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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The IHS pharmacovigilance program is a component of the National Pharmacy and Therapeutics Committee (NPTC) that is focused on performance improvement activities and evaluations of formulary decisions to promote medication safety and rational medication use.

Mission

to oversee medication safety within the Indian Health System. The pharmacovigilance program provides clinicians with knowledge, tools, and resources to reduce the risks associated with medication therapy in an effort to promote safe and rational use.

Vision

to prevent adverse medication events from occurring and to use medications appropriately to achieve optimal health outcomes.

Adverse Drug Events 

Adverse Drug Events (ADE) should be documented in the patient’s medical record. If the ADE is serous or unexpected, it will be reported to the MedWatch reporting program or the Vaccine Adverse Event Reporting System (VAERS) as described in the Indian Health Manual.

Documenting Common ADEs

Common adverse events are the anticipated but unwanted experiences that patients have after taking a medication. These adverse events can be documented in the patient’s problem list as a purpose of visit. An Adverse Drug Event pick list has been created to easily find commonly reported adverse events. It is important that the name of the suspected medication be included in the purpose of visit narrative to associate the medication with the finding.

Documenting Serious or Unexpected ADEs 

Serious adverse drug events can be captured prominently in the patient’s medical record using the Adverse Reaction Tracking System (ART).

Reporting Serious or Unexpected ADEs

Submit an Adverse Drug Event report for a medication with the MedWatch reporting program. There are three options for submitting a MedWatch report:

  1. Complete the Online Voluntary Reporting Form Exit Disclaimer: You Are Leaving www.ihs.gov  on the FDA website.
  2. Complete the FDA 3500 form [PDF] and mail or fax the form to the FDA per the instructions on the form.
  3. For sites using the RPMS EHR, you can install the IHS Adverse Event EHR note template . This template will help craft your note and create a MedWatch submission at the same time. For sites not using RPMS EHR, a similar template can be developed.

Submit an Adverse Vaccine Event report using the VAERS online reporting tool Exit Disclaimer: You Are Leaving www.ihs.gov .

Medication Safety Resources

Drug Safety Communications (DSC)

Important communications distributed by the FDA regarding the prescribing and monitoring of FDA approved medications and devices. DSC are the result of pharmacovigilance through clinical research findings and post marketing surveillance data. A listing of recent DSC can be found on the FDA website Exit Disclaimer: You Are Leaving www.ihs.gov  .

Recent Drug Safety Communications:

Drug Recalls

Actions taken by a drug manufacturer and overseen by the FDA to remove a drug from the market to reduce the risk of adverse events. Recalls can occur for many reasons. Some recalls may result from minor labeling violations while others may occur due to impurities in the medication or a risk of life-threatening adverse events. Recent medication recalls can be found on the FDA website Exit Disclaimer: You Are Leaving www.ihs.gov  .

The Medication Recall Process [PDF - 138 KB] used by the Indian Health Service informs local service units when they may be affected by a medication recall.

Sample patient letters to be used for medication recalls:

06/2020 Metformin Recall Letter [DOC - 53 KB]

02/2020 Lorcaserin Recall Letter [PDF - 151 KB]

11/2019 Patient Letter - Ranitidine recall [PDF - 50 KB]

Drug Safety Alerts

Provide important information about the safe and effective use of one or more medications. Drug safety alerts provide information about current topics and findings to help raise awareness and promote medication safety.

Recent Drug Safety Alerts: