is this not a no brainer? how about just eating better and less...
The dangers of Ozempic: Why we need more oversight
by Aron Solomon, opinion contributor - 08/20/24 1:00 PM ET
Drugs like Ozempic and Mounjaro continue to jump in popularity and the patient population could grow exponentially in the next few years as further potential uses for these medications are studied.
At this point, we all know about Ozempic. Over the last year or so, the drug has become the go-to name in the world of weight loss. It’s everywhere, and its popularity is soaring more than ever.
But this rise in fame hasn’t come without significant risks.
Recently, the FDA issued warnings about compounded versions of semaglutide, the active ingredient in drugs such as Ozempic, Wegovy and Rybelsus, highlighting a big problem: People are using these powerful drugs without enough medical supervision, setting the stage for potential medical malpractice.
The FDA’s warnings aren’t about the agency’s approved versions of semaglutide, which come in handy pre-filled injection pens or oral tablets. The trouble lies with the less expensive compounded versions that are flooding the market. These are not held to the same strict standards, making them significantly riskier.
Compounded semaglutide is easy to get — as Wired noted last month, shockingly easy. Many people opt for it because it’s readily available and promises quick weight loss. But without proper medical supervision, these unregulated products can lead to serious problems, including life-threatening dosage errors.
The FDA has reported many cases of patients overdosing on compounded semaglutide. These errors happen because people aren’t familiar with how to withdraw medication from vials and get confused by different units of measurement.
From where I sit, it’s time to have a broader discussion about this drug and how it’s being used. It’s not just patients making mistakes; it’s a systemic issue allowing potent drugs to be used without enough supervision.
I work closely with medical malpractice lawyers and have had discussions about where the balance lies between physician and patient responsibility when it comes to Ozempic use. Healthcare providers are supposed to keep patients safe, but they do make mistakes.
The same FDA report has, for example, noted several cases where providers miscalculated doses, sometimes prescribing 20 units instead of two. In other cases, providers using the drug themselves accidentally took 10 times the intended dose.
These errors show a critical flaw: The current system doesn’t do enough to protect against the risks of compounded semaglutide. Healthcare providers need to be more careful, and the system that exists for the provision and use of Ozempic must ensure these drugs aren’t so easily accessible without proper oversight.
So what happens if someone overdoses on Ozempic? As Health has reported, patients report intense nausea, vomiting and dangerously low blood sugar levels. These symptoms can lead to serious health issues if not treated right away. The prevalence of dosage errors with compounded semaglutide is a significant public health concern.
Telemedicine has also played a role in these errors. As these convenient services become more common, patients sometimes receive unclear instructions and turn to the internet for advice. The FDA reported that one patient, unable to get clear dosing instructions from a telemedicine provider, ended up taking five times the intended dose after looking online.
What we’re going to see — and I’ve been predicting this since Ozempic use became prevalent for weight loss — is for Ozempic and medical malpractice to soon intersect far, far more.
Here, we enter the world of medical malpractice, in which a healthcare provider deviates from the standard of care, harming the patient. In the case of compounded semaglutide, several factors come into play in a potential medical malpractice claim, including unclear instructions from healthcare providers, lack of supervision and miscalculations by providers.
Healthcare providers always need to ensure patients understand how to use their medications correctly. When patients feel a need to turn to the internet for dosing instructions, it indicates that providers failed to give clear guidance.
It’s no secret that letting patients self-administer potent drugs without supervision is risky. The many dosage errors show the dangers of this practice. Providers should either give pre-measured doses or ensure that patients know how to measure doses accurately. Instances of providers miscalculating doses shows a lack of diligence and care.
The new FDA report is a stark reminder that these errors aren’t just unfortunate; they represent a deviation from the standard of care that can have serious consequences for patients.
But there may ultimately be some good news in all of this.
The FDA’s warnings about compounded semaglutide are a step in the right direction, but only if they lead to far more robust regulatory measures. This could include stricter controls on the availability of compounded semaglutide products and more stringent guidelines for telemedicine providers who prescribe these drugs.
Policymakers need to consider implementing mandatory training programs for healthcare providers on the proper use of compounded medications. There should also be stricter penalties for providers who fail to adhere to safety protocols, and this will come through an increase in medical malpractice claims.
I think we are getting closer to a tipping point with Ozempic where we finally understand that the documented cases of dosage errors and adverse effects are not isolated incidents but are symptomatic of a broader system failure that puts patients at risk.
How it has taken us this long to get here is something I don’t fully understand. That we have reached the point where people are harming their health through the use and abuse of Ozempic raises not only questions about the manufacture, supply and distribution of the drug itself but about our society. These are all difficult questions that we seem to have deftly avoided so far in the Ozempic boom, but whose time has finally come.
Aron Solomon is the chief strategy officer for Amplify. He has taught entrepreneurship at McGill University and the University of Pennsylvania.
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