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 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 410-333-5398.  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. 

    The link below is a  PDF file . Download Adobe Acrobat Reader for viewing .pdf files

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

Return to Pharmacy Program Forms