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COVID-19 Supply Chain Update
- citilife 7y agoThis almost read like a bot wrote it... > A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage. They don't name the manufacturer, the drug, or really much of anything.
- drugones 7y agoMaybe in purpose to avoid drugs related panic purchases.
- rubber_duck 7y agoWhy publish anything then ?
- taywrobel 7y agoBecause otherwise once shortages begin they'll be accused of a "cover-up"?
- ydnaclementine 7y agoSo they can't say you they didn't tell you anything
- wyldfire 7y agoWell, we know that there is a disruption and that as far as the FDA knows it's just the one report so far. In an administration that frequently gets involved in cover-ups, you can't fault the FDA for trying to disclose as much as they can without causing new problems. Plus the press release goes on to detail many other areas of FDA's regulatory domain that are also helpful.
- TheSpiceIsLife 7y agoThis this other comment (not mine) detailing these FDAs transparency re drug shortages: https://news.ycombinator.com/item?id=22445961 https://news.ycombinator.com/item?id=22445961
- zerkten 7y agoThis is what I'd expect having worked for ~10 years in pharma. These companies are very sensitive to announcements like these because they can be misinterpreted by the public/media. They'll be trying to find some alternative options and the details of the shortage will become evident from other sources eventually.
- deleted 7y ago[deleted]
- frisco 7y agoThis is called “Special English” aka “Simple English” or “Voice of America English”. It is meant to be very clear and straightforward to understand to minimize the possibility of miscommunication and make it so that non-experts of all backgrounds can take away the important messages. Given how important the medicine supply chain is to lots of people’s daily lives, I’m sure they didn’t want this page to seem understandable only by the educated. https://en.m.wikipedia.org/wiki/Special_English https://en.m.wikipedia.org/wiki/Special_English
- metalliqaz 7y agoThat's interesting, thanks. Non mobile link: https://en.wikipedia.org/wiki/Special_English https://en.wikipedia.org/wiki/Special_English
- gizmo385 7y agoIs there anything similar in other languages? I would love to have a similar resource for my German learning.
- tomjakubowski 7y agoI'm also interested in this question of "Special $LANG" for other languages. For German learners, DW has a daily podcast Langsam gesprochene Nachrichten ("News read slowly"), which I have found invaluable. https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030 https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030
- teagee 7y agoLinguistica 360 has news in slow ____ for a number of languages https://www.linguistica360.com/ https://www.linguistica360.com/
- yorwba 7y agoThe equivalent term is "leichte Sprache". https://en.wikipedia.org/wiki/Leichte_Sprache https://en.wikipedia.org/wiki/Leichte_Sprache The websites of government agencies usually have a version in leichter Sprache, although it tends to be counterproductively hidden. The NDR offers news using leichte Sprache: https://www.ndr.de/fernsehen/service/leichte_sprache/ https://www.ndr.de/fernsehen/service/leichte_sprache/ Edit: or any of the other sites on this list: https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle/245442/webseiten-mit-nachrichten-in-einfacher-oder-leichter-sprache https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle... Further edit: there's a Wikipedia category for simplified languages, which in addition to English and German also has Latin and French: https://en.wikipedia.org/wiki/Category:Simplified_languages https://en.wikipedia.org/wiki/Category:Simplified_languages
- dfsegoat 7y agoFDA has an entire drug shortage database that is updated daily and publicly accessible. There are tons of drug shortages at any given time, and most of them go back to API (Active Pharm Ingredients) - the raw active chemicals produced in bulk, that are then put into pills, injection solutions etc. You could probably figure it out from there. My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. https://www.accessdata.fda.gov/scripts/drugshortages/ https://www.accessdata.fda.gov/scripts/drugshortages/ Supply chain security has also been a major focus at FDA over the last ~5 years, basically to ensure there are not "choke points" with respect to approved medicines: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/are-you-ready-drug-supply-chain-security-act https://www.fda.gov/drugs/drug-supply-chain-security-act-dsc... So in general, I appreciate their transparency on this since they have been building up regs around this very type of issue for awhile.
- adrianmonk 7y ago> My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. Not only could it harm the company, it could be bad for patients. Naming it could cause a run (https://en.wikipedia.org/wiki/Market_run https://en.wikipedia.org/wiki/Market_run) on the drug, and if some people hoard it, there will be other people who are unable to get it.
- TeMPOraL 7y agoAnd even worse than the hoarders: the sudden appearance of "entrepreneurs" smelling easy profit.
- adrianmonk 7y agoPrice gouging? Of drugs? In the United States?
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- orblivion 7y ago> This almost read like a bot wrote it... Particularly with reference to "a human drug"
- Seenso 7y ago> Particularly with reference to "a human drug" Veterinary drugs are a thing, and it appears the FDA regulates them, too: https://www.fda.gov/animal-veterinary/resources-you/fda-regulation-animal-drugs https://www.fda.gov/animal-veterinary/resources-you/fda-regu...
- wh1t3n01s3 7y agoHuman drug it’s just a drug. Only if it’s not ‘human’ you have to specify.
- Mountain_Skies 7y agoPurchasing over the counter animal drugs for use in humans is somewhat common in prepper communities. Perhaps the wording was aimed at them.
- samatman 7y agoThat's certainly true if you're an ordinary person. If you're the person who writes press releases for an organization which regulates both human and animal drugs, then you have a reason to be specific.
- deleted 7y ago[deleted]
- throwaway9878 7y agoCalifornia looks set to explode into another Italy scenario as local, human-to-human transmission now appears to be taking place in Solano County, where a woman now critically ill with the coronavirus previously exposed dozens of hospital workers in two hospitals. She was not tested for 11 days because the CDC’s testing flow chart excludes the testing of people who contract the virus in America and who didn’t visit China. The Governor of California stated yesterday that California has only around 200 test kits for the entire state. To this very day, there is virtually zero testing of anyone happening in the entire United States — a fact that many people still are unable to believe (they remain in total denial). The SF Chronicle also confirms this story. According to a highly disturbing Wall Street Journal story (https://www.wsj.com/articles/whistleblower-says-federal-employees-flown-from-coronavirus-sites-didnt-follow-safety-protocols-11582840144 https://www.wsj.com/articles/whistleblower-says-federal-empl...) federal employees who ran the quarantine sites in California and elsewhere failed to wear proper protective equipment (PPE) and also weren’t trained in how to handle people exposed to the virus. Most disturbingly, as the WSJ subhead says, “Employees weren’t tested for virus before leaving California quarantine sites on commercial flights.” I am astounded by the frequency of idiots in key decision making positions globally.
- anarazel 7y agoA lot of the US problems around covid handling seem to be coordination related. There used to be coordinating personnel specifically for that at the NSC. But that has been slashed over the last few years. That kind of short sightedness drives me nuts.
- ryanmercer 7y agoThere is a good general daily thread in https://www.reddit.com/r/supplychain/ https://www.reddit.com/r/supplychain/ that's a decent starting point each day for what's going on in the world of supply chain/logistics.
- dfsegoat 7y agoThis is a little different. The FDA has an entire infrastructure setup around Supply Chain security - basically to ensure critical medicines are always available from SOMEONE. Not to spam on my comments, but see here: https://www.accessdata.fda.gov/scripts/drugshortages/ https://www.accessdata.fda.gov/scripts/drugshortages/
- TheSpiceIsLife 7y agoYou’re message here and in your other comment is quite important. There are quite a few people in this thread assuming the press release is all the FDA has to say, and who appear to have made little effort to test that assumption. I guess this proves the point that the use of Special English as per this comment https://news.ycombinator.com/item?id=22445952 https://news.ycombinator.com/item?id=22445952 is well warranted.
- pkaye 7y agoSomeone had posted this on Reddit today. Mentioned some of the drugs made in China to be aware of. https://www.reddit.com/r/gout/comments/faym30/pharmaceutical_supply_chain_concerns_allopurinol/ https://www.reddit.com/r/gout/comments/faym30/pharmaceutical...
- rahan46g 7y agoHi
- someonehere 7y agoI stumbled on a daily supply chain sub over at reddit. r/supplychain which gets a daily update from a user who pulls his data from across manufacturing, shipping, and other sources. I recommend anyone interested in supply chain detailed analysis, that’s where to go.
- Zaskoda 7y agoI've been reading the updates there and have been making specific purchases as a result. For example, I read about disruption to clothing manufacturing and bought some summer shorts, pairs of boxers, and packages of socks - stuff I was expecting to buy soon anyway.
- andreygrehov 7y agotl;dr?
- jefftk 7y ago"Regarding personal protective equipment—surgical gowns, gloves, masks, respirator protective devices, or other medical equipment designed to protect the wearer from injury or the spread of infection or illness—the FDA has heard reports of increased market demand and supply challenges for some of these products. However, the FDA is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and other U.S. partners of increased ordering of a range of human medical products through distributors as some healthcare facilities in the U.S. are preparing for potential needs if the outbreak becomes severe." This is very weird: my understanding is that masks are sold out at standard suppliers and have been for a while (though available at extremely high prices from resellers). This seems like it is beyond "supply challenges" and into being a "specific widespread shortage"?
- SargeZT 7y agoI think they're referring to availability for medicine. My facility has zero issue ordering PPE at the moment; we order many thousands of boxes of gloves and masks and have no issue with that.
- alasdair_ 7y agoI wonder how many boxes of masks "go missing" in a given month and if this will spike now that the resale price is so high.
- hanklazard 7y agoWe're starting to keep a more careful eye on inventory for that reason.
- Consultant32452 7y agoI'm guessing they mean "specific widespread shortage (at medical facilities)." Which is categorically different from a retail shortage at your local pharmacy or retail store.
- ssully 7y ago
- mark-r 7y agoJust make sure you're all stocked up on Forsythia. (Oblique reference to the movie Contagion)
- 1001101 7y agoI was reminded of that when reading about a compound in licorice (glycyrrhizin) that seem to be effective in reducing the replication of SARS, (another coronavirus): https://www.ncbi.nlm.nih.gov/pubmed/12814717 https://www.ncbi.nlm.nih.gov/pubmed/12814717 https://www.nature.com/articles/news030609-16 https://www.nature.com/articles/news030609-16 https://en.wikipedia.org/wiki/Glycyrrhizin https://en.wikipedia.org/wiki/Glycyrrhizin
- qrbLPHiKpiux 7y agoRelying on another nation like this for our critical supplies if a national security threat that I'm surprised is even in operation like this, today. China Rx is a very good book about this.
- Fomite 7y agoThings conspicuously not mentioned that always drives me nuts: Medical oxygen.
- extrapickles 7y agoThe main difference between industrial and medical oxygen is that for medical oxygen the providence of the tank is tracked to make sure that it has only been used to store oxygen, and hasn't been left unused for a long period of time. With the massive need for various gasses and the cost in transporting them long distances, most large metro areas have at least one air distillation plant that produces them. Pressure Swing Absorption oxygen generators have been getting cheaper, and will separate oxygen from air as long as they have electrical power and maintenance every few months. PSA is not suitable for all medical uses though as it typically produces 90-95% oxygen and is not directly capable of producing pure oxygen.
- Fomite 7y agoYeah - but doing some work for one such distributor, "Are we delivering to hospitals?", "Are we unloading at hospitals?", "Do we have surge inventory?" and "Do we want the cylinders back if they've been used for coronavirus patients, or do you need to decontaminate them first?" are all questions being asked. They have various answers, but my experience now working on H1N1, SARS, Ebola and COVID-19 is that hospitals weirdly take the flow of oxygen as a given.
- gpm 7y agoA quick search suggests that we produce 99% oxygen just by running it through two stages of pressure swing absorption. Is that also not good enough for hospitals? If so, what do we use for even purer oxygen.
- Fomite 7y agoThe issue is not making the oxygen. It's distributing and delivering it.
- 01100011 7y agoJust saw there's a community acquired case in Santa Clara county: https://www.mercurynews.com/2020/02/28/santa-clara-county-announces-new-coronavirus-case/ https://www.mercurynews.com/2020/02/28/santa-clara-county-an...
- dchasson 7y agoSo they aren't predicting anything, are relying on manufacturers to self report, already have surprise shortages, and are monitoring and mitigating? These statutory authorities and responsibilities to assure blah blah blah, that doesn't give permission to prepare or ramp up requirements? "Implementing critical infrastructure monitoring" is giving out an email address? Hmmm.
- totalZero 7y agoThey're doing their job. My view is that bureaucracy has its own doublespeak for everything. So when I see this: > It is important to note that no law exists requiring medical device manufacturers to notify the FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when the FDA requests information about potential supply chain disruption. ...in my head, I translate it to this: > We welcome a law requiring medical device manufacturers to notify the FDA when they become aware of a potential shortage or discontinuation, and requiring manufacturers to respond when the FDA requests information about potential supply chain disruption.
- jonahbenton 7y agoReally glad this was posted. It is absolutely insane to be in the position where essential medical equipment is not going to be available in the US because of COVID19 quarantine in China. What the absolute F are we paying US Pharma 1000% premiums for, if not in part to maintain control over supply chain. Shameful.
- phyzome 7y ago« We are not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging. » Given the number of illnesses that can be transmitted by indirect contact, including cases of sick food workers contaminating a supply, I feel like they should indicate a little more caution in this section.
- jaakl 7y agoMaking a basic mask to protect for “USA nuclear attack” was mandatory lesson in all Soviet region schools. It takes less time and skills than whining about supplies here. China has has won us by creation of total learned helplessness?
- kragen 7y agoN95 masks are a pretty fine filter material and they seal pretty well while minimally obstructing breathing; I think it would be hard to equal their performance out of improvised materials, and perhaps more important, it would be impossible to know whether you had succeeded. Would you like to share the instructions you learned? Even if the result was less effective than an N95 mask, it might be useful.