Fast Adverse-Event Reporting Turnarounds Mean a Translation Challenge

by Kathleen O’Brien

Workloads in pharmacovigilance (PV) are soaring, and with new medicines constantly entering the global market, the need to track adverse events (AE) from drugs is more critical than ever. Regulators’ demands are unrelenting, and reports must be filed within a strict 24-hour window.

This also poses a translation challenge because notifications of adverse effects come in from a wide variety of sources and languages. The mounting workload and tight turnaround times are creating all kinds of risks for companies, including failing to meet the reporting deadline and increased compliance costs. 

This article considers how to bring worldwide AE reporting under control.

PV has never been more crucial than now. During the pandemic, workloads in the field have soared. Although self-isolation and social distancing have limited infection spread, people who were already clinically vulnerable have become even more so. Patients who are taking drugs long-term also tend to be at higher risk for COVID-19, so some risk factors have multiplied, and clinicians are extra vigilant about prescriptions.

Simultaneously, the global market has been flooded with new and updated products as regulators and pharmaceutical companies expedited medicines and vaccines to help ameliorate the effects of COVID-19. While the health industry insists the highest safety standards are applied, it is crucial to track various unknown factors globally as new virus strains and pharma formulations have converged. Usually, new drugs or vaccines are rolled out in a carefully controlled manner, region by region: Global rollouts on the scale we’ve seen over the last 12 to 18 months are unprecedented.

Tight turnarounds

To keep on top of the risks, regulators have remained unwavering in their demands that AE reports must be filed within 24 hours to keep people safe and prevent products withdrawals after release. 

But this impacts translation.

AE notifications arrive via multiple sources and languages. Within a single-day reporting window, pharmaceutical companies have to convert these details into English, which serves as the common business language, so that the reports can be submitted to the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and the Medicines and Healthcare products Regulatory Agency (MHRA). 

These pressures create risks for pharma companies — not only for failing to meet the reporting deadline, but also for increased compliance costs. A large organization might have to process hundreds of thousands of AE reports annually. Few can afford their own dedicated bank of translators, and their drug safety teams are often already overstretched. So they find themselves leaning heavily on external resources. In some cases this costs a fortune — such as contracting large clinical research organizations to do the work even when this may not be their core competence. It might also mean engaging linguists/translators on an ad-hoc basis, thus losing out on the economy-of-scale benefits of a retainer arrangement. 

Taking back control

The best way companies can keep on top of their global AE reporting activity is to coordinate it centrally. Once they have central control over everything that’s coming in, companies have greater scope for process streamlining, automation, and efficient turnaround for managing incoming reports. 

But as long as in-country teams are left to their own devices to engage local support as needed, achieving economies of scale and consistent quality/speed is very difficult, as is the ability to aggregate data across what could be 150 or more countries. As workloads rise, AE reporting can stress the process to the point that health authority KPIs may become all-consuming. Drug safety teams may have little time to focus on other critical aspects of safety and PV.

Changing the process

Where pharma companies have sought help up to now, the approach has often not been well-coordinated. Local drug safety offices might carry on with inefficient manual processes or enlist the help of a contractor or a local language agency to convert incoming reports to business English. This ad-hoc approach, which often scrambles to meet deadlines, doesn’t make best use of external resources and can’t pick up on trends in emerging safety data, because these siloed resources do not have access to the bigger picture. This tactical PV activity isn’t linked to any global drug safety knowledge repository, nor does it feed into clinical, quality, or labelling systems to enable swift and efficient extrapolation of the latest data.

Aggregation and analysis of safety data as a means of tracking emerging trends should be a critical focus for pharma companies, particularly now. This is what enabled Allergan to spot the correlation between Botox and reduced migraine symptoms in patients, for example. In the evolving coronavirus pandemic, the discovery of positive coincidences between existing medicines and the severity of COVID-19 is hugely important — an opportunity that is not lost on the leading pharma brands. Cases of a routine asthma drug (budesonide) having a beneficial effect on COVID-19 sufferers’ symptoms are among the discoveries made recently.

“The first step is agreeing on a central capability and process with the right support from a specialist-managed service provider.”

Practical steps

So what’s the best approach to centralizing and streamlining AE reporting for staying ahead of authority deadlines and maximizing safety-signal insights? 

Companies can take several practical steps. The first step is agreeing on a central capability and process with the right support from a specialist-managed service provider. This provider should have not just appropriate language skills across all markets, but also the safety/PV experience to drive change in how the company handles and uses incoming AE information.

Additionally, companies often rely on cleaning up data after the fact, pulling it into data lakes to perform analysis and extract meaningful insights. But the ideal approach should be to achieve cleaner, more centralized, reliable data earlier in the AE data capture process, putting the organization in a better position for success — both in regulatory compliance and business intelligence.

Pharmaceutical companies should also invest in stronger and more consistent connectivity between dispersed operations and information silos. One option here might be to build a portal through which translations of AE reports are submitted and managed by a central service, which pushes this content directly into a central drug safety database for ongoing analysis. As long as there is a global, centralized view, this kind of development can help to streamline processes, introduce greater consistency and speed of turnaround, and reduce human touch points as information is collated and processed.

With regard to translation, centralizing resources could help with retaining experts in languages subject to high-volume demand and thus creating economies of scale. Specialized language service providers should do this anyway, and having experts on standby rather than buying in more ad-hoc support can cut AE report translation costs down by as much as seven eighths.

Another benefit of standardizing and streamlining approaches to global AE report management is the potential for using artificial intelligence/machine learning (AI/ML). It is difficult to apply this kind of technology to scribbled notes jotted down by busy medics, or the wide variety of formats and languages through which AE information is submitted. But the greater the consistency in the record, the greater the scope for repetitive pattern recognition. At the very least, this could help with trend identification because the same terms and phrases could be picked up in translated reports. 

The scope for near real-time AI/ML-enabled trend capture is likely to grow, including voice-to-text capture, as digital/online/mobile AE reporting increases. This can provide more clarity in event recording — but only as long as information is captured and processed centrally, enabling a 360-degree view of global input. And the earlier and more reliable the trend information that’s captured, the greater the potential for making timely improvements to drug formulations, thus enhancing patient safety and improving clinical outcomes.

The final area where AI/ML technology has great potential is in processing content from threads in public online forums and published global medical safety literature. Together, these form a large and growing element of PV, and the input exists in all languages and character sets. This all needs to be interpreted, cross-referenced, and included in PV reports. Although “crawler” software can easily find and filter this content, key information still needs to be translated, examined, and amalgamated. This is labor-intensive work that can add up over the course of a year. A million words of such content is not uncommon for larger companies over a 12-month period. 

The more that a single specialist resource can be tasked with centralizing and consistently managing the work process, the greater will be the scope for cost efficiencies — and also for breakthrough insights to be made in the field of drugs and medicines.  

Kathleen O’Brien is Director of Business Development at Amplexor Life Sciences. She has worked in the translation industry for 17 years and is based in New Jersey. 



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