via GIPHY

We’ve received questions about how we’re getting semaglutide, the active ingredient in Ozempic and Wegovy, since it’s currently so backordered.

We’re ordering our semaglutide from a compounding pharmacy. Never heard of a compounding pharmacy? That’s ok, chances are you’ve used medication from a compounding pharmacy before.

Examples of what a compounding pharmacy offers:

• Allergic to a dye or certain ingredient in a medication? A compounding pharmacy would recreate that medication without the dye or allergen
• Have a child, or elderly parent that can’t swallow the pill form of a medication? A compounding pharmacy can recreate the medication in liquid form
• Ever received botox or filler at a doctor’s office? The topical numbing cream placed on the skin prior to treatment was made at a compounding pharmacy
• On bioidentical hormone replacement therapy (BHRT)? From a compounding pharmacy.
• Medications that are in short supply, including medication for COVID, can be produced by compounding pharmacies too

This last example is why we’re able to get semaglutide. It’s on the FDA’s shortage list, and as such, the FDA allows a compounding pharmacy to duplicate a commercially sold drug that’s currently unavailable or in short supply.

So what if semaglutide is removed from the shortage list? There are two schools of thought on this point.

If brand name medications are taken off the FDA shortage list, it’s possible compounding pharmacies will no longer be allowed to manufacture semaglutide. The other school of thought is that because most compounding pharmacies are combining B-12 or L-carnitine with their sterile compounded semaglutide, they are making a materially different compound than the patented version of semaglutide manufactured by NovoNordisk. And as such, compounding pharmacies can continue producing a novel version of semaglutide with this additive.

Which school of thought will win out? The FDA has not weighed in on this question yet.

Generic vs “Generic”

Also, we may use the term generic when referring to our compounding pharmacy version of semaglutide. We are aware that generic within the context of pharmaceuticals can mean a drug that is being manufactured after a previous name-brand drug has lost its patent protection. That’s certainly not the case here because Ozempic and Wegovy have not lost their patent protection.

But we will sometimes reflexively refer to our semaglutide as generic because it is 1) an alternative way of saying the medication is not a name brand, which is certainly generic in some contexts and 2) less confusing for most patients. Regardless of whether we use the term generic or replicated or analogue, it is the same active ingredient whether it was created at a compounding pharmacy or at a large pharmaceutical company that makes “generic” drugs.

Quality standards of compounding pharmacies

In regards to the quality of medications produced by a compounding pharmacy, the facility we get semaglutide from is considered an “outsourcing facility,” as defined in The Drug Quality and Security Act, of 2013. That law created a new section, 503B, in the Federal Food, Drug, and Cosmetic Act. As such, an outsourcing facility is overseen and inspected by the FDA, along with state regulators.

Under the law, outsourcing compounding pharmacies must comply with section 503B and current good manufacturing practice (CGMP) requirements. In other words, they have very high standards to keep.

And we’ve had a great experience with this compounding pharmacy providing our semaglutide. It’s a relationship that predates this particular drug. So for now, we have a robust supply of semaglutide and will maintain at least a 6 month availability while supplies last.

If you’re not in our program, read more about semaglutide here and prioritize scheduling your consultation by paying online here.

The post How we’re able to get “generic” Ozempic/Wegovy 🤔 first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

In the run up to the current vaccine approvals and post approval process, I’m blown away by what is making people worried about this vaccine. I’m not surprised they’re worried. Totally get that. But surprised by what they’re worried about!

Anxiety and fear are completely understandable for a vaccine that was developed in record time and with “newer” technology (mRNA (m = messenger)(RNA = ribonucleic acid). I say “newer” because while it’s the first vaccine coming to market using mRNA technology, the technology was actually developed decades ago. Yes, it was approved under an emergency use authorization so we don’t have years of follow up studies confirming its safety. However, with the millions of people who’ve received the vaccine either during trials or since release, severe reactions are very rare. Most side effects include short-term fatigue or headache. But with a greater than 94% effectiveness, these side effects are a reasonable tradeoff.

Of course we shouldn’t go into anything blindly. Of course we should have an idea of what we’re putting into our body. But the concerns people are bringing up suggest misinformation and rumors without a clear basis. My post below, along with this article and this article seek to allay some of those concerns.

Fertility

When someone expresses a concern, I don’t believe we should dismiss those concerns. I think we should be curious as to what is the underlying reasoning for their concern. Once we know, we can more accurately address that concern.

But in the case of fertility, it’s not clear where this fear is coming from. Do they think the vaccine causes a person to become sterile? Impotent? This article suggests the concern is a debunked cross reaction with placental proteins! I want to ask the people that cite this as the reason for not getting the vaccine, “what do you know about placental proteins?!”

An alternative reason for concerns about fertility may lie with the vaccine’s mechanism of action. The Pfizer and Moderna vaccines are messenger RNA-based vaccines. mRNA is genetic code that the cell uses as a blueprint for manufacturing proteins. In the case of the Pfizer and Moderna vaccine, the mRNA goes into the cell and stimulates the cell to create the coronavirus’ spike protein.

The spike protein then goes to the cell surface and stimulates the body’s immune system to create antibodies to that protein. Keep in mind the presence of these manufactured spike proteins on your cell surface don’t last forever. They degrade over time like any protein. They’re there just long enough for your body to stimulate antibodies to them. And if the real coronavirus with its spike proteins enters the body, your immune system is primed and ready to produce antibodies to neutralize the virus.

But at no time does the mRNA ever enter the “inner sanctum” of the cell, the nucleus. This is where our genetic code is kept. Our genome, our DNA. By remaining outside of the nucleus when creating the spike protein, the mRNA never incorporates into our DNA. Therefore it is not passed on to your kids and does not affect fertility.

If additional reassurance is necessary in regards to fertility, keep in mind that The American College of Obstetrics and Gynecology are very clear about vaccination during pregnancy and lactation. They’re for it!

Ultimately, the attempt to dispel a myth regarding fertility is the difficulty in addressing the underlying source of the concern (since it’s not always clear).

So imagine yourself listening to the news during this pandemic and the news anchor says, “Breaking News! Two companies have developed new vaccines for the coronavirus. They work by injecting the actual coronavirus into your bloodstream.”

Concerns over the vaccine technology

Back to the technology used in these first two vaccines. They use mRNA as a way to stimulate the body’s immune response as explained previously. Whether people are concerned that it’s the first vaccine using this technique or because of fear that it interacts with our own DNA (again, it doesn’t), I think it’s important for concerned citizens to consider the alternative types of vaccines.

Keep in mind that all of the vaccines you’ve ever received, stimulated your immune response by using 1) a live, weakened (attenuated) virus (eg MMR or measles vaccine), or 2) a dead virus (eg polio, hepatitis A, most flu vaccines). So imagine yourself listening to the news during this pandemic and the news anchor says, “Breaking News! Two companies have developed new vaccines for the coronavirus. They work by injecting the actual coronavirus into your bloodstream.” It wouldn’t matter that the vaccine contained weakened or dead viral particles. You’d run for the hills!

Therefore, a vaccine that produces a protein that allows your body to produce antibodies to the virus, without ever interacting with the virus itself, is progress. Consider yourself lucky to be living in a time where this technology is available. Now go out and get vaccinated!

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post You’re worried about this vaccine?! And other myths! first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

I just attended the Fall meeting of the Cleveland Clinic Alumni Board of Directors. The biannual meetings of the Board of Directors provides an opportunity for the Clinic to show alumni from around the country, what various departments are up to. The alumni in turn, disseminate that information to their respective communities. As you’ll see in the three snippets below, there’s plenty of activity.

Synopsis of current activities at “the Clinic”

1. Minority Men’s Health Center
Dr. Charles Modlin, Founder and Director of the Center explained the significant health disparities between caucasians and other minority populations. Aside from determining the cause of those disparities, the Center holds annual health fairs for outreach to reduce those disparities.

2. Tomislav Mihaljevic, MD, President and CEO, Cleveland Clinic.
The newly minted President and CEO discussed the growing reach of Cleveland Clinic in Abu Dhabi, Florida and London. Coincidentally, the first patient to be seen in the new London expansion will be on February 24th, 2021 – 100 years after, to the day, that the first patient was seen at the original Cleveland Clinic on February 21st, 1921!

3. Cleveland Clinic Florida
The CEO of Cleveland Clinic Florida, Wael Barsoum, MD, discussed the expansion of the Cleveland Clinic Weston campus plus the alignment with two additional health systems in Southeast Florida.

Last but not least, the Cleveland Clinic College of Medicine continues to provides medical school tuition free of charge and has been doing so for years.

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post What’s the Cleveland Clinic up to? A lot! first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.

Cleveland Clinic Alumni Board of Directors

Dr. Kaplan will serve on the Cleveland Clinic Alumni Board of Directors for a three year term. During that time, he will serve as a liaison between the alumni board and alumni of the Department of Plastic Surgery. Dr. Kaplan finished his plastic surgery training at the Cleveland Clinic in 2007.

In this capacity, Dr. Kaplan will facilitate alumni events throughout the year at various plastic surgery meetings. Additionally, he will attend twice-yearly meetings at the main campus in Cleveland, OH. For more information about the Cleveland Clinic, click here.

As many readers know, BuildMyBod Health provides pricing information on healthcare services typically paid out of pocket. BuildMyBod Health offers pricing across the US, including the Cleveland Clinic Department of Plastic Surgery. To check their pricing, click here.

Click here for the original blog post written by Dr. Kaplan for BuildMyBod.

The post Dr. Kaplan appointed to Cleveland Clinic Alumni Board of Directors first appeared on Plastic Surgeon San Francisco | Pacific Heights Plastic Surgery.