title: The views of healthcare professionals, drug developers and regulators on information about older people needed for rational drug prescription.
abstract: BACKGROUND
  The ICH E7 guideline intends to improve the knowledge about medicines in geriatric patients. As a legislative document, it might not reflect the needs of healthcare professionals. This study investigated what information healthcare professionals, regulatory agencies and pharmaceutical industries consider necessary for rational drug prescribing to older individuals.
  
  
  RESULTS
  A 29-item-questionnaire was composed, considering the representation in trials, pharmacokinetics, efficacy, safety, and convenience of use in older individuals, with space for additions. Forty-three European professionals with an interest in medication for older individuals were included. In order to investigate their relevance, five items were included in a second questionnaire, with 11 control items. Median scores, differences between clinical and non-clinical respondents and response consistency were analysed. Consistency was present in 10 control items. Therefore, all items of the first questionnaire and the five additional items were analysed. Thirty-seven (86%) respondents returned the first questionnaire; 31/37 (84%) the second. Information about age-related differences in adverse events, locomotor effects, drug-disease interactions, dosing instructions, and information about the proportion of included 65+ patients was considered necessary by most respondents. Clinicians considered information significantly more important than the non-clinical respondents about the inclusion of 75+, time-until-benefit in older people, anticholinergic effects, drug-disease interactions, and convenience of use. Main study limitations are the focus on information for daily practice, while the ICH E7 guideline is a legislative document focused on market approval of a new medicine. Also, a questionnaire with a Likert scale has its limitations; this was addressed by providing space for comments.
  
  
  CONCLUSIONS
  This study reveals that items considered necessary are currently not included in the ICH E7 guideline. Also, clinicians' and non-clinicians' opinions differed significantly in 15% of the items. Therefore, all stakeholders should collaborate to improve the availability of information for the rational prescribing to older individuals.
authors: Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Erna
authors: E
authors: Beers
authors: Toine C G
authors: TC
authors: Egberts
authors: Hubert G M
authors: HG
authors: Leufkens
authors: Paul A F
authors: PA
authors: Jansen
mesh_terms: D000368:Aged; D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic; D004345:Drug Industry; D011307:Drug Prescriptions; D004335:Drug and Narcotic Control; D005060:Europe; D005260:Female; D019538:Health Care Surveys; D006282:Health Personnel; D006299:Health Services for the Aged; D006801:Humans; D008297:Male; D017410:Practice Guidelines as Topic; D012040:Regional Health Planning; D011795:Surveys and Questionnaires
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