ISMP responds to deadly drug error in Oregon

Last week I wrote about the tragic death of a patient caused by a drug error (CSP error results in death of a patient). One day later on December 18, 2014, ISMP also addressed the error in the Acute Care edition of their biweekly ISMP Medication Safety Alert, i.e. one of their newsletter. I had hoped that ISMP was going to provide much greater detail and insight into the error, but that’s not the case. At least not at this point, anyway.

I had hoped to find out what occurred in the pharmacy to allow such a mistake to happen. Perhaps more details will come to light as time goes on. All we can do is wait.

With that said here are some things from ISMP worth noting:

To prevent inadvertent use, identify neuromuscular blockers available within your organization and where and how they are stored. Regularly review these storage areas, both inside and outside of the pharmacy, including agents that require refrigeration, to consider the potential for mix-ups.

Limiting access to these products is a strong deterrent to inadvertent use. Consider limiting the number of neuromuscular blockers on formulary, and segregate or even eliminate storage from active pharmacy stock when possible.

Restrict storage of paralyzing agents outside the pharmacy and operating room by sequestering them in refrigerated and nonrefrigerated locations.

ISMP recommends highly visible storage container for neuromuscular blockers (one example here: www.ismp.org/sc?id=458).**

ISMP recommends affixing warning labels on vials and admixtures that clearly communicate the dangers of neuromuscular blockers.**

ISMP recommends the use of IV workflow technologies. “Now is the time for hospital leadership to support the acquisition of IV workflow technologies that utilize barcode scanning of products during pharmacy IV admixture preparation.” While the article lists only three systems, there are several on the market [see  In the Clean Room TOC for a current list of many of the available systems].

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**I know that many think this is a good idea, but I’m not so sure that I’m one of them. On the surface, using highly visible storage containers and labels might seems like a good idea, but over time people become used to the idea and become blind to the differences. In addition, over the years the number of items that require alternate storage and labeling has grown, making differentiation “the norm”. It’s like the student that highlights everything in the textbook with five different colors. Eventually the entire book is highlighted, making the process meaningless to the reader.

CSP error results in death of a patient

A 65-year-old woman died at St. Charles Medical Center in Oregon after being given an infusion of rocuronium instead of fosphenytoin.

“The prescription was entered correctly into the electronic medical records system, and the pharmacy received the correct medication order, the AP reported. The IV bag was also labeled properly. After the pharmacy worker mistakenly filled Macpherson’s IV with rocuronium, a second employee did not catch the error while checking the vials of medication and the IV bag for the 65-year-old patient.” (via: Pharmacy Times).

As details of the tragedy continue to emerge, here’s what we know so far:

  • An infusion of fosphenytoin was ordered for the patient, presumably a piggyback.
  • Instead of fosphenytoin (anti-seizure med) the patient received rocuronium (a paralytic)
  • It is unclear at what point in the compounding process, if at all, the infusion was verified by a pharmacist. According to the article “a second employee did not catch the error while checking the vials of medication and the IV bag”. Not entirely sure what that means.
  • The infusion was hung
  • A fire alarm sounded
  • The nurse closed the patient’s door and didn’t check on her for 20 minutes. That was more than enough time for the drug to cause irreparable harm to the patient.

It is unclear what process was used to make the infusion, or what safety safeguards were in place. The real shame here is that there are any number of available technologies that could have prevented the error. Any of the semi-automated workflow management systems on the market today would have worked. Bar code scanning, gravimetrics, perhaps image assisted verification, etc. Take your pick.

According to an article from The Bulletin “To help prevent similar mistakes from happening, the hospital’s pharmacy has begun placing orange stickers on IV bags containing paralytic agents that indicate what’s in them. [The patient’s] IV bag had a blue sticker indicating it was a neuromuscular agent, which Boileau [Dr. Michel Boileau, St. Charles’ chief clinical officer], said both fosphenytoin and rocuronium are.” Not exactly sure how using orange stickers instead of blue is going to do much. Seems kind of silly. I think I’d start looking at something a little more aggressive. I’d also rethink my classification of both fosphenytoin and rocuronim as “neuromuscular agents”. I think I’d call fosphenytoin a hydantoin anticonvulsant and rocuronium a nondepolarizing neuromuscular blocker. They’re clearly not the same class of drug.

It will be interesting to see how organizations like ISMP and ASHP respond to this latest error.

Lexicomp’s new Drug ID mobile module [video]

Lexicomp has a new Drug ID module for their suite of mobile applications.

Based on the Tweet I thought the new application would identify “loose drugs” with the camera on a mobile device like Medsnap, but that’s not the case.
Continue reading Lexicomp’s new Drug ID mobile module

Monitoring Pharmaceutical Products in Twitter [article]

Pharmacovigilance of TwitterThere’s an interesting article in the April 2014 edition of Drug Safety that looks at English Twitter posts from November 2012 through May 2013 to see if there is any correlation between adverse event (AEs) reporting via Twitter and more “official” channels.

The authors collected public Tweets, which were subsequently stored for analysis using Amazon Web Services. See how they did that? Nothing magical about it. They used readily available information and a commercially available storage source.

Through the use of some human ingenuity, a “tree-based dictionary-matching algorithm”, and some manual labor, the authors collected 6.9 million Tweets, of which 61,402 were examined, ultimately leading to 4,401 AEs identified; referred to as Proto-AEs by the authors. During the same period 1,400 events were reported by consumers to the FDA.

While not perfect, and most certainly limited, I think the results were surprising, encouraging, and disappointing all at once.

Surprising because of the number of Proto-AEs found in the Twitter stream. People are savvy. “There was evidence that patients intend to passively report AEs in social media, as evidenced by hashtags and mentions such as #accutaneprobz and @EssureProblems. Even within 140 characters, some tweets demonstrate an understanding of basic concepts of causation in drug safety, such as alleviation of the AE after discontinuation of the drug.”

Encouraging because being able to mine social media streams like Twitter could open up an entirely new avenue of real-time AE tracking; we all know that AEs are under reported, which leads to a lack of information for pharmacists and other healthcare professionals.

Disappointing because of the limited number of AEs reported to the FDA. I used to see AEs in the hospital that were never reported. I’m as guilty as many for not reporting AEs.

More work needs to be done in this area before we can begin to rely on data mined from social media, but they again it’s probably as reliable as information collected elsewhere.

The article is open access and the full version is online for free, so there’s no excuse not to read it.

Gema Kit – NFC-enabled medication compliance tracking for consumers

GemaKitThis is interesting, the use of NFC tags to track patient’s medication compliance. Makes sense when you consider the ubiquitous nature of NFC on mobile devices these days.

MedCityNews: “[Gema Kit] features stickers embedded with sensors that link to a patient reporting website. These small circles go on pills, pill bottles or blister packs. The sensor is proximity-based, so when a person’s cell phone is waved at the sticker, it brings up the reporting portal. In addition to recording when a pill was taken, a user can report symptoms, side effects and mood. The touch-to-activate patches include proprietary technology but also meet NFC Forum Type 2 Tag standards. They can be read by any NFC-enabled mobile device including cell phones, tablets or readers.”

From the website:

The Gema Kit includes:

  • Dual NFC and bar code/quick response coded “patches” of various sizes that the patient adheres to the outside of their pill bottles and packs
  • Links to a free engagement website
  • Back-end data tracking and reporting service for providers

Each patch within the kit is paper thin. Through proximity of a user’s mobile device, the patch enables an instantly to a web-based patient system that will:

  • Enable logging of NIH PROMIS guided, quality of life measures at the point of care, as well as
  • Connecting patient’s to other stakeholders that are important them and to their fight.

Fresh application of older healthcare technology

I came across an interesting article in the July issue of Pharmacy Practice News. The article describes some of the posters presented at the 2013 ASHP Summer Meeting in Minneapolis. The technology covered is relatively old, and a little antiquated when you look at much of the technology floating around the world these days. Nonetheless, this technology still represents opportunity in healthcare.
Continue reading Fresh application of older healthcare technology

Saturday morning coffee [June 7 2013]: Fast & Furious 6, Peach Cobbler, PRISM, Pharmacy, MedPod

So much happens each and every week that it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

The headline for SMC is a bit different today in case you haven’t noticed. I’ve taken the advice of a Twitter colleague, Charles Webster, MD (@EHRworkflow). Charles has recommended a couple of times now that I make my headline more descriptive. I like the idea so I’m giving it a shot. Feedback welcome.

My trip to Minneapolis, MN for the ASHP Summer Meeting has me waxing nostalgic. The coffee cup below was my trophy for winning the first ever ASHP Midyear Meeting Twitter contest. I’m not even sure what year it was, but I believe it was 2009; don’t hold me to that recollection though. At that time ASHP  was unable to use any of the official Twitter logos due to some time of licensing issues. So instead they generated a Wordle from my website and placed it on the mug you see below. My Twitter handle (@JFahrni) and web address (JerryFahrni.com) are displayed on the back near the handle.

ASHP Twitter contest mug
Continue reading Saturday morning coffee [June 7 2013]: Fast & Furious 6, Peach Cobbler, PRISM, Pharmacy, MedPod

Saturday morning coffee [October 13 2012]

So much happens each and every week that it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts….

The coffee mug to the right is from The Sixth Floor Museum at Dealey Plaza in Dallas, Tx. My family and I spent some time there during our summer vacation in Texas. One of the things I really wanted to do in Dallas was visit Dealey Plaza and the site where JFK was assassinated. Well, I finally got that chance as my family and I spent some time walking around the plaza area, visiting the location of the assassination and spending a little time at the book repository and museum. JFK is one of the few men in history that I would have liked to have met in person.

Taken 2 was #1 at the box office last weekend. My wife and I saw it last Saturday. Not bad. If you decide to go see it make sure you don’t want a good story line or incredible acting range. Just enjoy the senseless violence and be entertained. Hotel Transylvania was #2 at the box office. I saw that last night with my wife and youngest daughter. Good, clean humor. Worth seeing especially if you have little ones.

Continue reading Saturday morning coffee [October 13 2012]

More on the meningitis outbreak caused by contaminated steroid injection

Things just keep getting worse: death toll rose to 14 and people affected was up to 172 in 11 states as of this afternoon. It’s difficult to find accurate information on the exact cause of the meningitis, but it appears that most of the cases are related to either Aspergillus or Exserohilum.

Fungal infections are notoriously difficult to treat, especially when they’re in the central nervous system (CNS). The CNS is designed like a fortress to keep things out, like fungus and bacteria, thus keeping you safe and healthy. Unfortunately it doesn’t discriminate and does a great job of keeping medications out as well. That’s why it’s hard to treat infections in the CNS.

I’ve been involved with several meningitis cases over the years, but rarely those involving a fungus. The outcome generally depends on several variables including how quickly the infection is discovered, how soon treatment is started, how aggressive the treatment is – you can never be too aggressive when treating meningitis – and the general health of the person you’re treating. A little divine intervention is always desirable as well. However, as I mentioned above, meningitis is difficult to treat and the outcomes associated with fungal meningitis aren’t great.

The CDC has released treatment recommendations. You can find them at the ASHP Pharmacy News site here.

“The Centers for Disease Control and Prevention (CDC) recommends i.v. voriconazole and liposomal amphotericin B as initial therapy for patients who meet the current case definition for fungal meningitis.

According to CDC, the antifungal therapy for patients with meningitis should be administered in addition to routine empirical treatment for potential bacterial pathogens.

CDC Medical Epidemiologist Tom Chiller said during an October 10 conference call that broad-spectrum antifungal therapy is advisable because it is “unclear as to how many potential fungal pathogens could be involved” in the outbreak.

For patients who meet CDC’s current case definition for fungal meningitis, the recommended dosage of voriconazole is 6 mg/kg administered every 12 hours. Chiller said the dosage should be maintained “for as long as the patients tolerate it.”

Liposomal amphotericin B should be administered intravenously at a dosage of 7.5 mg/kg/day, according to CDC. The agency stated that liposomal amphotericin B is preferred over other lipid formulations of the drug.

The optimal duration of therapy is unknown but is presumed to be lengthy.”

Emphasis above is mine.

Outsourcing sterile product preparation and the importance of quality assurance

I’m sure you’ve heard about the recent meningitis outbreak tied to a contaminated batch of preservative-free methylprednisolone acetate. The story has received significant attention as more that 100 people have been sickened and as many as eight have died as a result of receiving an injection of the contaminated steroid (this data is already out of date since I started composing this post yesterday).
Continue reading Outsourcing sterile product preparation and the importance of quality assurance