New JCAHO Medication Management Standards for 2004

Darryl S. Rich


Am J Health Syst Pharm. 2004;61(13) 

In This Article

Changes Related to Preparing and Dispensing Medications

Standard MM.4.10 (formerly TX.3.5.2) All prescriptions or medication orders are reviewed for appropriateness. A pharmacist must review all medication orders before dispensing a medication, removing it from floor stock, or removing it from an automated storage and distribution device. Exceptions include situations in which a licensed independent practitioner controls the ordering, preparation, and administration of the medication and urgent situations when a delay would harm the patient (e.g., the new onset of nausea or pain or a sudden change in the patient's clinical status). When an onsite licensed pharmacy is not open 24 hours a day, seven days a week, a health care professional determined to be qualified by the organization must review the medication order in the pharmacist's absence, and the pharmacist must conduct a retrospective review of the order as soon as he or she is available or the pharmacy opens. The process for review of medication orders includes the specific elements listed in Table 4 , regardless of who performs the review. All concerns, issues, and questions must be clarified with the prescriber before dispensing the medication. A number of companies that provide pharmacist review of orders remotely when the pharmacy is closed are now appearing, which provides another acceptable alternative for meeting this requirement.

Standard MM.4.20 Medications are prepared safely. When an onsite, licensed pharmacy is available, sterile medications, i.v. admixtures, and other drugs are compounded or admixed only in the pharmacy, except in emergencies or when this practice is not feasible (e.g., when the duration of product stability is short). This requirement does not apply to simple reconstitution of medications. JCAHO has defined i.v. admixture as "the preparation of pharmaceutical product which requires the measured addition of a medication to a 50 mL or greater bag or bottle of IV fluid."[4] This does not include the drawing up of medications into a syringe, adding medication to a Buretrol or i.v. line, or the assembly and activation of an i.v. system that does not involve the measurement of the additive (e.g., ADD-Vantage system, Abbott Laboratories). It should be noted that situations in which a licensed independent practitioner controls the ordering, preparation, and administration of the medication do not constitute an exception to the pharmacy preparation of i.v. admixtures or sterile medications.

JCAHO requires all staff who prepare medications to use techniques to ensure accuracy (e.g., double-checking calculations) and avoid contamination, including using clean or aseptic technique as appropriate; maintaining clean, uncluttered, and functionally separate areas for product preparation to minimize the possibility of contamination; using a laminar-airflow hood (or other class 100 environment as defined by Federal Standard 209d, General Services Administration) while preparing any i.v. admixture in the pharmacy, any sterile product made from nonsterile ingredients, or any sterile product that will not be used within 24 hours; and visually inspecting the integrity of the medications. JCAHO does not require that sterile products be prepared only in a cleanroom or laminar-airflow hood because there are circumstances when the nursing staff may need to prepare a dose of a sterile product for immediate use (or use within 24 hours) in the patient care area. However, products should not be prepared in a cluttered area or the hallway, where cleanliness may be compromised. The anesthesiology department should not prepare sterile products two or three days before use; the pharmacy should prepare sterile products that are not to be administered within 24 hours after preparation.

Staff must use safety materials and equipment while preparing medications that are hazardous (e.g., biological-safety cabinets for cytotoxic drugs). This requirement is intended to protect the staff and environment from contamination.

Standard MM.4.30 (formerly TX.3.5.1) Medications are appropriately labeled. Medications must be labeled in a standardized manner according to organizational policy, applicable laws and regulations, and standards of practice to minimize errors. This requirement applies to any medication that is prepared but not administered immediately (i.e., this requirement does not apply to a medication prepared and administered immediately in the emergency department or operating room). At a minimum, labels must include the drug name, strength, and amount (if not apparent from the container); the expiration date when the medication is not used within 24 hours after preparation; the expiration time when expiration occurs within less than 24 hours after preparation; and the date prepared and the diluent for all compounded i.v. admixtures and parenteral nutrient solutions. A label does not need to be affixed to containers of i.v. solutions that are labeled by the manufacturer if nothing is added to the solution.

When preparing individualized medications for multiple patients or when the person preparing the individualized medication is not the person administering the medication (e.g., when pharmacy prepares an i.v. admixture for administration by nursing staff), the label also should include the patient's name and location. Directions for use and any applicable cautionary statements (e.g., requires refrigeration, for i.m. use only) also should be added to the label or attached as an accessory label.

Standard MM.4.40 (formerly TX.3.5) Medications are dispensed safely. JCAHO requires that medications are dispensed in quantities to meet patient needs but minimize diversion (i.e., quantities dispensed are neither insufficient to meet patient needs nor excessive to permit diversion), and dispensing must occur in a timely manner to meet patient needs. Dispensing must adhere to laws, regulations, licensure requirements, and professional standards of practice, including those legal requirements for record keeping.

Medications must be dispensed in the most ready-to-administer forms available from the manufacturer (e.g., unit dose) or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager. This requirement is analogous to the requirements in standard MM.2.20 for medications stored in patient care areas and standard MM.2.30 for emergency medications. The organization must consistently use the same dose-packaging system; if a different system is used, education about the use of the dose-packaging system should be provided as appropriate. For example, education or instructions should be provided for staff if a tablet is not provided in unit-dose form (e.g., it requires splitting) or if the hospital uses premixed i.v. minibags as the dosage system but, because of a drug shortage, the ADD-Vantage or another system is introduced at the health care organization. Because such systems are not routinely used, staff may not know how to handle them (e.g., the system may require activation), resulting in dosage errors.

Standard MM.4.50 (formerly TX.3.5.4) The organization has a system for safely providing medications to meet patient needs when the pharmacy is closed. The rationale for this standard is to ensure that the organization has the ability to provide medications to meet urgent or emergent needs when the pharmacy is closed.

JCAHO requires several safeguards when nonpharmacist health care professionals are allowed by law and regulation to obtain medications after the pharmacy is closed. Access must be limited to a set of medications that have been approved by the organization. Open access to the entire pharmacy by a nonpharmacist is not allowed, even when permitted by law and regulation. These medications may be stored in a night cabinet, automated medication storage and distribution device, or a limited section of the pharmacy. Only trained, designated prescribers and nurses are permitted to have access to this limited supply of medications. Quality-control procedures (e.g., an independent second check by another individual or secondary verification built into the system) are in place to prevent medication retrieval errors. The organization must provide for a qualified pharmacist to be on-call or available at another location (e.g., at another organization that has 24-hour pharmacy services) to answer questions or provide medications beyond those accessible to nonpharmacist staff.

JCAHO requires the process for providing after-hours medications to be evaluated on an ongoing basis to determine what medications are accessed routinely and why. Changes must be implemented as appropriate (e.g., adding certain frequently needed medications to the night cabinet) to reduce the number of times that nonpharmacist staff obtain medication after the pharmacy is closed or require an on-call pharmacist to come in to the pharmacy.

Standard MM.4.70 (formerly TX.3.5.6) Medications dispensed by the organization are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration for safety reasons. Medications must be retrieved and appropriately handled in accordance with laws, regulations, and organizational policies when a medication is recalled or discontinued (this standard only discusses recalls for safety reasons, not all recalls). Although recalls are generally made by lot number, an organization may retrieve all lots of a recalled medication instead of recording and identifying medications by lot number. JCAHO also requires the notification of all persons ordering, dispensing, or administering a recalled or discontinued medication and identification and notification of patients who may have received the medication.

Standard MM.4.80 Medications returned to the pharmacy are appropriately managed. JCAHO requires a process that addresses whether and when unused, expired, or returned medications will be managed by the pharmacy. The pharmacy is held responsible for controlling and accounting for all unused medications that are returned to the pharmacy. A process must be in place for the return of medications to the pharmacy, including procedures for preventing diversion of medications. If outside sources are used for the destruction of returned medications, the organization should have a process for how that activity occurs. Accountability only need be at a gross level, not at an individual tablet level.