The Formulation Unit has a “Monday Morning Meeting”. A few of us decide on what jobs have to be done, and then we have a ‘group hug’ so we all know what’s going on. (It’s not really a hug, but we do squeeze nearly 20 folks into a very small room!). The benediction is usually given by Rev-Gav, and takes the form of some project update (‘The Notices’) or a witty anecdote (‘The Children’s Address’)! But this week it was a cautionary tale of some hapless organisation that has strayed from the narrow path of Good Manufacturing Practice!
So what? Why blog? Well because scratch the surface of this story and there are some important issues that are worth thinking about.
What’s the news?
The news is that the UK’s pharmaceutical regulators, the Medicines and Healthcare Products Regulatory Agency (MHRA) has instructed a drug manufacturer to recall some of its pharmaceutical products because they weren’t manufactured to an acceptable quality standard. The BBC covered the story, and a similar recall for the same company in July. Recalls happen from time to time, ‘no biggy’. The really interesting part was one paragraph in the MHRAs press press release.
“Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK. This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine.”
But before we dive into this, a bit of background information on quality might be useful.
“We put the ‘K’ In Kwality”
Or so went the caption on a cartoon that circulated via email a few years ago!
Quality Assurance is a much part of the pharmaceutical industry as science and money: it can’t operate without it. One of the key mantras of Quality Assurance is that quality has to be built into a product. Once a product is made it’s quality is fixed, you can test it, but that testing can never change the quality. Think of cars: they work when they leave the showroom (the test), but ‘quality’ shows only after several thousand miles!
50 years ago when most cars bought in the UK were made in the UK, customers would sometimes end up with “Friday Cars”. A Friday Car was one which constantly had mechanical problems (ie was of low quality) and it was blamed on the production line workers thinking more about the weekend ahead than putting the engine together properly. If your manufacturing ‘quality systems’ are compromised, so is your product (or at least its down to luck if the product any good!).
Have the MHRA made the right call?
I think so, yes. They have decided that the risk to UK patients of not getting their drugs due to supply problems outweighs the risks that the patients might be harmed by the drugs being made without the proper ‘checks and cross checks’. They have done their job and protected patients (albeit there’s a bit of the ‘lesser-of-two-evils’ about it). But…
It’s behind the lines!
What could this mean for the future? This company supplies such a large slice of the UK market for certain drugs that, even although they aren’t made to the required quality standards, the company are being allowed to continue to sell (and presumably make a profit on) them.
It’s tricky to know the exact issues at play on this particular case, so let’s look bigger picture.
In a world where medical care budgets are being squeezed and health managers are looking to reduce drug costs, they are naturally going to buy cheaper medicines. But quality costs (especially when it’s a quality standard like Good Manufacturing Practice!), so at some point someone, somewhere, will start cutting costs by cutting corners.
So if Company X cuts corners, so cuts cost, so cuts prices and so can cut themselves a majority slice of the market, what the MHRA press release points to is that when they get caught they will be allowed to continue to sell their products because to ‘remove them from the market’ will adversely affect patients. Traditionally the pharmaceutical industry believed that if a company failed to manufacture to the right quality standard they lost the right to sell their drug products – end of story: this seems to have now changed.
It doesn’t sound like the company, who can still sell their product. In this case I don’t think it’s the patients. But long-term I think it’ll be the public, pharmacy and pharmaceutical production. In pharmaceutical circles we talk about Quality, Quality Assurance, Quality Management and Quality be Design all the time, but when the driver stops being quality and starts being cost it’ll just become a race to the bottom. We need to make sure that we are well and truly on the blue flow chart, not the red one!
Somehow, we (and by that I mean the industry, regulators and health care managers) need to try to raise the bar again, and make sure we drive quality upwards, not just cost downward. Are we going to get to a point where the public start talking about “Friday Capsules”?
Horse burger anyone?
If this all sounds familiar, then you might be remembering last year’s horsemeat scandal. The blame for that failure in quality was put down to cost drivers and bulk buying consumers. I think it’s naive for the public to drive down costs via competitive tendering and thinking “It’ll all be OK” regardless of how cheap it is. The MHRA have found themselves on the horns of a dilemma (hopefully the horns are made of keratin with a TSE-free certificate!), but it’s the cost-cutting procurement processes and squeezed health care budgets that have provided the bull!
1) Company X is not intended to represent any parties associated with this recall. Neither do I have any inside information about the product recall: only what comes from the MHRA press release. This piece concerns the change of drivers from quality to cost and its long-term implications.
2) The background capsule image on the covershot was taken by Graeme Fleming (Strathclyde University Photographer).