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Varsow, 7 October 2011 Risk Management Plan and the elderly.Some thoughts Dolores Montero • General considerations – Demographic data – Particularities of the elderly • Current situation.- Some examples • Thinking for the future.- Some ideas Number of People Age 65 and Over, by Age Group, Selected Years 1990-2000 and Projected 2010-2050 Chronic Disease Age—A Major Risk Factor Chronic Disease The Number of People with Chronic Conditions is Rapidly Increasing Prevalence of Cardiovascular Disease: Heart Disease and Stroke Age—A Major Risk Factor Particularities in the Elderly (drug oriented) • PK – Higher distribution of liposoluble drugs – Decreased hepatic metabolism capacity – Progressive deterioration of renal function (not reflected by serum creatinine) • PD: less studied and probably more relevant – Decrease hemostatic response (postural control, termoregulation, cognitive function). Altered by a number of drugs: psychopharm, anticoagulants Some data • SPC specific information on the 100 drugs most consumed by the elderly: – 52% specific PK info – 6% specific PD info – 81% specific posology – 46% specific warings – 16% specific interactions – 15% specific info on ADRs Particularities in the elderly (Patient oriented) • Functional status (calcium antagonists in patients with chronic constipation) • Cognitive status (ASA above 100mg) • Co-morbidities, which deals to polymedication and relevant drug interactions – 35% of patients above 65 with 3 or more concomitant illnesses – Integral review often lacking, dealing to duplications and cascade of drugs Specially relevant in frail patients • Is the elderly accurately represented in clinical trials? • What about risk management plans? • Does the SPC provides helpful information? CT authorised by AEMPS (1993- 2009) • Elderly population included in 30% of the trials • The percentage has increased over time (14% of trials in 1993; 50% of trials in 2009) 800 700 600 500 CT elderly CT total 400 300 200 100 0 2000 2002 2004 2006 2008 Active substance Therap indication Patients above 65 years in clinical development RMP SPC Ambrisentan PPH 21% Nothing nothing Bivaluridin Prevention of thrombotic events in ACS 65-75y: 30% >75y:10% Nothing “caution in the elderly due to age-related decre. in renal F Ticagrelor Antiaggregant 65-75y: 25% >75y: 10% Nothing Nothing Pravast/fenofibr Mixed dislipem 65-75y: 20% >75y: 2.6% Nothing “limited safety data in>75y. Care to be exercise” Romiplostim TIP >65y: 25% Nothing Care advise due to the small nr of elderly pat Eltrombopag TIP 65-75y: 10% >75y: 6% Nothing Limited data. Greater sensitivity of some older indivd not ruled out Active substance Therap indication Patients above 65 years RMP SPC Belimumab Add-on SLE >65y: 2% nothing Efficacy and safety not established. Not recommended unless benefits outweight risks Roflumilast Maintenance of severe COPD >65y: 22% nothing nothing Duloxetine (somatic pain) 65-75y: 17% >75y: 22% nothing NA • Are we requiring useful data? • Are we giving meaningful information? Thinking on the issue.- Some ideas • Before authorisation – Enough sample? (prevalence of illness, duration of treatment). Sufficiently analysed? BUT ALSO – Inclusion and exclusion criteria in CT – Posology – Easiness of administration Thinking on the issue.- Some ideas • At the time of authorisation – Requirement of post-authorisation efficacy studies (PAES) in real conditions. Specially for chronic treatments in frail patients (common comorbidities). FIRST CRITERIA IDENTIFIED FOR THESE STUDIES?? • Recent examples: cilostazol, dronedarone Thinking on the issue.- Some ideas • At the time of authorisation – Specific informative material in case of potential cognitive/functional impairment or meaningful interactions? – Standard text in the SPC encouraging the periodic review of medication, in case of chronic treatments? Thinking on the issue.- Some ideas • After authorisation – Different approach for assessing spontaneous reports? • cilostazol – Other criteria for assessing seriousness taking into account functional or cognitive impact? Conclusions • Some attention has been paid, but probably not enough • A systematic approach during the different phases of drug regulation may be a step forward