Medicines and vaccines are remarkable tools for improving health and saving lives. Yet, even with rigorous testing, they’re not without potential risks. That’s why we need pharmacovigilance.

Hold up, what’s with this “pharmacovigilance” jargon? Think of it as the science of keeping tabs on meds and vaccines, making sure they’re doing their job without any nasty surprises.

Why Not Stop With Just Clinical Testing 

While clinical trials play a vital role in assessing safety and efficacy, they have limitations. They involve a relatively small group of participants and a restricted time frame. This means that rare or longer-term side effects might not be identified until the medicine or vaccine is used by a larger, diverse population over a longer period. This is why we need to know the importance of pharmacovigilance.

Continuous Monitoring: 

Pharmacovigilance isn’t a one-time event; it’s an ongoing process. Once approved, medicines and vaccines are continuously monitored to ensure their continued safety and effectiveness. This involves several key players:

Patients:

• Report any side effects you experience: Even if unsure if the medicine caused them, reporting helps build a comprehensive picture of potential risks.
• Read the package insert: This information leaflet provides details about known side effects and helps patients understand what to watch out for.

Healthcare Professionals:

• Report any side effects observed in your patients: This includes both confirmed and suspected reactions.
• Share relevant information with patients: Help them understand the importance of reporting and how to do so effectively.

Market Authorization Holders (Pharmaceutical Companies):

• Proactively monitor and report side effects: As the product developers, they have a crucial responsibility to track and report any safety concerns.
• Collaborate with regulatory agencies and healthcare professionals: Sharing data and insights is essential for understanding and addressing potential risks.

What to Report

The information leaflet accompanying any medicine provides details on potential side effects. 

However, it’s important to report any unexpected reactions, especially:

• Serious Adverse Reactions: Any effect that results in death, life-threatening conditions, prolonged hospitalization, disability, or other serious medical events.
• New Medicines and Vaccines: Any reactions observed with recently introduced products.
• Medication Errors: Cases where the wrong medicine, dose, or administration route was used, leading to serious harm.
• Lack of Efficacy: If the medicine seems ineffective in its intended purpose.
• Overdose and Off-Label Use: Any serious reactions resulting from taking more than the recommended dose or using the medicine for a purpose not approved by regulatory authorities.
• Suspected Product Defects: If you believe the product itself might be faulty and causing adverse reactions.

What constitutes “serious”?

• Death
• Life-threatening situations
• Hospitalization or extended stays
• Permanent disabilities or birth defects
• Other critical medical interventions

Importance of Pharmacovigilance in Identifying and Documenting Adverse Reactions

1.Reporting as a Patient:

As a patient or caregiver, you witness firsthand how a particular medicine or vaccine impacts your health. If you experience any unexpected symptoms or changes in your well-being after taking a medication or receiving a vaccine, don’t hesitate to report it. Even seemingly minor side effects can provide valuable insights.

Why Report as a Patient?

Every report you submit contributes to a larger network of information, making medicines and vaccines safer for everyone. While extensive testing happens before these products become available, unexpected side effects sometimes emerge when used by a wider population. Your report could

• Identify previously unknown or uncommon side effects.
• Lead to updates in product information or labeling to better inform users.
• Prompt regulatory actions like product recalls or adjustments if necessary.
• Contribute to international data analysis, leading to improved understanding of overall benefits and risks.

How to Report as a Patient:

• Talk to your doctor or pharmacist: They are best equipped to assess your symptoms and understand potential connections to the medication or vaccine.
• Use online reporting systems: Many countries have user-friendly online platforms for reporting side effects. For example, in India, you can use the Pharmacovigilance Programme of India (PvPI) portal.
• Contact your national regulatory agency: Most countries have specialized agencies responsible for monitoring drug safety. They might have alternative reporting channels for patient use.

2.Reporting as Healthcare Professionals 

Doctors, nurses, and pharmacists play a critical role in identifying and reporting side effects. Your expertise in patient care and understanding of medications makes your reports invaluable.

Why Report as a Healthcare Professional?

You see a wider range of patients and potential reactions than individual patients do. By reporting, you

• Contribute to a more comprehensive picture of medication and vaccine safety.
• Help identify trends and patterns that might otherwise go unnoticed.
• Assist in ensuring the best possible care for your patients and future generations.

How to Report as a Healthcare Professional

• Use established reporting systems: Most countries have dedicated healthcare professional portals for reporting side effects. These portals often offer additional resources and guidance.
• Follow your national regulations: Many countries mandate healthcare professionals to report specific types of side effects. Familiarize yourself with your obligations.
• Encourage patient reporting: Educate your patients about the importance of reporting side effects and provide them with easy access to reporting channels.

3.Reporting as Pharmaceutical Industry

Pharmaceutical companies have a primary responsibility to ensure the safety of their products. This includes actively monitoring and reporting adverse events.

Why Report as a Pharmaceutical Company?

• Proactive reporting demonstrates your commitment to product safety and transparency.
• Early identification of potential issues allows for swift corrective actions, minimizing harm to patients.
• Your data contributes to the broader understanding of medication and vaccine safety, benefiting the entire industry.

How to Report as a Pharmaceutical Company

• Follow regulatory requirements: Each country has specific regulations for reporting adverse events by pharmaceutical companies. Adherence is crucial.
• Maintain robust internal reporting systems: Ensure your company has efficient mechanisms for collecting, analyzing, and reporting data on adverse events.

Collaborate with regulatory agencies: Work openly and transparently with regulators to facilitate effective monitoring and safety measures.

Pharmacovigilance has grown significantly in recent years and its importance in the healthcare sector has been recognized worldwide. To prevent or lower the patient hazards, improvements in public health and precise evaluation and monitoring of drug safety has become extremely important. This makes the need for a highly efficient Pharmacovigilance (PV) database essential for all the Pharma, Biotech, and Clinical Research Organizations.

Being a highly essential system in the life sciences sector, a PV database should be able to achieve maximum productivity at the same time keeping track of compliance where the humans can fail to complete the processes with accuracy and efficiency.

To obtain this kind of productivity and efficiency, you must keep in mind some of the essential features which a PV system should comprise.

1. The Must-Have Basic Features:

Below are some essential features that a pharmacovigilance database should have:

• The system should have the ability to report adverse events via configurable web form over secured internet.
• Custom validation should be present to ensure data consistency & completeness of cases.
• ICSRs – R2 & R3 compliance.
• Periodic Reports (like NDA, PADER, PSUR, etc.) and Line listings must be present.
• Must have an automated configuration for listedness.
• Auto narratives.
• Should support medical devices, clinical studies, spontaneous, literature cases, etc.
• MedDRA and WHO Drug dictionary integration
• The system should have more configurations and less customizations
• Must have an in-built AS2 gateway for regulatory e-submissions.

2. User Friendly and Easy-to-Use:

A PV database with a lot of advanced features without a user-friendly interface will gradually reduce the performance and the interest of the team and gradually impacts the timelines and the overall business.

3. Configurable to meet sponsor SOPs

The timelines of submission differ for each regulatory agency and sponsors. The SOPs differs from sponsor to sponsor. A PV database should be dynamic enough to be confirmed to address all the changing regulatory and sponsor needs with configurations. The system should not make the sponsor to change his SOP according to the system, but the system should be capable of meeting sponsor SOP and timelines.

Example:

The system should provide dynamic workflows to create different workflows for different types of cases (serious cases vs. non-serious vs. death cases). A company should be able to configure different timelines and different QC/MR process for a serious case and death case.

For a serious case, the admin should be able to set the duration of the complete process as 5 days – set 2 days for the completion of Data Entry, 1 day each for the other three processes, whereas he can set a 15-day duration for a non-serious case and can assign 4 days for Data Entry, 4 days for Quality Review, 4 days for Medical Review, 3 days for Reporting or whatever sequence he requires. Similarly, he can assign the 4 days to the serious and death cases giving 1 day each for every process and so on.

4. Automated Case Tracking / Monitoring Case Submission Timelines

Meeting timelines of the regulatory compliance is a crucial task in Pharmacovigilance. When the number of cases increases, it becomes hard for the CROs/ Pharma companies to track every case to ensure it is processed and submitted to agencies on time.

PV database should be capable of assigning timelines for the cases based on the sponsor / regulatory timelines and track the cases to ensure it is submitted to regulatory agencies on time. The feature should allow the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case has not been dealt with within the required time period.

5. Regulatory Compliance and Inspection Ready

6. Should be Cost-Effective:

Pharmacovigilance is an expense for any company. Some Pharma/CROs on the verge of saving costs, they cut the costs on the teams they hire, and they spend a lot on procuring traditional Pharmacovigilance databases. This strategy is completely wrong. Just an expensive PV system cannot meet all the regulatory guidelines without a strong team in place.

7. Website and Call Centre ADRs / MI / PQCs

With the changing regulatory guidelines and increasing regulations, it is important to completely get rid of any information that is tracked out of the Pharmacovigilance databases.

ADRs are generally completely processed and tracked in the Pharmacovigilance database. But most of the PV databases does not support capturing and tracking of the medical inquiries and product quality complaints. Since the MI, PQCs and ADRs goes hand in hand, the Pharmacovigilance database should support handling of MIs and PQCs as well. Pharmacovigilance database should also support receiving the ADRs, MIs and PQCs directly from the Sponsor websites and Sponsor / CRO call centres.

8. AI & Automation

9. Multilingual Capabilities

There is a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / Pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.

For countries like Japan and China, new rules for Pharmacovigilance are on the way. CROs, Biotech and Pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.

Multilingual system would also be of great use as the local Pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.

Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world hence the Pharmacovigilance database should be multilingual.

10. Signal Detection

As manual signal detection processes consume considerable time, PV team might require a few weeks to analyse a signal. The system should have an in-built signal detection feature as the PV team require focusing on real-time issues while reducing the time and effort spent in determining the fake signals. Hence it is important that the PV database supports signal detection.

Hope you found this article informative. Please reach out to prasanna.g@clinevotech.com, if you have any comments.

 

 

Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pharmacovigilance being an extensive part of healthcare and clinical trials requires the combination of deep understanding of medical translation with the intricacies of clinical research, marketing and reporting. Some countries have made the reporting in their local language mandatory.

The Need for Multilingualism in Pharmacovigilance

There’s a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.

For countries like Japan and China, new rules for pharmacovigilance are on the way. CROs, biotech and pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.

Multilingual system would also be of great use as the local pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.

Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world.

Clinevo Safety & It’s Multilingual Capabilities

Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end to end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case processing, Regulatory submissions / AS2 gateway, Analytics, and Safety signals capabilities under one platform.

It is supported by technology that enables quick turnaround of your specialist requirements. Clinevo Safety can process data in any language like German, Japanese, Chinese, etc. The complete system gets adopted to any language with just an admin configuration.

Apart from just multilingual capabilities, Clinevo Safety also offers dual language support where all the text is available in two different languages and these languages can be set according to the user preference. The multilingual and dual language capability of Clinevo Safety makes it a language friendly, efficient and cost-effective multilingual global system.

Pharma, Biotech, CRO and Life Sciences companies have pharmacovigilance as a mandatory regulatory responsibility. As there’s an exponential increase with the volume of Individual Case Safety Reports (ICSR) increasing every year it has become quite mandatory to design an automated solution for the largely manual pharmacovigilance process for these companies.

What is Robotic Process Automation?

Robotic process automation is one of the emerging forms of business process automation technology based on the notion of metaphorical software robots or artificial intelligence.

The current wave of automation in the pharmacovigilance industry usually refers to Robotics also known as RPA (Robotic Process Automation), where the repetitive manual steps can be automated and no human intervention is required. Repetitive tasks performed by the robotic process can remarkably help in reducing the dependency on humans with a direct increase in efficiency and also improvement in overall quality, productivity and compliance.

About Clinevo Safety

Clinevo Safety is a cloud-based, user-friendly, easy to use, regulatory compliant, end-to-end Pharmacovigilance / Drug Safety System. This all-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals Capabilities under one platform.

Robotic Process Automation in Clinevo Safety

Clinevo Safety has been designed with regards to the robotic process automation automating some of the key process to achieve maximum productivity at the same time keeping track of compliance where the humans can fail to complete the processes with accuracy and efficiency.

Below are some of the key features of Clinevo Safety which uses RPA based automation:

1. RPA based Dynamic Workflows – Prioritizes the cases based on seriousness

Traditional standard workflows:

In the traditional PV system, the workflow is completely fixed where for the entire organization and for all the scenarios the workflow is going to be standard. Be it a serious case, non-serious case, etc., the workflow is going to be exactly the same.

For Example: The admin will only be able to set a fixed time period of up to 15 days or less for every type of case making every process completion utilizing the same amount of time irrespective of the seriousness of the case. This will make the process slower and inefficient.

 

Dynamic workflows:

Clinevo Safety provides RPA based dynamic workflow to create different workflows for different types of cases. The feature enables the time period to be easily changed for all the cases and not lock them into a specific schema.

For example: For a serious case, the admin can set the duration of the complete process as 5 days and set 2 day for the completion of Data Entry and 1 day each for the other three processes, whereas he can set a 15 day duration for a non-serious case and can assign 4 days for Data Entry, 4 days for Quality Review, 4 days for Medical Review, 3 days for Reporting or whatever sequence he requires. Similarly, he can assign the 4 days to the serious and death cases giving 1 day each for every process and so on.

Based on the setup by the administrator, the system will automatically determine which workflow has to be followed for any case and performs the case assignment automatically. Hence Prioritizing the cases on its serious is completely automated.

2. Robotic Workload Balancer

Usually the case assignments are manual where there is a need of a workflow manager who has to determine the complete load of every individual manually and assign the cases. Sometimes, he has to wait for someone to take up a case from the respective group.

Along with the manual case assignment option, Clinevo Safety provides an Automated Workflow Manager which enables the system to determine the workload of every individual and assigns the cases to them based on their availability, current workload and capacity by examining their history of case handling.

If the bandwidth of the team is completely utilized and the system determines that the case cannot be processed on time, it triggers alerts to the reporting managers for taking the case on manual assignment mode .

3. Robotic Case Monitor

Clinevo Safety has a RPA based monitor for monitoring and reporting (sending auto-notifications) to the process groups/ workflow manager/ head of the department whenever there is any pending case from any group performing the processes is observed.

The feature allows the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case hasn’t been dealt with within the required time period. The feature also escalates the issue to the person in charge of the pharmacovigilance of that company. It ensures you don’t fail to complete any case due to uninformative reasons.

4. Automated Traffic-Light Color Coding

The PV system also comprises of automated traffic-light color-coding for providing an intimation about the status of any case.

There are three colors visible in front of every case. Green is referred to a case that is processed right on time, Yellow is for a case that is nearing its due date and Red is for a case that is already overdue and is yet to be processed.

The color coding makes it easier for the users as well as the administrator of the system to have knowledge about the status of their cases and help in a timely procession of each case.

The list of the color-coded cases is visible on a highly interactive customizable dashboard which makes the system excessively user-friendly. This list enables the users to be well aware of the status of every case they’re handling.

5. Automated Daily Report Generation

The system also has the ability to generate daily status reports on an everyday basis. The report provides an overview about the status of every case at each processing phase.

The status of the cases is available on the interactive dashboard. It also generates automated notifications in the form of emails which consists of information regarding the same. The report helps the users as well as other concerned personnel to stay updated about every case and the process it’s going through.

Conclusion

In comparison to the existing systems in the market, Clinevo Safety has the following features which are enabled by RPA:

1. Clinevo Safety is prioritizing the cases (serious cases) that have to be taken over before the other cases (non-serious cases).
2. Automatic workload balancer will ensure the work is shared among people and high productivity is achieved.
3. It automatically sets the due dates for all the cases and their processes and sends automated follow-ups keeping you updated about the status of every case.
4. It also sends automated alerts to the concerned person when there has been no action taken for a certain case when it is nearing its due date.
5. Overall, it tracks all cases ensuring that none of the cases are gone out of hand and are efficiently processed on time.

Thus, the application of RPA features in Clinevo Safety makes it a highly productive, reliable and efficient PV system resulting to improved compliance and productivity in pharmacovigilance.

Author: Arunkumar Devaraj, Director of Products and Solutions, Clinevo Technologies.

Date: 17-Jul-2019

The Indian Pharmacopeia Commission published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which was effective January 2018. The new guidance is heavily influenced by USFDA and EMA Pharmacovigilance regulations.

According to the guidelines: “MAHs are required to collect and process comprehensive safety information related to pharmaceutical products and reports to the regulatory authority within the prescribed timelines. Every MAH shall have a system in place that ensures the overall quality of AEs/ADRs.” Term “MAH” refers to the manufacturer or importer of the drug, who has a valid manufacturing or import license in India”.

According to the guidelines, below are the 6 key components that a Pharmacovigilance department of a MAH should consist of:

1. Pharmacovigilance System Master File (PvMF) & Pharmacovigilance Officer In-charge (PvOI):

• PvMF: (similar to the pharmacovigilance system master file PSMF) must contain all the information related to the MAH’s PV system, including the PV Officer In-charge (PvOI), PV organization structure, sources of safety data, PV processes and PV systems.

• PvOI: PvOI shall have sufficient authority over the pharmacovigilance system and be responsible for compliance. The PvOI is mandated to be a Medical Officer or a Pharmacist trained in the collection and analysis of Adverse Drug Reaction (ADR) reports.

2. ICSRs and Pharmacovigilance Database (Software):

A Pharmacovigilance database may be required to do the mandated activities mentioned below:

1. MAH must collect and report Individual Case Safety Reports (ICSRs), from different sources.
2. Monthly literature review using electronic literature database is required.
3. Screening of medical inquiries, internet/digital media, solicited reports, special populations is required.
4. The MAH is required to code ADRs using a dictionary.

Importantly all ICSRs received by MAHs are mandated to be submitted to PvPI in XML-E2B format.

3. PSURs – Periodic Safety Update Reports (PSURs):

PSURs shall be submitted every six months for the first two years after approval of the drug and annually for the subsequent two years unless extended by the licensing authority in the interest of public health. PSURs due must be submitted within 30 calendar days of the last day of the reporting period.

4. QMS – Quality Management System:

QMS must be in place to monitor the quality cycle of the pharmacovigilance system, quality objectives for pharmacovigilance, responsibilities of the quality system, training of MAH personnel, and required facilities and equipment, with special emphasis on compliance management, record management, documentation of the quality system, and critical pharmacovigilance processes.

5. PV audits and inspections should be conducted both internally and externally to the PV systems.

6. RMPs: Risk Management Plans, including the objectives, their content and risk minimization activities, and highlights specific pharmacovigilance activities must be in place. The general understanding is that an RMP must be submitted at the time of product approval and/or upon request by the competent authorities, although it is not explicitly mentioned in the guidelines.

Although complying with the pharmacovigilance requirements pronounced by this guideline may be quite challenging there are provisions for outsourcing most of its mandated activities to Pharmacovigilance vendors. With India serving as the global capital of pharmacovigilance outsourcing today, MAHs may make use of these provisions and quickly augment their Pharmacovigilance systems by choosing appropriate pharmacovigilance partners.

For the drug manufacturers/MAHs who do not yet have PV systems in place, implementing these changes can seem to be an insurmountable task. However, we already have an end to end Pharmacovigilance database/software in addition to the services needed to address the new requirements. We can help companies to establish and maintain a PV system, Call Center, Screening Literature and Social Media Cases, QMS, PvMF, ICSRs, PSUR, RMP and Signal Management. In addition, we can also provide support on the PvOI and PV audits. We can help you in the transition to the new requirements and address your end to end PV needs.

If you are interested in learning more about Clinevo’s PV Software and Services, please contact us at arun.d@clinevotech.com