CMS SOM App. A, Tag A-0511

quality pharmaceuticals at reasonable costs.

Interpretive Guidelines §482.25(b)(9)

The medical staff must establish a formulary system. The formulary lists medications for

dispensing or administration that the hospital maintains or that are readily available. In

accordance with accepted standards of practice, the medical staff, in consultation with the

pharmacy service, should develop written criteria for determining what medications are available

for dispensing or administration. At a minimum, the criteria include the indication for use,

effectiveness, risks (including propensity for medication errors, abuse potential, and sentinel

events), and costs.

Processes and mechanisms should be established to monitor patient responses to a newly added

medication before the medication is made available for dispensing or administration within the

hospital.

Medications designated as available for dispensing or administration are reviewed periodically

based on emerging safety and efficacy information.

The hospital should have processes to approve and procure medications that are not on the

hospital’s medication list.

The hospital should have processes to address medication shortages and outages, including the

following:

• Communicating with appropriate prescribers and staff;

• Developing approved substitution protocols;

• Educating appropriate LIPs, appropriate health care professionals, and staff about these

protocols; and

• Obtaining medications in the event of a disaster.

Survey Procedures §482.25(b)(9)

• Interview the pharmacist to determine that the medical staff has established a formulary

that lists drugs that actually are available in the hospital.

• Interview the Pharmacy Director to determine that there is a process for creation and

periodic review of a formulary system.

• Determine that the formulary lists drugs that are available.

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