PharmQD: “FDA is alerting pharmacists and other health care professionals of potential injury due to confusion between the FDA-approved eye medicine Durezol (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover Durasal (salicylic acid) 26%.

There has been one report of serious injury when a pharmacist mistakenly gave an eye surgery patient Durasal, the salicylic acid–containing wart remover, instead of the prescribed Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with ocular surgery.”

Seems like I’ve read about this mistake before. Being their typical efficient self, the FDA alert was issued on December 28, 2011, more than three months after ISMP alerted everyone.

Some things you can do to prevent stuff like this from happening include (taken from a Pharmacy Times article):

  • Include both brand and generic names, along with indication, when prescribing look- or sound-alike drug names.
  • Spell out drug names that have been confused when accepting telephone orders. Require staff to write down the prescription and then perform a read back (and spell back for drugs that are known to cause confusion) of the complete prescription for verification.
  • Assign time to provide counseling to patients and/or caregivers, especially for new prescriptions.

 

 

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A recent article in Pharmacy Times outlines some interesting examples of Sound-Alike-Look-Alike-Drugs (SALAD) causing trouble in pharmacy. We’ve all seen them, and I’ve blogged about them before. Hydralazine and hydroxyzine represent a prototypical SALAD pair, but there are many others out there; ISMP’s list can be found here (PDF).
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From the Journal of the American Medical Informatics Association1. I was a little shocked by the number of errors, but as you can see in the abstract below, and in the title, the errors were during the administration phase of the medication use process. Seems a bit odd to look at medication errors during administration when talking about automated prescribing and dispensing. I’m sure there is an explanation in the full article. However that requires a subscription. Interesting nonetheless:

Abstract
Objective
To identify the frequency of medication administration errors and their potential risk factors in units using a computerized prescription order entry program and profiled automated dispensing cabinets.

Design Prospective observational study conducted within two clinical units of the Gastroenterology Department in a 1537-bed tertiary teaching hospital in Madrid (Spain).

Measurements Medication errors were measured using the disguised observation technique. Types of medication errors and their potential severity were described. The correlation between potential risk factors and medication errors was studied to identify potential causes.

Results In total, 2314 medication administrations to 73 patients were observed: 509 errors were recorded (22.0%)—68 (13.4%) in preparation and 441 (86.6%) in administration. The most frequent errors were use of wrong administration techniques (especially concerning food intake (13.9%)), wrong reconstitution/dilution (1.7%), omission (1.4%), and wrong infusion speed (1.2%). Errors were classified as no damage (95.7%), no damage but monitoring required (2.3%), and temporary damage (0.4%). Potential clinical severity could not be assessed in 1.6% of cases. The potential risk factors morning shift, evening shift, Anatomical Therapeutic Chemical medication class antacids, prokinetics, antibiotics and immunosuppressants, oral administration, and intravenous administration were associated with a higher risk of administration errors. No association was found with variables related to understaffing or nurse’s experience.

Conclusions Medication administration errors persist in units with automated prescription and dispensing. We identified a need to improve nurses’ working procedures and to implement a Clinical Decision Support tool that generates recommendations about scheduling according to dietary restrictions, preparation of medication before parenteral administration, and adequate infusion rates.

1. J Am Med Inform Assoc. 2012 Jan 1;19(1):72-8. Epub 2011 Sep 2.

 

I suppose this could really be cool tech for nursing or lab, but I thought it was worth having a deeper look.

The ReVac Retracting Safety Syring by Revolutions Medicaluse a proprietary patented technology in which a vacuum causes the needle to retract into the barrel of the syringe or device after an injection is administered or blood is drawn.

According to the Revolutions Medical website “[t]he RevVac™ Safety Syringe and Phlebotomy (blood drawing) Device operate the same as a standard syringe and device. No additional training, skills, or procedures are necessary. The both products work on a vacuum principle, where pressing the plunger in them creates a vacuum. When the plunger reaches the bottom, the needle is captured. A further push on the plunger breaks the seal, and the needle retracts into the plunger barrel. The vacuum is maintained, so the needle cannot be removed from the plunger.

 

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.

 

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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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.

 

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.

 

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.
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