COMMITTED TO PATIENT SAFETY
At Dompé we are committed to ensuring the safety of our products for the patients we serve. We know that adverse events can happen, and it's not always possible to predict who will get them. It is vital for us to continuously monitor the safety of our products. Through hearing about your experiences using a Dompé product and others like you we are able to offer the best possible information to patients, and health care providers.
WHAT IS AN ADVERSE EVENT?
Title 21 of the Code of Federal Regulations (CFR) 314.80, defines an Adverse Drug Experience (ADE) as: Any undesirable event that is associated with the use of a drug in humans, whether or not considered drug-related.
This may also include:
- Events occurring in the course of the use of a drug product in professional practice
- Drug overdose
- Drug abuse
- Drug withdrawal
- Any failure of expected pharmacologic action.
As a pharmaceutical company, Dompé collects safety information arising from the use of its medicinal products pertaining to special conditions, even in the absence of an adverse event, such as:
- Off-label use,
- Medication error or any problem related to the use of the product,
- Exposure during pregnancy or during breastfeeding,
- Suspected transmission of an infectious agent via medicinal product,
- Falsified medicinal product.
An ADE maybe defined as serious if:
- It results in death
- It is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- It is clinically significant based on healthcare professional’s appropriate medical judgment.
Dompé Pharmacovigilance Department will notify the Regulatory Authorities about any ADE in line with applicable law requirements.
WHAT TO DO IN CASE OF A SUSPECTED ADVERSE EVENT
Suspected adverse events and serious problems can be reported to FDA at 1-800-FDA(332)-1088 www.FDA.gov/medwatch
You may email USDrugSafety@dompe.com, or call us 1-833-366-7387 to report an adverse event.