Jerry Fahrni

Tag: Medication Errors

  • 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.

  • Healthcare is beyond repair, and I can prove it

    Before we begin let me get a few things out of the way. First, I am a healthcare professional. Yes, a pharmacist is a healthcare professional. Second, I’ve spent a large portion of my adult life working in the healthcare industry, both inpatient and out. This includes more than a decade working in a hospital as either a “staff” pharmacist or a “clinical” pharmacist. Third, the average person has no idea what goes on in a hospital or their physician’s office. A majority of people that are misdiagnosed, receive unnecessary labs, get the wrong drug, etc. will never know because they have no reason to think they’re getting anything but the best of care. And finally, I’ve been called a pessimist. I don’t see it that way, but I’m simply giving you all the data I have.
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  • Realistic view of medication reconciliation?

    Hospitals & Health Networks: “Despite progress, medication reconciliation remains a bitter pill. Un-intended changes in medications occur in one-third of all patients transferred between hospital departments, and in 14 percent of patients at hospital discharge, according to the Agency for Healthcare Research and Quality.

    Most medication inconsistencies could be avoided if reconciliation were performed at patient admission, transfer and discharge. Hospital information systems are helping some wired hospitals rdo this across the care continuum despite the lack of a universal solution.

    Medication reconciliation was designated a 2005 National Patient Safety Goal by the Joint Commission, which recommended that organizations accurately and completely reconcile medications across the continuum of care. In 2009, however, the commission announced it would no longer score medication reconciliation during on-site accreditation surveys, because of difficulties with implementation strategies. Then, in December 2010, the commission announced a new version of the NPSG (08.01.01), to be effective July 1 of this year. According to the commission, the new streamlined version focuses on critical-risk points in the medication reconciliation process.

    The Institute for Safe Medication Practices still is disappointed in the current status of medication reconciliation. “It’s not what we expected for a process that on the surface seems so simple,” says Stu Levine, an ISMP informatics specialist.”

    I received a link to this article through the Healthcare IS – Pharmacy IT/Pharmacy Informatics CPOE Group on LinkedIn. The article is titled “Medication Reconciliation Only as Good as the IT Allows”. I find the title a little strange, and a bit misleading. Consider that the medication reconciliation process is best handled by diligence among healthcare providers, not IT. The technology to provide clinicians with medication lists is only a tool to make the process easier. Reconciling a patient’s medications is at best a difficult task. The “general public” knows surprisingly little about their own medications; including the simplest of things like names and doses. Getting physicians to reconcile a medication list isn’t much better. More often than not they simply sign the “transfer med list” without really scrutinizing what’s on it.

    Unfortunately the article makes it sound like a simple process of looking at the medication list on admission, transfer and discharge. It really isn’t as simple as that. We utilized this process at my previous hospital and I can tell you that we were lucky to have a patient medication list that was accurate. Most were haphazard attempts that lead to confusion and lots of phone calls and clarification.

  • FMEA and BCMA, two acronyms that work well together

    During my time as an IT pharmacist I was fortunate enough to be part of two Failure Modes and Effects Analysis (FMEA) groups; one for CPOE and another for BCMA. The FMEA process is labor intensive and time consuming, but well worth the effort in my opinion. In both the CPOE and BCMA instances several important pieces of information were discovered that may have otherwise gone unnoticed.

    I don’t often see articles that talk about using FMEAs, which is a real shame secondary to their value. So it was a pleasant surprise to see a recent article in Pharmacy Purchasing & Products on the use of an FMEA post BCMA implementation. I’m not familiar with using an FMEA after the fact, but it makes more sense to me now after reading the article.

    According to the author, they “had conducted an FMEA prior to initially employing BCMA; however, we never performed any post implementation follow-up on the system.” An all too common occurrence in healthcare, i.e. implement and forget. We did something similar at Kaweah Delta when I worked there, but we referred to the process as a gap analysis rather than calling it an FMEA. Regardless of the verbiage, the results were similar.

    The reason cited for the second FMEA was an increase in errors associated with the BCMA system. “Errors were primarily due to unscannable bar codes, mislabeled medications, the wrong medications being dispensed, and most commonly, nursing staff’s failure to scan.” This sounds familiar. The errors cited are simply side effects of the implement-and-forget mentality. Regardless of the system in place, humans inevitably develop bad habits and workarounds. We need to be constantly reminded to do the right thing. Implementation is only a small part of the work involved with any new system. Follow-up, maintenance and optimization is when the real work begins.

    And the results of the second FMEA? “Three months after completing the FMEA, the team compared the before and after scan rates. We found significant improvements in the scanning of both the patients and the medications throughout the system. In addition, we have witnessed a culture change: nurses now become anxious if they cannot scan a product.” Not bad.

    Read the article, it contains some good information.

  • BCMA Technology: Characterization of Med Triggers and Workarounds (Article)

    There’s an interesting article in the February 2011 issue of The Annals of Pharmacotherapy dealing with BCMA and what the author describes as “clinical workarounds”.1

    Abstract

    BACKGROUND: Bar code medication administration (BCMA) technology is gaining acceptance for its ability to prevent medication administration errors. However, studies suggest that improper use of BCMA technology can yield unsatisfactory error prevention and introduction of new potential medication errors.
    OBJECTIVE: To evaluate the incidence of high-alert medication BCMA triggers and alert types and discuss the type of nursing and pharmacy workarounds occurring with the use of BCMA technology and the electronic medication administration record (eMAR).
    METHODS: Medication scanning and override reports from January 1, 2008, through November 30, 2008, for all adult medical/surgical units were retrospectively evaluated for high-alert medication system triggers, alert types, and override reason documentation. An observational study of nursing workarounds on an adult medicine step-down unit was performed and an analysis of potential pharmacy workarounds affecting BCMA and the eMAR was also conducted.
    RESULTS: Seventeen percent of scanned medications triggered an error alert of which 55% were for high-alert medications. Insulin aspart, NPH insulin, hydromorphone, potassium chloride, and morphine were the top 5 high-alert medications that generated alert messages. Clinician override reasons for alerts were documented in only 23% of administrations. Observational studies assessing for nursing workarounds revealed a median of 3 clinician workarounds per administration. Specific nursing workarounds included a failure to scan medications/patient armband and scanning the bar code once the dosage has been removed from the unit-dose packaging. Analysis of pharmacy order entry process workarounds revealed the potential for missed doses, duplicate doses, and doses being scheduled at the wrong time.
    CONCLUSIONS: BCMA has the potential to prevent high-alert medication errors by alerting clinicians through alert messages. Nursing and pharmacy workarounds can limit the recognition of optimal safety outcomes and therefore workflow processes must be continually analyzed and restructured to yield the intended full benefits of BCMA technology.

    The study described in the article utilized a combination of retrospective analysis and direct observation to identify alert triggers generated by a BCMA system. In addition the study looked at various workarounds utilized by nursing as well as pharmacy. The article is a much more limited version of the one by Koppel in 2008.2

    The Annals article identifies some disturbing trends at the Medical University of South Carolina (MUSC) where the study took place. Examples include failure to document override reasons for 77% of alert messages and 468 directly observed workarounds during 121 administration attempts over a 6 hours period. Those number are a sure sign of a poorly designed system and lack of institutional oversight. It certainly has nothing to do with BCMA and the overall effectiveness of the technology. Sounds like some disciplinary action is in order.

    One other thing I found unusual in the article was the classification of pharmacy workarounds. “Specific pharmacy workarounds included duplicate orders, lack of medication order verification, medications within the incorrect section of the eMAR (prn vs standard administration time), and incorrectly timed medications causing administration too late/early for the nursing staff.” I’m not sure how you see this, but a duplicate order isn’t a workaround, it’s an order entry error. Same goes for entering an order as PRN instead of SCH. Not sure what the author had in mind when he made the decision to classify these as workarounds. Weird.

    1. Daniel F Miller, Christopher R Fortier, and Kelli L Garrison Bar Code Medication Administration Technology: Characterization of High-Alert Medication Triggers and Clinician Workarounds Articles Ahead of Print published on 1 February 2011, DOI 10.1345/aph.1P262. Ann Pharmacother ;45:162-168.
    2. Koppel R, Wetterneck T, Telles JL, et al. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc 2008;15:408-23.

  • Do smaller hospitals get the shaft when it comes to automation and technology?

    I’ve worked in several acute care hospitals during my career, from the small one horse operation that did little more than care for minor inconveniences, to larger, multi-pharmacy facilities that handled everything from pneumonia to severe trauma. As I’ve mentioned elsewhere on this blog each one of those pharmacies offered a slightly different way of doing things. Granted, some were variations on a similar approach, but they were all different.

    However, one trend I’ve discovered across the range of facilities is that the smaller the hospital, the less automation and technology the pharmacy has. Why? It’s quite simple. Automation and technology is expensive. It’s also time consuming to plan for, implement and maintain. Of course another argument is that smaller hospitals - and therefore smaller pharmacies – need fewer technological advances. That doesn’t make much sense to me. I agree that a small 50 bed hospital pharmacy may not need a giant robot to fill their med carts, but they can certainly benefit from clinical decision support, pharmacy surveillance software, bar code medication administration (BCMA), computerized provider order entry (CPOE), automated dispensing cabinets (ADCs), smartpumps, mobile devices, so on and so forth. The problem is that much of this technology is expensive and takes a sizable chunk out of smaller budgets.
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  • “What’d I miss?” – Week of January 9, 2011

    As usual there were a lot of things that happened during the week, and not all of it was pharmacy or technology related. Here’s a quick look at some of the stuff I found interesting.
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  • S.A.L.A.D.

    Sound-Alike, Look-Alike Drugs (SALAD) have recently floated to the top of my attention with the release of the Institute for Safe Medication Practices (ISMP) recommended list of Tall Man Letters for look-alike drugs. I mentioned the new list on Twitter which resulted in a short, but interesting conversation with some colleagues.

    SALADs have been problematic for quite some time and many solutions have been proposed, including Tall Man Lettering, physical separation of look-alike drugs, printing of both brand and generic names on packaging and storage bins, use of colorful warning labels, and so on and so forth. The problem with all these solutions is human involvement. Working in acute care pharmacy has taught me over and over again that all the above systems may decrease error, but certainly don’t eliminate them.
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  • CPOE failure modes and effects analysis brings up some good questions

    A Failure modes and effects analysis (FMEA) is basically a methodology for predicting potential pitfalls in a project and preemptively finding solutions. This is in contrast to a root cause analysis (RCA) in which case you figure out what went wrong after the fact. Kind of like asking “what could make a plane crash and how to prevent it?” (=FMEA) versus “what made the plane crash and how do we prevent it from happening again?” (=RCA).

    My current position is the first in which I’ve been involved in an FMEA, and I’ve personally found them to be powerful tools. We did an FMEA prior to implementation of our BCMA system and came up with what I thought was a pretty good list of things to look out for. Of course what the administration chooses to do with that information is a different story, but at least it’s available if needed.
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  • Drug error occurs, but not for the reasons you’d expect

    I was reading through the most recent issue of the ISMP Medication Safety Alert! and came across an incident where a CLINIMIX E solution was infused on a patient prior to being mixed, resulting in the patient receiving a concentrated dose of amino acids and electrolytes. Fortunately no harm was done.

    CLINIMIX E is a dual chamber parenteral nutrition (PN) product consisting of two chambers separated by a seal. One chamber contains dextrose and calcium and the other chamber amino acids along with electrolytes. Simply bust the seal, mix the contents with some gentle agitation and hang it on the patient. Nothing could be easier. I loved these types of products when I used to work in the IV room. They don’t fit the bill for all patients, but when they do it sure makes life in the pharmacy simpler. Otherwise you have to make the PN from scratch which can be time consuming.

    In the incident described in the ISMP article the CLINIMIX E bag was retrieved from the pharmacy after hours by nursing staff. This type of procedure is common in hospitals that don’t have a 24 hour pharmacy, i.e. small acute care hospitals. I think this type of system is dangerous, and certainly contributed to the mistake, but that’s not what stands out about this error.

    The two things that really irritate me about this error are the physician’s directions and the nurses retrieving and starting a PN in the middle of the night. First and foremost, PN is never a life or death medication. Take a look at the ASPEN guidelines if you don’t believe me. PN is something that should only be used after serious consideration, and in a patient that has been NPO for several days. PN should never be used to adjust a patient’s electrolytes, temporarily augment a patients diet when they can eat solid food or to “stimulate appetite”. In this case if the patient needed PN it could have easily waited until morning. And second, the physician in this case wrote for the CLINIMIX E to be given “’if the patient does not eat at least 50% of breakfast.” For those of you that think this order is ok, raise your hand. Now everyone look around and find the people that raised their hands. Make a mental note to never allow them to treat you for anything serious. Again, PN is serious business and not something that should be started based on an “if, then” statement. Either start it or don’t, but don’t write orders for PN that may be interpreted more than one way depending on who’s looking at it.

    Errors occur too frequently in hospitals now, we certainly don’t need to make committing them any easier.