220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

352/3 of the patients (non-compliers) do not take medications asprescribed (time, frequency, dose, duration, not filling a prescription/nottaking the drug at all, inappropriate use with other drugsor alcohol, a.s.o.) which causes enormous burdens to health caresystems by direct costs such as costs resulting from increased hospitalisationand interventions, but also indirect costs such as fromlost productivity and premature deaths; compliance must be consideredon a disease-by-disease basis and is also dependent on theage of patients with elderly being less compliant; a statement oncompliance must be included in the final report of a clinical studyas appropriate; increasing numbers of prescribed items are likelyto cause decreasing compliance; methods for controlling c. are e.g.drug measurements in urine (e.g. colorimetric test on isoniazide)or blood, pill-counting, interviews and comments by the treatingphysician a.s.o.; regardless of the degree of compliance all patientsinitially included in studies should be reported (intent-to-treatprinciple); compliance can be increased with appropriate doseformulations (e.g. transdermal patches), low dosing frequency,pill calendars (or other forms of medication packaging), reminderdevices (e.g. electronic pill boxes, counter caps, prescription labelscratch-offs); → see also drug holidays.composite variable Combines multiple measurements into a singlenew endpoint, so called composite variable, using a pre-definedalgorithm; this avoids the problem of adjustment to the type I errordue to multiple testing; in case rating scales are used, contentvalidity, inter- and intra-rater reliability and responsiveness for detectingchanges in the severity is particularly important; → see alsoglobal assessment variable, variable.compulsory licensing (CL) syn. forced licensing; in some countries(e.g. Germany, Japan) health authorities can grant CL for a drugon a specific therapeutic area for public interest reasons or e.g.when a patented invention is not used by the originator duringseveral years; use of the invention by a firm induces payment of aroyalty to the patent owner.computer assisted new drug application → see canda.computer assisted product licence application → see capla.computer assisted product licensing application review → see caplar.computerised system OECD: “A group of hardware components andassociated software designed and assembled to perform a specificfunction or group of functions … Where computerised systems areused to capture, process, report or store raw data electronically,system design should always provide for the retention of full audittrails to show all changes to the data without obscuring the origi-com