Adverse Event and Follow-up
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
When Is an Adverse Event Considered Serious?
The patient's death is suspected as being a direct outcome of the adverse event.
The patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient's death.
Hospitalization (initial or prolonged)
Admission to the hospital or prolongation of a hospital stay results because of the adverse event. Examples: Anaphylaxis, pseudomembranous colitis, or bleeding causing or prolonging hospitalization
The adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
There are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.
Adverse Event Follow-Up
For some events, Lilly may ask 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 health care provider 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 understand the relationship between the event and medication - information that may be critical to determine if there is a risk to patients that could possibly lead to changes in the labeling of a medication.
The more information provided, the better Lilly can aid the health care provider in the future in tailoring medical therapy and reducing the risks of adverse events.
The Lilly Global Patient Safety staff understands that medical practices are busy and we try to keep requests for additional information as concise as possible. Health care providers are welcome to call and speak directly to the Global Patient Safety staff member involved in reviewing the adverse event report.
HIPAA Privacy Rule Concerns
Many health care providers 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).
HIPAA Privacy Rule - Disclosure for Public Health Activities
Health care providers are covered entities under HIPAA and may disclose protected health information to a pharmaceutical company such as Lilly, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that pharmaceutical company 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, product defects or problems (including problems regarding use or labeling), or biological product deviations;
- Tracking FDA-regulated products;
- Enabling product recalls, repairs, replacement or look back (which includes locating and notifying individuals who received recalled or withdrawn products or products that are the subject of look back); and
- Conducting post-marketing surveillance. 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.