Entries in Pharmacy (6)


Pharmacy Owner Takes Fifth in Meningitis Hearing

Chris Maddaloni/CQ Roll Call(WASHINGTON) -- The owner and co-founder of the New England Compounding Center, the pharmacy at the center of a deadly fungal meningitis outbreak, declined to testify before a congressional hearing Wednesday.

When pressed by members of Congress on his role in ensuring safe and sterile products, Barry Cadden invoked his Fifth Amendment right.

“On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States,” he said at the hearing in Washington, D.C.

The House of Representatives had subpoenaed Cadden to the hearing to address the outbreak that has sickened 461 people in 19 states and killed 32. The outbreak has been traced to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain made by Cadden’s pharmacy.

But the Subcommittee on Oversight and Investigations panel became clearly frustrated with the testimony of U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg.

Republican lawmakers noted inspections of NECC going back to 2002 that found sterility issues at the facility, and asked why the FDA had not taken action against the pharmacy.

“You are in charge of the FDA. You are the chief honcho. You’re the great Pooh-Bah of the FDA and I’m asking you, basically, could you have prevented this tragedy? And you are saying you can’t because you didn’t have jurisdiction?” said Rep. Cliff Stearns, R-Fla.

“I think it is very hard to know if any one action that we might have taken could have stopped this terrible tragedy,” Hamburg replied, adding that in her opinion, the FDA did nothing wrong.

The commissioner told the panel that her agency needed stronger authority over “compounding” pharmacies.

“The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take,” said Hamburg. She said there were “gaps” and “ambiguity” in the FDA’s authority, and described a “crazy quilt” of laws.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. NECC, however, acted more like a manufacturer by filling thousands of prescriptions and shipping across state lines causing confusion in the FDA’s jurisdiction.

Republicans were visibly irritated at Hamburg’s lengthy responses to their yes or no questions, at certain points even chastising the FDA commissioner for her responses.

“Can you ever give straight answer to a question?” Rep. Joe Barton, R-Texas, asked, while Stearns reminded Hamburg  that she was under oath.

Joyce Lovelace spoke about her husband Eddie, who died from fungal meningitis in September after receiving a tainted steroid injection, saying she wanted “people to know what kind of person has perished because of their lack of concern.”

“My family is bitter. We are angry. We are heartbroken. We’re devastated and I just come here begging you to do something about the matter,” Lovelace said. “It was a nightmare to see this man who was perfectly healthy one moment and then just so quickly going downhill and everything the doctors were doing for him was to no avail. The medicine, whatever they did, it was not helping him in the least.”

Lovelace begged the committee to “legislate this.”

“Whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life, cost my family…It may not appear to be anything to you, but you are affecting valuable human lives,” she said. “I cannot beg you enough. Bi-partisan. I don’t care what party, work together and please legislate this so no family has to go through what we have.”

Copyright 2012 ABC News Radio


Meningitis Outbreak: Minnesota Woman Sues Pharmacy

Jared Wickerham/Getty Images(SHAKOPEE, Minn.) -- A Minnesota woman is the first person to sue the compounding pharmacy at the center of a fungal meningitis outbreak that has claimed 14 lives.

In a class action filed Thursday in U.S. District Court, Barbe Puro of Shakopee, Minn., claimed she developed symptoms of meningitis after receiving a spinal injection of methylprednisolone acetate tainted with fungus.

The drug, a steroid used to treat back and joint pain, was made by the New England Compounding Center in Framingham, Mass. Fifty sealed vials of the drug, obtained by the U.S. Food and Drug Administration, were found to contain fungus. The company has recalled all its products and shut down operations.

Calls to the compounding pharmacy were not immediately returned, and its website is down.

Puro is one of roughly 14,000 people believed to have been exposed to the suspect steroid. The U.S. Centers for Disease Control and Prevention confirmed that 169 people in 11 states have contracted fungal meningitis after spinal injections of the steroid. One person has contracted a joint infection after receiving an injection for ankle pain.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

Puro claimed she received a spinal steroid injection Sept. 17 and developed headaches and nausea -- subtle symptoms of fungal meningitis. The following week, she received a call from the clinic that administered the shot, saying she might be at risk for fungal meningitis. The results of her spinal tap, a diagnostic test for meningitis, are pending, according to the lawsuit.

Puro filed the class action on behalf of all patients in Minnesota who received the recalled steroid. So far, the state has three known cases of infection and no reported deaths. Infections have also been reported in Tennessee, Michigan, Virginia, Indiana, Maryland, Florida, North Carolina, Ohio, New Jersey and, most recently, Idaho.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he said, adding that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

People affected by the current outbreak are being treated with two different types of antifungal medications until the type of fungus causing the infection -- aspergillus or exserohilum -- can be identified.

The CDC has confirmed one case of aspergillus meningitis and 10 cases of exserohilum meningitis. It's unclear how the fungi landed in the steroid vials.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Puro claims the New England Compounding Center "was negligent because it failed to use reasonable care when it designed, tested, manufactured, marketed and sold doses of methylprednisolone acetate," and that she and others who received the recalled drug have "suffered serious bodily harm, other personal injuries and emotional distress, and have incurred medical and other expenses." She is seeking compensation for damages, attorney fees and other costs.

Copyright 2012 ABC News Radio


FDA: Beware Buying Prescription Drugs Online

iStockphoto/Thinkstock(WASHINGTON) -- A moving target of as many as 40,000 active online pharmacies, a huge majority of them fly-by-night start-ups, may sell products at a cut-rate price but they may also deliver expired, contaminated and fake drugs that can harm consumers, the FDA said Friday.

"You have no guarantee of the safety, efficacy or quality of those products," Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, told ABC News. "You want to go to an online pharmacy that is licensed, located in the United States, [and] importantly, that will ask for a prescription from a doctor."

On Friday, the FDA launched BeSafeRx, a national campaign to alert consumers to the possible dangers of buying pharmaceuticals online.

"This a real problem. In fact, it is a growing problem, it is a problem that we are doing everything we can ... to try and protect the safety and security of the drug supply chain," Hamburg said. "The consumers have a role to play, as well, and that's why we want them to be informed about how to recognize a safe and legal online pharmacy so they can get those drugs that they really do need."

In May, the FDA surveyed more than 6,000 adults and found that almost a quarter of Internet shoppers bought prescription drugs online, and three in 10 said they weren't confident they could do so safely.

What many consumers don't realize is they are more likely online to get fake drugs that are contaminated or past their expiration date, or contain no active ingredient, the wrong amount of active ingredient or even toxic substances such as arsenic and rat poison.

They could sicken or kill people, cause them to develop a resistance to their real medicine, cause new side effects or trigger harmful interactions with other medications being taken.

Just how easy is it to set up an online pharmacy?

Two University of California, San Diego medical researchers showed ABC News how they set up their own fake drug store using search engines, Facebook and Twitter to draw potential buyers, and no pharmaceutical degree or any medical license, is required to set up any of these websites.

Timothy Mackey, a doctoral student in the joint doctoral program between San Diego State University and the University of California, San Diego created a fake pharmacy in less than 15 minutes and for less than $80.

"We basically created a Web app which is very descriptive and has a medical professional, a picture of a person that we just purchased, and we were able to post it online without any verification or requirements at all," Mackey said.

A hit-and-run pharmacy is lightning fast to start and even faster to disappear -- all before authorities can catch up.

"The bad guys know when they're getting chased, so they just shut down with a minute, and then literally within another hour they've set themselves right back up again," said Brian Liang, head of the Center for Patient Safety at the University of California, San Diego School of Medicine. "What it's telling us is that there's clearly no enforcement, and Facebook and others in this space are making money off of illicit drug sales."

Liang and Mackey said their mock sites saw more than 1,000 unique users in the 10 months they were active. The outgoing links they included went to a "dead page," and they did not actually sell any pharmaceuticals.

While there are some legitimate online pharmacies, about two percent according to the Alliance for Safe Online Pharmacies, how can you tell which are legitimate and which are fake?

According to the FDA, watch out for sites that ...

1. ... allow you to buy drugs without a prescription;
2. ... offer deep discounts that seem too good to be true;
3. ... send unsolicited emails offering cheap drugs;
4. ... are located outside of the United States, beyond the reach of regulators.

"If you find out about the website because of spam or unsolicited email, be very, very careful," Hamburg said. "If the price is bedrock cheap and it seems too good to be true, it probably is too good to be true. And if it is not located in the United States and it's offering to ship drugs worldwide, another red flag; don't go there."

Liang added that when they were searching for online pharmacies, the first 10 pages of hits was comprised entirely of fake pharmacies, and they did not come to a legitimate site until page 10 in the Google search results.

The new "BeSafeRx" website allows consumers to check a pharmacy's license through state boards of pharmacy, as well as providing tips for shopping online and seeing the signs of a fake pharmacy.

"We want consumers to be able to get safe, effective, high-quality drugs," Hamburg said. "And if they want to order them online that is terrific, but use a safe and legal online pharmacy."

"The important messages," Hamburg added, "are have a prescription, know your online pharmacy, make sure it is safe and take your medication as directed."

The National Association of Boards of Pharmacy also recommends only using Internet pharmacies accredited through Verified Internet Pharmacy Practice Sites or Vet-VIPPS program. It also provides a listing of "Not Recommended Sites."

Copyright 2012 ABC News Radio


You Say ‘Durezol,’ I Say ‘Duresal’ -- FDA Warns of Drug Mix-Ups

Comstock/Thinkstock(WASHINGTON) -- If you want the prescription eye drops called Durezol, make sure your pharmacist doesn’t hand you a bottle of the salicylic acid-containing wart remedy Duresal.

At least one patient has been seriously injured in just such a mix-up, according to a warning to pharmacists and health care professionals the U.S. Food and Drug Administration issued Wednesday. And according to the FDA, several other cases of confusion between the two drugs have been reported, likely as a consequence of the similarities between the names of the two very different drugs.

It’s far from the first time similar names have led to confusion and drug mix-ups, and it’s unlikely to be the last. After all, in the sea of drugs available to treat everything from your anemia to your zygomycosis, there are bound to be some names that resemble each other. The FDA, as part of the drug approval process, screens the names of these medications in an effort to ensure that they don’t sound too much like an existing medicine.

In this case, however, Durasal was never required to undergo the FDA’s drug approval process; subsequently, its name was never vetted. To make matters worse, Durasal entered the market shortly after the FDA had already approved Durezol.

It may also be worth noting that the packaging for Durasal, displayed on the National Institute of Health’s DailyMed site, includes the warning “NOT FOR USE IN EYES” in its design.

As of Wednesday, Elorac, Inc. -- the Vernon Hills, Ill.,-based distributor of Durasal -- had not yet responded to inquiries from the FDA regarding the removal of the product from the marketplace or its recall. A message left with Elorac on Thursday afternoon requesting comment was not immediately answered.

It’s safe to say that similar-name issues have dogged regulators for years. In 2002, the FDA issued a report detailing six cases of children who were prescribed methylphenidate, a drug to treat attention-deficit disorder, receiving methadone, a drug to treat narcotic addiction, instead.

In 2004, the FDA issued a similar report after four patients who were supposed to receive the anti-seizure pill Keppra instead received the HIV drug Kaletra.

And in 2010, manufacturers of the popular antacid medication Kapidex renamed their product at the FDA’s request, in light of its confusion with the prostate cancer drug Casodex. This name change was part of an FDA crackdown that began last year on the long list of drugs with similar-sounding names.

Past FDA efforts include the agency’s 2001 launch of the Name Differentiation Project, during which the manufacturers of 16 drugs were encouraged to add “Tall Man” lettering to labels for the syllables that differentiated one drug from another. Pretty important, if you happen to be taking MethylPREDNISolone for your allergies and your pharmacist hands you MethylTESTOSTERone, an anabolic steroid instead.

Copyright 2011 ABC News Radio


Pharmacy Errors: Swallowing the Wrong Pill

Comstock/Jupiterimages/Thinkstock(WASHINGTON) -- Have you ever left the doctor’s office not remembering exactly which medication your doctor prescribed and later, whether the pharmacist got it right?

Names like Darvan and Diovan can sound the same. But one is a pain reliever while another is used to treat high blood pressure. And when a pharmacy gives one of the medications to a patient who really needs the other, it could lead to some serious consequences.

Anecdotal evidence suggests that this problem is more common than believed, especially since there are various ways to fill prescriptions, including in-store and online. But there’s no formal method used to track pharmacy errors, according to Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality.

Besides medications that may sound or look alike, other factors can contribute to the wrong prescription getting filled.

Reading a doctor’s handwriting may be just as difficult for some pharmacists as it is for patients. And because some prescriptions are filled with the cheaper generic alternative of a prescribed brand name drug, it’s difficult for many patients to tell whether they’re receiving the correct substitute.

Most pharmacies don’t report prescription errors because they’re not required to. Neither the federal government nor most states in the U.S. have laws requiring that drugstores report prescription errors, even if the cases lead to serious complications or death.

“Pharmacies consider even one prescription error to be one too many,” said Chrissy Kopple, spokeswoman for the National Association of Chain Drug Stores. “Recognizing that human error is a possibility in any profession, pharmacies constantly pursue opportunities to improve safety.”

Scanning technology is used in some instances to verify that the medication that has been prescribed matches the medication that’s dispensed. Also, the use of electronic prescribing is on the rise, which can potentially reduce the risk of errors from prescribers’ handwriting and from incorrectly entering prescription information.

But until these technologies catch on, both pharmacists and patients should create their own checks and balances to make sure the right medication gets into the right hands, said Kopple.

The Agency for Healthcare Quality and Research offers a few tips that consumers can use to lower the chance of  pharmacy errors:

When your doctor writes a prescription for you, make sure you can read it.

When you pick up your medicine from the pharmacy, ask the  pharmacist if this is the medicine that your doctor prescribed.

Open the bag containing your medication container and make sure the medicine matches your prescription, and your name is on the container.

Make sure you understand how to properly take the medication -- ask your pharmacist about how much medication to take, when, and whether you should expect to experience any side effects.

Copyright 2011 ABC News Radio


Electronic Prescribing Systems Make Mistakes, Too

Jupiterimages/Thinkstock(BOSTON) -- Electronic prescribing systems are capable of the same mistakes made by manual systems, a study from the Massachusetts General Hospital found.

After looking at 3,850 computer-generated prescriptions submitted to a pharmacy chain in three U.S. states over a month period, researchers found that nearly 12 percent contained a shocking total of 466 errors.  One-third of these errors could be considered potentially harmful.  The researchers reported, however, that none of the errors was life-threatening.

The study authors said the most common types of drugs related to the computer prescriptions were nervous system drugs (27 percent), cardiovascular drugs, (13.5 percent) and anti-inflammatories/antibiotics (12.3 percent).  

Authors of the study, published in the online Journal of the American Medical Informatics Association, concluded that although health care providers are increasingly adopting electronic health records and prescribing devices, the use of "a computerized prescribing system without comprehensive functionality and processes in place to ensure meaningful use the system does not decrease medication errors."

Copyright 2011 ABC News Radio

ABC News Radio