Risk management workshop: Identifying and developing effective stakeholder communication during drug development
12-13th December 2002, Washington DC, USA
“Risk is complex and in managing it we must be aware of public perception, social expectation and acceptance. Every day we undertake activities that carry a far greater risk than we are prepared to accept from a new medicine.”
This quotation from the first CMR International Workshop on Risk Management, April 2002, encapsulates the starting point for the second Workshop, held in Washington in December 2002. The focus of discussions had moved on from the predominantly scientific and regulatory aspects of risk assessment discussed at the first Workshop to the broader topic of risk communication as part of the management strategy. Whilst ‘risk management’ has been a subject of discussion for many years, industry has been slow to introduce formal risk management programmes into the drug development process.
By holding a second workshop on the topic, within a year of the first, CMR International underlined the urgent need for both industry and regulators to build risk management into the fabric of the product approval process. The workshop highlighted the need for a paradigm shift away from the traditional model, where product information intended for those who will be using the medicine (Summary of Product Characteristics in the EU, product labeling in the US) is only discussed at the end of the approval procedure and involves only the company and regulatory agency. A clear message from the Workshop was that risk communication strategies needs to be implemented at a much earlier stage and involve a far wider range of stakeholders.
Pivotal to such communication strategies is the need to develop better communication skills in order to put the risks and benefits of new medicines into perspective for health care providers and patients. At the Workshop, the old adage that ‘the patient is waiting’ was revisited. The patient is not waiting, participants were warned, when it comes to seeking information about medicines and if the information they require is not forthcoming from the authorities and companies, patients will be looking elsewhere.
The ‘traditional’ preoccupation with identifying serious but rare side effects and adverse reactions to drugs was also a subject for discussion. Whilst this aspect of pharmacovigilance is vital, in reality patients are at far greater risk, statistically speaking, of being harmed by inappropriate prescribing, prescribing errors and by not following instructions for dosage and use. These aspects need to be included and addressed in developing risk management strategies.
Among the other messages from the meeting was the suggestion that both industry and regulators might be over cautious in their approach to risk and may be under estimating the degree of risk that patients are prepared to accept for medicines that offer a clear improvement in the quality of life. Such issues need to be discussed in an open and transparent manner with all the stakeholders at the table.