Tools of Change: Addressing the Shortcomings of Current Pharmacovigilance Strategies

Helen Winsor

Torbjörn Callréus, Chief Medical Officer at the Danish Medicines Agency, joins Pharma IQ to discuss pharmacovigilance and risk management strategies. Callréus discusses the common shortcomings of the current pharmacovigilance systems and how they can be improved; how we can use healthcare databases as a tool for generating and assessing signals and assessing the effects of regulatory action; new drug development paradigms coming on stream and their implications for pharmacovigilance.

Pharma IQ: What are the common shortcomings of the current pharmacovigilance systems and how they can be improved?

T Callréus: The current pharmacovigilance systems are, to large extent, based on spontaneous reporting systems. Although they readily identify odd reactions occurring shortly after exposure, they can rarely detect late reactions or reactions occurring after chronic use. Also, it is difficult to identify reactions that manifest themselves as a modest increase of the relative risk of fairly prevalent diseases, for example diabetes. Lastly, the efficiency (value of the information in relation to the costs) of the current system can be questioned. The system can be improved by increased use of other sources of information, for example health care databases.

Pharma IQ: How can we use healthcare databases as a tool, firstly for generating and assessing signals, and secondly for assessing the effects of regulatory action?

T Callréus: The FDA Sentinel Initiative and the EU-ADR project are examples of how healthcare databases can be used to generate signals, another example was shown in my own article (together with Svanström and Hviid in Drug Safety). Signals can be assesed by ad-hoc analysis of cohorts of incident users (as described inPharmacoepidemiol Drug Saf. 2010 Aug; 19(8):858-68). Drug utilisation studies are useful for monitoring the effects of regulatory action, for example, to observe how drugs are used in real practice, and question whether they are in line with recommendations or not.

Pharma IQ: Looking towards the future, what new drug development paradigms do you see coming on stream and what are their implications for pharmacovigilance?

T Callréus: New drug development models mean increased use of biomarkers and adaptive trial designs, this will mean that development programs probably will be shorter and include a lower number of patients. Hence, very little safety data will be available at marketing and this has somehow to be compensated with a more ambitious post-marketing program, and could mean "controlled" or "staggered" launch of the drug, and perhaps more intensive use of health care databases.

Pharma IQ: Why do you think an event on this subject is important at the present time and what do you think will be the most valuable discussion points at the Pharmacovigilance and Risk Management Strategies Conference 2011?

T Callréus: It is always important to discuss the performance of a pharmacovigilance system. Valuable discussion points will be the ‘shortcomings of the current system’, how to improve it and factors within the industry, the regulatory world (the new EU PV legislation), science, politics and the wider society that may be of importance for future pharmacovigilance strategies and systems.

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