by Amanda Conschafter, Blog Editor
Tracking and analyzing patients’ adverse reactions to medications – a process known as pharmacovigilance – is crucial to patient safety. But, as experts on PhRMA’s recent Science Series panel explained, it’s also complicated by whether people accurately report the drug they’re using. Panelists argued that assigning distinct identifiers to biologics and biosimilars can help limit the risk of confusion, better allowing the FDA to track adverse events and safeguard patient safety as biosimilars become available in the United States.
Identifiers used to report drug responses may include batch or lot numbers, brand names, international non-proprietary names and national drug codes. Research suggests that distinct brand names would increase clear reporting, said panelist and Pfizer Director of Worldwide Regulatory Strategy Dr. Helen Hartman, but the government cannot dictate companies’ trade names. Thus, requiring dual identifiers, or two means of identifying the drug being reported, offers the best available means of accurately matching the reported incident with the correct drug. Dr. Hartman argued for biologics and biosimilars’ having not only unique identifiers but also distinct labels.
Fellow panelist Dr. Greg Schimizzi of the Coalition of State Rheumatology Organizations and a member of the National Physicians Biologics Working Group, maintained that physician notification – whereby some states require pharmacists to notify doctors when they swap a prescribed biologic for an “interchangeable” biosimilar – will help minimize inaccurate reporting data as well. As discussed in a recently released IfPA Policy Brief, physicians treating adverse effects on behalf of their patients must know which medication the patient was taking; if the pharmacists switched the medicine without the physician’s knowledge, when reporting the adverse event the physician could unintentionally introduce flawed data into the Food and Drug Administration’s Adverse Events Reporting System (FAERS).
Though not infallible, the FAERS plays an important role in equipping the FDA to monitor the safety of drugs after they receive FDA approval. Panelists argued that this process plays a particularly important role for biologics and biosimilars because these drugs are more likely to cause immunological responses than less complex, small molecules drugs. Thus, accurate reporting data is critical for maintaining drug safety as more patients utilize these therapies.
