‘Pharmacovigilance’ is in relation to the potential for inherent biases in healthcare algorithms and their deployment.
Also known as drug safety, it relates to the ‘collection, detection, assessment, monitoring, and prevention’ of adverse effects of pharmaceutical products.
For obvious reasons it’s important for clinicians to know how the drugs they prescribe to patients will interact with other medications they’re already on.
The wrong combination could reduce the effectiveness of the medication or increase the risk of side effects. It’s the reason why the process is heavily vetted and certified.
I’ve been a doctor since 1999 and a GP since 2008. When I prescribe medication to a patient there are systems – called clinical decision support – that will check which medications the patient currently has and their general health
This could for example, highlight that a particular patient has a poor kidney function or asthma condition and which medications are unsuitable. Last but not least it will look at whether a patient has an allergy to a particular drug.
In each of these circumstances the system will alert me as to whether it’s safe to prescribe a particular medication to avoid any harm being done.
The clinician has the ultimate decision to override and prescribe or accept the alert and not prescribe or suggest an alternative.
This process saves time and prevents harm. It’s a good example of how technology has made prescribing safer and more efficient.
The system is a brilliant example of how clinical technology solutions can be implemented.
Another word that is less well known but has huge implications for artificial intelligence (AI)-driven healthcare is ‘algorithmovigilance’.
The term was coined by the then CEO and President of the US-based Regenstrief Institute – Dr Peter Embi – about the potential for inherent biases in healthcare algorithms and their deployment.
“We wouldn’t think of treating patients with a new pharmaceutical or device without first ensuring its efficacy and safety,” Dr Embí said. “In the same way, we must recognise that algorithms have the potential for both great benefit and harm and, therefore, require study.”
Dr Embi made the case for creating a surveillance system for algorithms on the same lines as pharmacovigilance.
The principle behind ‘pharmacovigilance’ and ‘algorithmovigilance’ is the same: Do not harm the patient.
What it is does do is highlight the absolute importance of the role of the Clinical Safety Officer (CSO) among clinicians and commissioners as the CSO has to oversee the clinical risk assessment of a health IT product.
Removing any inherent biases in healthcare algorithms is critical, which is why ‘algorithmovigilance’ is so important.