As drug-resistant superbugs and increasingly virulent viruses menace the medical world, patients face a threat that was supposed to die with the advent of the disposable syringe 150 years ago: dirty needles.
When seven people arrived at a Delaware hospital in March with drug-resistant MRSA infections, the similarities were alarming.
All of the patients had the same strain of MRSA, all had the infections in joints, and all had gotten injections in those joints at the same orthopedic clinic in a three-day span. State health officials found that the clinic had injected multiple patients with medication from a vial that was meant to be used only once, spreading the MRSA bacteria to a new patient with each shot.
A month later, three patients in Arizona were hospitalized with MRSA infections, also following shots at a pain clinic. Again, state and county health officials tied the cases to the injection of multiple patients from a single-dose vial. A fourth shot recipient died; investigators noted that MRSA "could not be ruled out" as a cause.
In July, more than 8,000 patients of an oral surgeon in Colorado were advised to get tested for HIV, the virus that causes AIDS, and hepatitis after state health investigators found that his office reused syringes to inject medication through patients' IV lines. Six patients have tested positive for one of the diseases.
Since 2001, more than 150,000 patients nationwide have been victims of unsafe injection practices, and two-thirds of those risky shots were administered in just the past four years, according to data from the U.S. Centers for Disease Control and Prevention. The errors led to at least 49 disease outbreaks, a USA TODAY examination shows, and a trail of victims suffering with potentially life-threatening bacterial infections, such as MRSA, and sometimes fatal viruses, such as hepatitis.
"You just feel betrayed, vulnerable," says Evelyn McKnight, 57, who contracted hepatitis C a decade ago while being treated for cancer at a Nebraska oncology clinic. The virus required six months of debilitating drug treatment on top of her chemotherapy, and it could re-emerge at any time.
"People think, 'This can't happen in the United States; this is a Third World thing,' " adds McKnight, who heads HONOReform, a foundation that advocates safe injection practices. "Unfortunately, it happens on a regular basis, and it affects a lot of people, families, communities."
Without question, the overwhelming majority of the hundreds of millions of injections administered annually in hospitals, nursing homes, clinics and doctors' offices are done safely and without incident. But a significant percentage of clinicians -- some studies suggest more than 5% -- don't follow accepted safety standards.
That translates into a lot of bad shots.
"It's a huge issue. ... It makes us crazy," says Michael Bell, the CDC's associate director for infection control. "We're trying to eliminate a range of harms in health care -- high-level, complex challenges -- and we look behind us and these basic, obvious, completely preventable problems are still occurring. ... It really comes down to a matter of greed, ignorance or laziness."
USA TODAY reviewed state and federal outbreak reports, regulatory records and court documents to gauge the scope and impact of unsafe injection practices. The newspaper also interviewed public health officials, doctors and nurses -- and victims. Key findings:
• The CDC's official tally of 150,000 people who were affected by unsafe injections likely represents a fraction of all cases. Although that figure comprises all of the patients who got bad shots -- including those who weren't sickened -- it's ??based only on incidents that are reported, and many are not. Symptoms from injection-related illnesses, such as hepatitis, can take years to emerge, so many cases are not traced back to their true cause.
• Federal and state data show that unsafe injections are more common in clinics, smaller outpatient facilities and long-term care centers than in acute care hospitals. Some of the biggest illness outbreaks linked to reuse of syringes or the injection of multiple patients from single-use vials have occurred at stand-alone clinics, such as oncology and endoscopy facilities, or outpatient surgical settings.
• Many clinics and other outpatient facilities with suspect injection records operate in a regulatory gray area with little oversight. Concerns about injection practices in those settings often are the purview of state medical boards, which generally lack the regulatory authority or investigative resources of health departments. Few states have passed laws to address concerns about injection practices in such facilities.
"The volume of poor (injection) practice is very large and unmonitored, and I really do think it's a huge problem that the country is facing," says Neil Fishman, an infectious-disease specialist and associate chief medical officer at the University of Pennsylvania Health System. "It is, in some respects, a hidden epidemic ... (and) the oversight is very weak."
Henry Chanin and his wife waited a lifetime to see the ruins of ancient Greece, but when they finally got there in the summer of 2006, the ever-fit headmaster of a private school couldn't muster the energy to climb the Acropolis of Athens. Days later, they cut short their trip and went home.
On the flight back, Chanin's wife looked at him and gasped. "My God," she said, "you're yellow."
Chanin had felt increasingly lousy in the weeks after a routine colonoscopy at the Endoscopy Center of Southern Nevada, a clinic near his Las Vegas home. Within 24 hours of returning from Europe, he was diagnosed with hepatitis C.
Chanin, 64, was a victim in one of the nation's worst injection-related health scares.
Investigators concluded that the endoscopy center reused syringes to draw anesthetic from vials that were used for multiple patients. In early 2008, the state notified 50,000 patients who had visited the clinic over several years that they should be tested for hepatitis and other ills. Warnings also went to 13,000 patients from a sister clinic.?
Chanin's hepatitis required a brutal regimen of drug treatment, leaving him covered with rashes, crippled by headaches and nausea, too weak to walk more than a few paces. The hepatitis is in remission, but he still suffers joint pain and can't handle strenuous activity -- he has given up morning dog walks and sometimes needs a golf cart to get around his school's campus.
"I'm not cured, but the virus is inactive, so I'm not in danger of having my liver eaten up," Chanin says. "I'm actually lucky -- there are others whose lives have been smashed, who went through the treatment, twice, and it didn't work. ... They're in need of a liver transplant; it's not treatable."
In all, the state identified 115 patients with hepatitis, but the official toll is just nine -- those whose infections were tied absolutely to the bad injections through genetic testing. The other 106 cases are listed by the state as "possibly linked."
"Although these (106) patients did not report any major risk factors for hepatitis C infection," the state concluded, "the clinic's role as the source ... cannot be confirmed."
The endoscopy center and its sister clinic were closed in the wake of the outbreak; many patients, including Chanin, filed successful lawsuits seeking damages.
Measuring the problem
It's hard to quantify the impact of unsafe injections.
Given the challenges in linking hepatitis and other ills to injections that might have occurred years before a patient shows symptoms, there's little hope of pinning down the true number of victims.
"We think the outbreaks we've seen are the proverbial tip of the iceberg," says Joseph Perz, an epidemiologist who heads the CDC's injection safety program. "Unless there are two or three cases, a cluster of patients who all have had the same health care exposure," he adds, illnesses linked to bad injections are "easy to miss."
So public health experts are focusing more on the front end: figuring out how many people are administering bad shots.
In an anonymous 2010 survey of 5,446 clinical personnel who administer injections, 6% said they "sometimes or always" use single-use medication vials to draw shots for more than one patient -- a practice that violates CDC infection safety protocols barring repeated shots from a single-use vial once its sterile seal is broken. In the same survey, published in the American Journal of Infection Control, 1% of respondents reported reusing syringes on multiple patients.
"Even the small percentage of health care providers that were identified as not complying with recommended practices is alarming," the study reported.
The big problem -- drawing multiple doses of medication from single-use vials -- often stems from misunderstandings about infections and a desire among clinicians to avoid wasting drugs, says Gina Pugliese, an infection control specialist who led the survey for the Premier Safety Institute. The institute is an arm of Premier health care alliance, a network of 2,700 hospitals and health systems.
Often, a drug might come in vials no smaller than, say, 10 milliliters, Pugliese says, but certain procedures require no more than 2-3 ml. Some clinicians believe it is safe to draw multiple doses from such a vial, either using the same syringe for the same patient, or using different syringes for different patients, she adds. But both practices violate infection control protocols.
The fact that 1% of clinicians reuse syringes, often after swapping out the needle, is "more surprising," Pugliese says, noting that the practice, which some clinicians see as a way to save time or money, has long been identified as an infection risk.
The pharmaceutical industry could help by manufacturing drugs in vial sizes that better suit doctors' requirements, Pugliese says. But the most immediate need is better education of clinicians on best practices for reducing infection risks.
"There are a lot of misconceptions about (injection safety) based on old practices that haven't necessarily kept pace with the science," she adds.
Falling through the cracks
The physician-owned oncology clinic where Evelyn McKnight got hepatitis typifies the sort of facility where injection problems are most common.
A USA TODAY analysis of CDC records on injection-related disease outbreaks shows that at least 80% occur in doctors' offices and outpatient clinics, from pain management and endoscopy centers to alternative medicine operations that provide services such as vitamin injections.
Many of those facilities are not subject to inspection by the U.S. Centers for Medicare & Medicaid Services (CMS), which oversees hospitals and surgical centers that participate in the federal insurance programs for the elderly, poor and disabled. And they generally don't seek the independent accreditation obtained by larger health care facilities.
"The lack of oversight in non-hospital settings is a big gap in the regulatory environment," McKnight says. "I think the American public would be surprised that pharmacies and restaurants, which have inspections of their facilities, are more closely regulated than a lot of these clinics."
McKnight was one of 99 cancer patients who contracted hepatitis from oncology treatment at the Fremont (Neb.) Cancer Center from 2000 to 2001. Investigators found that staff reused syringes to draw saline from a single bag and flush multiple patients' IV ports. The clinic owner left the country before the investigation was complete.
"Six of our 99 (patients) that we know of died from hepatitis, not from their cancer," McKnight says, noting that the outbreak was particularly heartbreaking because it hit people already fighting for their lives. "The treatment is terrible -- worse than chemotherapy, and I've had a lot of chemotherapy."
McKnight says patients can help protect themselves by learning about safe injection practices, asking clinicians what sort of infection control measures they employ, and even asking to watch as syringes are loaded before getting a shot.
Meanwhile, several states have responded to injection-related disease outbreaks by passing laws that require better training on injection-safety measures.
• North Carolina began requiring all health care facilities to have designated staff trained in safe injection practices in 2009, after seven hepatitis cases were tied to unsafe injections at a cardiology clinic where as many as 1,200 patients were put at risk.
• New York passed a law in 2008 requiring the health department to issue new injection safety rules for all health care facilities after several hepatitis outbreaks were linked to bad injections, including the infection of 19 patients at an endoscopy clinic.
• Nevada in 2011 began requiring all health care professionals to certify their knowledge of safe injection practices as a condition of licensure after the hepatitis outbreak that sickened Henry Chanin.
Public health officials generally support new education and training requirements, but many believe that fundamental regulatory gaps still need to be addressed.
The dividing line for determining whether a clinic is subject to federally required inspections by states or CMS is if it performs surgery and is certified by Medicare as a surgical center. So a pain management center or an oncology clinic often would not be subject to that oversight. Instead, those facilities would be regulated more like a doctor's office, which might do some surgical procedures but typically would not be considered a surgical center. And supervision of those facilities often falls to state medical boards, which generally don't do inspections.
Even a clinic that does perform surgical procedures routinely, such as an endoscopy clinic or a plastic surgery center, could avoid oversight if it opted not to be certified by Medicare.
"A lot of procedures can be very safely done in (a clinic), often more conveniently for a patient and at far less cost, but there is a gap in terms of the ability to inspect and regulate," says Paul Jarris, executive director of the Association of State and Territorial Health Officials. "When do these sites reach a point where more regulation would be advisable? It's something state legislatures and health departments need to look at."
But Jarris, who served previously as Vermont health commissioner, cautions that states can't put more responsibility on health departments without providing resources to support the added work.
Meanwhile, at least one state has opted for a different route.
After a dermatologist in Grand Rapids, Mich., was found in 2008 to have put 13,000 patients at risk of hepatitis and other illnesses by reusing syringes, victims raised concerns because no criminal penalties were available for such practices. Lawmakers responded in 2010 with a law that imposes felony penalties for health care providers who "knowingly reuse/recycle a single-use device" for any sort of injection.
The penalty: up to 10 years in prison or a fine of up to $50,000.