Like many other articles I’ve read recently, this one is from data collected quite a while ago. The information was obtained from 61 patients between  June and October 2010. The article is from the March 2012 issue of the journal. I always marvel at how long it takes study results to get published.

The only problem with the information is that it’s from a 20-month period between January 2005 and August 2006. I hate to break it to you Joint Commission Journal on Quality and Patient Aafety, but that makes the information all but useless. Interesting, but useless.

4/18/12 - Putting Pharmacogenomics into Practice Strategies for Successful Implementation

Leslie Mackowiak, RPh, MS will briefly introduce pharmacogenomics and some standard terminology. She will then review the experience of the pharmacists in supporting the practical application of pharmacogenomics into clinical practice using computer tools. This will involve describing the role of electronic health records and clinical decision support in facilitating drug management using pharmacogenomics. She will identify strategies and techniques for pharmacists to lead the introduction of pharmacogenomics at their practice site.

Pharmacogenetic information is currently included in more than 200 drug labels in the United States and the field continues to grow rapidly. There has not been a commensurate effort to establish the resources, methods, and infrastructure, which would allow the translation of such evidence, representing a major obstacle in the application of testing.

Mackowiak will describe how Vanderbilt University Medical Center assembled a multidisciplinary, multidepartment team consisting of pathology, informatics, pharmacy, practicing clinicians, ethicists, and legal and regulatory administrators to oversee the implementation of pharmacogenetics.

5/2/12 - Mistake Proofing to Reduce Medical Errors

A mistake-proofing device is any mechanism that either prevents a mistake from being made or makes the mistake obvious at a glance. The ability to find mistakes at a glance is essential because, as Shingo writes, “The causes of defects lie in worker errors, and defects are the results of neglecting those errors.  It follows that mistakes will not turn into defects if worker errors are discovered and eliminated beforehand.” Most mistake-proofing devices are physical objects which can be photographed. 

Dr. John Grout has been researching, documenting and teaching Mistake-proofing for 20 years.  Learn about this technique for eliminating defects, improving quality, and streamlining work. He will discuss mistake-proofing within the specific context of health care, including lots of examples.  

Failing to employ available dose error-reduction software (DERS) as intended and to heed important clinical alerts are common contributors to these errors. In particular, the misuse of custom concentration options (i.e., user must fill in the concentration) that do not employ a hard (requires reprogramming) minimum concentration limit is a prime example. This issue contributes largely to preventable errors with smart pumps given the counterintuitive, inverse relationship between concentration and volume. More concentrated drugs require less volume to deliver a specified dose; less concentrated drugs require more volume to deliver a specified dose. When using “fill-in-the-blank” custom concentrations, the concentration must be programmed into the pump so it can calculate the volume needed to deliver the prescribed dose. If the programmed concentration is lower than the actual concentration in the infusion bag or syringe, the pump will deliver an overdose. If the programmed concentration is higher than the actual concentration in the bag or syringe, the pump will deliver an underdose. Without a hard minimum concentration limit, the former scenario has led to life-threatening events, such as those described below.

Here’s a great example from the article that made the light bulb go off in my mind:

A physician prescribed IV HYDROmorphone 20 mg/100 mL (0.2 mg/mL) to infuse at 2.5 mg/hour. In this hospital, the standard concentration for this infusion was 0.1 mg/mL, so the custom concentration of 0.2 mg/mL had to be entered into the smart pump. The nurse selected the custom concentration option then mistakenly entered 2.5 mg/100 mL as the concentration instead of 20 mg/100 mL. Given the erroneously programmed concentration of 0.025 mg/mL, the pump issued a soft (can be overridden) low concentration alert. The nurse overrode the warning, mistakenly believing the warning was inconsequential. Based on the erroneous concentration, the smart pump infused the drug at a rate of 100 mL/hour, while the intended rate was 12.5 mL/hour. The pump delivered the entire bag of HYDROmorphone 20 mg to the patient in 1 hour.

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 basically a search engine for the Food and Drug Administrations (FDA) Adverse Event Reporting System (AERS). Acording 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.