|
AUGUST
2000 Adverse Drug Reaction Report A total of 155 ADRS were reviewed and recorded via the KUMC ADR Reporting Program from July 1999 thru June 2000 utilizing voluntary reporting by nurses, physicians, and pharmacists and E-code medical records retrieval system. Of the reactions reported, 18.7% were reported to the FDA and 8.4% were reactions involving new chemical entities (a new drug marketed within the last 3 years). Adverse reactions categorized by drug classes are presented in Graph 1. Some drug classes, such as anti-infectives, are prescribed more frequently, and may appear to have a higher rate of adverse drug reactions. However, it is important to remember that this data is based on a voluntary reporting system and thus does not truly represent incidence. Therefore, it is not accurate to assume that medications with higher adverse event rates are not as safe as those with lower rates. Agents were administered parenterally in approximately two-thirds (67%) of reported cases; less than one-third (30%) were administered orally. Topical/transdermal and aerosol routes accounted for 2% and 1 %, respectively. Incidence by age group is illustrated in Graph 2. Overall, patients 41-60 years old experienced the highest incidence of adverse reactions (35%), followed by the 21-40 year old age group (23%). Patients 0-10 years old represented the smallest percentage of ADRs (<10%). All reported reactions are classified by their severity. According to hospital reporting criteria, mild reactions require no treatment or require treatment with nonprescription medication. Moderate reactions require treatment with prescription medication or prolong hospitalization less than 24 hours. Serious reactions prolong hospitalization greater than 24 hours or cause hospitalization, permanent disability, or death. The majority of ADRs reported at KUMC were mild (45%) or moderate (38%). Only 17% of the reported reactions were considered serious.
Adverse effects are also classified into outcome categories. The outcome definitions are numbered and identified in the key below. Symptoms resolved or improved in 56.6%, treatment with a prescription drug was required in 34.9% and prolonged hospitalization resulted in 6.2% of reported adverse drug reactions.
Outcome Number Symptoms resolved or improved |
