Nurofen – entire product recall – sabotage suspected

Hi PaulF

Hi PaulF

My head of Regulatory Affairs and Lead Internal Auditers would be fried by the FDA. I was a humble research assistant in those days and was happy to conform to very high standards and receive no ‘yellow perils’.

Production lines in Pharma have evolved to be devoid of human contamination hence accidental contamination can be considered a minimal risk.
I would by that same argument suggest that deliberate contamination (in this case apparently at least two other products) was even less likely. Yet it appears to have happened.

Hypothetical but each tablet/capsule has a low plus/minus tolerance in weight/volume and production line systems can be made (if not in place already) to detect any item that does not conform to tolerance levels and even appearance (identity markers/letters not visualised by micro imaging CCTV). This would normally halt the line automatically requiring a manual override after investigation.

How and at what point did contamination occur?

Are there not likely to be event triggered CCTV footage that would now get reviewed. (e.g. if someone vaults over a ticket turnstile at a rail station good CCTV systems automatically mark the event electronically as abnormal hence assisting review later)

What hasn’t been revealed in this case and may never is whether it was individual blisters that were contaminated in several strips, or an entire strip of blisters, …….

I think a lot should be learnt by Pharma by this scare as the technology is all available and they if any have the money to invest to safeguard their own backs.

Let me give you a parallel example from the microelectronics world. A large very reputable computer server manufacturer used home grown automated quality assurance systems in verifying if each mother board was acceptable. The test programs were home authored and it produced excellent results. Every board was checked at each stage of layering (additional components) and failures went automatically into a potential failed line and went through further checks to see where the failures were introduced. They then were able to identify batches of components or material that caused the failure and deal with supplier issues. Quality was very high on any board that left that manufacturing plant and still is.

Microelectronics by its name suggests items and components many of which are far smaller than most Pharma tablets/capsules and if microelectronics can get it right then Pharma can.

I totally agree it is a mindset, screening and standards of employee quality that also must be upped but the errors at manufacturing in Pharma can be reduced to almost zero.

I also agree with you that ticking boxes isn’t my idea of quality and it’s continuously upping the standards and reducing risk levels that gets things to 100% or near 100%.

Getting audited to FDA standards is one thing (been there got the tee shirt) but to be actually audited by the FDA is another ball park (would not wish to be there)

Hi nJayM,

Been there done that a few times, as I have been in tech/quality area of pharma (or allied) industry for 25 years 🙁 . Indeed, the incident will prompt a thorough review of procedures and controls at the manufacturing/packing site involved, and prompt a wider review of risks/controls elsewhere.

However, while “accidental” cross-contamination (i.e. inadvertant and genuine “mistakes” made on the line) can largely be overcome/avoided by good procedures and cross checks, DELIBERATE contamination/adulteration is far harder to engineer out of a process.

Short of opening and testing every single pack that has been assembled (thus leaving nothing unopened to sell), deliberate contamination/ adulteration of this nature will always be hard to stop. Employee training and pre-employment screening is about all you can do to ensure staff can be trusted to behave in an acceptable manner, plus all the usual “pocket free” garment rules etc that make it so much harder to take unnecessary/unwanted articles into the packing/production areas etc.

The issue of widescale deliberate counterfeiting/adulteration of pharmaceuticals and their active components is a different issue, and a major concern, especially when API (active pharmaceutical ingredients) are sourced from countries where “less professional” business procedures are a part of the established culture. (No names, no pack-drill 😉 ). That said, I have visited production sites in parts of Asia that many consumers might feel are a quality risk that I would happily recommend to anyone… as with any business
/site, reputation and trustworthiness can only be assessed by building a relationship with the people involved. Indeed I have also visited a number of pharma-approved sites in Western Europe that I would never place business with, as although they have been auditted by EU Medicines agencies, I felt the “business culture” and mindset was all wrong. Anyone can show endless reams of “perfect” procedures and documentary evidence to an auditor – it’s getting under the operation’s skin, and understanding the mindset that really identifies the quality culture that operates on a day-to-day basis, that tells me whether a site/company meets our expectations.

Standing quietly by and watching an operation function often yields far more valuable info than an active “box ticking” audit……

I sum up my approach by saying that I believe quality must be “built in” at every stage of the operation rather than just bolted on afterwards (QA vs QC!). QC tests may often fail to identify a case of deliberate contamination (such as this appears to be), it is far better to have built/nurtured a quality culture into properly motivated and committed staff, thereby meaning deliberate contamination is far less likely to occur in the first place (hopefully!).

Regards
Paul F

I guess you could call it that if you wish

I guess you could call it that if you wish – original;)

I presume he’d be looking at his credit card bill.

Regards,

kev35

Jim, but you didn’t get it for 20 years

Jay, Where on earth did you get that name from, Ahh Just got it,;)
Jim.

Lincoln .7

Jim, but you didn’t get it for 20 years (your story not ours).:rolleyes:

It’s all better now obviously after those mail order pills arrived I guess, and you look down and say “I don’t believe it!”:)

Yo Jim and Michael, I get junk mail every day from those guys. 😡 What do they think I am? 😮

That include enhancement pills? :diablo:

Every day, I get several messages re purchasing Meds from, Companies mainly in Canada. I would never purchase any medications from the internet.
You never know what you may get.The same applies to vitamin tabs.
Jim.
Lincoln .7

Josephine is the name I suppose did not know your wife was French.:rolleyes:

Jay, Where on earth did you get that name from, Ahh Just got it,;)
Jim.

Lincoln .7

I shall be interested to see how much is actually revealed about the problem

I shall be interested to see how much is actually revealed about the problem and the actual causes.

Reckitt Benckiser shares will take a hammering if a whole lot of lax procedures come out of this and even if the MHRA don’t crucify them (unlikely) the FDA will start heavy machinery rolling to prevent a similar thing occurring in the USA.

Getting audited to FDA standards is one thing (been there got the tee shirt) but to be actually audited by the FDA is another ball park (would not wish to be there)

Josephine is the name I suppose did not know she was French

My wife has had a headache every night for 20yrs or more 😀
Jim.

Lincoln .7

Josephine is the name I suppose did not know your wife was French.:rolleyes:

Yes it’s sad as to what’s happening out there

There are a lot of counterfeit drugs down this end of the world (darkest Africa). The rest of the world dumps all their trash here.

Hi Ralph
Yes it’s sad as to what’s happening out there. There was a programme or two some months or maybe even a year back that told the emotional crusade by a woman spearheading the campaign in Africa to end the corrupt distribution of counterfeit medication (as opposed to legally produced Generic OTC ones).

The problem is proliferate in Asia too.

People make a lot of ‘dosh’ and innocents die or have complications from taking these counterfeit medication.

It is indeed a cruel world.

http://www.unodc.org/unodc/en/frontpage/2009/July/fake-medicines-pose-health-risk-in-west-africa.html

As stated in my opening post the warning was issued when the programme was screened that counterfeit medication could find it’s way into high street pharmacies (the small private ones) in the western world. Frightening I guess but possible.

My mom was hospitalized after taking a generic which was supposed to be the identical molecule. (this was in South Africa, I’m not sure of the UK regulations).

Agreed, Nuerofen and similar are a waste of money. The same drugs can be had from ASDA ect and are just as effective.

ASDA Ibuprofen (16 pack) – 28p
ASDA Paracetamol (16 pack) – 19p

At that price its well worth buying some so you have them if you ever needed them, and probably keeping some in the car in case you get a headache while you’re out 🙂

Can you buy codeine as an over the counter BP ?

Not codeine, but you can buy cocodamol (codeine + paracetamol), but only from a pharmacy. If you want codeine you’ll need a prescription. Cocodamol can be had from boots for £1.75 for 32 tablets.

There are a lot of counterfeit drugs down this end of the world (darkest Africa). The rest of the world dumps all their trash here.

Can you buy codeine as an over the counter BP ?

Always buy any OTC drug in its BP format. Aspirin, paracetemol, codeine etc – there is never any need to buy a branded version.

Yes. Has some added codeine (Also available as a generic).

Moggy

But neurofen plus is different from the stock neurofen.

when you say identical drug ???

Yes. Identical.

Take a look at the active ingredient list.

You will find nothing in Nurofen other than Ibuprofen.

Generic Ibuprofen can be bought for about 35p for 16 tablets anywhere.

Moggy