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Drug handling and patient compliance in an outpatient paediatric trial
Insights
This study introduced new drug handling procedures for a clinical trial comparing naproxen and acetylsalicylic acid in juvenile rheumatoid arthritis patients. The innovative pharmacy dispensing method resulted in high patient compliance and trial validity.
Area of Science:
- Pharmacology
- Clinical Trials
- Rheumatology
Background:
- Juvenile rheumatoid arthritis (JRA) management requires accurate drug administration.
- Traditional drug handling in clinical trials can introduce errors and affect patient compliance.
Purpose of the Study:
- To evaluate novel drug handling routines in a clinical trial setting.
- To assess the impact of these routines on drug ordering accuracy and patient compliance.
Main Methods:
- A 24-week, double-blind, outpatient trial involving 80 JRA patients.
- Naproxen and acetylsalicylic acid were dispensed by a pharmacy in sealed, labeled 1-week containers.
- Drug ordering accuracy and patient compliance (via tablet count) were monitored.
Main Results:
- A total of 2176 medication containers were dispensed with only two drug ordering errors detected.
- Patient compliance was calculated at 95% based on returned medication containers.
- The new drug handling procedures demonstrated high accuracy and patient adherence.
Conclusions:
- The implemented drug handling routines are effective and enhance the validity of clinical trials.
- Local pharmacy staff are valuable partners in ensuring the success of clinical drug trials.
Abstract:
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.