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    Maryland Medicaid Pharmacy Program

    Medwatch Form

    To comply with amendments to COMAR 10.09.03.07 H(3), prescribers are required to complete a DHMH Medwatch form. A copy of the form must be forwarded to the Maryland Pharmacy Program for its review and approval before the Program will reimburse at the brand rate for prescriptions dispensed as “Brand Medically Necessary”.

    DHMH will send all approved forms to U.S. Food and Drug Administration (FDA) as official reports of adverse events or product problems regarding generic drug products. The FDA may choose to further investigate the incident and seek documentation of the adverse drug reaction (ADR) or otherwise substantiate the circumstances and veracity of the ADR complaint. Adverse events are defined as life threatening, disabling, impairing, or damaging situations and/or the involvement of a hospital stay. Product problems are defined as an allergic reaction to an allergen present in the generic product that is not included in the brand name product or a therapeutic failure of the generic product when plasma levels are below efficacious published pharmacokinetic profiles for the brand name product.

    To request an over-ride for a “brand medically necessary” prescription, the prescriber must complete and sign the DHMH Medwatch form and fax a copy to the Maryland Pharmacy Program at 866-440-9345. Mere submission of the form is no guarantee that the request will be honored. The prescriber should write “MEDWATCH FORM SUBMITTED” in addition to “BRAND MEDICALLY NECESSARY” on the prescription order to indicate to the dispensing pharmacist that the necessary documentation has been submitted. If a generic version of the drug made by a different manufacturer is available, the Program may require a trial with the other generic drug before approving the brand name product. A copy of a DHMH Medwatch form and instructions are available at the links below.

    Medwatch Form (Required for all “Brand Medically Necessary” prescriptions)

    Instructions for Completing the Medwatch Form