The narrative section of the MedWatch 3500A form is the heart of the SAE report, and should contain all important information about the case, presented in a reader-friendly fashion. The narrative is likely the first part of the MedWatch read by the medical reviewer (and possibly the only part!), and should be concise, well-written, and provide all important details about the case.
Remember that the minimal elements that FDA requires are:
- An identified injured person
- An identifiable initial reporter
- Identity and contact information of responsible person
- A suspect dietary supplement
- A serious adverse event or fatal outcome
However, in order to best promote safety and demonstrate to FDA that your company is serious about safety, you need to do more than the minimal. You must demonstrate that you’re serious about safety by investigating all reports, and documenting those reports well. Let’s look at an example.
Adverse Event: irregular heart beat and passing out
Minimal Elements Approach
A nurse from a biotech company (initial reporter) called customer service at The Greatest Supplement Company, Inc., to report that a male employee (injured person) experienced an irregular heart beat and passed out (adverse event) during work hours and was transported to a nearby emergency room. The employee said that he had just started taking supplement MBC, a.k.a., Mass Building Compound (suspect dietary supplement) within the past week.
If following the minimal elements approach, the Responsible Person would simply report the text as above to FDA in the Form 3500 or 3500A [Note: it is not necessary to write out the words “initial reporter” or “adverse event” in parentheses. This was done here for illustrative purposes].
High-Quality Approach
If the Responsible Person is doing his/her job at or for the Supplement Company, additional investigations should occur. These may include contacting the user, getting permission to talk to the treating nurse and emergency room physician, obtaining additional medical history and medical records. After having a ten-minute conversation with the injured person, a five-minute conversation with the ER physician, and reviewing the emergency room notes, the Responsible Person writes the following narrative.
A nurse from Biotech Company ABC called customer service at The Greatest Supplement Company, Inc., to report that a 25-year-old male employee experienced an irregular heart beat and passed out (adverse event) during work hours and was transported to a nearby emergency room. When seen in the emergency room, the patient’s heart rate ranged between 180-200 beats per minute (bpm), and the electrocardiogram showed supraventricular tachycardia. The patient’s blood pressure was 100/60 mm Hg, and he complained of feeling slightly lightheaded. He was given Verapamil 10 mg by intravenous push, and within 2 minutes, his rhythm reverted to normal sinus rhythm with a rate of 80 bpm, and he became symptom-free. He was observed for another hour in the ER, and told to contact his primary care physician the next day. The ER note documented a weight of 240 pounds and a height of 5’10”.
Additional history obtained from the patient revealed that he had been taking the supplement Hydroycut 2 tabs twice a day, and green tea extract product approximately four times per day. He had started taking Supplement MBC (2 scoops per day) during the past week in order to put on muscle. During the 4 days prior to the ER visit, he complained of having a head cold, and had taken an over-the-counter nasal decongestant with phenylephrine.
Company Comment (optional): in the opinion of the Responsible Person, these events are not likely related to Supplement MBC, but rather to Hydroxycut, phenylephrine or a combination of the two. Supplement MBC does not contain any cardiac stimulatory components, while Hydroxycut and phenylephrine are known to increase heart rate, and have been associated with rapid heart rate.
Which report of would you like FDA to see?
Which report provides better information on the safety of your product?[/vc_column_text][/vc_column][/vc_row]
