New JCAHO Medication Management Standards for 2004

Darryl S. Rich


Am J Health Syst Pharm. 2004;61(13) 

In This Article

Changes Related to Medication Selection and Procurement

JCAHO now requires written criteria for the addition and removal of items in the list of medications available for use in the health care organization (i.e., formulary), as established by standard MM.2.10 (formerly TX.3.1) Medications available for dispensing or administration are selected, listed, and procured based on criteria. JCAHO does not use the term formulary because its standards apply to organizations that do not use that term (e.g., long-term-care facilities, home care organizations, behavioral health care facilities). Members of the medical staff, licensed independent practitioners, appropriate health care professionals, and staff involved in the ordering, dispensing, administration, and monitoring of medications should be involved in development of the criteria; the effort should not be a unilateral one by the pharmacy department. At a minimum, the criteria should include the medication's indications for use, effectiveness, risks (including propensity for medication errors, abuse, and sentinel events), and costs. A list of medications stored in the organization, including strengths and dosage forms, must be maintained and readily available. This does not mean that the pharmacy and therapeutics (P&T) committee must approve every strength and dosage form, only that these parameters for stock drugs must be included on the list. Drug samples need not be listed.

JCAHO requires that processes and mechanisms be established to monitor patient response to a newly added medication before it is made available for dispensing and administration. For example, a drug for which specific laboratory testing is required cannot be used in a health care organization that does not have the capability to perform that testing. More commonly, this means that the organization must disseminate information regarding adverse effects and monitoring parameters to nursing, pharmacy, and medical staff before the drug is officially added to the formulary.

A new JCAHO requirement calls for a review at least annually of all medications on the medication list or formulary to determine whether they should continue to be listed on the basis of emerging safety and efficacy information. This review has the potential to be labor intensive but should not be if the focus is on emerging safety and efficacy data.

Health care organizations must have processes to approve and procure medications that do not appear on the medication list (e.g., nonformulary drugs). The approval process used to meet this requirement may be brief and involve the chief of staff or head of the P&T committee. The requirement is intended to serve as a safeguard to prevent the use of questionable medications (usually those available only in foreign countries) without careful consideration.

Organizations must have processes for handling drug shortages and outages, including communicating with prescribers and staff as appropriate, developing approved substitution protocols and educating appropriate staff about these protocols, and obtaining medications in the event of a disaster. These requirements reflect JCAHO's recognition of the increasing frequency of drug shortages and the potential adverse effect of drug shortages on patient care.