Next Generation Pharmacovigilance

For enhanced patient safety

Andres Gomez,  Executive Director-Epidemiology Global Pharmacovigilance & Epidemiology Bristol-Myers Squibb USA

Amrit Ray,  Vice President Global Pharmacovigilance & Epidemiology Bristol-Myers Squibb USA

John D Balian,  Senior Vice President Global Pharmacovigilance & Epidemiology Bristol-Myers Squibb USA

The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most cost-effective healthcare intervention, they should bring about a significant transformation in their organisations to realise the glorious future.

In an environment where development costs have increased exponentially while filings and launches have dropped drastically, the pharmaceutical industry and drug regulators face numerous challenges in Pharmacovigilance (PV), patient safety and in addressing areas of unmet medical needs.

This combination of issues not only adds unsustainable access restrictions and costs in the long term, but also creates an urgent demand for investments in new, enhanced PV capabilities. These enhanced capabilities will allow companies to improve the processing of safety data with the goal of providing analyses rapidly and transparently to regulators, healthcare providers and patients.

Existing PV systems need to be reviewed in order to improve the availability, evaluation and communication of the information. This fact is pushing companies to collaborate with local / national and international government agencies, regulators and healthcare delivery systems to create a model that will ensure operational efficiencies and meet the needs of physicians, patients and payers by automating a large portion of the event reporting and processing.
For a true breakthrough, first and foremost, the status of PV must change to one that creates value for the industry, regulators, and patients. To achieve this paradigm, we present some key aspects to be considered for a comprehensive PV transformation.

Innovative partnerships
Traditionally, the tendency has been to maintain the status quo until an event occurs that highlights drug safety issues. Due to these responsibilities, the pharmaceutical industry has long viewed PV as a sacrosanct dominion, in which the sole intent is adherence to established data collection and reporting obligations. We have applied temporary and ad hoc solutions to address PV issues and employed right methods to address the new problems and challenges that involved more complex, burdensome, and resource-intensive solutions.

Changes in the regulatory environment both in the USA and EU have also accelerated an organisational transformation for PV. The need for new adverse event reporting, and safety monitoring requirements as well as risk management, have made the usual approach of signal detection and evaluation through existing PV strategies a non-workable paradigm. Therefore, the development of an agile and efficient “next generation” PV solution will not only require internally dictated transformational leaps but also innovative external partnerships to be successful.

The new PV model that is more effective and agile should display the attributes required for the delivery of efficient signal detection, proactive risk-benefit assessment and the timely transactional components of PV, such as receiving and processing of adverse events and authoring of aggregate reports cost-efficiently. These changes will depend on a number of factors such as mature technologies, superior methods of exchanging safety information, and visionary leadership leading to new collaborations between different partners and disciplines. These new approaches will ease the transition from a historically reactive discipline to a proactive paradigm of sustainable and productive models designed to continuously enhance the patients’ safety.

The success of this proactive system depends on external and innovative partners for the identification and assessment of risks as well and risk management. Continually monitoring risk-benefit throughout the product life cycle is a central theme for improving drug safety systems. This is particularly true post launch, when the ongoing assessment of risk-benefit is required as new data is available. As such, PV departments will have to proactively develop their science through the integration of already existing PV methods with methodologies from epidemiology, health services research and health economics. This integration of disciplines will provide PV departments with a synergistic advantage on detection and management, and risks by combining different data, scientific disciplines and methodological expertise. This supplementation of already existing PV methods with new disciplines will only be feasible by the partnering of industry, regulators, academic centres and healthcare delivery systems. The creation of sentinel observation networks by the Food and Drug Administration as well as PhRMA’s Observational Medical Outcomes Partnership initiative are initial approaches to a new proactive paradigm of signal detection, and risk management; where consortiums of academic, government and industry centres of excellence will work on developing new methodologies to be incorporated into the proactive practice of drug safety.

Globalisation
Cost reductions have pushed the development of global sourcing from a trend to a relatively standard practice among multinational companies. However, global sourcing is not a mere cost reduction tool. For PV, global sourcing will mean the integration of onsite, and offshore capabilities, and establishment of overseas centres of excellence for the development and implementation of surveillance methods. Thus, the success of global outsourcing will depend not only on the reduction of PV expenses but on the integration of these capabilities and the improvement of methods with direct impact on risk communication and risk management.

Early and proactive safety launches
The launch of a product is a critical point in drug development, and represents the culmination of discussions between industry, regulatory agencies, payers and patients. The launch presents a determining opportunity to educate healthcare providers, regulators and patients on the safety profile of the product. However, the new vision for PV should encompass earlier education of stakeholders even before the commercial launch. As such, the possibility of “conditional marketing authorisations” would allow for the proactive implementation of earlier active surveillance and education practices prior to the market release of the drug. In addition, the proactive safety advertising will improve and increase the reporting of adverse events. Moreover, it would lead to optimal use of the product, and optimisation of the benefit-risk profile of the drug.

This would open the door for PV to educate on safety issues and take the opportunity to gather more robust safety data during early usage of the drug. This approach would create a reasonable hybrid alternative, combining standard methods used in safety surveillance and the assessment of post-marketing safety through the use of large mortality and morbidity trials prior to the approval and launch of the drug.

Transparency
The new paradigm of an enhanced and proactive pharmacovigilance system will only be viable if safety findings are communicated in a clear, concise and timely fashion. This will require the creation of a unified adverse event reporting system, including a storage database and analytical tool, which would be shared by sponsors, thus, guaranteeing that all available safety data are used in the risk assessment of potential signals. New advances in technology permit the creation of such a cross-company safety data tool that would allow for robust determination of background rates and more reliable signal detection.

In addition, transparency around the transmission of safety data will create an established process for addressing safety concerns during the life cycle of the drug (e.g. observational data assessments, registries, epidemiological studies, safety studies). The establishment of such processes will also allow the industry to potentially avoid regulatory and commercial pitfalls associated with ad hoc or improperly communicated safety signals.

An industry-wide objective
Current changes in the pricing and reimbursement of new drugs, the regulatory environment, and the impact of worldwide financial changes on the pharmaceutical industry will play a defining role in the establishment of a ‘Next generation PV’ model. Now, more than ever, pharmaceutical companies are being asked to reinvent themselves by reducing development times, through agility, and efficiency, and by addressing existing unmet medical needs while improving the value for patients. PV departments will have to establish collaborative partnerships with existing and new stakeholders to transform existing systems into high-performing organisations where new signal detection technologies, emerging markets, world-class talent on safety assessment and cost-efficiencies will be consistently integrated. However, these organisational changes will require the company to bring about philosophical changes at the business level. These changes will encompass the establishment of proactive ‘Safety launches’, and ‘PV branding’ to precede commercial launches and DTC efforts in order to ensure the best value for patients by truly optimising the benefit-risk profile of new medicines. The creation of a new and innovative PV system based on transparency, collaborative partnerships and optimisation of resources through global sourcing will improve the way signals are evaluated and managed and will add value to the pharmaceutical industry by delivering on regulatory obligations, and pricing and reimbursement decisions, ultimately improving the safety of patients.

Author Bio

Andres Gomez
Amrit Ray
John D Balian
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