Revised meds management standards took effect 7/1

As of July 1, Joint Commission on the Accreditation of Healthcare Organization (JCAHO) surveyors have expected hospitals to be compliant with changes to four medication management standards, some of which have caught them by surprise, according to the American Society of Health-System Pharmacists (ASHP).

The revision causing the greatest confusion appears to be a portion of standard MM 4.50 dealing with access to medications when a hospital's pharmacy is closed. In the past, JCAHO allowed qualified nurses to enter a limited area of the pharmacy after it had closed to retrieve medications, so long as the practice complied with state laws and relevant Joint Commission requirements. Under the revised standard, however, only pharmacists may enter the pharmacy after hours, and medications that will be needed after the pharmacy closes must be safely stored elsewhere.

JCAHO vice president of standards and survey methods Robert Wise said that health care organizations that had relied on nurses to obtain medications after the hospital pharmacy closed also required that the nurses have special training. But he said it is JCAHO's position that even the specially trained nurses lack the expertise needed to be allowed full access to the pharmacy.

Under the revised standard, only a limited number of medications specifically defined by a hospital can be stored outside the pharmacy. If a drug that is stored in the pharmacy is needed, an on-call pharmacist must be brought in to provide the medication, or the hospital can obtain it from an open pharmacy away from the hospital.

Wise said JCAHO is not specifying what type of storage space is to be used for any after-hour medications. He said those hospitals that want to keep the majority of their medications available to nonpharmacists are the ones most likely to have an issue with the standard, while those hospitals that just maintain a small cache of medications outside the pharmacy for after-hours use put them in a closet or something smaller and don't have a problem with the standard.

Storing meds to be used later

Also taking effect July 1 was a section of MM 2.20 addressing storage conditions for medications that are dispensed by a hospital pharmacy but not immediately administered to a patient. Included are drugs that are sent through a hospital's pneumatic tube system but not retrieved right away, and medications that health care providers carry around the hospital for prolonged periods before administering them to the patient.

Wise told ASHP that respiratory therapists are a specific group who might carry medications with them for several hours before administering the drugs to patients, but said other health care providers also might do the same thing.

"We certainly have heard that people are getting medications for convenience and then knowingly using them sometime (later) in the day," he said. By requiring hospitals to have policies and procedures in place to deal with storage of drugs after they leave the pharmacy, he said, JCAHO is forcing organizations to address the practice even if they don't condone it.

"Just by bringing it up," he said, "the hospital is made aware that this is going on. And then they have to decide if they will let the practice go on or not. If you allow the practice, you have to make sure the medication is stored properly and safely."

MM 4.20, a third revised medication management standard, requires health care facilities to adopt specific policies and procedures for the safe use of medications brought into the institution by a health care provider outside of the normal pharmacy acquisition process. The standard requires hospitals to state whether the practice is allowed and if it is, to adopt policies ensuring the products' integrity.

Opportunity to circumvent safety and efficacy?

ASHP says it strongly opposed this standard when it was first proposed, fearing it would provide an opening for health care providers to circumvent the safety and efficacy requirements governing placement of drugs on a hospital's formulary. JCAHO said medications that practitioners might want to bring into a hospital include samples of a new drug not yet on the market, investigational drugs, homeopathic or herbal products, certain compounded medications, and drugs that don't have FDA-approved labeling but can be obtained from outside the United States. ASHP director of practice standards and quality Kasey Thompson said bringing such medications into a hospital without going through the facility's pharmacy and therapeutics committee jeopardizes patient safety. "Current JCAHO standards should adequately address these situations without the creation of new subprocesses to bring medications into the organization," Thompson said.

The fourth standard revised as of July 1 was MM 8.10, evaluation of a hospital's medication management system. It now requires that once a hospital identifies a best practice or new technology that is an improvement on the existing system, it must adopt that technology or practice.

(Editor's note: More information is available at www.jcaho.org.)