It's every doctor's nightmare: you recommend a product to help a patient feel better and are disappointed to receive an upset voicemail when you arrive at the office the next morning. Your patient thinks they've had a reaction to their prescribed supplement. Whether serious or not, no provider wants to consider that they've caused further harm to the patient, and if it was a supplement from your office, you may have additional questions about refunds, reporting and more.
There are two classes of drug and supplement reactions: "adverse events" and "serious adverse events." A serious adverse event describes an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or a congenital anomaly or birth defect or an adverse event that requires medical or surgical intervention to prevent one of the outcomes described above. Adverse events describe all other, non-life-threatening reactions such as a rash or a headache. In all cases, it is very valuable for manufacturers to receive the information about all adverse events so they can monitor their products and ensure that any trends of reactions on a product or ingredient are discovered. This helps to assure the best quality of dietary supplements.
What To Do
Generally, it is not required for retailers (including doctors offices) to report serious adverse events to the Food and Drug Administration (FDA). The exception to this rule is if the practice's name is on the label, such as for practices which private label products for sale out of their office. Under normal circumstances, it is the responsibility of the manufacturer to report serious adverse events to the FDA. With that in mind, the manufacturer has to learn of the adverse event somehow, right?
So, what should you do if an adverse event is reported to your practice?
1. Support your patient first. While prompt reporting is essential to allow manufacturers or the FDA to track problematic or unsafe products, your first responsibility is to your patient. Make sure that their condition is stabilized and work with them to help them overcome the unwanted side effect.
2. Determine whether this is an adverse event. This involves determining whether the symptom could be related to the product and is not an expected consequence of taking the product. For example, if you recommended using a topical capsaicin cream (derived from chile pepper) and the patient experienced a burning sensation, which would be an expected result, this may not be an adverse event. If a patient misunderstood your directions and took a sleep support product with breakfast and felt groggy, that would, again, be an expected (although very undesired) result. Err on the conservative side and if you have a question around whether it was an adverse event or not, report it.
3. Encourage reporting of all adverse events to the manufacturer. No matter how minor the adverse event, it is very helpful to provide detailed information to the manufacturer of the product that caused the reaction. Typically, when you or your patient calls the manufacturer, they will want to know the reason it was prescribed, how it was taken (dose, frequency and for how long the patient had been taking the product) and how the product was stored. They will want to collect details of the reaction and will take information on the product such as the lot number and expiration date. They might ask additional questions such as what other supplements and drugs the patient was taking concurrently or whether the patient was prone to similar reactions. When an adverse event occurs, either you or your patient can report the event to the manufacturer. By law, the manufacturer is required to provide contact information on their labels, enabling you to easily find the correct telephone number at which to report the event. If the adverse event is serious, the manufacturer is required by law to report it to the FDA. If you wish to, you may also do so directly. Typically, there is no legal obligation on the part of the medical provider in reporting dietary supplement adverse events, but it is highly recommended and can ensure the highest quality in the industry.
