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Comment That's not [sic]... (Score 1) 82

The Apple marketing people may not like it, but it's time to admit it â" yes guys, your system is as vulnerable as Windows. Don't ignore the lesson of Flashfake. Think serious about security, not just different [sic].

Because whoever posted this doesn't seem to get it: Apple's marketing slogan at around the turn of the millennium was "Think Different". It's a joke, not an unintentional grammatical error.

Comment Re:What about a healthy brain (Score 2) 62

I know you're just being flippant regarding depression in Alzheimer's, but one of the big problems with Alzheimer's can be what you do remember. It's not total retro- and anterograde amnesia. My great-uncle developed dementia after a stroke, and was somehow forced into nearly constantly reliving his part in the battle of Stalingrad and subsequent interment in a Russian POW camp. He was unable to recognise some of his own family but remembered more than enough of the events of WW2.

Comment Re:Recalls aren't that complicated... (Score 1) 99

Well, we don't have something called compounding pharmacies here as such, so I think they'd be considered a "specials manufacturer" - premises licensed for the production of unlicensed medications, usually things like syrup versions of tablets or unusual mixtures. But specials manufacturers are still required to notify the MHRA and get a recall cascade going, just like a "proper" manufacturer.

Comment Re:Recalls aren't that complicated... (Score 1) 99

Yep, it's a bit of both. There are two registers of pharmacies:
- a national one, run by our regulatory body, which includes both hospitals and community pharmacies
- more local ones, held by the PCTs

You could get the national listing involved but it adds a layer of bureaucracy (the organisation that holds all that data has many other functions which might interfere with speed of recall). So you talk to the PCTs instead, who know exactly whom they're paying locally and don't have as many people to contact. Additionally, the national register of pharmacy premises does not include any details on doctors or dentists, so you'd have to go back to either the PCTs (who again hold data on the local level) or their regulatory bodies whenever doctors or dentists need recall information. Doctors and dentists do hold some stock of drugs and sometimes need to know about recalls.

Comment Re:Recalls aren't that complicated... (Score 1) 99

I think it's because the hospital system and the community pharmacy system are very separate, and while both are regulated by a central body (the General Pharmaceutical Council) that body has no involvement in drug recall cases, because it doesn't regulate drug standards, only pharmacists and pharmacy premises. So you can either: be the MHRA and directly contact all hospitals plus all PCTs (who will do the legwork of then contacting primary care doctors/dentists/community pharmacists), or be the MHRA and contact the GPhC and wait for the GPhC to pass it on. The GPhC also only work Mon-Fri 9-5.

Things may well change as the PCTs are due to be abolished next year, but requiring the PCTs to contact all pharmacies on their patch reduces the numbers that any one body has to contact. (PCTs cover areas of up to about 1 million patients. Their replacements cover much smaller areas, but of course there's more of them.)

Comment Recalls aren't that complicated... (Score 3, Informative) 99

So, I work in a hospital pharmacy in England. If we were in this situation:

1. The drug company would be required by law to notify the Medicines and Healthcare Regulatory Agency (MHRA) upon realising there is a problem. This can be done out of office hours if it is a serious problem (we have class 4 recalls for things like typos in leaflets, which tend not to qualify for urgent action).

2. The MHRA would fax out a drug recall notification to all hospital pharmacies, private hospital pharmacies and Primary Care Trusts in the country, who would be responsible for forwarding it to any community pharmacies, doctors and dentists in their area (assuming this was a drug those groups would be likely to have - this won't happen if the drug is hospital-only). Many pharmacists are also signed up for instant email notifications of drug recalls. The MHRA doesn't waste time working out which hospitals have been affected - it's the hospital's responsibility to determine whether they stock(ed) that drug using the brand names, manufacturers and batch numbers given.

3. In the case of direct harm to patients, this would be a Class 1 Recall ("potentially serious or life-threatening") requiring removal of the product from hospitals/pharmacies/doctors etc immediately. If you are the on-call pharmacist for a hospital and it's 6pm on a Sunday, tough, you'd need to go in and sort it out there and then - quarantine the drugs, take them out of ward stock, etc.
3a. In this case, the original recall has been expanded to include things that only might be problematic, so those could be done as a class 2 recall (action within 48h, not immediate) or even class 3, so hospitals can concentrate on the stuff that's actually killing people.

4. The hospital is also required to contact all potentially affected patients (we don't usually record batch numbers for which drugs have been given to patients except in certain specific cases, so we would usually need to contact all patients who received Drug X within an appropriate timescale).

So that sounds quite simple to me. At which stage does the US system differ? The recall list is very long here, but on the other hand, chances are your hospital doesn't use everything on the list and you can completely ignore the ones you haven't stocked.

(Don't just say "it's because the US has 300m people and you have 60m"; that just means your regulatory agency needs to send out more faxes initially and I'm sure the faxes are done via some sort of batch method.)

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