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.
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