Are you ready for JCAHO’s medication standards?

Proposed changes call for revamped policies

If you’re expecting that the Joint Commission on Accreditation of Healthcare Organizations’ proposed revisions to medication management standards will add to your workload, you’re probably right.

"As with everything else, a few new things will be added to the data collection to-do list of the quality manager," says Kathleen Catalano, director of regulatory compliance services at PHNS Inc. in Addison, TX. PHNS provides information technology, health information management, coding, transcription, and receivables management services to approximately 160 hospitals.

The proposed revisions would increase safe practices related to the selection and procurement of medications and address safe medication management practices for medications brought into an organization by a licensed independent practitioner. In addition, the revised standards would address risks associated with medications that are used as part of a procedure, regardless of whether there is a specific order for the medication.

It is unclear how greatly the new medication management standards will affect quality managers because the category of the elements of performance is not known at this time, says Sherryl Ray, RN, CPHQ, director of quality improvement at Arkansas Children’s Hospital in Little Rock. "Regardless, services and departments across an organization will be affected by the changes if approved," she says.

The most challenging aspect will be the measurement component, says Ray. "I am not sure what we would be required to measure; it all depends on whether there is an associated measure of success," she says. If there is, organizations would need to collect data to assess compliance, and if a standard is noncompliant, measurement is required for the Evidence of Standards Compliance, she explains.

Key focus for 2005

Regardless, medication management will be a key focus during surveys in 2005, predicts Ray. "Medication management is such an integral aspect of overall patient safety," she says. "We saw patient safety become a real focus for surveys in 2004, and there is no reason to think that it will be any less so in 2005."

In many cases, organizations will bring the new requirements to the pharmacy and therapeutics committee for decisions on how best to implement them, Catalano says. "A group may be selected to act as an ad hoc committee and assigned the task of determining what will be in the best interest of the organization and also allow compliance with the standards," she says.

To develop a policy, organizations may rely on LD.4.20, the standard that discusses the design of new or modified services or processes, Catalano adds.

"A literature search may be helpful, or even site visits to see how other organizations are implementing these standards," she says. "There will also be a need for in-depth education and training regarding any changes made."

Data collection and documentation of quality control procedures most likely will be performed by pharmacy personnel and then reported through pharmacy and therapeutics to the quality committee, depending on the committee structure of the organization, Catalano notes.

The deadline for feedback on the proposed revisions was Jan. 10, 2005. "JCAHO can move very quickly when they choose, but I don’t expect these revisions to be implemented until June or July of 2005," she says. "But they may do this sooner — it’s hard to tell."

Since medication management was a system tracer for 2004, it may well be a system tracer in 2005, Catalano adds. "Perhaps some of the findings regarding the medication management systems in 2004 led JCAHO to write these revisions."

Organizations probably will implement some of the changes faster than others, she says. "I believe many organizations already are in compliance with the proposed revision for MM.2.20, regarding how medications are to be properly and safely stored throughout the organization."

As for standard MM.4.10, which would require that all prescriptions or medication orders be reviewed for appropriateness, the Elements of Performance (EPs) 8, 9, and 10 will need some planning, Catalano adds. These EPs require evaluation of the risk of medications used as part of a procedure, when there is no specific order for the medications or the medication is not directly provided by the pharmacy. Strategies to address these risks must be based on literature review, best practices, and internal data, and developed in conjunction with the medical staff and pharmacy.

"Medications typically used for different types of procedures will be reviewed and decisions made accordingly," she explains.

Standard MM.4.20 would require a policy addressing safety and the use of medications acquired by a practitioner from sources other than the organization, specifying when these medications may be used and the process to evaluate them. "This type of policy may already be in place in many facilities," Catalano adds.

According to proposed standard MM.4.50, medications that are obtained after hours by nonpharmacist health care professionals now must be maintained outside the pharmacy and must be locked.

"How will the organization decide which medications they will place in this area? What type of training will be required for those who are allowed to access these medications?" she asks. "I believe the quality control, requiring an independent second check by another person or secondary verification system such as bar coding, may be more difficult to accomplish — but it is doable."

The EP requiring a pharmacist to be on call or available at another location may present a dilemma for some organizations, Catalano notes. "This is doable in most organizations, but it may be problematic in the rural areas," she says.

One surprise was EP 16 for MM.2.20, which requires the organization to define in policy how practitioners "carry and maintain" medications. "This is the only EP that may be outside the current policy of organizations — I’m not sure all policies address this," Catalano explains.

The requirement may be related to clinicians carrying medications in "fanny packs," which typically is done by respiratory therapists for inhalation treatments, suggests Ray. "There has been some literature recently related to this practice and how body temperature affects medication stability," she says. "It seems that the USP storage requirements should be the universal standard."

MM.8.10 requires the organization to evaluate its medication management system, including risk points and areas in which safety can be improved, routine evaluation of literature for new technologies or successful practices that have improved safety in other organizations, and a review of internally generated reports for trends and issues in the organization’s medication system.

"It is my opinion that this is already done by the majority of pharmacies today. This is simply good practice," Catalano notes. "Of course, the organization is to take action to implement improvements, by using information from data analysis to identify subsequent changes to improve its medication management system."

[For more information on the proposed medication management standards, contact:

Kathleen Catalano, Director, Regulatory Compliance Services, PHNS Inc., One Lincoln Centre, 5400 LBJ Freeway, Suite 200, Dallas, TX 75240. Phone: (972) 701-8042, ext. 216. Fax: (972) 385-2445. E-mail:

Sherryl Ray, RN, CPHQ, Director, Quality Improvement, Arkansas Children’s Hospital, 800 Marshall St., Little Rock, AR 72202-3591. Phone: (501) 364-1683. E-mail:]