural areas of many poor countries. The cheapest tests for malaria are more expensive than the cheapest drugs, so patients may choose to self-treat for malaria even though the fever may have another cause. Even good drugs affect different people differently, and the threat posed by poor-quality drugs makes the practice of self-treatment even more dangerous. Identifying bad drugs takes considerable training and skill; self-treating patients have little chance of recognizing that a drug is of poor quality before the damage—sometimes fatal—is done.

"New ways to falsify medicines are invented every week to squeeze out more profits."--Roger Bate

Only the vaguest estimates of the size or spread of the problem exist, and they have been hotly contested. There is controversy even about how to define these dangerous drugs because some are cheaply made pills with ersatz ingredients pretending to be something they are not (falsified or counterfeit), others are just shoddily produced (substandard), and still others are degraded. These may have been stored or transported badly—some require cold-chain storage, which many developing countries are far from able to guarantee—or they may have been offered for sale in less than optimal conditions, such as after being inadvertently baked out in the open by a tropical sun. There is also a flourishing trade in drugs at or near expiration, which—instead of being destroyed or returned to the distributor—are sold on the black market with new expiration dates. 

Three main types of drugs are dangerous to consume. The most universal are degraded products. Most people have come across these: any drug past its expiration date is technically degraded. If you have Tylenol, or any brand of acetaminophen, in your bathroom cabinet that has expired, throw it away. Some products degrade slowly and may be useful after expiration, sometimes years after, but others, such as acetaminophen, can be lethal. Unexpired products that have been stored badly in transit or at their final location may decay before their official expiration date. This problem is considerable in the poorest locations; from my team’s samplings, about 2 percent of the drugs procured in Africa were degraded versions of the correct medicine. However, our protocol limited covert buyers to sampling only from formal pharmacy premises. This was necessary to ensure we used a standard methodology in all of the cities we sampled from, to allow us to compare our findings. In the poorest places, the poorest people cannot afford pharmacy prices and instead buy from street markets, kiosks, hawkers on buses and trains, and quacks traveling from village to village selling drugs from the back of a bicycle. To my knowledge, nobody has systematically surveyed these outlets in more than one location, but from what we do know, the quality of products sold is likely to be frighteningly low because all of the factors that make drugs dangerous are likely present in these informal settings. 

The second category of dangerous drugs is substandard products, that is, those products that, generally speaking are unintentionally made poorly. Most people in the West have never come across these products because of good quality controls, but they are prevalent in poorer locations. 

The final category of dangerous drugs is falsified medicines: these are products intended to lead buyers to believe a product is something it is not. These are found in every country in the world, and the deception can range from repackaging discarded expired medicines to intentionally producing cheap drugs without caring about quality. Most illegal drug manufacturers are more inclined to perfect the packaging of their products than the contents, and they then try to pass their dangerous wares off as the real thing. 

The problem in combating all of these dangerous drugs is that the remedies for each category often differ greatly, and the myriad interests involved in addressing policy promote their particular concerns above others, which can lead to stalemate. Conflicting interests have often led to an impasse in efforts to control dangerous drugs. 

Dangerous drugs cause problems in at least four ways. First, the drugs may be contaminated with pathogens (fungi, bacteria, viruses, or parasites) or with heavy metals or other toxic elements (such as dangerous organic solvents -  diethylene glycol contamination has killed at least 750 patients over the past 50 years or so). Second, drugs that do not contain the correct ingredients or the correct ratio of ingredients will not treat the conditions or diseases for which treatment was prescribed, and death may result (as is the case with the TB drugs). Third, drugs that contain some of the right active ingredient but are badly formulated may lead to death because the drugs are not biologically available; that is, they may not be absorbed in the gastrointestinal tract, so they are not taken into the blood stream (this is a major problem for many suspect antimalarial drugs I encountered in my research). Fourth, even fairly well-formulated drugs made by legitimate firms can contribute to drug resistance across the population if the formulation is reasonably good—such that it partially cures or prevents immediate death—but is not completely right and encourages the most robust bugs to become resistant. This renders even the very best quality drugs useless. 

Public health professionals everywhere, but especially in emerging markets, bitterly resent the loss of faith bad drugs cause among their patients; they spend much of their energy trying to steer patients away from hocus-pocus remedies toward (much more expensive) Western medicine, only to have the rug pulled out from under them by the fake-drug trade.

These drugs directly or indirectly cause thousands of deaths every year. My sense is that they kill hundreds of thousands across emerging markets, but that is just a guess.

Roger Bate is the Legatum Fellow in Global Prosperity at AEI

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