Outside of North America and northern Europe, 19-100% of total antimicrobial use occurs without a prescription, according to an early online publication from the Lancet, co-authored by CDDEP s Ramanan Laxminarayan.

What are the consequences of non-prescription use?   The short answer is that there isn t enough robust research to really know.  But there are a few areas of concern namely the impacts on consumer safety and the development of drug resistance.

Antimicrobials may not typically be thought of as particularly dangerous.  But the article points out that they are actually the 2nd most common cause of adverse drug events in the United States. Non-prescription use in particular is associated with inadequate knowledge and discussion of patient allergies and potential side effects, shorter duration of therapy, lower doses, and in some cases, lower-quality drugs.  The practice is also prevalent in many places where counterfeit drugs are a significant problem.

Whether the availability of antibiotics without a prescription hastens the evolution of drug resistance is up for debate.  Any use of antibiotics contributes to drug resistance, but it s not clear from the literature that overuse is necessarily exacerbated by non-prescription availability.   Would enforcing a prescription requirement be enough of a barrier to cut down on inappropriate use?  And, if the regulation was effective, would it also negatively impact access to lifesaving treatment for those who need it most?

A useful case study is Kenya, where over two-thirds of pharmacies dispense antibiotics without prescription, despite the fact that the practice is technically illegal (highlighting the reality that rules on the books don t necessarily translate into enforcement). Kenya provides an example the nuances of regulation and enforcement namely that restricting antibiotics could potentially exacerbate another unfortunate circumstance antibiotic underuse. From the Global Antibiotic Resistance Partnership’s report on antibiotic use and resistance in Kenya:

To stem the tide of antibiotic resistance, policymakers look for ways to limit antibiotic use for example, by enforcing prescription only laws for antibiotic sales. But the situation is not simple. In Kenya, one is confronted with evidence of both overuse and underuse. The evidence for underuse a lack of access to antibiotics comes from the large proportion of deaths from pneumonia during infancy and childhood, which would not occur if those children were properly treated with antibiotics.

 

Although access is related to socioeconomic status, the reasons may not be directly financial; low education levels, lack of nearby facilities, and inconsistent presence of both medicines and healthcare workers also contribute. Would even more people go untreated and die if nonprescription access were cut off? In Kenya, we do not have the data to answer this question.

It seems from the surveyed literature that we are lacking answers in many places where non-prescription use is the norm.  But the situation suggests that that if we want to tackle non-prescription use we need to focus on increasing access to health services at the same time.  The goal, ultimately, is not so much to restrict antibiotics as it is to reduce the overall burden of bacterial infections worldwide.

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