While at HIMSS12 in Las Vegas last month I was asked to do a little review work. That’s not all that uncommon. People ask me to do things on occasion; review a blog post, review an app, give my opinion on something and so on. But this was completely different as Dr. Heather Leslie (@omowizzrd), Director of Clinical Modeling for Ocean Informatics and Editor for the openEHR Clinical Knowledge Manager asked me to review an archetype. A what? Yeah, that was my response when Heather and I first spoke about the topic nearly two years ago.

According to good ol’ Merriam-Webster an archetype is “the original pattern or model of which all things of the same type are representations or copies: also : a perfect example“. Simple enough, but still too vague for my brain so I went in search of a better explanation which I found at Heather’s blog – Archetypical.

According to the Archetypical site ”openEHR archetypes are computable definitions created by the clinical domain experts for each single discrete clinical concept – a maximal (rather than minimum) data-set designed for all use-cases and all stakeholders. For example, one archetype can describe all data, methods and situations required to capture a blood sugar measurement from a glucometer at home, during a clinical consultation, or when having a glucose tolerance test or challenge at the laboratory. Other archetypes enable us to record the details about a diagnosis or to order a medication. Each archetype is built to a ‘design once, re-use over and over again’ principle and, most important, the archetype outputs are structured and fully computable representations of the health information. They can be linked to clinical terminologies such as SNOMED-CT, allowing clinicians to document the health information unambiguously to support direct patient care. The maximal data-set notion underpinning archetypes ensures that data conforming to an archetype can be re-used in all related use-cases – from direct provision of clinical care through to a range of secondary uses.” That gave me a better understanding of what they were trying to do.

Anyway, when Heather asked me to review the Adverse Reaction archetype I was a little hesitant. The projects I’m asked to be involved with are typically much smaller in scale. This was something different and I felt a little intimidated. My gut reaction was to politely decline, but when someone asks you to do something face to face it makes excusing yourself for some lame reason a lot harder. So I agreed with more than a bit of trepidation.

The openEHR project utilizes a system called the Clinical Knowledge Manager (CKM). In the most basic terms, the CKM is an online content management system for all the archetypes being designed by the openEHR project, and it’s impressive. A more in depth description can be found  here.

Logging into the system was simple. The email invitation I received to review the Adverse Reaction Archetype contained a link that took me to the exact location I was supposed to be. From there things got a bit more complicated. The CKM is easy enough to navigate, but the amount of information and navigational elements within the system is staggering. It took me a while to figure out exactly what I was supposed to do. Once I figured it out I was able to quickly go through the archetype, read what other comments people had made and make a couple of minor notes myself. One thing I could never completely figure out was how to save my work in the middle and continue later. Sounds simple enough, but for whatever reason it just wasn’t obvious to me. I ended up powering through my “review” in one extended session because I was afraid I’d lose my place.

The archetype itself was impressive. It’s clear from the information and detail that people have spent a lot of time and effort developing the adverse reaction archetype. There’s no question that a lot of great minds had been involved in this work. The definition made sense as did the data that was being collected and presented. The archetype offered flexibility for information gathering that included the simplest form of adverse reaction to complex re-exposure and absolute contraindication notation (this is sorely missing in many systems I’ve used over my career). Overall I had little insight to offer during the review, only a couple of minor comments.

I’d say the entire process was pretty straightforward with some minor complications. Like everything else I’m sure the process would get easier over time and multiple uses.

ABSTRACT

Background: Adverse drug reactions (ADRs) are an important source of morbidity and mortality during medical care.
Objective: To examine the trends in mortality related to ADRs reported through the US vital statistics system since January 1999.
Methods: Demographic characteristics of people reported as dying as a result of ADRs from 1999 to 2006 were evaluated. The National Mortality Statistics database was queried for International Classification of Diseases, Tenth Revision, codes Y40-Y59, which are specific for deaths due to adverse effects of drugs in therapeutic use. The data were subgrouped based on demographic factors to identify important trends. Crude rates were calculated based on incidents per 100,000 population. Odds ratios and 95% confidence intervals for subgroups were calculated by logistical regression.
Results: During the 8-year study period 2,313,902,748 person years were evaluated and 2341 ADR-related deaths were identified. Annual rates ranged from 0.08/100,000 to 0.12/100,000, and rates increased significantly over time at a rate of 0.0058 per year. ADR deaths were significantly more likely in persons older than 55 years. The risk was greatest in those aged 75 years or older (OR 6.96, 95% CI 6.30 to 7.69). ADR deaths were higher among men than women. Rates varied by race and ethnicity and were highest among blacks (OR 1.38, 95% CI 1.23 to 1.54). Geographically, rates varied widely between states. Based on urbanization, rates were highest in extremely rural (non-core) areas (OR 2.05, 95% CI 1.76 to 2.38). The most common drug classes associated with death were anticoagulants, opioids, and immunosuppressants.
CONCLUSIONS: ADR death rates have a clear association with age, race, and urbanization subgroups. Older individuals, males, blacks, and individuals residing in extremely rural areas experienced higher ADR death rates; these findings warrant further study to develop prevention strategies.

1. Ann Pharmacother February 2012 vol. 46 no. 2 169-175

While there are several definitions of an EMR, the basic components consist of clinical documentation (physician notes, history and physical, care giver notes, discharge summary), laboratory data, patient demographics, prior encounters, pharmacy, radiology results, etc. More advanced ideas of an EMR may include computerized provider order entry (CPOE) and bedside-barcode-scanning. Like all technology, an EMR is designed as a tool to help not only physicians, but all healthcare workers involved in the care of a hospitalized patient.

While it is true that a computer cannot take the place of a physician’s mind, it can certainly help correct a poor decision making process. Examples where an EMR may be useful include illegible physician writing or the continuous battle of prescribing medications for patients with allergies to a like or similar medication. The popular cephalosporin cross reactivity with penicillins is one example.  As a pharmacist, I know the chances of a dangerous cross reaction are unlikely, especially if the penicillin allergy is mild. Unfortunately I am forced to call on every single occurrence for clarification, regardless of my opinion. A notation on the order from the physician acknowledging the allergy and their desire to continue with therapy would prevent my phone call and save valuable time.  Asking a physician to note this by hand on a paper order form is a lost cause. Believe me, I’ve been asking for 12 years with little to no affect. A CPOE system could be programmed to prompt the physician to note the allergy on the order prior to submitting it. Voilà, no phone call from the pharmacy.

How about the order I received a few years ago for gentamicin and tobramycin to both be given to a patient simultaneously. The physician requested dosing “per pharmacy for therapeutic levels of both.” Huh? Only if you want possible renal failure or permanent deafness. The physician indicated that the infection was sensitive to both agents and wanted to “double cover”. After a lengthy discussion I convinced him to use one aminoglycoside combined with a different agent.

Another common scenario is the inclusion of several different pain medications existing together on a patient’s active medication profile. A surgery patient will frequently have orders from the anesthesiologist, the surgeon and the attending physician. With all those hands in the cookie jar the patients profile frequently looks like you were trying to include something from every drug class. Don’t laugh, this is serious business. I can’t imagine the nurse trying to make heads or tails out of orders like these. The solution lies in a system that gently nudges the provider to acknowledge the patient’s current medication regimen and allows for changes on the fly.

A few years back, I was involved in a case where the wrong dose of tacrolimus was accidentally recorded in the patient’s discharge summary. The result was a ten fold overdose to the patient that led to drug induced pancreatitis and renal failure. The mistake resulted in a six month hospital stay including a four week stint in the Intensive Care Unit where we didn’t think the patient was going to make it. This could have been prevented with an electronic medication reconciliation system.

Yet another example where technology could have intervened, occurred when a patient reported dizziness and fainting following discharge from the hospital. An inspection of her medication list reveled that she had been given a discharge prescription for methyldopa, a medication that she had never taken before. No one could explain how the methyldopa ended up on her discharge medication list, but it was filled and taken nonetheless. Fortunately, the medication was discontinued and the patient resumed her normal daily activities without permanent harm.

The list of examples could go on and on, but you get the point. Consider that this is only the point of view from a pharmacist. Now imagine the problem growing as you add several other services involved during a hospital stay (lab, nursing, respiratory therapy, admitting, etc).

An EMR is not only about making information available to the caregiver, but also about helping prevent errors. I encourage people to think of an EMR as a tool to be used for increased efficiency in your practice. I for one look forward to the integration of systems that will provide me with a complete EMR. Anything that makes my job easier and allows me to focus on more important issues surrounding patient care will be a welcome addition.