Reporting a Side Effect or Safety Concern

If you experience a side effect, an unexpected reaction, or any problem you believe is related to your medication, tell us.

Email [email protected] with the subject line Adverse event.

Your report is routed to the physician responsible for your care at Stotland Medical LLC, the provider organization whose physicians review and prescribe your treatment. Reporting is always appropriate. You do not need to be certain the medication caused the problem, and you do not need to wait to see whether it resolves.

Include as much of the following as you can. Send the message even if you cannot answer everything.

• Your name and the email address on your account
• The medication and the dose you are taking
• What you experienced, and when it started
• Whether it is ongoing or has resolved
• Whether you have stopped taking the medication
• Whether you have sought medical care
• Photographs, if the concern is about the appearance of the medication, the vial, or the packaging

Your report is reviewed by a physician. You may be contacted for more information. Depending on what is reported, your treatment may be changed or stopped, and the pharmacy that prepared your medication may be notified.

Reports that meet applicable criteria are submitted to the U.S. Food and Drug Administration.

If your concern is about the medication rather than a reaction to it — the wrong appearance, particles in the vial, a damaged or compromised container, a labeling problem, or a shipment that arrived warm — report it the same way, and do not use the medication.

Photographs of the vial, the label, and the packaging help significantly.

You may report an adverse event or a product quality problem to the FDA yourself, at any time. You do not need our involvement, and you do not need to tell us first.

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

• Online: www.fda.gov/medwatch
• Telephone: 1-800-FDA-1088
• By mail or fax: FDA Form 3500

Reporting to the FDA is voluntary for patients and it is encouraged. Reports help the FDA identify safety problems, including problems with compounded preparations.

The medications prescribed through ElliotMeds are compounded preparations. Compounded medications are not reviewed or approved by the FDA for safety or effectiveness before they are dispensed. Reporting side effects and quality problems is one of the primary ways safety information about compounded preparations is gathered.

Reporting a side effect or a safety concern will not affect your account standing, and we will not treat a report as a reason to restrict your access to care.

Questions about billing are handled separately and are never a condition of reporting a safety concern.