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.

DrugCite is a database hosted by the FDA that houses all the reported side effects associated with a drug. According to the website:

“One of the primary ways that the United States Food and Drug Administration monitors the safety of marketed drugs is the collection and analysis of reported adverse events (an event that was not the intended outcome of the prescribed drug and has a negative impact on health) through the Adverse Events Reporting System (AERS). These reports are submitted by physicians, healthcare consumers, lawyers amongst others, and then the FDA scientific staff will assess these events in the context of other databases to determine if a particular safety concern is associated, and possibly caused by, exposure to a particular drug. Since this is a public database and useful to prescribers and patients alike to know if “has what I’m experiencing been described in patients taking this drug before?” DrugCite has created a more friendly interface to answer that question. Use of this data should in no way be confused with the FDA’s rigorous process of evaluating the potential link of adverse events to drugs as causal but merely represents a portal into what is currently being reported to the Agency.”

It’s a neat concept, but please take the information with a grain of salt. Remember that the FDA will list anything that is reported while an individual is on a medication, whether or not the drug is truly the offending agent or not. For example, I searched for acetaminophen and received the graphs below. Looks pretty scary on the surface, but I consider acetaminophen to be one of the safest medications on the U.S. market when used properly. Something to consider when using this tool.

Several methods have been used to prevent errors associated with high-alert medications. Examples include the use of tallman lettering – which I don’t think actually works – physical separation of the SALAD pairs, the use of brightly-colored warning labels, double checks, etc. All these prevention methods sound promising on the surface, but people are prone to error regardless of the precautions put in place to prevent them. The best we can hope for is to eventually remove humans from the equation.

The Pharmacy Times article recommends the following to help reduce errors associated with high-alert medications:

• 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.
• The pharmacist who intercepted the methotrexate error [mentioned in the article] made 2 recommendations that can help catch wrong-drug errors involving highalert medications:
• With all high-alert medications, even if a DUR verification was previously completed, review the prescription’s directions and strength as well as confirm that it is for the right patient before placing it in the bag for pickup.
• Some pharmacy computer systems allow a pharmacist to put a “register hold” on prescriptions so that when the patient picks up the medication they are flagged to speak to a pharmacist. Require an automatic hold to be placed on all high-alert medications so that mandatory counseling occurs, increasing the chance that errors can be discovered. PT

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.

The ReVac Retracting Safety Syring by Revolutions Medical “use 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.”

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.

Ok, lets get down to business. In the 14 years that I’ve been a pharmacist I’ve had hope for the healthcare industry even though it’s done nothing to bolster optimism. I’ve seen nothing to prove that the healthcare industry is doing anything to actually improve the care that patients receive. Oh sure, governmental agencies have lots of rules and regulations, but a significant portion of those are kneejerk reactions to some problem that could have been dealt with in a much more effective manner. Medication errors continue to happen at an alarming rate, patients continue to have surgeries they don’t need while others sit waiting for surgeries they desperately need. Pharmacists scream for more authority in the healthcare system, but cower when confronted by anyone questioning their opinion. Physicians refuse to take advice from anyone besides the voices in their heads, and sometimes those voices are wrong; flat out wrong. Nurses find themselves in the unenvious position of being the first line of defense in the healthcare system only to realize that they’re unarmed to defend themselves or too hurried to care. And yes, we continue to develop new treatments and procedures to prolong life, but that doesn’t mean better care.

Unfortunately the years continue to go by without much changing. Has it gotten worse? In my tenure as a pharmacist I believe it has. Why do I believe this? Well, let’s just say that I’ve been on the wrong end of some interesting healthcare problems involving loved ones over the past several years. I shudder to think that this happens to every person, but I have no evidence to suggest otherwise. I’ve seen some pretty interesting things inside the walls of a hospital. I believe some stories are better, while others are worse, making my experiences average.

Exhibit 1: Physician induced drug overdose and failure to communicate – 5 years ago
My mom has a rare autoimmune disease that is destroying her liver. That’s a bad thing. She’s on the liver transplant list at the University of California San Francisco (UCSF) Medical Center. That’s a good thing. Several years ago she was overdosed on tacrolimus because her physician ordered 10mg bid instead of 1mg bid. Yep, a tenfold overdose. That’s a bad thing. She was admitted to a small hospital here in the Central Valley with a diagnosis of “dehydration”. She continued to go downhill and her primary care physician at this particular hospital refused to talk to me and my brother about it. Yes, he refused. My mom’s condition continued to deteriorate and when I asked to see the physician the hospital sent me a priest instead. He asked if I was ready to pull the plug on her. Uh, no, not yet. I made some calls to some people I still knew at UCSF, got her transferred and admitted to the ICU. Several weeks later she left the ICU, went to a general med floor followed by a couple of months of rehab and on to home where she’s still alive and well. That was 5 years ago.

Exhibit 2: Drug error – 4 years ago
Upon discharge from a hospital stay from a local hospital in the Central Valley my mom complained to me about being dizzy. The first thing a pharmacist does when someone complains about being dizzy is check their drug regimen. Sure enough, one of the physicians at this podunk hospital had prescribed methyldopa instead of magnesium. How the heck do you go from magnesium to methyldopa? It was so bizarre that it took me a couple of phone calls to get it straightened out. We discontinued the methyldopa and lo and behold she wasn’t dizzy anymore. Go figure.

Exhibit 3: Lack of caregiver attention – 2.5 years ago
My wife’s mother, Mary Lou died from lung cancer in December 2008. We had several problems with her care during her battle with the disease. Over anti-coagulation, under treatment of pain, inability to get ahold of physicians when needed, lack of communication with the hospital, pharmacy and oncology center, and so on. I mentioned it briefly in a previous blog. What made the entire experience so terrible was the toll it took on both Mary Lou and my wife, Lori. There were a lot of sleepless nights, tears shed and words of frustration spoken during a short six month period. And it was all because the healthcare system refused to deal with Mary Lou as an individual. Many times I argued with her physician because she would say “this is what we typically do“. A “typical” patient is not every patient.

Exhibit 4: He gave you what? – 1 week ago
I received a call from my Grandma last weekend. That’s not all that unusual. Sometimes I’m a bad grandson and forget to call her for a few weeks. She always finds time to call me and remind me that I haven’t called.

Me: “Hello”
G: “Hi Hun, you busy?”
Me: “At Mikaela’s track meet. What’s up?”
G: “The doctor gave me some sulfa drug and now I have red bumps all over. I called him and he gave me some c-e-t-i-r-i-z-i-n-e for the itching and rash.”

At this point I’m thinking two things: First, aren’t you allergic to sulfa? And if so why did your doctor give it to you? Second, why on earth would he give you cetirizine for a rash that sounds pretty bad and uncomfortable? …ok, back to the scintillating dialogue…

Me: “Yeah, it’s an antihistamine. Is it helping?”
G: “No, not really. Is there something else I can take?”
Me: “You know what Benadryl is?”
G: “Yeah”
Me: “Take 2 of the 25mg tablets. It will make you sleepy, but it should work a lot better than that other stuff”
G: “Ok, Hun”
Me: “Call me if you don’t feel better in a couple of hours, ok?”
G: “Ok”

Seriously? The physician gave her cetirizine for what I would consider a fairly significant allergic reaction to sulfa. Holy under-treatment Batman!

Exhibit 5: Poor communication, lack of empathy and stupidity – today
My father-in-law, Wayne, was involved in a rather nasty car accident about a week ago. He will survive, but he’s got a long road ahead to recovery. He’s already had one surgery to repair some damage to his spinal column, will require another surgery for a compound fracture to his ankle, has several stiches in his face and the pleasure of a couple of broken ribs. Each time I’ve been to visit him he seems to be improving. That’s good. But here’s the thing…

Problem one: He’s getting discharged to a skilled nursing facility today for rehab. That’s good. No one told my wife, a.k.a. his daughter that’s responsible for his care. That’s bad.

Problem two: The little pack of trauma surgery folks came by to see him while my wife and I were visiting. That’s good. They wouldn’t really answer our questions. They kind of danced around the subject. That’s bad.

Problem three: Wayne is an incredibly sharp, fit and healthy man. He was acting a little weird so I asked the physician and nurse about it, and they just shrugged their shoulders. The physician actually said, “from a physical standpoint he’s doing surprisingly well”. That’s good. “But as far as mentally, well, we have no way of knowing what his baseline is.” That’s bad. No further explanation was offered. No promise to think about it. No question as to whether we thought it was a problem. No discussion as to whether it would be permanent or temporary. Nada.

Problem four: Wayne doesn’t take medication. As I mentioned above, he’s very healthy. But I decided to ask the nurse what he was on, thinking that something might be affecting his cognition. Hey, it’s what pharmacists do. And to my surprise they’d put him on a medication that I thought was a little odd. The med didn’t really seem to fit any of his needs and in addition it requires routine labs to monitor drug levels. I voiced my concern to the nurse and she said “all drugs require levels”. Really? Hmm, I’ve been a pharmacist for a while and this is the first time I’ve heard that. Thanks for the education. Of course I didn’t tell her that I was a pharmacist because it typically creates problems. Nurses hate pharmacists. It’s just part of the circle of life; like cats and dogs.

I pressed the nurse on the issue and she grabbed one of Wayne’s physicians. The physician briefly looked up from her patient list as I ran through my concerns. In fact she acted annoyed that I was wasting her time with such trivial matters. She ended the conversation by saying that that wasn’t her area and I’d have to talk to someone else. Nice. Very nice.

Needless to say my wife and I left the hospital with more questions than answers.

As you can see, things really haven’t changed much in the past five years. Everyone is so caught up in healthcare that they’ve forgotten about the patient. And when healthcare forgets about the patient, well, let’s just say it’s over. Just sayin’.

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.

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.

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.