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 Storage

Standard MM.2.20 Medications are properly and safely stored throughout the organization. This new standard for medication storage was adopted from standards in other programs. JCAHO requires that only approved medications are routinely stocked or stored; in this context, approved medications include nonformulary medications that have been briefly reviewed and approved, as well as formulary medications. Medications must be stored under proper conditions (e.g., temperature, humidity, protection from light) to ensure stability.

Medications must also be secured in accordance with laws, regulations, and organizational policies so that unauthorized persons cannot access them. The Centers for Medicare and Medicaid Services (CMS) defines "secured" as stored in a sealed or locked container (e.g., a drug cart or box) or a locked room or kept under constant surveillance (e.g., at or near a nursing station) (Rich DS, Joint Commission on the Accreditation of Healthcare Organizations, personal communication). JCAHO strives to be consistent with CMS and is reasonable in its expectations for what constitutes constant surveillance; however, JCAHO will accept any interpretation of medication security from CMS or the state agency responsible for compliance with Medicare's "Conditions of Participation for Hospitals."

Controlled substances must be properly stored to prevent diversion and according to state and federal laws and regulations. Drug Enforcement Administration requirements apply.

All expired, damaged, or contaminated medications must be segregated until they are removed from the organization, according to JCAHO. Medications that are readily confused (i.e., look-alike and sound-alike medications, reagents and chemicals that may be mistaken for medications) must be segregated in all areas of the health care organization. This may require the modification of alphabetical medication storage systems.

Stored medications (and chemicals used to prepare medications) must be accurately labeled with the contents, expiration date, and appropriate warnings. Available concentrations of the drug must be standardized and limited. This means that the rate of infusion must vary, rather than the drug concentration, to achieve a specific dose and that individualizing the concentration of medications for all patients is not allowed. Thus, some practices, such as the use of the "rule of six" (i.e., 6 multiplied by body weight, in kilograms, equals the amount of drug to be added to 100 mL of solution) in pediatric patients is no longer acceptable. Concentrated electrolytes should be removed from patient care areas, unless patient safety is at risk if the concentrated electrolyte is not immediately available in a specific area, and specific precautions must be taken to prevent inadvertent administration (e.g., restricting access, using specialized labeling or separate storage). Standardizing drug concentrations, limiting the number of drug concentrations available in an organization, and removing concentrated electrolytes from patient care areas are considered National Patient Safety Goal requirements.[4,5,6] Compliance with these requirements will be counted toward compliance with the National Patient Safety Goals and is publicly disclosed. Medications stored in patient care areas must be maintained in the most ready-to-administer form available from the manufacturer (e.g., unit dose, pre-filled syringes, premixed bags) or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager. JCAHO does not allow the use of bulk containers as floor stock when unit doses are commercially available or available from the pharmacy.

All medication storage areas must be periodically inspected in accordance with the organization's policy to ensure that medications are properly stored. Most organizations conduct these inspections at least monthly; however, JCAHO does not specify a required frequency.

Standard MM.2.30 (formerly TX.3.5.5) Emergency medications and/or supplies, if any, are consistently available, controlled, and secure in the organization's patient care areas. This standard applies to supplies and emergency medications. Standard MM.2.20 also applies to emergency medications.

According to JCAHO, the organization's leadership, in conjunction with members of the medical staff and licensed independent practitioners, must decide which emergency medications and supplies, if any, will be readily available in patient care areas. The leadership may decide that no emergency medications or supplies will be available in certain areas where staff are not properly trained to handle emergencies and that patients will be best cared for by calling 911 or otherwise summoning assistance from an emergency medical team with its own emergency medications and supplies.

Emergency medications must be available in unit dose, age-specific, and ready-to-administer forms whenever possible. Emergency medications must be stored in sealed or locked containers in a locked room or under constant supervision; this requirement is consistent with CMS's requirement for security. Emergency medications must be replaced as soon as possible after use in accordance with the organization's policies and procedures. Sending an emergency medication cart to the pharmacy for restocking and leaving the patient care area without an emergency supply is not acceptable; a cart exchange procedure, whereby a new cart would be brought to the patient care area while the used cart is taken to the pharmacy for restocking, is acceptable.

Standard MM.2.40 (formerly TX.3.7) A process is established to safely manage medications brought into the organization by patients or their families. Health care organizations must have a policy that addresses when medications brought into the organization by patients or family members may be used, if they may be used at all. JCAHO recognizes several valid reasons for such use, including avoidance of interruption in therapy, use of a nonformulary medication, and a lack of alternatives to the patient's personal medication. Such a policy in itself would not constitute approval as required in standard MM.2.10.

The policy must specify a process for identifying the patient's personal medication and visually evaluating product integrity. The inspection does not need to be scientific or performed by a pharmacist, but it should preclude the use of unidentified or obviously deteriorated or contaminated medications. JCAHO requires that both the prescriber and patient be notified if the use of medications brought into the organization is not permitted because of a policy prohibiting such use or because of problems establishing product identity or integrity.