Information for rational drug prescribing to older patients: Availability and applicability

Abstract

Rational drug prescribing is the process of making decisions about whether the benefits of a medicine outweigh the risks for the individual patient. This process is usually taken in relative uncertainty of the outcome in individual patients. With respect to older patients, rational drug prescribing is even more challenging, since older adults are at greater risk than younger adults of experiencing negative effects of medication. To make the best possible decision about the benefit-risk balance of medicines for older patients, healthcare professionals need drug information that is evidence based and applicable to their patients. To help them make these decisions, healthcare professionals often refer to drug compendia. The content of drug compendia originates for a major part from the European summaries of product characteristics (SmPCs) and US product labels (PLs), which are based on the application dossier. In turn, the application dossier describes, amongst other things, the efficacy and safety results of clinical trials performed during the pre-authorisation phase. It is important that these results are generalizable to older, often frail, patients in daily practice. It has long been recognised that the inclusion in clinical trials of older people who are representative of the target population in clinical practice could be improved. Since older patients are at greater risk of adverse effects of medicines, and relatively little information is available about the effectiveness and safety of drugs in older people, the principal objective of the studies described in this thesis was to investigate the current status of information available to healthcare professionals to help them prescribe medication rationally to older people. The first aim was to investigate the availability and clinical applicability of information for healthcare professionals. The second aim was to analyse the evidence base of information originating from clinical practice. The studies described in this thesis show that the availability and applicability of information relevant to rational drug prescribing to older people in SmPCs, PLs, and drug compendia can be improved. In addition, information considered necessary by healthcare professionals is currently not collected in pre-approval studies. In order to prescribe rationally to older patients, the information about drugs gathered during the pre-approval and post-approval phases needs to be relevant for, and applicable to, older patients in daily practice. Moreover, this information should be adequately reflected in SmPCs, PLs, and drug compendia. Furthermore, information gained in daily practice, by means of, e.g., observational studies and spontaneous reporting of suspected adverse drug reactions, is a valuable complement to the findings of studies performed in the pre-authorisation phase. With respect to older people, it appears important to know more about safety measures and about the practical use of medicines. It will only be possible to improve the information available to support rational drug prescribing to older patients if all parties work together to increase knowledge about medicines and their use.