How important is a package insert for drug therapy in ambulatory care?

Abstract

German regulations demand an extensive package insert for drugs. However, to what extent the information given is used and what consequences this use actually has remain unclear. The aim of this study was to describe different patterns of patient package insert (PPI) use, to estimate the proportion of each of these patterns, and to evaluate the impact of the information on patients’ reported medication compliance. In spring 2005, 45 randomly chosen customers from five urban pharmacies were questioned about their behaviour regarding PPI. Interviews were based on a structured interview guideline, and were electronically recorded, transcribed and coded in a consensus process. Less than one-half of the patients interviewed were able to repeat specific PPI content. A minority of patients had probably read the PPI, but could not remember any details. Patients had read the PPI only superficially, did not understand its meaning, had read it long time ago, or gave a socially requested answer. Reading the PPI has fewer consequences in terms of an arbitrary change of the prescribed drug concept than has been previously assumed. Recommendations of physicians and pharmacists were more helpful than information contained in a PPI. Due to a sense of responsibility, the PPI is read more thoroughly if third persons are affected. PPIs are read only selectively, a finding that should be considered when writing them.