Stability of Essential Drugs in Tropical Climates: Zimbabwe - EDM Research Series No. 013
(1994; 86 pages) Voir le document au format PDF
Table des matières
Afficher le documentAbbreviations
Afficher le document1. Summary
Ouvrir ce répertoire et afficher son contenu2. Introduction
Ouvrir ce répertoire et afficher son contenu3. Study design and methods
Afficher le document4. Results
Ouvrir ce répertoire et afficher son contenu5. Discussion
Fermer ce répertoire6. Conclusions and recommendations
Afficher le document6.1 Initial quality of drugs
Afficher le document6.2 Stability of drugs
Afficher le document6.3 Factors influencing the quality of drugs
Afficher le document6.4 Outcome of the study
Afficher le document6.5 Practical recommendations for a quality assurance system
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuAnnexes
 

6.2 Stability of drugs

The following four drugs showed no quality problems at GMS and retained their potency at the facility level: amoxicillin capsules, acetylsalicylic acid tablets, phenoxymethylpenicillin tablets and tetracycline capsules. For three other drugs (ferrous sulfate tablets, retinol tablets and ampicillin injection) the outcome in facility samples reflected the problems of initial quality without additional loss of active ingredient. These seven drugs therefore did not show any problems with instability.

Incidental, clinically unimportant failures in facility samples occurred with three drugs: ampicillin capsules, doxycycline capsules and epinephrine injection. Measurement error is a possibility.

When matched batches at the central medical stores and facility level were compared, the mean loss of potency was statistically significant for two drugs: ergometrine injection (p<0.0005) and procaine benzylpenicillin injection (p<0.001). With ergometrine injection, the initial quality problem worsened at facility level: 72% of facility samples failed, compared with 65% failures at GMS.

The mean assay in the facility sample group was 73.5% of stated content compared with 82.4% at GMS, For procaine benzylpenicillin injection the assay was consistently lower in the facility sample group (mean 98.3%) compared with GMS samples (101.0%) with a mean sample interval of only 4.3 months.

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Dernière mise à jour: le 3 mai 2013