New JCAHO Medication Management Standards for 2004

Darryl S. Rich


Am J Health Syst Pharm. 2004;61(13) 

In This Article

Changes Related to High-Risk Medications

Standard MM.7.10 The organization develops processes for managing high-risk or high-alert medications. JCAHO defines high-risk and high-alert medications as medications involved in a high percentage of medication errors or sentinel events and medications that carry a high risk for abuse, error, or other adverse outcomes. Examples include medications with a low therapeutic index, controlled substances, medications not approved or recently approved by FDA, psychotherapeutic medications, and look-alike and sound-alike medications. JCAHO requires organizations to identify high-risk and high-alert medications used within the organization. National lists, as well as organization-specific data, on drug use should be used for defining the drugs considered high risk or high alert by the organization. The organization also must develop additional processes for selecting, procuring, storing, ordering, transcribing, preparing, dispensing, administering, and monitoring these high-risk and high-alert medications. For example, cancer chemotherapeutic agents might be stored separately from other medications, ordered using a standardized order form with an extra step to verify dosage calculations, administered only by certain staff qualified through specialized training, and monitored using specialized procedures because of the high risk of toxicity from these agents.

Standard MM.7.40 (formerly TX.3.8) Investigational medications are safely controlled and administered. JCAHO requires organizations to protect the safety of patients participating in clinical studies. The organization should be sensitive to the use of particular patient populations (e.g., children, patients with cognitive impairment) in such studies and should review all investigational medications for safety.

Procedures for the use of investigational medications must be implemented and maintained, including a written process for reviewing, approving, supervising, and monitoring investigational medication use. When an investigational medication protocol is conducted independent of the organization, the organization must review and accommodate, as appropriate, the patient's continued participation in the protocol. When pharmacy services are provided, the pharmacy (not the researcher) must control the storage, dispensing, labeling, and distribution of all investigational medications in the organization.