For medicines that are sold worldwide, reporting drug adverse effects is a crucial measure to gather information that can be used to increase the effectiveness in treatment. In general, the public does not know how and what information is gathered to make the report effective or even how to manage the gathered information. In the pharmaceutical industry, this activity is called pharmacovigilance (PV).
WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem*” It is widely accepted that PV system is an important tool in regulatory process to support public health and also a component that fulfill patient care as described by WHO that PV is “an obligatory investment in the future public health of the territory (country)**”
Product-level traceability is a core objective of PV system, especially for biotherapeutic medicines because of the complexity of the products that may cause unwanted immune reactions which may vary depending upon the range and severity. Therefore, the challenge is to identify the adverse effect in a short time because the production of biotherapeutics is a complex process that is very strictly controlled to ensure consistent drug quality. Any changes, whether intentionally or unintentionally, can induce adverse drug reaction (ADR) which may not appear after months of treatment. Hence, the traceability for biotherapeutic medicines in product-level after market launch is essential when comparing to synthesized drug from chemical substance.
The traceability for biotherapeutic medicines must be clearly identified by product and recorded in detail so that the product that cause adverse effects to patients can be easily traced. The distinguishable name of medicine can be used for identification. Therefore, it is important that the medicine name remains unchanged in every country. Batch number is also important for traceability as it can be used for quality improvement of treatment by informing medical professionals and improving drug safety information, and served as a tool to link exposure to possible adverse outcomes so that the government is able to assess benefits and risks of that particular drug throughout its product life cycle.
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* WHO (2014) Essential Medicines and Health Products: Pharmacovigilance. World Health Organization, February 3, 2014 [online]. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
** The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool, following link: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf