One in seven of us will suffer an adverse reaction at some point according to the authors of a study who suggest that electronic patient records can be used to identify the root causes of such problems – including those linked to formulation – and help find solutions.
Lead author Michael Rieder from the University of Western Ontario told us: “The re-purposing of existing drugs and the development of dosing and monitoring guidelines for already existing drugs is an area where e-medical records have tremendous potential.”
In addition to greater use of electronic medical data, Rieder and his co-authors advocate the use of informatic analysis to try and determine the sometimes complex links between adverse events and drug components.
“It is in fact sometimes quite difficult to identify whether a problem was caused by a drug or an ingredient in a drug. The first step is a careful causality analysis which in the past has been done by intuition and experience.
“Fortunately there are a number of new tools being developed to provide clinicians with better approaches for the diagnosis of adverse drug reactions” he continued, citing drug excipient research being conducted at the University of Liverpool as an examples.
“The issue of an excipient causing an adverse event is an important one, notably for drugs used in children, and points to the need for a close collaboration between clinicians and drug information sources such as clinical pharmacists as well as being able to address issues with drug regulatory authorities.”
Access to patient data is a contentious issue. In April, a UK Department of Health (DoH) study revealed that most British people want greater control over their own medical and genetic information.
Similarly, patient privacy is one of the most contentious aspects of the ongoing debate about clinical trial result publication. The drug industry has suggested making data public threatens patient privacy, although opponents have repeatedly rejected such concerns.
Rieder acknowledged that, in the currant climate, formulators who use of electronic records must take patient privacy into consideration, telling us “Clearly any research needs to be conducted to the highest ethical standards but also needs to use data protection protocols such as unlinking personal data from clinical records and the need for high level encryption.
“This includes the need to encrypt devices such as portable hard drives or laptops which are more and more commonly used in clinical research. Researchers in this area need to work closely with IT specialists to ensure that no linkages can be made that are not consented for and that data security is of the highest quality.”
Source: British Journal of Clinical Pharmacology
Review title: Adverse drug reactions
Authors Michael Rieder and Albert Ferro