Business process outsourcing (BPO) firms can assist pharmaceutical and medical device companies with adverse event and product quality complaints in several ways. BPOs provide trained staff to efficiently handle high call volumes during recalls or issues. They also offer customized support and expertise in regulatory reporting. Additionally, BPOs can free up company resources to focus on investigations and compliance through outsourcing routine processing tasks.

1. The Role of Business Process Outsourcing Firms During Adverse Events and Product Quality Complaints
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OCTOBER 16, 2012
The Role of Business Process Outsourcing Firms During Adverse Events and
Product Quality Complaints
October 3, 2012
Barry Peters, Vice President of Corporate Quality and Compliance, Telerx
and
Heather D. Ferrence, Director of Corporate Compliance, Telerx
Every pharmaceutical, biotech and device company has faced Adverse Events (AE) and Product
Quality Complaints (PQC) daily. Depending on a number of factors, those issued may have been
minor or garnered front-page news and endangered the company’s reputation. Nonetheless, as
the industry faces increased regulations and competition, many have turned to Business Process
Outsourcing (BPO) firms to help them overcome the challenges and problems surrounding AEs
and PQCs.
All pharmaceutical, biotech and device companies are aware of the need to uphold the strictest
standards of quality as outlined in the U.S. Food and Drug Administration’s (FDA) Code of Federal
Regulations Title 21 and have a clear, strong governance for compliance expectations. Those
companies that make use of BPOs, further ensure effortless compliance, process coverage and
have the added benefits of unique input and counsel BPOs provide about how best to approach
their business. Additionally, BPOs can provide benefit and scalability in reaching a large population
and may be involved at many points in the lifecycle of a pharmaceutical, biotech or device product.
When BPOs Step In
In 2010, a U.S. manufacturer of pharmaceutical products began a voluntary recall of several over-
the-counter products, after a routine FDA inspection found that the products did not meet required
quality standards.
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As the recall unfolded, many consumers who may have been affected could not get through to the
company via phone due to the call volume. As companies have an ethical responsibility during the
course of a recall to respond to all concerned customers, record every event and retrieve product CONNECT WITH PCM
as completely as possible, this manufacturer realized they needed more personnel, in addition to
their current BPO, to handle consumer inquiries. With the call volume continuing to grow,
additional BPOs were brought on to help, employing hundreds of specially trained individuals to
more efficiently meet the recall requirements and stem consumer worries. The BPOs were also
able to assist the company by maintaining their regular processing in addition to the recall.
COMPLIANCE CLOUD
As a result of the involvement of multiple BPO firms, the manufacturer was able to maintain
customer satisfaction as well as their short-term and long-term reputation. Additionally the
company was able to improve their ability to capture AEs and PQCs due to a much larger
workforce dedicated to the task of recall management.
BPO Qualifications
The importance of properly trained and experienced BPO staff in the course of AE and PQC
processing is crucial. Some companies mandate that much of the medical information be collected
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2. The Role of Business Process Outsourcing Firms During Adverse Events and Product Quality Complaints
by a healthcare professional (normally a licensed nurse or pharmacist) whereas, others simply use
individuals who hold four-year degrees, but may not necessarily be healthcare-related. Other
companies may use one department or group for inquiries, AEs and PQCs altogether, while others
yet may use dedicated staff for each circumstance.
NEWSLETTER
There are many advantages of working with a qualified BPO; from experience with the type of
event, familiarity and comfort-level with the reporting routines and content requirements, trained Name
and experienced staff that is extremely comfortable in stressful and highly-regulated environments E-mail
and most importantly the assistance of additional staff at a time when the event is driving call,
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email, etc. volume beyond normal capacities, all while keeping company costs low.
BPO exposure to various methods, systems and process across manufacturers enables them to
develop a best-of-breed approach that can be customized in any situation and for any company.
Additionally the right BPO is an industry leader which stays abreast of regulations, such as the
currently forthcoming Health Information Technology for Economic and Clinical Health (HITECH)
rules, allowing pharmaceutical, biotech and device companies to entrust them with tasks such as
AE and PQC processing.
A good BPO partner will also have its own quality framework, which ensures accuracy of reporting
and continual improvement through baseline expectations. Some of the components include:
1. Training – Continually improving listening skills, product knowledge, AE/PQC regulations, and
good documentation practices, among others.
2. Case review – If a BPO suspects that reported interactions may contain AEs or PQCs, the
cases are placed in a queue for review by a second individual prior to submission.
3. Quality Monitoring – Occurring after an alleged event is reported, but allows for review of the
actual interaction with the reporting party (via an audio recording).
BPOs and Event Reporting
The role of BPOs extends long after the AE or PQC event has been recorded and, if necessary,
reported to the FDA. Specifically, the Source Documentation and Quality Monitoring recordings,
which must be retained as part of the file, might remain in the possession of the BPO. Each
pharmaceutical, biotech and device manufacturer may also set their own rules about the length of
retention time in addition to FDA expectations, and in some cases, that timeframe tends to be
longer than what is required. Companies also differ in regards to reporting of events and the
necessary related documentation. Specifically, each manufacturer will train their employees using
certain examples or types of AEs or PQCs in order to prepare for the real-life event, but because
companies cannot train for every possible eventuality, some manufacturers may subscribe to the
“when in doubt, report it” theory. In this case, BPOs can provide a case review after intake and
help decide if the manufacturer may require further action.
Once a company reports a case, it is important to determine its classification (especially with
PQCs) and investigation. Although there are no standard PQC classifications currently in place,
there are basic requirements for a Quality System and its complaint reporting outlined in 21 CFR.
Miss-classification can result in an oversight of a real and serious manufacturing issue because
the quality of a product is only as good as the proper processing through the whole life of the
product.
Since Quality Systems are designed to ensure the manufacturing and packaging of
pharmaceutical, biotech and device products, manufacturers who fail in the responsibility and
authority to self-monitor these factors will experience FDA-mandated product recalls. In addition to
recalls, the FDA can enforce the following actions:
1. Warning Letters – for flagrant or continual violations
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3. The Role of Business Process Outsourcing Firms During Adverse Events and Product Quality Complaints
2. Consent Decrees – Use of third party consultants to remediate, fines for not meeting agreed
upon timetables
3. Judicial Actions – Including seizures, injunctions and criminal prosecution
These enforcement actions have caused some firms millions of dollars in fines and lost revenue
from having to suspend production at problem facilities
Why BPOs?
As outlined above, one of the most important roles of a BPO is to manage AE and PQC
processing and improve efficiency in other core areas of pharmaceutical, biotech or device
company’s business including data management and analytics. With more and more companies
realizing the benefits and moving towards the use of a BPO for one reason or another, they are
able to put more resources and efforts toward investigation, process validation, Annual Product
Review, and training.
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Filed Under: Business, Outsourcing, Pharmaceutical Risk Assessment
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