The meaningful use standards put in place by CMS and ONC in July have everyone talking about what they need to do to get certified -- and what additional criteria might be coming in Stage 2. But an equally important question is: What's been left out? Asking (and answering!) that question is how EHR vendors can build systems that stand out in the marketplace and deliver benefits that aren't being provided by a hundred other systems.
Dosage precautions: My vote for the most important missing piece
As far as clinical decisions support goes, meaningful use requirements are surprisingly paltry. Even an important topic like medicine interactions only gets briefly covered in two areas: drug-drug interactions and drug-allergy interactions. (The missing pieces of this complex topic could be fodder for a whole other blog post!)
But dosage precautions are just as important as medicine interactions. We've heard a lot this year about how Dennis Quaid's infant twins ended up in a fight for the lives after being given a dose of the blood thinner heparin that was 1,000 times what should have been administered. Other children have died from similar mistakes. And yet, nothing in Stage 1 of meaningful use addresses this. But it's clear: dose administration and dose calculation -- especially as regards dosing in pediatrics -- are just as important to patient safety as drug interactions.
Patients, doctors, and pharmacists don't decide what's important based on certification guidelines
Fortunately, the absence of dosage precautions in the meaningful use final rule doesn't mean that the healthcare industry is ignoring this. Clinical guidelines in hospitals and practices govern dose calculation and dose administration on some level -- but mistakes sometimes still happen. There is definitely an appetite among healthcare professionals (and an increasing number of patients!) for better tools to help with this.
Better dose calculators are one way to respond to this need. Another way is alerts based on dosage range checking, or even more sophisticated systems that control dose administration with barcodes. But to drive any of these functions -- especially in pediatric dosage calculations -- your underlying data needs to be much more detailed and rigorous than what is usually available. FDA guidelines and prescribing information especially are inadequate because there are many circumstances they don't address.
Lexicomp has led the market in dose range checking for decades
Luckily, Lexicomp has exactly the data needed to make sophisticated dosage calculators and alerts a reality. Their decades of experience makes them the overwhelming choice of pediatrics hospitals across the U.S. Their data goes far beyond prescribing information published by drug companies, and draws from the expert consensus of the best hospitals in the nation, as well as a rigorous review of published studies on the topic.
Quoting a colleague of mine: "A recent article by HealthData Management summarizes that, 'The new law mandates use of electronic prescribing by Jan. 1, 2011. Prescribers and dispensers must use either the Health Level Seven messaging standards or the National Council for Prescription Drug Programs’ SCRIPT standard to transmit prescriptions and prescription-related information. The law does not mandate use of electronic health records. But to ensure EHR systems are interoperable, they must be CCHIT-certified. Further, the EHRs must meet the e-prescribing provisions of the law.'"
Looks like ePrescribing will become a widespread reality within 2 years. There will likely be some business opportunities for some small companies to fill in the gap between ePrescribing as part of robust EMR systems and those that just need a tool to facilitate ePrescribing, without integration into their system.
As more companies look for opportunity in the business "seams," they will need to work with a drug database company to close the loop. And if they want to do it quickly and work with a vendor who serves as a partner, and not just a supplier, more and more are turning to Lexicomp.
Not only will Lexicomp provide all the basic drug data information such as: drug interactions; drug-allergy interactions, therapeutic dosages, drug classifications, dosage administration, pediatric drug information, and more; but Lexicomp will also provide the service and support to allow the vendor to move quickly. With this quickly changing marketplace, working with a drug interaction software company to facilitate the product launch is imperative. If you are looking for a stand alone online ePrescribing application, I would strongly suggest taking a look at DoseSpot. They have a great product.
More and more EMRs are scrambling around to secure drug data to include their product. Some of the EMR vendors are looking to do this after they have received certification and some are doing this as part of their certification process. One area that they might be overlooking involves the APIs (and the concomitant support provided) that the drug data vendor provides. Many EMR developers decide they want to do this in-house. Some decide they want to do this to save money, while others decide to do this because their IT staff wants to own the entire process. But there is a problem with this. Even if they are IT experts, they are not experts in the management of this drug data.
Whether their EMR product includes drug-drug or drug-allergy interactions, pediatric dosing charts, medication or generic brand names, therapeutic dosages drug classifications, medicine lists, dosage administration, duplicate therapy, clinical guidelines, or more; the EMR vendor does usually have the internal experience and expertise to manage this information.
You are better off working with your vendor, whether it be Lexi-Comp, DoseSpot, or Cerner/Multum and relying on the APIs they offer. It will be faster, less error-prone, eat up fewer resources and keep more folks in the organization happy.
What will hospital information and practice management systems look like in 2014? Will it be a radical shift, "encouraged" by government requirements? Or will the government have to retrench a bit from their demands because of the difficulties - both financial and developmental - that smaller hospitals will encounter? Hard to say, but there is a great deal at stake - including money, disruption, lost time, turning off patients etc.
EMR and EHR developers, hospitals and group practices have a lot on their plates. One area that tends to be an afterthought is the integration of drug information into the various systems. Many of these systems need drug data to generate medicine interactions, dose administration, pediatric dose calculations, therapeutic dosages, drug classifications and drug lists. There are only few providers of this information. The key is to select the provider who will provide the greatest support in integrating this data into your system. One that will help from assisting in clinical guidelines to eprescribing to drug nomenclature.
To convert raw data into a system that will like a drug interaction database for clinical decision support, means you need to look beyond just the data. You need to discern who will be the easiest vendor to work with and will hand hold if necessary. Sometimes going with the biggest provider is the best, other times, when customer support is critical to a successful implementation, it is best look to look long term.
One challenge in arriving at the therapeutic dosage for a medication is the need to adjust to levels of organ function. Automated dosage checking converts a string of inputs such as amount, unit, frequency, etc. which can be compared to defined ranges which are based on age, weight, and other parameters. In the absence of specific information (such as creatinine clearance) the system generally defaults to a range which corresponds to normal organ function. Although a pediatric dosage calculator or pediatric dosage chart may be used in the original dose estimation, organ function cannot be assumed to be normal. Automated checking prior to dose administration should prompt the user to evaluate these factors. Ideally, pediatric dose calculations are modified by indicators of organ function. Hepatic function, in particular, is difficult to estimate objectively. Synthetic activity, detoxification, and genetic factors are important parameters to evaluate. Dosage precautions which are embedded into EMR applications (dose range checking, dosing advice) facilitate the appropriate adjustment of dose based on these parameters. Periodic review of medicine lists may permit the identification of therapies which were initiated at unadjusted dosages. Medicine interactions may also be reviewed in light of changes in organ function changes to ensure medication safety.
Well, the term, "Meaningful Use" certainly has become a mantra in the healthcare information community in the last six months. Just check out the last few blog postings by my colleagues on
blog.lexi.com and you'll see what I mean. It's a mad scramble, especially among medium to smaller hospitals. It's like a scrum in rugby. Groups of people moving in tandem together trying to move the ball forward, with some of them coming out bloody and scratched.
A few of the Meaningful Use areas that don't have to be that difficult to implement deal with drug databases for clinical information systems and various ePrescribing systems. Much work has already been done in the ePrescribing arena. Why reinvent the wheel? For example, companies like DoseSpot have developed flexible and customer friendly packages. ePrescribing is a major component of Meaningful Use so make sure you pick the right vendor.
Integrating drug information databases are a bit more complicated and take more time, but don't make it any more complicated than you need. There are only three or four well-known vendors who can provide the necessary information, with Lexi-Comp and Cerner/Multum providing strong options. You want to look for a vendor that is easy to work with, has easy-to-use APIs, is cooperative in developing interoperability structures, and who provides great value.
All of the vendors should have basic information like dose administration, drug nomenclature, pediatric dose calculations, medication brand names, drug classifications, drug interaction databases, therapeutic dosages, and more. But the providers are not all the same in their service, ease of integration, and likelihood for ultimate success.
As with renal impairment, all pharmacokinetic processes may be affected by hepatic disease and must be considered in dosage administration. Unfortunately there is not a dosing calculator which can encompass these elements, and individualized assessment is needed. The primary process affected by hepatic impairment is the metabolism of drugs. This can affect bioavailability (increases) and systemic clearance/removal of drug (decreases) from the circulation. Both of these effects lead to increased concentrations in the body. As with renal impairment, the potential accumulation of drugs and an increase in adverse effects/toxicity which may occur is the primary concern. Specific dosage precautions must be considered.
It is important to evaluate the degree of liver impairment. Just like in renal impairment, liver impairment is not an “all-or-none” phenomenon, and must be evaluated in relative terms. Unlike renal impairment, there is no quick way to estimate hepatic function. Sometimes that is better, since it requires a more thoughtful and complete analysis. Liver function CAN be evaluated by looking at what the liver does from a physiologic standpoint.
Elevation of hepatic transaminases (AST and ALT) is not a very reliable indicator of function. These enzymes are released from hepatic cells and serve as an indication of acute injury. But the liver has a large redundancy and damage which occurs over long period of time can lead to serious impairment even in the absence of transaminase elevations.
The liver is responsible for synthesis of proteins, including albumin and clotting factors. Elevated prothrombin/INR and/or low serum albumin concentrations indicate that the synthetic capacity of the liver is diminished. The liver is also responsible for excretory functions through the conjugation of bilirubin. Elevations in bilirubin may indicate impairment of this function. There are also other indicators of hepatic function, such as serum ammonia. There is a classification scheme (the Pugh-Child scale) which takes several of these factors into account and may be used to classify the degree of liver impairment into mild, moderate, and severe levels. Specific dosage adjustment and/or contraindications have been published using these criteria for some drugs.
It is important to note that medicine interactions are not obvious in evaluating hepatic impairment. Interactions which block a metabolic pathway may be considered as a type of transient, functional hepatic impairment.
EHR vendors developing clinical decision support applications must include dosage range checking into their ePrescribing systems. These clinical guidelines are particularly important for dosing in pediatric populations.
Medication ePrescribing involves the appropriate selection of an agent, a route of administration, and definition of a dosing strategy. For most medications, dosing is adjusted to specific demographics such as age and weight. In some instances, dosing may differ from the general range for treatment of a specific condition. Additional parameters associated with dosing include major organ function (renal / hepatic) and / or the use of dialysis.
Dosages are typically ordered by an amount and a schedule for administration. In some cases, this is also limited to a defined duration (ex. 10 mg once daily for 10 days). In order to maximize the safety of drug dosing, it is useful to evaluate the ordered dose relative to typical ranges used in patients with similar characteristics. For this reason, dose range checking data are particularly important in many applications.
Effective CPOEs require common sense, good input from practitioners and meaningful decision trees at the point of care. The design and implementation of the system is an art, not a science.
The Leapfrog Group for Patient Safety just released a report on the
safety of electronic prescribing (ePrescribing) systems in hospitals(pdf). In a study of 214 hospitals testing efficacy of their clinical decision support systems using the Leapfrog CPOE Evaluation Tool, the systems, on average, missed half of the routine medication orders and a third of potentially fatal disorders. From the executive summary:
"For the sake of safe patient care, hospitals must test and monitor their CPOE systems on an ongoing basis to achieve true meaningful use. In addition, vendors and hospitals must collaborate more closely during the pre-implementation and implementation phases to ensure that best practices are shared and followed."
My reading of the report doesn't suggest that progress isn't being made, but rather that these systems require some fine touches, meaningful tweaking, and important dialog between the end users and the system implementation team to ensure that the system will be utilized in a meaningful way. To say that routine medication orders were missed doesn't mean the information was not available, it more likely suggests that information wasn't communicated to the end user in a way that was actionable and, equally importantly, avoided alert fatigue.
To minimize these outcomes, it is critical for the developers and designers to work closely with the "real" end users. By doing this, the effectiveness of the system will increase manifold.
It is also critical that flexible drug interaction databases be used as part of the overall CPOE. This also means that the drug database provider must also be flexible and easy to work with. Providing easy to use, but effective, APIs is another factor in ensuring a favorable outcome. There is a lot information under the hood, from dosage administration, drug classifications, drug interactions, pediatric dosing, generic vs brand medication names, dose calculators, and so on. The more effective the tool, the more likely it will be used properly, the more likely one will achieve desired outcomes.
The are only a few providers of drug database information (including Lexi-Comp and Multum/Cerner) which narrows down assessment choices. Make sure you consider the endgame before going down the drug data path.
As an increasing number of companies and institutions are getting deeper into developing systems for clinical decision support, these organizations have to make critical decisions regarding the information they include in these systems. Some of these areas include: eprescribing, drug classifications, pediatric dosage calculations, generic drug names, medicine lists, duplicate therapy, drug interactions, clinical guidelines, dose administration, therapeutic dosage and more. This is a lot to absorb by firms that are not specialized in this area. And often it is very difficult to distinguish the subtle distinctions between data providers.
Decisions about which vendor to go with should include: quality of data, cost, commitments to fixed pricing on renewals, history in the marketplace of the vendor not raising prices to the customer on renewal (at the point the customer feels trapped), reputation for being easy to work with, good APIs at an affordable price to facilitate integration and speed up transition time (thus reducing transition costs), and well known pediatric dosing charts and interaction information which improves pediatric safety.
Many EHR vendors are becoming more sensitive to this criteria, especially as meaningful use of the EHR becomes a bigger issue.
There are only a small few drug data providers to the EHR and EMR marketplace, with Multum and Lexi-Comp well-known for meeting the criteria described above.
Alteration of dose should be approached with an appreciation for several key factors. Other factors should be considered related to dosage administration. A drug reference book is only a starting point. One should not be so cautious about drug dosing that the therapeutic benefit of the drug is lost. Inadequate dosing may lead to treatment failure. Accumulation related to impaired elimination requires repeated dosing. In evaluating possible risks of accumulation, it is also important to balance the timing of drug accumulation, and the relationship of elevated concentrations to specific adverse effects. Drugs which are dosed for a very limited period of time, or drugs which have wide therapeutic “windows”, may not warrant much in the way of dosage adjustment.
The initial dose of a regimen is often not adjusted, serving as a “loading” dose to achieve therapeutic response. Subsequent dosage may be adjusted by lengthening the interval or reducing the size of an individual dose. Different drug classifications may require different dosing adjustment strategies. It is important to employ a strategy which does not compromise the efficacy of the drug – so drugs which need high “peaks” for efficacy should generally be adjusted by interval, while drugs which need a continuous presence in the serum should be adjusted by the size of the individual dose.
Selection of an alternative which is hepatically metabolized may be an option, but one must consider metabolites as a part of evaluation. For example, Morphine and meperidine are hepatically metabolized, but each has a metabolite which accumulates in renal impairment. In the case of morphine, additional sedation/respiratory depression may result. Meperidine’s metabolite results in neuroexcitation, potentially leading to seizures with repeated dosing. However, a single dose of either agent is not likely to result in harm. Other metabolites which may be of concern include NAPA, and desmethyldiaepam.
The implementation of electronic health records (EHR) claims to help reduce medical errors by providing healthcare professionals with clinical decision support. Some of the existing EHR providers in the hospital setting have the software architecture that allows the hospital to choose the drug data knowledge base that the hospital prefers to use however, there are other EHR providers in the hospital setting that force the hospital to use the drug data knowledge source without any choice. Drug data is a critical component that has an impact on healthcare costs and the overall quality of patient care, so having the ability to select which knowledge base should be a consideration of the EHR vendor.
I have had discussions with various hospitals that are not satisfied with their current EHR provider's drug knowledge base and have expressed an interested in evaluating other drug data resources such as Lexi-Data.
Lexi-Comp offers a product called Lexi-Data that contains decision support information such as drug interaction software (drug-drug and drug-food), drug allergy checking, therapeutic duplication checking, dose range checking (adult and pediatric) and more. Lexi-Data also contains drug reference book information, dose administrations, dosage precautions, dosing in pediatrics, and much more. Delivery options include database tables that are compatible with Oracle, SQL Server, and MySQL and an easily implemented Software Development Kit (SDK) powered by Jav or .NET APIs.
Integrating drug data and drug interaction databases into EHR, HIS, EMR systems and the like is not an easy task. One must feel comfortable that the data is accurate, the provider is easy to work with, and the price is right. In the last year, the landscape of vendors has started changing, along with the demands for implementing systems establishing meaningful use. For those hospitals and software providers in search of drug information for clinical decision making support, they must keep an open mind and look for a vendor that provides the best balance of accuracy, easy of working with, the right price.
The demands of interoperability and nomenclature coordination are indeed a great challenge. The government is involved at some level setting up standards, but these standards are only the beginning. The actual pragmatic application (a la John Dewey) occurs in the marketplace. It is not simple and there are changes taking place daily.
There is much to be concerned about, such as: dosage administration, drug brand names, drug generic names, dosage precautions, medicine interaction, drug product information, duplicate therapy, ePrescribing, therapeutic dosage, meaningful use, and on and on.
When all is said and done, pick a vendor carefully. You might be together for a long time and stormy relationships don't make for good ones.
In an effort to promote quality, safety, and efficiency through electronic health record (EHR) technology, the Centers for Medicare and Medicaid Services have proposed language defining meaningful use of EHR technology. This new technology is designed to enhance EHR systems with clinical decision support that helps healthcare professionals with drug lists, medication dosing, medication interactions, dosage range checking, and dosage administration.
To be considered a meaningful user of an EHR system three basic requirements must be met: use a certified EHR in a meaningful manner; the EHR is connected to allow for electronic exchange of health information for improving the quality of patient care; and the submission of clinical quality measures.
As EHR vendors continue to make progress on the meaningful use of EHR, new definitions of the term will certainly be introduced.
With the new study released from Medco Health Solutions regarding the dramatic increase in childhood drug prescriptions, it is now more important than ever for proper information in calculating pediatric doses. Giving an incorrect amount of medication is one the most common ways for a pediatric patient to be harmed during treatment, according to the Institute of Medicine study
To Err is Human: Building a Safer Health System. Calculating the correct dosage for a child can be very complex because of the many different factors involved including:
- Weight
- Height
- Age
- Conditions
- Other medications
In addition, because not all medications provide dosing guidelines for administration to children, pharmacists, doctors, and nurses are left to their own resources. All of this leaves an unsettling feeling for those in the medical field and parents everywhere.
In a recent study at Brigham & Women's Hospital, researchers found that a barcode system helped
reduce medication errors by an astonishing 57%.
The chances of dosage administration errors fell by 42% and the chances that a patient would receive a medication at the wrong time fell by 27%.
According to the study, "Given the high number of doses administered and orders transcribed in any acute care hospital, implementation of the bar-code eMAR could substantially improve medication safety."
Barcoding and other clinical decision support systems are not without their own inherent risks, namely: they're expensive, can be time-consuming to implement, and it can be a challenge to overcome staff resistance to using a new and, initially difficult, technology. The importance of implementing clinical information systems cannot be overstated, however, as the rising cost of medication interaction errors and adverse drug effects top $60 million per year per hospital.
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