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States Face Huge Task In Tracking Meningitis-Tainted Drugs

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  • by dandelionblue (2757475) on Sunday October 21, 2012 @07:17PM (#41724523)

    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.)

  • by PPH (736903) on Sunday October 21, 2012 @08:23PM (#41724807)
    Compounding pharmacies [wikipedia.org] are regulated by the states, not the FDA the way drug manufacturers are.

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