Rx Update: March 2004

Adverse Drug Reactions Reports and Nitroglycerin Tablets

Joan Murhammer, R.Ph., Mary Ross, R.Ph., M.B.A., Kevin Bebout, R.Ph.
Peer Review Status: Internally Reviewed

Do you have an adverse drug reaction to report?

Beginning in March 2004, the UIHC Adverse Drug Reaction (ADR) Reporting Program will begin receiving ADR reports via INFORMM Patient Record (IPR), which is currently utilized by staff to report and document other types of patient adverse incidents. The Adverse Drug Reaction Reporting Program (administered under the auspices of the Pharmacy and Therapeutics Subcommittee and coordinated by the Department of Pharmaceutical Care) monitors adverse drug reactions that affect our patients. The World Health Organization has defined an adverse drug reaction as "any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function." Please note that adverse drug reactions are distinct from medication errors. Medication errors are defined as "an error at any stage in the medication ordering, dispensing, and administration process that may lead to inappropriate medication use or patient harm."

ADR reports involve a wide variety of medications, including agents that are new to the market as well as older, well-established products. All health care professionals must perform vigilant post-marketing surveillance in order to continue necessary monitoring after new agents reach the market. New data are used to update the prescribing information of recently approved agents and, in some cases, drug entities that have been marketed for years. The data may also lead to the market withdrawal of products associated with adverse reactions that were previously unrecognized or occur frequently with widespread use. We have all heard or seen information about adverse drug reactions that have occurred in the course of patient care within the hospital; unfortunately, many of these occurrences are never documented or reported by staff who are most familiar with the patient and the adverse event.

Whenever you become aware of an adverse drug reaction (whether in the inpatient or ambulatory care setting), please complete and submit an adverse drug reaction incident report using the (IPR). In IPR, under the Incident Reporting Tab, choose "Adverse Drug Reaction (NOT Med Error)" to report these occurrences. The yellow adverse drug reaction reporting cards formerly located on patient care units and ambulatory care clinics will no longer be available for this purpose.

If you have questions about whether an adverse event should be reported as an adverse drug reaction, please feel free to contact Kevin Bebout, Administrative Pharmacy Practice Specialist or contact the Drug Information Center.

Thank you for your support of this important patient safety program.

Nitroglycerin sublingual tablets should maintain their potency through the manufacturer's expiration date on the bottle provided the following conditions are met:

• Tablets should be kept in the original glass container.
• The cap is tightly replaced after each use and tablets are not handled unnecessarily.
• The cotton should be discarded once it is removed.
• Tablets should be stored at controlled room temperature and protected from heat (do not carry close to body heat, do not store in auto, and so forth), cold (do not refrigerate), and excess humidity (avoid storage in bathroom medicine cabinet).

The nitroglycerin sublingual tablets are potent through the manufacturer's expiration date; therefore, the bottles do not require dating once they are opened.

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