Skip to content

Enalapril Medication Error RCA – Reliability Center Inc.

  • by

Medication Error case history performed in PROACT Root Cause Analysis software. Patient Death due to Medication Error and Missed Diagnosis of Anaphylactoid Reaction.

Hi and welcome back to our rc a lessons learned series today’s case will be narrated by myself robert j latino ceo of reliability center incorporated and dr. tricia pihl today’s case a patient death due to medication error and misdiagnosis of an anaphylactic reaction i’d like to thank dr. david benjamin for use of the source document reducing medication errors and

Increasing patient safety case studies in clinical pharmacology i’m going to turn it over to dr. pill now for a description of the case background tricia thank you bob the here’s our case for today a 63 year old male had been on enalapril for one year for treatment of hypertension he experienced some difficulty swallowing and discomfort in the back of his throat

And was instructed by his physician to go to the emergency room of a local hospital upon arrival in the mergency room the exam was significant for mild difficulty breathing he received the dose of intramuscular diphenhydramine and oxygen by facemask within 30 minutes he was breathing more comfortably and was subsequently admitted to a general medical floor for

Overnight observation the next morning the patient’s wife arrived with a bag of her husband’s other medications meds that she said her husband took daily the nurse called the admitting physician and received permission to administer these medications including another dose of enalopril the patient was discharged later that day the day after discharge the patient

Suffered an episode of acute angio neurotic edema with dysphasia lip swelling and airway obstruction and unfortunately he died before paramedics could respond now turn the presentation back over to bob to begin our root-cause analysis thank you trisha now let’s move to a review of the logic tree okay i’m gonna leave the legend up which is to the left and this will

Describe any icons that may not be understood that are on the blocks what we need to understand basically about the logic tree is that from level the level represents a cause-and-effect relationship after we leave the mode level we’re going to be asking the same question how could the previous event have occurred and then as we get down the tree and we start to

See human decision-making we’re going to switch the questioning to why why would someone have made that decision at the time that they did okay the event in this case is a fatal anaphylactic reaction post-discharge the mode is going to be that the patient received a second dose of an hour perl and now will become hypothetical and say well how could that occur the

Staff permitted the administration of the non pharmacy issued meds and there was an unrecognized adverse reaction to the medication itself please recognize in the lower left hand corner is what we call a confidence factor there’s scale ranges from zero to a five where the five means that with the evidence that we have this is absolutely true and a zero means that

With the evidence we have this is not true and obviously there’s shades of gray for lack of conclusiveness of the evidence behind each of these blocks is going to be a verification log it’s going to represent that the verification method used the verification outcome and any file links that we have to support our hypothesis so let’s get started with drilling down

The tree how could the staff have permitted the administration of non pharmacy issued meds there was a communication breakdown between the nurse and the attending md why was that inadequate quality control systems in place to protect against communication gaps and this will be seen throughout this particular case okay the fact that we administered non pharmacy meds

Was a rule violation because there were protocols in place to prevent that from occurring yet we did it anyway and then we had a communication breakdown between the admitting floor team and the idi again inadequate quality control systems in place to protect against communication gaps okay let’s go to the other side of the logic tree now and address the issue of

Unrecognized adverse reaction to medication how could that have occurred lack of knowledge about the potential regarding the effects of enalopril and the anaphylactic reaction as well as idi records not available not accessed by the floor okay well i was there a lack of knowledge about the potential regarding the enalapril and anaphylactic reaction well the incidence

Is rare and tricia is going to be talking about that in the upcoming slides about exactly how rare that is and there was a failure to link the signs of the patient presentation to the side effects of this particular drug why again the rare incidence aspects and there was unrecognized clinical presentation the idi records were not available not accessed by the floor

Why communication breakdown between the admitting floor team and the idi as well as interdepartmental computer interface issues that contributed to this as well okay so this gives us a feel for the cause and effect and notice that we put a circle around anything that’s considered a systemic or a latent root cause because by addressing these we will address the

Behavior and the decision-making of the people involved okay let’s review our rca findings the latent or systemic root causes of this incident can be directly attributed to the following inadequate quality control systems in place to protect against communication gaps rule violation allowing the administration of non pharmacy dispensed medications communication

Breakdown between the admitting floor team and the idi a rare and unrecognized clinical presentation a failure to link the signs of patient presentation to the side effects of the drug and lastly interdepartmental computer interface issues okay i would like to make one point before turn it over to dr. pill about the ending of weed weed is the equivalent of like

An anaphylactic reaction is like an anaphylactic reaction but it does not involve the immune system for clinical description of this i want to turn it over to dr. pill dr. pill thank you bob at this point it will be helpful to talk about anaphylactic reactions from the clinical perspective and then see how this knowledge combined with the rca findings we just heard

About can lead us to a potential solution for averting a future fatal and a black-tie event let’s start with the basic definition an anaphylactic reaction is a rare non immune mediated hypersensitivity reaction that is clinically indistinguishable from true ige mediated anaphylaxis and that’s a mouthful even for those of us in the medical field so let’s just break

It down to the essentials that anaphylactic reactions are non immune and non ige mediated means that the body does not need to produce immunoglobin e antibodies in order for the reaction to occur typical allergic reactions to be and peanuts for example happen when a patient’s immune system has been previously exposed or sensitized to the offending agent as a result

Of this initial exposure the body produces immunoglobin e antibodies that prime the patient’s immune system for a full-blown and affa lastik reaction with the next bee sting or peanut ingestion this sensitization process does not occur in an anaphylactic reaction and so an anaphylactic reaction can occur without warning and following a single first-time exposure to

An agent as if this weren’t scary enough anaphylactic elastic reactions look and kill the same patients may experience the full range of symptoms of respiratory distress low blood pressure tongue and lips swelling difficulty breathing and swallowing and widespread hives there’s no diagnostic test for an anaphylactic reaction if the clinical diagnosis you make when

You see a patient that looks for example like the picture on this slide treatment is supportive and again the same as for anaphylaxis airway stabilization oxygen diphenhydramine epinephrine steroids and iv fluids because ana phylactery actions are rare and i’ll get to the statistics on the next slide and because they can happen without prior warning or history it’s

Essential that clinicians be aware of the possibility and be prepared to treat quickly unfortunately the list of medications associated with anaphylactic reactions is fairly small it includes a class of drugs commonly used to treat hypertension and congestive heart failure known as angiotensin converting enzyme or ace inhibitors enalopril captopril and lisinopril

Are all frequently prescribed drugs in the eighth inhibitor family you may recognize them from their trade names vasotec capitan and vest roll the mechanism of action for eighth inhibitor associated anaphylactic reactions is not well understood one hypothesis is that ace inhibitors mimic a substance in the body called bradykinin which is known to cause lip swelling

However it happens though it’s important to know that ace inhibitors exhibit cross reactivity that is if the patient experiences an anaphylactic reaction to one ace inhibitor he or she is likely to experience in ana last word reaction to other ace inhibitors as well anaphylactic reactions to ace inhibitors are rare according to post-marketing studies conducted

By one major pharmaceutical manufacturer the incidence was between point zero two and point one percent besides ace inhibitors other drugs have been associated with similar adverse medical reactions including aspirin non-steroidal anti-inflammatory agents like ibuprofen and naproxen and i ordinated contrast media used during cardiac catherization procedures so

Again a high degree of suspicion and preparedness is necessary when dealing with anaphylactic reactions turning back to our case which involved an unrecognized fatal anaphylactic reaction to the ace inhibitor enalapril what could have been done differently to prevent this outcome the root cause analysis logic tree shows us the full range of possibilities well in

Today’s case we attack in a major branch point in the tree after the patient has already experienced and been treated for an adverse reaction to enalapril in emergency room but before he receives the second fatal dose on the hospital ward yet we know from our rca that a major contributing factor to this patient’s death was that the clinicians did not recognize

The critical link between the anaphylactic reaction in the emergency room with the enalapril that was on the patient’s medication list how then can we provide a system-level solution to this problem our proposed solution harnesses information technology to provide a conditional situation alert system for detecting rare but potentially fatal anaphylactic reactions

To medications the alert is activated when two conditions are present simultaneously in the patient’s medical record one administration of medications typically used to treat anaphylactic reactions such as diphenhydramine epinephrine and prednisone and two an order to pharmacy for medication associated with anaphylactic reactions such as an eighth inhibitor when

These two conditions are met an alert is triggered on the computer to the physician for example doctor your patient is on enalopril enalapril is rarely associated with anaphylactic reaction have you considered this diagnosis do you wish to continue to order an alle prell the physician would then have the choice to discontinue the drug put the drug on hold and choose

An alternative or override the alert although our specific case example today is with enalopril a computerized physician order entry algorithm could easily include any of the previously mentioned medications also associated with anaphylactic reaction now this type of conditional alert system is commonplace in many industries outside of healthcare bob would you

Like to say a few words now about this thank you tricia yes in industry compressors have safety mechanisms that use something called voting logic to safely shut them down this mechanism is embedded in their controls and their instrumentation for instance a safety issue may exist if an alarm limit is exceeded on two of the following three parameters temperature

Pressure and/or flow if two of the criteria are met then the system will automatically go into a routine to safely shut down the equipment to prevent catastrophic damage and risk of injury to personnel this concept could also be applied to the medication alert systems in this case okay this concludes this case for more information on this case or the rca approach

Used please visit

Transcribed from video
Enalapril Medication Error RCA – Reliability Center Inc. By Reliability Center Inc. PROACT® Root Cause Analysis Training Consulting Templates \u0026 Software