Taking a Strategic View to Overcoming Pharmacovigilance Challenges in Asia
As an increasing number of pharmaceutical companies move into the Asian markets at a rapid rate, the limited amount of personnel with experience in pharmacovigilance and drug safety in some Asian countries has raised concern in the global pharma community.
Facing unique challenges
Pharmaceuticals companies in Asia face unique challenges to drug safety. In an interview with Pharma IQ, Steve Bukvic, regional director, international pharmacovigilance at Johnson & Johnson, said: “There is a limited pool of personnel with relevant pharmacovigilance and drug safety experience. Health authority’s (HA) knowledge, expertise, organisational structure and resource is limited, thus restricting their ability to effectively manage the HA-Sponsor company interface, regarding pharmacovigilance and drug safety.”
Training is key
Drug safety is of paramount concern to manufacturers, patients and regulatory bodies, therefore, implementing a strategy for training and managing effective drug safety teams is vital for success in the industry. Drug safety teams must provide real value to their companies and their training needs to be recognised, not just on regionally, but on an international level.
Pharmaceutical companies require market access on a global scale. In order to obtain and maintain an advantage over their competitors, they are increasingly working within Asian markets, where their development costs are greatly reduced. This shift of services from West to East is increasing demand for staff with the right skill sets and better pharmacovigilance training.
Rapid growth = high risk
In a rapidly growing market, the risk of adverse drug reactions (ADRs), adverse drug events (ADEs) and serious adverse events (SAEs) is high. As a result, pharmaceutical companies are addressing the importance of drug safety, and formulating effective strategies for managing pharmacovigilance in clinical trials and in the post-marketing of drugs.
According to a recent report by Cutting Edge Research, Benchmarking Drug Safety and Pharmacovigilance: “Some high-profile examples of poor drug safety efforts over the past decade — and even some more recently in 2010 — have prompted the pharma industry to invest more in drug safety. Beyond changes to investments and added resources, companies are beginning to regard drug safety in more strategic terms.”
Improving data collection
With a growing number of clinical trials being held in Asia, it is important that data collection and monitoring can be carried effectively for pharmacovigilance investigations. When discussing the hurdles to a harmonised pharmacovigilance system in Asia, Bukvic said: “There also needs to be an improved collection of data when lack-of-effect / adverse events (AEs) are reported, i.e. batch numbers.”
Is harmonisation possible?
Unlike the US and EU, at present there is no harmonised pharmacovigilance system in Asia. When speaking to Pharma IQ, Jean Christophe Delumeau, head of pharmacovigilance Asia-Pacific at the Bayer HealthCare Global R&D Centre, said: “There is a lack in the harmonisation of safety reporting requirements across countries. No possibility of electronic submission of adverse events, except in Japan. In China, Korea, Japan and to some extent Indonesia request AE of submissions must be in local languages, except for domestic cases to some extent. There is an increasing amount of AE cases.”
Developing pharmacovigilance system for the region will take time, and Bukvic predicts, it could be more than 10 years, before there is an Asian equivalent of EU harmonised pharmacovigilance and drug safety regulatory system. It is not just a lack of a cohesive language, such as English in the EU and a vast difference in health and political systems, but also the fact that this may not necessarily be the right model for this region.
Reporting ADRs and electronic submission
Delumeau also raised the issue of cultural diversity on reporting ADRs. He said: “In my opinion, signal detection should be done not only in the overall population, but also with regards to ethnicity, particularly in the East Asian group (i.e. Chinese Korean and Japanese who, ethnically result from the admixture of the same three ethnic groups).” In the US and EU, signal detection is generally carried out with a global focus rather than ethnicity. The requirements for safety database systems and electronic submission of ADE/ADR reports in Asia are diverse. Bukvic predicts: “Asia may leapfrog EU / US systems if new technology permits.”
The Asian markets offer high growth potential. If pharmaceutical companies want to optimise their drug safety activities and manage AEs effectively, they will need to adapt existing strategies and integrate new systems. “This really requires global collaboration, dedicated resource, continual development of technology, and increased training and awareness at multiple levels,” said Bukvic.