An investigational drug reduces constipation among patients taking opioids for noncancer pain, according to two phase-III, industry-funded studies reported in the New England Journal of Medicine.

The trials, conducted in the U.S. and Europe, together enrolled nearly 1400 adults who had been taking an oral opioid for noncancer pain for at least 4 weeks and had confirmed opioid-induced constipation. Patients were randomized to 12.5 or 25 mg/day of naloxegol, a peripheral μ-opioid receptor antagonist, or placebo for 12 weeks. Response was defined as three or more spontaneous bowel movements per week and an increase in bowel movements over baseline.

In both studies, patients taking 25 mg of naloxegol had a significantly higher response rate than those taking placebo (roughly 40% vs. 30%). The 12.5-mg dose was significantly better than placebo in only one of the studies.

Adverse events were highest in the 25-mg group and were most often gastrointestinal.

Hospitals and other healthcare organizations need to do a lot more than what they’re currently doing to guard against drug diverters and catch them before they harm patients and themselves.

Federal health officials have sounded an alarm this week about a group of healthcare workers who are surely harming patients somewhere this very minute, engaging in behaviors about which most hospital officials are unaware or choose to ignore.

These are drug-addicted healthcare workers who divert injectable drugs and, in the process, contaminate the syringe and infect patients for whom the drugs were intended, depriving the sick of the sedation they require.

The problem is huge, it’s growing, it’s often swept under the rug or ignored, and we only know about the tip of the iceberg.

That’s the scary warning from Melissa Schaefer, MD, medical officer, and Joe Perz, prevention team leader, for the Division of Healthcare Quality and Promotion at the Centers for Disease Control and Prevention.

Perz said that hospitals and other healthcare organizations need to do a lot more to guard against drug diverters to catch them before they harm patients and themselves. But so far there just hasn’t been much interest.

“The tendency has been first of all, to not look for a problem. And then, when a problem presents itself, a common approach is to deal with it as discreetly as possible. Unfortunately that ignores the laws and regulations that require prompt reporting of diversion…We have to overcome this idea that it’s somehow optional because it’s not optional to report when theft or a loss of a controlled substance is identified.”

A Bigger Problem Than Perceived

In a paper published Monday in Mayo Clinic Proceedings, Schaefer and Perz report findings from their extensive review of CDC records, including unpublished reports, to crunch some numbers. They’ve concluded that healthcare worker “tampering” with patients’ medications has resulted in 118 patients infected in the last 10 years in six episodes, more than expected.

Of those six incidents, four have occurred since 2008, affecting 84 patients and indicating a mushrooming problem. For the healthcare facilities involved, the workload was enormous and devastating to institutional reputations. In total, some 30,000 patients put at risk by the four most recent incidents had to be contacted for testing, and had to deal with the emotional and practical repercussions of possible exposure to infection.

Perhaps best known is the nightmare of David Kwiatkowski, a traveling catheterization lab technician now serving a 39-year prison term. He was convicted in December, 2013 of stealing the drug fentanyl from syringes he first used on himself. His theft and disregard for patients transmitted his hepatitis C infection to some 45 unsuspecting patients undergoing procedures, including one who died.

Kwiatkowski, had worked in as many as 12 hospitals in eight states, though suspicious behavior prior to his capture went unreported. Finally in 2012, a cluster of infections at a single, small facility led investigators to his employment at the 100-bed Exeter Hospital in New Hampshire.

This week, to announce its call for more awareness and hospital-based drug diversion prevention programs, the CDC launched a website devoted to the topic of healthcare worker drug diversion. It explains that theft of a controlled substance by a drug diverter can result in:

·Substandard care delivered by an impaired provider,

·Denial of essential pain medication or therapy, and

·Risks of infection with hepatitis or bacterial pathogens.

As Serious as an SSI

Perz believes hospitals should start thinking of drug diversion as an adverse event as serious and common as a surgical site infection, The rate for those approaches 1% in some hospitals and drug diversion is likely just as common, he says.

The 118 incidents he and Schaefer reviewed, he says, are “clearly an underestimate of the true burden of patient harm that results from healthcare workers stealing controlled substances and tampering with opioids and other drugs. It struck Dr. Schaefer and me that awareness and appreciation of this issue and its magnitude are lacking.”

Perz points to estimates from the federal Substance Abuse and Mental Health Administration showing that more than 100,000 employed healthcare workers have substance abuse issues. And he references a survey of anesthesiologists in training last year that found 1% were caught or died from their addictions.

Happening Everywhere Controlled Substances Are Used

Kim New, who until recently was hospital manager of controlled substance surveillance at the University of Tennessee Medical Center, tells me that in that role, she apprehended—through diligent tracking—one or two addicted nurses per month for diverting drugs from patients.

“I think diversion of controlled substance medications intended for patients occurs at absolutely every institution that handles controlled substances —every nursing home, physician practice, and hospital, and it’s something that will happen at every institution regardless of what prevention efforts you put into place. It’s gone too far,” says New, now a drug diversion consultant and blogger for the CDC’s new website.

The best thing a healthcare facility can do, to the extent they are capable, she says, is to “identify it quickly and respond appropriately.”

But hospitals have many reasons and incentives to look the other way. In talking with experts, I counted at least six:

Plausible Deniability

·The time between the patient’s exposure to the drug diverter’s theft and appearance of symptoms and diagnosis may be years.

·Linking the patient’s infection back to the drug diverting healthcare worker requires genetic analysis that may require sophisticated and costly testing.

·If symptoms of infection do appear relatively soon after the patient is discharged, they may be written off as stemming from the patient’s original medical condition that drew them to the hospital for care. Some patients die.

·Reporting to law enforcement and public health or state licensing agencies means assignment of hospital personnel and resources to conduct investigations of staff workers, which may lead to morale problems, especially for smaller hospitals.

·Negative publicity could cripple a hospital.

·Reporting can expose a hospital to lawsuits from patients even if they weren’t infected but merely exposed. Recent litigation has resulted in financial findings against hospitals accused of improper infection control and drug administration practices.

There are more, but the point is this: The weight needs to shift so it’s riskier to ignore the problem than to fight it.

Hospital Financial Survival at Stake

In an accompanying editorial in the same issue of the Mayo Clinic Proceedings, two anesthesiologists called the Perz and Schaefer paper “frightening,” as they expanded on the financial ramifications for each hospital where such an incident took place.

“When taken in aggregate, these experiences hint at the magnitude of potential hazards that disease transmission by drug diverters…creates for not only the patients but also the financial survival of the healthcare facility,” wrote Mayo Clinic anesthesiologists Keith H. Berge, MD and William L. Lanier, MD.

“The sum of awards against a given entity can potentially be an immense sum of money.”

And because every facility that handles divertible drugs “is at risk for an unscrupulous HCW not only diverting drugs but doing so in a manner that could harm patients and others, then the question becomes not ‘How can we afford a program to prevent and detect drug diversion by HCW’s?’ but instead ‘How can we afford to not have such a program.’ “

Errors slow productivity and frustrate everyone. So it’s tempting to chastise or quickly terminate employees who repeatedly make mistakes.

But don’t be so quick with that trigger finger. Employees make slip-ups for different reasons—miscommunication, carelessness, lack of training, unfamiliarity with the process and more.

Good management means finding out why mistakes occur.

First, determine the circumstances under which mistakes tend to occur. Are errors connected to certain tasks? Find how often an employee makes mistakes and whether other workers are involved. Then ask questions like these:

1.Do you feel more likely to make mistakes while working fast or juggling several things simultaneously? Determine whether the employee habitually makes errors under pressure.

2.Do you feel comfortable asking questions about assignments? Some employees believe questions signal incompetence.

3.Do you feel the need to always figure things out yourself when you don’t know what to do? You don’t want employees guessing.

4.Do you know when you make mistakes or do you find out afterwards? Self-awareness helps self-correction.

5.Do you feel comfortable reporting mistakes to management? You want to know they don’t try to hide slip-ups.

6.Do you sometimes feel you lack the job knowledge to avoid mistakes? Perhaps the employee feels that training is an issue.

7.Do you understand the instructions for tasks? Maybe the employee feels that explanations are unclear.

8.What do you think needs to be done to avoid repeating the mistake? Most employees will know.

Authors: Clarke H et al., BMJ 2014 Feb 11; 348:g1251

A small but substantial percentage of opiate-naïve patients were still taking pain medications 90 days after major surgery.

Annually, more than 200 million patients undergo major surgery worldwide. Many patients require treatment with opiates for moderate-to-severe postoperative pain; most quickly transition off of pain medications. However, the number of opiate-naïve patients who remain on chronic opioids postoperatively is unknown.

Researchers conducted a retrospective, observational study of older patients (age greater than 66) with no prior use of opioids who underwent one of nine major elective surgical procedures (cardiac, intrathoracic, abdominal, or pelvic) in Ontario, Canada, during a 7-year period. Among greater than 39,000 patients analyzed, 49% were discharged with opioid prescriptions, and 3% used opioids for >90 days following surgery. Type of surgical procedure was associated with opioid use, with intrathoracic procedures conferring the highest risk. In adjusted analyses, patient-related risk factors associated significantly with higher risks for prolonged opioid use included lower household income, specific comorbidities (i.e., diabetes, heart failure, and pulmonary disease), and use of specific drugs preoperatively (i.e., benzodiazepines, selective serotonin reuptake inhibitors, and angiotensin-converting–enzyme inhibitors).

Comment

Whether the results of this study are generalizable to other populations, such as younger patients or those most likely to use opiates preoperatively (e.g., patients with severe osteoarthritis), is unclear. Although the percentage of opiate-naive patients who become dependent on pain meds postoperatively is relatively low on an individual basis (3%), the population number of greater than 6 million represents a public health concern. Understanding specific surgical and patient risk factors that are associated with long-term use of opioids postoperatively will better define subgroups who warrant preventive interventions.