Addressing the Challenges of Complaint Handling, Investigations and Adverse Event Reporting WHITE PAPER
Quality is an ever-growing problem in the fields of pharmaceutical, medical devices, medical diagnostics and biologics, and its negative impact is significantly palpable to manufacturers as well as their patients, employees and investors. Furthermore, as the globe’s dependence on medicine continues to heighten, as does the trend toward pervasive personalized medicine, the quality reigns are getting harder for many firms to hold on to. While some of this is due to poor products, a large amount can be attributed to inadequate quality reporting infrastructure on behalf of the manufacturers. It is true that regulatory bodies across the globe impose regulations and guidelines for manufacturers in the managing, reporting and resolution of complaints, investigations and adverse events. However, many of these companies simply haven’t invested heavily enough in their quality staffs, systems and procedures to ensure quality products and practices. This has to change in order to better protect patients, manufacturers and investors. The best combined, proactive solution is to refine testing, higher quality manufacturing and to implement a holistic quality management program across the entire product development lifecycle.
Incident Management Challenges Life sciences manufacturers introduce their products to their target market once they have received the proper regulatory approval to do so – typically following over 15 years of diligent research, development and testing. While the approval to market the product is the indication that the product is safe or medically necessary to a target population, negative incidents can occur from use of the products related to the product itself, its formulation, its labeling, delivery, packaging or a host of other reasons. These complaints come in to manufacturers through call centers established to handle customer issues, the company’s website or email address or through field service during onsite services visits by the vendor. However, the receipt of these adverse notifications is not typically where the problem lies. It is what happens to these complaints/reports of adverse events once they are received by the manufacturer or service provider. By law, these manufacturers are required to have a quality management program in place to handle and then act on these issues, but many of these “programs” are disjointed and foster inconsistencies and information flow breakdowns. Without a centralized system and processes, it is easy to imagine how this critical information can be lost or mismanaged. And let’s not forget just how serious the implications of this erroneous quality management can be to all constituents involved. When a centralized, automated and fully integrated quality management process and reporting system is not in place, there are many challenges that arise, which put a serious strain on a company’s quality management efforts. These difficulties can consequently lead to some significant issues that can result in some very serious consequences. Resulting challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting as well as decentralization of systems and procedures can include: The most prevalent issues today regarding change control among companies are: Poor data quality – Inconsistent and incomplete reporting of adverse events, coupled with inadequate links to a company’s CAPA
system makes proper and accurate information sharing very difficult. This can lead to data inconsistency and hinder all relevant departments from benefiting from the knowledge. It can also cause confusion over what is reportable as an adverse event and what is not. Inefficient response and reporting – Slow and redundant workload, can delay corrective and preventive action efforts and stall
closure of investigations. False findings – Failure to properly investigate and determine root cause of complaint or adverse event. This can result in false
findings, and can lead to inadequate corrective or preventive action. Inadequate corrective and preventive action – Ineffective utilization of data for trending and reporting to identify improvement areas.
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The negative impact of these challenges can lead to dire consequences, including patient harm or death, product withdrawal and negative financial and brand impact to the organization.
Regulations To curb this trend toward inconsistent and insufficient quality monitoring practices, regulators across the globe have published regulatory guidances and imposed regulations for quality management. Chief and most pervasive among the regulations is the U.S. FDA’s 45 CFR part 46, which ensures protection for human research subjects. Under the guidelines of this regulation, all manufacturers in the life sciences field must report all “adverse events that are unanticipated problems and unanticipated problems that are not adverse events.” (According to Office for Human Research Protections, and Department of Health and Human Services)
According to CDER Facts and Figures from the U.S. Department of Health and Human Services: Reported drug quality complaints and adverse events:
Product defect 27% Formulation 24% Labeling 13% Delivery 13% Packaging 6% Fill problem 5%
For an event to be deemed an “unanticipated problem”, it must be unexpected, related or possibly related to participation in the research, and suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized. If the event meets all three of these criteria, then it is considered “unanticipated” and must be reported. Other policies exist within each industry subset. For example, for the medical device industry, there is a medical device reporting (MDR) regulation which requires the filing of an MDR whenever an adverse event occurs for products undergoing remedial action. In the pharmaceutical industry, FDA mandates each company have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, and so on. It also requires a structured approach to the investigation process with the objective of determining root cause (May 2007 FDA guidance titled “Pharmaceutical Quality System”). The biologics industry also has regulations for quality monitoring. The Bioresearch Monitoring (BIMO) Program was created to monitor all aspects of the conduct and reporting of FDA-regulated research. With these and a number of other regulations and guidance documents, it is easy to discern just how difficult of a task it can be to maintain quality management of products once they hit the market. When violated, each of these regulations triggers a warning letter from the governing body to the manufacturer, instructing them on how to become compliant with regard to the specific complaint or adverse event. Depending on the severity of these events and their ubiquity, these warning letters can go as far as initiating a lawsuit, requiring product recall, recommending post marketing surveillance, further data research, the conduct of a Phase IV trial, and so on. In the ideal scenario, all of these warnings would be tied directly into the manufacturer’s CAPA system so the company could develop a corrective action plan to address the violations and prevent any future complaints or adverse events.
Solutions Fortunately, there are comprehensive quality management systems available to automate all of these functions and requirements for manufacturers. These software programs provide the organization with a centralized, consistent and standardized intelligent mechanism for recording, tracking and trending customer complaints, investigations and adverse event reporting according to regulatory standards. Many companies have been recently cited in warning letters for inconsistencies in their quality management procedures as well as for failure to properly investigate complaints/adverse events and determine their root causes.
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Companies have also been warned for having deviant processes for deciding what is reportable as an adverse event and what is not, for late closure of investigations and submission of regulatory reports, and also for inadequate links to a CAPA system. The impact of these deficiencies, on any company (and potentially its patients) in this industry, can be quite substantial. By implementing a web-based quality management system, organizations can avoid these problems as well as improve and enhance overall data integrity and consistency, increase workflow efficiency and precision, keep patients safe and investors satisfied, and maintain a positive relationship with customers and the public at large. In short, these effective systems also help life sciences manufacturers maintain credibility in the eyes of the public and stay away from any negative publicity, because potential problems will be caught and handled immediately upon receipt. More specifically, there are many areas a quality management system impacts an organization to help maintain compliance, reduce patient risk, improve product quality, streamline and centralize workflow, avoid litigation and produce positive business outcomes: Compliance - Within 15-30 days (depending on event severity and type) of complaint or adverse event notification, the manufacturer
must report the incident to the regulating bodies. Having a centralized, standardized and compliance-adhering system to help automate this process makes it far easier to remain compliant – both externally and internally. S afety – Quality lies at the very core of product safety, that is, safety in development and consumption/utility. Moreover, without
quality/accurate/timely data, safety resolutions can be less than optimum and even lead to serious harm. An integrated quality management system ensures data integrity and consistency through secure entry, validation and integration with other systems (e.g. ERP, EDI). This standardization enables timely and accurate complaint and adverse event assessments, structured root cause analyses and appropriate corrective and preventive actions. Workflow Performance – The right quality management system can help secure workflow efficiency, consistency and precision
across the organization. There is no longer a need for ad-hoc reporting and tracking of complaints and adverse events. These items are immediately captured and put into a strict, pre-set and government-compliant system with clear SOPs. This ensures proper and timely performance across the workflow lifecycle from complaint notification and assessment to investigation, regulatory reporting, root cause analysis, corrective action, preventive action and effectiveness checks.
A qualified quality management system will help a manufacturer by automating and streamlining all complaint, investigation and adverse event related issues across the organization by centralizing data. It will keep the company compliant with ever-increasing regulations, ensure patient safety, maintain a strong bond with customers and the public, and avoid any litigation. The law says you need a quality management system for handling all of these issues. Why not arm yourself and your organization with the right tool that will ensure the right results for you, your organization, your patients and your investors?
To learn more about this topic and how Sparta Systems can help, visit www.spartasystems.com Sparta Systems, an industry pioneer and leading provider of enterprise quality management software (EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its TrackWise® EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.
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