Tackling The Pharmacovigilance Crunch At The Local Level

By Alex Brenchat, Ph.D. and José Miguel Rivas Romero

Local affiliates face significant time demands, often with very limited resources. These demands are perhaps most keenly felt in pharmacovigilance (PV). In many markets, requirements can include assurance of 24/7 cover, local presence, and local language.

In this demanding environment, marketing authorization holders (MAHs) are advised to find ways to standardize PV processes as much as possible while navigating divergent requirements in local markets. They should consider how best to manage when faced with local staff who lack the necessary PV expertise, which can result in a precarious situation of inefficiencies, compliance risks, and potential regulatory breaches.

Understanding Local Barriers

It is not uncommon for affiliates in smaller markets to juggle multiple responsibilities — regulatory compliance, quality assurance, and medical affairs. In addition, experience shows that local organizations are largely driven by commercial objectives. For them, PV is not the main priority.

At the same time, management at the central level may not be aware of the local requirements or how certain business models might impact local PV expectations. For example, our experience has found that when companies have decentralized decision-making it is more difficult to harmonize the PV system, which increases the level of complexity and diversity of processes at the country level.

One way companies have sought to address local PV challenges is to engage third-party vendors to oversee these activities. The challenge, however, is to ensure that these external partners uphold the same rigorous compliance standards, since any mismanagement or lapses in adherence can result in compliance issues for which the MAH or sponsor remains legally liable, as mandated by regulatory authorities. Most national health authorities state that the sponsor is legally responsible for meeting PV reporting requirements for their medicines — an example being Australia’s Therapeutic Goods Administration (TGA).

Consequently, it is imperative for companies to maintain comprehensive oversight of the pharmacovigilance system master file (PSMF) to mitigate risks associated with outsourcing these critical functions.

Diving Into Local Differences

In the wake of globalization, the pharmaceutical industry has sought to expand its reach into various markets, each governed by its own unique PV regulations. These regulations can vary widely, particularly regarding the timelines for reporting adverse events, documentation and formatting requirements, language specifications, and risk management plans tailored to local demographics. Navigating these differences and ensuring compliance can be daunting.

Many more countries globally are tightening their PV requirements, adding to the demands facing pharmaceutical companies.

Taiwan has fairly extensive requirements for submission of foreign cases and other safety information from abroad to the authority, which must be managed in close collaboration with the central PV function and close contact with the authority.

Other significant PV developments we have witnessed in global markets include:

• Botswana recently has changed the local PV legislation requiring nomination of a local PV contact.
• South Africa has increased inspection activities within the past year and has initiated an ambitious PV inspection plan in the country. It’s also important to note that South Africa requires the qualified person for pharmacovigilance (QPPV) to be a full-time employee of the MAH.
• The Austrian authority has started requesting a local PV presence in the country, rather than cover Austria from other German-speaking countries, our experience during inspections has found.
• Oman requires a QPPV pharmacist who resides in Oman if the company does not have a scientific office in the country.

There are markets that have a nuanced approach to PV requirements. For example, while the Eurasian Economic Union (EAEU) regulatory framework has harmonized and streamlined certain regulatory processes across member states — Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia — experts in the region report that local requirements remain. These include translations into local language for some documentation such as risk management plans; local safety data to support safety assessments; and specific risk management plans to reflect country-specific safety concerns, population demographics, or healthcare practices.

To ensure compliance, companies should adapt their global strategies to meet specific local needs, which may necessitate investments in language translation, staff training, and local regulatory expertise.

Regulatory intelligence remains a key problem for companies since information about regulatory updates is not always shared via standard channels, such as the authority’s website. As such, companies need local presence and contact through alternative channels such as personal relationships and private industry groups. This underscores the importance of having expert support to navigate and understand the local requirements. It further demonstrates the importance of maintaining strong relationships with local regulatory authorities to make sure local requirements are met.

Outsourcing Local PV Activities

Resources and other pressures have led companies to seek outsourcing partners for their local PV activities, according to a report from Fortune Business Insights. While these relationships have proved to be invaluable, without careful planning problems can arise.

One key step is to make sure the outsourcing partner has been fully integrated into the organization. This integration includes providing access to vital information and establishing connections with key stakeholders within the company. Conversely, it is equally important to foster local engagement by clearly conveying the intentions of headquarters to local affiliates, since buy-in has been shown to be key.

Clear communication of expectations is paramount; both parties must agree on these expectations and the associated compensation. Service providers should be compensated for the specific activities they perform, and any additional expectations should be realistic and well-defined.

A significant number of issues related to local PV outsourcing stem from insufficient information-sharing between headquarters and affiliates, as well as outsourcing partners. Relationship-building responsibilities should not rest solely with local affiliates; it is critical for headquarters to actively participate. Similarly, if affiliates fail to communicate their processes and local agreements back to headquarters, problems can arise. For instance, central management may not always be aware of local collaborations with third-party vendors. While local affiliates may prefer to manage PV agreements independently, it is generally expected that these agreements are communicated to headquarters and documented in the PSMF.

Additionally, the role of the project manager needs to be clearly defined, and objectives need to be established so PV teams understand their roles and responsibilities.

Best Practices For The Local PV Process

The local affiliate journey is a complex one. For companies outsourcing their local PV processes, mutual trust is key to building a robust PV system and meeting local compliance requirements.

That trust is built through regular communication between global PV teams and local affiliates. It is imperative that local PV teams — whether in-house or vendor partners — proactively engage with local regulatory authorities and healthcare professionals, and  are transparent with all stakeholders.

Local affiliates should have predefined escalation pathways and communication protocols for responding to emerging safety issues.

Training should be tailored to each region and include simulations or workshops on handling PV inspections. Furthermore, local staff should not be burdened with unnecessary information or complex processes that could be handled more seamlessly.

Finding ways to streamline processes where possible is also key. For example, AI can be used to automate the local literature screening process and digital tools can be used to streamline tracking the reporting of locally sourced adverse events. That should be balanced with a proper understanding of the challenges and specifics at the local level.

All these steps can help to improve PV activities at the local level and build trust between the local affiliate, global headquarters and PV outsourcing partners.  

About The Authors:

Alex Brenchat, Ph.D., is Vice President, Practice Area Lead for Local Pharmacovigilance Services, at PharmaLex, a Cencora company. Alex has more than 20 years of experience in the pharmaceutical industry, including in preclinical and clinical research, publishing scientific articles, as well as supporting posters and patents for innovative pharmaceutical products. For more information, visit www.pharmalex.com or www.cencora.com.

José Miguel Rivas Romero is Program Manager, Service Line Lead for LPVS and Pharmacovigilance Expert, at PharmaLex. José Miguel has more than 10 years of experience in the pharmaceutical industry specializing in the design and implementation of local pharmacovigilance strategies across organizations.

Disclaimer:

The information provided in this article does not constitute legal advice. PharmaLex and Cencora strongly encourage readers to review available information related to the topics discussed herein and to rely on their own experience and expertise in making decisions related thereto.