The objective of this study was to estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. The authors performed a meta‐analysis of 39 prospective studies done in the United States over a period of 32 years on the incidences of Adverse Drug Reactions (ADRs). The goal of this study was to “estimate injuries incurred by drugs that were properly prescribed and administered.” If the event was determined to be a “Possible ADRs” it was excluded from this study. The authors noted:
“We estimated that in 1994 overall 2,216,000 (1,721,000‐2,711,000) hospitalized patients had serious ADRs and 106,000 (76,000‐137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.”
“We have found that serious ADRs are frequent and more so than generally recognized. Fatal ADRs appear to be between the fourth and sixth leading cause of death. Their incidence has remained stable over the last 30 years.”
“It is important to note that we have taken a conservative approach, and this keeps the ADR estimates low by excluding errors in administration, overdose, drug abuse, therapeutic failures, and possible ADRs. Hence, we are probably not overestimating the incidence of ADRs.”
This study on ADRs excluded medication errors “to show that there are a large number of serious ADRs even when the drugs are properly prescribed and administered.”
“The incidence of serious and fatal ADRs in US hospitals was found to be extremely high.”
The incidence of hospital adverse drug reactions detailed in the Lazarou and colleague’s study is stunning:
•106,000 yearly deaths; these deaths rank between the 4th and the 6th leading causes of death yearly.
•2,216,000 yearly events that required hospitalization to recover or resulted in a lifelong disability.
Importantly, these numbers require additional discussion. These statistics pertain only to hospitalized patients; they did not assess similar such events occurring outside of the hospital setting, in locations such as nursing homes, extended care facilities, at home, etc.
Additionally, and more startling, these deaths and serious adverse events occurred as a consequence of taking the correct drug for the correct diagnosis in the correct dosage. As such, these deaths and serious adverse events are not considered to be as a consequence of error. Rather, they are considered to be “fallout” of a health care delivery discipline that is heavily dependent upon pharmacology.
Cliff Atwell, B.S., D.C.