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Letters |

Drug Safety MonitoringDrug Safety Monitoring

JAMA. 2006;296(13):1590-1590. doi:10.1001/jama.296.13.1590-a
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AUTHOR INFORMATION

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

DRUG SAFETY MONITORING

To the Editor: The Commentary by Dr Strom1 points out several of the problems with the current drug safety monitoring system and offers several suggestions for improving the system. One recommendation calls for the use of independent and complementary nongovernmental organizations in the process of drug safety.

We believe that certified poison control centers (PCCs) fit this requirement and can significantly enhance postmarketing drug surveillance. Poison control centers are staffed with health care professionals trained to obtain detailed medication-related information and health histories, document calls, perform triage, assist in treating patients who are experiencing adverse drug reactions, follow up on outcomes, and perform surveillance. Acting as a focal point for the reporting of suspected adverse drug reactions would be consistent with the public health and surveillance activities currently performed by PCCs.

Data from individual PCCs are sent to the Toxic Exposure Surveillance System (TESS), a surveillance database coordinated by the American Association of Poison Control Centers.2 3 TESS data are already used by the pharmaceutical industry and regulatory agencies for postmarketing surveillance.3 4 The advantages of using the PCC system to collect medication safety data include it being nonpunitive, confidential, and independent; having a toll-free telephone number as a point of access; serving as a source for information regarding drug interactions; and providing immediate availability of reported data.4 5

Financial Disclosures: None reported.

References
Strom BL. How the US drug safety system should be changed.  JAMA. 2006;2952072-2075
PubMed
Litovitz T. The TESS database: use in product safety assessment.  Drug Saf. 1998;189-19
PubMed
Centers for Disease Control and Prevention.  Toxic Exposure Surveillance System.  MMWR Morb Mortal Wkly Rep. 2004;53(suppl)  262
Wolkin AF, Patel M, Watson W.  et al.  Early detection of illness associated with poisonings of public health significance.  Ann Emerg Med. 2006;47170-176
PubMed
Woolf A, Litovitz T. Reporting of adverse events.  N Engl J Med. 2003;3481410-1411
PubMed

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Strom BL. How the US drug safety system should be changed.  JAMA. 2006;2952072-2075
PubMed
Litovitz T. The TESS database: use in product safety assessment.  Drug Saf. 1998;189-19
PubMed
Centers for Disease Control and Prevention.  Toxic Exposure Surveillance System.  MMWR Morb Mortal Wkly Rep. 2004;53(suppl)  262
Wolkin AF, Patel M, Watson W.  et al.  Early detection of illness associated with poisonings of public health significance.  Ann Emerg Med. 2006;47170-176
PubMed
Woolf A, Litovitz T. Reporting of adverse events.  N Engl J Med. 2003;3481410-1411
PubMed
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