Potential Risks and Prevention, Part 3
Potential Risks and Prevention, Part 3
Potential risk factors for and the preventability of drug-induced threats to life were studied.
Case reports of adverse drug events(ADEs) published in Clin-Alert during 1977-97 were the source of information on drug-induced life threats. Patient, drug, and event variables were identified, and the causality, predictability, and preventability of each case were assessed. Data were entered into a relational database for analysis.
The data indicated 846 drug-induced life threats. Seventy-four percent of the cases were assessed as definite or probable. Patients received usual or below-usual dosages in 89% of the cases. Patients tended to be middle-aged and only moderately ill.The drug categories most frequently associated with life threats were antimicrobials and central-nervous-system agents. Plasma drug level monitoring should have been performed in 127 cases but occurred only in 31 cases (24%). Event types were distributed as adverse drug reactions (50%), allergic reactions (35%), drug interactions (11%), and medication errors (4%). A commercial reference classified almost half of the drug interactions associated with a life threat as posing minimal or no potential risk to the patient. Half of the life-threatening events were judged to have been preventable;about half of these could have been prevented by a pharmacist. Litigation was reported for only 1% of the cases of drug-induced threats to life; judgments and settlements averaged $1.2 million.
A review of published case reports of ADEs for 1977-97 yielded information on possible risk factors for drug-induced life threats and on which events may have been preventable.
This report is the third in a series of four describing significant adverse drug events (ADEs), including adverse drug reactions(ADRs), allergic drug reactions, drug interactions, and medication errors. The present study was conducted to generate hypotheses about what may contribute to drug-induced threats to life and to discover what mechanisms or guidelines are needed to prevent these events.
The primary objectives of this study were to (1) identify case reports of drug-induced life threats, (2) develop a relational database of these events, (3) analyze the database for trends, (4) identify potential risk factors,and (5) identify events that may have been preventable, including those that may have been prevented by a pharmacist.
Potential risk factors for and the preventability of drug-induced threats to life were studied.
Case reports of adverse drug events(ADEs) published in Clin-Alert during 1977-97 were the source of information on drug-induced life threats. Patient, drug, and event variables were identified, and the causality, predictability, and preventability of each case were assessed. Data were entered into a relational database for analysis.
The data indicated 846 drug-induced life threats. Seventy-four percent of the cases were assessed as definite or probable. Patients received usual or below-usual dosages in 89% of the cases. Patients tended to be middle-aged and only moderately ill.The drug categories most frequently associated with life threats were antimicrobials and central-nervous-system agents. Plasma drug level monitoring should have been performed in 127 cases but occurred only in 31 cases (24%). Event types were distributed as adverse drug reactions (50%), allergic reactions (35%), drug interactions (11%), and medication errors (4%). A commercial reference classified almost half of the drug interactions associated with a life threat as posing minimal or no potential risk to the patient. Half of the life-threatening events were judged to have been preventable;about half of these could have been prevented by a pharmacist. Litigation was reported for only 1% of the cases of drug-induced threats to life; judgments and settlements averaged $1.2 million.
A review of published case reports of ADEs for 1977-97 yielded information on possible risk factors for drug-induced life threats and on which events may have been preventable.
This report is the third in a series of four describing significant adverse drug events (ADEs), including adverse drug reactions(ADRs), allergic drug reactions, drug interactions, and medication errors. The present study was conducted to generate hypotheses about what may contribute to drug-induced threats to life and to discover what mechanisms or guidelines are needed to prevent these events.
The primary objectives of this study were to (1) identify case reports of drug-induced life threats, (2) develop a relational database of these events, (3) analyze the database for trends, (4) identify potential risk factors,and (5) identify events that may have been preventable, including those that may have been prevented by a pharmacist.
