MEDICATION ERRORS

SUMMARY: Adverse Drug Events are in the top half-dozen causes of death in the US. Each year medication errors cause 20 deaths per million North Americans and many more are seriously injured. Preventable Adverse Drug Events are often difficult for the medical malpractice lawyers to detect and litigate.

About 1 in 15 hospitalised patients will have a serious Adverse Drug Events (ADE), and for 1 in 300 it will be fatal¹. 

3-4% of people admitted to hospital  are injured or disabled by adverse events that occur there ². 

About a fifth of those adverse events are medication-related.  Mistakes in continuing regular medications at hospital admission are particularly common^2a. 

Adverse Drug Events - mistakes that result in harm - are only the tip of the iceberg. 

Medication errors that have no recognised consequences, are a hundred times as common³.

Nearly 6% of prescriptions for pediatric inpatients had errors⁴. 

Depending on definitions, and excluding merely incorrect timing of drug administration, between 6%⁵ and 33%⁶ of medication administrations in Intensive Care Units had at least one error. 

However, not all ADEs are caused by drug errors. 

Not only may idiosyncratic drug reactions occur after first exposure to a medication but, in any particular patient,  the adverse effects of a newly prescribed drug may unpredictably outweigh the benefits.

Each year medication errors cause 20 deaths per million North Americans and many more are seriously injured.

It is preventable ADEs, arising from substandard medical care ⁷, that are the concern of medical malpractice litigators. 

About a third of ADEs are considered preventable⁸.

Overall, medication errors are estimated to cause 7000 deaths a year in the US³, and there is no reason for thinking that figure does not translate into around 700 a year in Canada. 

Drug errors are of various types and occur at different stages in the prescribing-dispensing-administering cycle. 

Changes in a wide range of activities by health-care providers will be needed to achieve substantial improvement in performance.  

Leaders in Risk Management are keenly aware that weaknesses throughout the system (System as Defendant) combine to create errors, and that finger-pointing and punitive  approaches are counterproductive⁹. 

With hindsight analysis, it is often easy to see how cumulative minor errors have led to an adverse outcome. 

Medicolegal Aspects

Identifying Substandard Drug Care

Preventable Adverse Drug Events are often difficult for the medical malpractice lawyers to detect and litigate.

Detecting ADEs that arise from substandard care has its own particular problems. 

Depending on the need for documentation of the medication error for ongoing care, details of the mistake may be partly or completely absent from the hospital chart. 

Reading “between the lines” of the nurse’s notes and reviewing all laboratory results may reveal clues to undocumented incidents. 

Practice Point Do not allow Health Records to omit copies of Nurse’s Notes and laboratory results “for economy” if Cause of the adverse outcome is unclear

Thus, the cause of an adverse event may be discussed openly by the management team but, if that cause is irrelevant to future care, prudence may dictate that it not be documented in the patient record. 

Hopefully in most instances the error will at least be the subject of confidential reporting and routine enquiry, but such information will not, of course, be available to medical malpractice counsel. 

On occasion, verbal disclosure to patient or family will alert the litigator, even though there is no official documentation. 

In some instances, circumstantial evidence will be fairly obvious. 

If an inappropriate drug, combination of drugs or dose has been prescribed, there will usually be little difficulty in establishing causal connection. 

Commonly, however, administration error will have to be deduced from unexpected deviation from the natural history of the illness. 

A classic example would be hypoglycemic (low blood sugar) coma after Insulin is administered in the wrong dosage or to the wrong patient. 

In the “unexpected deviation” situation, counsel may be hard-pressed to obtain robust medical expert opinion on Causation. 

Causation and Quantum

Even when substandard care can be shown to have Caused a serious Adverse Drug Event, the adverse outcome of the hospitalisation, death or disability may not be more than minimally attributable. 

In the absence of substantial pecuniary damages, any potentially defensible aspects of the case may threaten the economic viability of an Action.  

Medical Expert Opinion

It has been well established that hindsight bias is strong in the determination of medication error negligence.  

Practice Point Hindsight Bias may strongly favour the plaintiff in cases of preventable Drug Adverse Event

Anecdotal evidence suggests that assessors are much more ready to find that care was substandard when they have access to knowledge of an adverse outcome¹⁰. 

With all the facts, it may be obvious to an inquiry why things went wrong, but those facts were not available to any one player at the time. 

His or her performance must be judged on the basis of what information actually was, or could have been, accessible before the event occurred.