1. The Role of Healthcare Professionals in ADR reporting Michael Bonett Post-Licensing Section Medicines Authority

2. “There are no safe drugs, there are only safe doctors” B Berde, 1997

3. Are there any safe drugs? Perhaps the greatest of all drug disasters was the thalidomide tragedy of 1961-1962 when thalidomide caused major birth defects in an estimated 10 000 children in the countries in which it was widely used for the treatment of nausea and vomiting in early pregnancy. 10,000

4. Are licensed drugs safe? The thalidomide disaster led to the establishment of the drug regulatory mechanisms of today, however Tests in animals are insufficiently predictive of human safety In clinical trials patients are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited Information about rare but serious adverse drug reactions (ADR’s), chronic toxicity, use in special groups or drug interactions is often incomplete or not available

5. Healthcare professionals may have expectations that licensed drugs are “safe” and are surprised when a very small proportion of licensed drugs have to be withdrawn due to unexpected drug toxicity Not all ADRs are detected before licensing Are healthcare professionals safe?

6. A potential reporter may have an exaggerated confidence in the safety of a drug Based on the incorrect belief that the phase III development of a drug reveals its entire safety profile A form of scientific naiveté, assuming that “only safe drugs are marketed.” Promotion of the drug may stress efficacy at the expense of safety issues

7. Greek Pharmakon Drug Latin Vigilare To keep awake or alert, to keep watch Pharmaco - vigilance To keep watch on drugs, in particular their safety

8. Medicina Cockrel Aesculapius’ staff Medicina – The first healthcare professional Wreath of laurels A symbolic representation of what pharmacovigilance entails, (van Goothest, 2003) Snake

9. The Essential Role of HCPs The signals of adverse drug reactions derived from experiences with patients using drugs as reported by doctors and pharmacists lie at the heart of pharmacovigilance. In all countries, where pharmacovigilance systems operate the role of HCPs is vital in recording and reporting suspected ADRs observed in their practice. The advantages of an ADR reporting system include that it operates for all drugs throughout their lifetime and that it is the only affordable method of detecting really rare ADRs. The participation of HCPs is therefore considered essential for the functioning of the pharmacovigilance system.

10. HCPs & ADR reporting ADR reporting is now an accepted and understood routine in many countries ADR reporting is integral to the healthcare professionals’ duties Healthcare professionals are motivated by their professional conscience to comply with reporting requirements established by law

11. Causality Causality is the probability that an ADR is due to a drug and refers to individual cases and the assessment of what a healthcare professional would call clinical likelihood that the ADR was due to the drug. (Biron et al., 2002) The healthcare professional may be uncertain that the drug caused the ADR

12. Uncertainty about the causality between a suspected ADR and the drug used is mentioned by both physicians and pharmacists as a barrier to the submission of reports. This is perhaps unsurprising, and signifies a scientific way of thinking that requires certainty for action. However, it is unfortunate that this mind-set prevents some from reporting. After all, pharmacovigilance concerns the gathering of data on suspected ADRs. It is the task of the national reporting centres to establish the causality between reported suspected ADRs and the drugs used by elimination of as many uncertainties as possible by means of causality assessment and statistical methods (Meyboom, 1997)

13. Healthcare professionals should not refrain from publishing a first case report until they have a second or third case in their practice The Answer: “When there is a suspicion, report’ This phenomenon is an important source of delay in the publication or reporting of important signals, particularly when the second case occurs a year or two after the first

14. Although the desire for scientific validation with a second case is very understandable, the healthcare professional is requiring that the second case occur in his or her own practice, although it could, in fact, be seen and thus validated by a different observer. The failure to report to the health agencies or the manufacturer can delay the appropriate analysis and actions (e.g. a call for additional cases) of a serious signal. (Barton et al, 2002)

15. The decision to use a particular treatment is based on the analysis of the benefit/risk ratio

16. There also exists the entirely understandably impression in the prescriber that he or she has given a patient a medication that has produced harm. In a study of Irish physicians, 7.6% expressed this idea (Feely, 1990). This factor might also impede ADR reporting.

17. The fear of being ridiculed for having sent to a pharmacovigilance unit “an ADR that everybody is already aware of” and is “of little or no signaling value” was cited by Irish physicians in a study as a reason to hesitate about reporting a suspected ADR. (McGettigan, 1995)

18. If the drug was used for an unapproved indication (off-label prescribing) the prescriber may not wish to call attention to this. (Biron et al, 2002) The reporter may not want to supply privileged details even if anonymised, along with his or her name and address to government and manufacturers. (Biron et al, 2002)

19. In Great Britain and Australia, healthcare professionals are proud of their publications Current Problems in Pharmacovigilance and the Austrialian Drug Adverse Reactions Bulletin, respectively. In countries where no such bulletin exists, awareness to ADR reporting is lower. (Biron et al, 2002)

20. You can be reassured that the Medicines Authority will value your reports

21. Factors dissuading hospital pharmacists from participation included lack of clinical knowledge, pressure of work and a lack of time

22. Relationship between GP & Pharmacist Discussed reports with GPs and other pharmacists relationship between the pharmacist and doctor Where pharmacists lack confidence about their knowledge level or skills

23. Reporting Form The Reporting form is easy to fill in Not too time-consuming

24. Feedback Feedback is the prime motivator for ADR reporting Publications on ADR are the most important stimulus in reporting

25. Benefits of Reporting Reporting is an indication of taking your patient’s complaints seriously

26. Thank you for your attention You can visit our website at: http://www.health.gov.mt/mru