One of the highlights of last years drug safety meeting was the round table session which included a number of pharma representatives, a patient representative and a doctor. Having the input from the customer is invaluable to Pharma and this session allowed free and open discussion to happen and threw up a few good talking points around the topic of risk communication.
We spent a few minutes speaking to Ameet Bakhai who is a Consultant Cardiologist at Spire Bushey Hospital and is taking part in a similar session at this years event. He had some great input on the current status of the drug safety industry.
How is your company identifying new sources of product safety data with the current intense focus on drug safety & risk management by regulatory agencies?
I work within the NHS at an acute trust. We always introduce new drugs in the context of clinical trials or pilots. If these are conducted well, the safety data speaks for itself when enough appropriate patients are in the studies to be generalizable.
How will the new European pharmacovigilance legislation shape your company's safety activities and work structure in the next 6 months? And what do you see as the main difficulties?
While my NHS trust is not directly focusing on this, we appreciate there is an appropriate balance between having solid safety data and not strangling new drugs before they have a chance to arrive. The key is to use technology to collect all the small signals of safety data and centralise these to arrive with sensible data monitoring committees. The latter should be composed of the best, most questioning minds to ensure as much of the future is predicted as possible from these signals. At this stage I do not always have a sense that the DSMBs are the brightest, the best and the most skilled in data analyses techniques. I would favour these critical decision makers to be amongst the brightest and able.
How do you see the role and capabilities of post-marketing monitoring of medicines changing in the near future?
Diffusion of new technology is very difficult to control. There are pros and cons here. An early / staggered approach allows greater exposure outside a trial setting. However this early arrival risks use in hands that are not always diligent and revenue will take precedent over reputation and responsibility. It maybe that certain key centres and investigators are allowed to use drugs early providing they are the most diligent at surveillance for adverse events and fully resourced to do so: preferred pilot sites and innovation investigators!
Thanks Ameet for your input! I'm sure you will agree it is very valuable.