Doris I. Stenver, MD, MPA
Independent Pharmacovigilance Adviser Founder of Unique Advice
How do you see the main trends which are shaping the pharmacovigilance area?
Pharmacovigilance has undergone significant change since the kick-off in the 1960s, in the aftermath of the thalidomide tragedy. Initially the pharmacovigilance environment was a national, non-involving and non-transparent environment. But today pharmacovigilance is characterized by international cooperation, involvement of a lot of different stakeholders, not the least the patients, and frequent and extensive communications to the public, leading to a significant level of transparency. These trends – internationalization, involvement and transparency – will be further accentuated in the years to come
Where do you see main challenges?
One main challenge is the complexity of the pharmacovigilance system and network. Even pharmacovigilance professionals can struggle with finding their way through. Which are the roles and responsibilities of different stakeholders, e.g. the national regulatory authority, the PRAC rapporteur, the marketing authorization holder? How is a referral procedure run? Who can participate in public hearings? But when it comes to health professionals and patients, the uncertainty is even more pronounced. And this fact is also challenging, because lack of knowledge can result in lack of contribution from very important stakeholders, e.g. the treating physician and the treated patient, who are first line observers of adverse drug reactions. Besides the complexicity of the system a range of other challenges can be identified, e.g. new data sources, new technology and new scientific approaches. One example is real world data retrieved at individual patient level from electronic health databases. There is no doubt that this data source is also an opportunity to strengthen drug safety surveillance. However it is also clear, that we need more experience in this evolving field to be able to utilize it in the best possible way.
Where do you see main improvements?
Seven years after the EU Pharmacovigilance legislation entered into force it is evident that pharmacovigilance practice and procedures has improved considerably, judged in comparison with the pre-2012-era. For all areas included under the PRAC mandate, e.g. referrals, PSURs, RMPs, we today have streamlined – although still complex – procedures. Another major improvement is the close and frequent dialogue which has become standard in-between different stakeholders and at various times during the product life cycle. Examples are the scientific advice which can be sought by the marketing authorization applicant regarding the pre-authorisation risk management plan, or the scientific advice which can be sought by the marketing authorization holder regarding a post-authorisation safety study protocol. A third major improvement is the close involvement of health professionals and patients as active participants in drug safety surveillance. Their contribution is of the utmost importance, as it can guide us to e.g. what is an acceptable risk level in the opinion of the patient and also how to prevent risk.