This post is an update to one posted about a month ago suggesting that the spread of the Coronavirus might impact the supply chain for some prescription meds.
Here is yesterday's (02/28/2020) FDA update on the current/possible impacts to the medical products supply chain by the Coronavirus.
From the FDA press release:
"Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China."
"Also, as part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China. We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs."
"We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way."
Sometimes shortages are the result of the hysteria surrounding an event which results in hoarding vs the event itself.
According to what you have posted, there are no shortages in supply of critical drugs. I think it would be a questionable practice for doctors to over prescribe drugs out of a concern for a potentially impending shortage. It’s unfair to those who don’t hoard.
There evidently is no shortage nor anticipated supply disruption for Ibrutinib as of now. If doctors start over prescribing so people can hoard, that might be the event that triggers a shortage. I would think it might be illegal, unethical or both for doctors to favor their patients over others by promoting hoarding.
With all due respect to you and your opinion, my objective is to inform people of a potential problem down the road. And while I am of the opinion that things will get much, much worse before they get better, what people chose to do with the information is up to them.
As the health care industry continues to understand COVID-19, it’s understandable that patients with cancer may feel alarmed about the supply of their treatments that come through China. For instance, Imbruvica (Ibrutinib) has much of its product manufactured in China but its manufacturer, Pharmacyclics, has stated that they do not expect coronavirus spread to impact their ability to manufacture the drug. At this time, no other companies have sounded an alarm to impact the patient's supply of treatment.
Thank you for that!!! I was concerned that we might not be able to get Imbruvica. I get mine through Diplomat Pharmacy and I guess they are not affected........I haven't heard anything that they have been.
I think it’s okay to have differing opinions. And I am fine with making people aware of a possible shortage. I was just pointing out that if there a shortage, those who over supply themselves may cause those who do not to be deprived of life saving drugs.
I would think that doctors can’t favor some over others by doing this. But I don’t know. It just doesn’t seem right to me. I could be wrong, often am.
I believe the post said there were not shortages if NON critical drugs - what about those that are indeed critical that we need each day such as imbruvica ? I’m really worried
i cannot speak for other countries but in usa your insurance processor controls how many and how fast you can refill. It's also my experience as a retired retail pharmacist that most people will refuse to pay the cash price because insurance says refill too soon or over maximum quantity.
IVFN, Rather than get into a battle of opinions over the mechanisms/ethics of prescription drugs, I have edited the post and deleted my persona views. As I said in my response to Jeff, what people do with this information is entirely up to them. Same applies to people's opinions about where the Coronavirus outbreak is headed. As with all things do your own research.
i was not stating ethics or anything else. 95 percent of rx's in usa are filled under prescription insurance. Computer programs govern refill too soon or quantity limitations. The pharmacist cannot override these rejections.
it's got nothing to do with changing a prescription. If it's put in exactly as written but it's too soon based on the last prescription it won't go thru . your dealing with a computer. the insurance won't let it thru no matter what the pharmacist does
Also note: it doesn't matter if your doctor writes for 100000 pills, your insurance is the one to decide. That is unless you would like to pay the cash price....which is not the same price per pill your insurance would be paying.
I heard on a news program yesterday from an official talking about this virus that instead of stocking up on masks etc we should try to have a 90 day supply of prescription drugs that we need .
Now wether we are able to get it either from the pharmacy or the insurance company is another matter - unless you are wealthy no one can afford to pay out of pocket for imbruvica !
This is very troublesome to me . It’s a matter of life or death ! And if the supplies are not being shipped from China because their factories are closed down or other reason the insurance company should step up and protect n understand the situation - it’s not a matter of hoarding it’s just getting it ahead of time like many other drugs that are given out at 9O day supply
Insurance very often limits expensive medications to 30 days supplies because it is so common for people to change regimens. Pills cannot be returned or redistributed so $1000 go to waste if a 90 day supply is not used.
I'm sure I wouldn't be able to get a 90 day supply. As said, my insurance probably would not pay for a 90 day supply, and I certainly couldn't pay for it myself!!!! I only get 30 days worth or 28 days..not sure.
Here is an example of what I was referring to if people start hoarding drugs and medical supplies like masks. The hysteria itself creates a shortage that did not exist.
It’s not an easy subject. We all want to be prepared. But it is a reality that if we all buy masks and all seek to oversupply ourselves with meds, we can create shortages for others.
It’s probably controlled to a certain extent with ibrutinib where even if our doctors prescribed an oversupply for us, our insurance won’t likely pay for it. Masks which don’t require a prescription are different.
The surgeon general is wearing against buying masks:
This maybe a stupid question, however is there any risk that the meds made in China are contaminated with the virus. Or the packaging? Is Ibrutinib the only Cll treatment drug made in China? Although the virus does seem to be all over the world.
But if concerned wipe the package with 70%+ alcohol cleaner and then wash your hands with soap for 20+ seconds! Not touching your face and frequent hand washing are super important.
FDA
Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed.
CDC
Q: Am I at risk for COVID-19 from a package or products shipping from China?
A: There is still a lot that is unknown about the newly emerged COVID-19 and how it spreads. Two other coronaviruses have emerged previously to cause severe illness in people (MERS-CoV and SARS-CoV). The virus that causes COVID-19 is more genetically related to SARS-CoV than MERS-CoV, but both are betacoronaviruses with their origins in bats. While we don’t know for sure that this virus will behave the same way as SARS-CoV and MERS-CoV, we can use the information gained from both of these earlier coronaviruses to guide us. In general, because of poor survivability of these coronaviruses on surfaces, there is likely very low risk of spread from products or packaging that are shipped over a period of days or weeks at ambient temperatures. Coronaviruses are generally thought to be spread most often by respiratory droplets. Currently there is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. Information will be provided on the Coronavirus Disease 2019 (COVID-19) website as it becomes available.
doggers, Below is the link to the earlier post about the Chinese sourcing of pharma products and ingredients for products produced elsewhere. This statement from that article pretty much sums up the problem:
"Roughly 80% of active ingredients used by commercial sources to produce finished medicines come from China, Christopher Priest, deputy assistant director at the U.S. Defense Health Agency, said in testimony given last July to the U.S.-China Economic and Security Review Commission."
Even the many pharma products from India get many of their ingredients from Chinese sources.
‘The time to worry is now’: The coronavirus in China could threaten pharma’s ingredient sourcing - STAT - January 27, 2020
It is a good idea for all patients on regular meds of any type to stay on top of potential shortages before they find themselves without supply options.
When people say no evidence in law or medicine doesn't it depend on if something has yet to have been investigated? Also...and I apologize if this is interpreted as being political...but how did our US politicians allow our health , our lives, to be dependent on China, a known competitor of the US and the West and not great at human rights? We need to mandate that any important drug be made in the US or a proven US ally. 80% of our antibiotics are made in China! These are not paper plates! Did it occur to anyone that they could use that as leverage against the world? Or inadvertant contamination? I totally respect the Chinese people...I've enjoyed traveling there, but this is too important not to address. They also need to close these filthy wet markets where all manner of creatures are abused and eventually eaten. And yes, I am ethnocentric, sorry...eating dogs and cats is wrong. Or at least the poor treatment of them in these markets. I may call the Inrutinib manufacturer and see what's up.
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