Report an Adverse Event

1If this is an emergency

Do not use the portal, email, or messaging to report an emergency. Messages are not monitored continuously. Get emergency care first; report to us afterward.

2What counts as an adverse event

Report anything unexpected. You do not need to be sure the medication caused it — that determination is not yours to make, and a report is useful either way.

• Any side effect, whether or not it appears in the Important Safety Information;
• An allergic reaction of any severity;
• An injection-site problem — expanding redness, warmth, pus, a hardened lump, or fever;
• A product quality problem — a cloudy or discolored solution, visible particles, a cracked or leaking vial, a broken seal, a missing or incorrect label, or a package that arrived warm;
• A medication error — wrong dose dispensed, wrong instructions, or a dose you took incorrectly;
• A hospitalization, disability, or any life-threatening event that occurred during treatment;
• Lack of any expected effect, which is also worth recording.

3How to report to us

Use whichever is easiest:

• Secure message — portal → Messages → your care team. Best for anything clinical, because your clinician sees it directly.
• Email — support@getCoreScripts.com, subject line “Adverse Event”.
• Phone — 1-888-888-8888, Monday–Friday, 9am–6pm Eastern.
• Mail — Patient Safety, CoreScripts, 1309 Coffeen Ave, Ste 1200, Sheridan, WY 82801.

What to include

1. Your name, date of birth, and the email on your account.
2. What happened, in your own words.
3. When it started, how long it lasted, and whether it has resolved.
4. The dose you took and when you took it relative to the reaction.
5. The pharmacy lot number and beyond-use date from the vial label, if you still have it — this is the single most useful thing for tracing a quality problem.
6. Any other medications or supplements you take.
7. Whether you sought medical care, and what you were told.
8. Photographs, if there is anything visible — the injection site, the vial, the packaging.

4What happens after you report

1. Acknowledgment within one business day.
2. Clinical review. A clinician of CoreScripts Medical Group, P.A. reviews the report and will contact you if any change to your treatment is warranted.
3. Pharmacy notification. Quality problems are reported to the dispensing pharmacy, including CraftedRX, for investigation of the lot.
4. Regulatory reporting. Serious adverse events and product quality problems are reported to the FDA as required.
5. Resolution. Where a product problem is confirmed, a replacement is issued at no cost under the Refund & Cancellation Policy.

5Reporting directly to the FDA

You may report to the FDA yourself, at any time, whether or not you tell us. You do not need our permission and we will not ask you not to.

• Online: www.fda.gov/medwatch
• Phone: 1-800-FDA-1088
• Fax: 1-800-FDA-0178
• Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

MedWatch is the FDA’s voluntary reporting program for adverse events and product problems. Because compounded drugs are not FDA-approved and are not subject to pre-market review, voluntary reports are one of the few ways problems with them are detected at all. Your report matters more here than it would for an approved product.

You may also contact your state board of pharmacy about a dispensing or product-quality concern.