The following discourse focuses on Medication Safety in the Electronic Heath Record, especially in the Hospital setting.
Pharmacists have long been the agents of one of the most highly regulated professions. The Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), state Boards of Pharmacy and the Drug Enforcement Agency (DEA) all dictate how medications will be controlled. The main reason for the governance and oversight is that medications are dangerous. Pharmacists spend years in school and residencies, and dozens of hours of continuing education each year, to be the experts in medications and help other health care professionals and patients use medications safely, effectively, and efficiently. Our regulatory partners provide the authority we need to put safeguards in place and continually monitor various processes until a medication can safely reach and be used by patients. With all of this focus on safety, it seems that we need to add another agency, the Office of the National Coordinator for Health Information Technology (ONC).
One of the many reasons for Meaningful Use (MU) was to decrease the number of medication errors related to the misinterpretation of medication orders and prescriptions. Over years of analyzing medication errors related to handwritten physician orders and prescriptions, the pharmacy profession, in conjunction with the Institute for Safe Medication Practices (ISMP), developed a set of standards to help minimize errors. Some of these standards include very simple but effective measures, such as not using abbreviations, never using trailing zeros after decimals, always using leading zeros before decimals, abandoning Latin, and for drugs dosed by weight — writing the weight-based dose rather than the final dose (i.e. mg/kg or mcg/kg/min).
In the hospital setting, pharmacists were one of the first to use computerized systems to translate the traditional handwritten physician order to an electronic medication administration record (eMAR). Today, one of the pharmacist’s main tasks continues to be ensuring that nurses have clear instructions on how, and when, to administer medications to the patient, and what to monitor after administration. We also review drug regimens to make sure drugs and dosages are appropriate and safe for the specific patient. Some of these processes are appropriate for a computer to perform such as allergy checking and weight-based dose calculations. Electronic systems can also put safeguards in place such as hard-stops for certain interactions, restricting specific drug orders to appropriate routes of administration, and assuring that essential monitoring labs accompany drug orders when necessary. In fact, EHRs have now been in place long enough that there are those we can point to as having best-practices in place for computerized physician order entry (CPOE) of medications.
When Meaningful Use was first created, the idea was that basic foundational criteria would allow fairly simplistic Electronic Medical Records / Electronic Health Records to receive certification. As the program matured and evolved, these EMRs / EHRs were expected to improve in functionality and capabilities. As a Pharmacist working in hospitals well before the MU program was conceived and still working in hospitals today, I can unequivocally state that the evolution of pharmaceutical capabilities of EHRs were not appropriately scoped as part of the meaningful use program, and that this oversight puts our patients in danger. Currently, the only criteria for CPOE of medications in an EHR is that medications can be ordered and modified electronically, with the option of being able to enter a reason for the medication. Unfortunately, there are many substandard EHRs that have been certified by the ONC because they meet this minimalistic criteria, but that do little (or nothing) more to address medication safety issues. If a hospital elects to purchase and use one of these substandard EHRs because they cannot afford one of the others that has striven to enhance and improve functionality to make a safer system, they put both their patients and their health care professionals at risk of serious medication errors — all due to a lack of clear communication. This usually, if not always, happens in the vulnerable population of small rural hospitals. Health care professionals that elect to work in the rural small hospital setting should not be relegated to utilizing a substandard, frustrating and unsafe system.
It is imperative that the ONC establish a much higher set of standards around pharmaceutical management and medication safety as part of their standards and certification process. As an example, the ISMP will soon publish their Guidelines for the Safe Electronic Communication of Medication Information: safe presentation of drug nomenclature and dose expressions (the draft can be viewed at ISMP.org). This highly respected, non-partisan, non-lobbied group has created the tools, and ONC should adopt these standards as essential components of electronic systems. This would not be unprecedented, because ONC did adopt requirements for a standard vocabulary (think SNOMED). In addition to these guidelines, best-practices based on what is currently available in some of the more highly utilized EHRs should be used to develop minimum standards for functionality related to the ordering of medications. In regards to medications, EHRs should utilize sophisticated standardized drug databases for drug information that require minimum customization. If I, as a pharmacist, by regulatory law, must check every tablet that leaves the pharmacy, why is a non-pharmacist allowed to “build” the medication drug database of an EHR and then deploy that product to be mass used?
EHRs must also be validated and certified by subject matter experts that have experience as end users. Accreditation agencies need to incorporate a review of how the EHR is used by the facility. If an EHR does not meet these standards it needs to be decertified and facilities utilizing decertified EHRs will need to find a way to switch. These practices will cull substandard EHRs from the market as well as prevent hospitals from selecting a product that cannot prove it meets this much higher and appropriate set of minimum standards.
Finally, EHRs need to be intuitive and all function in much the same way so that health care professionals can easily transition between facilities utilizing different systems, and so that they don’t have to spend time “nuancing” the system to communicate exactly what they want for their patient. The idea that every hospital has to customize their EHR also needs to be replaced by the option of some “out of box” systems. Smaller hospitals just do not have the monetary and human resources to customize and maintain sophisticated EHRs; but they should still have access to these to provide the best patient care and allow their health care professionals access to good tools.
Unfortunately, we have seen some of the most innovative companies in the world begin to undertake the challenge of building these new systems, only to see them quickly drop the idea (Google Health, Microsoft Amalga). This has created an environment where subpar system can still demand prices in the millions of dollars for software unable to effectively enable provider-to-provider communications.
We all will be patients in a hospital or have a loved one in the hospital at some point. At the very least we should imagine that it is us or our loved one in the hospital bed. How can we make the leap into a reality of a sophisticated and safe EHR available to all health care institutions and professionals, a reality where every patient accessing health care in every possible venue can know that their nurses, physicians, pharmacists, respiratory therapists, lab specialists, radiologists, physical therapists, dieticians, and those behind the scenes in coding and accounting are not being hampered by inefficient, clunky, unsafe systems?
For the love of our patients, we need to raise the bar of the EHR.