Pharmacovigilance must reinvent itself through a transversal approach including all stakeholders

Deborah Szafir, Corporate Quality, Vigilances and Medical Information, Pierre Fabre, Paris, France (Deborah.SZAFIR@pierre-fabre.com)

Why Pharmacovigilance?  The drama case of Thalidomide.

Drug marketed in Germany in 1957 in nearly 50 other countries in total, as sedative and anti-nauseous. The tolerance was considered better than barbiturates.

This drug was prescribed in the pregnant woman. It was quickly observed a recrudescence of cases of malformations including the very rare phocomelia. The alert was given by a gynecologist

This drug has been withdrawal from the market in 1961(4 years later) after 12 000 identified cases of malformations (publications report an incidence of malformations between 10 000 and 20 000).

The tragedy led to the establishment in 1967 by the WHO of the Center for the Detection of Adverse Drug Reactions in Upsala (Sweden)

From pharmacovigilance to risk management: Example of recombinant Erythropoietin’s (EPO)

Drug class in the treatment of anemia of renal failure, the initial predictable effects during marketing was: coronary risk and hypertension

In 1998, spontaneous reports highlight a causal relationship between medullary depression and the presence of anti-EPO antibodies. The subcutaneous injection is identified as favoring the risk of the occurrence of marrow depression (more immunogenic); Change of excipient in manufacturing (protein stabilizer) was suspected. This example has contributed to the establishment of RISK MANAGEMENT PLANS in the marketing of innovative products / biotechnology

Today, a drug is allowed based on a benefit / risk ratio considered positive in a given indication for a given target population. In post-MA, the Benefit / Risk ratio is assessed in the light of tolerance data collected on a wider population, under conditions of use in 'real life'

Pharmacovigilance has made fantastic progress for patient safety, but in a clear way, it remains almost a one to one interaction between regulatory authorities and various stakeholders. 

The world and mode of communication has changed, we should also. The patient is imposing itself and wants to take part to the decisions involving their health.  We must create another collaborative model where each stakeholder contributes with their expertise.

Pharma industry has already integrated this approach through RMPs and their success will only happen with the integration of all health actors.

Industry can and must work to be the trigger for this new approach and must work to integrate all stakeholders. 

Pharmacovigilance:  everyone's business. How can Industry contribute? 

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Abstract Reference & Short Personal Biography of Presenting Author

Deborah Szafir is Vice President of Pierre Fabre Worldwide Corporate International Quality , Regulatory, Vigilances and Medical Information : contributes throughout the life cycle of the products in developing and securing the business while guaranteeing ethics and quality of processes and products and insuring patient’s safety.

Prior to join Pierre Fabre, Deborah was head of EU Regulatory liaison at Hoffman-La Roche. : represents the global regulatory function on general policy matters and critical product issues with EU regulatory agencies, advises on EU regulatory strategy, develops with heads of EU regulatory affiliates strategies to enhance relationships with local health authorities.

Before, Deborah was head of Safety Risk Management strategy at Hoffmann-LaRoche : develops relationships with the major Health Authorities and represents Roche on advancing the science of Safety Risk Management, contributes to the evolution of policies and guidelines, coordinates other similar strategic initiatives in various Pharma organizations and key stakeholder organizations representing the physicians and the patients.

Before, Deborah was head of Communication and congresses at Hoffman-La Roche and prior to that, was Global Drug Safety Affiliate Director and European QP at Roche

Deborah is graduate of the faculty of Medicine of Paris Creteil Val de Marne with 2 years’experience of surgery in French, UK and Israel’s hospital as first operative assistant and training placements, 2 years of experience working for Health Authorities within one of the 31^st French regional Centre (Pharmacology’s department of Prof.Tillement in Creteil) and 16 years in the pharmaceutical industry in senior medical positions including 10 years of European/International experience as European Drug Safety Coordinator (Qualified Person for Pharmacovigilance), Globad Head of Drug Safety Affiliates and EU Regulatory liaison.