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Double Check the Labels on Your Compounded Drugs
Tap Water Used with permission from ISMP TOO CLOSE FOR COMFORT The similarities between these two drug syringes makes them very easy to mix up if someone is in a hurry.

Drug shortages may be behind the increase in reports of look-alike compounded syringes according to the Institute for Safe Medication Practices (ISMP).

The recent drug shortage has hospitals and surgical facilities reaching out to unfamiliar compounders to obtain much needed medications. As the FDA does not have strict labeling requirements for compounded medications, facilities have been surprised by unexpected labeling on their usual prefilled syringes.

For example, some compounders do not use the standard USP labeling standards that require the strength per total volume be prominently displayed on the label with the strength per ml in parenthesis underneath. A facility reported finding the strength displayed differently on syringes of succinylcholine from two different compounders. One followed the standard labeling while the other displayed the strength per ml more prominently. This could lead to dosing errors if the strength per ml is mistaken for the strength per total volume.

Another compounder used the same color tamper-proof caps and syringe sizes for two different drugs, fentanyl and hydromorphone. Although the drug name is clearly displayed, someone in a hurry just looking at the cap color and syringe size could easily grab the wrong drug.

The "FDA should not allow products from compounders to follow different container labeling standards than commercial manufacturers, thus creating unsafe conditions," a recent ISMP newsletter says. The newsletter also calls on the FDA to convene an advisory committee to address the non-standard labeling and create guidance that requires all compounders to follow the same safety standards as commercial manufacturers.

JoEllen McBride, PhD

Opioid Misuse Among the Year's Top Safety Concerns
Cleaning Endoscopic TARGETED APPROACH Pain management strategies should be tailored to an individual patient's needs.

The current opioid epidemic, improper instrument reprocessing and ineffective communication among healthcare providers made ECRI Institute's annual top 10 list of patient safety concerns. The independent research firm in Plymouth Meeting, Pa., identified several key issues that could jeopardize safe surgical care:

  • #2 Opioid Misuse Opioid prescriptions given in the outpatient setting are contributing to the nationwide abuse crisis, but the problem impacts the entire continuum of care. ECRI says limiting the use of opioids is a multifaceted problem that requires healthcare providers in all clinical settings to base pain management strategies on a patient's individual need and set realistic expectations of the pain experience.
  • #3 Care Coordination A lack of effective communication among providers increases the risk of patient harm caused by preventable errors. ECRI says handoff tools, checklists and team huddles ensure vital patient information is shared among providers at every step of the care pathway.
  • #4 Workarounds Shortcuts in clinical settings based on habits or "the way things are done" in a facility put patients in jeopardy says ECRI, which suggests facility leaders encourage staff to speak up without fear of retribution if they see colleagues cutting corners and make sure policies and procedures are feasible in actual practice before requiring them to implemented.
  • #7 All-Hazards Emergency Preparedness ECRI says healthcare facilities must have plans in place for responding to the unexpected, including natural disasters, mass shootings and ransomware attacks.
  • #8 Instrument Reprocessing Failing to properly clean, disinfect and sterilize devices, instruments and flexible endoscopes is a growing concern. Facility leaders must ensure reprocessing areas have adequate staffing levels and the equipment needed to handle workloads, and make sure staff follow current reprocessing guidelines and manufacturers' instructions for instrument care.
  • #9 Patient Health Literacy Patients who don't know how to take active roles in their own care are at increased risk of serious harm. That's why ECRI suggests providers must do a better job of ensuring patients understand the directives they've been given, present educational materials in easy-to-understand formats and use clear and concise language when conducting one-one-discussions with patients.
  • #10 Leadership Engagement ECRI says patient safety initiatives are limited without investment from facility leaders. Risk managers can achieve leadership buy-in by recruiting champions who support patient safety initiatives from the frontline of care to the C-suite.

"The list does not necessarily represent the issues that occur most frequently or are most severe," says William Marella, MBA, MMI, executive director of operations and analytics of patient safety, risk and quality at ECRI Institute Patient Safety Organization. "Most organizations already know what their high frequency, high-severity challenges are. This list identifies concerns that have appeared in our members' inquiries, their root cause analyses, and in the adverse events they submit to our organization."

Daniel Cook

Health Literacy's Impact on Surgical Recovery
Surgical Recovery GIVE KNOWLEDGE Spending extra time educating outpatient surgery patients may improve outcomes.

Patients with lower functional health literacy (FHL) have poorer outcomes after undergoing day surgery, according to a new study. Yet, as more patients gravitate to ASCs where they must manage their own recovery at home based on written and verbal instructions functional health literacy is increasingly important.

The Swedish study looked at 704 patients undergoing day surgery from October 2015 to July 2016 and followed up with them 14 days afterward with a questionnaire survey (Swedish Quality of Recovery, SwQoR) about their recovery.

The study concluded: "Inadequate FHL (Functional Health Literacy) in patients undergoing day surgery was associated with poorer post operative recovery and a lower health-related quality of life." This was true in categories ranging from post surgical bodily pain to mental health.

The study defined FHL as "an individual's capacity to gain access to and to understand and to use" health related information. Of the 704 patients 223 (31.7%) reported "problematic" FHL while another 54 (7.7%) reported "inadequate" FHL. The authors cautioned that the study, a secondary study, unfortunately required all participants to have a cell phone despite evidence that patients without one are more likely to have low FHL. Nonetheless, "this is the first study that has examined whether there is any association between postoperative recovery and functional health literacy in patients undergoing day surgery," the authors note.

The authors recommend that day surgery centers spend more time providing guidance to patients with low FHL. "Surgical patients with low health literacy levels need extra time and resources before discharge for information and instruction regarding wound care and dietary changes, arranging home care needs, and managing anxiety regarding self-care," the researchers explain.

Richard Abowitz

InstaPoll: When Do You Disconnect Sequential Compression Devices?

After the surgery is complete, when do you disconnect SCDs? Tell us in this week's InstaPoll.

Only nonscrubbed surgical staff can wear their wedding bands in the OR, according to more than half (56%) of the 632 respondents to last week's poll. The results:

Can staff wear wedding bands in the OR?

  • yes 24%
  • nonscrubbed personnel only 56%
  • never 20%

Dan O'Connor

News & Notes
  • Surgical headgear accord reached The heated debate over whether surgeons should wear bouffants or skull caps during surgery appears to be over after representatives from several professional organizations representing surgery, anesthesia, nursing and infection prevention decided the clinical evidence is insufficient to support mandating that surgeons wear bouffants to cover their ears. AORN, which was part of the multi-disciplinary team summit last February, is revising its surgical attire guideline based on the meeting's collaborative discussions and a study that suggests disposable bouffants are the least effective barrier to microbial shed among the head-covering options. The new recommendation will be available for public comment from Jan. 2 to Feb. 22, 2019, and published in April 2019.
  • Does anesthesia lowers intelligence in young children? A study by the Mayo Clinic of the long-term impact of anesthesia on children under 3 found that even repeated exposure does not lower intelligence. The study tracked 997 people of whom 411 had no exposure before age 3; 380 of whom had a single exposure; and 206 children who had multiple exposures to anesthesia. Subjects were given neuropsychological testing at ages 8-12 or 15-20. "The primary outcome of intelligence quotient did not differ significantly according to exposure status," the study concludes. However, one area of concern, children who received multiple — though not single — exposures were reported to have slightly decreased processing speed and motor skills as well as more likely to have behavior and learning problems as reported by parents.
  • Complications after rotator cuff surgeryFor older patients, 1 or 2 out of every 100 will experience complications following rotator cuff surgery a study from the Hospital for Special Surgery in New York finds. Infections were the leading complication that required additional surgery, while heart failure and dialysis were the common risk factors found in most readmitted patients.