The effect of non-compliance of PPI instruction on the stability of reconstituted oral antibiotics

The patient package inserts (PPIs) should contain all the required information for the patient. It must be clear and understandable. There are several problems with the PPIs including the wrong information, readability and comprehensibility. Thus the pharmacists have to take an active role in making sure that patient is aware of important instruction including correct storage. Five antibiotics namely Erythromycin ethylsuccinate, Amoxicillin, Cefdinir, Flucloxacillin sodium and Clarithromycin powder for suspensions, were selected for this study, these antibiotic were reconstituted as directed on the label and tested initially and after 7 days when stored at room temperature and in refrigerator. Several chemical and physical pharmacopeial tests were performed. The results showed that two of the antibiotic oral suspensions namely erythromycin ethyl succinate and flucloxacillin sodium failed the accepted shelf life specification limits when stored at room temperature while both passes these limits when stored in refrigerator. Erythromycin ethylsuccinate has failed the tests of taste and odour while the flucloxacillin sodium has failed the assay test. Clarithromycin has failed some tests as viscosity, taste and pouring test when stored in refrigerator while passes all the tests when stored at room temperature. The study showed the vital role of the pharmacist to reiterate the important patient package insert instructions specially those concerned with the storage condition of the drug.