| (a) Applying to have a drug added to the HHSC Psychiatric
Drug Formulary.
(1) Any member of the PEFC, any service system component
practitioner, or any contract practitioner may apply to have a drug
added to the HHSC Psychiatric Drug Formulary by completing the New
Drug Application form found in the HHSC Psychiatric Drug Formulary
on the HHSC Psychiatric Formulary website.
(2) Include the following with the New Drug Application
form:
(A) published articles in biomedical literature that
substantiate the efficacy and safety of the proposed drug;
(B) information on the advantages of the proposed drug
compared with similar formulary drugs;
(C) a list of formulary drugs that the proposed drug
would replace or supplement; and
(D) cost effectiveness data.
(b) Submitting the application.
(1) An HHSC facility practitioner or HHSC facility
contract practitioner shall submit the application to the facility's
pharmacy and therapeutics committee for approval. If the committee
approves the application, the committee forwards the application to
the PEFC.
(2) A non-facility service system component practitioner
or non-facility service system component contract practitioner shall
submit the application to the component's clinical/medical director
or designee who determines if the application is appropriate and complete,
and if so, shall forward the application to the PEFC.
(3) A member of the PEFC shall submit the application
directly to the PEFC.
(c) Considering the application. The PEFC considers
the drug application and shall:
(1) approve the proposed drug's inclusion and, if appropriate,
approve audit criteria and recommend dosage guidelines;
(2) approve the proposed drug on a trial basis for
a specified period of time;
(3) approve the proposed drug as a reserve drug, with
guidelines;
(4) postpone the decision until a later meeting; or
(5) deny the proposed drug's inclusion.
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