An outsourced model for pharmacovigilance at an affiliate level

In the past, the primary role of the Affiliate office was to liaise with local health authorities. However with the harmonisation and globalisation of pharmacovigilance regulations, its role has been extended more recently to perform multiple roles.

In addition to liaising with the local health authorities, Affiliate offices are now performing more commercially focused activities and as a consequence the risk of pharmacovigilance activities being overlooked has increased.  This can have repercussions for the pharmacovigilance manager who is responsible for local and global compliance, reporting on oversight of each Affiliate office to senior management and the QPPV. Pharmaceutical companies have recognised this challenge and are starting to look at an alternative approach which enables the affiliate office to focus more on building commercial growth.

Affiliate offices tend to work independently which makes standardising processes and gaining transparency a challenge. This autonomy also introduces regulatory risk associated with managing and overseeing multiple entities and in the period of April 2017 to March 2018, the MHRA PV inspectors issued four critical findings.

A common theme throughout these critical findings was in relation to the lack of oversight, ranging from EU QPPV oversight through to Marketing authorisation holder (MAH) oversight of the pharmacovigilance system. Other challenges that were highlighted related to compliance to risk management plans and signal detection.

An outsourced affiliate model enables pharmaceutical companies to access skilled resources, with expertise in local pharmacovigilance activities whilst also benefiting from the scalability, transparency and standardisation required to improve regulatory compliance, and enabling the required MAH and QPPV oversight.  This model for pharmacovigilance that is centrally managed and geographically dispersed brings the benefits of ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.

This article explores the current challenges associated with managing local affiliate pharmacovigilance activities and why an outsourced model should be considered for improved outcomes.  

Improving compliance and avoiding unnecessary costs

MAHs that manage local affiliates have to deal with a number of challenges relating to geographical diversity, working in silos and lack of focus on local pharmacovigilance activities.  This results in reduced oversight of the affiliates local pharmacovigilance activities and can lead to poor compliance metrics. The failure to take action regarding control of the local affiliate pharmacovigilance activities inevitably results in repercussions that can be lengthy and costly to fix. It also increases the likelihood of National Competent Authorities inspecting a complicated pharmacovigilance system.

By outsourcing the affiliate pharmacovigilance activities to a service provider, the accountability and responsibilities are transferred to a single entity and interface. This single entity is then responsible for delivering the affiliate pharmacovigilance activities through a centrally managed service which not only harmonises pharmacovigilance processes globally, but also introduces robust infrastructure through a network of established Local Contact Persons for Pharmacovigilance (LCPPV).

Flexible, scalable and dynamic resources

Local affiliate offices tend to have finite resources based on workload and available budget which restricts the ability to take on additional resources due to absences or sick leave. This limitation could potentially lead to service interruption.

The advantage of an outsourced solution is that it gives sponsors access to readily available resources as part of an already established network of LPPVs. By tapping into this network, the MAH can also optimise the network of LPPVs in their pharmacovigilance system. Resources are strategically managed by service provider including centralising resources for increased efficiency and reduced costs

The service provider’s network of LCPPVs, the MAH will ensure business continuity as there will always be back-up resources available.  By leveraging the expertise and knowledge of each LCPPV, it is also easier to understand where geographical or linguistic requirements dictate in-country resource requirements and where in-country requirements are not needed a centralised system can be deployed.

Traditionally, the procurement and financial management of each individual affiliate office results in significant administrative challenges with managing multiple and varied invoices and inflexibility with scope of service. In the outsourced model finances can be managed through a single interface, consolidating multiple invoices into one single transparent invoice. By leveraging the network of LCPPVs, it also means that billing can be quickly adjusted to meet the demands of ever changing pharmacovigilance requirements and also to roll out pharmacovigilance affiliate services to new countries.

As the network already exists, the infrastructure is optimised to be flexible and dynamic thus allowing the quick roll out of pharmacovigilance services in new countries including emerging markets. These factors all contribute to cost efficiencies and resource optimisation.

Local expertise in emerging markets

When managing affiliates directly, the MAH has the responsibility to ensure that the appropriate qualified persons are in place. This means they must meet the minimum requirements of the national competent authority, and also have adequate experience and documented training. Failure to do so, could result in non-compliance to regulations and inspection findings. By utilising an already established network of LCPPVs, the MAH can ensure that the LCPPV has the local expertise required to fulfil roles, through processes, which ensure consistent regulatory intelligence surveillance. This reduces the burden from the MAH in maintaining resources and associated management costs where pharmacovigilance demands are low. Having the local expertise, means that local regulatory intelligence, literature and submissions are always completed as per

the current local regulations, thus ensuring adherence to local legislations.

The LCPPVs appointed will meet the requirements necessary to take on the role in their nominated country while the service provide performs in-depth selection processes by reviewing the following various aspects including IT security, business continuity, code of conduct and pharmacovigilance SOPs. Shifting this responsibility to the service provider transfers accountability for any ongoing pharmacovigilance training that is required during the life-cycle of the partnership with the MAH.

Having experienced, knowledgeable LCPPVs as part of the pharmacovigilance system, means that they can use their network of contacts in the national competent authorities, to contentiously have the latest local regulations readily available. Information can then feed into the global pharmacovigilance system, ensuring the MAH is in compliance with the latest local regulations at all times. In addition the MAH will have access to an overview of local regulations from the service provider.

In summary, an outsourced solution provides a cost-effective way to access a network of local and global expertise, which can be optimised based on specific business models and product portfolio. This also ensures the MAH is in compliance with local regulations in each country.

Avoiding silos

The silo mentality of local affiliates, can result in very disparate pharmacovigilance procedures and activities. As legislation and requirements are ever evolving, this has become an increasing challenge for the MAH.

The risk of affiliate offices following different procedures is that there is variance in submission compliance, quality, accountability and misalignment between headquarters and each local affiliate office. The lack of a common organisation and governance framework, results in increased demands for management to control the different pharmacovigilance procedures followed.

By agreeing a set of procedures and KPIs that are rolled out to each LCPPV, via the service provider, ensures safety responsibilities are carried out consistently and in accordance with global policies. When all LCPPVs are following the same procedures and quality standards, not only will pharmacovigilance processes be harmonised, but this also provides access to global harmonised metrics. By analysing metrics and submission compliance at a global level, local pharmacovigilance metrics can be viewed holistically, with greater oversight of the compliance on an individual, country and global level. The advantages of having this vantage point is that it expedites the identification of aspects of the service that may be facing increased risk or issues than can be remediated.

The harmonisation of processes lends itself to greater oversight of signal detection activities and ensures that signal related communication is escalated and communicated to the EU QPPV and relevant persons at HQ within the appropriate timelines to ensure that signals can be detected and actioned quickly.

The coordination of signal detection activities, such as risk management plans, can also be managed through a single outsourced interface, thus enabling the EU QPPV to have oversight of all the signals and ongoing activities across the entire global pharmacovigilance system.  This also means the MAH can perform impact analysis of each signal at a global level, or communicate signal related actions to the entire LCPPV network quickly via a single interface.

In implementing the above consistent integrated workflows, these tools can be used to create and maintain the harmonisation of local PV processes, which ensures consistent regulatory compliance and quality across the network of LCPPVs. This can be measured through metrics against KPIs. In addition, signal management procedures can also be rolled out across the entire PV system for consistent signal management surveillance.

Direct oversight and global quality management

Inadequate oversight of pharmacovigilance at an affiliate level can result in unidentified risks or issues, which left unmanaged can develop into major findings or quality deficiencies, with a potential consequence of poor regulatory compliance.

By outsourcing the local pharmacovigilance activities, the MAH delegates the responsibility for ensuring the oversight of those activities. The service provider has direct oversight of the LCPPVs, through robust communication, global quality management and the harmonised processes. Any potential risks, issues or safety information can be communicated through to the EU QPPV and headquarters quickly, via the single interface model. This model enables quick identification of any issues and impact analysis of any non-compliance to be highlighted efficiently.

Leveraging technology and deploying shared collaboration spaces accessible by the LCPPV, EU QPPV and the service provider ensures key information is accessible and up to date at all times.  This would include contact details for the local person, product labels, reconciliation activities, local literature activities and detailed documentation of global and local pharmacovigilance procedures.  Storing this information in collaboration spaces gives assurance to the EU QPPV and headquarters of complete oversight of all local pharmacovigilance activities, on a global scale.

Conclusion

By outsourcing the local pharmacovigilance activities to a service provider, the MAH gains access to a network of LCPPVs and the technology and tools to ensure an efficient and compliant delivery of regulatory and pharmacovigilance services at the affiliate level.  This is achieved through flexible and dynamic resources, with insight and expertise in their respective countries.  It will also provide a set of global pharmacovigilance procedures and quality standards, to ensure direct oversight of the pharmacovigilance service delivery with compliance metrics and key performance indicators for improved outcomes.

References

1.   Linkedin global recruiting trends report 2017. www.slideshare.net/pedrooolito/linkedin-global-recruiting-trends- report-2017

2.   Pharmacovigilance Inspection Metrics Report April 2017 – March 2018. https://assets.publishing.service.gov.uk/government/uploads/system/ uploads/attachment_data/file/761289/GPvP_Metrics_2017-18_.pdf

Authors

Barry Rice

Director Project Management, Pharmacovigilance and Safety Services 

Sharlene Ahmed

Drug Safety Manager, Pharmacovigilance and Safety Services, ICON