Safety Reporting: What It Is and Why Is It Important
One of the more important aspects of working in pharmaceuticals is ensuring the products are safe for human use. This means the proper filing of safety reports with the relevant Health Authorities around the world, where your drug is approved for Clinical Studies, or Marketing.
Safety Reports come in a variety types, and it is up to a good Pharmacovigilance departments to know the difference. The most critical thing with all of the various types, and we will look at those shortly, is that no matter which type of report you get, your reporting system cannot have a single-point of failure.
So what are the types of reports you can get? In general, they are Physician reported, Patient reported, Emergent events, and anecdotal.
Physician reported are the ones you *generally* get during a clinical trial. These are the ones that come to you from a physician and are generally complete in the information they provide. They also sometimes contain assessments of the causality of the issue in relation to a study drug or procedure, but not always.
Patient reported are those which are called in by the patient themselves. These are not always as analytical as those reported by the physician, but are usually well completed in general, depending on the system set up by the company to collect this information. There will not be any causality evaluation here, aside from the patients own interpretations. This could be something similar to "I didn't have a headache before taking your product and now I do." There is no good way to be able to actually define causality here, as this kind of evidence is so difficult to judge.
Emergent reported events are those reported as a result of a patient going into the hospital. These could be in a few different situations, including, but not limited to, patients in clinical trials, and patients who come in on their own. Very often, these reports result in multiple follow-ups as the initial report is just a simple one that indicates the patients hospitalization status, and that they were on your drug.
Anecdotal reports are always the hardest and the most controversial. These also, often have the least follow-up, and are the least likely to impact labeling of your product. You are at a neighborhood picnic, and a neighbor learns that you work for a pharma company. They approach you, and they say something like this, "My sister's third cousin twice removed took your product and it just gave her the worst diarrhea." As a good company employee, you try to get as much information as possible, but all you manage to get is her first name. So now all you have is that a female patient named Lucy took your companies product and had diarrhea while on it. It is your job to report this to your company, but the likelihood of getting any additional information is very slim.
These are the four main types and ways which safety reports reach pharma companies. It is vitally important that companies follow-up on these to the best of their abilities as they can have an effect on not only how the drug is administered, but any specific changes to labeling as well. Being safety conscious is the role of everyone in a pharma company, not just the Pharmacovigalence or Drug Safety departments.
