MedWatch Plus: Preparing for Electronic Adverse Events Reporting in the US

The Food and Drug Administration is pressing on with plans to make electronic reporting of adverse events mandatory. Brenda Percy examines how companies can make a seamless transition from paper to electronic submissions.

The life sciences industry in the US has become engulfed in talk of electronic medical device reporting of adverse events as the Food and Drug Administration presses ahead with improvements to the way in which side effects or injuries associated with medical devices or drugs are reported.

Most medical technology firms will have by now heard of the terms associated with electronic medical device reporting such as electronic submissions gateway, FDA adverse event report systems, MedWatch Plus and e-submitter – and the list goes on. Throw in the word “mandatory” – eMDR is to become compulsory in the near future – and it is enough to make some companies want to run for the hills.

Well, don’t start running yet. Since everyone is talking about eMDR, let us shed some light on the subject, why it is important and the steps you can take to prepare for its impending, mandatory implementation.

Within the life sciences industry, consumer safety is a top priority. A defective product can have severe consequences for both the consumer and the manufacturer. Therefore, it is necessary to ensure that all adverse events due to product issues are reported directly to the FDA.

The FDA is charged with ensuring that all products from industries encompassed within the food, drug and medical technology arenas are produced safely and effectively; it receives more than 600,000 reports on adverse events each year. In order to give each of these events the individual attention necessary to mitigate risk, it is crucial that the agency is properly informed by organisations of all reportable adverse events. It is also important that the FDA receives this information in a format that it can process efficiently.

Evolution of MedWatch Plus

Since 1993, the FDA has catered for adverse events reporting through the use of MedWatch forms 3500 and 3500A. The MedWatch initiative began as a manual process. All adverse events reports were submitted on paper and were transcribed by the FDA into an electronic format for usability and analysis.

While paper-based submissions have in the past been deemed sufficient, an increase in their volume each year has rendered them increasingly unwieldy for the FDA. The paper processes are time-consuming and often result in inconsistent or lesser quality information¹. In addition, the FDA is resource-strained with regard to its ability to update these manual forms in a manner that keeps pace with evolving postmarket safety standards. The FDA also allows companies to submit certain safety reports in electronic format either through its electronic submission gateway or on CD-ROM, digital tape or floppy disk. However, most submissions today are still made using the paper format.

The FDA recognised that in order to effectively meet the needs of the consumers in regulated industries and to ensure product safety, there was a need for a fully automated web-based system that could seamlessly submit information to the agency without the use of paper-based methods.

As such, it began developing in 2008 a new electronic system for collecting, submitting and processing adverse event reports. The MedWatch Plus portal, which the FDA expects could be ready for use by all of its centres by fiscal year 2011, will enable companies to submit both voluntary and mandatory adverse events reports for drugs, medical devices and other FDA-related products to a single point of entry through the agency’s electronic submissions gateway. The agency believes one point of entry will better enable organisations to submit information².

MedWatch Plus follows the FDA’s Health Level 7 Individual Case Safety Report (HL7 ICSR)³ standard for receiving reports on adverse events. It is a compilation of the current MedWatch system, and integrates the 3500 and 3500A forms into the FDA adverse event reporting systems (FAERS) database, which will allow the agency to more efficiently analyse and identify safety reports.

Speeding up processes

Once a product hits the shelves, a company begins receiving feedback on it, some of which will be complaints from physicians or institutions using the product – even complaints directly from patients themselves. The company must then determine the seriousness of any adverse events and whether they warrant a voluntary or mandatory FDA notification. Voluntary notifications are submitted via MedWatch form 3500 and are for events that do not carry significant consequences for the patient or consumer. Mandatory FDA notifications are submitted via MedWatch form 3500A and cover events that carry significant consequences for the patient or consumer.

Both forms are currently available on the FDA’s website. However, while MedWatch 3500 allows for the submission of individual reports through the FDA’s web interface, MedWatch 3500A can only be submitted electronically through the FDA’s voluntary, downloadable software, the eSubmitter (for low volume reporting). Previously, the 3500A form could only be faxed or mailed to the agency; however, many reporters continue to use this method as it is not yet mandatory to submit the 3500A form electronically. On average, the communication time from a fax submittal to the FDA and an FDA acknowledgement is five to seven days.

Using the MedWatch Plus portal, the time between submission and FDA acknowledgement will be significantly reduced. The FDA and National Institutes of Health worked collaboratively to build into MedWatch Plus a “rational questionnaire” software, which is a data collection tool that helps the user determine the data that need to be included for each individual report. The reporter will be able to choose whether to submit a report via MedWatch Plus using either the online rational questionnaire (accessed via the FDA website) or gateway-to-gateway access, which allows companies to submit reports directly from their own gateway to the FDA’s gateway. Using the rational questionnaire, the reporting burden is estimated to be one hour. With gateway-to-gateway access, the reporting burden is ten minutes. Current reports estimate that in the future about 80% of reports will be submitted via gateway-to-gateway access, and 20% through the MedWatch Plus rational questionnaire⁴.

Weigh your options: build or buy?

The MedWatch Plus initiative provides an electronic submissions gateway from an organisation’s internal quality and compliance management system to the FDA’s database. For this method of reporting to be effective, the MedWatch Plus form will be best integrated directly into an organisation’s quality and compliance management software system. Like any software solution, MedWatch Plus will require a certain degree of integration to be effectively implemented into an organisation’s existing quality and compliance management solution. There are two options that an organisation might be faced with when deciding on a solution: “Do we build the solution, or can we buy something?” A decision on this matter is usually dependant on the cost-effectiveness and convenience of the organisation’s existing quality and compliance management system.

Both are sound options but both have their benefits and pitfalls. The key is for an organisation to select the option best suited for its business needs. Building a software solution around MedWatch Plus will require significant development resources. For example, a custom-developed MedWatch Plus solution that integrates with existing business systems can cost between $200,000 to $350,000 to implement. These developed systems are often “hard-coded” and offer little flexibility. So, if business processes change six to 12 months down the line, an organisation must put forth more development resources to adapt to the change. While this option offers a true custom solution, the development overhead can often outweigh the benefit.

If an organisation chooses to buy its MedWatch Plus solution, there are quality and compliance management solutions available that will offer a MedWatch Plus integration package built into the application and, through use of configurations, will allow adjustments to be made to the business rules, forms and workflow to meet individual business needs. The benefit behind this “out-of-the-box” solution is that organisations are able to focus their resources on the usage of the tool, rather than on its development. This allows many organisations to have the same flexibility offered in a custom solution, but without the development time and resources that usually make up a majority of the cost. An organisation should look for solutions that are robust enough to accomplish the quality and compliance processes needed for their unique business needs, with the regulatory reporting package built in. The system should also be configurable, so that changes made to the business processes can be implemented seamlessly and without programming or development.

What’s in it for you?

Collaboration: The entire concept behind the MedWatch Plus electronic submission tool is to enhance the collaboration between an organisation and the FDA. The agency’s goal is to not only provide an environment for easy and seamless submission of adverse events, but to also speed up the time in which it is able to respond to events. MedWatch Plus also enhances the communication process with the FDA and eliminates or reduces “crossover emails”. Those who use MedWatch Plus will benefit from an immediate receipt and acknowledgement – within six to 12 minutes – as opposed to waiting days or longer with the manual reporting process.

Cost reduction: Use of MedWatch Plus will result in cost savings, as it will eliminate the need for the administrative overhead incurred from traditional communication. Through the use of batch event reporting, and immediate interaction with the FDA, companies can literally “upload” multiple adverse events in a single click to the FDA, saving time and resources in the process.

Record retention: One of the major challenges with the traditional MedWatch forms is that they are recorded on paper. These manual processes require a lot of paperwork and the forms usually end up in a filing cabinet or file server and can take a long time to even locate. With the electronic MedWatch Plus submission, old records will be able to be retrieved in real time, as everything is automated and centrally stored in a data repository. Similarly, all related documentation is available at the click of a button. For example, MedWatch Plus automatically links the FDA’s acknowledgement to the original submission, eliminating any confusion as to which acknowledgements belong with which submissions. This provides complete transparency and accuracy of correlating data and results in an efficient and reliable process.

Responsiveness: MedWatch Plus will enable involved parties to flag submission errors quickly, as opposed to the more manual and time-consuming correspondences to and from the FDA. This allows for the efficient and real-time response to all events from the agency. Furthermore, MedWatch Plus will provide a collaborative environment between companies and the FDA to proactively review and correct errors and respond to questions. In the case of major adverse events, time is a critical factor in responding to the market, and MedWatch Plus will allow for significantly reduced response time from the FDA.

Single environment for all adverse events: Technology is all about the consolidation of systems and providing a comprehensive, enterprise method for storing data. Much like any business systems integration, MedWatch Plus is being designed to provide a holistic environment for all regulatory submissions. It will act as a single point of entry for processing all electronic submissions in a highly secure environment. This is beneficial because complaints to the company can be directly linked to a MedWatch form and integrated with the FDA’s gateway. Within a single environment, companies can store not only their internal compliance data, but also any FDA responses to the original event. Complaints or adverse event data can also be linked to product lines in external systems such as enterprise resource planning, customer relationship management and laboratory information management systems, providing multiple points of data throughout the business.

MedWatch Plus 101: preparing for implementation

As with any software implementation, there will be challenges in ensuring the MedWatch Plus software is designed to meet specific business needs. But with careful consideration, steps can be taken to ensure that implementation of MedWatch Plus will be smooth, seamless and will completely meet business needs. The best practices for companies to take into consideration before implementing an electronic reporting system are discussed below.

Identify the optimal submission tool for your business: Options that are currently available for organisations to submit adverse event reports to the FDA electronically include gateway-to-gateway access or the FDA’s eSubmitter (formerly the Center for Devices and Radiological Health eSubmitter (CeSub)). The eSubmitter is best suited for organisations that do not send out reports in batch and whose submissions do not exceed 50 each month. Integration with the FDA’s gateway is designed for batch submissions or submissions that exceed 50 per month. Organisations should weigh the costs versus the benefits of implementing either the eSubmitter or using gateway-to-gateway access to determine which tool is best suited for their individual needs. MedWatch Plus will continue to expand its capabilities for accepting electronic submissions – a future release of the system, slated for 2010, will include the integration of existing electronic reporting systems, such as those for devices and drugs⁵.

If the needs of an organisation include integrating MedWatch Plus with its existing compliance management system, the most effective solution is to implement a tool that incorporates MedWatch Plus, integrated with an automated quality and compliance management (quality management system) application. Some QMS functions that can be integrated with the MedWatch Plus tool, enhancing the overall effectiveness of the system, are as follows:

• complaint handling – through the use of a QMS complaint handling module, complaints are filtered through the QMS and then integrated with the MedWatch Plus tool, ensuring a well-rounded process. Complaint handling applications manage the investigation and resolution of customer complaints or adverse events in compliance with FDA guidelines. A system that can also record all complaints made by customers/patients and archive these records is also necessary – the FDA mandates that any record of an adverse event must be kept a minimum of two years;
• decision trees – when recording an adverse event, it must first be determined whether the event is reportable to the FDA. Medical devices organisations whose QMS solutions integrate decision tree technology into their complaint system are able to automate and streamline the decision tree process and can automatically trigger a MedWatch form based on the responses to the decision tree.
• quantitative risk assessment – another benefit that is offered by leading QMS solutions is the concept of quantitative risk assessment. When determining whether an adverse event is reportable to the FDA, it is important to weigh the potential risks associated with the event. Quantitative risk assessment tools aid in the decision-making process in determining the overall impact of the event, and whether the event is reportable; and
• corrective and preventive action – another QMS function that can be integrated with the MedWatch Plus tool is corrective and preventive action. The CAPA function generates a corrective action request that routes through review, root cause, corrective action taken and verification stages, ensuring proper actions when dealing with a defective product. This software should also have the ability to process multiple complaint reports in a single batch and submit them to the FDA, providing an effective mechanism for submitting a large number of complaints and tracking the status of all events in the system.

Select a tool that can record and review data: In the event of an FDA audit, the auditor will need to see the submission history in legible report format, not in raw data. Choose a tool with the ability to convert documents into a viewable format such as PDF. PDF can also be used in the event of system malfunction and can be sent directly to the FDA if needed.

Test the system: Before sending out actual adverse event reports, the FDA requires that a test run be conducted through the FDA gateway by setting up a test account. This is necessary to ensure that the system, whether built or bought, is running seamlessly.

The future

MedWatch Plus is designed to enhance adverse events reporting by enhancing functionality for both the reporter and the FDA. It will provide a seamless solution for submitting reports directly through the FDA’s portal and will increase efficiency and reliability in the process through automation. Once it has been fully implemented and made mandatory, the FDA will benefit from time savings, increased collaboration and electronic retrieval of MedWatch Plus data. Similarly, companies will benefit from a web-based, central point of entry, resulting in significantly shorter wait time between submissions and less chance of the human error factor that often accompanies manual processes.

It is important that life sciences companies start taking advantage of the convenience of online reporting now by integrating their quality and compliance management systems to the FDA’s electronic submissions gateway and reaping the benefits of real-time collaboration. During the transition to electronic submission, it is expected that the FDA will be able to provide firms with assistance in implementation. But as the mandatory deadline comes closer, the FDA will have fewer resources to assist participants.

Those who act now by taking steps towards electronic adverse events reporting will avoid the mad dash for implementation that will most certainly occur once MedWatch Plus is made mandatory. By taking the necessary steps to prepare, the transition from paper to electronic can be executed seamlessly.

References

1. Federal Register, 20 May 2009, 74(96), 23722-23727, www.thefederalregister.com/d.p/2009-05-20-E9-11687

2. Federal Register, 23 October 2008, 73(206), 63153-63157, http://edocket.access.gpo.gov/2008/pdf/E8-25211.pdf

3. Individual Case Safety Report, www.fda.gov/ForIndustry/DataStandards/IndividualCaseSafetyReports/default.htm

4. See Reference 1

5. MedWatch Plus/FAERS, www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083295.htm

Brenda Percy is the product marketing analyst for EtQ, Inc, a US company that specialises in enterprise quality and compliance management software for identifying, mitigating and preventing high-risk events through automation. EtQ, Inc is headquartered in Farmingdale, New York. Email: [email protected]. Website: www.etq.com.