Investigating Patient Complaints About Combination Products

Q. My company got a complaint from a patient that their prefilled syringe failed to inject. We make the drug product and purchase the syringe. How do we investigate a problem with the commercial syringe component that we used?

A. The drug manufacturer is responsible in the end for whatever the product does, even if it’s made up of components where the manufacturer doesn’t really have a lot of control over.

The question is, how well have you assessed the quality of the product? Have you assessed the supplier of this syringe? Because it’s all too easy to say, “Oh, something is off the shelf.”

But just because a product has been used by many doesn’t mean it’s suitable for everyone.

If the complaint is coming from the patient and the patient is self-administering the product, did they get instructions from the physician before they got the medication? Is this human error on the part of the patient?

Even if the patient did something wrong. The manufacturer needs to take this into account and should create either patient instruction or a device that is suitable for everyone. Because you can’t just say, “Well, we only sell to those who are capable and who do it right all the time.” That would be wrong.

The device, when you look at the regulations, needs to be fit for purpose, and fit for purpose means if you have a patient population that is from young to old, from very able to handicapped, then you need to provide for all of those.

And one way to do this, to prepare for this at least, is to perform usability tests If these usability tests weren’t done with a wide enough population of potential patients, perhaps you need to go back to these tests and see if they were good enough. Did they really understand, or were these already people who were used to do such testing?

We need to be very careful with testing because we can only test a certain limited number of people. And what we have here is real-world evidence if you want, and that points to where we have a gap here.

Complaint numbers can go up and down. It’s very unpredictable. The key thing is you don’t just need to have a procedure to address complaints, but you should revisit your procedure in intervals to look at not just what the regulators are saying, but also how the business environment has changed.

Look at your communication and supply chain and check your quality agreement for its robustness and to see who is responsible for these types of complaints. Because, if you don’t spell out who is responsible in your supply agreement, there may be finger pointing. This is a shortcoming with a lot of quality agreements; they may not be granular enough.