Marina Aslanyan, Sparta Systems

	For pharmaceutical companies, managing change across the organization is critical throughout the lifecycle of a product. Yet just as critical — if not more so – is how a pharma company is able to manage complaints and control adverse events that arise in the post-market environment.

Recent high-profile drug headlines have brought post-market adverse event reporting and customer complaint handling to the forefront of market concerns. The US Supreme Court’s recent ruling that drug companies can be held liable for problems with unsafe drugs even after products have passed regulatory approval only serves to underscore the important of having adverse events reported diligently and proactively before they do significant damage to the business. 

Though vital to the success of any pharmaceutical company, adverse event reporting and complaint handling are frequently given short shrift. The ever-expanding nature of the pharma industry makes this all the more challenging, as differing international regulatory standards for the reporting of these events and customer complaints make it difficult to automate processes and implement standard operating procedures (SOPs) across the enterprise. Yet this must be done if companies are to successfully resolve incidents post-market and continue on a path of innovation that results in better treatment for the ultimate stakeholder in their organization — the consumer. 

In determining the best way to tackle the adverse event reporting and customer complaint handling processes, it is important to explore the various approaches companies take to manage these functions currently, pointing out the drawbacks and advantages of each approach and ultimately determining which enables the most efficient management of these business-critical functions to foster business growth. 

	Customer complaints and post-market adverse events vary widely in severity, but are alike in that they all pose a significant challenge for drug manufacturers. In most cases, products have been approved for sale, shipped to market and can thereby no longer be controlled internally by the manufacturing organization. 

Complaints are received by manufacturers via a number of different avenues: call centers established to handle customer issues, the company’s website, simple e-mail, fax or through field service during onsite service visits. Complaint handling is a focal point of regulators as it represents a key indicator of the overall health of a quality system. Properly handled and categorized complaints control product reputation and are a measure of customer satisfaction. They may be the result of issues that were not caught in-house or otherwise represent a breakdown in the supply chain or internal quality procedures, but also can be attributed to a perception or expectation of the product. 

Adverse events also must be properly categorized. Adverse events can include issues with drug safety, incorrect use of a product, incorrect labeling and packaging, or any number of other problems with a specific drug that has found its way into the hands of the consumer. Of critical importance, therefore, is making sure these adverse events are categorized and reported to regulatory agencies in the proper manner. 

In recent months regulatory agencies have begun turning a more discerning eye to post-market adverse events. For example, the FDA voted on whether to remove combination cold medications containing acetaminophen from store shelves due to problems with overdoses. According to the FDA, incidents with acetaminophen-containing drugs result in 5,600 trips to the emergency room annually, and the drug itself is related to approximately 200 consumer deaths per year. Acetaminophen is one of the most widely used painkillers in the US, and though the FDA ultimately voted not to recall the drugs, the mere prospect of a recall posed a very real threat to the OTC pharma industry. 

Adverse event reporting reared its head in yet another recent high-profile OTC drug incident in that was recalled from store shelves by its parent company. Though there were more than 800 consumer complaints on this specific product, only 130 were reported to the FDA, by physicians and customers rather than the company itself. As a result, the FDA issued a warning letter to cease manufacturing the drugs, and its stock price dipped to a 52-week low in the wake of the recall. This clearly illustrates the need for an automated reporting system. 

These examples clearly highlight the importance of automated, diligent complaint handling and adverse event reporting processes in the pharma industry. Insufficient reporting can lead to regulatory problems and damage brand reputation in such a way that it can take a company, and the broader industry, years to recover. 

Yet the question of just how companies go about tackling this vital function needs be answered. 

	Pharma companies can, and do, manage complaint handling and adverse event reporting using a number of different approaches, some more effective than others. Most agree that automation is necessary in collecting and reporting complaints to regulatory authorities, but the question of just how to automate is where things can become muddled. 

Option 1: Manual recording: The first step towards automation for many organizations is to address the way in which spreadsheets are used to support manual processes. Many organizations still track complaints and adverse events manually, whereby the data can kept on record for the lifecycle of the complaint (through resolution). 

It shouldn’t come as a surprise, however, that this approach causes significant problems when it comes to the reporting of complaints and adverse events to regulatory authorities, since spreadsheets are not validated tools and do not support auditing, version control or e-signatures. Issues with version control, user authorization and increasingly distributed operations can result in missed reporting deadlines, insufficient or incorrect data and an overall breakdown of the complaint resolution process as globally dispersed units are left scrambling to determine just where they fit into the process. Add to this the differing nature of international regulations and the reporting of complaints quickly becomes a logistical and regulatory nightmare. 

Though the widespread use of spreadsheets requires little ramp-up and employee training investment, these advantages quickly translate into major headaches for drug safety and quality and IT departments looking to manage and report their complaints efficiently in the post-market. 

Option 2: Customizing an ERP: Larger pharma companies willing to invest more heavily in using IT to automate the process of complaint handling and adverse event reporting often do so through the use of their existing ERP deployments. Because ERP systems are used for multiple enterprise-wise business functions, and organizations conclude that quality processes and post-market issues should be managed and resolved in these systems as well. While this is possible in some cases, the amount of customization required to tailor ERP applications for managing complaints and post-market adverse events often ends up giving organizations more trouble than they bargained for. 

The process of ERP customization is an arduous one requiring an enormous investment in time and resources, and constant maintenance as new complaints are added to the system. This “one-size-fits-all” approach may initially seem preferable in the broader scheme of the complaint resolution and adverse event reporting process, as the ERP can be managed centrally and users assigned via a single authorization within the system. But the path of costly customizations to ERP systems is one that should be considered carefully before companies commit to it as these customizations return them to the predicament from which they attempt to depart. 

Several ERP platforms offer functions that are positioned as “quality modules,” or add-ons for managing quality-related processes. This functionality is typically designed to manage an isolated element of the overall holistic quality system. Frequently, the goal and driver behind implementing this isolated component of an enterprise quality management solution is to provide visibility into quality issues during manufacturing, packaging and at the time of product release. 

The reality — often only realized once engaged in these projects – is that the scope of data needed at the time of product release is much broader and further diluted across multiple quality system processes and even additional enterprise applications than originally anticipated. This results in extensive customization work that must be done within the ERP to gain access to the additional information. It could also mean redundant data and the introduction of procedural steps. Simply put, in using ERP to manage quality functions such as customer complaint handling and post-market adverse event reporting, these companies are challenging the necessity and value of each and every proposed customization. 

Option 3: Enterprise Quality Management System (EQMS): More frequently this trend and revised perspective are driving organizations away from the view that ERP platforms are a “one-size-fits-all” solution. Prudent IT leaders now seek to leverage purpose-built applications for their intended functions to provide the fastest time-to-value and help prevent the errors of the past. It’s these purpose-built, dedicated quality systems (also known as Enterprise Quality Management System — EQMS) that serve as the third and most effective approach to resolving customer complaints and adverse events in the post-market. 

Using a dedicated quality system to manage complaint handling and adverse event reporting removes the barrier of having to extensively customize an ERP such as SAP or Oracle, as they are generally designed to work out-of-the-box with a limited amount of tweaking and customization necessary. These specialized systems collect complaints and adverse event reports into a single repository for quick and easy reporting to regulatory authorities while facilitating closed-loop processes for investigation of complaints so that any adverse events are resolved in a timely fashion. The workflows built into the systems make for a continuous, globally-harmonized process, as complaints are handled and managed across the enterprise with the correct personnel assigned and no question left unanswered as to which department is responsible for resolution and closing the loop on a specific complaint. 

The purpose-built enterprise quality systems leverage an intelligent rules-based engine at the core, which provides many of the automated alerts and decision making capabilities used in adverse-event reporting, complaint tracking and so on. These engines are intuitive in nature and automatically make intelligent decisions, unlike traditional manual systems such as spreadsheets. For example, there may be various routes through a prescribed workflow, but the path depends greatly on the data being analyzed. A rules engine can make the determination as which path to take based on the data, minimizing the potential for choosing the incorrect path and therefore requiring additional review and reworking. 

In the pharmaceutical world, these specialized quality management tools likely reside within the regulatory department, the quality monitoring department or more specifically, with medical affairs officers (the individuals typically responsible for adverse-event reporting and complaint handling). These systems empower individuals with proactive intelligence-gathering and decision-making capabilities to help them work smarter.

Furthermore, an EQMS can speed and automate the regulatory reporting process with built-in capabilities for electronic data submission. As the FDA will recently announced new electronic reporting submission regulations, having one of these systems prepares organizations for the mandated electronic reporting. Built-in reporting templates that have been approved by such agencies as CBER and CDRH (branches of the FDA), for example can be auto-populated for seamless, rapid regulatory reporting. 

	Data classification is something pharmaceutical organizations also face when it comes to adverse event reporting, complaint handling and more. Regulatory agencies such as the FDA require certain classifications and the manufacturers themselves create additional ones to support other trending capabilities. 

Spreadsheets and customized ERP systems fall short when it comes to true data classification, which is why many organizations are turning to purpose-built enterprise quality systems. With simple configuration, the customer can set up the tool to compile different types of data in different ways. Dashboards provide instant visibility into the data and common trends, and ad hoc query tools with a graphical user interface provide additional trending identification. Additionally, automatically generated monthly and quarterly reports can be distributed to synthesize and provide other critical data. 

Purpose-built and ad-hoc quality system integration

	As these quality systems have grown to become enterprise systems, the value gained from sophisticated integration with other enterprise ecosystem applications has also increased significantly. An EQMS can serve as a flexible bridging and aggregation point for all quality systems elements that may in fact touch or interact with other applications within the ecosystem, including ERP. 

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. This addresses a number of concerns for organizations with global operations, as systems can be deployed across the enterprise and centrally managed and configured for multi-site usage, multilingual capabilities, regional reporting requirements and unlimited security levels. 

By implementing a dedicated quality system, organizations can — and do – avoid many of their reporting problems as well as improve overall data integrity and consistency and increase workflow efficiency and precision. 

Clearly much work remains to be done in the pharma industry for companies to successfully manage and report their customer complaints and post-market adverse events, and the recent high-profile recalls only demonstrate how much farther the industry has to go. Multiple approaches to automating these processes have been taken at pharma companies both large and small, and the industry clearly lacks a consensus opinion on just how best to manage the collection and reporting of these business-critical events. 

And although companies still struggle to determine the best way to automate these critical processes, the implementation of a dedicated quality management system will help a manufacturer by automating and streamlining all complaint, investigation and adverse event-related issues across the organization. Purpose-built quality management systems can keep a company compliant with ever-changing industry regulations, enabling that company to continue on its path of innovation toward developing and introducing products to market that demonstrate real benefits for the consumer. PC 

	Marina Aslanyan is Vice President, Professional Services & Customer Care, at Sparta Systems, Inc. Before Sparta Systems, she worked at Barr Laboratories as a senior IT leader. During her tenure at Barr, Aslanyan was tasked with improving organizational performance and client satisfaction, working with a team to ensure quality and regulatory compliance across the global organization. Prior to Barr, Aslanyan held consultant positions at PricewaterhouseCoopers and Anderson Consulting. 

	In filling the void of quality management in a highly regulated industry like biopharmaceuticals, there are two types of “quality” solutions organizations can choose: either a holistic, all-encompassing and integrated “Enterprise Quality Management System” (EQMS) or a siloed, modular quality system. As this distinction reveals, the EQMS is comprehensive and aggregates and integrates all quality related departments, data and processes across the organization for a true enterprise-wide approach to quality management. Modular solutions, on the other hand, are just that — modular. They serve a single purpose, such as ensuring quality reporting, but they lack other much-needed functionality such as – for example - quality manufacturing practices or quality monitoring of final product. A holistic EQMS system provides this advanced, integrated and centralized functionality while a modular system stops far short.

	Some industry experts refer to EQMS solutions as closed-loop because they do effectively “close the loop” on quality assurance across applications, processes, procedures and projects. The modular solution operates in isolation without the benefit of centralized data management, links to other enterprise systems and so forth.

	In the end, a modular system leaves the organization vulnerable while the EQMS helps to ensure quality manufacturing; compliant, accurate and 

Articles

Usually associated with manufacturing or laboratory processes, quality systems can improve post-marketing compliance efforts