Ensuring patient safety and regulatory compliance in an era of ever expanding complexity: Key considerations for today s pharmacovigilance leader

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1 FOR PHARMA & LIFE SCIENCES WHITE PAPER Ensuring patient safety and regulatory compliance in an era of ever expanding complexity: Key considerations for today s pharmacovigilance leader SUMMARY There is an increasing focus on drug safety issues for pharmaceutical and biopharmaceutical companies across the organisation. No longer can drug safety, or indeed management of benefit-risk, be constrained to a single department regulatory agencies across the globe have made it clear that drug safety is a company-wide responsibility. Accordingly, the scope of what pharmacovigilance leaders in organisations must consider has also greatly increased. This paper will address some of the key challenges and considerations posed by that widening scope, with a focus on two main areas: global oversight, and end-to-end pharmacovigilance.

2 There is a regulatory requirement for a pharmaceutical company to ensure global oversight for activities related to its product. Getting and maintaining global oversight There is a regulatory requirement for a pharmaceutical company to ensure global oversight for activities related to its product. This requirement applies regardless of product commercial status. This is a growing challenge given: Mergers and acquisitions: Multiple company systems must be consolidated into one pharmacovigilance system, and continuing oversight needs to be ensured during this process. The increasing number and type of commercial partnerships: This can apply across the product lifecycle, if a product is both licensed and in development, perhaps as part of lifecycle management. Responsibilities may also be shared across a regulatory authorisation, or with a mix of licensor/licensee and distribution responsibilities. The proliferation of varying regulations: Regulations are increasing worldwide, and they are not always harmonised. In addition, some regulators are introducing their own national or regional regulations, which may not fully be in-line with those from Europe or the USA. This can present challenges when working with a global compound, for example when it comes to developing global risk management strategies. There continues to be an expansion in the scope of what pharmacovigilance departments, and in particular the QPPV (for products with at least one license in Europe), are expected to have oversight. Many responsibilities sit primarily with pharmacovigilance. For instance, demonstration of oversight for case processing, signal management, and risk management is straightforward. 2

3 Appropriate organizational alignment is a crucial enabler of the operating and data management models that govern the efficiency and effectiveness of a company s pharmacovigilance activities. To establish an organizationwide pharmacovigilance program companies should develop clearly defined safety roles and responsibilities that cover a drug from development through postmarket. Unlocking the power of pharmacovigilance: An adaptive approach to evolving drug safety environment, PwC Health Research Institute 3

4 There are activities that the pharmacovigilance department needs to know about but that the department does not typically lead. However, there are activities that the pharmacovigilance department needs to know about but that the department does not typically lead. For example, it is critical that companies consider what systems are in place to ensure the pharmacovigilance department and the QPPV have oversight of information such as: Product licensing information: This includes those for joint procedures where a partner may hold the Reference Member State (RMS) authorisation. Global oversight requires that you consider how changes to these are managed, including where these authorisations are withdrawn (including under the sunset clause) or cancelled. Consider whether or not you are notified by your commercial partner in these situations and if your QPPV has access to this information. Out of stock situations: As per GVP VI and articles 116 and 117 of Directive 2001/83/ EC, there is a requirement to inform either the EMA or national authorities (dependent on the product authorisation type and the reason for the situation) when there is an out of stock situation. It is important to have a system in place for informing global PV and the QPPV of out of stock situations down to the local level, where this may be handled by an affiliate, for example. Implementation of safety-related variations into product packs: There is a need to monitor not only the timeliness of submitting safety-related variations to the authorities, but to monitor the timeliness of the approved variations getting into product packs. Given this is often a process across many departments and may have vendors involved (e.g. artwork production, contract manufacturers, and others), it is recommended to have a process for tracking all safety related variations, from regulatory authority approval until incorporation into packs. Be certain that your QPPV has a plan to keep oversight of this data. Quality systems: As IR 520/2012 states, quality systems should form an integral part of the pharmacovigilance system. These systems are across the lifecycle of a product, and encompass all GxPs. Develop company-wide systems covering quality systems, such as: Auditing Training both ensuring all company staff have received at least basic pharmacovigilance training, and that all staff are trained to perform the job responsibilities they have been assigned Documents and procedures CAPA management and continuous quality improvement For many companies, the challenge will be bringing together information across the GxPs. If these are performed by different functions or departments, consider how information can be brought together to give the QPPV an overall picture of systems performance. 4

5 In support of getting and maintaining global oversight, there are three fundamental steps that pharmacovigilance leaders can and should take. In support of getting and maintaining global oversight, there are three fundamental steps that pharmacovigilance leaders can and should take. STEP 1 The first step is to gain an understanding of the scope and risks within the current pharmacovigilance system for the purpose of addressing problems that that might expose the company to risk and thus lead to audits, fines, lawsuits and other costly actions. STEP 2 The second step involves organization-wide education and alignment, ideally supported by senior management. STEP 3 The third step is proactive updating and maintenance of the system going forward. In an upcoming whitepaper we will outline more detailed considerations and guidance in support of these steps. 5

6 Pharmacovigilance activities should cover the whole lifecycle management of medicinal products for human use in relation to safety. End-to-end pharmacovigilance Pharmacovigilance activities should cover the whole lifecycle management of medicinal products for human use in relation to safety. This includes ensuring that different parts of the organisation pharmacovigilance, clinical, medical affairs, and local affiliates are communicating to make certain that there is a complete dataset for pharmacovigilance activities. CLINICAL PHARMACOVIGILANCE MEDICAL AFFAIRS LOCAL AFFILIATES However, it also relates to how processes are linked to create a systematic approach in relation to safety across the life cycle of products. For instance, consider: Is the DLP for signal detection for a specific product harmonised with the DLP for the related periodic reports? Are RMPs developed outside the PSUR schedule, meaning that common modules (GVP VII) may not contain consistent data? What is the process and procedure for the cascade of activity, documentation updates, and distribution following a newly identified risk? This includes linking signal detection with periodic reports, RMPs, labelling updates, and distribution to stakeholders such as medical information and the sales force. Updating of training material, promotional material, websites, and more, must also be addressed in this context. Are different parts of your organisation performing multiple literature searches (e.g., case management group, periodic report writing group, risk management group, and local affiliates)? Is there a single process for taking information from searching the literature on a regular basis, then taking the necessary actions and communicating it to the relevant stakeholders, be that for case processing and reporting, or for including in a periodic report or RMP? 6

7 As the operating environment has grown more complex, internal and external pressures are also increasing. Internally there is a focus on driving greater efficiencies and operational excellence. Externally, companies can ill afford more reasons to attract public and media scrutiny. Pharmacovigilance leaders and their teams must be better linked with functions across the organization such as manufacturing, clinical, regulatory, and commercial operations. Here, again, there are three fundamental steps that pharmacovigilance leaders can take to drive efficient and effective processes and ensure end-to-end pharmacovigilance. These three steps are: STEP 1 Understanding the main hand offs within the current PV systems. STEP 2 Identifying areas where efficiencies can be improved and agreeing on what the system should look like. STEP 3 Undertaking implementation of the desired state and effectively communicating the rationale for changes. As with getting and maintaining global oversight, we will explore these three steps in more detail in an upcoming whitepaper. Summary It remains a very exciting time to work in the pharmaceutical industry. However, it is an increasingly challenging time to be a pharmacovigilance leader. Maintaining safety and compliance amidst increasing regulations, across the globe, sometimes while navigating complicated mergers, and all while dealing with often antiquated and disconnected systems and processes, is intensely difficult and creates significant opportunity for risk to the company. Meanwhile, as the scope and complexity of activities required is increasing, budgets and available resource have not kept pace. It is necessary, therefore, that leaders take a highly strategic approach and find innovative solutions to getting more with less, using the available resources more intelligently and effectively. This may very well involve re-thinking current systems and processes, as well as the use of technology solutions to drive efficiencies, protect patient safety, and ensure compliance. It will most certainly require a great deal of vision and preparation. Sources 1 Vicki Page-Clark, Founder and Director of Lighthouse Pharmacovigilance Limited; Honorary Fellow of the Pharmaceutical Information and Pharmacovigilance Association (PIPA); Adjunct Lecturer for the Pharmacovigilance MSc programme at University of Hertfordshire and for the EU2P programme 2 Unlocking the power of pharmacovigilance: An adaptive approach to an evolving drug safety environment, PwC Health Research Institute The Future of Pharmacovigilance: Five Imperatives that Will Drive Improved Business Outcomes, Botsakos, George. Cognizant Insights, October

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