The recently released Consumer Reports’ Hospital Ratings of more than 1,000 U.S. hospitals highlighted the need to reduce hospital-caused patient harm. On a safety scale with 100 being the highest, only 158 hospitals received a score of higher than 60.
While many hospitals are making tremendous strides to improve the safety of patient care, issues such as miscommunication regarding medications and infections were cited as leading causes for the low scores. The report also highlights studies indicating that there is at least one medication error per day for every patient and that uncontrolled pain following surgery is common, resulting in longer hospital stays and reduced quality of life.
Particularly prone to malfunction and human error are the infusion devices used to administer medications to patients. Between 2005 and 2009, more than 56,000 adverse events and 700 patient deaths were linked to infusion pumps. During that same period, 87 unique pumps were recalled because of safety errors.
A subset of these pumps is used to deliver opium-like painkillers. These devices, referred to as intravenous patient-controlled analgesia (IV PCA), have been crucial to inpatient care. They allow patients themselves to control the delivery of their pain medications, improving treatment satisfaction and recovery results.
But there are also serious risks — a study on IV PCA reports that errors occur an estimated 407 times per 10,000 people treated in the United States each year. Much more must be done to improve pump safety and better patient outcomes.
As an academic physician specializing in pain management, I was often called as an expert witness for a number of cases along the West Coast, in which patients suffered injury or death from post-operative opioid infusion pumps.
Problems with IV PCA occur for a variety of reasons, including adverse side effects from typical opioids and infections from the required venous access, but a common and serious reason for these events involve human fault — pump programming errors and incorrect dosages.
Patient-controlled infusion pumps have been in use for 40 years, and while incremental improvements have been made, error rates remain unacceptably high — these preventable mistakes must be avoided for future patients.
Advocates are now working to address safety concerns and raise awareness of IV PCA risks, while innovators in the medical sector are improving pain management systems.
The Physician-Patient Alliance for Health & Safety (PPAHS) is one such advocacy group dedicated to improving health and safety through innovation and awareness, particularly in the use of PCA. The Institute for Safe Medication Practices, Anesthesia Patient Safety Foundation, National Patient Safety Foundation, and the Association for the Advancement of Medical Instrumentation (AAMI) have also come forward acknowledging the risks of infusion pumps.
In 2010, AAMI partnered with the Food and Drug Administration to sponsor two major multidisciplinary summits on infusion devices to identify and prioritize the most salient issues with this medication delivery technology.
The summits drew together a broad range of professionals and patients and emphasized the “five rights” of medication safety: right medication, right dose, right time, right route, and right patient.
Raising awareness of PCA dangers is an important step, but alongside these advocacy efforts, medical innovators must work to develop pain management systems that eliminate many of the risks of invasive programmable infusion pumps altogether.
I founded AcelRx with this vision in mind. Our investigational NanoTab PCA System – currently in the final phase of clinical testing – involves a self-dosed tablet administered under the tongue, eliminating the invasive route of delivery. The device is equipped with numerous safety features to ensure the appropriate patient receives the proper dosage.
Two years after the 2010 FDA summits and 40 years after the advent of IV PCA technology, limitations still exist in our efforts to provide safe and effective post-operative pain management. Initiatives to raise awareness of infusion pump dangers, in combination with efforts to develop safer delivery methods, are critical to improving both public health and individual outcomes.