Pharmacovigilance, what’s in a name

I read an interesting discussion about pharmacovigilance (PV) software a few weeks ago on one of the pharmacy listservs I belong to. The conversation struck me as odd because much of it sounded an awful lot like a discussion on clinical decision support (CDS). This led me to wonder whether or not PV and CDS are the same thing, completely different or subsets of one another. I am not familiar with the term PV myself, so I set out to gather some information. And here’s what I found.

The World Health Organization (WHO) defines PV as:

Pharmacovigilance is concerned with the detection, assessment and prevention of adverse reactions to drugs. Major aims of pharmacovigilance are:

1. Early detection of hitherto unknown adverse reactions and interactions

2. Detection of increases in frequency of (known) adverse reactions

3. Identification of risk factors and possible mechanisms underlying adverse reactions

4. Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

The ultimate goals of pharmacovigilance are:

• the rational and safe use of medical drugs
• the assessment and communication of the risks and benefits of drugs on the market
• educating and informing of patients.

Almost every mention of PV I found referred back to the WHO definition, so I will consider it my working definition for now. Based on the WHO definition it appears that PV focuses on surveillance of problems after the fact with emphasis on finding ways to prevent them from occurring in the future.

HIMMS defines CDS as “a clinical system, application or process that helps health professionals make clinical decisions to enhance patient care. Clinical knowledge of interest could range from simple facts and relationships to best practices for managing patients with specific disease states, new medical knowledge from clinical research and other types of information.” The HIMMS definition of CDS is very broad and could be used to describe almost any piece of hardware or software used in the healthcare industry. So based on this definition I suppose PV would be considered a sub-category of CDS.

Personally I have always considered CDS to consist of systems designed to present clinicians with important patient related information during the decision making process, hence the ‘DS’ in ‘CDS’. This would include clinical alerts, drug-drug interactions, real-time laboratory notification, disease-drug incompatibilities, etc. While these systems can act as standalone applications, I’ve found them to be more beneficial when used in conjunction with existing clinical systems, such as a pharmacy information system (PhIS) or computerized provider order entry system (CPOE).

Some third party vendors that provide CDS software include:

• Clinical XPert Clinical Workflow Solutions by Thomson Reuters. This solution is designed to “give clinicians real-time access to patient data to support clinical surveillance, patient rounding, medication reconciliation, and clinical care coordination.”
• MedMined Data Mining Surveillance Service by CareFusion. Because MedMined is a “tool for discovering clinically meaningful patterns in complex data sets” I suppose this makes it specifically a PV system under the CDS heading. Right?
• Dynamic PharmacoVigilance Module (DPV) by Vigilanz. I suppose there is no arguing that this system clearly falls into the PV category.  DPV “automates the monitoring of drug therapy and its effect on patient physiology, as well as the changes of patient physiology and the resultant impact on drug therapy. It identifies preventable adverse drug events in real-time and provides the clinician with actionable data and guidance.”
• TheraDoc by Hospira. There are several products under the TheraDoc umbrella.
• Sentri7 by Pharmacy OneSource. “Sentri7 is a software as a service (SaaS) web-based platform that pulls information in real-time from your disparate hospital information systems, stores, and analyzes it to assist you in making decisions. You can use preconfigured clinical rules or set up your own that notify healthcare personnel about intervention opportunities.”

To be truly effective I believe that any type of CDS tool must be available on any device independent of platform. It shouldn’t matter whether the device is a smartphone, tablet, netbook, laptop or full blown desktop computer. In addition, CDS tools must also be well integrated into any and all hospital systems to be beneficial to the end user.

Consider CDS a centralized database hub with the brains and logic to find potential outliers in your system and intervene before something bad happens.