Rx Update: December 2000

UIHC Adverse Drug Reaction Reporting

Mary Ross, R.Ph., M.B.A.
Peer Review Status: Internally Reviewed

During fiscal year, 1999-2000, 292 adverse drug reaction reports supplied to the UIHC Adverse Drug Reaction (ADR) Reporting Program were forwarded to the Pharmacy and Therapeutics Subcommittee for review; 67 of these were subsequently reported to the Food and Drug Administration (FDA) via the MedWatch Program. Reports are identified for inclusion in the MedWatch Program when the reaction is serious or unusual in nature or when the adverse reaction involves a newly marketed agent. Post-marketing surveillance of newly marketed agents is an especially important function of the FDA. This was most recently demonstrated by the manufacturer's announcement of the withdrawal of alosetron (Lotronex®) from the market. This withdrawal was prompted by reports received by the FDA that included cases of ischemic colitis, severe constipation, the need for surgical procedures, and death secondary to use of alosetron. Identification of safety issues such as these can only be effectively carried out if all healthcare professionals continue to report ADRs that may be discovered in the course of their practice.

The importance of equally vigilant surveillance of older agents was demonstrated this past year by market withdrawals and addition of black box warnings to prescribing information. The FDA requested that all drug companies discontinue marketing products with phenylpropanolamine (PPA) and issued a public health advisory to recommend that consumers not use products containing this agent. This action is a result of studies that linked phenylpropanolamine use to increased risk of hemorrhagic stroke in women. Men may also be at risk. Additional reports to the FDA prompted labeling changes for thioridazine (Mellaril®) due to prolongation of the QT interval, torsades de pointes-type arrhythmias, and sudden death. Valproic acid derivatives (Depakote®, Depacon®, and Depakene®) had made changes in package insert information because of their association with life-threatening pancreatitis.

Bright yellow Adverse Drug Reaction Cards are available on all Patient Care Units for easy reporting. Over the past three years, the staff of the Department of Nursing have supplied from 5.4% to 6.6% of the reports each year. During the first five months of fiscal year 2000-2001, 7% of the reports submitted to the ADR Reporting Program have been provided by Nursing Staff.

When completing the cards, please supply as much information as possible. If you need assistance in identifying a potential ADR or in filling out the card, contact the Pharmacy serving your patient care area or the Drug Information Center at 6-2600. Completed cards should be forwarded to the Drug Information Center (CC-101GH). Additionally, if you have suggestions that will make reporting more convenient in your area, please do not hesitate to contact the Drug Information Center. Thank you for your participation in the past and continued assistance in reporting ADRs.

 

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