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“Pharmacovigilance: the tool to complete the picture of medicines utilization” Claudia P Vaca G Member of Advisory Committee on Safety of Medical Products ACSoMP Teacher of Universidad Nacional de Colombia Technical Advisor of Minister of Health Colombia 1 Outline • Human and financial cost of irrationality • Pharmacovigilances is a key component of public health policies • Challenges and priorities 2 Clinical/Therapeutic Rationality Social Rationality (needs based) Efficiency (the best outcomes for each dollar investment). t2 t1 Spend (P* Q ) Irrational practices: High prices, markups Irrational Use Rational spend Pharmaceutical inflation= P*Q 3 Irrational out-of-pocket spending Private Colombian pharma-market Top 10 2007 2008 2009 Drospirenone + Ethinylestradiol Pesos col US 18.192.701.796 20.399.394.022 10.107.057 11.332.997 2010 30% 22.303.027.117 23.678.266.205 12.390.571 13.154.592 Fuente: IMS The venous thromboembolism risk of Oral Contraceptives (OC) with drospirenone, is higher than OC with levonorgestrel (second generation OC) and could be the same of OC with desogestrel or gestoden (Third generation OC). AEMPS 2011 http://www.aemps.gob.es/informa/informeMensual/2011/mayo/informe-medicamentos.htm www.cimun.edu.co 5 Rosiglitazone (Avandia®) pos-marketing approval 48 h 50.000 drugstores USA 10 days 100.000 doctors contacted 42 days 100.000 patients 80M US$ 3.200 prescripc / day in USA The guardian 21/07/1999 (42 day after mktg.) CV Risk pharmacovigilance alert CV 2007. Withdrawm from the market in some countries since 2010 Taken and adapted of Figueras 2010 6 Consider rosiglitazone example Given a known prevalence of cardiovascular deaths (due to MI or to CHF) among middle-aged persons with diabetes in some country, given the relative risks of CHF and MI associated with rosiglitazone, and given the consumption figures of rosiglitazone in that country during its market life, how many deaths would this drug have caused in? In terms of general public perception , it is not important to say how many deaths could be caused (or prevent) by the specific drug or to know the risk of MI or the risk of CHF , and decide if it must be removed from the market for this reason. On the side of possible benefits, these had not been shown for rosiglitazone. Adapted from ISDB Forum (Groc/Prescrire). Septiembre 2011 7 With access Without access Taken and adapted of Figueras 2010 8 Without access With access INEFICIENT Access EFICIENT Access 9 IRRATIONAL USE (PhV!!) Without access With access INEFICIENT Access EFICIENT Access 10 Acceso INEFICIENTE Without access SIN acceso EFICIENT Access 11 Pharmacovigilances is a key component of public health policies, pharmaceutical policies and health system as a whole. So it must be strengthened: • • • • In the Public Health Programs. As an essential function of DRA. As a part of Patient safety policies and programs. Providing enough, qualified and stable human resource. 12 Challenges and priorities – Register and clinical research – Vigilance of Innovations – Linked with Off label uses – Linked with promotion and marketing activities 13 Regional/Global level challenges – PhV as part of essential functions of DRAs – To promote Drug Utilization (consume) analisys in order to provide signals to PhV programs – PhV of new vaccines – New training tools – To strength focal points network 14 Thank you 14