Rx Update: December 2003

Reporting Adverse Drug Reactions to the FDA and Maintaining HIPPA Compliance

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

The Pharmacy and Therapeutics (P&T) Subcommittee is required by the JCAHO to review suspected adverse drug reactions experienced by UIHC patients. Adverse drug reactions identified by the P&T Subcommittee as unusual or serious are recommended for reporting to the FDA's voluntary adverse drug reaction program. The adverse drug reaction data provided to the FDA are potentially useful for changing package insert information, including contraindications, warnings, precautions, and stated adverse effects.

However, some healthcare practitioners have voiced concern that because of regulations associated with the HIPAA Privacy Rule such reports can no longer be submitted to the FDA. This is not the case, and organizations such as the UIHC can continue to submit adverse event reports under the HIPAA regulations. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. In fact, the Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.

In order to keep effective drugs and devices available on the market for use by our patients, FDA relies on the voluntary reporting of serious adverse events or product problems suspected to be associated with drugs or medical devices. FDA uses these data to maintain the safety surveillance of all FDA-regulated products. A report from our facility may be the critical action that prompts a modification in use or design of the product, improves the understanding of the safety profile of the drug or device, and leads to increased patient safety.

The Privacy Rule requires that reporters make a reasonable effort to submit the minimum protected health information necessary to achieve the purpose of the report. Adverse drug reaction reports sent to the FDA via the UIHC's Adverse Drug Reaction Reporting Program are only identified by institution; these reports remain anonymous with respect to specific patients or particular physicians associated with a patient's care.

If you have questions regarding the reporting of adverse drug reactions to the FDA, please contact Kevin Bebout, Administrative Pharmacy Practice Specialist, at 6-2577, or the Drug Information Center at 6-2600.

IV Hang Times and Tubing Changes

The current policy for IV hang times and tubing changes for routine tubing, add-on device, and solution change frequencies are as follows (Nursing Policy 07.030 Administration of IV Therapy):

• Continuous IV therapy tubing should be changed every 96 hours. The solution bag/syringe can be hung for up to 96 hours or in the time frame that the additives expire, whichever comes first. Medications that are prepared by Pharmacy and have a longer expiration date or products that are commercially available (e.g., D5 1/2 NS with 20 mEq KCl/l, morphine PCA syringes) can be hung for up to 96 hours.
• Intermittent IV therapy tubing and solution bags should be changed every 24 hours.

The November issue of the RxUpdate summarized the UIHC policy for assigning expiration dates to drug doses prepared on patient care units (PCU). An IV solution or syringe prepared on a PCU can get a maximum expiration date of 24 hours.

Please contact the Drug Information Center (6-2600) with any questions on expiration dating.

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