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The workload in pharmacovigilance (PV) is soaring and as new vaccines and medications enter the market, it’s crucial to track adverse events (AE). As AE reports still have to be filed within 24 hours, Kathleen O’Brien of Amplexor Life Sciences lays out a blueprint for centralising global AE reporting.
AE notifications come in from a host of different sources and arrive in many different languages, but they then have to be translated for regulators inside the 24-hour window. These increased workloads and tight turnarounds are creating risks for pharma companies, such as higher costs and even failing to meet the reporting deadline.
The Covid pandemic has only increased the workload in pharmacovigilance. In particular, although routine infections have fallen as people have socially distanced and self-isolated, clinically vulnerable people who take immunosuppressants or medications long-term, remain at higher risk for Covid. Therefore, clinicians have to be vigilant about avoiding side effects, comorbidity and drug interaction in this vulnerable cohort.
Meanwhile, the global pharma market has seen a flood of new and updated products hit the market as pharma firms and global regulators have worked in concert to expedite the development of vaccines and other medications that might help cure Covid or relieve symptoms.
The industry cannot afford to reduce the standard or frequency of safety checks, which means that multiple unknowns have had to be carefully tracked as new virus variants and new pharma formulations converge around the world – an unprecedented situation in an industry where medications are usually rolled out in a much more controlled manner, region by region.
Playing with fire
The requirement to file AE reports inside 24 hours has an impact on translations, which have to be turned around in double-quick time – within a couple of hours, for preference – in order to keep companies’ AE reporting on schedule. AE notifications arrive in the native language of patients or the medical personnel treating them and, within the single-day reporting window, pharma companies must convert details of all of these incoming AE events into English as the common business language for onward submission to regulators such as the European Medicines Agency in the EU, the US Food and Drug Administration and the UK’s Medicines and Healthcare products Regulatory Agency. It’s not uncommon for a large pharma company to process many hundreds of thousands of AE reports annually and mounting workloads and tight turnaround times mean that companies could fail to meet the reporting deadline, or encounter higher costs for compliance. Organisations that lack their own bank of translators often have to rely heavily on external resources. This can mean they end up spending a fortune contracting large clinical research organisations (CROs) to do the work – even though safety may not be the CRO’s core competence – or hiring linguists and translators on an ad-hoc basis when a retainer arrangement would be cheaper and more efficient.
The best way to stay on top of global AE reporting is for companies to co-ordinate it centrally. This is reflected in a drive by pharma organisations to develop a more efficient, centrally-controlled capability.
Once central control is established, companies will have greater scope to streamline processes, automate, and ensure efficient turnaround on incoming reports. But if in-country teams are left to their own devices, and engage local support on an ad-hoc basis, achieving economies of scale and consistent quality and speed becomes more difficult. Data might have to be aggregated across 150+ countries and as workloads rise, AE reporting can become a major source of stress, to the detriment of other aspects of safety and PV.
Replacing the ad-hoc approach
Where pharma companies have sought help up to now, the approach has often not been well-co-ordinated. Local drug safety offices might continue with inefficient manual processes, or use local language agencies to turn incoming reports into business English. But this approach fails to use external resources effectively (for instance, a general CRO will probably not have pharmacovigilance at its core) and may also fail to pick up on trends in emerging safety data because when resources are siloed they do not have access to the bigger picture. Pharmacovigilance of this kind doesn’t enable manufacturers to swiftly and efficiently extrapolate data, nor does it feed into Clinical, Quality or Labelling systems.
Aggregating and analysing safety data in order to track emerging trends should be a critical focus for pharma companies, especially at present. This kind of activity enabled Allergan to spot the link between Botox use and reduced migraine symptoms, while as the pandemic progresses, discovering positive coincidences between existing medicines and Covid severity could be hugely important. This is an opportunity that should not escape the leading pharma brands. For instance, the fact that Budesonide – a drug routinely prescribed for asthma – may have a beneficial effect on Covid symptoms is just one discovery made recently.
Seven practical steps
So how can pharma companies best centralise and streamline AE reporting, stay ahead of regulators’ deadlines and maximise strategic insights from incoming safety data?
Here are seven practical steps they can take:
- Work towards global AE input management
Step one should be to agree a central capability and process. This can be established with support from a specialist managed service provider. The latter will need the right language skills across all relevant markets, and must also have the right safety/PV experience to improve how the company handles incoming AE information.
Prioritisedata quality & consistency
Many companies have relied on cleaning up data after the fact, pulling it into data lakes to analyse and extract meaningful insights, but ideally, data should be centralised and made cleaner earlier in the process. This puts the company in a better position in terms of regulatory compliance and business intelligence.
- Connect the silos
When moving to centralised AE management, it’s good to introduce strong, consistent connectivity between dispersed operations and information silos. Options might include building a portal through which translations of AE reports are submitted and managed by a central service. Apart from processing the content, this could push it directly into a central drug safety database, from which it can be analysed. Provided there is a global, centralised view, this helps to streamline processes, ensure greater consistency, hasten turnaround and reduce human touch points.
- Retain experts
When it comes to translation, centralising resources helps to retain on-demand translators for languages that are in high demand. Keeping experts on standby can reduce AE report translation costs by as much as seven eighths, compared with buying in ad-hoc support.
- Facilitate AI-based automation
Standardising and streamlining approaches to global AE report management also releases the potential to the most of artificial intelligence (AI) and machine learning (ML). When AE information is submitted in hand-written notes or in different formats and languages, it is hard to make the most of this technology but if the created record is consistent, there is possibility for repetitive pattern recognition and ML. As the same terms and phrases are picked up in translated reports, trends are identified.
- Trend capture
Digital, mobile and online AE reporting is on the rise, including voice-to-text capture, and as well as providing more clarity in event recording, this increases the scope for near-real-time AI/ML-enabled trend capture – but only if information is centrally captured and processed in order to give a fully rounded viewpoint. The earlier and more reliably such trend information can be captured, the greater the potential for making timely improvements to drug formulations and thereby improving patient safety.
- Take a wider view
Another area where AI/ML technology has potential is in processing content from public online forums and from medical safety literature published worldwide. These form a growing element of pharmacovigilance, existing in numerous languages and character sets. This content needs to be analysed, cross-referenced and included in PV reports. ‘Webcrawler’ software can read and filter this content, but the key information still has to be analysed, translated and compiled. This is labour-intensive work, especially in a large company that might compile a million words in a year. But the more it can be centralised and managed consistently via a single specialist resource, the more scope pharma companies have to make both cost savings and breakthrough insights.
Volume 22, Issue 4 – Fall 2021
About the author
Kathleen O’Brien is Director of Business Development at Amplexor Life Sciences. She is a 17-year veteran of the translation industry and held previous positions at Newtype Inc and Language Works. She studied at Loyola University, Maryland and the Universidad de Sevilla, Spain, and is based in New Jersey.