Adverse Event Follow-up

For some events reported by clinicians, Lilly may ask the reporting clinician for additional information to understand the characteristics of the reported event as completely as possible. We may call, send a fax, send a letter with specific questions or ask your clinician to complete an event-specific questionnaire.

Why Follow-Up is Important

For some cases, we may need specific diagnostic or other medically relevant information to help confirm a relationship between the event and medication - information that may be critical to determine if there is a potential risk to patients that could potentially lead to changes in the labeling of a medication.

The more information provided, the better Lilly can aid clinicians in the future in tailoring medical therapy and reducing the risks of adverse events.

The Lilly Patient Safety staff understands that medical practices are busy and tries to keep requests for additional information as concise as possible. One or two specific pieces of information about an adverse event may assist us in understanding the issue. Healthcare providers are welcome to call and speak directly to the Patient Safety staff member involved in reviewing the adverse event report.

HIPAA Privacy Rule - Disclosure for Public Health Activities  

Covered entities may disclose protected health information to a person subject to FDA jurisdiction, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that person has responsibility. Examples of purposes or activities for which such disclosures may be made include, but are not limited to:

  • Collecting or reporting adverse events (including similar reports regarding food and dietary supplements), product defects or problems (including problems regarding use or labeling), or biological product deviations;
  • Tracking FDA-regulated products;
  • Enabling product recalls, repairs, replacement or lookback (which includes locating and notifying individuals who received recalled or withdrawn products or products that are the subject of lookback); and
  • Conducting post-marketing surveillance. See 45 CFR 164.512(b)(1)(iii). The "person" subject to the jurisdiction of the FDA does not have to be a specific individual. Rather, it can be an individual or an entity, such as a partnership, corporation or association. Covered entities may identify the party or parties responsible for an FDA-regulated product from the product label, from written material that accompanies the product (known as labeling), or from sources of labeling, such as the Physician's Desk Reference.

HIPAA - Disclosures for Public Health Activities

HIPAA Privacy Rule Concerns

Many clinicians worry about providing diagnostic or treatment information as a possible violation of Health Insurance Portability and Accountability Act (HIPAA) regulations, and appropriately so. However, HIPAA recognizes the need for controlled disclosure of safety data. The process of pharmacovigilance - tracking and understanding reported adverse events - is an activity where patient specific information can be shared with the pharmaceutical manufacturers (with all information protected within secure systems).