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.

Here’s some stuff on CPOE and CDS in the third edition of ACI that caught my eye:

• Comparing the Effectiveness of Computerized Adverse Drug Event Monitoring Systems to Enhance Clinical Decision Support for Hospitalized Patients
• Best Practices in Clinical Decision Support (The Case of Preventive Care Reminders)
• Decision Support Alerts for Medication Ordering in a Computerized Provider Order Entry (CPOE) System (A systematic approach to decrease alerts)

The Waltham, Mass.-based IntrinsiQ’s IntelliDose calculates and tracks the administration of chemotherapy treatments and will enable Allscripts’ multi-specialty and oncology clients to manage oncology patient care workflow, according to the company.

Under the agreement, oncology practices will work with Allscripts account managers to coordinate with implementation and training specialists from the IntelliDose team. Integration of IntelliDose into Allscripts tools will enable Allscripts clients to select the add-on program to navigate patient records across both systems, IntrinsiQ stated. “

This sounds like an interesting concept. I tried looking for detailed information on IntelliDose, but really couldn’t find much. Based on information at the IntrinsiQ website it appears that IntelliDose is a clinical decision support system designed specifically for chemotherapy. Based on the description, IntelliDose does many of the same things that a pharmacy information system does, i.e. checks for “body surface area limitations, patient allergies, and exceptional lab results” in addition to reviewing “dosage variables such as ideal weight, serum creatinine, and creatinine clearance.” Sounds like a pharmacist.

- What’s that? Oh, Avatar is still #1 at the box office. It’s now #2 on the list of top grossing movies of all time with its crosshairs squarely set on #1.

- KevinMD: “But when this health-care reform package passes, and if it does to the economy and to medical practice what many of us fear, will anyone be accountable? Will they step up and say, ‘yep, that was me! Sorry, I’ll try to fix it!’ It’s unlikely. That’s not how politics are conducted.” – Scary thought

- The Apple iPad was announced this week. It’s basically a giant iPod Touch. It isn’t available for purchase yet, but is already creating quite a buzz in heath care. Every card carrying clinician is claiming the iPad is going to revolutionize how they practice health care. I’m looking forward to getting my hands on one and spending some quality time figuring out how best to use it, but I’m a little gun shy about making claims like that.

- You can find positive blog posts on the iPad everywhere, so here a couple of negatives to help balance it out: interesting view from a 16-year old boy and another from VentureBeat and one final one from GottaBeMobile.

- Hitler responds to the iPad. I find these “Hitler” videos very funny. Be warned, however, they contain some offensive language.

- Here’s a tablet PC survey aimed at health care spurred on by the arrival of the iPad.

- Healthcare IT Consultant Blog: “Medical records for about 4,400 UCSF patients are at risk after thieves stole a laptop from a medical school employee in November, UCSF officials said Wednesday. The laptop … stolen on or about Nov. 30 … was found in Southern California on Jan. 8. There is no indication that unauthorized access to the files or the laptop actually took place, UCSF officials said, but patients’ names, medical record numbers, ages and clinical information were potentially exposed.” – This is why you never, ever store patient information on any type of physical media be it hard drive, CD, flash drive, etc. This is also why storage of patient information on the cloud should be considered.

- This is funny.

- Pharmcotherapy : “The genetic study of disease states can be the stepping stones for thoroughly understanding the genetic basis of ADEs. Gene polymorphisms are implicated in the development of diseases and corresponding disease-like ADEs.” – Pharmacogenetics, the study of genetic variation on the effects of drug, has been around for several years now, but has never really taken hold like many thought it would. The idea behind genetic testing to determine how you will respond to medications makes sense, but I don’t see it in practice. I wonder why?

- The Palmdoc Chronicles: “VisualDx Mobile for the iPhone and iPod Touch aids physicians in their decision making efforts by increasing diagnostic accuracy, helping to reduce health care costs associated with unnecessary return visits, referrals, and tests– all of which increase patient satisfaction.” – Clinical decision support for the iPhone/iPod touch.

Endgadget: “Researchers aim to give surgeons 3D maps, directions of human body – the group’s TLEMsafe system does provide surgeons with a complete 3D map of the lower body, which can actually be personalized for each individual patient, giving surgeons a reference and means to practice before any actual surgery takes place — and, yes, even an “automated navigation system” during surgery.” – Pretty cool stuff.

- LiveScience: “Researchers have built a new super-small “nanodragster” that improves on prior nanocar designs and could speed up efforts to craft molecular machines.” – This is amazing, The nanodragster is built using a combination of phyenylene-ethynylene molecules for the chassis and buckyball wheels. Cool!

- medGadget: “To see if clinical measurements can be performed using a cheaper solution, researchers at University of Melbourne tested Nintendo’s Wii Balance Board (WBB) against a laboratory-grade force platform (FP), and concluded that the cheaper option can provide results “suitable for the clinical setting” – So having a Wii is totally worth it, right?

- ASHP: “Health care facilities can expect the Environmental Protection Agency (EPA) by October to release a set of best practices for managing excess, expired, and unwanted pharmaceuticals.” – What to do with these medications has always been an issue.

- LA Times: “Unfortunately, even great stories have their endings, and the chapter on Warner’s NFL career closed today when the 38-year-old quarterback announced his retirement.” – I’m disappointed for my team, but happy for Warner. The man is a class act and a lock for the Hall of Fame. Check out his stats sometime. They are impressive. Kurt Warner is one of the few professional football players that I would like to meet in person. Perhaps I’ll get the opportunity some day. Good luck Kurt.

- I went 1-1 last weekend, bringing my playoff record to 7-3. The Vikings game was one of those rare moments in the NFL where the better team lost. Even with all the Vikings turnovers and bad penalty calls, they were only one play away from a trip to Miami for the Super Bowl. I was really hoping the Vikings could pull it off, but it wasn’t meant to be. My hat goes off to the Saints for hanging staying in the game. Now I hope Favre retires and enjoys being one of the greatest quarterbacks to have ever played the game.

- I’ll give you my Super Bowl pick next week.

Have a great weekend everyone.

From the article:

Clinical surveillance tools are atype of clinical decision support system (CDSS), providing pharmacists with patient information that has been filtered according to predefined criteria and is presented at appropriate times to enhance patient care. These tools pull data from 3 sources—admission/discharge/transfer (ADT), laboratory, and pharmacy—and use clinical rules to analyze the data and alert the user of instances that meet the rules’criteria. Though there is some variability in methods across the different vendors’ products, these Webbased applications enerally function by interfacing (HL7) with the hospital’s information systems to securely pull the data to the vendor’s server where the data are analyzed against a set of clinical rules. Some vendors allow the client to build their own rules, some provide a foundational set of rules, and others do not allow user-defined rules. This is an important distinction to make when evaluating the different applications.

For more information try visiting John’s Evernote repository for Clinical Decision Support.