Availability of data within the study period.

<p>Availability of data within the study period.</p

Flow chart of eligibility.

<p>Flow chart of eligibility.</p

The Views of Healthcare Professionals, Drug Developers and Regulators on Information about Older People Needed for Rational Drug Prescription

<div><p>Background</p><p>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.</p><p>Methods and Findings</p><p>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.</p><p>Conclusions</p><p>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.</p></div

Differences in scores between clinical and non-clinical respondents.

*<p>Items of the second questionnaire.</p

Association between relative burden of diabetes in countries and the total number of essential diabetes medicines selected on their NEML by each country in the study.

<p>Association between relative burden of diabetes in countries and the total number of essential diabetes medicines selected on their NEML by each country in the study.</p

Inclusion of diabetes medications in the NEMLs of low and middle income countries (n = 32).

<p>Inclusion of diabetes medications in the NEMLs of low and middle income countries (n = 32).</p

Gender, specialty, and working country of the respondents.

*<p>Internist, nursing home physician.</p

Association between gross domestic product (GDP) per capita and the total number of essential diabetes medicines selected on their NEML by each country in the study.

<p>Association between gross domestic product (GDP) per capita and the total number of essential diabetes medicines selected on their NEML by each country in the study.</p

Number of selected essential medicines for diabetes on NEMLs in different geographical regions and across different income levels.

<p>*: p values were 0.386, 0.663, 0.865 across different WHO regions and 0.008, 0.008, 0.018 across different income levels for the number of essential medicines for diabetes, number of “Insulin and analogues” and number of “Oral blood glucose lowering” medicines, respectively.</p><p>Number of selected essential medicines for diabetes on NEMLs in different geographical regions and across different income levels.</p

Median availability of any product type (originator brand/generic) of essential and non-essential medicines by ATC categories.

<p>*Ectoparasiticides, including scabicides, insecticides and repellents, **Anti-inflammatory and anti-rheumatic products, ***Agents acting on the renin-angiotensin system.</p