In some countries around the world, antibiotics are sold over-the-counter (without a prescription). So people have sometimes asked me: why aren’t antibiotics available over-the-counter (OTC)?
The shortest answer to this question because overusing antibiotics is bad for you and for the population.
The long answer is… well… long.
Since I’m in Canada I will be reviewing it from a Canadian perspective; however, much of the same reasoning would apply for other countries where they aren’t available OTC (e.g. United States).
Who decides if a medication is sold over-the-counter or not?
In Canada, there are two groups that have a role in deciding how medications can be sold: Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA).
Health Canada is ultimately the one that decides if the medication will be approved for use in Canada, and then also determines if a prescription will be required for its use. NAPRA is a group of provincial/territorial pharmacy governing bodies. Their role is concerning products that have already been deemed not to require a prescription. Their role is more about deciding how easily available certain OTC products should be (i.e. only after consulting with a pharmacist, only if a pharmacist is present to answer questions, or without any restrictions).
But…back to Health Canada.
When Health Canada evaluates if a medication requires a prescription or not, they ask the following questions:
Is supervision by a practitioner necessary?
Reasons for this can include:
- The disease is not easily self-diagnosed by the public
- The medication could mask other serious diseases
- The medication requires close monitoring or supervision
- Instructions to use are complex
- Administration of the medication requires expertise
- The medication has a narrow therapeutic window (i.e. it has a very limited range where it’s effective without causing excess toxicity)
- Potential to cause very serious side effects
- Potential for misuse/addiction
Is there a level of uncertainty concerning the medication?
This can include:
- Medication is new to the market
- There is limited experience with its use for a new disease
- Medications where we don’t yet understand how they work
Can the medication cause harm to the individual or to the public, and would supervision by a prescriber lower this risk?
This can include:
- A potential for misuse or addiction
- A potential for harm to public health
What factors would influence the decision not to make antibiotics available over-the-counter?
The following factors contribute to why antibiotics are not available over-the-counter:
- Most bacterial infections are not easily self-diagnosed by the public.
- Taking an antibiotic could mask the presence of a more severe infection that requires a medical intervention (such as surgery, drainage, etc.)
- Some classes of antibiotics have a narrow window between effectiveness and toxicity, and could cause debilitating/deadly side effects in certain individuals
- Misuse of antibiotics is a major threat to public health
What’s so dangerous about misusing antibiotics?
Many people will wonder how taking a drug themselves will impact someone else. It’s not like if you take blood pressure medication improperly that it will affect your neighbour’s blood pressure treatment. But antibiotics have the particularity that they can induce antimicrobial resistance.
What is antimicrobial resistance?
When bacteria are exposed to antibiotics, most of the really susceptible bacteria will quickly die off. However, by random mutations, some bacteria may be left over that aren’t killed as easily by the antibiotic. What can eventually occur, is that you can artificially select for the most resistant bacteria by over-exposing them to antibiotics. For a great visual illustration of how antimicrobial resistance can develop, check out the video below:
And, it’s not just the bacteria causing the infection that can develop resistance. When you take an antibiotic, you are exposing most bacteria in your body to that antibiotic (i.e. it’s not a “magic bullet” that will specifically target only the bacteria causing the infection). By doing this, you can start selecting for even more of these resistant bacteria. This is exactly how infections like C. difficile can arise (for more information on how antibiotics can cause C. difficile, check out my previous post).
We also have some good evidence to back this up. One such example is that the overuse of a family of antibiotics called fluoroquinolones (e.g. ciprofloxacin, levofloxacin, moxifloxacin) can result in the selection of a multi-drug resistant bacteria called Methicillin Resistant Staphylococcus aureus (also known as MRSA).
But how does this affect public health?
You don’t just keep bacteria to yourself. Through close contact, bacteria can spread from one person to another. So you could transmit the resistant bacteria to those around you. Then they could develop an infection from a multidrug resistant bacteria, despite not having taken an antibiotic themselves.
There are also types of antibiotic resistance that can be “traded” between different types of bacteria. I’ll first clarify that it’s not an intentional “trade”; it happens randomly. This is done via small mobile pieces of genetic code that are called plasmids. Think of these plasmids like little frisbees that can be thrown from one bacteria to another. Each “frisbee” contains genetic instructions for various functions. Sometimes, they can contain instructions for antimicrobial resistance mechanisms.
One type of resistance known to have this plasmid (frisbee) potential is something referred to as an extended spectrum beta-lactamase (ESBL). This type of resistance can often convey resistance to almost all oral antibiotics (i.e. taken by mouth); meaning that for any type of infection caused by an ESBL-producing bacteria, no matter how mild the infection is, it could require IV treatment.
And, it’s not just limited to our bodies. Studies have shown that bacteria in irrigation water could “share” this resistance with other bacteria. So, even our waste waters can be a breeding ground for more resistant bacteria once humans introduce them into the environment.
Impact on healthcare
In a 2016 report out of the UK chaired by Jim O’Neill, it was estimated that approximately 700,000 people (worldwide) die every year from antimicrobial resistant infections. This is probably an underestimate, since the reporting in some countries may not be capable of capturing all resistant infections. On top of the human cost, it can also have economic consequences. It’s estimated that antimicrobial resistance costs the US healthcare system an extra 20 billion (that’s right, billion with a B) dollars every year.
I’m assuming that might have gotten your attention.
We aren’t sheltered from the problem in Canada either. I have already had to treat some patients where we had almost no antibiotic options available due to multidrug resistant infections. If we don’t act now, this will start to become even more common.
That’s why we need to be very careful with how we use antibiotics; to prevent that worst case scenario from occurring.
The inappropriate use of antibiotics can have a grave impact on public health, so they should not be available over-the-counter. On top of this, self-treatment with antibiotics could also pose risk to the individual if they are not able to choose the right drug, the right dose, the right duration, or the right monitoring plan to avoid toxicity.
Hopefully other countries around the world also stop making them so easily available, as it’s a global problem which needs a global solution.
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