Cheap Black Market Antibiotics- Bad Choice for Uninsured

No Prescription for Antibiotics? No Problem
By HOWARD MARKEL - Contributor to The New York Times

Jose Martinez, a 29-year-old Dominican immigrant who runs a bodega on the Upper West Side of Manhattan, almost always manages to find whatever his customers need on his store's bulging shelves.

When asked for medicine for an infection, Mr. Martinez often reaches for a box of pills called Ampitrex, a brand name for the antibiotic ampicillin.

The pills sell for 50 cents each and are easily bought at bodegas on the Upper West Side and in Washington Heights, East Harlem, Brooklyn, Queens and the Bronx.

Under federal law, ampicillin, like all antibiotics, requires a doctor's prescription. But Ampitrex is made in the Dominican Republic, where it is readily available and smuggled in small quantities into the United States. It is then sold in small markets much like over-the-counter pain relievers.

''In my country you can go into any store and get antibiotics like this one,'' Mr. Martinez said. ''This Ampitrex, it's 500 milligrams and absolutely pure. For throat pain, infections, it works by the next day. One to two days tops. Once you feel better, that's it. You're done taking the pills.''

Carlota Hurtado, 69, of Washington Heights said that getting antibiotics without seeing a physician, or even a pharmacist, was easy. ''Once in a while, when I have been sick with a cold or a sore throat, I have gone into a bodega to buy antibiotics,'' she said. ''I know a lot of people who when they are sick do the same thing. I take them until I feel better. When the cold goes away, I throw the pills away.''

Easy access to antibiotics is now common in certain areas around the nation, especially in border states. Dr. Richard Besser, director of the Campaign for Appropriate Antibiotic Use for the Centers for Disease Control and Prevention, said the sales at bodegas were only part of a much broader problem involving antibiotic overuse in America.

Many health officials are increasingly concerned. Antibiotics are prescribed only for bacterial infections. They are ineffective against viruses. Different antibiotics are used for different types of bacteria, so merely taking one does not mean it will cure an ailment. Taking the wrong antibiotic may cause worsened infections or allergic reactions.

Most antibiotics need to be taken for 7 to 14 days. When taken for only a few days, the likelihood of a mutation in a bacterium's genetic structure is increased. These changes can make the germs resistant to the antibiotics meant to kill them.

Unlike folk remedies, some of which may be toxic but pose a risk only to the person taking them, antibiotic misuse has far wider ramifications. For example, until recently, ampicillin was the drug of choice for infections of bacteria called streptococcus pneumoniae, a common causes of pneumonia and ear infections. But according to the C.D.C. about 35 percent of the strains of this germ across the nation are now resistant to ampicillin.

Dr. Stuart Levy, a microbiologist and the author of ''The Antibiotic Paradox: How the Misuse of Antibiotics Destroys Their Curative Powers,'' published this year, described antibiotics as societal drugs. ''Their use by an individual impacts others in the society because of the drug's ability to affect the bacteria in that community and to propagate resistant germs,'' he said.

''Over-the-counter antibiotics are more likely to be misused,'' he added, increasing the likelihood of resistance and the spread of resistant bacteria to others.

This problem often begins as a local phenomenon, he said, but the resistant germs spread as people move from place to place.

Dr. Jaime Lopez-Santini, a physician at Settlement Health, a nonprofit clinic in East Harlem, says his patients tell him they can get any antibiotic they want. ''By the time they come to see me with a sore throat,'' he said, ''they have already treated themselves with antibiotics they purchased at bodegas.''

Pharmacists like Orlando Cueva of Morningside Heights try to warn customers of the dangers of self-prescribed antibiotics, but often with poor results. ''Many people come in and ask for antibiotics, and I tell them that it requires a prescription from a doctor,'' he said. ''But they say: 'No, it doesn't. I can buy them at any bodega.' ''

An East Harlem pharmacist, Godette Wallace, said, ''You have to understand, these are very poor people, and they don't have the money to see a doctor.'' As a result, he added, they have to find other ways to get medicine.

Elissa Maas, vice president of community health for the California Medical Association Foundation, which researches health care for the state, said her agency had seen ''an antibiotic underground,'' extending from the Mexican border to northern California.

''In our focus groups, Chinese and Russian immigrants, as well as Latinos, spoke about the relative ease with which they can obtain antibiotics at small markets, even swap meets,'' Ms. Maas said.

In El Paso, Salvador Balcorta, who directs the Faith Family Health Center, a community health and human services organization, says that many people in the United States are just beginning to experience a phenomenon that is part of daily life on the border. ''When you couple the problems of poor access to health care and poverty with the ease of self-medication, you have a much bigger problem,'' Mr. Balcorta said.

Dr. Jeffrey Brosco, a pediatrician who sees many Cuban and Nicaraguan patients in Miami, said it was not enough to ask what medicines a child was taking or if he was taking home remedies.

''We also ask if the child is already taking antibiotics and, specifically, which antibiotic, and how frequently they are taken,'' Dr. Brosco said. ''Amoxicillin is the most common, but I have seen many others. All are self-prescribed and easily purchased.''

While the practice is illegal, it is extremely difficult to control. Dr. David A. Kessler, the former Food and Drug Administration commissioner, who is now dean of Yale Medical School, said: ''F.D.A. 101 tells us that this is illegal. No question. It is being sold illegally and shipped into this country in ways that don't comply with our laws.''

But practically, he added, the agency cannot go to every bodega, although it can go after the company that makes these antibiotics if they are involved in their distribution.

In New York, the sale of Ampitrex and other antibiotics without prescription goes largely unchecked. Spokesmen for the State Health Department, the New York City Health Department, the Drug Enforcement Administration, the State Board of Pharmacy and the State Education Department's Office of Professional Discipline all said that while they occasionally reported complaints to the state attorney general's office, they neither seized the antibiotics nor apprehended those selling them.

The New York City Police Department said it rarely, if ever, arrested people for the sale of antibiotics.

Dennis Murphy, a spokesman for the Customs Service, said seizing antibiotics at the borders was not a high priority.

Dennis Baker of the office for regulatory affairs of the F.D.A. said:

''Even when a local or state regulatory authority moves in to close down these operations, they tend to move to another location. It's very difficult to get our hands around this.''

Infection Risk Linked to Premature Delivery

Each year in the United States, more than half a million babies are born prematurely, before 37 completed weeks of pregnancy. Many pre-term births are induced labor or cesarean delivery due to pregnancy complications or health problems in the mother or fetus, the premature rupture of membranes (PROM), or infections such as vaginal or urinary tract. But the trigger of almost half of all preterm births remains unknown. However, researchers suspect that an undiagnosed infection may be the trigger in a significant number of these cases.

To better understand the role infection plays in preterm birth, researchers at Stanford University in California studied samples of amniotic fluid saved from 166 women who went into premature labor at the Hutzel Women's Hospital in Detroit from 1998 to 2002. At the time, doctors used standard tests to check for signs of infection, but doctors David Relman and Dan DiGiulio used more sophisticated molecular testing known as polymerase chain reaction (PCR). They discovered that of the 113 women who delivered prematurely, 25 showed infection-those with the heaviest infection delivering the earliest. "We were surprised with the amount of unexpected bacteria we found in the fluid and the fact we encountered new species of bacteria," said Dr. DiGiulio.

Dr. Robert Goldenberg of the Drexel University College of Medicine in Philadelphia was not surprised by the results and suspects that as scientists continue to study amniotic fluid with improved techniques many more pathogens will be identified, according to ScienceNews. "We only know the names of relatively a few of all the bacteria that exist, and a lot of them are difficult to culture or can't be cultured with our current technology."

The researchers say this is likely their findings are an understatement, considering that the samples were so old the DNA in them had begun degrading. Currently, Dr. Relman and his team are studying fresh, rather than stored, amniotic fluid from 2,000 women who get routine amniocentesis in their second trimester. They hope that by identifying the infections before they induce preterm labor or birth, they "could potentially create a treatment for these infections and prevent a lot or possibly all of premature births."

Premature birth is a serious health problem. Premature babies are at increased risk of developing a wide range of health problems, as well as lasting disabilities, which include cerebral palsy, mental retardation, neurological, lung and gastrointestinal problems, vision and hearing loss, and learning disabilities. Premature babies often require care in a neonatal intensive care unit (NICU), whose specialized staff and equipment can deal with the multiple problems these ‘preemies' face.

The Stanford study was reported in PLoS One, the online journal of the Public Library of Science.

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Increased Scrutiny Has Hospitals Focusing More on Safety

By Keith Darcé
August 9, 2008

Sharp HealthCare executives have spent the past two weeks trying to reassure the public that their hospitals are safe amid news that recent lapses in management and medical care at Sharp Grossmont caused the deaths of at least three patients.

They're not alone in that challenge. Hospitals everywhere are vulnerable to human error, and they've all had to deal with patient-care crises.

In the past 16 months, state and federal regulators have named at least five hospitals in San Diego County with serious problems that contributed to the deaths of five patients, including those at Sharp Grossmont, and put hundreds of others in harm's way.

Since the California Department of Public Health began issuing fines in January 2007 for “immediate jeopardy” mistakes – those causing death or grave injury – it has penalized 39 hospitals statewide.

Local hospital administrators have strived to reduce errors by boosting training for their staffs, hiring more workers who focus on regulatory compliance and borrowing ideas from the airline industry, where workers contend with pressures and risks similar to those in an operating room or emergency department.

Health regulators and the public are paying more attention to the quality of patient care at hospitals:

California regulators are imposing fines as high as $25,000 on hospitals for each “immediate jeopardy” mistake that endangers patients. They're also publicizing the penalties.

In October, Medicare will stop paying for the cost of treating many infections and injuries caused by hospital errors.

Consumers, emboldened by the power of the Internet, are increasingly choosing hospitals based on quality rankings and reports.

The administrators said significant mistakes at their facilities generally have not increased over the years, but that scrutiny and prevention efforts have.

“I don't think there is any question that hospitals are more focused on quality and safety than ever before,” said Chris Van Gorder, president and CEO of Scripps Health, which operates four hospitals in the county.

Two of the network's hospitals – Scripps Memorial and Scripps Green, both in La Jolla – have suffered “immediate jeopardy” cases since last year.

The other facilities with such incidents include Sharp Grossmont, UCSD Medical Center in Hillcrest and UCSD's Thornton Hospital in La Jolla.

Besides handing out penalties, California health regulators are drawing the public's attention to big hospital mistakes by issuing news releases.

Starting in October, Medicare will stop paying hospitals for the cost of treating many of the mistakes their doctors and nurses cause.

And consumers concerned about the quality of their medical care can tap dozens of Web sites to compare hospitals.

Other policies are helping to create an overall carrot-and-stick approach to making hospitals safer. For example, Medicare and a growing number of private insurers base some of their payments on hospitals' ability to meet or exceed quality standards for patient care.

The elevated scrutiny is transforming the way many hospitals operate.

Teamwork has become the mantra among doctors and nurses, who traditionally have been divided by strict codes of hierarchy. Also, some hospitals have asked patients to join their systems of checks and balances.

At Thornton Hospital and the UCSD Medical Center in Hillcrest, surgery patients go through a checklist with their doctors and nurses before receiving anesthesia. Among other things, the list is designed to ensure that the right person has the right operation.

It was modeled after safety checklists that pilots use before flying.

“The culture of silence and the culture of secrecy that used to exist in hospitals is being stripped away,” said Memphis-based hospital consultant Stephen Harden, a commercial airline pilot and former Navy Top Gun instructor.

He helps hospitals, including those in the University of California system, and physicians apply safety practices from the aviation world to their health care settings.

The higher level of monitoring will push even the best medical centers to do a better job of preventing errors, said regulators and some hospital operators. But they also wonder whether heightened attention to each “immediate jeopardy” case will help patients make better decisions when choosing a hospital.

“It's difficult for consumers to judge whether a particular problem is isolated or whether it's part of a series of events,” said Ken August, spokesman for the state Department of Public Health. “Trying to decide the quality of care of a facility strictly from news stories is difficult at best.”

Sharp HealthCare's four hospitals have always done as much as possible to keep patients safe, said Nancy Pratt, the network's senior vice president of clinical effectiveness.

“Every health care organization wants to fix these things. It's not a lack of interest or effort,” she said.

But for decades, hospitals largely didn't face outside pressure to improve patient care.

In California, the shift kicked into high gear in January 2007, when state regulators began issuing fines as high as $25,000 for each serious safety breach. Regulators are developing rules to double that limit, and there is a bill in the Legislature to raise the maximum penalty even higher.

Nationwide, the current drive to minimize hospital mistakes dates back to 1999, when the Institute of Medicine issued its landmark report “To Err is Human.” The study estimated that 98,000 Americans die each year because of hospital and physician errors.

The recent increase in federal and state requirements for hospital patient care suggests that regulators aren't satisfied with the pace and breadth of change, said Roy Snell, CEO of the Health Care Compliance Association, which represents 7,000 professionals who manage regulatory compliance for hospitals and physician groups.

Most health care organizations are proficient at identifying lapses, Snell said, but they often fall short when correcting a weakness that requires changing well-established routines or punishing specific staff members.

Part of the problem is that the people charged with enforcement and disciplinary actions frequently come from the same ranks of doctors and nurses who make the mistakes, he said.

One solution is to transfer those duties to regulatory compliance specialists.

In a recent survey, about 52 percent of the compliance association's members said their responsibilities include helping ensure the quality of patient care, Snell said. That represents a major shift since the association was created 12 years ago, when almost none of the group's members dealt with quality assurance.

But some health care providers worry about giving oversight of medical care to people lacking clinical backgrounds. They said those individuals might not fully understand the complex and technical nature of hospital medicine.

“The idea is to improve patient care, not to punish doctors,” said Dr. Gary Vilke, who heads UCSD Medical Center's peer review committee.

An increasingly punitive regulatory system runs the risk of discouraging hospitals from disclosing mistakes, said Debby Rogers, vice president of quality and emergency services for the California Hospital Association.

“There's a balance of creating an environment where reporting (errors) is rewarded,” she said. “The last thing we want is for people not to report.”