What happens to the safety data once it is captured in the database in the Pharmacovigilance unit:

Safety data collected from the original reporting sources (i.e apart from partners’ exchange safety data and reports from regulatory authorities) is like raw material and it requires further processing and evaluation in order to determine the reporting criteria and further identify its safety signals.

To ensure complete and correct data is captured in the database, regulatory authorities require single cases and follow-up information to be processed. An important tool for a pharmacovigilance department is, therefore, an efficient follow up system, equipped with reminders and instant retrieval of contact/reporter details. It helps keep track of the development of patients’ health conditions as well as detecting potential safety signals.

The pharmacovigilance department needs to systematically and periodically review the cumulative safety data for signals, and generate periodic reports for regulatory reporting. Coding and assessment are key to identifying a reliable safety signal (for signal detection, incomplete reports containing less than the four minimum criteria also count). This process can be improved by designing a system that prioritizes specific safety issues based on medical significance and highlights new safety trends in the collected data.

Sources and collection of safety information

The core of any pharmaceutical company’s pharmacovigilance process is the safety data. This data is collected through multiple sources, including spontaneous reports, clinical trials, observational studies, registries and surveys of patients or healthcare providers.

The safety data from a product may be collected from thousands of clinical trial patients before it is approved for the market; however, the signal will become more profound and new signals will arise when the product finally reaches millions of consumers. Post-marketing surveillance studies and observations are a significant source of safety signals in drug safety. But contrary to the clinical safety data, the collection of postmarketing safety data is less structured and more diverse, so pharmaceutical companies need to proactively seek and acquire safety data through multiple media and sources.

Collecting post-marketing safety data is complex, largely because of the amount of communication required to reach multiple media, sources and destinations. By identifying an effective communication system that channels the knowledge of the safety profile and the importance of product risk surveillance to the targeted media, the pharmaceutical company can enhance the quality of the safety data it receives, while extending the risk management programme outwards.

Safety data collection can be proactively planned through the implementation of product-driven web forums and patient registry programmes that promote direct lines of safety surveillance to capture the rational and desirable data.

Various elements required in a Pharmacovigilance Set-up

Data can come from different sources like:

IVRS(Interactive Voice Reporting System),,Patient registries,,Clinics,,CRO, Letters, Press, Sales contacts;

Literature, Calls, Company, Customers web forums/sites, Databanks, Reports, Journals, Emails.
Pharmacovigilance team is involved in collecting data related to

• Clinical Trails data
• Adverse events
• Complaints
• Product related info

The cases are processed in the following fashion:

Data entry/Coding/Medical review: The safety data is prepared and then submitted to the respective regulatory authority.

Why postmarketing surveillance and reporting ADR is needed:

The information collected during the pre-marketing phase of drug development is inevitably incomplete with regard to possible ADRs. This is mainly because :

❖ Tests in animals are insufficient to predict human safety;
❖ Patients used in clinical trials are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited;
❖ By the time of licensing exposure of less than 5000 human subjects to a drug allows only the more common ADR to be detected;
❖ At least 30,000 people need to be treated with a drug to be sure that you do not miss at least one patient with an ADR which has an incidence of 1 in 10,000 exposed individuals;
❖ Information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is often incomplete or not available;

Thus, post-marketing surveillance is important to permit detection of less common, but sometimes very serious ADRs. Therefore health professionals worldwide should report on ADRs as it can save lives of their patients and others.