I. PURPOSE: 

To assure that all requirements of the Risk Evaluation and Mitigation Strategy (REMS) for each drug falling under the FDA’s REMS program are adhered to by the organization.

II. POLICY:

Application of this procedure shall be to all drugs requiring a Risk Evaluation and Mitigation Strategy (REMS) by the FDA. Supervision of this procedure shall be by the Pharmacy and Therapeutics Committee.

III. PROCEDURE:

A.  Upon receiving notification of the REMS for a drug already included in the hospital formulary, the pharmacy department shall review the requirements of the REMS, and develop a brief overview of said requirements for review by the Pharmacy and Therapeutics Committee.

B.  For non-formulary drugs, review of the REMS program if applicable shall be included in the formulary review process.

C.  The REMS information will be forwarded to the MEC committee for informational purposes

D.  Education:

a.          Physician Staff shall be educated about the drug and its REMS program via the monthly Physician Newsletter, and other venues as deemed necessary.

b.         Hospital Staff shall be educated about the drug and its REMS program via newsletters, huddles, and other avenues as deemed necessary.

c.          When required by the REMS program, patients shall be given a Medication Guide and educated about the drug as deemed necessary.

d.         The nurse shall document that the medication guide has been reviewed with and given to the patient.

E.   For REMS programs requiring Informed Consent, the physician shall obtain a written informed consent from the patient prior to use of the drug and forward a copy to the Pharmacy for placement in the REMS Drug binder.

F.   For REMS programs requiring provider or patient enrollment, the drug shall not be dispensed to the patient until verification of enrollment has been obtained.

G.  All other requirements of the REMS shall be adhered to as outlined in the REMS program for each drug as outlined above. REMS requirements may include, but are not limited to: lab and patient monitoring, certification of providers and/or healthcare facility, registry of patients, mandatory reporting of adverse effects, etc.