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Use case 1 - Device Adverse Event

On December 12, 2005, J. Doe, a 54 year old female was admitted to the Outpatient Surgery Center for the placement of a Medical Corporation X, Model LS 4700, implantable pain pump. In surgery, the pain pump was implanted without difficulty and was determined to be functional.

After the procedure the patient was transferred to the recovery area for stabilization. In the recovery room, the anesthesiologist, Dr. Zoe, initiated the programming of Ms. Doe’s implanted pump. During this set-up procedure the pump stopped functioning and the pump’s visual display went blank. The anesthesiologist was unable to troubleshoot the cause of the device failure, nor restore its function. The patient was informed of the device failure and opted to return to the O.R. the next day for the removal of the defective device and placement of a new pain pump. The second Model LS 4700 implantable pain pump was implanted and completed its programming process without difficulty.

Use Case 2 - Procedure Adverse Events with Complications

Mrs. Jones is a 68 year old female scheduled for a routine colonoscopy in an outpatient surgery center.  Her current medical history included hypertension for which she took Cozaar 50 mg daily, and Naproxen 500 mg daily for her osteoarthritis. 

The patient followed the usual bowel preparation routine (polyethylene glycol solution) and the procedure began with the introduction of the endoscope by the gastroenterologist, Dr. Colon.     The ascending and transverse colon showed no significant findings but the presence of a .5 cm sessile adenoma in the sigmoid colon merited removal.  The gastroenterologist performed a polypectomy with electrocautery and completed the procedure. 

Mrs. Jones was discharged two hours after the procedure.  One the second day after the procedure the patient experienced symptoms of fever, localized abdominal pain, localized peritoneal signs and leukocytosis.  Upon examination by Dr. Colon, Mrs. Jones was found to have an electrocoagulation injury to the bowel wall that caused a transmural burn and localized peritonitis without evidence of perforation on radiographic studies.  Her postpolypectomy electrocoagulation syndrome was managed with intravenous hydration, antibiotics, and nothing by mouth until the symptoms subsided. 

Use Case 3 - Drug-Drug Interactions

A 39-year-old female was evaluated for episodes of syncope and light-headedness that began two days prior to her hospital admission. The history was consistent with possible cardiovascular causes, and the patient was admitted and placed on telemetry where the preceding rhythm strip was observed.

Ten days prior to admission she had been prescribed terfenadine (Seldane—an antihistamine) 60 mg twice-a-day and cefaclor (Ceclor—a cephalosporin antibiotic) 250 mg three-times-a-day. On the eighth day of terfenadine therapy the patient began a self-medicated course of ketoconazole (Nizoral—an azole antifungal) at 200 mg twice-a-day for vaginal candidiasis. She was also taking medroxyprogesterone acetate at a dosage of 2.5 mg a-day. Upon admission to the hospital the patient was noted to have a QTc interval of 655 milliseconds (normal is less than 440 milliseconds). During the hospitalization the patient experienced near syncopal episodes associated with torsades de pointes noted on telemetry.

After discontinuing the medications, the QTc interval normalized. She had no further episodes of torsades de pointes, and she was discharged with no recurrence of syncope.

Monahan BP, Ferguson CL, Cleave ES, Lloyd BK, Troy J, Cantilena LR. Torsade de pointes occurring in association with terfenadineuse. JAMA 1990;264:2788–2790.

Use Case 4 - Fall with injury

A 75 year old woman Mrs. Jones was admitted to an in-patient oncology service for treatment of Non-Hodgkins lymphoma because of a persistent fever.  The patient used a cane for ambulation because “she felt unsteady on her feet” and therefore, a fall-risk protocol was implemented. 

During the second night of her in-patient stay Mrs. Jones awoke and rather than ringing the nurse call bell, decided to ambulate on her own to the bathroom.  After getting out of bed, Mrs. Jones fell and broke her hip. The hip fracture was treated with internal fixation (e.g. single compression hip screw).  The broken hip extended Mrs. Jones’ stay by one week and required an admission to a rehabilitation facility for physical therapy.  The hospital documented the incident in the occurrence reporting system, and Mrs. Jones’ care and treatment was documented in her electronic health record. 

Use Case 5 - Near Misses

Annie Patient a 78 year old woman is scheduled for a hip replacement.  After her arrival in the operating room but before induction of anesthesia it is discovered that the size of prosthesis that was felt to be most appropriate has not been sent to the OR, although the size above and below are available.  The missing size prosthesis is brought to the OR from central supply and arrives before anesthesia has begun.

Use Case 6 - Medication Administration Error (no harm adverse event)

Arnold Bear, a 70 year old male patient hospitalized for an elective hip replacement is inadvertently given a capsule containing 3,000 IU of Vitamin D intended for a patient in the adjacent room who is receiving a daily Vitamin D supplement because of Vitamin D deficiency in the past. 

Mr. Bear experiences no symptoms and has no conditions which would be affected by Vitamin D intake. The inadvertent administration of Vitamin D is documented in his medication administration record and in a clinical note in his record. An incident report is completed in the hospital’s incident reporting system.

Use Case 7 - Adverse Reaction with assumed causality

A 64 year old woman was experiencing profound dryness of the eyes resulting in blurred vision.  A treatment regimen with tear duct plugs and Xiidra, a twice daily ocular solution.   Following a week of this regimen, the patient experienced a yellowish exudate from both eyes, with inflammation of the eye lid.  An examination by a lacrimal specialist revealed calcium deposits in tear glands, and recommended that the Xiidra be stopped.  The tear duct plugs remained in place but dissolvable.

After stopping the Xiidra, the symptoms abated after 72 hours.  The patient filed a MedWatch report detailing the symptoms experienced with Xiidra. (Note that a patient reported event automatically assumes causality). 

Use Case 8 - Clinical trial: significant adverse event

Clinical Trial – Significant Adverse Event

This scenario involves a phase 2, clinical study evaluating the safety and efficacy of a new oral agent administered daily for treatment of severe psoriasis unresponsive to FDA-approved treatments.  There are two arms of the study – subjects receiving the new oral agent or a placebo.  Only the research pharmacist is aware of the arm assignment.    The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. 

The known risk profile of the new oral agent prior to this event included mild elevation of serum liver enzymes in 10% of subjects receiving the agent during previous clinical studies, but there was no other history of subjects developing clinically significant liver disease.  The IRB approved protocol and informed consent document for the study identifies mild liver injury as a risk of the research.

The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

Use Case 9 - Adverse Event resulted from a separate prior breach

A 39 yo male patient with terminal pancreatic cancer in a palliative care agency is prescribed morphine hydrochloride 40 mg/24 hours + hyoscine butylbromide 80 mg/24 hours by continuous subcutaneous infusion via syringe driver for symptomatic control of pain, respiratory secretion/rattles, and anxiety.

Breakthrough doses of 5 mg q1h prn SC is also prescribed for incidental pain (related to care or ADL activities).

Pre-mixed morphine hydrochloride 40 mg + hyoscine butylbromide solution 80 mg in 20 ml syringes are ordered by the pharmacy from a pharmaceutical supplier and delivered to the palliative care ward in 3-day supply batches.

The medications are administered as continuous SC infusion using a syringe driver device. Each syringe containing the pre-mixed medications are double checked by two nurses, attached to the syringe driver, administration rate setting on the device checked, and start button pressed. The patient on average also receives 3-4 breakthrough doses per day 30 mins before certain care/ADL activities.

In week 5, a new 3-day batch of supply was delivered by the pharmacy. In the morning of the third day, the nurse found that the patient appeared to be a bit drowsy. On observation, the heart rate was 62/min (patient’s baseline heart rate = 76-82/min), temperature = 38.7C (with no indicative signs of infection); dry skin and mucosa; bilateral increased pupil size; patient also complained of slight difficulty in urination.

A pancreatic enzyme capsule (Creon / Nutrizym / Pancrease / Pancrex) is the only other drug that this patient is prescribed and taking.

The nurse immediately stopped the syringe driver, initiated review all previous medication administration record to the moment adverse event was identified. There was no evidence of adverse reaction to the medications administration since the start of the morphine + hyoscine therapy.

The nurse made an assessment that there was a temporal relationship between the adverse reactions and administration of this new batch of premixed morphine + hyoscine medication supply, recorded the S/S, the assessment. The nurse reported the adverse event to the pharmacy for investigation.

The pharmacy contacted the supplier to initiate an investigation, which revealed that a software error had occurred resulting in a wrong label (morphine 40 + hyoscine 80) being printed and attached to this batch of pre-mixed morphine + hyoscine with dose strength of 60 + 120.

NOTE - a use case in which the initial reporting of adverse event will not have a "condition" or "diagnosis"

The nurses at palliative care agency are unlikely to have the clinical knowledge to determine that the S/S exhibited by the patient are those of morphine toxicity and anticholinergic syndrome resulted from drug overdose.

It is more likely that the nurse will record the adverse reaction S/S

The case will be reviewed by a physician and the diagnosis of morphine toxicity and anticholinergic syndrome caused by drug overdose will be determined and recorded

(See also the "Adverse Event and Consequences" confluence page for another similar use case)


Use Case 10 - Adverse Event from workflow breach (substandard care)

A patient with congestive cardiac failure (comorbidity) was seen in ED for urinary tract infection. Antibiotic was prescribed and furosemide dose was increase. He stayed in an observation bed for 12 hours and was discharge home with antibiotic and increased dose furosemide. He was not told to see his primary care physician for follow-up assessment and monitoring.

Four days later, patient returned to ED complained of generalised weakness and reduced urine output. Creatinine was significantly elevated and he was diagnosed with acute renal failure secondary to furosemide.

This is a case of adverse medication reaction due to workflow breach (patient not advised to see his primary care physician for assessment and monitoring)

Use Case 11 - Adverse Event with no breach of clinical or workflow protocol

An adverse event may result even when proper protocol was followed.

For instance, giving a medication to a patient allergic to that medication represents a breach in protocol or standard of care 

However, giving a medication to a patient with no known allergies to the medication in question constitute an adverse event with no associated protocol or clinical workflow breach. But there is a causal relationship between the event (the administration of the given medication) and the adverse reactions. The adverse event report shall document both cause and effect but shall not label the cause a breach of clinical or workflow protocol.

Note: this is important when adverse event reports are used to assess the quality of care or for quality improvement purposes. In this case, no error was committed even though an adverse reaction resulted









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