Safety surveillance is the key component of efficient drug regulation, clinical care, and public health programs. Comprehensive post-market safety surveillance is fundamental to protect drug manufacturer, drug distributor, and end-consumer.
The quality and efficiency of new pharmaceutical products must be necessarily demonstrated before approval. Despite this, many adverse drug events are detected when the pharmaceutical product is being already used, causing morbidity and mortality.
It is therefore crucial that the safety compliance of the new medicine is monitored both during clinical trials and after market launch.
But how do you ensure alignment with the stringent regulations of authorities such as the EMA and FDA?
Safety requirements in the United States and Europe
The established pharmacovigilance system is an extensive discipline primarily designed to ensure patient safety. It includes the detection, assessment, understanding, and prevention of adverse drug effects or other medication-related problems.
The acknowledged pharmacovigilance system is governed:
- By the European Medicines Agency (EMA) in the European Union, which is established to:
– Gather information from all available sources (case reports, epidemiological analysis)
– Analyze data
– Identify signals
– Assess risks
- By the Food and Drug Administration (FDA) in the United States
- the FDA requires manufacturers, packaging providers, and distributors to establish and maintain accurate records and submit those to the FDA to monitor unexpected effects associated with pharmaceutical products
The EMA obliges marketing authorization holders to conduct imposed post-authorization compliance studies. Speaking about certain authorized medicinal products, responsible MAHs (marketing-authorization holders) might have additional requirements to monitor pharmacovigilance databases and include gained findings in the relevant PSUR (Periodic Safety Update Report).
The FDA requires manufacturers to submit post-authorization safety reports on a regular basis:
- Quarterly for the first 3 years after approval
- Annually thereafter
Post-authorization reporting data management
The identification and management of so-called safety signals is essential for marketing authorization holders. The inability to detect safety signals hinders further safety assessment.
Most commonly, responsible MAHs use the following sources:
- Databases containing medical records, which include patient age, gender, morbidity, and else
- Databases containing administrative claims
An electronic healthcare database with systematic or automated data collection presents an alternative source. It can be integrated with official disease registries, prescription databases and functionary mortality registries to ensure more accurate data capture.
Within the framework of MAHs’ compliance management, this approach might assure:
- Continuous monitoring of relevant pharmacovigilance data
- Data quality, integrity, accuracy, and legibility
- Source verification
- Endpoint validation
- Right selection of techniques, linkage methods, search strategies
- Justified assumptions
- Data management and coding
- Record validity
Safety compliance’ core challenges
Biopharmaceutical organizations are producing and distributing efficient medicines at an unprecedented rate. But still, with billions being invested in research and development, bringing brand-new high-quality medication to the pharma market comes with grueling challenges.
The main compliance roadblocks can be reduced to:
- Inconsistent and spontaneous reporting
- Priorities shifted towards efficacy, not safety
- Analytical limitations
- Reporting limitations
Another roadblock to address is the ever-increasing volume of information originating from different sources. In addition to the increasing pressure coming from countless sources to be carefully reviewed, it is also the overhanging demand for integration and management of ever larger amounts of data being used to evaluate safety signals.
These challenges are hindering regulatory compliance, respectively causing:
- Low competitiveness
- Detained growth
- Reputational damage
- Financial loss
AWS-based pharmacovigilance safety software
The platform we suggest is a cloud-based SaaS safety software providing access to multiple virtual databases to facilitate data processing for subsequent data analysis and reporting:
- Data management
- Signal management
- Data validation, cross-field checks
- Case creation, modification, monitoring, and access
- Advanced analytics
- Expedited and periodic reporting (in both E2B (R2) and E2B (R3) formats)
- Electronic signatures
- Electronic submission
- PSUR submissions, PBRER and DSUR documentation
- eMDR XML file creation
By incorporating useful tools, the custom, AWS-based SaaS safety software can help to process structured and unstructured documents:
- Full-text and abstract publications
- Scientific literature (dissertations, theses)
- Systematic reviews
- Competitor analysis
- Regulatory reports
- Unpublished materials (case reports, clinical studies, safety findings, and more)
The concept we suggest conjugates multiple smart and scalable products to leverage the potential of modern cloud technologies:
Some of the services that might be integrated to harvest maximum benefit:
- AWS Lambda — data processing
- AWS KMS — key creation and management, data encryption, HMACs generation
- Amazon CloudWatch — infrastructure and application monitoring
- Amazon OpenSearch — real-time monitoring, log analytics, and search
- Amazon Cognito — easy and secure authorization
- Amazon Kendra — unified search across multiple structured and unstructured repositories
- Aurora repository — fully managed, simple, reliable, and cost-efficient database
- Darktrace vSensor — cyberthreat detection
- Amazon Comprehend Medical — data capturing and processing (medical records, discharge summaries, test results, and other supportive documentation)
- Document Understanding Solution — data search, discovery, filtering and extraction along with workflow automation
Safety software to boost business growth
The cloud-based compliance software might automate manual routines, providing for increased productivity. The AWS-driven safety solution can help you handle clinical trials (from small Phase I to large Phase III and IV) and adverse post-marketing events ensuring adherence to the good pharmacovigilance practices (GVP).
When adopting computational technology, you leverage:
- Cloud computing
Enjoy accessibility, accelerated flexibility and scalability, optimized collaboration, advanced security, and other business benefits that come with adopting advanced technology in healthcare and pharma.
- Process automation
Significantly minimize manual activities by incorporating artificial intelligence, in particular machine learning and natural language processing.
- Data-driven decision-making
Easily access valuable insights from diverse data sources to leverage data-driven decision-making.
- Regulatory compliance
Confidently detect, analyze, manage, and trace safety signals to ensure regulatory compliance.
Safety software business value
A cloud-based compliance software might diminish operational expenses by optimizing:
- Waste management
- Budget reinvestment
The AWS-driven safety solution might boost overall performance by providing:
- Reduced time and cost
- Increased performance and interoperability
- Streamlined communication and collaboration
- Eliminated bottlenecks
As stated by McKinsey, about 60% of productivity could come from digitalization and automation of processes.
Post-authorization analysis and reporting can be notably improved by implementing computational technology to handle:
- The identification of risks
- The evaluation of measures to take
According to recent research:
- The cost of adverse medication events causing mistreatment and damage to global healthcare systems is estimated at over $42 billion
- The majority of adverse drug events related to VTE treatment are hospital-acquired, with costs estimated to range between:
– €1,5 to €13,5 billion in the European Union
– $7,5 to $39,5 billion in the United States
By adopting computational technology, responsible authorities can eliminate financial damage by quickly detecting, investigating, and remediating emerging issues.
The pharmacovigilance service platform can turn obligatory reporting into an efficient and convenient practice by helping:
- Immediately respond to incidents and problems using automatically synchronized runbooks
- Seamlessly support compliance processes using automation, best practices, and templates
The suggested service platform can optimize operational security:
- Encrypting data
- Filtering data to restrict content access
- Gathering data in form of logs, metrics, events
- Analyzing data to quickly identify threats
Computational technology ensures instant, uninterrupted monitoring without requiring human surveillance. The solution might accurately gather information from all available resources, analyze data, identify signals, assess risks, and create comprehensive reports.
Modern tools easily detect relevant patterns and deliver valuable insight without constant human intervention. The solution can streamline data collection and analysis providing for data-driven decision-making.
According to Kofax’ research, about 22% of productive employee time is wasted on repeated manual tasks. Utilizing the suggested pharmacovigilance safety software, a company can optimize employee performance, respectively improving employee satisfaction and motivation.
According to DownToEarth’ publication, an increase from about $150 billion in 2019 to over $1 trillion by 2030 in clean energy investment is needed to put the world on track to reach net-zero emissions by the year 2050. Using the AWS-based software means minimizing the amount of water commonly used to cool data centers, respectively returning more water to communities.
In general, there are numerous opportunities pharmaceutical organizations might leverage:
- Business automation (ERP & CRM platforms)
- Telemedicine and telehealth solutions (for example, smart chatbots)
- Predictive analytics (enterprise tools for discovering data patterns and making accurate predictions)
- Recommendation systems (EMR & EHR systems)
What’s more, pharma companies can enhance operational processes by adopting:
- Artificial Intelligence (ML, DL & NLP)
- Computer vision
- Optical character recognition (OCR)
- Blockchain technology
Speaking about regulatory compliance, most businesses are under great pressure to control large workloads, numerous sources of information to evaluate, and rapidly changing requirements, all with limited resources. What about alleviating that sensible pressure while improving pharmacovigilance activities and ensuring regulatory compliance?
A pharmacovigilance management software can help:
- Seamlessly control safety signals
- Continuously track submission deadlines
- Assure uncompromising data reliability
- Ensure compliance with the industry-specific standards