October 2013 - for a PDF copy of the published version go HERE.
Pharmacies and Their Vendors Worry About Quality
The hospital drive to implement health
information technology (HIT) systems, driven in good part by Medicare and
Medicaid incentives (and penalties), has certainly affected pharmacy systems,
and will continue to do so as the definition of "meaningful use" is
expanded to incorporate more required medication tasks. So anyone who works in
a hospital pharmacy ought to be interested in how the federal government regulates
these new technologies, be they hardware or software. Retail pharmacies, too,
even though they are not being pressured by incentives, are concerned about how
any regulation would affect mobile
medical devices such as glucose
monitoring/diabetes management, at home hypertension monitoring/management,
medication management, and medication reconciliation at transitions of care.
Pharmacy organizations such
as the Pharmacy e-HIT Collaborative are communicating with a work group within the Department of Health and
Human Services (HHS) Office of the National Coordinator for Health Information
Technology (ONC) which will be making HIT recommendations to Congress
imminently. That report will provide directions to the Food and Drug
Administration (FDA).
Surescripts, too, is
concerned about the failure of some pharmacy systems vendors to police the
quality of their products. Surescripts provides the e-prescribing electronic
backbone which software vendors plug into. Those vendors sell plugged-in
e-prescribing systems directly to end-user pharmacies. David
Yakimischak, General Manager, E-Prescribing, says the company has worked hard
to encourage its vendors to adopt quality programs leading to fewer pharmacy
errors. "Vendor responsiveness has been relatively random," he
explains. "Quality/patient safety performance does not appear to play
heavily in end-users’ purchasing decisions. Our conclusion is that in the absence
of new incentives and penalties, there is currently little or no business case
for vendors to make significant investments in high quality patient safety
programs."
The FDA is under a congressionally-mandated
deadline of January 2014 to produce a regulatory framework for HIT. The key issue is
whether the FDA should be allowed to regulate all HIT as it does medical
devices. Or should some HIT, especially software where pharmacists and
physicians interact with a system to make clinical decisions or observations,
even be regulated at all. There are those who think systems requiring clinical
intervention should be certified, not regulated, by a non-federal body such as
The Joint Commission, with that certification process overseen by the ONC. The
ONC already has a few years of experience certifying HIT eligible for
incentives (which go to the purchasers, such as hospitals) decreed by the 2009
stimulus bill. "The ONC is well positioned to coordinate oversight among
these various organizations to ensure patient safety, prevent overlap and
continue to foster innovation and adoption of health IT by providers," states
Ann Richardson Berkey, Senior
Vice President, Public Affairs, McKesson Corp. She says organizations such as
the National Committee for Quality Assurance (NCQA), The Joint Commission or
URAC have track records in the rigorous accreditation of healthcare software.
The American Hospital Association (AHA) thinks
products should be regulated based on the risk they pose to patients. Key factors
to be considered include the potential for harm, the extent of harm, and the
extent to which software is automating and or guiding clinical decision-making.
"For example, when drug dosage data are sent from an order entry system to
a pharmacy information system, it is crucial for safety that both the data
points and their units of measure are accurate within each system and across
systems," says Linda E. Fishman, Senior Vice President, Public Policy
Analysis & Development, AHA.
Last February,
the Bipartisan Policy Center, a think tank of sorts meant to meld Democratic
and Republican views, produced a report called An Oversight Framework for Assuring Patient Safety in Health Information
Technology. It stated: "The FDA’s current regulatory approach for
medical devices is generally not well-suited for health IT." The report recommends
that HIT products be divided into three categories according to the relative
risk to patients and the opportunity for clinical intervention. Those where
there is no or little opportunity for clinical intervention represent a higher
potential risk of patient harm. Such devices are currently regulated by the FDA
as Class I, Class II, or Class III medical devices. The FDA would continue to
regulate these devices.
The
lowest risk category would be administrative software which supports
the administrative and operational aspects of healthcare but is not used in
direct delivery of clinical care. Population analytics, back office billing
systems, claims payment systems, and prescription
drug refill reminders are all examples of software that are not used for
patient specific treatment or diagnosis. The BPC recommends no additional
oversight for this category.
The middle category
would include products which can be used to recommend a course of care; call
this category clinical software. Very few participants in the debate, at least
on the industry side, think this category should be regulated by a federal
agency.
Meanwhile, the
ONC's ability to translate its considerable HIT experience into political
weight in any upcoming battle with the FDA over new regulations is compromised
by the absence of a National Coordinator, given the departure of Farzad Mostashari, M.D. The
position needs to be filled quickly, and for a lot of reasons.
