Erna Beers1, Toine C G Egberts, Hubert G M Leufkens, Paul A F Jansen. 1. Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), University Medical Center, Huispost B05.256, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. e.beers@umcutrecht.nl
Abstract
BACKGROUND: Historically, older patients have been frequently excluded from clinical trials. This has a knock-on effect on the availability of relevant information from trials for health-care professionals prescribing medicines to older individuals in daily clinical practice. OBJECTIVE: To investigate the availability of information relevant to appropriate prescribing for older people in the summaries of product characteristics (SmPCs) of recently approved medicines. METHODS: An analysis was undertaken of the SmPCs and European public assessment reports (EPARs) of all non-generic medicines indicated for diseases that are common in older individuals and that were approved by the European Medicines Agency between January 2008 and December 2010. The EPARs were considered the second most complete, publicly available document after the pre-authorization dossier. The availability of information was evaluated for 19 items on the representation of and clinical experience in older people, as well as pharmacokinetic and drug-drug interaction studies. These items were derived from the ICH E7 guideline for studies involving geriatric populations in the SmPCs and EPARs. Information not included was classified as being essential or non-essential, based on the product characteristics. RESULTS: Fifty-three medicines were investigated. Overall, information on the ICH E7 items was available in 56 % of the SmPCs (EPARs 79 %); 41 % of the SmPCs (EPARs 24 %) did not provide information that should have been included. Twenty-seven percent of the SmPCs, but 78 % of the EPARs, provided information about the number of patients included. Moreover, 2 % of the SmPCs (EPARs 51 %) provided information about the exclusion of patients with common comorbidities, and 14 % of the SmPCs, but 81 % of the EPARs, provided information about exclusion based on age. CONCLUSIONS: SmPCs, unlike EPARs, do not sufficiently provide adequate information about older individuals. Consequently, it is not clear whether the information about efficacy and safety applies to the frail older patients often seen in daily practice. The SmPC is intended for use by health-care professionals in daily clinical practice and provides basic information for safe and effective prescribing. As the EPAR describes regulatory considerations relevant to drug approval and is too long for daily use, the information about older individuals included in the SmPCs should be improved.
BACKGROUND: Historically, older patients have been frequently excluded from clinical trials. This has a knock-on effect on the availability of relevant information from trials for health-care professionals prescribing medicines to older individuals in daily clinical practice. OBJECTIVE: To investigate the availability of information relevant to appropriate prescribing for older people in the summaries of product characteristics (SmPCs) of recently approved medicines. METHODS: An analysis was undertaken of the SmPCs and European public assessment reports (EPARs) of all non-generic medicines indicated for diseases that are common in older individuals and that were approved by the European Medicines Agency between January 2008 and December 2010. The EPARs were considered the second most complete, publicly available document after the pre-authorization dossier. The availability of information was evaluated for 19 items on the representation of and clinical experience in older people, as well as pharmacokinetic and drug-drug interaction studies. These items were derived from the ICH E7 guideline for studies involving geriatric populations in the SmPCs and EPARs. Information not included was classified as being essential or non-essential, based on the product characteristics. RESULTS: Fifty-three medicines were investigated. Overall, information on the ICH E7 items was available in 56 % of the SmPCs (EPARs 79 %); 41 % of the SmPCs (EPARs 24 %) did not provide information that should have been included. Twenty-seven percent of the SmPCs, but 78 % of the EPARs, provided information about the number of patients included. Moreover, 2 % of the SmPCs (EPARs 51 %) provided information about the exclusion of patients with common comorbidities, and 14 % of the SmPCs, but 81 % of the EPARs, provided information about exclusion based on age. CONCLUSIONS: SmPCs, unlike EPARs, do not sufficiently provide adequate information about older individuals. Consequently, it is not clear whether the information about efficacy and safety applies to the frail older patients often seen in daily practice. The SmPC is intended for use by health-care professionals in daily clinical practice and provides basic information for safe and effective prescribing. As the EPAR describes regulatory considerations relevant to drug approval and is too long for daily use, the information about older individuals included in the SmPCs should be improved.
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