Pharmacovigilance: opportunities for active surveillance and other fanciful stuff

1. Pharmacovigilance: opportunities for active surveillance and other fanciful stuff Dodoo ANO, Pal S (WHO-HQ), Olsson S, Lindquist, M., Edward IR (all of UMC) Director, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana Medical School, Accra, Ghana alexooo@yahoo.com // alex.dodoo@who-umc.org With some diagrams/illustrations from Geraldine Hill, CARM/IMMP New Zealand

2. The issues • There is the need to collect real-life safety information on all medicines used in all countries • Because • Pre-licensure clinical studies are of short-duration, limited in extent and exclude several groups of people including typically the elderly, children, pregnant women, lactating mothers • Global health initiatives have helped to expand access to life saving medicines for conditions like HIV/AIDS, malaria, TB; BUT • These medicines are being used in countries with little or no systems for safety monitoring • Some of these medicines or combinations are new and are being used for the first time ever – no experience of use anywhere else • Safety issues can compromise public health programmes and interventions

4. In short .... • The global community has very little information on the safety profiles of medicines deployed for priority conditions • Genetics (pharmacogenetics), differences in healthcare practices, endemic diseases and other considerations e.g. malnutrition can all have an effect on medicine safety • Countries could rely on the classical method of pharmacovigilance in most countries - spontaneous reporting • Or countries can develop and/or utilise newer methods to address national safety issues bearing in mind the well known limitations of spontaneous reporting

5. Spontaneous Reporting Spontaneous report (ICSR - individual case safety report) ‘an unsolicited communication by healthcare professionals or consumers that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme’ Adverse drug reaction ‘a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man’ (WHO)

6. Spontaneous Reporting •    •   •  •  •   •  •    •  •  •  •                     ADR report

7. Spontaneous Reporting

8. Targeted Spontaneous Reporting Targeted spontaneous report (‘targeted ICSR’) ‘a spontaneous report from a healthcare professional or consumer within a defined cohort that describes one or more adverse drug reactions in a patient who was given one or more medicinal products’

9. Targetted Spontaneous Reports (of adverse events and reactions)

10. Targeted Spontaneous Reporting

11. Active Surveillance e.g. Cohort Event Monitoring • “Hot pursuit” • Identify, recruit and follow-up cohort of patients who receive specified medicines e.g. antimalarials, anti-retrovirals • Document demographic & drug information, mode of diagnosis • Solicit information on adverse events during follow-up visits • Usually once for anti-malarials and continuously for anti-retrovirals • Phone follow-up where possible • Provides rapid safety information and denominator

12. Cohort Event Monitoring Adverse event report ‘a solicited communication by healthcare professionals for a patient within a defined cohort that describes one or more adverse events in a patient who was given one or more actively monitored medicines’ (G. Hill) Adverse event Any new clinical experience (favourable or unfavourable) that is worthy of a record in the patient’s file, regardless of its severity and without judgement on its causality (D. Coulter)

13. Spontaneous Reporting •    •   •  •  •  •  •    •  •  •  •                                           Targeted Spontaneous Reporting CEM  ADR report

14. Cohort Event Monitoring

15. Several mechanisms for collecting information during follow-up • Home visits • Diary cards • Telephones • Cell phones • SMS

16. Collecting event information?

17. Diary/AE Card – Outer Fold

18. Diary/AE Card – Inner Fold InjectionSite AbscessDate:

19. Social Media and SMS for Pharmacovigilance

20. “Hello. My name is John twitter. I have an ADR that I intend to report to pharmacist or that failing to Dr You. …” facebook Tube

21. Conventional social media

22. Usage and Impact • In the US, 22% of all online time or one in every 4.5 minutes is spent on social networking; with 74% of internet consumers using social networks (http://blog.nielsen.com/nielsenwire/global/social-media-accounts-for-22-percent-of-time-online/) • One in four people aged 65yrs and above now join social networking (http://www.cbsnews.com/stories/2010/11/15/national/main7055992.shtml)

23. Usage and Impact • Facebook recorded 750 million users in June 2011 and would be the largest third if it were a country (http://techcrunch.com/2011/06/23/facebook-750-million-users/ ,http://www.socialnomics.net/category/statistics/). • In the US facebook tops Google for weekly traffic (http://www.socialnomics.net/category/statistics/). • 93% of business use social media for marketing. (http://en.wikipedia.org/wiki/Social_media)

24. Guidance to industry and pharmacovigilance (EMA Vol. 9a) • 4.3.3 Information on Adverse Reactions from the Internet • The Marketing Authorization Holder should regularly screen websites under their management or responsibility, for potential reports on adverse reactions. The Marketing Authorization Holder is not expected to screen external websites for information of adverse reactions. However if a Marketing Authorization Holder becomes aware of an adverse reaction on any other website the Marketing Authorization Holder should review the case and determine whether it should be reported in expedited manner in accordance with Chapter I.4, Sections 3.1 and 3.5

25. Vol. 9a (continued) • The Marketing Authorization Holder should consider utilizing their websites to facilitate adverse reaction collection, e.g. by providing adverse reaction forms for reporting or by providing appropriate contact details for direct communication. In relation to such reported adverse reactions, identifiability of the reporter and Patient refers to the existence of actual

26. New EC PV regulation (2010/84/EU) • Article 102 • The Member States shall: • (a) take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority; for these tasks, organizations representing consumers, patients and healthcare professionals may be involved as appropriate; • (b) facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats; • (c) take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

27. WHO-CC Ghana and Tigo Collaboration • Simple SMS system for ADR collection • Patient gets enrolled at point of dispensing • Demographics, initials, gender, medicine (name, dose, route) taken • SMS to server and to patient (serves as carrot: personal patient medication record) • Second carrot: patient gets reminders to take medicine if patient so requests • PV centre able to use the data in the server to either request manually ADR information or to send SMS soliciting for ADRs • System finalised and roll out just starting.....

28. Conclusions • Mechanisms exist for collecting safety information in all countries including resource limited countries • Active surveillance is key when new products are deployed • Newer technologies hold great promise