Clinical Summary
Mr. F. was a 66-year-old man with diabetes, hypertension, and heart failure.
He presented to the primary care physician for a 3-month follow-up appointment, having seen his cardiologist and his endocrinologist in the interim since his last appointment. He reported increased fatigue for 1 month.
He reported that both the cardiologist and endocrinologist had made changes to his medication regimen, but he did not bring the medicines and could not report the changes.
His primary care doctor did not have any documentation from the subspecialist visits .
The patient also had not had his electrolytes, BUN, and creatinine checked as ordered by his primary care physician at the prior visit, which were expected to be reviewed at today’s visit. His daughter who cares for him stated that his endocrinologist had ordered laboratory tests the prior month, so she thought he did not need any more blood drawn. He reported feeling generally weak and unwell .
The primary care physician decided that the subspecialty visit information would be helpful and had his offi ce call their offi ces to obtain it. The clinical documentation arrived by fax from the endocrinology offi ce, and it was found that the endocrinolo- gist increased the dose of metformin from 500 mg twice daily to 850 mg twice daily.
The blood test the patient and daughter referred to was a hemoglobin A1c of 7.4 mg/dl obtained last month. The cardiology offi ce had not yet faxed the last visit note.
Upon further history, the patient denied localizing symptoms. On physical exam- ination, his vital signs were normal. In contrast with his usually elevated blood pressure, his blood pressure at this visit was 110/65 with a pulse of 70. A thorough physical examination was unrevealing, but the primary care physician elected to order a stat panel of electrolytes, BUN, and creatinine. While the patients’ blood was being analyzed, the primary care offi ce received the cardiology documentation from 2 months ago, which includes a dose escalation in furosemide from 20 mg daily to 40 mg daily. There was no mention of laboratory monitoring following this medication change. Mr. F and his daughter were able to corroborate the addition of a second “water pill.”
A few hours later, the chemistry panel showed a serum sodium of 125 mg/dl, accounting for Mr. F’s symptoms.
Root Cause Analysis: Why Did This happen?
Fundamentally, this adverse event stemmed from suboptimal self-management of chronic diseases [ 1 ] and, similar to most adverse events, can be attributed to multiple contributing factors [ 12 ]. The most important root causes and potential solutions are discussed below.
Treatment Complexity
Mr F. has multiple comorbid conditions, and as such, multi-morbidity is known to be associated with adverse drug events and poor health outcomes [ 8 ]. Evidence sug- gests that adverse drug events are less related to any particular medication than to the overall number of medications prescribed [ 13 ], which implies that complex regi- mens, as well as “high-risk” medicines, should be considered a safety risk.
Medication Understanding
Neither Mr. F nor his daughter is able to name his medications. This type of medica- tion confusion is the norm rather than the exception due to the high cognitive demand in managing medications [ 14 ]. Literature shows that most patients cannot name all of their medications [ 15 ] or report medication changes accurately even immediately following an outpatient visit [ 16 ].
Mr. F’s medication confusion could be due to limited health literacy that leads to a lack of medication understanding [ 17 ] or to visual impairment leading to diffi culty reading medication labels. Individuals with limited health literacy and language barriers report greater problems across a range of communication domains, including informed consent, shared decision making, and elicitation of concerns. Mr. F could also have cognitive impairment, a common condition for which there is often a delay in diagnosis, further impairing medication understanding.
Patient–Physician Communication
Mr. F’s medication confusion also stems from inadequate patient–physician commu- nication. The adequacy of communication between patients/caregivers and providers is crucial to patient safety. Suboptimal clinician–patient communication in chronic disease care is a consequence of multiple infl uences at the practice and system level, including medication labeling procedures and the communication practices of physi- cians and pharmacists. Most physicians fail to explain the four key aspects of a medication—name, dose, indication, and potential adverse effects—when initiating a new medication in the outpatient setting [ 18 ]. Time pressure in the outpatient visit is often cited as a reason for suboptimal medication communication [ 19 ].
Aggressive Treatment Goals
Mr. F’s various physicians were likely trying to achieve recommended blood pressure and glucose targets by intensifying his medications. Increased attention to stringent treatment goals may paradoxically lead to adverse events, as has been demonstrated for elders [ 20 ]. Aiming aggressively for lower blood glucose or blood pressure in hopes of reducing risk of future complications may increase adverse treatment
effects such as symptomatic hypoglycemia or orthostasis, respectively, as reported by the ACCORD and ADVANCE clinical trials [ 21 , 22 ].
Symptom Recognition
Mr. F. experienced fatigue for 1 month after initiating a new medication, but did not report his symptoms either to the prescribing physician (cardiologist) or his primary care provider. Recognition of medication-related symptoms is part of self- management. Had Mr. F. reported his symptoms earlier, the medication could have been discontinued sooner without the resulting morbidity.
Transitions Among Multiple Providers
Communication
Mr F. sees multiple physicians who all adjust his medications and perform monitor- ing. It is well documented that transitions between care settings, and between primary care, specialty care, pharmacy, other providers, caregivers, and home care, pose a risk for adverse events [ 23 ]. In current outpatient practice, providers often rely on patients to report the outcome of subspecialty visits. However, many chronic disease patients like Mr. F cannot report the result of physician visits to the subse- quent physician reliably and accurately. Therefore, Mr. F’s primary care provider must rely on documentation from subspecialists, outside his practice, which he did not receive.
This case highlights the risk inherent in the transitions between ambulatory physicians (safety risks in care transition and handoff during inpatient settings is discussed in another chapter). Timely communication among providers is critical for comanagement of chronic conditions [ 24 ], and is known to be inadequate [ 25 ].
Although electronic health records (EHRs) are expanding rapidly, most ambulatory practices still use paper records and communicate with each other with faxed or mailed information. The lack of information about Mr. F’s cardiology and endocri- nology visits made it more diffi cult for his primary care provider to determine the cause of his fatigue, which turned out to be related to hyponatremia from an increased dose of his diuretic medication.
Medication Monitoring
One would expect that changing the dose of a diuretic medication would require monitoring for symptoms and a blood test to ensure that electrolytes remain within normal limits. The cardiologist did not specifi cally document that she planned to monitor the patient following his medication change. This omission of medication monitoring is a frequent problem in the ambulatory setting [ 26 ]. A related concern is the patient and caregiver’s lack of understanding about monitoring. Mr. F’s daughter did not take him to have the blood tests ordered by his primary care
physician because she assumed that the prior month’s blood test ordered by the endocrinologist would be suffi cient and would be communicated to the primary care physician. Had Mr. F undergone the blood test as scheduled prior to his primary care visit, he would have been diagnosed earlier.
Shared Physician Responsibility
When multiple providers are involved in a patient’s care, it is often unclear which provider assumes responsibility for following up on a problem. It is possible that the cardiologist thought that the primary care provider would be checking the patients’
electrolytes and thus decided not to order blood tests following the medication change. There is currently no clear standard about who should follow-up in an area of subspecialty-primary care overlap, and this lack of clarity leads to safety prob- lems [ 27 ].
Table 20.1 summarizes the root causes and solutions/best practices applicable to Mr. F’s case.