Patient Safety

The weakest link in building a safer medication use model

I’ve just spent four days at the ASHP Summer Meeting in Denver, CO. The meeting offered a nice variety of topics, but seemed to focus on medication safety and informatics more this year than in the past. In fact, this is the first year that ASHP has offered a medication safety tract at one of their meetings.

I avoided the more traditional sessions on therapeutics, choosing instead to focus on the informatics and medication safety sessions. Based on the information presented it was obvious to me that these two disciplines are intimately linked. After all, the idea behind much of the technology we use in healthcare today is to improve patient safety.

In 1999, the Institute of Medicine (IOM) published the now infamous To Err Is Human: Building a Safer Health System. The information presented in that report sent shockwaves through the healthcare industry. More than a decade later we haven’t seen much improvement in the number of mistakes made in hospitals, but To Err Is Human effectively changed the foundation of healthcare forever. While healthcare remains squarely focused on caring for patients, the approach to how we provide that care has changed dramatically. The interest on patient safety has generated an immense body of literature aimed at using automation and technology to improve patient care.

The tail wagging the dog

WSJ: “The Food and Drug Administration said Tuesday that it will require some painkiller manufacturers to produce new educational tools in an effort to quell prescription-drug abuse.

The requirements will affect makers of long-acting and extended-release opioids, which include oxycodone, morphine and methadone.

Letters have been sent to manufacturers of the drugs describing the medication guides and tools for physician training that are now required, FDA Commissioner Margaret Hamburg said. The FDA will approve the materials, which will also be accredited by professional physician-education providers, she said, a step meant to combat bias in the materials.

Oh. My. Gosh. Let me see if I can wrap my brain around this. The FDA is going to require that manufacturers of certain “painkillers” tell physicians how to properly use the drugs instead of requiring physicians to read the literature and do exactly what they’re trained and paid to do. Crud, it’s nothing a good pharmacist couldn’t fix. Why doesn’t the FDA simply require physicians to run these same prescriptions through a pharmacist for approval or give pharmacist prescriptive authority instead. It makes a lot more sense than putting the manufacturers in charge of the asylum. I would be utterly embarrassed if a drug manufacturer had to tell me how to properly use a drug because I couldn’t get it right. I think the healthcare system has officially reached a new low. Unfortunately this ain’t no limbo contest.

 

Cool Pharmacy Technology – Codonics SLS Safe Label System

Labeling syringes has always been difficult for anesthesiologists in the OR. It must be because they never seem to get it right. If you don’t believe me, just look at the image below. These drugs were found during routine inspection of an OR suite. Well that’s all changed now with the Codonics SLS Safe Label System.

The Codonics SLS Safe Label System is based upon the SmartLabels technology licensed from Massachusetts General Hospital. The system was developed by anesthesiologists at Massachusetts General Hospital to prevent intravenous medication errors via barcode assisted medication labeling. At the 2008 ASA Annual Meeting, the system was awarded the Ellison C. Pierce Award from the Anesthesia Patient Safety Foundation for best scientific exhibit in patient safety.

Massachusetts General Hospital SLS Article

Practice Fusion EHR gets allergy alerts

I am a fan of web-based healthcare applications, including EHRs. I especially like the web-based EHR available from Practice Fusion. The application is full featured, easy to use and free. I spent a little time playing with it back in June 2010. One of the things I noted during my review was that “there appears to be no cross checking between allergies and newly entered medications.” As a pharmacist this was pretty important. Well, I’m happy to say that allergy checking no longer appears to be an issue.

EHR Bloggers: “We’re excited to bring you a major new feature for your EHR account today: drug-drug and drug-allergy interaction alerts. It’s a frequently requested enhancement and also a big step towards Meaningful Use. And, like all our features, this clinical decision support system (CDSS) is entirely free.

Drug Interaction Alerts
You will now be automatically alerted when a drug you are adding, prescribing or refilling interacts with another drug or with an allergy listed in the patient’s chart. The following video shows you how to set permissions, heed alerts and override alerts. “

Cool Technology for Pharmacy - Sproxil

Counterfeit drugs are not only big business, they're dangerous to consumers as well. Counterfeit medications have no quality assurance program, which means they can contain contaminants, sub-therapeutic levels of the active ingredient, the wrong active ingredient, or even no active ingredient at all. Thus they can cause more harm than good. While these medications can certainly cause problems here in the United States, it's really the developing countries that are taking a beating.

According to a speech delivered by President Clinton at the Clinton Global Initiative conference as much as 30% of medications in some developing countries are counterfeit, while in developed countries the number is less than 1%. Even 1% is too much when you consider the potential consequences.

More problematic barcodes

Recently I've heard of hospitals having problems with barcodes on pre-mixed IV bags. The problem isn’t related to the legibility or quality of the barcodes, but rather the location and/or the information contained within the barcode itself.

Here are a couple of examples of what I’m talking about.

It may be time to consider robotic IV preparation at the bedside

Hospitals make a lot of intravenous (IV) preparations. That makes sense when you consider that most people admitted to the hospital are there because their acute illness requires more care than can be administered at home; not always, but in most cases. This is especially true for patients in the intensive care unit, i.e. the ICU.

A fair number of the medications used in the ICU are prepared on demand for a host of reasons including stability, differences in concentration, difficulty in scheduling secondary to rate variability, etc. Any pharmacist or nurse reading this will understand what I'm talking about. Example medications that fall into this category include drips like norepinephrine, epinephrine, phenylephrine, amiodarone and nitroprusside.

Last year I mused about using devices on the nursing stations designed to package oral solids on demand at the point of care. I still like the idea for several reasons, all of which can be found in the original post.  Based on currently available technology the same concept could be applied to preparation of IV products at the bedside. Robotic IV preparation has come a long way and these devices could be used at the point of care to make a nurses, and patient's, life a whole lot easier. The use of robotic IV preparation at the bedside could reduce wait times for nurses and lesson the workload on pharmacy.

Is the 30-minute rule for medication administration good or bad?

The June 17, 2010 issue of ISMP Medication Safety Alert I received has an interesting article on the unintended negative consequences of the Centers for Medicare & Medicaid Services (CMS) regulation requiring medications to be administered within 30 minutes of their scheduled dosing time. I’m sure that the CMS 30-minute rule was created with good intentions in mind, but in reality it creates a lot of anxiety and bad habits. According to the ISMP article, the CMS 30-minute rule “may be causing unintended consequences that adversely affect medication safety. While following the 30-minute rule may be important to hospitals, many nurses find it difficult to administer medications to all their assigned patients within the 30-minute timeframe. This sometimes causes nurses to drift into … unsafe work habits.” Those unsafe work habits include removing meds from automated dispensing cabinets (ADC) for multiple patients at once, removing meds ahead of time, falsifying documentation to meet the 30-minute rule and preparing doses ahead of time; all dangerous practices.

The problem is more widespread than most realize and often flies under the radar. I knew about the issues, but wasn’t prepared to deal with them until we went live with our bar-code medication administration (BCMA) system. A side effect of the BCMA system is that it tends to catch things like late and/or early medication administration. That means no more mythical med passes with all medications administered at exactly the same time.

Cool Technology for Pharmacy – RxVerify

While reading through a pharmacy listserv I came across a seemingly simple piece of software that fills an important gap in the pharmacy distribution process. RxVerify, by Pharmacy Ideas, is a bar-code verification system used during the medication restocking phase for code boxes, anesthesia trays, transport boxes, etc.

The concept is simple and goes something like this:

1) Place labels containing the drug name and associated bar-code on the pockets of your code boxes, anesthesia trays, transport boxes, etc.

2) Pull items that need to be placed in these trays/boxes from pharmacy stock.

3) Scan the bar-code on the pocket followed by the bar-code on the medication. If the bar-codes match you get a stamp of approval and proceed to enter the lot number and expiration information found on the medication for tracking. If the bar-codes don’t match the software gives you a rude warning in the form of a visual queue that says “No Match!” in big red letters. In addition to the “No Match!” warning, a pop-up window appears that prevents the user from continuing.

Pretty simple, but effective if used properly.

In addition to the safety features offered by RxVerify, the system offers various reports for tracking and record keeping purposes. The ability to track lot number and expiration dates is a big plus.  One of the reports that is of particular interest to me is the “Med Error Prevention Report”. This report identifies what I like to call “bad scans”. Basically it tracks potential errors caught by the system. Of course not all the bad scans would result in a drug error, but the information can be useful nonetheless.

OTC drug interaction analyzer for smartphones

Medilyzer is a smartphone application designed to provide mobile information and drug interaction checking for various over-the-counter (OTC) medications. The application is available for both the iPhone and Android smartphones, and according to the Medilyzer website a BlackBerry edition is on its way.

iPhone version

Created with consumers in mind, the iPhone application delivers information about OTC products using the barcode located on the medication package. Users simply type in the numbers on the barcode and receive a picture of the medication along with important drug facts. By simply touching the picture of the medication, a screen will appear where users can view the medicine’s active ingredients, warning, dosage information, and comparable generic products. To compare multiple medications users can touch “Check Interaction” located on the main screen. A green check means the OTC medications are ok to take at the same time; a red stop sign means you should not take the medications together and consult with a pharmacist.

A recent trifecta for bar-coding

Bar-code medication administration has been around for a while, but hasn’t gained the same notoriety as other forms of healthcare technology like computerized provider order entry (CPOE) and clinical decision support (CDS). However, it looks like the tide is starting to change as we’re currently in a unique position to see bar-coding from several different angles.
 

Part 1 - the beginning, i.e. the pharmacy:
Earlier this week I briefly touched on the ASHP Statement on Bar-code Verification During Inventory, Preparation, and Dispensing of Medications. As clearly stated in the title of the paper, ASHP’s position is aimed squarely at what happens from the time a medication arrives in the pharmacy until it is dispensed, i.e. sent to the patient or placed in an automated dispensing cabinet. The document concludes that “Prudent use of bar-code scanning in inventory management, dose preparation and packaging, and dispensing of medications can enhance patient safety and the quality of care.” I can agree with that, especial the part that states “prudent use of bar-code scanning”. Technology won’t do much for you if it is implemented poorly or used recklessly.

More thoughts on standardization

I've mentioned this before several times on this blog, but feel like I have to say it yet again; we need to start standardizing certain things about health information technology. The lack of standardization reared its ugly head at me again last week when our Pyxis med stations kept dropping medications off of patient’s active profiles. It appeared to always be the same drug, IV ketorolac. It took me a while to figure out the problem, but it turns out that Pyxis and our pharmacy system don't agree on certain basic elements of time. Go figure.

Here's an HL7 feed from a ketorolac order. Note the red lettering:

PID|||0000194291^9^M10^KDHCD^PN~3017197^^^KDHCD^MR|3017197|ZZZTESTINGDRAEGRXXXX, ZZZTESTING||19740525|F|||361 N ABC AVE^^VISALIA^CA^93291|||||S|UNK|00001942919||| PV1||I|3N^29^A||||TEST, A DOCTOR|||OP|||||||TEST, A DOCTOR |||||||||||||||||||||||||||200810231335|||||| ORC|NW|1|||||^Q6H&0600,1200,1800,2400&^^201004292400^201004302400^^^11111110||201004281226||JFT|TEST, A DOCTOR|||201004290000|| RXE||543^KETOROLAC TROMETHAMINE^2502190|30||MG|VIAL|THIS IS ONLY A TEST.....|||1|||AM1405427|JFT||||||||||| NTE|||EVERY 6 HOURS|RXR|IV||||

Pyxis doesn't recognize 2400 as a “real” time, and rightfully so. For those of you that don't know, 2400 hours doesn't exist in military time. Midnight is 0000 hours. Why would Siemens use 2400 hours to represent midnight? I have no idea, but Pyxis didn't like it so it refused to deal with the order and simply discontinued it. The fix was a programmatic change by Siemens.

A look at one pharmacists unwanted potential

A recent post by John Poikonen got me thinking about medication errors. They're part of every pharmacists day, but we rarely give them much thought.

I’ve been a pharmacist for more than 10 years now and I’ve make my fair share of mistakes. I would like to think that none of those errors caused harm, but that would be naïve to say the least. And forget about the errors that were never detected because one can only speculate about those.

Cool Technology for Pharmacy - Alaris AutoID

Bar code medication administration (BCMA) is nothing new, but remains a hot topic in healthcare nonetheless. Another topic that has generated significant interest in healthcare over the past couple of years is the use of smart pumps, which I have posted on before. Unfortunately for most hospitals the two remain independent of one another with no appreciable integration. The integration of smart pumps with BCMA was one topic of discussion at this years ASHP midyear. I attended a couple of presentations from healthcare systems that had successfully integrated information from their pharmacy information system (PhIS) directly into their smart pumps for use with their BCMA system. Like many other ideas presented at large conferences, the situation is the exception rather than the rule.

Conceptual design for electronic communication in the outpatient setting

From Implementation Science 2009 Sep 25;4:62:

Abstract:

BACKGROUND: Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. 123 In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). AIM: Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. DESIGN: This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis.

Although the information in the article is only a design concept, it is still worth reading. Concepts like these could be useful for many outpatient as well as many inpatient alerts; labs that are outside normal parameters, results from blood tests, incorrect antibiotic choice following culture results, etc. With the advances in mobile technology, especially mobile communication devices, this is worth serious consideration

Cool Technology for Pharmacy - ValiMed

The ValiMed Medication Validation System by CDEX, Inc.

According to the ValiMed website:

CDEX’s technology stands alone, able to precisely identify medications in real time with its patented Enhanced Photoemission Spectroscopy technology.

Energy at a preset wavelength interrogates the selected substance, capturing a unique emission spectrum which is then compared to the propriety signature, resulting in a simple “VALIDATED” reading when matched.

Each medication reveals its own distinct and easily readable signature. By comparing the fingerprint of a tested medication against the signature for that medication in our data library, the ValiMed technology is able to verify a match, presuming there is one.

The ValiMed Medication and Narcotic Validation System offers superior value to hospital medication safety programs and quality control processes by:

- Providing immediate, real-time validation of the substance itself.

- Providing an opportunity to standardize and optimize internal medication safety processes including Training, QA and Regulatory Compliance.

- Providing a real-time means of validating narcotic returns and mitigating narcotic diversion.

- Providing pharmacy staff and clinicians with a simple, fast, straightforward and cost-effective way to ensure that the RIGHT drug in the RIGHT dose is administered to the patient.

We need a better system for medication reconciliation

Medication reconciliation is defined by JCAHO as “the process of comparing a patient's medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions.” The process should be fairly straight forward, but it is actually very difficult and time consuming.

Most consumers don’t do a very good job of keeping track of their medications; much less the medication names, dosages, what they are used for and when they were last taken. It’s not uncommon on admission to the hospital for a patient to say things like “I take a blood pressure pill” or “a pain pill” or “a water pill”. As a pharmacist I can make gross generalizations about these medications, and can narrow the options down with aggressive questioning, but can rarely be sure without seeing the medication for myself.

Technology to prevent medication errors (article)

Forni A, Chu HT. Technology Utilization to Prevent Medication Errors. Curr Drug Saf. 2009 Oct 7 [ePub]

This is a nice review article explores current technologies available to healthcare and what role they play in the reduction of medication errors. The article provides a short review of literature to support each technology reviewed. Technologies covered include: Computerized Physician Order Entry (CPOE), Clinical Decision Support Systems (CDSS), Patient Monitoring: Electronic Surveillance, Reminders, and Alerts, Telemedicine, Bar Code Medication Verification (BMV), a.k.a. Bar Code Medication Administration (BCMA), Smart Infusion Pumps, and electronic medication administration record (eMAR).

Denis Quaid Redux of Speech to ASHP

Actor Dennis Quaid gave the key note at the recent ASHP Midyear Clinical Meeting.   Initially I found it to be fantastic presentation.  Shortly after I felt cheated and conflicted.  Soon after the speech I ran into some folks that knew a lot of about the specific incident that brought Mr. Quaid to speak to the pharmacists organizations.  It turns out that he either took artistic license to embellish his presentation or out right lied about the details of the tragic medical error.   Either way, my respect for him was crushed.

His new born twins were victims of an awful medication error.  While the twins survived and are fine now, it was a horrible error.  This blog post does not mean to minimize the error.  As a father of twins, I was close to tears during the speech, and can not even imagine the emotional toll it must have had on him.

Mr. Quaid could have taken the large settlement from the hospital and rode into the sunset.  Instead he works to help bring attention to the issue of medication errors.  For that he is to be commended.   So why he would make up aspects of the incident is perplexing and disturbing.  I trust my sources of the details of the incident completely, therefore, believe them and not the details that Mr. Quaid recounted.  So here are some positive and negative specifics and selected commentary of the speech.

The complete speech can be downloaded here.
http://www.ashp.org/DocLibrary/MCM09/MCM2009-Dennis-Quaid.aspx

“You may have a nagging question – why is he here? He is not a pharmacist…he is an actor.”

Clinical Surveillance

There is a nice article in the November 2009 issue of Hospital Pharmacy on the use of clinical surveillance in pharmacy. I've mentioned these types of systems before here and here.

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.

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