Patients need to know that the medications they’re taking are safe. This is why before medications are marketed and prescribed, trained clinical researchers run trials to determine their efficacy, as well as any adverse effects patients might experience while taking them.
But the process of protecting patients’ safety doesn’t end there. Even well-run trials can sometimes miss adverse effects or underestimate their impact. Sample sizes can be limited. They could fail to reproduce real-world conditions. Subjects might even be averse to reporting adverse effects for fear of being pulled out of a trial. For these reasons, it’s important to continue monitoring possible adverse drug effects (ADRs) even after a drug has been released to the market. This practice of continued monitoring is what’s known as pharmacovigilance.
When this monitoring began, it was strictly up to doctors and dentists to provide these ADR reports to pharmacovigilance centres. This was later spread to other healthcare professionals and pharmacists, and eventually, in some countries, to patients themselves. Direct patient reporting has made it possible for patients to report their issues without a medical intermediary, and it’s a practice that’s raised some concerns, but shown many significant benefits to clinical researchers and pharmacovigilance professionals.
Why Direct Patient Reporting Is Beneficial
Students in clinical research training might be surprised to learn that under-reporting of ADRs by doctors and other healthcare professionals is sometimes an issue. Allowing patients to report directly to pharmacovigilance centres, such as the Canada Vigilance Program, can therefore greatly increase the number of reports received, and provide a lot of useful information that might otherwise go unreported.
There are also some issues that patients might be embarrassed or otherwise reluctant to discuss with their doctor. Allowing patients to report these issues directly, particularly through an online form, can greatly increase their likelihood of being reported.
By circumventing doctors and healthcare professionals, direct reporting also allows a pharmacovigilance centre to collect ADRs relating to over-the-counter medications, natural health products, and counterfeit medications, all of which might otherwise go unreported.
Students in Clinical Research Training Should Be Aware of the Concerns Raised
Despite the clear benefits of direct personal reporting, some concerns have also been raised that students in pharma courses should be aware of. It’s been suggested, for example, that consumers may lack the knowledge and skills necessary to properly report their own symptoms, and may accidentally misattribute unrelated symptoms to a particular medication. As long as certain minimum requirements are met when reporting, however, this doesn’t present a significant concern, particularly when direct patient reports are still being supplemented by reports from trained doctors and health care professionals.
Another risk is the possibility that self-reporting by patients could increase the level of noise in the data and make it harder to pick out serious patterns. But likewise, having both patients’ and doctors’ reports seems to limit this risk.
Direct Reporting Can Illuminate How ADRs Affect a Patient’s Quality of Life
Direct patient reporting has other more general benefits as well. By including patients’ own reports of their ADRs, pharmacovigilance centres can better gauge the impact of a given effect on patients’ quality of life. What medical professionals deem tolerable adverse effects may not seem as tolerable to the patients themselves, so being able to understand the effect of a given ADR through a patients’ firsthand account represents an invaluable opportunity for those who work to protect and inform consumers seeking to make wise choices about their medications.
Are you interested in a career in clinical research?
Contact AAPS for more information about our pharmacovigilance course.