August 20, 2007

A Big Headache Cured? Making a Standard Medication List a Reality
By Kathryn Foxhall
For The Record
Vol. 19 No. 17 P. 29

Standard-setting organizations are slowly but surely moving toward incorporating a common medication list into personal health records.

There is widespread agreement that a medications list is a key and primary part of a patient’s record. However, progress on this front has traditionally been slow. Let alone having an electronic medication list, the healthcare establishment has not even agreed on a format for a hard-copy list. But, in recent weeks, major steps have been taken to standardize medication lists in paper and electronic formats.

In June, the American Society of Health-System Pharmacists (ASHP) convened several key players in an effort to reach a consensus on a format and the information elements to include and begin laying the framework for a campaign to get patients and providers to use it.

A number of groups offer a format for a “personal medication record,” said the ASHP, but the documents vary widely, and studies on their use find they also vary in utility.

Included in the ASHP discussions were representatives of several major healthcare players, including The Joint Commission, the American Association of Retired Persons, the National Quality Forum, and the Agency for Healthcare Research and Quality.

Eventually, the pharmacists’ organization would like to see the standardized medication list fitting into an electronic personal health record (PHR). But for now, the primary goal is to get an accepted format in widespread use, even if it’s on paper.

The ASHP said, “We recognize that electronic transmission of health information, including medication information, to patients and providers is optimal in comparison to the current array of paper-based systems. However, it is not likely that complete implementation of electronic systems will occur in the next five to 10 years.” It noted Census Bureau estimates that only 34% of people over the age of 65 have computers, and minority populations are less likely to own computers.

ASHP officials also mentioned recent guidance from the World Health Organization, The Joint Commission, and The Joint Commission International calling for development of a standard card or form for medication lists.

At the meeting, the representatives planned a research agenda on the use of medication lists and laid the groundwork for a public relations push—which the ASHP and ASHP Foundation will plan in upcoming months—that will bring attention to the need for maintaining the records.

The following data elements were agreed on for inclusion in a standard medication list:

• a patient’s personal information;

• details about allergies and other medicine-related problems; and

• current medicines, including amount used, frequency of use, and how each is taken, and information on who prescribed or recommended the medication.

The form will also have instructions for use, as well as a place to enter when and by whom the list was last updated. The ASHP is looking forward to a time when a patient’s pharmacist inside the hospital and in the community can easily communicate to discuss medications.

ASHP President Cynthia Brennan, PharmD, said the group also wants to make sure the list is as portable as possible, which may mean different things to different members. For example, some people may want it on a standard piece of paper, while others prefer something the size of a credit card.

The conference participants recognized that there are numerous hurdles to clear before a standard format can be adopted nationwide, according to Daniel J. Cobaugh, PharmD, the foundation’s research director. Members listed concerns about accuracy, privacy and security, ease of use, and the need to seamlessly integrate the format into current workflows.

Following the format’s launch, the group plans to study how the list is being used and its impact on patient care, safety, and economics.

The effort is an outgrowth, in part, to a national push for greater medication safety. An Institute of Medicine (IOM) report on preventing medication errors estimated that “on average, a hospital patient is subject to at least one medication error per day.” The IOM has said thousands of people die each year from adverse drug events, and those mistakes alone cost the nation millions of dollars in medical care.

“For medication safety, consumers and providers [including physicians, nurses, and pharmacists] should know and act on patients’ rights; providers should engage in meaningful communication about the safe and effective use of medications at multiple points in the medication-use process; and government and other participants should improve consumer-oriented written and electronic information resources,” the IOM said.

The ASHP effort also relates to the campaign for “medication reconciliation” in healthcare facilities, including The Joint Commission’s new standard for such reconciliation. According to an article from the Institute for Healthcare Improvement, “Reconciliation is a process of identifying the most accurate list of all medications a patient is taking—including name, dosage, frequency, and route—and using this list to provide correct medications for patients anywhere within the healthcare system. Reconciliation involves comparing the patient’s current list of medications against the physician’s admission, transfer, and/or discharge orders. Experience from hundreds of organizations has shown that poor communication of medical information at transition points is responsible for as many as 50% of all medication errors.”

As more companies get involved with developing PHRs, Cobaugh said it’s important that the ASHP get the word out about its work on a standard format so these companies can integrate it into their electronic structure. He said the organization also hopes that increasing consumer awareness of medication lists will be a step toward an increase in PHR use.

In the meantime, Cobaugh said, the ASHP will also be involved with the electronic health record standardization processes driven by Health and Human Services (HHS).

And, indeed, within a few days of the ASHP conference, the HHS structure on HIT was accepting standards for a medication list within an electronic PHR, a step meant to bring a standard electronic list closer to reality.

The Health Information Technology Standards Panel (HITSP), under a contract with HHS, is selecting among the many standards and languages for transmission of electronic information. With more than 300 organizations participating, its choices relate to and feed into the certification process for electronic health records. Those choices are expected to eventually become the choices nationwide, if only because the government programs, including Medicare, will relate to programs that are certified.

At the June 12 meeting of the American Health Information Community (AHIC), the advisory group to HHS, HITSP presented standards for communication in a PHR, including a medication list.

John D. Halamka, MD, MS, HITSP chair, referred to the standard as replacing the clipboard, “the idea that you would have demographics, medications, allergies, and specific patient care preferences like advance directives in an interoperable electronic document that could be stored in a personal health record and be transportable.”

He said its development required a “historic” collaboration among such groups as the ASTM standard-setting organization Health Level Seven (HL7), Accredited Standards Committee X12, and SNOMED to “incorporate all the best of all those organizations in terms of transmitting content and technology to create a parsimonious set of standards for the PHR functions.

“It required one of the very first-rate acts of harmonization within HITSP,” said Halmaka. He explained that the ASTM has a continuity-of-care record, what he called a clinician-driven construct that describes patient data that travels between caregivers or is used in a PHR. On the other hand, HL7 has a clinical document architecture, a detailed, terminology-based, controlled way of describing a document that is commonly used in hospitals.

To leverage the strength of both standards, he said, HL7 and the ASTM worked collaboratively to create the continuity-of-care document for the HITSP process. It will be implemented in several vendor systems over the coming year.

“It meets the tests of using a clinician-driven set of data but also controlled vocabularies,” usable by all stakeholders, said Halamka.

He also presented completed standards for biosurveillance and laboratory results within an electronic health record.

Also important to PHRs—and medication lists within them—will be HITSP’s next major deliverable: an opinion on privacy and security standards, due this October, which Halamka said will enhance many current standards. “It’s not the role of HITSP to make privacy policy,” he said, noting that it is the responsibility of the AHIC workgroup on security and privacy and other organizations. “But we can come up with security standards that help enforce all the variations of privacy policy,” including common mechanisms to audit lookups, common means of authentication and access control, and even common measurements of time.

In addition, among the standards HITSP is selecting this year is a medication management construct to be used in an actual electronic health record—that is, a record controlled by healthcare providers rather than consumers. That set of standards will include medication reconciliation, ambulatory prescriptions, and contraindications. Halamka told HHS Secretary Michael Leavitt he expects to present some “low-hanging fruit” on the medication management standard in October.

The HITSP rounds of choosing communication standards is expected to continue for years to come, with standards for various sorts of transmissions selected. In terms of medications, standards that may be set in 2009 and beyond include vaccines, medical errors, patient-reported outcomes, linkage to FDA structure product labeling, and ordering, prescribing, and dispensing.

Information on the HITSP Consumer Empowerment standards is available at www.hitsp.org.

— Kathryn Foxhall is a freelance writer in the Washington, D.C., area. She covers health informatics, public health, health policy, reimbursement, mental health, and other issues.