An ongoing dialogue on HIV/AIDS, infectious diseases,
December 15th, 2019
Should Oseltamivir Become an Over-the-Counter Drug?
News broke last week that oseltamivir — most commonly known by its clever (expired) brand name, Tamiflu — may be heading to pharmacies soon as an over-the-counter (OTC) drug, available without a prescription.
After hearing this, I immediately thought of several reasons both supporting and opposing this change — an ideal question for a poll!
Oseltamivir (brand name Tamiflu) may soon become an over-the-counter medication, available without a prescription. How do you vote, #IDTwitter and other clinicians, and why?
— Paul Sax (@PaulSaxMD) December 14, 2019
Clearly, way more ID-oriented clinicians support the status quo, with oseltamivir remaining available by prescription only. This 70%/30% split shows they feel even more strongly about it than the Brits did in their opposition to Jeremy Corbin.
(Too soon? Sorry.)
But even more fascinating than the poll results were the comments after the poll, many of them thoughtful and backed by clinical and scientific data. These were evident on both sides of the question.
I’ll summarize some of the more interesting opinions below. First, the NAY votes:
- Does the drug even work? A longstanding controversy, linked to concerns that the initial publications included only favorable data. Many cite various Cochrane Reviews (there have been several) as a reason to consider oseltamivir only modestly effective at best. Symptom improvement of only 1 day, or even less than that? Big deal, take some analgesics, curl up in bed, and wait it out.
- Most people have little idea what influenza actually is, using the term “flu” for all kinds of symptoms. “Stomach flu”, for example, is a commonly used lay term. Clearly oseltamivir would do nothing for this illness.
- “Flu-like symptoms” are a common harbinger for several severe infections, and people who start themselves on oseltamivir will delay seeking attention for these conditions that need alternative treatments. Some of these might be respiratory infections such as pneumonia; others are systemic infections that cause fevers and chills first (such as pyelonephritis, streptococcal skin infections, and endocarditis).
- Some will jump the gun and think they need to start oseltamivir at the first sniffle, when all they have is a cold. Distinguishing influenza from other respiratory viral illnesses can be challenging — and the common cold (mostly from the zillions of rhinoviruses out there) is way more common (naturally) than influenza, especially when it isn’t flu season.
- Not only that — if people take it for a common cold or a “stomach flu”, they’ll be both wasting their money and risking side effects for no benefit. We don’t know what OTC oseltamivir will cost, but suspect it won’t be cheap — and this is an out-of-pocket cost, no insurance, with costs passed on to the patient. And no drug is 100% safe. Systematic reviews cite nausea and vomiting as the most common side effects of oseltamivir, but headache and psychiatric symptoms also may occur.
- Increasing access to oseltamivir will breed influenza resistance to it. A huge worry, one that we see globally already with ready access to antibacterial drugs. Do we want to risk this with oseltamivir and influenza? Of course not.
- We have enough trouble getting people to take their flu shot — now it will be even harder since they can get ready access to flu treatment. It’s like statin drugs and an unhealthy diet, right? License to ignore good medical advice.
Now, the YAY votes:
- Oseltamivir works best if started soon after the onset of flu symptoms — hence improving access to the drug is critical. Clearly sooner is better — the package insert says it should be started within 48 hours after symptoms start; studies show the greatest benefits if started in the first 6-12 hours. And who can reach their provider that quickly? What if it’s a weekend? What if your provider doesn’t believe it works? (See above.)
- Just the fact that there’s a controversy about whether it works shows it must work better than existing OTC “cough and cold” drugs, which are widely used. Can’t argue with that, as most of the colorful pills, liquids, and lozenges in that aisle are useless.
- The most rigorous and comprehensive overviews of the oseltamivir studies demonstrate conclusively the benefits of treatment. The key strength of this widely cited Lancet paper is that it used individual patient level data from the trials, which are much more reliable than aggregate study results. Those at high risk for influenza complications appear to benefit the most, reducing the need for antibiotics or hospitalization. (Addendum: And now I can link this recently published trial as additional evidence!)
- If people can get the drug easily at a pharmacy, it will limit the time they spend in doctors’ offices or hospital emergency rooms, reducing the risk they’ll spread flu to vulnerable other people. The elderly, the immunocompromised, those with multiple comorbid medical conditions (especially cardiac and pulmonary), pregnant women — they frequently visit health care settings, and the last thing they need is to spend time in waiting rooms with someone who has active influenza. Many hospitals (ours included) advise people to stay home if they have flu symptoms (unless of course they also have shortness of breath, difficulty staying hydrated, or other worrisome issues). “Sharing Isn’t Always Caring” say the signs in our hospital — clever.
- Making it over-the-counter doesn’t mean it needs to be in the aisle with the cough and cold “remedies” — a pharmacist could release it based on a symptom questionnaire or other screening tool. New Zealand and Japan have taken this approach — the drug is “behind the counter”, so not literally OTC — and this strategy apparently limits inappropriate use.
- There is no evidence that use of oseltamivir in people without influenza selects for influenza resistance. Indeed, without influenza being actually the diagnosis, the drug may not be doing any good — but it’s not leading to resistance. And in the countries that have it without prescription already, resistance to oseltamivir has not (yet) led to more local resistance.
- Influenza resistance to antivirals is unpredictable (to say the least), and not necessarily triggered by overuse. Take a look at this slide set reviewing the issue! Quoting Dr. Marc Lipsitch (who shared the slides): “The usual paradigm of use driving resistance doesn’t appear to hold.”
So where do I stand on the issue?
Gosh, this one is complicated.
While all the YAY and NAY votes make sense, for their own reasons, ultimately I thought about what I currently do in clinical practice.
When a patient calls me during flu season saying that they have fevers, chills, muscle aches, dry cough, and a runny nose, and that this illness “hit them like a truck” — I call in a prescription for oseltamivir rather than ask them to come in for an exam, blood tests, or a flu swab.
Why put them through this punishing trip to the hospital? Why expose other patients and health care providers?
Sure, it could be something else. And sure, it’s important to screen for other symptoms, and to tell them to come in if they’re not improving.
But the call to me seems like an unnecessary barrier; a good pharmacist can conduct the appropriate symptom screen and save people the hassle of reaching their providers by phone. They wouldn’t recommend osteltamivir for symptoms of “stomach flu”, or for a runny nose only, would they?
So bring on behind the counter oseltamivir, available without a prescription! Under the guidance of a wise pharmacist!
And remember — Tamiflu was selected as the one of the greatest expired (it’s now generic) antimicrobial brand names ever by Dr. Raphy Landovitz in this important podcast.
So go ahead, listen again to the whole thing.
And now that you’ve read this far, how would you vote?
Thanks to those who offered the numerous thoughtful responses and insights offered in the original poll. Let’s see what this one shows.