Drug handling and patient compliance in an outpatient paediatric trial.
New routines for drug handling were used in a 24-week outpatient double-blind trial of naproxen versus acetylsalicylic acid in 80 patients with juvenile rheumatoid arthritis. The clinician ordered tablets from the pharmacy for each patient by stating name, weight and randomization number. The pharmacy dispensed the drugs in sealed and labelled 1-week medication containers. Totally, 2176 containers were packed and distributed to the patients. Two errors in ordering of drugs were detected. Patient compliance was studied by tablet count in used containers returned by 25 of the patients. The calculated compliance was 95%. The procedures for drug handling seem useful and may increase the validity of clinical trials. The staff at the local pharmacy can be valuable partners in the planning and performance of clinical drug trials.
D000293:Adolescent; D000553:Ambulatory Care; D001171:Arthritis, Juvenile / Q000188:drug therapy; D001241:Aspirin / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009288:Naproxen / Q000627:therapeutic use; D010349:Patient Compliance; D010607:Pharmacy Service, Hospital
D009288:Naproxen; D001241:Aspirin