The monitoring of newly approved drugs for safety, primarily by the pharmacovigilance of voluntary adverse event reporting,
is broadly recognized as being haphazard, slow, and inaccurate. This paper proposes an alternative method of integrating comprehensive
pharmacovigilance with eHealth patient records for automatic, real-time adverse drug event reporting from across very large
patient populations. Integrating comprehensive pharmacovigilance with eHealth patient records would provide the most accurate,
precise, and timely postapproval detection and analysis of the risks of adverse drug events that are possible. Also, the connectivity
to eHealth patient records would provide a direct link to notify patients and physicians of findings of drug risks and related
information.
Current postapproval drug safety monitoring
Studies have shown that premarketing clinical trials in the drug approval process are inadequate for detecting adverse drug
events that occur rarely or are interactions with co-morbidities, concomitant medications, and risk factors that are routinely
excluded from clinical trial enrollments. Also, adverse drug events sometimes resemble symptoms that are not unexpected in
clinical trial enrollments and may, therefore, not be recognized as drug-related.1-3 Consequently, drug safety can only be assured by postapproval monitoring that plugs the gaps in the detection of drug risks
in premarketing clinical trials.4-6
Monitoring drug safety is based on the pharmacovigilance of patients and physicians submitting case reports to industry and
Food and Drug Administration (FDA) adverse event reporting systems. And yet, since the reporting is voluntary and since there
is no supervision or incentive for patients and physicians to take the time to carefully follow the reporting procedures,
only a small proportion of drug-related adverse events are reported and, even then, the submitted case reports are frequently
incomplete, inaccurate, and made long after the onset of adverse events. These deficits in pharmacovigilance severely diminish
the opportunity for timely and thorough detection of drug-related adverse events.3, 5-10 Another source of drug safety monitoring is with the postmarketing commitment studies that are mandated by the FDA for drugs
granted accelerated approval. Accelerated approval status is granted on the basis of abbreviated clinical trial evidence
that shows promise for treating serious, often life-threatening conditions. The approval is conditioned on the drug sponsor
agreeing to verify the drug's safety and efficacy with postmarketing commitment studies. Experience has shown, though, that
postmarketing commitment studies often languish, on average taking 10 years to complete. These delays put patients at risk
of not receiving the expected benefit or worse, compounding harm.11-13
Failures in drug safety monitoring have resulted in patients being unwittingly exposed to hazardous drug risks, causing serious
harm and even death. Instances of patient exposures to drug toxicities that would likely have been detected by responsible
safety monitoring have eroded the confidence of patients and health care practitioners in the validity of the FDA's approval
as an assurance of drug safety and efficacy. Likewise, public opinion of the competence, and even the honesty, of drug manufacturers
has suffered.5, 10, 12, 14-17
Perspectives on monitoring drug safety
The FDA's own institutional reform in 2005 has been to establish a Drug Safety Oversight Board. This Board oversees the postapproval
risk management for safe and effective drug availability and is composed of experts from FDA centers, HHS agencies, and the
Veterans Administration. The FDA will also practice greater transparency by making drug safety information available to the
public sooner and by releasing details of its own deliberations for drug approvals and postapproval monitoring.9,18 The Board's first meeting was June 17, so it is hard to judge its effectiveness yet. Thus far, though, some lawmakers have
publicly criticized the Oversight Board for not fulfilling its mandate of remaining independent from the Center for Drug Evaluation
and Research in the Board membership and for not holding open meetings.19
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