Problems and benefits of an antibiotic compassionate therapy program.
So-called compassionate therapy can provide life-saving drug(s) for patients but can also introduce liabilities that may discourage such treatment. The procedures required for compassionate use of imipenem/cilastatin and a summary of the results of its use are used as examples. Physicians requesting drugs for compassionate therapy face problems in the timely acquisition of antibiotic from the manufacturer and the completion of the regulatory and patient case report forms. The pharmaceutical company encounters difficulties with the return of documents, the ability to use the treatment data for registration claims, and the assessment of outcome and safety in patients with multiple confounding medical problems. The benefits of compassionate therapy for all participants should favor its continued use. Suggestions for the improvement of compassionate therapy programs include streamlining of case report forms and more disciplined completion of forms by investigators.
Calandra
G B
GB
Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania 19486.
Garelik
J P
JP
Kohler
P T
PT
Brown
K R
KR
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D015377:Cilastatin; D000077728:Cilastatin, Imipenem Drug Combination; D003521:Cyclopropanes / Q000627:therapeutic use; D004338:Drug Combinations / Q000627:therapeutic use; D004341:Drug Evaluation; D006801:Humans; D015378:Imipenem; D007880:Legislation, Drug; D013845:Thienamycins / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D000900:Anti-Bacterial Agents; D003521:Cyclopropanes; D004338:Drug Combinations; D013845:Thienamycins; D015377:Cilastatin; D015378:Imipenem; D000077728:Cilastatin, Imipenem Drug Combination