Drug Safety Monitoring for Business Process Outsourcing

by | Last updated Dec 29, 2023 | Published on Jul 15, 2015 | Business Process Outsourcing

Business Process OutsourcingMany industry experts believe that business process outsourcing (BPO) is here to stay despite market fluctuations. And trends are changing. A new avenue for outsourcing has cropped up – drug safety monitoring. As unlikely as it may sound, American and global pharmaceutical majors are outsourcing the vital and potentially life saving task of monitoring the safety of various drug ingredients to India. Outsourcing firms in the country are basking in the increased business opportunities this new field offers.

Drug Safety Monitoring — Lucrative Opportunity for BPO Companies

According to a head of one BPO company which has ventured into this field, this particular branch of outsourcing currently employs around 15,000 Indians, which is a massive leap from the 300-odd employees in 2007. According to the Transparency Market Research, the drug safety outsourcing industry could double in the next half decade, overtaking traditional outsourcing bastions such as software development, accounting and back office. Novartis, Bristol-Myers Squibb, and AstraZeneca are some of the drug manufacturers, ranked among the largest in the world, who prefer outsourcing this critical task.

Pharmaceutical companies are finding outsourcing drug ingredient safety checks a better way to streamline their functioning as it allows them to focus on developing new treatments and marketing them. At stake is the safety of their products, which Americans and probably patients around the world would use.

Concerns Raised, but Outsourcing Here to Stay

Concerns have been raised about outsourcing this specialized, knowledge-intensive task to people who are possibly inexperienced. Countering this argument, one of the major outsourcing companies insists that more than 90% of its staff carrying out drug safety monitoring is equipped with a degree in pharmacy or other relevant discipline. That still doesn’t seem good enough for some though. Mistakes could affect the safety of numerous patients. Any failure in reporting cases or addressing new side effects quickly could result in hefty penalties or even banning the drug till the issues are rectified.

However, these concerns have not succeeded in slowing down the outsourcing. The increasing tightness of regulations has demanded more stringent examination of interactions between medicines and rare or unknown side effects. This increases the workload of the pharmaceutical companies, which can affect their efficiency. Outsourcing is enabling them to meet case filing reporting deadlines more consistently.

Explaining Drug Safety Monitoring

So what does this drug safety monitoring task at the Indian BPO company involve? The employees review reports mentioning drug side effects. They then enter that data in a database that also deals with the medication taken by the patients, their biographical details, and clinical summaries. With this information, they assess how serious the drug reaction is. Serious reactions need to be notified immediately or drug companies would face the brunt of the regulators’ punishments. Once the reaction is notified, doctors review the cases.

Everyone is talking about this new $2 billion field of business process outsourcing. However, its future depends on how diligently BPO companies in India perform this critical task of tracking drug safety to help global pharmaceutical companies reduce product safety risk, achieve compliance, and improve efficiency of pharmacovigilance processes.

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