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.
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.
to prevent adverse medication events from occurring and to use medications appropriately to achieve optimal health outcomes.
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 Common ADEs [PDF - 224 KB]
Serious adverse drug events can be captured prominently in the patient’s medical record using the Adverse Reaction Tracking System (ART).
- Documenting Serious ADEs [PDF - 202 KB]
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:
- Complete the Online Voluntary Reporting Form on the FDA website.
- Complete the FDA 3500 form [PDF] and mail or fax the form to the FDA per the instructions on the form.
- 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.
- Submitting ADEs to MedWatch with the RPMS EHR Template [PDF - 134 KB]
When using the online voluntary Reporting Form or the FDA 3500 form, it is essential that the words "IHS" or "Indian Health Service" appear on the form, ideally in the address of the "Reporter" section.
Submit an Adverse Vaccine Event report using the VAERS online reporting tool .
It is essential that the words "IHS" or "Indian Health Service" appear on the form in item #26 (Immunization Project Report Number).
Quarterly IHS Adverse Drug/Vaccine Event Reports
The IHS Pharmacovigilance program presents a summary of adverse drug and vaccine events at each quarterly National Pharmacy and Therapeutics Committee meeting. This summary includes information from the MedWatch and VAERs reports that are identified as originating from an Indian Health Service, Tribal, or Urban program (i.e., "IHS" is documented in the reporter section of the MedWatch form or in item #26 of the VAERS form).
- November 2020 [PDF - 81 KB]
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 .
Recent Drug Safety Communications:
- 07/2021 Statins and Pregnancy [PDF - 131 KB]
- 06/2021 Alcohol-Based Hand Sanitizers [PDF - 140 KB]
- 05/2021 Obeticholic Acid [PDF - 35 KB]
- 03/2021 Lamotrigine [PDF - 116 KB]
- 03/2021 Propylhexedrine [PDF - 47 KB]
- 02/2021 Tofacitnib [PDF - 50 KB]
- 12/2020 V-Safe After Vaccination Health Checker [PDF - 137 KB]
- 10/2020 NSAIDS and Pregnancy [PDF - 90 KB]
- 09/2020 Benzodiazepines [PDF - 92 KB]
- 04/2020 Hydroxychloroquine and heart rhythm ADEs [PDF - 44 KB]
- 02/2020 Montelukastn Boxed Warning [PDF - 92 KB]
- 02/2020 Lorcaserin withdrawal [PDF - 204 KB]
- 01/2020 Clozapine and constipation [PDF - 76 KB]
- 12/2019 Gabapentinoids [PDF - 56 KB]
- 09/2019 CDK46 Inhibitors [PDF - 43 KB]
- 08/2019 Entacapone [PDF - 47 KB]
- 08/2019 Hep C Meds and Hepatoxicity [PDF - 97 KB]
- 07/2019 Tofacitinib [PDF - 47 KB]
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 .
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:
- 7/2021 Johnson & Johnson COVID-19 vaccination and Guillain-Barré Syndrome: FDA Revises Fact Sheets [PDF - 224 KB]
- 6/2021 Pfizer/Moderna COVID Vaccine and myocarditis/pericarditis Update [PDF - 141 KB]
- 5/2021 Pfizer/Moderna COVID Vaccine and myocarditis/pericarditis [PDF - 110 KB]
- 4/2021 Johnson and Johnson COVID-19 Vaccine Update [PDF - 110 KB]
- 4/2021 Johnson and Johnson COVID-19 Vaccine [PDF - 122 KB]
- 3/2021 Bamlanivimab and Etesevimab [PDF - 198 KB]
- 1/2021 Vaccine Safety [PDF - 141 KB]
- 11/2020 Remdesivir Update [PDF - 140 KB]
- 08/2020 Canagliflozin [PDF - 78 KB]
- 07/2020 Naloxone with Opioid Prescriptions [PDF - 165 KB]
- 07/2020 Methanol in Hand Sanitizers [PDF - 63 KB]
- 06/2020 Revokation of Hydroxycholorquine EUA for COVID-19 [PDF - 147 KB]
- 06/2020 Meformin NDMA Recall [PDF - 46 KB]
- 03/2020 Hydroxychloroquine for aquarium Use [PDF - 103 KB]
- 03/2020 Hydroxychloroquine for COVID-19 [PDF - 43 KB]
- 03/2020 NPTC Guidance_Unknown Risks with unapproved COVID-19 Treatments [PDF - 244 KB]
- 03/2020 NSAIDS for COVID-19 [PDF - 136 KB]
- 03/2020 Vaccinations and COVID-19 [PDF - 100 KB]
- 12/2019 Exosome DSA [PDF - 84 KB]
- 12/2019 Metformin NDMA [PDF - 135 KB]
- 10/2019 Ranitidine Recall [PDF - 111 KB]
- 09/2019 Look alike/Sound alike medications [PDF - 126 KB]
- 01/2019 SAAM [PDF - 136 KB]