Quality Assurance of Medicines in Practice

The quality of medicines in relation to their stability has previously been seen to be entirely the responsibility of scientists within the pharmaceutical industry. Nowadays, however, since pharmacists have an important role to play in the delivery of safe, effective and quality medicines (drug products), they are increasingly being required to make decisions related to the stability of drugs in the day-to-day practice of both hospital and community pharmacy. These decisions range from deciding on whether a liquid dosage form, extemporaneously prepared from a commercial tablet or capsule is stable or whether it is appropriate to repackage a drug product into a dose administration aid (DAA). Pharmacists always consider the stability of the drug concerned and whether it might be preferable to crush a tablet or sprinkle the contents of a capsule over food or mix it in a drink, as is common practice in many nursing homes, when patients are unable to swallow. Pharmacists are also required to consider the implications of the transfer to a non-manufacturer’s pack on the stability of a drug product. Despite the widespread use of DAAs, and the common practices of extemporaneous dispensing (compounding) and crushing tablets to be mixed with various liquid media, there is little available data regarding the drug stability following repackaging or alteration, involving compounding liquids or crushing of tablets.